RPF-III

Development of HACCP procedures for the production of soy based foods and their evaluation

Project No: 583
ICAR Code: PI-2007/6-IAE.Q00 Institute Code: CIAE/PHT/SPU/2007-6 Period: April 2007 to March 2009

Dr.A.P.Gandhi
Principal Scientist (Biochemistry)

Soybean Processing and Utilization Center

Central Institute of Agricultural Engineering Nabi Bagh, Berasia Road Bhopal-462038 (MP)

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RPF-III 1. Project No: 2. Institute Code No: 3. ICAR Code No: 583
CIAE/PHT/SPU/2007-6 PI-2007/6-IAE.Q00

4. Name and address of the Research Institute: Central Institute of Agricultural Engineering, Bhopal. 5 Title of the project: Development of HACCP procedures for the production of Soy based foods and their evaluation. 6. Title of the sub project: Nil 7. Name and designation of the leader: 8 Name(s) and designation(s) Project Leader and associate(s) together with time proposed to be spent and work to be done Sl. No 1 Name Dr.A. P.Gandhi Designation Principal Scientist (Biochemistry) Time to be spent 25% Work to be done Drafting of process flow sheets, preparation of HACCP charts, evaluation of production processes and report writing. Dr. A.P. Gandhi Principal Scientist (Biochemistry)

9. Location of the research project with complete address: Soybean Processing and Utilization Center, Central Institute of Agricultural Engineering, Bhopal. 10. (a) Objectives: i. To develop HACCP procedures for the production of different soy based foods.

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ii. To test the developed procedures with a few soy-based foods such as full fat soy flour, soy milk, soy paneer (tofu), soy nuts and soy sprouts. iii. To document the developed procedures and final report writing. (b). Practical utility All the aspects of food quality and safety through out each stage of food production, storage, and transportation, processing and marketing are very important. Hence food quality and safety assurance programmes include specific food risk control procedures such as Hazard Analysis and Critical Control Point (HACCP). HACCP systems can only be effective when they are a part of a broader food quality and safety programme based on the General Principles of Food Hygiene and Good Manufacturing Practices. HACCP has become synonymous with food safety. It is now recognized world wide a systematic and preventive approach that addresses biological, chemical and physical hazards through anticipation and prevention, rather than through end-product inspection and testing. These controls are internationally recognized as essential to ensuring the safety and suitability of food for human consumption and international trade. However such HACCP procedures are not available for soy based foods which are getting importance now days. Hence there is a need to develop these action plans for all the soy foods. In the present investigation, efforts will be made to draft HACCP procedures for different soy based foods. 11. (a). Technical program The drafting of procedures include the identification of hazards and control measures, determination of critical control points, preparing the decision tree, establishing the critical limits and marketing procedures, finding the corrective action, responsibilities and verification procedures and preparation of HACCP chart documentation and record keeping for the soy based foods. Flour (Full fat soy flour and medium fat soy flour). Soymilk and analogs (Soymilk (Plain) and, Soy paneer)

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Fermented foods (Tempeh and soy sauce) Bakery products (Cookies and bread) Soy nuts Soy sprouts Soy protein isolates

(b). Observations to be recorded: Protocols of HACCP for identified critical controls, product quality assessment and comparison with the traditional processes using the standard procedures. 12 Date of start 13. Date of completion April 2007 March 2009

14 Final report of the Project

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14.1 Review of literature

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About 840 million people were undernourished and 799 millions were from the developing countries. In India 233.3 millions were under nourished comprising about 24% of the total population (FAO, 2002). Hence there is every need to save millions of lives every year. This can be combated through dietary diversity and food fortification along with supplements. In this context soybean (Glycine max M) with 40% protein and 20% fat assumes the most predominant position in solving the nutritional imbalances prevailing. It not only provides the quality macronutrients but also various other micronutrients, which are otherwise required to fight against the hidden hunger.

Efforts are being made to popularize various soy-based foods besides the oil, which is very popular in India. In India about 9.3 million tones of soybeans are produced annually and 80% is utilized for oil extraction. Only 10% is available for direct food uses (Gandhi, 2006). The extruded soy chunks are very popular but too expensive and beyond the reach of a common man. Among various foods full fat soy flour is having a

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great potential, as it can be prepared at domestic level using the assets available. Simple methods were developed and scaled up for the production of a number of soy-based products by the investigator. Now with the introduction of food quality and safety systems HACCP has become synonymous with food safety. (FAO 1995). It is a world wide recognized systematic and preventive approach that addresses biological, chemical and physical hazards through anticipation and prevention rather than through end-product inspection and testing. Prior to application of HACCP the production of soy based should be according to Codex General Principles of Food Hygiene, the appropriate Codex Codes of practice and appropriate food safety legislation. Management commitment is necessary for implementation of an effective HACCP system. Hazard Analysis Critical Control Point: The very beginning The HACCP as it applies to food is considered to be a food safety management system using the approach of controlling critical points in food handling to prevent food safety problems. It is a system, which can be used to assure food safety at all levels of food handling, and is an important element in the overall management of food quality and safety more commonly referred to as Good Manufacturing Practices (GMP). The HACCP concept was developed in late 1960s as a quality assurance system to enhance food safety. The basic principles underlying the concept were not new, but the introduction of HACCP signaled a shift in emphasis from resource intensive end product inspection and testing to preventive control of hazards at all stages of food production. HACCP was initially developed by the food industry for use by food processors to prevent or control hazards, there by improving food safety. The application of HACCP system has been evolving and expanding to form a basis for official food control and for establishing food safety standards for the international trade as well. HACCP is considered to be one of the most effective ways to enhance food safety. Recognizing the importance HACCP to Food Control, the twentieth session of the codex Alimentarius Commission (CAC) held in Geneva 28 June to July 1993, adopted “Guidelines for the application of the Hazard Analysis Critical Control Point (HACCP) System.

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The food industry has traditionally ensured the quality of its products by employing the inspection and test methods managed under the banners of quality assurance and quality control. The evolution of food industry and the explosion of food poisoning out breaks made apparent and imperative the need for improved and more exhaustive controls over quality and safety. The need for a systematic approach to the production of food that meets the criteria of quality, safety and wholesome ness were addressed by the development of the ISO 9000 series and the HACCP system (Barendsz, 1998). The Pillsbury Corporation, with the participation of NASA and the US Army Natick Laboratories, first introduced the concept of the HACCP system in USA in 1959. The main stimulus for devising the HACCP system was the development of a preventive system for the production of foods with a high degree of safety, which is extremely crucial for a space mission (Pieson and Corlett, 1992). Principles of the HACCP system The HACCP consists of seven principles namely conducting a hazard analysis, determining the critical control points, establishing critical limit(s), identifying a system to monitor control of CCP, proposing the corrective action to be taken when monitoring indicates that a particular CCP is not under control, finding procedures for verification to confirm that the HACCP system is working effectively and finally put forth documentation concerning all procedures and records appropriate to these principles and their application. It enables the industry to establish a close relationship with consumers, which eventually contributes to the improvement of food quality and deals with legislative problems related to the internal quality standards of a firm (Arvanitoyannins and Hadjicostas, 2001). How ever prior to HACCP implementation it often proved very advantageous that several prerequisite programs, such as Total Quality Management (TQM), ISO 9000/ ASQ 9000 and BS 5750 and Good Manufacturing Practice (GMP) had already been in place. TQM is the most comprehensive approach towards improving competitiveness, effectiveness and flexibility through planning, organizing and understanding each activity

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at each level. On several occasions, TQM can comprise ISO 9000.ASQ 9000, which include management responsibility, design and document control, purchasing, identification, checking incoming materials, intermediate products and end products, non conforming products, quality records, audits and reviews, training, servicing and statistical techniques (Oakland, 1993; Ishikawa, 1989; Jouve, 1998). The problems that might appear in the food industry are caused by several factors such as the low quality raw, packaging and other materials used in the food processes, inappropriate methods adopted in the food production such as measurement systems, inadequate and/or unacceptable environmental conditions (contaminated or polluted environment)(Bonnel, 1994). The topic that became the subject of a long debate, especially recently, is the exact definition of the term quality. Many different aspects were put forward, ranging from consumer related statements to sensory definitions, concluding that the meaning of quality varies according to the group of people asked. However, it is realistic to define it as the measurement of whether a product meets the consumers’ expectations. HACCP has been evolving through the last four decades. In 1971, the system was outlined for the first time, further elaborated by ICMSF in publications for WHO and finally published in a book in 1988(Huss, 1992). In general HACCP system is a new preventive approach to food control to be tailored for each specific case. HACCP focuses only on the necessary things required from the plant management to be more concerned with the process rather than the finished product and it requires study and investigation. It cannot be emphasized often enough that any avoidable contamination of raw products un necessarily increases the severity of processing and annihilates all previous efforts. Therefore the prevention of contamination referred as sanitation is essential at all stages. However like any other system HACCP has some vulnerable points and they may be the major drawbacks for its non-international during recent years. A brief description of some of the suspicious areas of the HACCP concept is the following:

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• • • • • • • • •

Non uniform understanding of HACCP both nationally and internationally due to lack of an internationally accepted definition of the system. Disagreement among the different Institutions about what constitutes the hazard. Need for implementing HACCP through out the whole production process from raw material to consumption. Need for establishing the mutual trust between the government and the industry. Lack of coordination among the responsible authorities, public and private sectors. Regulations and procedures that are not very fruitful. Insufficient education and motivation of consumers and food handlers on food protection task. It has been shown in several cases that the appropriate implementation of HACCP is quite lengthy procedure. Efficiency of the system is frequently low, due to lack of political will and commitment, un willingness of industry representatives and over lapping of several institutions.

On the other hand HACCP becomes increasingly appealing considering that industry can acquire many benefits from implementation, such as productivity increase, waste decrease, developing a responsible personnel and motivating raw material suppliers to comply with sanitary measures. Food safety in today’s’ world is paramount. HACCP programmes go a long way to ensuring this. We rely on food to nourish and sustain us. We want food that is appealing and pleasurable to eat. We need food that will not cause us injury or illness or severe cases cause death. There are members of our communitythe young, the not so young, the immunocompromised and those who are susceptible to allergies and intolerances that rely on us in the food industry to supply them with safe food. May our efforts be not in vain as we meet this responsibility each day?

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PRINCIPLES OF THE HACCP SYSTEM The HACCP system consists of the following seven principles: PRINCIPLE 1 Conduct a hazard analysis. PRINCIPLE 2 Determine the Critical Control Points (CCPs). PRINCIPLE 3 Establish critical limit(s). PRINCIPLE 4 Establish a system to monitor control of the CCP. PRINCIPLE 5 Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control. PRINCIPLE 6 Establish procedures for verification to confirm that the HACCP system is working effectively. PRINCIPLE 7 Establish documentation concerning all procedures and records appropriate to these principles and their application. GUIDELINES FOR THE APPLICATION OF THE HACCP SYSTEM Prior to application of HACCP to any sector of the food chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety legislation. Management commitment is necessary for implementation of an effective HACCP system. During hazard identification, evaluation, and subsequent operations in designing and applying

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HACCP systems, consideration must be given to the impact of raw materials, ingredients, food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, categories of consumers of concern, and epidemiological evidence relative to food safety. The intent of the HACCP system is to focus control at CCPs. Redesign of the operation should be considered if a hazard, which must be controlled, is identified but no CCPs are found. HACCP should be applied to each specific operation separately. CCPs identified in any given example in any Codex Code of Hygienic Practice might not be the only ones identified for a specific application or might be of a different nature. The HACCP application should be reviewed and necessary changes made when any modification is made in the product, process, or any step. It is important when applying HACCP to be flexible where appropriate, given the context of the application taking into account the nature and the size of the operation. APPLICATION The application of HACCP principles consists of the following tasks as identified in the Logic Sequence for Application of HACCP (Figure 1). 1. Assemble HACCP team The food operation should assure that the appropriate product specific knowledge and expertise is available for the development of an effective HACCP plan. Optimally, this may be accomplished by assembling a multidisciplinary team. Where such expertise is not available on site, expert advice should be obtained from other sources. The scope of the HACCP plan should be identified. The scope should describe which segment of the food chain is involved and the general classes of hazards to be addressed (e.g. does it cover all classes of hazards or only selected classes). 2. Describe product A full description of the product should be drawn up, including relevant safety information such as: composition, physical/chemical structure (including Aw, pH, etc.), microcidal/static treatments (heat-treatment, freezing, brining, smoking, etc.), packaging, durability and storage conditions and method of distribution. 3. Identify intended use The intended use should be based on the expected uses of the product by the end user or consumer. In specific cases, vulnerable groups of the population, e.g. institutional feeding, may have to be considered.

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4. Construct flow diagram The HACCP team should construct the flow diagram. The flow diagram should cover all steps in the operation. When applying HACCP to a given operation, consideration should be given to steps preceding and following the specified operation. 5. On-site confirmation of flow diagram The HACCP team should confirm the processing operation against the flow diagram during all stages and hours of operation and amend the flow diagram where appropriate. 6. List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards. (SEE PRINCIPLE 1) The HACCP team should list all of the hazards that may be reasonably expected to occur at each step from primary production, processing, manufacture, and distribution until the point of consumption. The HACCP team should next conduct a hazard analysis to identify for the HACCP plan, which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of a safe food. In conducting the hazard analysis, wherever possible the following should be included:
• • • • •

the likely occurrence of hazards and severity of their adverse health effects; the qualitative and/or quantitative evaluation of the presence of hazards; survival or multiplication of microorganisms of concern; production or persistence in foods of toxins, chemicals or physical agents; and, conditions leading to the above.

The HACCP team must then consider what control measures, if any, exist which can be applied for each hazard. More than one control measure may be required to control a specific hazard(s) and more than one hazard may be controlled by a specified control measure. 7. Determine Critical Control Points (SEE PRINCIPLE 2) There may be more than one CCP at which control is applied to address the same hazard. The determination of a CCP in the HACCP system can be facilitated by the application of a decision tree (Figure 2), which indicates a logic reasoning approach. Application of a decision tree should be flexible, given whether the operation is for production, slaughter, processing, storage, distribution or other. It should be used for guidance when determining CCPs. This example of a decision tree may not be applicable to all situations. Other approaches may be used. Training in the application of the decision tree

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is recommended. If a hazard has been identified at a step where control is necessary for safety, and no control measure exists at that step, or any other, then the product or process should be modified at that step, or at any earlier or later stage, to include a control measure. 8. Establish critical limits for each CCP (SEE PRINCIPLE 3) Critical limits must be specified and validated if possible for each Critical Control Point. In some cases more than one critical limit will be elaborated at a particular step. Criteria often used include measurements of temperature, time, moisture level, pH, Aw, available chlorine, and sensory parameters such as visual appearance and texture. 9. Establish a monitoring system for each CCP (SEE PRINCIPLE 4) Monitoring is the scheduled measurement or observation of a CCP relative to its critical limits. The monitoring procedures must be able to detect loss of control at the CCP. Further, monitoring should ideally provide this information in time to make adjustments to ensure control of the process to prevent violating the critical limits. Where possible, process adjustments should be made when monitoring results indicate a trend towards loss of control at a CCP. The adjustments should be taken before a deviation occurs. A designated person with knowledge and authority to carry out corrective actions when indicated must evaluate data derived from monitoring. If monitoring is not continuous, then the amount or frequency of monitoring must be sufficient to guarantee the CCP is in control. Most monitoring procedures for CCPs will need to be done rapidly because they relate to on-line processes and there will not be time for lengthy analytical testing. Physical and chemical measurements are often preferred to microbiological testing because they may be done rapidly and can often indicate the microbiological control of the product. All records and documents associated with monitoring CCPs must be signed by the person(s) doing the monitoring and by a responsible reviewing official(s) of the company. 10. Establish corrective actions (SEE PRINCIPLE 5) Specific corrective actions must be developed for each CCP in the HACCP system in order to deal with deviations when they occur. The actions must ensure that the CCP has been brought under control. Actions taken must also include proper disposition of the affected product. Deviation and product disposition procedures must be documented in the HACCP record keeping.

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11. Establish verification procedures (SEE PRINCIPLE 6) Establish procedures for verification. Verification and auditing methods, procedures and tests, including random sampling and analysis, can be used to determine if the HACCP system is working correctly. The frequency of verification should be sufficient to confirm that the HACCP system is working effectively. Examples of verification activities include:
• • •

Review of the HACCP system and its records; Review of deviations and product dispositions; Confirmation that CCPs are kept under control. Where possible, validation activities should include actions to confirm the efficacy of all elements of the HACCP plan.

12. Establish Documentation and Record Keeping (SEE PRINCIPLE 7) Efficient and accurate record keeping is essential to the application of a HACCP system. HACCP procedures should be documented. Documentation and record keeping should be appropriate to the nature and size of the operation. Documentation examples are:
• • •

Hazard analysis; CCP determination; Critical limit determination.

Record examples are:
• • •

CCP monitoring activities; Deviations and associated corrective actions; Modifications to the HACCP system.

(Figure 3) TRAINING Training of personnel in industry, government and academia in HACCP principles and applications, and increasing awareness of consumers are essential elements for the effective implementation of HACCP. As an aid in developing specific training to support a HACCP plan, working instructions and procedures should be developed which define the tasks of the operating personnel to be stationed at each Critical Control Point. Cooperation between primary producer, industry, trade groups, consumer organizations,

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and responsible authorities are of vital importance. Opportunities should be provided for the joint training of industry and control authorities to encourage and maintain a continuous dialogue and create a climate of understanding in the practical application of HACCP.

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Figure-1 LOGIC SEQUENCE FOR THE APPLICATION OF HACCP

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Figure 3. A HACCP WORKSHEET

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14.2 MATERIALS AND METHODS The soybean variety JS 335 was obtained from the Institute Farm. It was cleaned thoroughly and made free from all the dirt, stubbles and other foreign matter. It was stored in airtight containers till further use. Various soy-based foods were prepared using the procedures developed by the investigator at this Center since 1979.AOAC (1990) methods were used for analyzing various chemical constituents and APHA (1984) recommended methods were used for microbiological examination of the products. All the chemicals used were of the analytical grade and the experiments were conducted in triplicate and the mean values were computed for assessment. FAO/WHO (2006) guidelines were used for the preparation of HACCP plans.

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SOY BASED FOODS

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15. RESULTS AND DISCUSSION The HACCP protocols were prepared for making various soy based foods and the details were as under:

Full Fat Soy flour:
Table 1.Product description 1. Product name Full Fat Soy flour 2. Important product characteristics of end Aw < 0.5;FFA < 1%; Total microbial counts product < 50000/g 3. How the product is to be used Normally fortified with other cereals/millets/pulses at 10-15% level in the preparation of traditional recipes. 4. Packaging Sealed polythene bags/ hermetically sealed metal containers. 5. Shelf-life One month at normal retail shelf temperatures. 6. Where the product will be sold Retail, institutions and food service. Could be consumed as a health food. 7. Labeling instructions Required to ensure product safety. 8. Special distribution control No physical damage, excess humidity or temperature extremes.

Full Fat Soy flour

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Figure-1 Plant Schematic/Floor Plan

Preparatory Area Silos/Storage Bins

Wet Processing Area

Dry Processing Area Dryers

Soaking in vats

Cleaners Milling Equipment Blanching Dehuller Sifters Retorts/Boilers

Filling/Weighing/Sealing

Transport

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Hazard identification: Biological Hazards Food borne biological hazards include microorganisms such as bacteria, viruses, fungi and parasites. These organisms are commonly associated with humans and with raw products entering the food establishment. Many of these microorganisms occur naturally in the environment where foods are grown. Most are killed or inactivated by cooking and numbers can be minimized by adequate control of handling and storage practices (hygiene, temperature and time). Pathogenic bacteria cause the majority of reported food borne disease outbreaks. A certain level of these organisms can be expected with raw soybeans. Improper storage and handling can contribute to a significant increase in the level of these microorganisms. Viruses can be food borne, water borne or transmitted to food by human, animal or other contact. Unlike bacteria, viruses are unable to reproduce outside a living cell. They cannot therefore replicate in food, and can only be carried by it. Fungi include moulds and yeasts. Fungi can be beneficial as they can be used in the production of certain foods (e.g. cheese). However some fungi produce toxic substances (mycotoxins), which are toxic for humans and animals. Examples Bacteria (spore forming) Clostridium botulinum Clostridium perfrigens Bacillus cereus Bacteria (non spore forming) Brucella abortis Brucella suis Campylobacter spp Pathogenic Escherichia coli Listeria monocytogenes Salmonella spp (S.typhimurium, S.enteriditis) Shigella (S.dysenteriae) Staphylococcus aureus Streptococcus pyogenes

Viruses Hepatitis A and E Norwalk virus group Rotavirus Protozoa and parasites Cryptosporidium parvum Diphyllobothrium latum Entamoeba histolytica Giardia lamblia Ascaris lumbricoides Taenia solium Taenia saginata Trichinella spiralis

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Vibrio cholerae Vibrio parahaemolyticus Vibrio vulnificus Yersinia enterocolitica Chemical hazards Chemical contaminants in food may be naturally occurring or may be added during the processing of food. Harmful chemicals at high levels have been associated with acute cases of food borne illnesses and can be responsible for chronic illness at lower levels. Examples: Naturally occurring chemicals Allergens Mycotoxins Added chemicals Polychlorinated biphenyls (PCBs) Agricultural chemicals • Pesticides • Fertilizers • Antibiotics • Growth hormones Prohibited substances • Direct • Indirect

Toxic elements and compounds Lead Zinc Cadmium Mercury Arsenic Cyanide Food additives Vitamins and minerals Contaminants o Water or steam treatment chemicals o Pest control chemicals From packaging materials Plasticizers Vinyl chloride Printing/coding inks Adhesives

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Physical hazards The physical hazards can result from contamination and / or poor practices at many points in the food chain from harvest to consumer including those with in the food establishment. Examples Glass, wood, stones, metal, plastic etc. Table 2.Product ingredients and incoming material Raw material Soybeans B, C, P Other Water (municipal) B, C Table 3.Flow diagram Soybeans 1. Receiving P 5.Storing B P 8. Cleaning P 11. De hulling P 12. Soaking B C 14. Blanching B C 15.Drying B P C 16. Milling B P C Packaging material 2.Receiving P 6.Storing B C P 9.Inspecting B P Dry ingredients 3. Receiving P 7. Storing B C P 10. Dumping Water 4. In taking Packaging material Polythene bags B, C, P Dry ingredients Sodium bicarbonate B, C, P

13. Chlorinating 17.Filling C P 18.Weighing B 19.Closing/sealing B 20.Inspecting B P 21. Labeling B 22. Storing B 23.TransportB

P=physical; B=biological; C=chemical

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HAZARD IDENTIFICATION: BIOLOGICAL HAZARDS Identified Biological Hazards Ingredients/materials: Soybeans - could contain soil borne/ air borne pathogenic organisms, yeasts or moulds. Dry ingredients - could contain microbial contaminants. - could contain rodent excrements. Water - could contain microorganisms Packaging materials - could contain defects that could result in leakage. Processing steps: Dehulling Soaking Blanching Drying Weighing Transport physical damage to packages results in leakage and contamination of product. overfilling may lead to leakage and prone to contamination. could be contaminated with microorganisms. could contain heat resistant spores. could contain microorganisms. could be contaminated with microorganisms.

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HAZARD IDENTIFICATION: CHEMICAL HAZARDS Identified Chemical Hazards Ingredients/materials: Soybeans - could contain pesticide residues. - could contain mycotoxins. Water - could be contaminated with toxic substances. Processing steps: Dry ingredients storage - could be contaminated with non-food chemicals as a result of improper storage. Blanching cleaning chemical residues could contaminate the beans. if live steam is used, boiled water additives could carry over and contaminate the product.

HAZARD IDENTIFICATION: PHYSICAL HAZARDS Identified Physical Hazards: Ingredients/ materials Soybeans could be contaminated with harmful extraneous materials namely glass, metal, plastic, wool etc. Dry ingredients - could be contaminated with harmful extraneous materials Soybean receiving inadequate protection against harmful extraneous material could result in contamination. -

Dry ingredient receiving in adequate protection against harmful extraneous material could result in contamination.

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Table 4.CCP determination: Process Category Q1 step/incoming and materials identified hazard Soybeans B=Pathogens Yes C=Pesticides Q2 Q3 Q4 CCP

Yes

Yes

Yes, thermal processing

Packaging materials Dry B= bacterial Yes ingredients as spores delivered B=rodent excretes (GMP) P=HEM (GMP) Water at B= GMP intake C= heavy metals & other toxins (GMP)

No (farmers/growers C= heat level-GPP) stable toxins No (farmers/growers P= harmful level-GPP) Yes extraneous material Yes (visual (HEM) inspection and foreign object removal) B=pathogens Yes Yes N/a

Yes

No

Yes Yes

Yes, sterilization Yes, thermal processing

Instructions: • Category and identified hazard: Controlled by Codex General Principles of Food Hygiene, if yes indicate GMP and proceed to next hazard. If no proceed to question 1. • Q1: Do control preventive measures exist, if no, not CCP; if yes proceed to next.

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• • •

Q2: Is this operation specifically designed to eliminate, if no proceed to Q3. if yes CCP and identify it in the last column. Q3: Could contamination with identified hazards occur in excess of acceptable levels, if no, not CCP. If yes Proceed to Q4. Q4: Will subsequent operation control the contamination levels, if no CCP; if yes not CCP.

Process Category Q1 step/incoming and materials identified hazard Cleaning and P=GMP grading of soybeans Dehulling of B Yes soybeans Soaking of Water soy splits (GMP) Sodium bi carbonates (0.5%) Blanching in B Yes water C Drying B C Yes

Q2

Q3

Q4

CCP

Yes

Yes

No

CCP-1 (Hulls %)

Yes

Yes

No

Yes

Yes

No

CCP-2 (time and temperature of water) CCP-3 (Moisture content and time allowed for drying)

Attrition Sifting Filling Weighing Packaging and sealing

B (GMP) P (GMP) P (GMP) P (GMP) B

Yes

Yes

Yes

No

CCP-4 (Proper gauge and sealing 30

clearance)

Instructions: • Category and identified hazard: Controlled by Codex General Principles of Food Hygiene, if yes indicate GMP and proceed to next hazard. If no proceed to question 1. • Q1: Do control preventive measures exist, if no, not CCP; if yes proceed to next. • Q2: Is this operation specifically designed to eliminate, if no proceed to Q3. if yes CCP and identify it in the last column. • Q3: Could contamination with identified hazards occur in excess of acceptable levels, if no, not CCP. If yes Proceed to Q4. Q4: Will subsequent operation control the contamination levels, if no CCP; if yes not CCP. Table 5.Unaddressed Hazards: Product: Full Fat Soy flour Unaddressed hazard from previous list Identified methods of addressing the hazard Soybeans could contain pesticide residues Up stream (farm level) programs such as A: Training persons who apply pesticides. B: Purchasing registered pesticides for growers. C: Auditing growers application of pesticides and records there of. D: Requiring periodic pesticide residual analysis reports. •

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Table 6.HACCP Plan Product name: Full Fat Soy Flour Process step Hazard description De hulling Inefficient de hulling may cause the contamination of the product with the microorganisms. Blanching/cooking In adequate heat treatment Critical Monitoring limits procedure Less than On line 0.1% check of the sample. Deviation procedures Line operator to adjust the clearance of the de huller drums. Operator should adjust the time and temperature as per the authorized contingency plan and to inform the QC. If moisture content is greater the splits may be dried again and inform QC Line operator to adjust the settings. HACCP records Operator log book

Cook the splits as specified in the scheduled process (under pressure/open vessel boiling) The moisture content should be less than 8%10%. Max fill weight as specified in the scheduled process. Proper sealing leaving recommended space.

Check the quality of splits for urease test

Operator logbook.

Drying (Sun/mechanical)

Improper drying

Check the moisture content as per the guidelines. On line check to reject over and under filled bags and improperly sealed bags.

Operators log book.

Packaging sealing

and Over filling, improper gauge polythene and improper sealing

Operators log book and quality control report.

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Table 7.HACCP for general activities: Stage Raw material harvest Activity Liaison with the farmers for unit operations like harvesting, threshing and winnowing. Transport in sacks to drying area. Sampling and routine inspection. Cleaning, grading, dehulling, conditioning and blending. Control activity Specifications of grain quality are required. Rejection of under sized seeds. Correct sacking and handling. Correct sampling methods, training and inspection methods. Training operators for equipment, preventing insect infestations, check for moisture content. Training in hygiene, implementation of cleaning, and assessment of product quality. Establish specifications for labels and fill weights.

Raw material transport Raw material inspection Preparation of seeds

Milling and sieving, Separation of components dehulling and expelling of seeds Packaging Filling in to containers and sealing.

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Description of full fat soy flour manufacturing process: Implementation of HACCP. Receiving soybeans (CCP-1): Soybeans must come from approved dealers. At the time of its receipt it must be accompanied with its complete quality certificate and microbiological assessment reports. The certificates should indicate the moisture content of the beans, degree of foreign materials and the microorganisms present (number of colonies), insects etc as compared to the upper approved standards of BIS/ISO. At the time of receipt, visual control of soybeans must be carried out to find out the contaminants if any. Further more the proximate composition of the beans must be established with reference to its macro and micronutrients. Defective beans mean that the soy flour will be most likely unsafe for the consumption. Storage of soybeans in silos (CCP-4): The temperature (<20oC) and the relative humidity (<65%) during the storage must be low. They should be recorded at regular intervals. If any deviation from the safer limits, must be immediately rectified. When soybean is stored for a long period, microbiological analysis should be carried out. Receiving secondary materials (greasing, detergents, insecticides, pesticides and sacs) (CCP-2): These materials must be procured from the approved suppliers with quality certificates. These materials must be suitable for using them with food items. No contamination must come from the packaging materials. If these materials do not comply with the standard specifications, must be returned to the suppliers and a new order should be placed with other suppliers. Storage of secondary materials (CCP-3): The temperature and relative humidity during storage must be below 20oC and 65% respectively. The place should be air-conditioned. The temperature and RH should be continuously recorded and corrective actions must be undertaken whenever any deviation occurs. Application of anti insect methods (CCP-5): Any chemicals used during storage along with the soybeans should comply with the safety legislations. The quantity should be with in the prescribed concentrations. Cleaning & grading of soybeans (CCP-6): All the physical contaminants should be removed. They should be graded. Only sound soybeans should be taken for processing.

34

Removal of stones: The stones, metals and dust must be removed from the soybeans so that the final product will comply the quality standards as prescribed by BIS/ISO. Weighing: the soybeans are weighed and passed through a magnetic system so that the magnetic materials are removed. Milling (CCP-7): The grinding is done in a burr/hammer mill. The clearance between the burrs should be adjusted so that the flour must be having particle size <140 micrometers. Similarly with the hammer mill, the sieve below the grinding system must allow flour particles less than 140 micrometers. The sieves should be of SS. The temperature during grinding should not rise too much, which affects the quality of the flour. Normally a temperature rise of less than 5oC is desirable. So arrangements must be made to maintain the temperature while grinding. Packaging (CCP-8): During packaging the flour can possibly be contaminated with the microorganisms causing quality deterioration. Hermetic sealing and upright position of the packaging material can avoid this. There should not be any migration of the low molecular weight substances from the packages. Further more contamination can take place from foreign materials like insects and rodents that accidentally happen to be packed with the flour. The personnel should comply with the GMPs. Storage of full fat flour (CCP-9): Both the temperature and relative humidity must be below 20oC and 65% respectively. They should be recorded and corrective actions must be taken when deviating. When the flour is stored for a long period, microbiological analysis is required. Metal detector (CCP-10): The packed product passes through a metal detector. The product is then checked for its weight and placed in boxes (secondary packaging). The boxes are placed on the pallets and the packets are wrapped with film.

35

Table 8.Quality Standard Expected: Composition: Protein: Fat: Crude Fiber: Ash: Moisture: Physical parameters: Granulation: Microbiology: Total plate count: Total coli forms: Salmonella: E.coli: Staphylococcus: Yeast: Mold: Protein solubility: TI: Urease activity: Available lysine: Sensory parameters: Color: Odor: Taste: Defects: Insect parts: Foreign material: Black specks: Total absence. Total absence. Total absence. Creamy to yellow Less beany Nutty 20,000/g max 100/10g max Negative/100g Negative/100g 100/10g maximum 100/10g maximum 100/10g max. PDI 20-80% less than 75% of original. Nil Min 5.5g/6g N 90% minimum pass thru US sieve 200(0.074 mm) a minimum of 35% a minimum of 18% a maximum of 4% a maximum of 6.5% a maximum of 10%

36

Table 9. Quality assessment of the Full Fat Soy Flour Quality standard expected Composition: Protein: a minimum of 35% Fat: a minimum of 18% Crude Fiber: a maximum of 4% Ash: a maximum of 6.5% Moisture: a maximum of 10% Physical parameters: Granulation: 90% minimum pass thru US sieve 200(0.074 mm) Microbiology: Total plate count: 20,000/g max Total coli forms: 100/10g max Salmonella: Negative/100g E.coli: Negative/100g Staphylococcus: 100/10g maximum Yeast: 100/10g maximum Mold: 100/10g max. Protein solubility: PDI 20-80% TI: less than 75% of original. Urease activity: Nil Available lysine: Min 123/10g 25% 50% Nil Nil 75% 80% Nil With out HACCP 35% 17% 5.2% 5.4% 10% 75% With HACCP 40% 20% 3.8% 6.3% 8% 95%

50,000/g 120/10g 10/100g 15/100g 135/10g 100/10g

10,000/g Nil Nil Nil Nil Nil

37

5.5g/6g N Sensory parameters: Color: Creamy to yellow Odor: Less beany Taste: Nutty Defects: Insect parts: Total absence. Foreign material: Total absence.

4.2g/6gN

6.2g/6gN

Yellow Beany Nutty Absent Absent

Creamy Less beany Nutty Absent Absent

38

Medium Fat Soy Flour
Medium fat soy flour is made entirely from soybeans through extrusion cooking and expelling a certain amount of oil from the extrudates. It is used as an important ingredient and supplement to cereal products (wheat/corn/rice). It can be used in a wide variety of products including bread, weaning foods, cereals, cookies, muffins, cakes, pastas and others. It is currently being used world wide by commercial processors. It is also a common ingredient in blended foods aid products. Soy fortified wheat flour etc. It can also be fortified with various micronutrients and minerals. Process Flow Chart for making MFSF Soybeans, 10%mc Cleaning Hulls Steam De hulling Preconditioning Splits with 40% mc Extrusion expelling (Temperature and time) Extrudate Fed to mechanical expeller (clearance, time &no of passes) Miscella Filtration Foots Filter oil (ready for use) Chemical Refining Refined oil Marc Drying/air cooling (temperature &time) Grinding (temp) Sifting (size) MFSF CCP-5 CCP-6 CCP-4 dirt, foreign matter CCP-1 CCP-2

CCP-3

39

Weighing &filling

Packaging Storage Table 11Product description 1. Product name Medium Fat Soy flour 2. Important product characteristics of end Aw < 0.5;FFA < 1%; Total microbial counts product < 50000/g, protein-min 45%, fat-min 6% 3. How the product is to be used Normally fortified with other cereals/millets/pulses at 10-15% level in the preparation of traditional recipes. In chickpea flour and papad it can be added up to 20-40% respectively. 4. Packaging Sealed polythene bags (HDPE 400 microns)/ hermetically sealed metal containers. 5. Shelf-life Six months at normal retail shelf temperatures and use with in a month after opening the packet. 6. Where the product will be sold Retail, institutions and food service. Could be consumed as a health food. 7. Labeling instructions Required to ensure product safety. It should give all the nutritional information and the ways to use it. 8. Special distribution control No physical damage, excess humidity or temperature extremes. Controlled o conditions of temperature (<25 C and RH <13%) Distribution

40

Medium Fat Soy flour Table 12.Product ingredients and incoming material Raw material Soybeans B, C, P Other Water (municipal) B, C Table 13.Flow diagram Soybeans Packaging material 1. Receiving P 2.Receiving P 5.Storing B P 6.Storing B C P 8. Cleaning P 9.Inspecting B P 11. De hulling P 12. Extrusion cooking B C 14. Expelling B C 15.Cooling/Drying B P C 16. Milling B P C 17.Filling C P 18.Weighing B 19.Closing/sealing B 20.Inspecting B P 21. Labeling B 22. Storing B 23.TransportB P=physical; B=biological; C=chemical Secondary materials Water 3. Receiving P 4. In taking 7. Storing B C P 10. Dumping 13. Chlorinating Packaging material Polythene bags B, C, P Secondary materials Greasing agents, disinfactants, C, P

41

42

Plant Schematic/Floor Plan

Preparatory Area Silos/Storage Bins

Extrusion cooking Area

Dry Processing Area Coolers/Dryers

Extrusion cooking

Cleaners Milling Equipment Thermo plastic Extrudates Sifters Expeller Grits Crude oil Cake Filling/Weighing/Sealing

Dehuller

Refining Transport

Consumption

HAZARD IDENTIFICATION: BIOLOGICAL HAZARDS Identified Biological Hazards Ingredients/materials: Soybeans - could contain soil borne/ air borne pathogenic organisms, yeasts or moulds. Secondary materials - could contain microbial contaminants. - could contain rodent excrements. Water - could contain microorganisms Packaging materials - could contain defects that could result in leakage. - may contain low molecular weights compounds that may migrate. Processing steps Dehulling - could be contaminated with microorganisms. Extrusion cooking Expelling could contain heat resistant spores. Cooling/Drying - could be contaminated with microorganisms. Weighing Transport physical damage to packages results in leakage and contamination of product. overfilling may lead to leakage and prone to contamination. cross contamination with microorganisms.

HAZARD IDENTIFICATION: CHEMICAL HAZARDS Identified Chemical Hazards Ingredients/materials: Soybeans - could contain pesticide residues. - could contain mycotoxins. Water - could be contaminated with toxic substances. Processing steps Secondary materials/packaging materials storage - improper storage may add to the release of chemicals. Soybean storage - improper storage may lead to the formation of toxins due to invasion of microorganisms. HAZARD IDENTIFICATION: PHYSICAL HAZARDS Identified Physical Hazards: Ingredients/ materials Soybeans could be contaminated with harmful extraneous materials namely glass, metal, plastic, wool etc. Secondary materials - could be contaminated with harmful extraneous materials Soybean receiving inadequate protection against harmful extraneous material could result in contamination. -

Secondary materials receiving in adequate protection against harmful extraneous material could result in contamination.

Table 14.CCP determination Processing Category step/incoming materials Soybeans delivered

and Q1

Q2

Q3

Q4

CCP no.

identified hazards as B= Pathogens Yes, treatment No, control is C= Pesticides at farms/grower s C= toxins Heat stable No, control is at farms/grower s Yes, P=Harmful Extraneous Materials (HEM) visual Yes No inspection & foreign object removal heat N/ A Yes Yes thermal processi ng

C CP1

Water in take

B=

faecal

coliforms (GMPs) C= heavy metals and Soybean receiving Packaging materials Filling other toxic chemicals(GMPs) P= HEM (GMPs) C=Low m.w compounds (Food quality) C= cleaning

chemicals, lubricants (GMPs) P= Weighing Metal Yes Yes No fragments (GMPs) B= products Yes, heavier than max weighing fill Extrusion cooking/thermal processing weight in control Yes of Yes No C CP6 scheduled process. B= non validated Yes, process could under and result survival in factors of process.

schedule critical processing scheduled

pathogenic microorganisms (GMPs) B= lack of and critical of result in heat and of of Yes, and factors control Yes of Yes Yes C CP7 adherence to time, temperature other factors could

scheduled process inadequate treatment growth Expelling pathogens. B= lack speed

adherence to time, critical clearance & other scheduled critical factors of process.

scheduled process could result in and inadequate expelling effect the quality of Cooling expelled cake the meal. of B= insufficient or excessive could spoilage contamination. Conveying/drying (GMPs) B= un clean wet equipment lead Milling Sieving Packing could to cooling in or result

thermophilic

contamination. P=HEM (GMPs) P=HEM (GMPs) C= migration of low from materials molecular packaging (food weight substances

Labeling/storing

grade) B= Post process contamination because (GMPs) B= Growth of thermopiles (GMPs) of damaged packages

Transportation

B= Post process contamination because (GMPs/GFHPs) of damaged packages

Table 15.Unaddressed Hazards: Product: Medium Fat Soy flour Unaddressed hazard from previous list Soybeans could contain pesticide residues Identified methods of addressing the hazard Up stream (farm level) programs such as A: Training persons who apply pesticides. B: Purchasing registered pesticides for growers. C: Auditing growers application of pesticides and records there of. D: Requiring periodic pesticide residual analysis reports.

Description of medium fat soy flour manufacturing process: Implementation of HACCP. Receiving soybeans (CCP-1): Soybeans must come from approved dealers. At the time of its receipt it must be accompanied with its complete quality certificate and

microbiological assessment reports. The certificates should indicate the moisture content of the beans, degree of foreign materials and the microorganisms present (number of colonies), insects etc as compared to the upper approved standards of BIS/ISO. At the time of receipt, visual control of soybeans must be carried out to find out the contaminants if any. Further more the proximate composition of the beans must be established with reference to its macro and micronutrients. Defective beans mean that the soy flour will be most likely unsafe for the consumption. Storage of soybeans in silos (CCP-2): The temperature (<20oC) and the relative humidity (<65%) during the storage must be low. They should be recorded at regular intervals. If any deviation from the safer limits, must be immediately rectified. When soybean is stored for a long period, microbiological analysis should be carried out. Receiving secondary materials (greasing, detergents, insecticides, pesticides and sacs) (CCP-3): These materials must be procured from the approved suppliers with quality certificates. These materials must be suitable for using them with food items. No contamination must come from the packaging materials. If these materials do not comply with the standard specifications, must be returned to the suppliers and a new order should be placed with other suppliers. Storage of secondary materials (CCP-4): The temperature and relative humidity during storage must be below 20oC and 65% respectively. The place should be air-conditioned. The temperature and RH should be continuously recorded and corrective actions must be undertaken whenever any deviation occurs. Application of anti insect methods (CCP-5): Any chemicals used during storage along with the soybeans should comply with the safety legislations. The quantity should be with in the prescribed concentrations.

Cleaning & grading of soybeans (CCP-6): All the physical contaminants should be removed. They should be graded. Only sound soybeans should be taken for processing. Removal of stones: The stones, metals and dust must be removed from the soybeans so that the final product will comply the quality standards as prescribed by BIS/ISO.

Extrusion (CCP 7): Conditioning of the grits with live steam is done prior to extrusion cooking. The quality of water is very critical. The moisture content of the feed must be 20-25%wb). The temperature of the barrel must be 150-180oC to attain the thermoplastic melt of the grits. The cooking time max 60 min. Expelling (CCP 8): The extrudate is passed immediately to the expeller. The speed and clearance of the rollers are very critical for getting maximum extraction efficiency. Milling (CCP-9): The cake is ground. The grinding is done in a burr/hammer mill. The clearance between the burrs should be adjusted so that the flour must be having particle size <140 micrometers. Similarly with the hammer mill, the sieve below the grinding system must allow flour particles less than 140 micrometers. The sieves should be of SS. The temperature during grinding should not rise too much, which affects the quality of the flour. Normally a temperature rise of less than 5 oC is desirable. So arrangements must be made to maintain the temperature while grinding. Packaging (CCP-10): During packaging the flour can possibly be contaminated with the microorganisms causing quality deterioration. Hermetic sealing and upright position of the packaging material can avoid this. There should not be any migration of the low molecular weight substances from the packages. Further more contamination can take place from foreign materials like insects and rodents that accidentally happen to be packed with the flour. The personnel should comply with the GMPs. Storage of MFS flour (CCP-11): Both the temperature and relative humidity must be below 20oC and 65% respectively. They should be recorded and corrective actions must be taken when deviating. When the flour is stored for a long period, microbiological analysis is required.

Metal detector (CCP-12): The packed product passes through a metal detector. The product is then checked for its weight and placed in boxes (secondary packaging). The boxes are placed on the pallets and the packets are wrapped with film.

Table 16.Quality Standard Expected: Composition: Protein: Fat: Crude Fiber: a minimum of 45% a maximum of 7% a maximum of 5 %

Ash: Moisture: Physical parameters: Granulation: Microbiology: Total plate count: Total coli forms: Salmonella: E.coli: Staphylococcus: Yeast: Mold: Protein solubility: TI: Urease activity: Available lysine: Sensory parameters: Color: Odor: Taste: Defects: Insect parts: Foreign material: Black specks:

a maximum of 8% a maximum of 10% 90% minimum pass thru US sieve 200(0.074 mm) 20,000/g max 100/10g max Negative/100g Negative/100g 100/10g maximum 100/10g maximum 100/10g max. PDI 20-80% less than 75% of original. Nil Min 5.5g/6g N light brownish Less beany Nutty Total absence. Total absence. Total absence.

Table 17. Quality assessment of the Medium Fat Soy Flour Quality standard expected Composition: Protein: a minimum of 45% 41% 46% With out HACCP With HACCP

Fat: a maximum of 7% Crude Fiber: a maximum of 5% Ash: a maximum of 8.0% Moisture: a maximum of 10% Physical parameters: Granulation: 90% minimum pass 80% thru US sieve 200(0.074 mm) Microbiology: Total plate count: 20,000/g max Total coli forms: 100/10g max Salmonella: Negative/100g E.coli: Negative/100g Staphylococcus: 100/10g maximum Yeast: 100/10g maximum Mold: 100/10g max. Protein solubility: PDI 20-80% 28% 80% 130/10g Nil 110/10g Nil 120/10g Nil 18/100g Negative 15/100g Negative 150/10g Nil 40,000/g 8,000/g 95% 10% 8% 7.4% 6.0% 5.2% 4.0% 8% 5%

TI: less than 75% of original. Urease activity: Nil Available lysine: Min 5.5g/6g N Sensory parameters: Color: light brownish Odor: Less beany Taste: Nutty Defects: Insect parts: Total absence. Foreign material: Total absence. Absent Absent Absent Absent Nutty Nutty Beany Less beany Brownish light brownish 5.2g/6gN 6.2g/6gN Nil Nil <60% <80%

Table 10.Synoptical presentation of hazards, critical control limits, observation procedures and control actions for the production of Full Fat soy flour
Processing step Receiving of soybean (CCP-1) Hazard description Presence of foreign material in soybean (P) CClimit (CCP) 5% Observation procedures Control of CCP Frequency Visual control of sample/control of lot Growth of micro organism (B)/insects Fungi (B) Out of five samples two of them 10210 . Humidity <13% Protein
4

Responsible QAM

Monitoring procedures Control of specifications and procure quality certificates from suppliers Evaluation of supplier

Corrective actions Rejection of lot or change supplier

Per lot

the

certifications per

Absence

Control of the certificates lot per

content 3840% Other macro and Receiving materials agents, secondary (greasing detergents, Chemical migrating substances from the micro “ “ “ “ “ nutrients Materials suitable for food items.

secondary materials.

insecticides, pesticides, sacs etc (CCP-2) Water Total Coli forms (B) In agreement with the community legislation 80/778 potable water (B) Faeces Coli forms (B) Faeces Streptococcus (B) Sulphur Clostridium (B) reducing “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ for Lab control of water quality Monthly QAM New drilling at greater depths, water chlorination of New drilling

Presence of undesirable and toxic substances in water (eg. Heavy metals, ammonia, quantity chlorine(C) Presence of foreign material Storage of soybeans in silos (CCP-3) in water (P) Growth of micro organisms (B)/insects hydrocarbons, of residual

parasites, nitrate). Excessive

“ Absence

“ Immediate control

“ Per lot

“ QAM

“ Control specifications

“ Use them immediately

Fungi

In

five

Notices of the results measuring. of

Daily

samples two of them 10210
4

Humidity <13% Temperature <25oC Air conditioning

Application insect

of

anti at

Residues chemicals

of

the

used

Tolerant levels prescribed as

Measuring amount chemical Control equipment appropriate functioning Control

the of

Per application

QAM

Control of the indication of the weighing machine.

methods

soybean (CCP-4) Presence of physical contaminants Residues of substances of physical origin in soybean.

by BIS/ISO Absence

of for

Daily

QAM

Monitoring

maintenance

Repetition

of

produces.

of the equipments

Calibration of equipment.

Magnet Storage (CCP-13) of products

Metal residues Control of temperature and RH

Absence Temperature < 20oC RH < 65%

of

Every hour

QAM

Repairing of the equipment

equipment Temperature and RH should be regularly tested. AC unit must be checked regularly for it’s functioning. Use anti insect methods disinfection the regularly maintaining GFHPs. Use the practices like: and of for vehicle

Transportation products

of

GMP/GFHP

Vehicle food transport.

for

Cleaning in Place

Automatic/manual cleaning of pipe lines, tanks etc.

CIP

plant

set

must be SS

and consists of tanks for water, lye & acid, disinfectant dosing system, SS centrifugal pump, SS air operated valves steam heating Dehulling of soybeans (CCP6) Presence of hulls in the splits. system. 5% absence. or and

Pre rinse with water, flushing water, flushing rinsing with rinsing with with lye, 70oC,

with acid 70oC, water and finally disinfection with disinfectant.

Control dehuller, adjustment

of of

Every run

Production Manager

Monitoring maintenance dehuller of

and the

Precautionary maintenance or else replace with new system. Repetition of the testing results and incase of deviation rejection of lot.

Steeping in water (CCP-7)

Water quality, operational parameters

Good quality water. Dry ingredients of quality food of

clearance. Quality check and observation of scheduled parameters.

Every run

Production Manager

Quality assessment of the ingredients and recording of temperature and time schedules.

Time/temp Blanching/steaming (CCP-8) Water quality, operational parameters. of soaking Good quality water, and temperature Drying (CCP-9) Drying time temperature and of holdings. Low temperature drying for qood quality. MC around Attrition (CCP-10) Grinding system and 10 %( wb). Minimum temp rise. As per QC of the milled product. QC of the final product. QC Every lot Every run. Production Manager QAM Regular monitoring. Every run. QAM Laboratory check up and evaluation. Regular monitoring. Repetition of the assessment and in case of deviation rejection of the lot. In case of deviation the system may be replaced. Replace the lot. QC recording parameters. and of Every run. Production Manager Evaluation of moisture of the dried splits in the lab. Repetition of the testing results and incase of deviation rejection of lot. of time QC recording parameters. and of Every run. Production Manager. Constant monitoring of the scheduled process. Repetition of the testing results and incase of deviation rejection of lot.

temperature rise Sifting (CCP-11) Desired granular size.

recommende Packaging (CCP-12) No migration of low weight d mesh size. Food grade film.

molecular compounds.

Table 18.Synoptical presentation of hazards, critical control limits, observation procedures and control actions for the production of Medium Fat soy flour
Processing step Receiving of soybean (CCP1) Hazard description Presence of foreign CClimit (CCP) 5% Observation procedures Control of CCP Frequency Visual control of sample/control of lot Growth of micro Absence Out of five samples two of them 10 10 . Humidity <13% Protein content 384 2

Responsib le QAM

Monitoring procedures Control procure certificates suppliers of quality from

Corrective actions Rejection of lot or change supplier

Per lot

material in soybean (P)

specifications and

the

certifications per

organism (B). insects Fungi

“ Control of the certificates lot per

“ “

“ “

“ Evaluation supplier of

“ “

40% Other macro and Receiving (greasing (CCP2&3) Water secondary agents, materials detergents, Chemical migrating substances from the micro “ “ “ “ “ nutrients Materials suitable for food items. In agreement with the community legislation 80/778 potable water (B) Faeces Coli forms (B) Faeces (B) Sulphur reducing “ “ “ “ “ “ Streptococcus “ “ “ “ “ “ “ “ “ “ “ “ for Lab control of water quality Monthly QAM New greater chlorination water drilling at of New drilling

insecticides, pesticides, sacs etc

secondary materials. Total Coli forms (B)

depths,

Clostridium (B)

Presence of undesirable and toxic substances in water metals, nitrate). quantity of chlorine(C) Presence Storage of soybeans in silos (CCP4) of foreign (eg. Heavy ammonia, Excessive residual

hydrocarbons, parasites,

“ Absence

“ Immediate control

“ Per lot

“ QAM

“ Control specifications

“ Use immediately. Otherwise of the lot. rejection them

material in water (P) Growth of micro organisms (B)/insects

Fungi

In

five

Notices of the results measuring. of

Daily

samples two of them 10210
4

Humidity <13% Temperature <25 C Air conditioning
o

Precautionary repair and maintenance of AC Otherwise with alternate. system. replace

Application of anti insect methods at soybean

Residues of the used chemicals

Tolerant levels prescribed as

Measuring amount chemical Control equipment appropriate functioning Control or equipment Control dehuller, adjustment

the of

Per application

QAM

Control

of

the

Rejection of the lot if exceeds the limits.

indication of the weighing machine.

Presence of physical contaminants

Residues of substances of physical origin in soybean.

by BIS/ISO Absence

of for

Daily

QAM

Monitoring maintenance of the equipments

Repetition of equipment. Repairing equipment “ of

of

produces. Calibration

Cleaning of soybeans (CCP-5) Dehulling of soybeans (CCP-6)

Metal residues Presence of hulls in the splits.

Absence 5% absence.

of of of the

Every hour Every run

QAM Productio n Manager

“ “

the

Extrusion cooking (CCP 7)

Destruction pathogens (B)

of

Temp: 150180 C 30-60 min. 20-25%(wb)
o

clearance. Recording schedules.

“ “

“ “

“ Observation of mc in the lab.

“ Repetition of the test and adjust the mc in case not observed optimal. “

Adjust the mc of the grits before the run.

Moisture content of the grits. Expeller (CCP 8) Speed (rpm) Clearance9mm) between the rolls. Storage of products (CCP-9) Control of temperature and RH

As per the scheduled runs prescribed. Temperature < 20oC

Adjust the speed and clearance of the rollers. Temperature and RH should be

Every an hour.

half

Productio n Manager

Precautionary maintenance of air

Rejection doubtful lot.

of

the

RH < 65%

regularly tested. AC unit must be checked regularly for it’s functioning. Use anti insect methods disinfection the regularly maintaining GFHPs. Use the practices like: Pre rinse with water, with flushing water, flushing rinsing lye,70 C, with rinsing with
o

conditioning unit.

Transportation of products

GMP/GFHP

Vehicle food transport.

for

Per lot

Productio n Manager

Precautionary maintenance of the vehicle.

Rejection of the lot if not maintains the quality as required by the food laws.

and of for vehicle

Cleaning in Place

Automatic/manual cleaning of pipe lines, tanks etc.

CIP

plant

set

Must be of best SS and equipment other from

must be SS and consists of tanks for water, lye & acid, disinfectant dosing system, SS centrifugal pump, SS air operated valves and

reputed Dealers

with acid 70oC, water and finally disinfection with disinfectant.

steam heating system.

Soy biscuits: Biscuits have been manufactured and consumed for hundred years. However, soy based biscuits are of recent origin and getting importance as neutraceutical foods. The main ingredients employed in the manufacturing of biscuits are soy flours (FFSF/MFSF/DFSF), wheat flour, fat and sugar. The industrial manufacture comprises a series of automated operations converting the raw materials in to finished varied categories of biscuits. A representative flow diagram of soy biscuit production accompanied with identification of CCPs is shown in Figure. All the hazards, critical control limits, observation of practices and corrective actions are given synoptically in the table. Table 19.Product description 1. Product name Soy biscuits 2. Important product characteristics of end Aw < 0.5;FFA < 1%; Total microbial counts product < 50000/g, protein-min 12%. 3. How the product is to be used It is consumed directly at any time either with tea or alone. 4. Packaging Sealed polythene bags (HDPE 400 microns)/laminated packages/ hermetically sealed metal containers. 5. Shelf-life Six months at normal retail shelf temperatures and use with in a month after opening the packet. 6. Where the product will be sold Retail, institutions and food service. Could be consumed as a health food. 7. Labeling instructions Required to ensure product safety. It should give all the nutritional information. 8. Special distribution control No physical damage, excess humidity or temperature extremes. Controlled conditions of temperature (<25oC and RH <13%)

Soy biscuits Table 20 Product ingredients and incoming material Raw material FFSF/MFSF/DFSF B, C, P Other Water (municipal) B, C Table 21.Flow diagram Soy flours Packaging materials 1. Receiving P 2.Receiving P 5.Storing B P 6.Storing B C P 8. Dough B P 9.Inspecting B P 11. Patternization B P 12. Baking B C 14.Cooling/Drying B P C 17.Filling C P 18.Weighing B 19.Closing/sealing B 20.Inspecting B P 21. Labeling B 22. Storing B 23.TransportB P=physical; B=biological; C=chemical Secondary materials Water 3. Receiving P 4. In taking 7. Storing B C P 10. Dumping 13. Chlorinating Packaging material Secondary materials Polythene bags/laminated Greasing agents, packages/tin containers B, disinfectants, C, P C, P

Plant Schematic/Floor Plan

Preparatory Area Silos/Storage Bins

Baking Area

Dry Processing Area Coolers/Dryers

Dough Making

Sifting of flours (Wheat/Soy flours) Weighing Patternizing Flour mixing Filling Baking

Sealing

Transport

HAZARD IDENTIFICATION: BIOLOGICAL HAZARDS Identified Biological Hazards Ingredients/materials: Soy flour/wheat flour - could contain air borne pathogenic organisms, yeasts or moulds. Secondary materials - could contain microbial contaminants. - could contain rodent excrements. Water - could contain microorganisms Packaging materials - could contain defects, which could result in leakage. - may contain low molecular weights compounds that may migrate. Processing steps Flour mixing - could be contaminated with microorganisms. Dough making/patternization Baking could contain heat resistant spores. Cooling/Drying - could be contaminated with microorganisms. Weighing Transport physical damage to packages results in leakage and contamination of product. overfilling may lead to leakage and prone to contamination. cross contamination with microorganisms.

HAZARD IDENTIFICATION: CHEMICAL HAZARDS Identified Chemical Hazards Ingredients/materials: Soy flour/wheat flour - could contain pesticide residues. - could contain mycotoxins. Water - could be contaminated with toxic substances. Processing steps Secondary materials/packaging materials storage - improper storage may add to the release of chemicals. Flour storage - improper storage may lead to the formation of toxins due to invasion of microorganisms.

HAZARD IDENTIFICATION: PHYSICAL HAZARDS Identified Physical Hazards: Ingredients/ materials Soy flour/ wheat flour - could be contaminated with harmful extraneous materials namely glass, metal, plastic, wool etc. Secondary materials - could be contaminated with harmful extraneous materials Flour receiving inadequate protection against harmful extraneous material could result in contamination.

Secondary materials receiving in adequate protection against harmful extraneous material could result in contamination.

Description of manufacturing process-Implementation of HACCP: Receiving flours (CCP-1): Flours must come from approved suppliers. Their receipt should be with quality certificates and microbiological analysis. The certificate should include the moisture content and absence of B, P and C contaminants. Up on receipt visual inspection must be carried out to detect any undesirable items. Probable defective flours mean that the final product will be most likely unsafe for the consumer. Receiving secondary materials and packaging materials (CCP-2&3): These materials must be procured from the approved suppliers. They should be accompanied with certificates. They should be suitable for use in food industry. There should not be any contaminants (B, C, and P), which affect the quality of the biscuits. If they do not comply with the specifications, they may be returned to the supplier and a fresh order should be placed with other supplier. Receiving and control of A/B materials (CCP-4): These materials should be conveyed to the factory through the vehicles employed exclusively for the transportation of food items. All the vehicles should be thoroughly sanitized. Prior to the receipt the QAM should check the suppliers’ specifications in order to confirm whether they comply with current legislation. Storage of flours in polypropylene sacs (CCP-5): The room temperature and humidity must be low (below 20oC and 65% respectively). They should be recorded and corrective actions should be taken whenever needed. When flours are stored over a long period, microbiological analysis should be conducted. Storage of secondary materials (CCP-6): The room temperature and humidity must be low (below 20oC and 65% respectively). They should be recorded and corrective actions should be taken whenever needed. Weighing/mixing of dough (CCP-7), preparation of dough and patternization: Correct weighing measures should be under taken. All the materials are kneaded and the dough is patternized in to various shapes as desired. During the kneading the wheat flour and soy flour absorb water resulting in inflation of the protein (glutin). Mixing induces

the formation of a three-dimensional network by hydrated proteins that is responsible for its viscoelastic properties. The butter reduces the amount of water required for mixing the components and contributes to the characteristic taste of the biscuits. Sugar is added to impart the color and taste to the biscuits. Additives can adjust the pH, inflate the dough and provide taste to the biscuits. During mixing the workers should comply with GMPs. A strict cleaning schedule should be applied in the plant operations. The water and the flours should be thoroughly mixed so that the proteins of flour do not promote the formation of gluten network. The mixing should be done in a high-speed mixer. The water employed should be cold (temp < 15-20oC) and the addition of flour should take place slowly. If yeasts are added, it will be kept for one hour otherwise with the chemicals it needs 10-20 minutes rest time. Other ingredients like oil 2.38%, lecithin 0.95%, NaCl 0.24%, Na H CO3 0.32%, soy flour/wheat flour (20g/100g) and water 47 %. (as required for making good dough). The added water promotes the gelatinization and the whole fission of the starch grains. As the water turns in to vapor, the material is spread on the plates thus leading to the formation of porous structure of the final product. Both the salt and sugar (6%) are added for improving the taste and increasing the crispiness. Baking at 150-230oC (CCP-8): The biscuits are baked at 150-230oC for 10 minutes and cooled to room temperature. The material on the disc is fit on the moving tempered plates. During the baking the pressure amounts to 20-30 psi. Every plate has a carved structure with parallel or crossed stripes. The distance among the plates is the major factor that affects the depth of baking pastry sheet during baking .the temperature is 180200oC for 1.5-3.0 minutes. After the end of baking the humidity is 1-3%. Cooling (CCP 9): First cooling of puff biscuits sheets at both sides of every sheet exposed to the atmosphere is accompanied by a quick adjustment of humidity at the sheet. Packaging and labeling (CCP-10): During the packaging the product could be contaminated with pathogenic microorganisms or microorganisms causing deterioration. This can be avoided by employing hermetic sealing in conjunction with the up right

position of the packaging. Packaging material should be suitable for food contact. The workers should comply with the GMPs in order to exclude the foreign materials such as insects and rodents with in the product. Palleting: The product in weighed (weight checking) and put in boxes (secondary packaging). The boxes are placed on the palette and are wrapped with cellophane film. Storage of packed product (CCP 11): The temperature during storage must be < 20oC and RH must be < 65%. The place should be air-conditioned. Both the temperature and RH should be recorded. Corrective actions should be taken if any of the conditions are not controlled. Table 22.Quality Standard Expected: Composition: Protein: Fat: Crude Fiber: Ash: Moisture: Microbiology: Total plate count: Total coli forms: Salmonella: E.coli: Staphylococcus: Yeast: Mold: TI: Urease activity: Available lysine: Sensory parameters: Color: Creamy to yellow 20,000/g max 100/10g max Negative/100g Negative/100g 100/10g maximum 100/10g maximum 100/10g max. less than 75% of original. Nil Min 5.5g/6g N a minimum of 12% a minimum of 50 % a maximum of 4% a maximum of 6.5% a maximum of 10%

Odor: Taste: Texture: Defects: Insect parts: Foreign material: Black specks: Quality standard expected Composition: Protein: a minimum of 12% Fat: a minimum of 50% Crude Fiber: a maximum of 4% Ash: a maximum of 6.5% Moisture: a maximum of 10% Microbiology: Total plate count: 20,000/g max Total coli forms: 100/10g max Salmonella: Negative/100g E.coli: Negative/100g

Less beany Nutty Crunchy Total absence. Total absence. Total absence. With out HACCP With HACCP

Table 23. Quality assessment of the soy biscuits

12% 51.0% 4.2% 5.9% 9%

12.8% 52.8% 3.8% 6.2% 8%

30,000/g 110/10g 18/100g 16/100g

9,000/g Nil Nil Nil

Staphylococcus: 100/10g maximum Yeast: 100/10g maximum Mold: 100/10g max. TI: less than 75% of original. Urease activity: Nil Available lysine: Min 5.5g/6g N Sensory parameters: Color: Creamy to yellow Odor: Less beany Taste: Nutty Texture Crunchy Defects: Insect parts: Total absence. Foreign material: Total absence. Absent Absent Absent Absent Crunchy Crunchy Nutty Nutty Less Beany Less beany Creamy Creamy 4.0g/6gN 6.0g/6gN Nil Nil <65% <80% 125/10g Nil 110/10g Nil 125/10g Nil

Table 24.Synoptical presentation of hazards, critical control limits, observation procedures and control actions for the production of soy biscuits Process step Observation procedures Responsible Monitoring Corrective actions Control of Frequency description control limit procedures CCP Receiving of soy Confirm the Soy flour Control of Per lot QAM Control of Rejection of lot or flour& wheat quality attributes MC-10% Protein-3840% Wheat flour MC-10% Protein-1112% Starch-70Receiving packaging of Contaminants 75% No Control per lot of “ “ “ specifications per lot/visual control specifications change supplier. and from suppliers required. Evaluation of suppliers. quality certificates flour (CCP-1) Hazard Critical

from packaging contaminants specifications “

materials (CCP- materials(C)

2) Receiving secondary 3) Receiving butter, powder, additives

of Contaminants from the Food grade “ “ “ “ “

materials (CCP- secondary materials(C). of Presence of Absence milk foreign sugar, materials etc and (P) In agreement with Codex Food. Laboratory Per lot “ Air conditioning of the silos. of Direct use of the flours or rejection if microorganisms exist in greater numbers. the “ of “ “ “

(CCP-4) chemicals(C). Storage of flours Growth of <107 cfu/g in sacks of poly micro organisms <106 propylene (CCP- (B) 5) when <16% t=20 days.

cfu/g control of the RH product. Control temperature and humidity according to storage time. at Thermometer Per annum for of the oven should checked. be

Baking (CCP-6)

Destruction the

of Baking 45-50

Production Manager

Precautionary Interrupt maintenance functioning and of the oven repair of the oven or and the air A.C. Rejecting the

pathogenic 180oC

microorganisms

and control of minutes,

development of cooling pathogenic microorganisms. 18-20oC.

at

conditioning of the unit.

doubtful lot.

Water

Total number of In Coli forms(B) the

agree Quality of water

Monthly

QAM

Chlorination of water

New source of water

ment with control community legislation 80/778 for potable water (B)

Fasces forms (B)

Coli “ “ “ “ “ “ “ “

“ “ “ “ “ “ “ “

Streptococcal (B) Sulphur reducing “ Clostridium (B) Presence undesirable of & “

toxic substances in water namely heavy ammonia, hydrocarbons, parasites, metals,

NO3&NO2, excessive chlorine)

“ “ Presence (P) of foreign materials “ “ “ “

Mixing (CCP-7)

Growth of micro Clean organisms (B) equipment with dough/

Visual control, cleaning

After usage of equipment

QAM

Application of schedules

Repeat

cleaning

of

cleaning equipment.

remains of schedule.

Cooling (CCP-8)

Destruction organisms (B)

of Cooling at Control temperatur e Hermetic upright packaging. cause No migration Visual & control effective right packaging. Control the

of Per lot

Production Preventive Manager maintenance of AC.

Interrupt functioning and repair of AC or rejection of doubtful lot. Interrupt functioning and repair the damage or

pathogenic micro room

cooling rate

Packaging (CCP-9)

Contamination by or microorganisms which Materials migrated packaging materials from deterioration. microorganisms

Every half Packing of an hour. up Unit Manager

Preventive maintenance of machinery.

pathogenic sealing

package rejection of doubtful lot. Rejection of lot and / or change of the supplier.

of Per lot

QAM

Observation of & quality certificates from supplier. Rejection of lot and / or the change of the supplier the supply specifications

specifications per lot.

Absence of Visual foreign materials, Contamination insects control effective & upright

Every half Packaging of an hour. Unit Manager

Evaluation of suppliers. Preventive maintenance

with & rodents

foreign rodents.

packaging.

of packaging machinery

materials, insects

Soy bread: Preparation of soy based white bread loaf is based on wheat flour, soy flour, water and yeast. It comprises the following process namely kneading, fermenting, proofing and baking. However, the ingredients role and importance of various steps differ considerably per process. The quality of flours affects the final quality of the bread. In general FFSF/MFSF/DFSF may be used for making breads depending up on the protein requirement at maximum level of 5% incorporation in the standard bakers’ formula. A typical dough system for yeast is prepared by blending flours with water. Gluten is formed from the two wheat flour proteins namely glidin and glutenin in the presence of water mixing. Attaining a satisfactory bread texture depends up on the uniform distribution of adequately hydrated and aerated nuclei to a certain extent. The fermentation plays an important role in the development of typical bread products. The released CO2 will initiate expansion of the cells developed during kneading and mixing. It imparts odor and flavor to the bread. Table 25.Product description 1. Product name Soy bread 2. Important product characteristics of end Aw < 0.5; FFA < 1%; Total microbial counts product < 50000/g, protein-min 30%. Fat-min 1%, carbohydrates-min 35%. 3. How the product is to be used It is consumed directly at any time either with tea or alone. 4. Packaging Sealed polythene bags (HDPE 400 microns)/laminated packages. 5. Shelf-life 3-4 days normal retail shelf temperatures. 6. Where the product will be sold Retail, institutions and food service. Could be consumed as a health food. 7. Labeling instructions Required to ensure product safety. It should give all the nutritional information. 8. Special distribution control No physical damage, excess humidity or temperature extremes. Controlled o conditions of temperature (<25 C and RH <13%)

Table 26.Product ingredients and incoming material Raw material FFSF/MFSF/DFSF B, C, P Other Water (municipal) B, C Table 27.Flow diagram Soy flours Packaging materials 1. Receiving P 2.Receiving P 5.Storing B P 6.Storing B C P 8. Dough B P 9.Inspecting B P 11. Pasteurization B P 12. Baking B C 14.Cooling/Drying B P C 17.Filling C P 18.Weighing B 19.Closing/sealing B 20.Inspecting B P 21. Labeling B 22. Storing B 23.TransportB P=physical; B=biological: C=chemical Secondary materials Water 3. Receiving P 4. In taking 7. Storing B C P 10. Dumping 13. Chlorinating Packaging material Secondary materials Polythene bags/laminated Greasing agents, packages B, C, P disinfectants, C, P

Soy bread

Plant Schematic/Floor Plan

Preparatory Area Silos/Storage Bins

Baking Area

Dry Processing Area Coolers/Dryers

Dough Making

Sifting of flours (Wheat/Soy flours) Weighing Patternizing Flour mixing Filling Baking

Sealing

Transport

HAZARD IDENTIFICATION: BIOLOGICAL HAZARDS Identified Biological Hazards Ingredients/materials: Soy flour/wheat flour - could contain air borne pathogenic organisms, yeasts or moulds. Secondary materials - could contain microbial contaminants. - could contain rodent excrements. Water - could contain microorganisms Packaging materials - could contain defects that could result in leakage. - may contain low molecular weights compounds that may migrate. Processing steps Flour mixing - could be contaminated with microorganisms. Dough making/patternization Baking could contain heat resistant spores. Cooling/Drying - could be contaminated with microorganisms. Weighing Transport physical damage to packages results in leakage and contamination of product. overfilling may lead to leakage and prone to contamination. cross contamination with microorganisms.

HAZARD IDENTIFICATION: CHEMICAL HAZARDS Identified Chemical Hazards Ingredients/materials: Soy flour/wheat flour - could contain pesticide residues. - could contain mycotoxins. Water - could be contaminated with toxic substances. Processing steps Secondary materials/packaging materials storage - improper storage may add to the release of chemicals. Flour storage - improper storage may lead to the formation of toxins due to invasion of microorganisms.

HAZARD IDENTIFICATION: PHYSICAL HAZARDS Identified Physical Hazards: Ingredients/ materials Soy flour/ wheat flour - could be contaminated with harmful extraneous materials namely glass, metal, plastic, wool etc. Secondary materials - could be contaminated with harmful extraneous materials Flour receiving inadequate protection against harmful extraneous material could result in contamination.

Secondary materials receiving in adequate protection against harmful extraneous material could result in contamination.

Description of manufacturing process, implementation of HACCP: Receiving flours (CCP-1): Soy flour and wheat flour must be purchased from approved suppliers. Their receipt should be accompanied with certificates of quality control and microbial analysis. The certificates should report the humidity of the flours, presence of any pieces of metals, pieces of hair from rodents, microorganisms and their number and comparison with the upper approved standards of BIS/ISO. Visual control of the flours must be conducted with reference to the color, high humidity and odor. The most important quality is the strength of gluten. Not more than 5% soy flour is incorporated; otherwise the loaf characteristics will be changed considerably. When wheat flour and soy flour are mixed with water, a protein nexus is formed due to the precipitation of two proteins, glutenin and glidinin. The glutinin poly merises forming an elastic nexus, while the glidinin is incorporated in to sticky extensible mass entering in to the nexus of gluten so that the dough becomes more extensible and flexible. The strong flours absorb the CO2 produced during the ripening of the dough, thus resulting in even more inflated bread. Receiving of secondary and packaging materials (CCP-2& 3): These materials must be purchased from approved suppliers. During their receipt, they must be accompanied along with the quality certificates. These materials must be suitable for being employed by the food industry. No substances are allowed to migrate from the packaging materials to the food product. If the packaging materials do not comply with the specifications of the BIS/ISO, they must be returned to the supplier. A new order should be placed on another supplier. Storage of flours in polypropylene sacks (CCP-4): The temperature and RH during the storage must be kept at low preferably 20oC and 65% respectively. They should be continuously recorded and corrective actions must be undertaken when ever the forgoing presuppositions are not met. When the flour is stored for a long period, microbiological analysis is imperative.

Storage of secondary materials (CCP 5): The storage temperature must be <20oC and the RH must be < 65%. The place should be air-conditioned. The temperature and relative humidity should be continuously monitored. Corrective actions should be undertaken when forgoing circumstances are not met. Weighing& mixing of flours and other ingredients (CCP-6): Wheat flour, soy flour, water and yeasts are weighed accurately and mixed to a homogenous mixture. At this stage, the personnel should comply with Good Manufacturing Processes (GMPs) and personnel hygiene as desired in the Good Food Hygiene Practices (GFHPs). Kneading (CCP-7): During mixing of flours, a fine dispersion of bubble air cell must be formed with in the volume of dough. It must contain active yeasts and adequate nutrients for the yeasts and production of CO2 during fermentation, so that the bubbles can be inflated. The kneading is done in a mixer (11 wh/kg) for 2-5 minutes. In this way heat is produced during mixing, resulting in a final temperature of 30oC. The materials before mixing should be at low temperature. Cutting the dough, first molding& first inflation at 30oC for 10 minutes and second molding followed by placing in matrices: After kneading, the dough is cut, patternized and finally molded. The first inflation takes place at 30oCfor 10 minutes. After the inflation, the dough is molded again and placed in the forms for baking. Final swelling: It takes place at 50oC for 60 minutes and RH .85%. Baking at 165oC for 40-50 minutes (CCP-8): During the baking the starch under goes the following changes: • • • • • Dilution of gluten in the right proportion. Provision of sugar to yeasts. Formation of a suitable surface for gluten adhesion. Flexibility enhancement, so that the bread gets more inflated. Water absorption from gluten during the baking, leading to lower flexibility of gluten.

Cooling (CCP 9): After baking, the cooling takes place at ambient temperature for 90 minutes. Faults that may occur are: • • • Over fermented dough will result in bread with a pale crust color and the crust may be weak and crumbly. If the yeast has fermented all the available flours, the bread will lack volume and springiness. Under fermentation results in bread with high crust color, small volume and dense firm crumb of poor color. Packaging and labeling (CCP 10): During the packaging process, the bread can be easily contaminated with the pathogenic and other micro and macro organisms. This can be avoided by hermetic sealing in conjunction with up right position of the packaging materials. Packaging items must be suitable for food items. Further contamination can occur from the foreign materials, insects and rodents that happened to be packed with the product. The personnel should comply with GMPs. Storage of packed bread (CCP11): The storage temperature must be < 20oC and the relative humidity must be less than 65%. The place should be air-conditioned. The temperature and RH should be recorded and corrective measures must be taken when deviation occurs.

Table 28.Ingredients used in making wheat and soy bread Ingredient Water Soy milk powder Soy flour Wheat flour Pure gluten Dough conditioner Sugar Yeast Salt Shortening Soy bread %(w/w) 45.0 6.6 20.0 17.5 2.5 0.2 4.5 1.0 0.9 1.7 Wheat bread %(w/w) 38.0 0 0 54.0 0 0 4.0 1.0 1.0 2.1

Table 29.Proximate composition of wheat and soy breads Composition, % Moisture Carbohydrates Fat Protein Wheat bread 37 81 2 14 Soy bread 44 40 2 14

Table 30.Quality Standard Expected: Composition: Protein: a minimum of % 30

Fat: Carbohydrates Crude Fiber: Ash: Moisture: Microbiology: Total plate count: Total coli forms: Salmonella: E.coli: Staphylococcus: Yeast: Mold: TI: Urease activity: Available lysine: Sensory parameters: Color: Odor: Taste: Texture: Defects: Insect parts: Foreign material: Black specks:

a minimum of % 1.5 a maximum of % 40 a maximum of % 4 a maximum of % 6.5 a maximum of % 40 20,000/g max 100/10g max Negative/100g Negative/100g 100/10g maximum 100/10g maximum 100/10g max. less than 75% of original. Nil Min 5.5g/6g N Creamy to yellow Less beany Nutty Soft Total absence. Total absence. Total absence.

Table 31. Quality assessment of the Soy Bread Quality standard expected Composition: With out HACCP With HACCP

Protein: a minimum of 30% Fat: a minimum of 1.5% Crude Fiber: a maximum of 4% Ash: a maximum of 6.5% Carbohydrates a maximum of 40% Moisture: a maximum of 40% Microbiology: Total plate count: 20,000/g max Total coli forms: 100/10g max Salmonella: Negative/100g E.coli: Negative/100g Staphylococcus: 100/10g maximum Yeast: 100/10g maximum Mold: 100/10g max. TI: less than 75% of original. Urease activity: <50% <80% 117/10g Nil 110/10g Nil 125/10g Nil 15/100g Negative 20/100g Negative 105/10g Nil 45,000/g 10,000/g 34 38 38 40 5.9% 5.0 5.1% 4.3 1.0 2.1 30 32

Nil Available lysine: Min 5.5g/6g N Sensory parameters: Color: Creamy to yellow Odor: Less beany Taste: Nutty Texture Soft Defects: Insect parts: Total absence. Foreign material: Total absence. Absent Absent Absent Absent Soft More soft Nutty Nutty Beany Less beany Yellow Creamy 5.2g/6gN 6.0g/6gN Nil Nil

Soy baked products

Table 32.Synoptical presentation of hazards, critical control limits, observation procedures, monitoring and corrective actions for the production of soy bread Process step Hazard description Critical Control limit Observation Procedures Control of Frequen CCP Control the certification per Visual control lot. cy of Per lot Responsib le Monitoring Correctiv procedures e actions

Receiving flours (CCP-1)

of Presence of 5% foreign materials in the flours(whea t/soy bean)(P)

Quality assurance Manager

Control n provide quality

of Rejection of lot or the suppliers. the and change

specificatio

certification from suppliers. Evaluation of suppliers.

Growth

of Absence

micro organisms (B) Out of five samples two of them Fungi 102-104 cfu/g, Humidity<13% Proteins: 12%(wheat)&38%(soybean) Other (strength Receiving packaging 2) of Low molecular compounds migrating from the packaging materials(C) chemical of characters gluten/amylase Control s per lot of Per lot QAM Control ns provide quality certificates from the suppliers. Evaluation Receiving of Chemical Materials suitable for food Control of Per lot QAM of suppliers. Control of Rejection of Rejection of lot or suppliers. and change

activity) No migration

certification

specificatio

materials (CCP- weight

secondary 3)

substances from the

handling.

specification s per lot.

specificatio ns provide quality certificates from the suppliers. Evaluation

of lot or suppliers.

materials (CCP- migrated secondary materials(C)

and change

Storage of the Growth flours in sacks of micro propylene (CCP- organisms 4) (B)

of <10 cfu/g <106 cfu/g when RH <16%, time: 20 days.

7

Laboratory testing the for quality. of flours the

Per lot

Lab Technician

of suppliers. Air Rejection conditionin g of the silo of the lot if nisms exist great in the microorga

QAM Control the temperature and RH with of Per lot Mixing the materials.

numbers. of Rejection of the lot if micro the

the

advent

organisms exist great Per lot QAM Cleaning and insect schedules should applied the equipment personnel should comply with GMPs. numbers Rejection if be nisms in exist great numbers. of the lot if micro the organisms exist great in the in the in

of time of storage. Cross dough Contaminati No contamination. with micro organisms (B). Cleaning schedules should applied the equipment. The personnel should comply with GMPs. be in

contamination of on of dough

anti of the lot microorga

places. The Rejection

Baking (CCP-5)

Destruction

Baking at 250oC for 40-45 The

Monthly Production

Precautiona

numbers Rejection

of pathogenic micro organisms and control of spore forming bacteria(Ba cillus Cooling (CCP 6) cereus) Control the cs

minutes.

thermometer of the oven should checked. be

Manager

ry maintenanc e of oven.

of the lot.

the

doubtful

of Cooling at room temperature The loaf (18oC) for 90 minutes. temperature must monitored regularly. The air conditioning unit must be checked for it’s be

Every half

Production an Manager.

Precautiona ry maintenanc e of conditionin g unit.

Rejection of the doubtful

characteristi

of the room hour.

air lot.

Storage of bread (CCP-7)

Control and RH

of Temperature < 20 C RH < 65%

o

functioning. Temperature and should regularly tested. checked regularly for it’s AC unit must be

Every

Production an Manager

Precautiona ry maintenanc e of conditionin g unit.

Rejection of the doubtful

temperature

RH half be hour.

air lot.

Transportation of GMP.GFHP the bread.

Vehicle for food transport.

functioning. Use anti Per lot insect methods and disinfection of vehicle regularly for maintaining GFHPs. the

Production Manager

Precautiona ry maintenanc e of vehicle.

Rejection of the lot if the quality as required by food laws. the not

the maintains

Receiving of flours Receiving of packaging materials Receiving secondary materials Storage Mixing in a mixer for 2-4 minutes Cutting Patternization Mechanical molding Molding 1st swelling 30oc for 10 minutes 2nd mechanical molding/ place in the form. Final swelling at 43oC, RH > 85% Baking at 210oc for 30 min 1st swelling 30oC for 10 minutes. 2nd mechanical molding/ Place in the form. Final swelling at 43oC, RH > 85% Baking at 210oc for 30 min Cooling Packaging Weighing/mixing flours. Kneading for 3 h Cutting dough 1st mechanical molding Storage at 20oC&RH65% of

Transport

109

Distribution

Soymilk (plain)/flavored milk Strictly speaking soymilk is a water extract of whole soybeans. It is an off white emulsion/suspension containing the water-soluble proteins and carbohydrates and most of the oil of the soybeans. Plain: Bean to water ratio 1:5 contains 4% protein. Dairy type soymilk: Bean to water ratio 1:7 and contains 3.5% protein. Slightly sweetened and contains oil, salt and imitation flavors. Soy beverages: Bean to water ratio 1:20 and contains 1% protein. Cultured products: Any of the above after lactic acid fermentation or acidification with lactic acid. Blends: Mixtures of soymilk and other vegetable or dairy milks. Soybean types required for making soymilk Large seeded soybeans. (larger than 20 g/100) with a yellow seed coat, yellow cotyledons, clear hilum and thin but strong seed coat. • • • • • Moderately high in protein content with improved ratio of 7S/11S. Lack of lipoxygenase and lower oil content. High NSI, high water uptake, low calcium and high germination rate. A high protein/ oil ratio provides a higher tofu yield and firmer texture. Taste is closely related to soluble carbohydrates content in seeds. High total carbohydrates, high sucrose, low raffinose and low stachyose, are highly desirable.

110

Soy milk (Plain) Table 33.Product description:
1. Product name 2. Important product characteristics of end product Soy milk (plain/flavored) Aw < 0.5; FFA < 1%; Total microbial counts < 50000/g. The soymilk may consist of pure water, soybean extract, sugar and salt. It has 3-4% protein, 1.5-2.0% fat and 8-10% carbohydrates. Flavored soymilk may consist of pure water, soybean extract, sugar, salt, and flavors and permitted food colors.

3. How the product is to be used

Plain/flavored milk is ready to drink and applicable to all sections of people suffering from lactose intolerance. (Infants/youth/old/pregnant etc).

4. Packaging 5. Shelf-life

Plain soy milk is packed in 200/500 ml polythene bags/ glass bottles/tetra packs, The soymilk has shelf life of six months when packed in tetra packs or else for few weeks under refrigerated conditions. It has to be stored and distributed at ambient temperature. Retail, institutions and food service. Could be consumed as a health food. Required to ensure product safety. No physical damage, excess humidity or temperature extremes.

6. Where the product will be sold 7. Labeling instructions 8. Special distribution control

111

The identified biological, chemical and physical hazards related to the production of soymilk are given as under. Table 34.Product ingredients and incoming material (P=physical; B=biological; C=chemical) Raw material Soybeans B, C, P Other Water (municipal) B, C Table 35.Flow diagram Soybeans 1. Receiving P 5.Storing B P 8. Cleaning P 11. De hulling P 12. Soaking B C 14. Wet grinding B C 15.Filteration B P C 16. Homogenization BPC Packaging material 2.Receiving P 6.Storing B C P 9.Inspecting B P Dry ingredients 3. Receiving P 7. Storing B C P 10. Dumping Water 4. In taking Packaging material Polythene bags B, C, P Dry ingredients Sodium bicarbonate B, C, P

13. Chlorinating

17.Filling C P 18.Weighing B 19.Closing/sealing B 20.Inspecting B P 21. Labeling B 22. Storing B 23.TransportB B= biological; C=chemical; P=physical

112

Table 36.The details of all identified hazards are enumerated as under. Biological Hazards Ingredients / Materials Soybeans could contain soil borne/ air borne pathogenic organisms, yeasts or moulds Dry ingredients could contain microbial contaminants. could contain rodent excrements Chemical Hazards could contain pesticide residues could contain mycotoxins. Physical Hazard could be contaminated with harmful extraneous materials namely glass, metal, plastic, wool etc. could be contaminated with harmful extraneous materials inadequate protection against harmful extraneous material could result in contamination could be contaminated with non food chemicals as a result of improper storage in adequate protection against harmful extraneous material could result in contamination could be contaminated with toxic substances

Soybeans Receiving

Dry Ingredient Storage Dry Ingredient Receiving Water could contain microorganisms Packaging could contain defects Material which could result in leakage Processing Steps Dehulling could be contaminated with microorganisms Soaking could contain microorganisms Grinding could contain heat resistant spores

cleaning chemical residues could contaminate the beans. if live steam is used,

113

boiled water additives could carry over and contaminate the product Filtration Weighing Transport could be contaminated with microorganisms overfilling may lead to leakage and prone to contamination physical damage to packages results in leakage and contamination of product

Soy milk (Plain)

114

The next step is identification of Critical Control Points (CCPs). The CCP determination is shown below. Table 37.CCP determination Instructions: • Category and identified hazard: Controlled by Codex General Principles of Food Hygiene, if yes indicate GMP and proceed to next hazard. If no proceed to question 1. • Q1: Do control preventive measures exist, if no, not CCP; if yes proceed to next. • Q2: Is this operation specifically designed to eliminate, if no proceed to Q3. if yes CCP and identify it in the last column. • Q3: Could contamination with identified hazards occur in excess of acceptable levels, if no, not CCP. If yes Proceed to Q4. • Q4: Will subsequent operation control the contamination levels, if no CCP; if yes not CCP. Process step/incoming materials Soybeans Category and identified hazard B=Pathogens C=Pesticides C= heat stable toxins P= harmful extraneous material (HEM) Packaging materials Dry ingredients as delivered Water at intake Cleaning and grading of soybeans Dehulling of soybeans B=pathogens B= bacterial spores B=rodent excretes (GMP) P=HEM (GMP) B= GMP C= heavy metals & other toxins (GMP) P=GMP B Q1 Yes Q2 Yes Q3 Yes Q4 Yes, thermal processing

No (farmers/growers level-GPP) No (farmers/growers Yes level-GPP) Yes (visual inspection and foreign object removal) Yes Yes Yes N/a

No Yes

Yes Yes

Yes, sterilization Yes, thermal processing

Yes

Yes

Yes

No

115

Soaking of soy splits Grinding/cooking in water Filtration

Water (GMP) Sodium bi carbonates (0.5%) B C B C P (GMP) P (GMP) B

Yes Yes

Yes Yes

Yes Yes

No No

Filling Weighing Packaging and sealing

Yes

Yes

Yes

No

116

Some of the unaddressed hazards connected to this process are presented in the preceding text. Table 38.Unaddressed Hazards Unaddressed hazard from previous list Soybeans could contain pesticide residues Identified methods of addressing the hazard Up stream (farm level) programs such as A: Training persons who apply pesticides. B: Purchasing registered pesticides for growers. C: Auditing growers application of pesticides and records there of. D: Requiring periodic pesticide residual analysis reports.

117

The detailed HACCP plans are shown as under. Table 39.HACCP Plan Process Hazard Critical step description limits De hulling Inefficient de hulling may cause the contamination of the product with the microorganisms . In adequate heat treatment Less than 0.1% Monitori ng procedur e On line check of the sample. Deviation procedures

Line operator to adjust the clearance of the de huller drums

Blanchi ng /cooking

Drying (Sun/me chanical ) Packagi ng and sealing

Cook the splits as specified in the scheduled process (under pressure/open vessel boiling) Improper drying The moisture content should be less than 8%-10%. Over filling, improper gauge polythene and improper sealing Max fill weight as specified in the scheduled process. Proper sealing leaving recommended space.

Check the quality of splits for urease test

Operator should adjust the time and temperature as per the authorized contingency plan and to inform the QC.

Check the moisture content as per the guidelines . On line check to reject over and under filled bags and improperl y sealed bags.

If moisture content is greater the splits may be dried again a inform QC

Line operator to adjust the settings.

118

Table 40.HACCP for general activities: Stage Raw material harvest Raw material transport Raw material inspection Preparation of seeds Packaging Activity Liaison with the farmers for unit operations like harvesting, threshing and winnowing. Transport in sacks to drying area. Sampling and routine inspection. Cleaning, grading, dehulling, conditioning and blending. Filling in to containers and sealing. Control activity Specifications of grain quality are required. Rejection of under sized seeds. Correct sacking and handling. Correct sampling methods, training and inspection methods. Training operators for equipment, preventing insect infestations, check for moisture content. Establish specifications for labels and fill weights.

119

Description of soymilk manufacturing process: Implementation of HACCP. Receiving soybeans (CCP-1): Soybeans must come from approved dealers. At the time of its receipt it must be accompanied with its complete quality certificate and microbiological assessment reports. The certificates should indicate the moisture content of the beans, degree of foreign materials and the microorganisms present (number of colonies), insects etc as compared to the upper approved standards of BIS/ISO. At the time of receipt, visual control of soybeans must be carried out to find out the contaminants if any. Further more the proximate composition of the beans must be established with reference to its macro and micronutrients. Defective beans mean that the soy flour will be most likely unsafe for the consumption. Soybean variety may play an important role. Bold seeded varieties are preferred. Storage of soybeans in silos (CCP-4): The temperature (<20oC) and the relative humidity (<65%) during the storage must be low. They should be recorded at regular intervals. If any deviation from the safer limits, must be immediately rectified. When soybean is stored for a long period, microbiological analysis should be carried out. Receiving secondary materials (greasing, detergents, insecticides, pesticides and sacs) (CCP-2): These materials must be procured from the approved suppliers with quality certificates. These materials must be suitable for using them with food items. No contamination must come from the packaging materials. If these materials do not comply with the standard specifications, must be returned to the suppliers and a new order should be placed with other suppliers. Storage of secondary materials (CCP-3): The temperature and relative humidity during storage must be below 20oC and 65% respectively. The place should be air-conditioned. The temperature and RH should be continuously recorded and corrective actions must be undertaken whenever any deviation occurs. Application of anti insect methods (CCP-5): Any chemicals used during storage along with the soybeans should comply with the safety legislations. The quantity should be with in the prescribed concentrations.

120

Cleaning & grading of soybeans (CCP-6): All the physical contaminants should be removed. They should be graded. Only sound soybeans should be taken for processing. Removal of stones: The stones, metals and dust must be removed from the soybeans so that the final product will comply the quality standards as prescribed by BIS/ISO. Weighing: the soybeans are weighed and passed through a magnetic system so that the magnetic materials are removed. Steeping (CCP-7): As per the quality standards of water prescribed by the GFHP and food grade chemicals. The duration of soaking depends on the season. In winter long durations are required as compared with summer. In general 4-8 hours soaking may be opted .The moisture content of the soaked beans may be about 45%(wb). Grinding (CCP-8): Type of grinders used is very critical. In general burr/colloidal/hammer mills are in vogue. The grinding may be done in two stages. Hot water may be used while grinding for inactivation of lipoxygenase, which may improve the flavor. The bean to water ratio depends on the type of milk to be prepared. In general 1:8 (w/v) is preferred for plain milks and for beverages still higher dilution factor may be considered. For paneer making 1:6 may be used. Cooking (CCP-9) Pressure-cooking at 1.2kg.cm2& temperature 121oC for 40 minutes is preferred to inactivate all the anti nutritional factors. Filtration (CCP-10): Use decanter centrifuge/rotating drum filter/batch type filters. Speed of the centrifuge or drums should be adjusted to get maximum residue separated. Homogenization (CCP-11): Thorough mixing of the oil/emulsifier as per the required quantity before homogenization. Homogenize at 3500 psi for 30 minutes. Standardization of soymilk base by adding ingredients like sugar syrup, water, flavors (flavored milk) may also be done during this process. UHT/pasteurization (CCP-11): Treatment of soymilk in UHT plant or direct pasteurization.

121

Application of pressure for texturization in case of paneer: • For soft paneer the pressures recommended are 2-4 g/cm2 for five minutes and then increased to 5-10 g/cm2 for 10-15 minutes or until the whey stops draining out. • For firmer paneer the pressure required is 20-100 g/cm2 for 20-30 minutes.

Packaging (CCP-12): During packaging the milk can possibly be contaminated with the microorganisms causing quality deterioration. Hermetic sealing and upright position of the packaging material can avoid this. There should not be any migration of the low molecular weight substances from the packages. Further more contamination can take place from foreign materials like insects and rodents that accidentally happen to be packed with the milk. The personnel should comply with the (Good Manufacturing Process). Containers: Food Processor: • • • • • • Reliable supply of packaging material. Low fixed cost per unit. Low energy consumption. Packaging should keep product quality. Service and spare parts availability. Space saving in storage/ minimum refrigeration.

Distributor: • • • • Light weight. Effective space utilization. Minimum refrigeration. Labour saving transport packaging.

122

Withstand rough handling.

Retailer: • • • Minimum refrigeration space. Attractive packaging with sales appeal. Minimized handling of empties and transport packaging.

Containers: • • • • • • Convenient size. Safe, easy to handle, drink and pour from. Retain product quality. Easy to dispose off. Have high image/ novelty. Product identification.

Kinds of packages: • • Returnable: usually for refrigerated distribution with in limited area. One-way: used for refrigerated (pasteurized) products distribution with in a limited area/ non refrigerated (UHT/sterilized) products for short and long distance distribution. Choice of container depends on the following factors: • • • • • • Desired retail price of the product. Product quality protection practices. Desired image. Refrigerated or non-refrigerated distribution. Type of distribution vehicle. Type of transport container available. 123

• •

Service of filling machine. Packaging size.

• • • • • •

Means of opening package. How to drink from or pour from container. Place of consumption. Fixed cost of equipment. Labeling possibilities. Novelty factor.

The pasteurized product (75oC for 15 sec) can be filled in cartons, plastic bags, glass or plastic bottles. The product should be stored under refrigeration and has then a shelf life of approximately one week. The UHT treated product (1400Cfor 4 sec) should be aseptically packed in cartons, plastic bags or plastic bottle. The shelf life is up to several months in ambient temperature. No preservatives are involved. It provides adequate shelf life and a product with good flavour and nutritional value. In bottle/can, sterilized soy milk (120oC for 20 min) has the longest shelf life but is also a less nutritious product. Taste and appearance are also affected. Crate/outer box/transport container: The outer container in which the individual packages or bottles are stored and transported should be considered early on in the planning of a suitable packaging system. Some factors to keep in mind are: • • • • • • Returnable or one-way container. Degree of automation. Degree of protection against physical impact, dust, rain, sunlight, theft and stacking height. Ease of handling in plant, storage, trucks and shops. Bulkiness/weight. Cost per volume of soymilk transported.

124

• •

Durability. Desirability of non-authorized uses.

Function as sales unit in shops.

Table 41.Types of containers and what they are suitable for Returnable One way For Pasteurized product For aseptic packed product Primary Container Glass bottle * Plastic bottle Plastic bag Carton Can Transport Container Wooden * grate Plastic crate Cardboard box Cardboard tray/shrink film Wrap around box Metal detector (CCP-13): The packed product passes through a metal detector. The product is then checked for its weight and placed in boxes (secondary packaging). The boxes are placed on the pallets and the packets are wrapped with film. * * * * * * * * * * * * * * * * * * * * * UHT For sterilized product treated

125

Storage of soy milk (CCP-14): The storage temperature and relative humidity must be below 20oC and 65% respectively. The place should be air-conditioned. Both the temperature and relative humidity must be recorded regularly and corrective actions must be undertaken whenever deviation occurs.

126

Table 42.Expected quality (Soy milk) Nutritional values per 100 g Protein: Fat: Carbohydrates: KJ: Kcal: Cholesterol: Lactose: SF: PUFA: MUFA: Crude Fiber: Ash: Moisture: Microbiology: Total plate count: Total coli forms: Salmonella: E.coli: Staphylococcus: Yeast: Mold: TI: Urease activity: Available lysine: 20,000/g max 100/10g max Negative/100g Negative/100g 100/10g maximum 100/10g maximum 100/10g max. less than 75% of original. Nil Min 5.5g/6g N a maximum of 4.0g a maximum of 2.0g a minimum of 3.0g 204 49 0 0 15% 63.5% 1.5% a maximum of 4% a maximum of 6.5% a maximum of 80%

127

Sensory parameters: Color: Odor: Taste: Defects: Insect parts: Foreign material: Black specks: Quality standard expected Composition: Protein: a maximum of 4% Fat: a maximum of 2% Carbohydrates A maximum of 3% Crude Fiber: a maximum of 4% Ash: a maximum of 6.5% Moisture: a maximum of 80% Microbiology: Total plate count: 20,000/g max Total coli forms: 100/10g max Salmonella: Negative/100g 20/100g Negative 130/10g Nil 30,000/g 6,000/g 80% 80% 4.4% 3.3% 5.0% 3.7% 2.2% 3.0% 1.6% 2.0% 3.2% 4.3% Total absence. Total absence. Total absence. With out HACCP With HACCP Creamy to yellow Less beany Nutty

Table 43. Quality assessment of the Soymilk

128

E.coli: Negative/100g Staphylococcus: 100/10g maximum Yeast: 100/10g maximum Mold: 100/10g max. TI: less than 75% of original. Urease activity: Nil Available lysine: Min 5.5g/6g N Sensory parameters: Color: Creamy to yellow Odor: Less beany Taste: Nutty Defects: Insect parts: Total absence. Foreign material: Total absence. Absent Absent Absent Absent Nutty Nutty Beany Less beany Yellow Creamy 5.2g/6gN g/6gN Nil Nil <50% <80% 112/10g Nil 100/10g Nil 135/10g Nil 15/100g Negative

129

Table 44.Expected quality (Soy paneer) Nutritional values per 100 g Protein: Fat: Carbohydrates: Crude Fiber: Ash: Moisture: Calcium: Iron: Phosphorus: Vitamin B1: Vitamin B2: Nicotinic acid: Microbiology: Total plate count: Total coli forms: Salmonella: E.coli: Staphylococcus: Yeast: Mold: TI: Urease activity: Available lysine: Sensory parameters: Color: Odor: Creamy to yellow Less beany 20,000/g max 100/10g max Negative/100g Negative/100g 100/10g maximum 100/10g maximum 100/10g max. less than 75% of original. Nil Min 5.5g/6g N a minimum of 5.0g a minimum of 3.0g a minimum of 2.0g a maximum of 1% a maximum of 6.5% a maximum of 90% 1.0 mg 1.8 mg 0.95 mg 0.05 mg 0.04 mg 0.5 mg

130

Taste:

Nutty

Defects: Insect parts: Foreign material: Black specks: Total absence. Total absence. Total absence.

131

Table 45. Quality assessment of the Soy Paneer (Tofu) Quality standard expected Composition: Protein: a minimum of 5% Fat: a minimum of 3% Carbohydrates a minimum of 2% Crude Fiber: a maximum of 1% Ash: a maximum of 6.5% Moisture: a maximum of 90% Microbiology: Total plate count: 20,000/g max Total coli forms: 100/10g max Salmonella: Negative/100g E.coli: Negative/100g Staphylococcus: 100/10g maximum Yeast: 100/10g maximum 100/10g Nil 115/10g Nil 18/100g Negative 12/100g Negative 120/10g Nil 50,000/g 10,000/g 90% 90% 7.0% 6.0% 1.4% 0.8% 2.0% 2.8% 3.2% 5.0% 4.5% 8.0% With out HACCP With HACCP

132

Mold: 100/10g max. TI: less than 75% of original. Urease activity: Nil Available lysine: Min 5.5g/6g N Sensory parameters: Color: Creamy to yellow Odor: Less beany Taste: Nutty Defects: Insect parts: Total absence. Foreign material: Total absence. Absent Absent Absent Absent Nutty Nutty Beany Less beany Yellow Creamy 4.2g/6gN 6.2g/6gN Nil Nil <50% <80% 123/10g Nil

133

Table 46.Hazard analysis worksheet of soymilk manufacturing:
Ingredient/pro cess step Identifying potential hazards introduced/controlled/enh anced at. Are any Justificati potential food on safety hazards significant (yes/no) What preventive measures can be applied to prevent the significant hazards? Associate Removal d with through outbreaks mechanical of food and manual borne cleaning. illness. Rejection of lot. Removal through mechanical and manual cleaning. Cannot Removal Yes be through removed repeated at later washing stage. steps. Quality No parameter s not associate d with safety. Is this step CCP (Yes. no)

Soybean cleaning

Biological-dead insects/worms

Yes

Yes

Chemical-chemical residues (pesticides/insecticides) Physical matter

Yes

extraneous Yes

Soybean washing

Physical-Dust/dirt/foreign matter.

Yes

Soybean soaking

Physical-moisture content

No

134

135

Table 47.Synoptical presentation of hazards, CC limits, observation procedures, monitoring and corrective measures for production of soymilk. Process step Receiving soybeans (CCP-1) Hazard Critical limit Observation procedures Responsibl Control CCP Frequency e Visual control Per lot QAM of sample/control of lot. Growth micro organisms (B) Insects Fungi Out of five Control of the samples two certification. of them 102of Absence the certification per Monitoring Corrective

description of Presence of 5% foreign matter in soybean (P)

procedures actions Control of Rejection specifications and quality certificates from suppliers. of lot and change the suppliers. provide or

136

104 cfu/g, Humidity <13% Protein: 40% Other quality parameters as Receiving (greasing detergents, insecticides, pesticides, sacks etc (CCP-2) Receiving (CCP-3) of Low molecular No migration. compounds migrating from packaging materials. Control of Per lot. QAM of Chemical per standards. Materials suitable Control of the Per lot QAM Control and quality certificates from suppliers. Observations of and quality certifications specifications Rejection and/or of the supplier. of Rejection of lot and change the suppliers. 38-

secondary materials substances secondary materials.

for certification.

specifications

agent, migrating from food contact.

provide or

packaging materials weight

specifications.

the of the lot supply change

137

from suppliers.

the

Evaluation of Water Total coli forms In agreement Lab control of Monthly. (B) with community legislation 80/778 for potable water. Faeces forms (B) Faeces Streptococcus (B) Sulphur reducing Clostridium (B) Presence of “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ Coli “ “ “ “ “ “ the water quality. QAM the suppliers. “ “

138

undesirable and toxic substances in water (eg. Heavy metals,

ammonia, hydrocarbons, parasites, nitrate). Excessive quantity residual chlorine©, Presence foreign materials (P). Storage of soybeans Growth of Absence in silos (CCP 4) micro organisms & insects. Fungi (B) In five sample Monitoring and Daily QAM “ “ (B) Quality control Per lot QAM Control of Rejection of lot unsuitable. of of

specifications.

139

two of them recording 102-104 cfu/g. Humidity 13% Temp: < 25oC Air Steeping (CCP-5) Conditioning. Quality of water As per the Inspection & used. chemicals quality standards water prescribed by the GFHP and food grade chemicals. Set them as Recording Steeping of the water time described in temperature and timings. and temperature the process. the humidity < temperature.

the and

of Per lot

Production Manager

Control

of Rejection of lot unsuitable.

quality

specifications.

of certifications

of Per lot

Production Manager

Control per season.

of Repair and the e and rejection of of the

conditions as maintenanc equipment

140

lot if not properly steeped.

Grinding (CCP-6)

Type of grinder: Highly burr/colloidal/ hammer mills efficient grinding systems water required. if

Inspection

of Per lot

Quality Testing personnel

As

per

the Adjustment s of the grinding systems to get desired particle size prior operation, otherwise replace the units. of Maintenanc e of the systems prior to use to the

the quality of the mash and and determine TSS. the

prescribed standards.

Addition of hot in two stages.

Cooking (CCP-7)

Pressure cooking 1.2kg.cm2& temperature

Precise at control pressure, temperature

Inspection of the systems recording

of Per batch and the

Production Manager

Control conditions.

cooking

141

121oC for 40 and minutes time.

holding parameters.

and in

repair case

required, otherwise replace Filtration 8) and Use ng filters. decanter Speed of the Inspection centrifuge or the units. drum drums should get maximum residue separated. Monitoring the Deodorization under vacuum vacuum Control the Per lot and the Production Manager Control conditions and inspection vacuum of the quality recording of the extract. Addition of additives Standardization (CCP-9) All the data. of Per batch QAM Observations of Rejection of Every run Production Manager Control conditions. them. of Maintenanc e of the systems prior to use and in repair case

deodorization (CCP- centrifuge/rotati

filter/batch type be adjusted to

required, otherwise of replace them.

dry Control quality

of soymilk base ingredients

the of lot and

142

by sugar water,

adding must syrup, flavors

be

of specifications of the ingredients and concentrations to be used for standardization. The the must exact product be of Per lot Production Manager composition of

specifications and quality certifications from suppliers. Evaluation of the suppliers the

or

change

ingredients like food grade.

supply the suppliers.

(flavored milk).

Homogenization (CCP-10)

Use

of

good Thorough oil/emulsifier as per the required quantity before homogenizati on. Homogenize

controlled. Control

Observations of and quality certifications from suppliers. Evaluation of the suppliers. the specifications

Prior e of the

quality vegetable oil/emulsifier.

mixing of the specifications.

the maintenanc supply system

143

at 3500 psi for 30 minutes.

Recording the pressure the homogenizer and time of holding. Evaluation of Maintenanc the regularly. units e of the units. of

UHT/Pasteurization (CCP-11)

Treatment

of Control

of Good

quality Per lot

Production Manager

soymilk in UHT steam pasteurization.

and instruments fitted with the systems for Per batch or and units be for accurate

plant or direct temperature.

Weighing

Correct weighing measures required as

Control weights.

recording of Weighing scales automatic weighing filling must inspected their

Production Manager

Evaluation of Maintenanc the regularly. units e of the units.

Aseptic (CCP-12)

filling Filling aseptic

in Quality containers

weights. The quality Per Batch must be

QAM

Observations of

Rejection

the of lot and

144

containers.

meeting

the verified.

specifications and quality certifications from suppliers. Evaluation of the suppliers Precautionary maintenance of unit. conditioning the

or

change

specifications.

supply the suppliers.

Storage (CCP-13)

Control RH

of Temperature RH < 65%

Temperature be must checked regularly for regularly be

Every half Production Manager

Rejection of lot. the

temperature and < 20oC

and RH should an hour. tested. AC unit

air doubtful

Transportation

GMP.GFHP

Vehicle food transport.

it’s functioning. for Use anti insect Per lot methods disinfection the regularly and of for vehicle

Production Manager

Precautionary maintenance of the vehicle.

Rejection of the lot if not maintains the quality

145

maintaining GFHPs. Cleaning in Place Automatic/man CIP plant Use the set Must other equipment from reputed Dealers be of

as required by the food laws.

ual cleaning of must be SS practices like: pipe lines, tanks and etc. consists Pre rinse with rinsing lye,70oC, with rinsing with and of tanks for water, water, lye & with acid, disinfectant dosing system, centrifugal operated valves system. water, SS flushing water disinfection and with flushing

best SS and

with acid 70oC,

pump, SS air finally

steam heating disinfectant.

146

147

Soymilk Processing Line
Weighing Unit Precleaner Steamer Dehuller Cleaner Bagging unit

Enzyme inactivator grinder

Plate heat exchanger

Decanter

Deodorizer

Mixing Tanks

Sugar/flavor solution tanks

Oil storage

Homogenizer Storage tanks Direct method sterilizer Aseptic homogenizer

Aseptic filling

148

Soymilk Plant Layout

Soybean Store

Shelling/Dehulling

Raw materials Store

Soymilk Processing
(Base/standardization/CIP plant)

Utilities

Packaging material store

Aseptic Filling and Packaging

QC Lab

Product store

149

150

Table 48.Synoptical presentation of hazards, CC limits, observation procedures, monitoring and corrective measures for production of Soypaneer. Process step Receiving (CCP-1) of Hazard Critical limit Observation procedures Responsibl Control CCP Frequency e Visual control Per lot QAM of sample/control of lot. Growth micro organisms (B) Insects Fungi Out of five Control of the samples two certification. of them 102of Absence the certification per Monitoring Corrective

description soybeans Presence of 5% foreign matter in soybean (P)

procedures actions Control of Rejection specifications and quality certificates from suppliers. of lot and change the suppliers. provide or

151

104 cfu/g, Humidity <13% Protein: 40% Other quality parameters as Receiving detergents, 2) of secondary Chemical per standards. Materials suitable Control of the Per lot QAM Control and quality certificates from Receiving of packaging Low molecular No migration. weight compounds migrating from packaging materials. Control of Per lot. QAM suppliers. Observations of and quality certifications specifications Rejection and/or of the supplier. of Rejection of lot and change the suppliers. 38-

materials (greasing agent, substances pesticides, sacks etc (CCP- secondary materials.

for certification.

specifications

insecticides, migrating from food contact.

provide or

materials (CCP-3)

specifications.

the of the lot supply change

152

from suppliers.

the

Evaluation of Water Total coli forms In agreement Lab control of Monthly. (B) with community legislation 80/778 for potable water. Faeces forms (B) Faeces Streptococcus (B) Sulphur reducing Clostridium (B) Presence of “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ Coli “ “ “ “ “ “ the water quality. QAM the suppliers. “ “

153

undesirable and toxic substances in water (eg. Heavy metals,

ammonia, hydrocarbons, parasites, nitrate). Excessive quantity residual chlorine. Presence foreign materials (P). Storage of soybeans in Growth of Absence silos (CCP-4) micro organisms & insects. Fungi (B) In five sample Monitoring and Daily QAM “ “ (B) Quality control Per lot QAM Control of Rejection of lot unsuitable. of of

specifications.

154

two of them recording 102-104 cfu/g. Humidity 13% Temp: < 25oC Air Steeping (CCP-5) Conditioning. Quality of water As per the Inspection & used. chemicals quality standards water prescribed by the GFHP and food grade chemicals. Set them as Recording Steeping of the water time described in temperature and timings. and temperature the process. the humidity < temperature.

the and

of Per lot

Production Manager

Control

of Rejection of lot unsuitable.

quality

specifications.

of certifications

of Per lot

Production Manager

Control per season.

of Repair and the e and rejection of of the

conditions as maintenanc equipment

155

lot if not properly steeped.

Grinding (CCP-6)

Type of grinder: Highly burr/colloidal/ hammer mills efficient grinding systems water required. if

Inspection

of Per lot

Quality Testing personnel

As

per

the Adjustment s of the grinding systems to get desired particle size prior operation, otherwise replace the units. of Maintenanc e of the systems prior to use to the

the quality of the mash and and determine TSS. the

prescribed standards.

Addition of hot in two stages.

Cooking (CCP-7)

Pressure cooking 1.2kg.cm2& temperature

Precise at control pressure, temperature

Inspection of the systems recording

of Per batch and the

Production Manager

Control conditions.

cooking

156

121oC for 40 and minutes time.

holding parameters.

and in

repair case

required, otherwise replace Filtration deodorization (CCP-8) and Use ng filters. decanter Speed of the Inspection centrifuge or the units. drum drums should get maximum residue separated. Monitoring the Deodorization under vacuum Coagulation (CCP-9) Type used of and Control the Per lot and the Production Manager Control conditions vacuum vacuum of Every run Production Manager Control conditions. them. of Maintenanc e of the systems prior to use and in repair case

centrifuge/rotati

filter/batch type be adjusted to

required, of otherwise replace them.

and inspection recording of the quality data.

of the extract. salt Nigari type the This produced

Select the salt Per lot type of tofu

Selection salt

of

is based on the

concentration.

157

from seawater during and

the required. salt

manufacture contains magnesium sulphate, magnesium chloride, and calcium chloride. It is used at 3% by weight of dry beans 78-85oC. Sulphates Calcium sulphate gypsum magnesium or and and coagulates at

158

sulphate

or

Epson salt are both used at 2.2% of dry beans at 7075oC. Gypsum coagulates more than give smoothest texture maximum precipitation. The hydrated form is heated and particles then ground to fine and slowly other the

coagulants to

159

before use. Acids Citrus citric juice, acid,

lactic acid or 4% vinegar is used. Lemon juice is used at 21% and vinegar at 16%. of dry beans at 8090oC. Lactone Glucono delta lactone mixed soymilk 0.6% is with at and

heated to 8590oC for 30-

160

50 minutes. The coagulation is important and requires care. If the curd has a crumbly texture, it is likely to have been much coagulant too fast and at too high temperature, causing paneer form quickly. Insufficient the to too caused by adding too

161

coagulant will give yield. Different coagulants are used mixture. either singly or as a a low

Heating and coagulation Mode of adding The (CCP-10) the salt A

soymilk Careful addition small of is

Per lot

Production Manager

is boiled. amount coagulant

162

placed into a wooden metal container and the hot milk is added. Finally reminder the of or

the coagulant is added and the mixture is left for 15-20 minutes coagulate. Filtration of the coagulum Mode (CCP-11) filtration of Unbleached cheesecloth is used to line a wooden container/met al perforated “ “ “ “ “ to

163

box which

into the

coagulated milk is pored carefully. The reminder of the cloth is folded on top and lid is fitted. a wooden/metal

Pressure applied (CCP-12)

Type of paneer For to be made paneer pressures

soft “ the

recommended are 2-4 g/cm2

164

for minutes

five and

then increased to 5-10 g/cm2 for minutes 10-15 or

until the whey stops draining out. For paneer pressure required is 20100 g/cm2 for 20-30 minutes. Cooling (CCP-13) Temperature of water The final “ may “ “ “ “ firmer the

and the quality product

be cooled in water at 5oC

165

for minutes before

60-90 being

packaged and refrigerated or sold directly. Storage (CCP-14) Control RH of Temperature RH < 65% Temperature be must checked regularly Transportation GMP.GFHP Vehicle food transport. for Production Manager Precautionary maintenance of the vehicle. Rejection of the lot if not maintains the quality as required it’s functioning. for Use anti insect Per lot methods disinfection the regularly maintaining and of for vehicle regularly be Every half Production Manager Precautionary maintenance of unit. conditioning Rejection of lot. the

temperature and < 20oC

and RH should an hour. tested. AC unit

air doubtful

166

GFHPs. Cleaning in Place Automatic/man CIP plant Use the set Must other equipment from reputed Dealers be of

by the food laws.

ual cleaning of must be SS practices like: pipe lines, tanks and etc. consists Pre rinse with rinsing lye,70oC, with rinsing with and of tanks for water, water, lye & with acid, disinfectant dosing system, centrifugal operated valves system. water, SS flushing water disinfection and with flushing

best SS and

with acid 70oC,

pump, SS air finally

steam heating disinfectant.

167

168

Tofu fingers

169

Isolated Soy proteins (ISP) • • • • • Concentrated form of commercially available soy protein products. They contain > 90% protein on a moisture free basis. The basic process involves solubilization of proteins in water. The solution is separated from the solid residue and finally precipitated, separated and dried. Free from objectionable odors, flavors, color, antinutritional factors and flatulances. ISP can be further modified and processed in to spun fibres as an ingredient for muscle food analogs, proteinates and enzyme modified ISP. Definition: Association of American Feed Control Officials (AAFCO) defines, as “SPI is the major proteinaceous fraction of soybeans prepared from dehulled soy beans by removing the majority of non protein components and must contain not less than 90% protein on a moisture free basis”. Conventional Procedure: • • • • Protein solubilization at neutral or slightly alkaline pH. Precipitation by acidification to the isoelectric pH 4.5. The isoelectric ISP has low solubility in water and limited functional properties. Resuspending isoelectric ISP in water neutralizing with different bases and spray drying the resulting solution or suspension can produce different proteinates. i. ii. iii. iv. Sodium Potassium Ammonium Calcium

The first three are highly soluble in water, high viscosity solutions, foaming, emulsification, gel forming etc. The later one is used for high level of incorporation without excessive viscosity.

170

Available in fine powders, granules, spun fibres and other fibrous forms.

Table 49 Product descriptions: 1. Product name 2. Important product characteristics of end product Isolated Soy Protein Aw < 0.5; FFA < 1%; Total microbial counts < 50000/g. The soy isolated protein may contain Protein: > 90%, Fat: max 0.5%, Ash: max 4.5% and Total carbohydrates: max 0.3%.

3. How the product is to be used

The protein may be used in all food formulations and health foods for enriching with protein and also for different functional properties as required.

4. Packaging

Packed in hermetically sealed glass/polythene/laminated packaging systems.200-500 g packets are available. The isolated soy protein has shelf life of 12 months at room temperature. It has to be stored and distributed at ambient temperature. Retail, institutions and food service. Could be consumed as a health food. Required to ensure product safety. No physical damage, excess humidity or temperature extremes.

5. Shelf-life

6. Where the product will be sold 7. Labeling instructions 8. Special distribution control

171

Soy protein isolate The identified biological, chemical and physical hazards related to the production of soy protein isolates are given as under. Table 50.Product ingredients and incoming material (P=physical; B=biological; C=chemical) Raw material Soybeans B, C, P Other Water (municipal) B, C Table 51.Flow diagram Soybeans Packaging material 1. Receiving P 2.Receiving P 5.Storing B P 6.Storing B C P 8. Cleaning P 9.Inspecting B P 11. De hulling P 12 De fatting B C 14. Alkali solubilization B C 15.Acid precipitation B C 16.Spray Drying B, C 17.Filling C P 18.Weighing B 19.Closing/sealing B 20.Inspecting B P 21. Labeling B 22. Storing B 23.TransportB B= biological; C=chemical; P=physical Dry ingredients 3. Receiving P 7. Storing B C P 10. Dumping Water 4. In taking Packaging material Polythene bags B, C, P Dry ingredients Sodium bicarbonate B, C, P

13. Chlorinating

The details of all the hazards are enumerated as under.

172

Identified Biological Hazards Ingredients/materials: Soybeans - could contain soil borne/ air borne pathogenic organisms, yeasts or moulds. Dry ingredients - could contain microbial contaminants. - could contain rodent excrements. Water - could contain microorganisms Packaging materials - could contain defects that could result in leakage. Processing steps: Cleaning De hulling Weighing Transport physical damage to packages results in leakage and contamination of product. Identified Chemical Hazards Ingredients/materials: Soybeans - could contain pesticide residues. - could contain mycotoxins. Water - could be contaminated with toxic substances. Processing steps: Dry ingredients storage overfilling may lead to leakage and prone to contamination. could contain microorganisms. could be contaminated with microorganisms.

173

De fatting -

could be contaminated with non-food chemicals as a result of improper storage. cleaning chemical residues could contaminate the beans.

Alkali solubilization - excess alkali may affect the quality. Acid precipitation - excess acid may affect the quality. Identified Physical Hazards: Ingredients/ materials Soybeans could be contaminated with harmful extraneous materials namely glass, metal, plastic, wool etc.

Dry ingredients - could be contaminated with harmful extraneous materials Soybean receiving inadequate protection against harmful extraneous material could result in contamination. Dry ingredient receiving in adequate protection against harmful extraneous material could result in contamination. Some of the unaddressed hazards connected to this process are presented in the preceding text. Table 52.Unaddressed Hazards Unaddressed hazard from previous list Identified methods of addressing the hazard Soybeans could contain pesticide residues Up stream (farm level) programs such as A: Training persons who apply pesticides. B: Purchasing registered pesticides for growers. C: Auditing growers application of pesticides and records there of. D: Requiring periodic pesticide residual analysis reports. -

174

Description of soy protein isolates manufacturing process: Implementation of HACCP. Receiving soybeans (CCP-1): Soybeans must come from approved dealers. At the time of its receipt it must be accompanied with its complete quality certificate and microbiological assessment reports. The certificates should indicate the moisture content of the beans, degree of foreign materials and the microorganisms present (number of colonies), insects etc as compared to the upper approved standards of BIS/ISO. At the time of receipt, visual control of soybeans must be carried out to find out the contaminants if any. Further more the proximate composition of the beans must be established with reference to its macro and micronutrients. Defective beans mean that the soy flour will be most likely unsafe for the consumption. Storage of soybeans in silos (CCP-4): The temperature (<20oC) and the relative humidity (<65%) during the storage must be low. They should be recorded at regular intervals. If any deviation from the safer limits, must be immediately rectified. When soybean is stored for a long period, microbiological analysis should be carried out. Receiving secondary materials (greasing, detergents, insecticides, pesticides and sacs) (CCP-2): These materials must be procured from the approved suppliers with quality certificates. These materials must be suitable for using them with food items. No contamination must come from the packaging materials. If these materials do not comply with the standard specifications, must be returned to the suppliers and a new order should be placed with other suppliers. Storage of secondary materials (CCP-3): The temperature and relative humidity during storage must be below 20oC and 65% respectively. The place should be air-conditioned. The temperature and RH should be continuously recorded and corrective actions must be undertaken whenever any deviation occurs. Application of anti insect methods (CCP-5): Any chemicals used during storage along with the soybeans should comply with the safety legislations. The quantity should be with in the prescribed concentrations.

175

Cleaning & grading of soybeans (CCP-6): All the physical contaminants should be removed. They should be graded. Only sound soybeans should be taken for processing. Removal of stones: The stones, metals and dust must be removed from the soybeans so that the final product will comply the quality standards as prescribed by BIS/ISO. Weighing: the soybeans are weighed and passed through a magnetic system so that the magnetic materials are removed. Defatting the beans and preparation of flakes (CCP 7): Care must be taken while defatting the beans and making white flakes. These flakes permit easier separation after extraction. The flakes must have the highest protein solubility for maximum recovery. The heat treatment of the flakes may be monitored in terms of the NSI values. The initial NSI values must be very high. Extraction Medium and Conditions (CCP 8): Flakes are mixed with extraction medium, in agitation (rpm?) and heated vessels (time/temp). Extraction medium in water to which an alkali (NaOH, Ca (OH) 2, NH4 or tribasic sodium phosphate) has been added (quality/conc?). pH to neutral or slightly alkaline. More proteins can be extracted at higher pH. However the proteins may undergo chemical modifications/ denaturation/ maillard reaction and formation of dark pigments and in loss of nutritive value. pH 7.5 pH 9.0 are most commonly preferred. Loss of cysteine-dehydroalanine and loss of lysinelysinoalanine may occur. Under these conditions, majority of the proteins go in to solution. The sugars and other soluble substances are also dissolved. Extraction time may 30 minutes-60 minutes. Temperature is up to 80oC. The solid/liquid ratio is2.5 times the weight of solid. Larger volumes of liquid mean larger extraction vessels, centrifuges and a larger volume of whey for disposal. Industrial level is in between 1:10 and 1:20Agitation; agitation (rpm?) increases the rate of protein solubilization. One-hour extraction time with moderate agitation is preferred. Strong agitation causes flakes disintegration. Solid-liquid separation after extraction (CCP 9): Extract clarification process in two steps. Screening (vibrating screen/ rotary screen) to separate the solids followed by centrifugal clarification or in one step by using the decanter centrifuges.

176

Extract treatment (CCP 10): The clarified extract can be treated to remove the impurities further ion exchanges to remove phytates/ash contents; activated carbon to remove the phonetic compounds; UF to concentrate and remove low MW components etc; use of membrane processes for extract purification. Precipitation (CCP 11): Isoelectric pH(type of acid/temp?). Separation and washing of the curds (CCP 12): Curd is separated from the whey by filtration or centrifugation (Desludger/decanted centrifuges). Curd must be washed to remove residues of whey soluble thorough washing is most important. Drying (CCP 13): Spray drying is mostly used. Packaging (CCP-14): During packaging the protein isolates can possibly be contaminated with the microorganisms causing quality deterioration. Hermetic sealing and upright position of the packaging material can avoid this. There should not be any migration of the low molecular weight substances from the packages. Further more contamination can take place from foreign materials like insects and rodents that accidentally happen to be packed with the protein isolates. The personnel should comply with the GMPs. Storage of protein isolates (CCP-15): Both the temperature and relative humidity must be below 20oC and 65% respectively. They should be recorded and corrective actions must be taken when deviating. When the flour is stored for a long period, microbiological analysis is required. Metal detector (CCP-16): The packed product passes through a metal detector. The product is then checked for its weight and placed in boxes (secondary packaging). The boxes are placed on the pallets and the packets are wrapped with film. Problems in conventional processing: Process losses: i. Okara: 40% of the solids in the raw material and carries away 15% of the protein entering the process.

177

ii. iii.

Whey: 25% of the dry matter and 10% of its nitrogen are found in this fraction. Curd: Contains 75% of the protein of starting material.

Quality: Impurities like phytates and phenols. Alternative processes: i. ii. iii. iv. Solubilization of the soy proteins in the salt solutions (salting-in) followed by precipitation with water. Precipitation from the extract at near boiling using calcium salts. (Tofu). UF of the extract to remove low molecular weight components & filtration through ion exchange / activated carbons. Physical separation of the intact protein bodies from very finely ground soy flour by density fractionation. Table 53.Expected quality of soy protein isolates (100g) Calories: 384 Total fat: max 0.5g Total carbohydrates: 1 g Protein: minimum 90g Sodium: 1.1g Ash: max 5g Calcium: 200 mg Potassium: 92 mg Phosphorus: 880 mg Folate: 200 mcg Isoflavones: 112 mg.

178

Proce ss flow chart:
White Flakes

Water (GMP)

Extraction

Alkali (CCP)

Pulp Washing Separation Residue

Separation (CCP)

Extract

Acid (CCP)

Precipitation

Curd Separation

Washing

Separation Alkali Washed curd

Whey

Neutralization

Re suspension

Water

179

Spray Drying Proteinate

Spray Drying Iso electric ISP

180

Table 54.Synoptical presentation of hazards, CC limits, observation procedures, monitoring and corrective measures for production of ISP Process step Receiving soybeans/defatted soy flakes (CCP-1) Hazard Critical limit Observation procedures Responsibl Control CCP Frequency e Visual control Per lot QAM of sample/control of lot. Growth micro organisms (B) Insects (B) Fungi Absence Out of five samples two of them 102of Absence Control of the “ certification. “ the certification per Monitoring Corrective

description of Presence of 5% foreign matter in soybean (P)

procedures actions Control of Rejection specifications and quality certificates from suppliers. Evaluation of “ the supplier. of lot and change the suppliers. provide or

181

104 cfu/g, Humidity <13% Protein: 40% Other quality parameters as Receiving (greasing detergents, insecticides, pesticides, sacks etc (CCP-2) Receiving (CCP-3) of Low molecular No migration. compounds migrating from packaging materials. Control of Per lot. QAM of Chemical per standards. Materials suitable Control of the Per lot QAM Control and quality certificates from suppliers. Observations of and quality certifications specifications Rejection and/or of the supplier. of Rejection of lot and change the suppliers. 38-

secondary materials substances secondary materials.

for certification.

specifications

agent, migrating from food contact.

provide or

packaging materials weight

specifications.

the of the lot supply change

182

from suppliers.

the

Evaluation of Water Total coli forms In agreement Lab control of Monthly. (B) with community legislation 80/778 for potable water. Faeces forms (B) Faeces Streptococcus (B) Sulphur reducing Clostridium (B) Presence of “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ Coli “ “ “ “ “ “ the water quality. QAM the suppliers. “ “

183

undesirable and “ toxic substances in water (eg. Heavy metals,

ammonia, hydrocarbons, parasites, nitrate). Excessive quantity residual chlorine. Presence foreign materials (P). Storage of soybeans Growth of Absence in silos (CCP 4) micro organisms & insects. Fungi (B) In five sample Monitoring and Daily QAM “ “ (B) Quality control Per lot QAM Control of Rejection of lot unsuitable. of “ “ “ “ “ “ of “ “ “ “ “ “

specifications.

184

two of them recording 102-104 cfu/g. Humidity 13% Temp: < 25oC Air Extraction (CCP 5) Agitation (rpm) humidity < temperature.

the and

Conditioning. As per the Monitoring the Per batch scheduled limit. speed grinding. while

Production Manager

Observe conditions and record.

the If deviating may be put in to order, otherwise replace the system.

Heated vessels “ (temp&time)

Monitoring the “ temperature and schedules. time

Extraction medium (quantity As per the Evaluation of Every Production Manager Observe the Reject lot the and and standards the quality and batch. certification

quality of the prescribed for concentration

of the supplier change the

185

salts

like isolation. or tribasic

before run.

for quality.

supplier.

NaOH, Ca (OH)
2.NH4

sodium phosphate. pH (neutral/slightly alkaline). pH 7.5-9.0 Observe and Every run QAM Verification of In the results. faulty results, replace the equipment. 30-60 Extraction time minutes. 80oC max. Extraction temperature Solid/liquid Solid/liquid separation (CCP 6) ratio Screening using vibratory/rotary screens. 1:10/1:20 case record the pH.

186

Centrifugal clarifications. Decanter centrifuge. Extract (CCP 7) treatment Use ted brane Precipitation 8) technology. (CCP Iso electric pH ion Remove phytates/poly phenols/ash/lo mw components pH 4.0-4.5 All parameters should monitored. be the Every run Product Manager Quality check Per batch QAM Laboratory the after treatment. Quality control report If deviating the

exchange/activa

of the product

assessment of repeat negative results.

extract process for

carbon/UF/mem w

Adjust the parameters and maintain the quality. Otherwise repeat process. “ the

Type

of

acid HCl/H2SO4

Quality must be Every

Product

Quality Check “

187

used Temperature of precipitation.

RT to 80oC

tested. Regulation temperature.

batch of Per lot

Manager QAM

Quality assessment and monitoring the results. “

Separation (CCP 9)

& Filtration/centri fugation (desludger.deca nter centrifuge)

All residues should removed. Optimized

the Quality of assessment. be Quality of

Every run.

QAM

washing of the curds

whey soluble

Drying (CCP 10)

Spray drying

conditions as assessment Weighing (CCP 11) Correct weighing measures required as per scheduled. the product. Control of Weighing weights. scales automatic weighing filling must inspected their weights.

Per batch or and

Production Manager

Evaluation of Maintenanc the regularly. units e of the units.

units be for accurate

188

Aseptic filling (CCP Filling 12) aseptic containers.

in Quality containers meeting specifications.

The must the verified.

quality Per Batch be

QAM

Observations of and quality certifications from suppliers. Evaluation of the suppliers Precautionary maintenance of unit. conditioning the specifications

Rejection or change

the of lot and supply the suppliers.

Storage (CCP 13)

Control RH

of Temperature RH < 65%

Temperature be must checked regularly for regularly be

Every half Production Manager

Rejection of lot. the

temperature and < 20oC

and RH should an hour. tested. AC unit

air doubtful

Transportation

GMP.GFHP

Vehicle food transport.

it’s functioning. for Use anti insect Per lot methods disinfection and of

Production Manager

Precautionary maintenance of the vehicle.

Rejection of the lot if not

189

the regularly

vehicle for

maintains the quality as required by the food laws.

maintaining GFHPs. Cleaning in Place Automatic/man CIP plant Use the set Must other equipment from reputed Dealers be of

ual cleaning of must be SS practices like: pipe lines, tanks and etc. consists Pre rinse with rinsing lye70oC, with rinsing with and of tanks for water, water, lye & with acid, disinfectant dosing system, centrifugal operated valves system. water, SS flushing water disinfection and with flushing

best SS and

with acid 70oC,

pump, SS air finally

steam heating disinfectant.

190

191

Plant Schematic/Floor Plan Preparatory Area Silos/Storage Bins Soaking in vats Wet Processing Area Dry Processing Area Dryers

Cleaners Extractors Blanching Dehuller Separators Flakers/flaking Precipitators

Separators

Whey neutralizers/ washers

Spray dryers

Storage rooms/Transportation

192

Production of Soy sauce
Soybeans/DFSF 50% Cooked Mixed Koji-Murami Koji Moromi Mash Brine fermentation Pressed Raw soy sauce Refining process Pasteurized Koikuchi-Shoyu Lactic acid bacteria/yeast Fermented Cake Incubated Brine Wheat 50% Roasted & crushed Seed mold (Aspergillus.oryzae) Salt

193

Soy sauce: Today soy sauce is made by two methods: the traditional brewing method, or fermentation, and the non-brewed method, or chemical-hydrolyzation. The fermentation method takes up to six months to complete and results in a transparent, delicately colored broth with balanced flavor and aroma. The non-brewed sauces take only two days to make and are often opaque with a harsh flavor and chemical aroma. Soy sauce has been used to enhance the flavor profiles of many types of food, including chicken and beef entrees, soups, pasta, and vegetable entrees. It’s sweet, sour, salty, and bitter tastes add interest to flat-tasting processed foods. The flavor enhancing properties, or umami, of the soy extract are recognized to help blend and balance taste. The condiment also has functional preservative aspects in that its acid, alcohol, and salt content help prevent the spoilage of foods. Raw materials: • Soybeans-The soybeans used in soy sauce are mashed prior to mixing them with other ingredients.

Wheat-In many traditional brewed recipes, wheat are blended in equal parts with the soybeans. Pulverized wheat is made part of the mash along with crushed soybeans. The non-brewed variety does not generally use wheat.

194

Salt- Salt, or sodium chloride, is added at the beginning of fermentation at approximately 12-18% of the finished product weight. The salt is not just added for flavor; it also helps establish the proper chemical environment for the lactic acid bacteria and yeast to ferment properly. The high salt concentration is also necessary to help protect the finished product from spoilage.

Fermenting agents-The wheat-soy mixture is exposed to specific strains of mold called Aspergillus oryzae or Aspergillus soyae, which break down the proteins in the mash. Further fermentation occurs through addition of specific bacteria (lactobaccillus) and yeasts which enzymatically react with the protein residues to produce a number of amino acids and peptides, including glutamic and aspartic acid, lysine, alanine, glycine, and tryptophane. These protein derivatives all contribute flavor to the end product.

Preservatives and other additives-Sodium benzoate or benzoic acid is added to help inhibit microbial growth in finished soy sauce. The non-brewed process requires addition of extra color and flavor agents.

The Manufacturing Process Traditional brewed method Brewing, the traditional method of making soy sauce consists of three steps: koji-making, brine fermentation, and refinement. Koji-making Soybeans/defatted soy meal mixed with roasted and coarsely broken wheat are cooked in continuous pressure cookers with adequate amounts of water until the grains are thoroughly cooked and softened... The mash, as it is known, is allowed to cool to about 27°C before a proprietary seed mold (Aspergillus) is added .The mass is inoculated with a mould, Aspergillus oryzae (A.sojae) and incubated in shallow vats with perforated bottoms. Air is forced through the molds. After three days of incubation under controlled

195

Conditions of temperature and moisture the mould growth cover the entire mass, which turns greenish as a result of sporulation. The mass is called Koji, essential ingredient of most of the oriental fermentations. It is concentrated source of amylolytic and proteolytic enzymes necessary for the decomposition of the carbohydrates and proteins. The koji is

Koji mixed with brine containing 22-25% salt (w/v) and transferred to deep fermentation tanks. The high concentration of salt inhibits the growth of wild microorganisms. Brine fermentation The koji is transferred to fermentation tanks, where it is mixed with water and salt to produce a mash called moromi. Lactic acid bacteria and osmophillic yeasts cultures are added and the slurry (called moromi-mash) is allowed to ferment at controlled temperature and occasional aeration. The starch is transformed to sugars, which are fermented to lactic acid and alcohol. pH drops from near neutral to 4.7-4.8. The moromi is held in the fermentation tanks for 6-8 months. The fermented mash is pressed to separate the sauce from the solid residue. The sauce is filtered, clarified and heated to 7080oC. Heating is necessary to pasteurize the sauce and to develop characteristic color and aroma. After final clarification the sauce is bottled. The use of defatted soybean meal instead of whole soybeans is justified, since most of the oil is lost in the residue. Soy sauce is popular in SE Asia. It contains much lower proportion of wheat and therefore less alcohol in the final product. It contains 28% soluble solids (18% salt& 7% protein). The moromi must ferment for several months, during which time the soy and wheat paste turns into a semi-liquid, reddish-brown "mature mash." This fermentation process creates over 200 different flavor compounds.

196

Soy sauce Refinement After approximately six months of moromi fermentation, the raw soy sauce is separated from the cake of wheat and soy residue by pressing it through layers of filtration cloth. The liquid that emerges is then pasteurized. The pasteurization process serves two purposes. It helps prolong the shelf life of the finished product, and it forms additional aromatic and flavor compounds. Finally, the liquid is bottled as soy sauce.

Non-brewed method (chemical hydrolysis) Instead of fermenting, many modern manufactures artificially break down the soy proteins by a chemical process known as hydrolysis because it is much faster. (Hydrolysis takes a few days as compared to several months for brewing.)

197

1. In this method, soybeans are boiled in hydrochloric acid for 15-20 hours to remove the amino acids. When the maximum amount has been removed, the mixture is cooled to stop the hydrolytic reaction. 2. The amino acid liquid is neutralized with sodium carbonate, pressed through a filter, mixed with active carbon, and purified through filtration. This solution is known as hydrolyzed vegetable protein. 3. Caramel color, corn syrup, and salt are added to this protein mixture to obtain the appropriate color and flavor. The mixture is then refined and packaged. Sauces produced by the chemical method are harsher and do not have as desirable a taste profile as those produced in the traditional brewed manner. The difference in taste occurs because the acid hydrolysis used in the non-brewed method tends to be more complete than its fermentation counterpart. This means that almost all the proteins in the nonbrewed soy sauce are converted into amino acids; while in the brewed product more of the amino acids stay together as peptides, providing a different flavor. The brewed product also has alcohols, esters, and other compounds that contribute a different aroma and feel in the mouth. In addition to the brewed method and the non-brewed method, there is also a semibrewed method; in which hydrolyzed soy proteins are partially fermented with a wheat mixture. This method is said to produce higher quality sauces than can be produced from straight hydrolysis.

198

Quality Control Numerous analytical tests are conducted to ensure the finished sauce meets minimum quality requirements. For example, in brewed sauces, there are several recommended specifications. Total salt should be 13-16% of the final product; the pH level should be 4.6-5.2; and the total sugar content should be 6%. For the non-brewed type, there is 42% minimum of hydrolyzed protein; corn syrup should be less than 10%; and carmel color 13%. The fermented sauce must be made from fermented mash, salt brine, and preservatives (either sodium benzoate or benzoic acid). This specification also states that the final product should be a clear, reddish brown liquid that is essentially free from sediment. The non-fermented sauce is defined as a formulated product consisting of hydrolyzed vegetable protein, corn syrup, salt, caramel color, water, and a preservative. It should be a dark brown, clear liquid. The Japanese are more specific in grading the quality of their soy sauces. They have five types of soy sauce: koikuchi-shoyu (regular soy sauce), usukuchi-shoyu (light colored soy sauce), tamari-shoyu, saishikomi-shoyu, and shiro-shoyu. These types are classified into three grades, Special, Upper, and Standard, depending upon sensory characteristics such as taste, odor, and feel in the mouth, as well as analytical values for nitrogen content, alcohol level, and soluble solids. Byproducts/Waste The fermentation process produces many "byproducts" that are actually useful flavor compounds. For example, the various sugars are derived from the vegetable starches by action of the moromi enzymes. These help subdue the saltiness of the finished product. Also, yeast acting on sugars forms alcohols. Ethanol is the most common of these alcohols, and it imparts both flavor and odor. Acids are generated from the alcohols and sugars, which round out the flavor and provide tartness. Finally, aromatic esters (chemicals that contribute flavor and aroma) are formed when ethanol combines with organic acids.

199

Chemical hydrolyzation also leads to byproducts, but these are generally considered undesirable. The byproducts are a result of secondary reactions that create objectionable flavoring components such as furfural, dimethyl sulfide, hydrogen sulfide, levulinic acid, and formic acid. Some of these chemicals contribute off odors and flavors to the finished product. Table 55.Nutritional values of soy sauce (per 100g): Water Energy Energy Protein Fat (total lipid) Fatty acids, saturated Fatty acids, mono-unsaturated Fatty acids, poly-unsaturated Carbohydrates Fiber Ash Isoflavones Calcium, Ca Iron, Fe Magnesium, Mg Phosphorus, P Potassium, K Sodium, Na Zinc, Zn Copper, Cu Manganese, Mn Selenium, Se Vitamin C (ascorbic acid) 71.0 g 53 Kcal 221 KJ 5.2 g 0.08 g 0.01 g 0.01 g 0.04 g 8.5 g 0.8 g 15.1 g 1.6 mg 17.0 mg 2.0 mg 34 mg 110 mg 180 mg 5715 mg 0.37 mg 0.11 mg 0.42 mg 0.8 µg 0.0 mg

200

Thiamin (vitamin B1) Riboflavin (vitamin B2) Niacin (vitamin B3) Panthotenic acid (vitamin B5) Vitamin B6 Folic acid Vitamin B12 Vitamin A Vitamin E

0.05 mg 0.13 mg 3.36 mg 0.32 mg 0.17 mg 16 µg 0.0 µg 0 IU 0.00 mg

201

Soy sprouts: The soybeans for sprouting must be having the following characteristics: • • • Medium seed size (10-12 g /100). High germination rate. High protein, high isoflavone, high sugars and lipoxygenase free.

Table 56.Product description 1. Product name Soy sprouts 2. Important product characteristics of end Aw < 0.5;FFA < 1%; Total microbial counts product < 50000/g 3. How the product is to be used Normally taken as such in salads or mixed along with other sprouted legumes. 4. Packaging Sealed polythene bags or in loose. 5. Shelf-life 2-4 weeks under refrigerated conditions. 6. Where the product will be sold Retail, institutions and food service. Could be consumed as a health food. 7. Labeling instructions Required to ensure product safety. 8. Special distribution control No physical damage, excess humidity or temperature extremes.

202

The plant schematic/floor plan is given as under. Preparatory Area Silos/Storage Bins Soaking in vats in cool water (15-20oC) (2-3 times) for 2-12 hours. Cleaners Rinse and drain for 812 hours. (4 times) Draining Cleaned soybeans Soysprouts, 1/4inch length roots. Harvest. Rinsing with cool water. Wet Processing Area Sprouting Area Germinators

Filling/Weighing/Sealing

Transport

203

The identified biological, chemical and physical hazards and flow diagram related to the production of soy sprouts are given below. Table 57. Product ingredients and incoming material Raw material Soybeans B, C, P Other Water (municipal) B, C Table 58.Flow diagram Soybeans Packaging material 1. Receiving P 2.Receiving P 5.Storing B P 6.Storing B C P 8. Cleaning P 9.Inspecting B P 11. Soaking B C 12. Draining B C 13.Rinsing B P C 15. Sprouting B P C 16.Harvesting B P 17.Filling C P 18.Weighing B 19.Closing/sealing B 20.Inspecting B P 21. Labeling B 22. Storing B 23.TransportB P=Physical; B=Biological, C=Chemical The details of all the hazards are enumerated as under. Identified Biological Hazards Ingredients/materials: Soybeans - could contain soil borne/ air borne pathogenic organisms, yeasts or moulds. Dry ingredients 3. Receiving P 7. Storing B C P 10. Dumping Water 4. In taking Packaging material Polythene bags B, C, P Dry ingredients Silica B, C, P

14. Chlorinating

Dry ingredients - could contain microbial contaminants. - could contain rodent excrements.

204

Water - could contain microorganisms Packaging materials - could contain defects that could result in leakage. Processing steps: Cleaning Soaking Rinsing Sprouting Weighing Transport physical damage to packages results in leakage and contamination of product. Identified Chemical Hazards Ingredients/materials: Soybeans - could contain pesticide residues. - could contain mycotoxins. Water - could be contaminated with toxic substances. Processing steps: Dry ingredients storage - could be contaminated with non-food chemicals as a result of improper storage. Rinsing overfilling may lead to leakage and prone to contamination. could be contaminated with microorganisms. could contain microorganisms. could contain microorganisms. could be contaminated with microorganisms.

- cleaning chemical residues could contaminate the beans. Identified Physical Hazards: 205

Ingredients/ materials Soybeans could be contaminated with harmful extraneous materials namely glass, metal, plastic, wool etc.

Dry ingredients - could be contaminated with harmful extraneous materials Soybean receiving Inadequate protection against harmful extraneous material could result in contamination.

Dry ingredient receiving in adequate protection against harmful extraneous material could result in contamination. The next step is identification of CCPs. The CCP determination is shown below. Table 59.CCP determination Process Category Q1 step/incoming and materials identified hazard Soybeans B=Pathogens Yes C=Pesticides Q2 Q3 Q4 CCP -

Yes

Yes

Yes, thermal processing

Packaging materials Dry B= bacterial Yes ingredients as spores delivered B=rodent

No (farmers/growers C= heat level-GPP) stable toxins No (farmers/growers P= harmful level-GPP) Yes extraneous material Yes (visual (HEM) inspection and foreign object removal) B=pathogens Yes Yes N/a

Yes

No

Yes Yes

Yes, sterilization Yes, thermal processing

206

Water intake

excretes (GMP) P=HEM (GMP) at B= GMP C= heavy metals & other toxins (GMP) Q1 Q2 Q3 Q4 CCP

Process Category step/incoming and materials identified hazard Cleaning and P=GMP grading of soybeans Soaking of Water soy beans (GMP) Draining Rinsing Filling Weighing Packaging and sealing Water, GMP P (GMP) P (GMP) B

Yes

Yes

Yes

No

CCP-4 (Proper gauge and sealing clearance)

Instructions: • Category and identified hazard: Controlled by Codex General Principles of Food Hygiene, if yes indicate GMP and proceed to next hazard. If no proceed to question 1. • Q1: Do control preventive measures exist, if no, not CCP; if yes proceed to next. • Q2: Is this operation specifically designed to eliminate, if no proceed to Q3. if yes CCP and identify it in the last column. • Q3: Could contamination with identified hazards occur in excess of acceptable levels, if no, not CCP. If yes Proceed to Q4

207

Q4: Will subsequent operation control the contamination levels, if no CCP; if yes not CCP. Some of the unaddressed hazards connected to this process are presented in the preceding text. Table 60.Unaddressed Hazards Unaddressed hazard from previous list Soybeans could contain pesticide residues Identified methods of addressing the hazard Up stream (farm level) programs such as A: Training persons who apply pesticides. B: Purchasing registered pesticides for growers. C: Auditing growers application of pesticides and records there of. D: Requiring periodic pesticide residual analysis reports.

Table 61.HACCP for general activities: Stage Raw material harvest Activity Liaison with the farmers for unit operations like harvesting, threshing and winnowing. Transport in sacks to drying area. Sampling and routine inspection. Control activity Specifications of grain quality are required. Rejection of under sized seeds. Correct sacking and handling. Correct sampling methods, training and inspection methods. Cleaning, grading, de Training operators for hulling, conditioning and equipment, preventing blending. insect infestations, check for moisture content. Filling in to containers and Establish specifications for sealing. labels and fill weights.

Raw material transport Raw material inspection Preparation of seeds

Packaging

208

Description of soy sprouts manufacturing process: Implementation of HACCP. Receiving soybeans (CCP-1): Soybeans must come from approved dealers. At the time of its receipt it must be accompanied with its complete quality certificate and microbiological assessment reports. The certificates should indicate the moisture content of the beans, degree of foreign materials and the microorganisms present (number of colonies), insects etc as compared to the upper approved standards of BIS/ISO. At the time of receipt, visual control of soybeans must be carried out to find out the contaminants if any. Further more the proximate composition of the beans must be established with reference to its macro and micronutrients. Defective beans mean that the soy flour will be most likely unsafe for the consumption. Storage of soybeans in silos (CCP-4): The temperature (<20oC) and the relative humidity (<65%) during the storage must be low. They should be recorded at regular intervals. If any deviation from the safer limits, must be immediately rectified. When soybean is stored for a long period, microbiological analysis should be carried out. Receiving secondary materials (greasing, detergents, insecticides, pesticides and sacs) (CCP-2): These materials must be procured from the approved suppliers with quality certificates. These materials must be suitable for using them with food items. No contamination must come from the packaging materials. If these materials do not comply with the standard specifications, must be returned to the suppliers and a new order should be placed with other suppliers. Storage of secondary materials (CCP-3): The temperature and relative humidity during storage must be below 20oC and 65% respectively. The place should be air-conditioned. The temperature and RH should be continuously recorded and corrective actions must be undertaken whenever any deviation occurs. Application of anti insect methods (CCP-5): Any chemicals used during storage along with the soybeans should comply with the safety legislations. The quantity should be with in the prescribed concentrations. Cleaning & grading of soybeans (CCP-6): All the physical contaminants should be removed. They should be graded. Only sound soybeans should be taken for processing.

209

Removal of stones: The stones, metals and dust must be removed from the soybeans so that the final product will comply the quality standards as prescribed by BIS/ISO. Weighing: The soybeans are weighed and passed through a magnetic system so that the magnetic materials are removed. Soaking of the beans (CCP-7): Add 2-3 times as much cool (15-20oC) water. Mix seeds to assure even water content for all. Allow seeds to soak for 2-12 hours. Prefer to soak for a shorter time. Check after 2 hours for softening. If they are still hard, let them keep soaking until they are all soft (up to 12 hours). Normally 4 hours is usually the right soak duration. If over soak they will fall apart, so will sprout poorly or even rot. Draining& rinsing (CCP-8): Drain off the soak water. Rinse thoroughly with cool water (15-20oC). Soy soak water is starchier than most other seeds, so rinse and rinse until the water that is drained off runs clear. Drain thoroughly. Set the sprouts away from the direct sunlight and at room temperature. Rinse and drain again 8-12 hours. And once more rinse and drain again for 8-12 hours. And perhaps once more rinse and drain again for 8-12 hours. And conceivably once more rinse and drain for 8-12 hours. Sprouting (CCP-9): Soy will sprout better with more frequent rinses and drains every 48 hours. With personal preferences, it may be rinsed and drained again at 4-8 hours. Stop here, many like the sprouts small. The rinsing and draining may be continued again at 812 hours interval up to 6 days. These sprouts have only i/4 inch roots, which is typically after just 3 rinses and drain cycles. Grow them as long as people like (continue rinse and drain schedules) and find out when they are most delicious. When rinsed, try not to disturb the seeds/sprouts. Let them stay where they are. On the 3rd day, soak the sprouts in cool water for 10-20 minutes. Rinse well after this soaking. Allow the sprouts to grow for 24 hours with out water. They will generate more heat (which all sprouts do as they grow out every stage) than usual and gain mass during this period. However, there is a slight danger in this- that the sprouts will generate too much heat and will start to slow cook, but it is a rare problem. Harvest (CCP-10): The sprouts are done 8-12(or 24 h) hours after the final rinse. Be sure to drain them as thoroughly as possible after the final rinse. The goal during the final

210

8-12 hours is to minimize the surface moisture of sprouts. They will store best in refrigerator if they are dry to the touch. Transfer the sprouts to a plastic bag or the sealed container of choice/ glass and put them in the refrigerator. Yield: 2:1 Packaging (CCP-11): During packaging the sprouts can possibly be contaminated with the microorganisms causing quality deterioration. Hermetic sealing and upright position of the packaging material can avoid this. There should not be any migration of the low molecular weight substances from the packages. Further more contamination can take place from foreign materials like insects and rodents that accidentally happen to be packed with the sprouts. The personnel should comply with the (Good Manufacturing Process). Storage of sprouts (CCP-12): Both the temperature and relative humidity must be below 20oC and 65% respectively. They should be recorded and corrective actions must be taken when deviating. When the sprouts are stored for a long period, microbiological analysis is required. Metal detector (CCP-13): The packed product passes through a metal detector. The product is then checked for its weight and placed in boxes (secondary packaging). The boxes are placed on the pallets and the packets are wrapped with film.

211

The synoptical presentation of HACCP is shown as under.

212

213

Table 62.Synoptical presentation of hazards, critical control limits, observation procedures and control actions for the production of Soy sprouts
Processing step Hazard description CClimit (CCP) Receiving of soybean (CCP-1) Presence of foreign material in soybean (P) 5% Observation procedures Control of Frequency CCP Visual control ol of of the sample/contr certification s per lot Growth of micro organism (B)/insects Fungi (B) Absence Out of five samples two of them 10 104 cfu/g, Humidity <13% Protein
2

Responsible

Monitoring procedures

Corrective actions

Per lot

QAM

Control specifications procure certificates suppliers

of and quality from

Rejection of lot or change supplier

“ Control the certificates per lot of

“ “

“ “

“ Evaluation supplier of

“ “

214

content 3840% Other macro and Receiving materials agents, secondary (greasing detergents, Chemical migrating substances from the micro “ “ “ “ “ nutrients Materials suitable for food items.

secondary materials.

insecticides, pesticides, sacs etc (CCP-2) Water Total Coli forms (B) In agreement with the community legislation 80/778 potable water (B) Faeces Coli forms (B) Faeces Streptococcus (B) Sulphur Clostridium (B) reducing “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ for Lab control of quality water Monthly QAM New greater drilling at New water source

depths,

chlorination of water

215

Presence of undesirable and toxic substances in water (eg. Heavy metals, ammonia, quantity chlorine(C) Presence of foreign material Storage of soybeans in silos (CCP-3) in water (P) Growth of micro organisms (B)/insects hydrocarbons, of residual

parasites, nitrate). Excessive

“ Absence

“ Immediate control

“ Per lot

“ QAM

“ Control specifications

“ Use immediately

them

Fungi

In

five

Notices

of

Daily

samples two of them 10210 cfu/g, Humidity <13% Temperature <25oC Air conditioning
4

the results of measuring.

216

Application insect

of

anti at

Residues chemicals

of

the

used

Tolerant levels prescribed as

Measuring the amount of chemical Control equipment for appropriate functioning Control of equipment Use the set practices like: Pre with lye, with acid with and rinse water, 70oC, water, 70oC, water finally of

Per application

QAM

Control indication

of of

the the

methods

soybean (CCP-4) Presence of physical contaminants (CCP-5) Residues of substances of physical origin in soybean.

weighing machine. Daily QAM Monitoring maintenance of the equipments Repetition produces. calibration equipment. Every hour QAM “ Repairing of the equipment of of

by BIS/ISO Absence

Magnet (CCP-6) Cleaning in Place

Metal residues Automatic/manual cleaning of pipe lines, tanks etc.

Absence CIP plant

must be SS and consists of tanks for water, lye & acid, disinfectant dosing system, SS centrifugal pump, SS air operated valves steam and

rinsing with flushing rinsing with flushing

217

heating system.

disinfection with disinfectant.

Soaking (CCP-6)

in

water

Water quality, operational parameters

Good quality water. Dry ingredients of quality Time/temp of soaking food of

Quality check and observation of scheduled parameters.

Every run

Production Manager

Quality assessment of the ingredients and recording schedules. of temperature and time

Repetition of the testing results and incase of deviation rejection of lot.

Rinsing with water (CCP-7) Draining the water (CCP-8) Sprouting the beans (CCP-9) Harvesting the

GMP SOP GMP GMP No migration of low weight Food grade film Vehicle food transport. for Use insect methods and anti QC Every lot QAM Regular monitoring Replace the lot

sprouts (CCP-10) Packaging (CCP-11)

molecular Transportation products of compounds. GMP/GFHP

218

disinfection of vehicle regularly for maintaining Storage (CCP-12) of products Control of temperature and RH Temperature < 20oC RH < 65% GFHPs. Temperature and should regularly tested. checked regularly for it’s functioning. AC unit must be RH be the

219

The quality of the product so prepared with and with out HACCP is shown below. Table 63.Quality assessment of the soy sprouts Quality standard expected Composition: Protein: a minimum of 12% Fat: a minimum of 6% Crude Fiber: a maximum of 4% Ash: a maximum of 1.0% Content Vitamin A, 11 Vitamin B Vitamin C Calcium Iron 0.340 28.1 67 3.0 mg/100g 8 0.250 22.0 52 2.1 60 156 450 11.5 0.358 30.1 72 3.3 75 161 490 1.4% 1.0% 5.2% 3.8% 5% 6.7% 10% 13.1% With out HACCP With HACCP

Magnesium 70 Phosphorus 160 Potassium 480

Moisture: a maximum of 69% Microbiology: Total plate count: 20,000/g max 50,000/g 10,000/g 60 65

220

Total coli forms: 100/10g max Salmonella: Negative/100g E.coli: Negative/100g Staphylococcus: 100/10g maximum Yeast: 100/10g maximum Mold: 100/10g max. Defects: Insect parts: Total absence. Foreign material: Total absence. Absent Absent Absent Absent 123/10g Nil 100/10g Nil 135/10g Nil 15/100g Nil 10/100g Nil 120/10g Nil

221

222

Soy nuts Roasted soy nuts are whole soybeans that have been soaked in water and then baked until browned. Soy nuts can be found in a variety of flavors, including chocolate covered. High in protein and isoflavones, soy nuts are similar in texture and flavor to peanuts. Table 64.Product description 1. Product name Soy nuts 2. Important product characteristics of end Aw < 0.5;FFA < 1%; Total microbial counts product < 50000/g 3. How the product is to be used Normally taken as such. They are available in different flavors like salted and paprika. They are also covered with a layer of chocolate. 4. Packaging Sealed polythene bags or in hermetically sealed metal containers. 5. Shelf-life 8 weeks under normal room conditions. 6. Where the product will be sold Retail, institutions and food service. Could be consumed as a health food. 7. Labeling instructions Required to ensure product safety. 8. Special distribution control No physical damage, excess humidity or temperature extremes.

223

The plant schematic/floor plan is given below. Wet Processing Area Preparatory Area
Spread in single layer on a oiled cookie sheet and roast at 190oC for 30-50 minutes, stirring often until well browned Or Spread on a large microwavable dish and microwave on high for 10-15 minutes, mixing the nuts to avoid burning

Baking/cooking area

Silos/Storage Bins Soaking in vats in cool water (15-20oC) (2-3 times) for 6-8 hours. Cleaners Garnish with salt/paprika/herbs Draining Cleaned soybeans Rinsing with cool water. Filling/Weighing/Sealing

224

Transport

The identified biological, chemical and physical hazards related to the production of soy nuts are given along with the flow diagram below. Table 65. Product ingredients and incoming material Raw material Soybeans B, C, P Other Water (municipal) B, C Table 66.Flow diagram Soybeans 1. Receiving P 5.Storing B P 8. Cleaning P 11. Soaking B C 12. Draining B C 13.Rinsing B P C 15. Baking B P C 16.Garnishing BC Packaging material 2.Receiving P 6.Storing B C P 9.Inspecting B P Dry ingredients 3. Receiving P 7. Storing B C P 10. Dumping Water 4. In taking Packaging material Polythene bags B, C, P Dry ingredients Silica B, C, P

14. Chlorinating 17.Filling C P 18.Weighing B 19.Closing/sealing B 20.Inspecting B P 21. Labeling B 22. Storing B 23.TransportB

P=Physical; B=Biological, C=Chemical

225

The details of all the hazards are enumerated as under. Identified Biological Hazards Ingredients/materials: Soybeans - could contain soil borne/ air borne pathogenic organisms, yeasts or moulds. Dry ingredients - could contain microbial contaminants. - could contain rodent excrements. Water could contain microorganisms Packaging materials - could contain defects that could result in leakage. Processing steps: Cleaning Soaking Rinsing Baking Weighing Transport physical damage to packages results in leakage and contamination of product. Identified Chemical Hazards Ingredients/materials: Soybeans - could contain pesticide residues. - could contain mycotoxins. 226 overfilling may lead to leakage and prone to contamination. could be contaminated with microorganisms. could contain microorganisms. could contain microorganisms. could be contaminated with microorganisms.

Water

-

could be contaminated with toxic substances.

Processing steps: Dry ingredients storage - could be contaminated with non-food chemicals as a result of improper storage. Rinsing cleaning chemical residues could contaminate the beans. Identified Physical Hazards: Ingredients/ materials Soybeans could be contaminated with harmful extraneous materials namely glass, metal, plastic, wool etc. Dry ingredients - could be contaminated with harmful extraneous materials Soybean receiving inadequate protection against harmful extraneous material could result in contamination. Dry ingredient receiving in adequate protection against harmful extraneous material could result in contamination. The next step is identification of CCPs. The CCP determination is shown in Table 3. -

227

Table 67.CCP determination Process Category Q1 step/incoming and materials identified hazard Soybeans B=Pathogens Yes C=Pesticides Q2 Q3 Q4 CCP

Yes

Yes

Yes, thermal processing

Packaging materials Dry B= bacterial Yes ingredients as spores delivered B=rodent excretes (GMP) P=HEM (GMP) Water at B= GMP intake C= heavy metals & other toxins (GMP) Process Category step/incoming and materials identified hazard Cleaning and P=GMP grading of Q1

No (farmers/growers C= heat level-GPP) stable toxins No (farmers/growers P= harmful level-GPP) Yes extraneous material Yes (visual (HEM) inspection and foreign object removal) B=pathogens Yes Yes N/a

Yes

No

Yes Yes

Yes, sterilization Yes, thermal processing

Q2

Q3

Q4

CCP

228

soybeans Soaking soy beans

of Water (GMP) Water, GMP Water, GMP P (GMP) P (GMP) B

Draining Rinsing Filling Weighing Packaging and sealing

Yes

Yes

Yes

No

CCP-4 (Proper gauge and sealing clearance)

Instructions: • Category and identified hazard: Controlled by Codex General Principles of Food Hygiene, if yes indicate GMP and proceed to next hazard. If no proceed to question 1. • Q1: Do control preventive measures exist, if no, not CCP; if yes proceed to next. • Q2: Is this operation specifically designed to eliminate, if no proceed to Q3. If yes CCP and identify it in the last column. • Q3: Could contamination with identified hazards occur in excess of acceptable levels, if no, not CCP. If yes Proceed to Q4. • Q4: Will subsequent operation control the contamination levels, if no CCP; if yes not CCP.

229

Table 68.Unaddressed Hazards Unaddressed hazard from previous list Soybeans could contain pesticide residues Identified methods of addressing the hazard Up stream (farm level) programs such as A: Training persons who apply pesticides. B: Purchasing registered pesticides for growers. C: Auditing growers application of pesticides and records there of. D: Requiring periodic pesticide residual analysis reports.

230

Table 69.HACCP for general activities: Stage Raw material harvest Activity Liaison with the farmers for unit operations like harvesting, threshing and winnowing. Transport in sacks to drying area. Sampling and routine inspection. Control activity Specifications of grain quality are required. Rejection of under sized seeds. Correct sacking and handling. Correct sampling methods, training and inspection methods. Cleaning, grading, de Training operators for hulling, conditioning and equipment, preventing blending. insect infestations, check for moisture content. Filling in to containers and Establish specifications for sealing. labels and fill weights.

Raw material transport Raw material inspection Preparation of seeds

Packaging

Description of soy nuts manufacturing process: Implementation of HACCP. Receiving soybeans (CCP-1): Soybeans must come from approved dealers. At the time of its receipt it must be accompanied with its complete quality certificate and microbiological assessment reports. The certificates should indicate the moisture content of the beans, degree of foreign materials and the microorganisms present (number of colonies), insects etc as compared to the upper approved standards of BIS/ISO. At the time of receipt, visual control of soybeans must be carried out to find out the contaminants if any. Further more the proximate composition of the beans must be established with reference to its macro and micronutrients. Defective beans mean that the soy flour will be most likely unsafe for the consumption. Storage of soybeans in silos (CCP-2): The temperature (<20oC) and the relative humidity (<65%) during the storage must be low. They should be recorded at regular intervals. If any deviation from the safer limits, must be immediately rectified. When soybean is stored for a long period, microbiological analysis should be carried out. Receiving secondary materials (greasing, detergents, insecticides, pesticides and sacs) (CCP-3): These materials must be procured from the approved suppliers with 231

quality certificates. These materials must be suitable for using them with food items. No contamination must come from the packaging materials. If these materials do not comply with the standard specifications, must be returned to the suppliers and a new order should be placed with other suppliers. Storage of secondary materials (CCP 4): The temperature and relative humidity during storage must be below 20oC and 65% respectively. The place should be air-conditioned. The temperature and RH should be continuously recorded and corrective actions must be undertaken whenever any deviation occurs. Application of anti insect methods (CCP-5): Any chemicals used during storage along with the soybeans should comply with the safety legislations. The quantity should be with in the prescribed concentrations. Cleaning & grading of soybeans (CCP-6): All the physical contaminants should be removed. They should be graded. Only sound soybeans should be taken for processing. Removal of stones: The stones, metals and dust must be removed from the soybeans so that the final product will comply the quality standards as prescribed by BIS/ISO. Weighing: The soybeans are weighed and passed through a magnetic system so that the magnetic materials are removed. Soaking of the beans (CCP 7): Prepare the soy before soaking. It will remove the starchy material from the water. Over sprouting and do not drain well enough causes discoloration and un pleasant odors. Add 2-3 times as much cool (15-20oC) water. Mix seeds to assure even water content for all. Allow seeds to soak for 2-12 hours. Prefer to soak for a shorter time. Check after 2 hours for softening. If they are still hard, let them keep soaking until they are all soft (up to 12 hours). Normally 4 hours is usually the right soak duration. If over soak they will fall apart.

232

Draining& rinsing (CCP 8): Drain off the soak water. Rinse thoroughly with cool water (15-20oC). Soy soak water is starchier than most other seeds, so rinse and rinse until the water that is drained off runs clear. Drain thoroughly. Baking/deep frying in oil (CCP 9): Spread the soybeans in one layer on a well-oiled cookie sheet. Roast at 190oC for 30-50 minutes, stirring often until well browned. Or alternately deep-fry the soaked beans in oil till golden brown color. Microwave cooking (CCP 9): First soak 100 g soybeans in water at room temperature for 6-8 hours. Dry them with a cloth or paper. Spread them on a large microwavable dish and microwave on high for 10-15 minutes, until the beans are crispy and golden brown. It is important to mix the soy nuts regularly to avoid burning especially at the end of the process. Flavor the nuts with salt and herbs. Garnishing (CCP 10): Salt the nuts to taste or may be garnished with other flavors or may be enrobed with other spices. The concentration of the salts and ingredients are very important. Packaging (CCP-10): During packaging the nuts can possibly be contaminated with the microorganisms causing quality deterioration. Hermetic sealing and upright position of the packaging material can avoid this. There should not be any migration of the low molecular weight substances from the packages. Further more contamination can take place from foreign materials like insects and rodents that accidentally happen to be packed with the nuts. The personnel should comply with the GMPs. Storage of soy nuts (CCP-11): Both the temperature and relative humidity must be below 20oC and 65% respectively. They should be recorded and corrective actions must be taken when deviating. When the nuts are stored for a long period, microbiological analysis is required.

233

Metal detector (CCP-12): The packed product passes through a metal detector. The product is then checked for its weight and placed in boxes (secondary packaging). The boxes are placed on the pallets and the packets are wrapped with film.

The synoptical presentation of HACCP is shown in below.

234

235

Table 70.Synoptical presentation of hazards, critical control limits, observation procedures and control actions for the production of Soy nuts.
Processing step Hazard description Critical Control Receiving of soybean (CCP-1) Presence of foreign material in soybean (P) Limit 5% Observation procedures Control of Frequency CCP Visual control ol of of the sample/contr certification s per lot Growth of micro organism (B)/insects Fungi (B) Absence Out of five samples two of them 10210 cfu/g. Humidity <13% Protein
4

Responsible

Monitoring procedures

Corrective actions

Per lot

QAM

Control specifications procure certificates suppliers

of and quality from

Rejection of lot or change supplier

“ Control the certificates per lot of

“ “

“ “

“ Evaluation supplier of

“ “

236

content 3840% Other macro and Receiving materials agents, secondary (greasing detergents, Chemical migrating substances from the micro “ “ “ “ “ nutrients Materials suitable for food items.

secondary materials.

insecticides, pesticides, sacs etc (CCP-2) Water Total Coli forms (B) In agreement with the community legislation 80/778 potable water (B) Faeces Coli forms (B) Faeces Streptococcus (B) Sulphur Clostridium (B) reducing “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ for Lab control of quality water Monthly QAM New greater drilling at New water source

depths,

chlorination of water

237

Presence of undesirable and toxic substances in water (eg. Heavy metals, ammonia, quantity chlorine(C) Presence of foreign material Storage of soybeans in silos (CCP-3) in water (P) Growth of micro organisms (B)/insects hydrocarbons, of residual

parasites, nitrate). Excessive

“ Absence

“ Immediate control

“ Per lot

“ QAM

“ Control specifications

“ Use immediately

them

Fungi

In

five

Notices

of

Daily

samples two of them 10210
4

the results of measuring.

cfu/g,

Humidity <13% Temperature <25oC Air conditioning

238

Application insect

of

anti at

Residues chemicals

of

the

used

Tolerant levels prescribed as

Measuring the amount of chemical Control equipment for appropriate functioning Control of equipment Use the set practices like: Pre with rinse water, of

Per application

QAM

Control indication

of of

the the

methods

soybean (CCP-4) Presence of physical contaminants (CCP-5)) Residues of substances of physical origin in soybean.

weighing machine. Daily QAM Monitoring maintenance of the equipments Repetition produces .calibration equipment. Every hour QAM “ Repairing of the equipment of of

by BIS/ISO Absence

Magnet (CCP-6) Cleaning in Place

Metal residues Automatic/manual cleaning of pipe lines, tanks etc.

Absence CIP plant

must be SS and consists of tanks for water, lye & acid, disinfectant dosing system, SS centrifugal pump, SS air operated valves steam and

rinsing with lye,70oC, flushing with acid with and water, 70oC, water finally rinsing with flushing

239

heating system. Soaking (CCP-7) in water Water quality, operational parameters Good quality water. Dry ingredients of quality Time/temp of soaking Rinsing with water Draining the water Baking the beans (CCP-8) GMP GMP Temperature of the oven 190oC 30-50 minutes food of

disinfection with disinfectant. Quality check and observation of scheduled parameters. Every run Production Manager Quality assessment of the ingredients and recording schedules. of temperature and time Repetition of the testing results and incase of deviation rejection of lot.

for

Quality check and observation of scheduled parameters

Every run

Quality Manager

Quality assessment

In case of deviation reject the lot.

Garnishing the nuts Packaging (CCP-9)

GMP No migration molecular compounds. GMP/GFHP

of

low weight

Food grade film Vehicle food transport. for

QC

Every lot

QAM

Regular monitoring

Replace the lot

Transportation products

of

Use insect

anti

methods and disinfection

240

of vehicle

the

regularly for maintaining Storage (CCP-10) of products Control of temperature and RH Temperature < 20oC RH < 65% GFHPs. Temperature and should regularly tested. checked regularly for it’s functioning. AC unit must be RH be

241

Table 71.Standard nutritive values to be maintained in the product: (100 g salted) Water Energy Protein Fat (total) MUFA PUFA Carbohydrates Fiber Ash Isoflavones Ca Fe Mg P K Na Zn Cu Mn Se Vitamin C Vitamin B1 Vitamin B2 Vitamin B3 Vitamin B5 Vitamin B6 2g 471 kcal/1972 kj 35.2g 25.4g 5.6g 14.3g 33.6g 17.7g 3.9g 200mg 138mg 3.9mg 145mg 363mg 1470mg 163mg 3.14mg 0.8mg 2.2mg 19.1mcg 2.2mg 0.1mg 0.145mg 1.41mg 0.45mg 0.21mg

Fatty acids, Saturated 3.7g

242

Folic acid Vitamin A Vitamin E

211 mcg 200 IU 0.91mg

243

Tempeh Tempeh is a cake of soybeans that is made by removing the hulls of cooked soybeans, mixing with a culture of tempeh starter and ageing for a day or two. The culture helps hold the soybeans together in a cake form. It is common to tempeh made with added ingredients such as vegetables, grains or other beans. During tempeh production the soybeans are acidified to prevent the growth of spoilage bacteria. Tempeh has a tender chewy consistency that makes it an excellent addition to variety of foods. The easiest way to prepare tempeh is bake the sliced tempeh in a pan with a lot of oil until it becomes crisp. Table 72.Product description 1. Product name Tempeh 2. Important product characteristics of end Aw < 0.5;FFA < 1%; Total microbial counts product < 50000/g 3. How the product is to be used Normally taken as such after baking in oil. It is also added as an ingredient with vegetables, grains and beans. 4. Packaging Sealed polythene bags. 5. Shelf-life 3 days under refrigerated conditions. 6. Where the product will be sold Retail, institutions and food service. Could be consumed as a health food. 7. Labeling instructions Required to ensure product safety. 8. Special distribution control No physical damage, excess humidity or temperature extremes.

244

The identified biological, chemical and physical hazards related to the production of soy nuts are given along with the flow diagram below. Table 73. Product ingredients and incoming material Raw material Soybeans B, C, P Other Water (municipal) B, C Table 74.Flow diagram Soybeans Packaging material 1. Receiving P 2.Receiving P 5.Storing B P 6.Storing B C P 8. Cleaning P 9.Inspecting B P 11. Soaking B C 12. Draining B C 13.Rinsing B P C 15. Dehulling B P C 16.Cooking B, P, C 16.Inoculation B 17Incubation B 18.Filling C P 19.Weighing B 20.Closing/sealing B 21.Inspecting B P 22. Labeling B 23. Storing B 24.TransportB P=Physical; B=Biological, C=Chemical Table 75.Unaddressed Hazards Unaddressed hazard from previous list Soybeans could contain pesticide residues Dry ingredients 3. Receiving P 7. Storing B C P 10. Dumping Water 4. In taking Packaging material Polythene bags B, C, P Dry ingredients Silica B, C, P

14. Chlorinating

Identified methods of addressing the hazard Up stream( farm level) programs such as A: Training persons who apply pesticides. B: Purchasing registered pesticides for growers. C: Auditing growers application of pesticides and records there of. D: Requiring periodic pesticide residual analysis reports.

245

Table 76.HACCP for general activities: Stage Raw material harvest Activity Liaison with the farmers for unit operations like harvesting, threshing and winnowing. Transport in sacks to drying area. Sampling and routine inspection. Control activity Specifications of grain quality are required. Rejection of under sized seeds. Correct sacking and handling. Correct sampling methods, training and inspection methods. Cleaning, grading, de Training operators for hulling, conditioning and equipment, preventing blending. insect infestations, check for moisture content. Filling in to containers and Establish specifications for sealing. labels and fill weights.

Raw material transport Raw material inspection Preparation of seeds

Packaging

Description of tempeh manufacturing process: Implementation of HACCP. Receiving soybeans (CCP-1): Soybeans must come from approved dealers. At the time of its receipt it must be accompanied with its complete quality certificate and microbiological assessment reports. The certificates should indicate the moisture content of the beans, degree of foreign materials and the microorganisms present (number of colonies), insects etc as compared to the upper approved standards of BIS/ISO. At the time of receipt, visual control of soybeans must be carried out to find out the contaminants if any. Further more the proximate composition of the beans must be established with reference to its macro and micronutrients. Defective beans mean that the soy flour will be most likely unsafe for the consumption. Storage of soybeans in silos (CCP-2): The temperature (<20oC) and the relative humidity (<65%) during the storage must be low. They should be recorded at regular intervals. If any deviation from the safer limits, must be immediately rectified. When soybean is stored for a long period, microbiological analysis should be carried out.

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Receiving secondary materials (greasing, detergents, insecticides, pesticides and sacs) (CCP-3): These materials must be procured from the approved suppliers with quality certificates. These materials must be suitable for using them with food items. No contamination must come from the packaging materials. If these materials do not comply with the standard specifications, must be returned to the suppliers and a new order should be placed with other suppliers. Storage of secondary materials (CCP 4): The temperature and relative humidity during storage must be below 20oC and 65% respectively. The place should be air-conditioned. The temperature and RH should be continuously recorded and corrective actions must be undertaken whenever any deviation occurs. Application of anti insect methods (CCP-5): Any chemicals used during storage along with the soybeans should comply with the safety legislations. The quantity should be with in the prescribed concentrations. Cleaning & grading of soybeans (CCP-6): All the physical contaminants should be removed. They should be graded. Only sound soybeans should be taken for processing. Removal of stones: The stones, metals and dust must be removed from the soybeans so that the final product will comply the quality standards as prescribed by BIS/ISO. Weighing: the soybeans are weighed and passed through a magnetic system so that the magnetic materials are removed. Ingredients: Besides whole soy beans, acidulant (vinegar), and tempeh starter are required to make the tempeh. Tempeh starter contains spores of Rhizopus oligosporus or Rhyzopus oryzae. They should be of superior quality and free of contamination. Soaking and dehulling of soybeans (CCP- 7): Whole soybeans can be dehulled by soaking the beans for 8 - 14 hours in water and then removing the hulls by hand. In doing so, the beans are split into two halves and the seed coats are discarded. Cooking the dehulled beans (CCP-8): The dehulled beans are cooked for 15-20 min. Drain and remove the cooked beans onto towels to drain off the excess water and to cool the beans, which are now swollen and soft. It's important that the beans become very dry.

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Otherwise undesirable bacteria can grow which will create off-flavours. Inoculation of the beans (CCP- 9): Put the cool and dry beans in a clean container and sprinkle them with 1 teaspoon of tempeh starter (can be ordered at tempeh.com) and mix thoroughly. Incubating the beans (CCP-10): Take 2 plastic bags 18 x 28 cm and perforate them with holes at a distance of about 1 cm by a thick but sharp needle. Divide the soybeans in the two bags and seal them. Press them flat, making sure that the total thickness of the beans is about 3 cm. Place the packed beans in an incubator at 30°C or at a warm place for about 24- 48 hours or until the container is filled completely with white mycelium and the entire contents can be lifted out as a whole piece. A simple incubator can be made with putting a light bulb in an old fridge. Depending on the room temperature bulbs with different wattage (15W, 25W,) can be used, but remember that the tempeh will also produce some heat on its own. Packaging (CCP-11): During packaging the tempeh can possibly be contaminated with other microorganisms causing quality deterioration. Hermetic sealing and upright position of the packaging material can avoid this. There should not be any migration of the low molecular weight substances from the packages. Further more contamination can take place from foreign materials like insects and rodents that accidentally happen to be packed with the nuts. The personnel should comply with the GMPs. Storage of tempeh (CCP-12): The fresh tempeh will feel warm and will have a pleasant mushroom flavor. The finished tempeh can be stored in refrigerator for 3 days. Metal detector (CCP-13): The packed product passes through a metal detector. The product is then checked for its weight and placed in boxes (secondary packaging). The boxes are placed on the pallets and the packets are wrapped with film.

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Before inoculation

After growth of fungus

Nutritional values of tempeh Since tempeh is made from whole soybeans, it is rich in fiber and soy isoflavones. It is also a generous source of many nutrients such as calcium, B-vitamins and iron. As opposed to other soy products, tempeh can contain a small amount of vitamin B12, which is coming from the bacteria, which do grow with the tempeh cultures.

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Table 77.Nutritional values of tempeh (per 100g) Water Energy Energy Protein Fat (total lipid) Fatty acids, saturated Fatty acids, mono-unsaturated Fatty acids, poly-unsaturated Carbohydrates Fiber Ash Isoflavones Calcium, Ca Iron, Fe Magnesium, Mg Phosphorus, Mg Potassium, K Sodium, Na Zinc, Zn Copper, Cu Manganese, Mn Selenium, Se Vitamin C (ascorbic acid) Thiamin (vitamin B1) Riboflavin (vitamin B2) Niacin (vitamin B3) Panthotenic acid (vitamin B5) Vitamin B6 Folic acid Vitamin B12 Vitamin A 54.9 g 199 Kcal 833 KJ 19.0 g 7.7 g 1.11 g 1.7 g 4.3 g 17.0 g 4.8 g 1.4 g 53 mg 93.0 mg 2.3 mg 70.0 mg 206 mg 367 mg 6.0 mg 1.81 mg 0.67 mg 1.43 mg 8.8 µg 0.0 mg 0.131 mg 0.111 mg 4.63 mg 0.355 mg 0.299 mg 52.0 µg 1.0 µg 69 µg

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15. Approximate expenditure incurred in the project (Rs): i. Salary of Scientific staff: ii. Salary of Technical staff: iii. Salary of Supporting staff: iv. Miscellaneous /contingencies: 3, 00,000 10,000

Cost of laboratory equipment/chemicals/glassware: Total: 3, 10,000

16. Conclusions and Recommendations 16.1 Conclusions

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HACCP procedures were developed for making Soy based foods with utmost quality and safe for use. 16.2 Recommendations The HACCP procedures developed may be used for the production of different soy based foods with Good Manufacturing Processes and Good Food Hygiene Practices recommended by the codex Alimanatarius Commission/FAO for maintaining the safety and quality of the products. It improves the utilization of soy-based foods domestically. These products will also have great export potential as per the International standards.

17.(a) Papers Published i. Gandhi, A.P. (2008) Development of HACCP procedure for the production of Full fat Soy Flour, International Food Research Journal 15(2), 141-154. ii. Gandhi, A.P. (2008). Production of Soy Nuts using the Hazard Analysis Critical Control Point (HACCP) procedure. Asian Food Journal 1 (3),p iii. Gandhi, A.P. (2009). Quality of Soybean and its food products-a review. International Food Research Journal.16 (1). (b) Papers presented i. Gandhi, A.P (2008) Development of HACCP protocols for the production of soy milk, presented in the ISPUC, held at CIAE, Bhopal, December 1014,2008. 18. Details of field/laboratory books and final materials and their location: The data registers are with the Project Leader and the reports are available in the center.

19 Acknowledgments:

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Gratefully acknowledges the cooperation received from the Director, CIAE; Project Director and staff of SPUCenter in accomplishing the project.

20 References:

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Bernard, D.1998. Developing and implementing HACCP in USA. Food Control, 9(2-3): 91-95.

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Burges, K.J. (1994) An overview of Good Manufacturing Process, International Dairy Federation, 271:12-19. CMSF. (1988). HACCP in microbiological safety and quality. Blackwell Science: London Codex (1993). Principles for the establishment and application of Microbiological Criteria for Foods, Codex Alimentarius Commission Procedural Manual, 8th Edition, 1993; 109-116. EC-ASEAN Economic Cooperation Programme on standards, quality and conformity assessment (2005). Guidelines on HACCP, GMP and GHP for ASEAN Food SMES. FAO (1995). The use of hazard analysis critical control point (HACCP) principles in food control, FAO Food and Nutrition paper 58. FAO (1998). Food Quality and safety systems-a training manual on food hygiene and the Hazard Analysis and Critical Control Point (HACCP) system. FAO (1999). Understanding the Codex Alimentarius. FAO (2001). Food Hygiene Basic Texts. Codex Alimentarius. FAO (2003). Recommended International Code of Practice- General Principles of food Hygiene. FAO/WHO (2004) Guidance to governments on the application of HACCP in small and/or less developed food business, FAO Food and Nutrition Paper 86. Food Quality and Safety Systems (1998). A training manual on food hygiene and the hazard analysis and critical control point (HACCP) system. FPI (1993). Establishing Hazard analysis Critical Control Point Programs, a workshop Manual. The food processors’ Institute, Washington, D.C.

Gandhi, A.P. (2006) General Principles of Food Sanitation and Hygiene, Beverage and Food world, 33(11), p 40-42.

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Gandhi, A.P. (2006) Soybean-the greater bean, World Grain (USA), February issue, p 5962. Gandhi, A.P. (2008) Development of HACCP procedure for the production of Full Fat Soy Flour, International Food Research Journal, 15,141-154. Gandhi, A.P. (2008). Production of Soy Nuts using the Hazard Analysis Critical Control Point (HACCP) procedure. Asian Food Journal 1 (3),p Gandhi, A.P.2009. Quality of Soybean and its food products-a review. International Food Research Journal.16 (1). Ioannis S. Arvanitoyannis and Athena Traikou (2005) A comprehensive review of the implementation of HACCP to the products of flour and flour based food products, Critical Reviews in Food Science and Nutrition, 45:327-370. Mauropoulas, AA and Arvanitoyannis, I.S. (2000). Application of HACCP system to feta cheese and manouni production line, Food Control, 10:213-219. Mc Swane, Rue, N and Linton, R. (2000). Essentials of Food Safety and Sanitation, 2nd Edition, Prentice Hall Inc; NJ, USA. Mortimore, S. and Wallace, C. (1994). HACCP: A practical approach. Chapman and Hall: London, USA. National Advisory Committee on Microbiological Criteria for Foods (NACMCF) (1997). Hazard Analysis and Critical Control Point Principles and Application Guidelines. Oakland (1993). Total Quality Management, pp 3-35, Butterworth Heinemann, Oxford, UK. Pierson, M. D. and Corset, D.A. (1992). HACCP. Principles and Applications. Chapman and Hall, New York. Sandron, D.K. and Arvanitoyannis, I. (1999). Implementation of HACCP system to meat and poultry industry: A review. Food Rev.Int.15 (3): 265-308. Sandron, D.K. and Arvanitoyannis, I. (2000). Implementation of HACCP system to the dairy industry: A review .Food Rev.Int.16 (1): 77-112.

Sandron, D.K. and Arvanitoyannis, I. (2000). Implementation of HACCP system to the cheese making industry: A review. Food Rev.Int.16 (3): 327-369.

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Sperber, WH (1998) Auditing and verification of food safety and HACCP. Food Control, 9(2-30,157-162. United States Department of Agriculture (USDA). (1997). Guide Book for the preparation of HACCP Plans. USDA: Washington, USA. USDHH/FDA/Centre for Food Safety and Applied Nutrition (2006). Managing Food Safety-a Manual for the voluntary use of HACCP principles for operations of foods service and retail establishments. USDHH/FDA/Centre for food Safety and Applied Nutrition (2006). Managing Food Safety-a Manual for applying HACCP principles to risk based retail and food service

21. Signatures and name of the Investigator:

(A.P.Gandhi) 22. Signature of Project Director:

(S.D.Kulkarni)

23. Signature of the Director (with comments if any)

(MMPandey)

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ANNEXURES

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Annexure-1 Forms /Register to be maintained by the manufacturer
Form No 1 2 3 Description Soybean Purchase Log Soybean Processing Chart Soybean Processing Chart 2 (Yield Estimation & 4 5 6 7 8 9 10 11 12 13 14 Processing Results) Factory Quality Checks Corrective Action Log Calibration Records Periodic Sanitation Control Record Factory Schematic. Floor Plan Chemicals, cleaners and sanitizers Product Testing Chart Customer Complaints Employee Health Daily Sanitation Control Record End of day clean up/ sanitation 15 Inspection Form Cold Room Temperature Chart Location Office Issue Status CCP monitoring Approval date

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Annexure-2 Soybean Processing Chart Date Batch No

Date unloaded Quality assessment Reject if does not confirm to the standards. Stored in silos at controlled temperature and RH Date removed from the silos Product Description Temperature of Processing Room Unit Operations (Step wise) Yield % of product Aw of final product Quality assessment of the product Storage of the product at standard RH and temperature. Destination and date transported Production problems Action(s) Taken

Factory Supervisor

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Annexure-3 Assessment of the implementation of pre-requisites
Inspection (audit) number …………………… HACCP Audit Grid (number 1/4) sa = satisfactory ac = acceptable ns = non satisfactory ab = absence na= not applicable Documents associated to these criteria Plan of the establishment (1/500 to 1/1000) showing: - drinking water supply - waste water drain off Plan of the establishment (1/100 to 1/300)showing: - identification of rooms............................................................................. - position of workstations and the equipment - position of cloakroom and toilets............................................................. - location of inputs/outputs of flows (staff, products,) .......................... - flowchart of flows (staff, products, raw materials, waste,).................. Explanatory leaflet of materials used and techniques of constructions employed ..............................................................................................................................

Control of Contamination sources Considered criteria 1 Buildings 1.1 Conformity of the premises: general organization: - Conformity of the establishment immediate surroundings........................ - compliance with the onward flow principle ............................................. - separation of clean sector and unclean sector .......................................... - no crisscross of the production lines ......................................................... - separation of hot zone and cold zone .......................................................

1.2 Conformity of the premises: construction : - wall coverings: smooth, light colored, washable, resistant...................... - floor covering: smooth, light colored, washable, resistant ...................... - floor and walls joined by round gorge assemblages .................................. - floor grids and U-bends to collect waste water ......................................... - ventilation devices ensuring steam and smoke elimination ……………... - lighting bright and neutral in color ……………………………………...

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HACCP Grid 1
Considered criteria 1.4 Lawful or normative conformity..……………………………. Documents associated to these criteria Documents attesting of: national approval……………………………………………............................... foreign country importation approval………………………................................ certification of voluntary setting in conformity with specific food safety standards………………………………………… Daybook of technical mending of buildings and equipment................................. Contracts past with suppliers criteria of acceptance of batches planed corrective actions for any case of loss of control...................................... Cards of specifications of raw materials. ............................................................ Composition ......................................................................................................... Microbiological standards .................................................................................... Residues limit content .......................................................................................... conditioning (type, volume, weight…) ................................................................ Preserving conditions ........................................................................................... lifespan ................................................................................................................. Organization of stock turnover ........................................................................... Recording cards of control of deliveries .............................................................. temperature of delivered products ....................................................................... intact conditionings............................................................................................... compliance with consumption deadlines............................................................... labeling compliance with official food safety marking rules...............................

1.5 Maintenance of buildings and equipment………………………… 2 Supplies 2.1 Contractual relationship with the suppliers ……………………… 2.2 Raw materials specifications.

2.3 Checking of deliveries ……………………………………………

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cleanliness of the delivery vehicle ........................................................................ 2.4 Water portability…………………………………………………. 3 Implementation of a system of traceability 3.1 System of upstream traceability........................................................................ 3.2 System of downstream traceability.................................................................. Analysis or certificate of water potability ............................................................ Specimen of simulation test of upstream traceability Recordings relating to upstream traceability: ..................................................... delivery control cards ........................................................................................... listing of raw materials stock .............................................................................. Specimen of simulation test of downstream traceability Recordings relating to downstream traceability .................................................. customers purchase orders ................................................................................... listing of finished product stocks .......................................................................... customers invoices ............................................................................................... 4 Pest control 4.1 Implementation of a pest control plan.............................................................. - management of the outdoor dustbins, absence of waste on the ground.............. - management of materials and equipment outdoor storage ................................. 5 Control of staff originated contaminations 5.1 Medical follow-up of the staff members 5.2 Plan of staff training 5.3 Clothing hygiene: standard work clothing supplied by the company washing of clothing by the company or under its responsibility management of clean and dirty clothing lockers with 2 compartments boots/shoes washstands in conformity with standards 5.4 Compliance with GHP and GMP 6 Hands and premises cleaning Pest control plan………………………………………………………………… Insect control plan…………………………………………………………… ….. Intervention forms of the pest control company (department)... Individual health certificates of food handling ability Time table and contents of training activities Staff members vocational training certificate In house management procedure of clothing , or washing supplier contract

Specific approved GHP and GMP guide of the production sector or .................. in house manual of the GHP and GMP of the company

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6.1 Hands washstands in conformity with standards or regulations washing hands procedures 6.2 Premises enforcement of a cleaning plan microbiological Control of effectiveness of cleaning

Posting of washing hands instruction near the washstands Sum of written cleaning procedures comprised in "cleaning plan" Check-grids of good execution of cleaning tasks Weekly check-grid of visual cleanliness of equipment surfaces Reports of microbiological controls of surfaces

Assessment of the phase of preliminary HACCP study
Assessment carried out following the chronological continuation of the method tasks Considered criteria Task number 1 1.1 Management engagement 1.2 HACCP team founding members of the staff involved in the HACCP team assignment of technical tasks and responsibilities training of the team to HACCP method calling in external experts 1.3 Means put at the disposal (computer, photocopy, budget…)............................ 1.4 Activities management organization, programming dissemination, updating of successive versions of HACCP documents field of study and compiling of specific data Documents associated to these criteria Management engagement declaration letter Organisation chart of the HACCP team ............................................................... Individual post sheets ........................................................................................... Individual vocational training certificates ............................................................

Listing of the HACCP team functioning means....................................................

Planning of activities............................................................................................. Timetable, deadlines file ..................................................................................... Working sessions reports ...................................................................................... Flow chart of dissemination of HACCP documents Bibliographical collection: technical and lawful data relating to the sector of production and the type of analyzed hazards.........................................................

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Task number 2 2.1 Description of the product composition, volume, conditioning raw materials specifications: composition, proportion in the finished product, physicochemical parameters, lifespan, preservation, pre treatment........................ Task number 3 3.1 Identification of the expected use lifespan expected groups of consumers conditions of use foreseeable deviations of use Task number 4 4.1 Draft of the flow diagram ............................................................................................................................... ............................................................................................................................... Task number 5 5.1 Verify the flow diagram flow diagram in accordance with real field conditions ........................................... taking into account of all the productions rates (high and low).............................. contents of the diagram: nature of the stages, inputs, contacts, physicochemical parameters (T°, time, Aw, pH) Task number 6 6.1 Hazards analysis analysis of the considered field hazards (biological, physical, chemical) based on the flow diagram risk assessment by calculation of index of criticality ................................................

Descriptive file of the product..............................................................................

User instructions manual....................................................................................... Labelling Mandatory ................................................................................................... Informative ..................................................................................................

Flow diagram(s) for each product or each family of products ........................................................ or by current elementary operations usually associated to carry out the products (cookery)............................................................................................................... or by work periods ................................................................................................

List of identified hazards...................................................................................... Transposition of the identified hazards on the flow diagram then on a table related to the stages of production Risks assessment report (calculation of index of criticality)................................ Identification and collection of the preventive measures relating to each risk... .............................................................................................................................. ..............................................................................................................................

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Operational procedures of implementation of these measures.............................. 6.2 Preventive measures drafting............................................................................... List of CCPs Task number 7 7.1 Determination of CCPs by the use of the Codex decision tree or by the intuitive method plus identification of a related quantifiable and manageable parameter(s) Task number 8 8.1 Determination of critical limits for each CCP selected criteria required justifications bibliographical data on the microbial flora results of ageing lawful obligations List of the selected criteria and their required justifications

Evaluation of implemented HACCP plan
Assessment carried out following the chronological continuation of the method steps Considered criteria Documents associated to these criteria Task number 9 9.1Implementation of a monitoring system for each CCP Manual of operational procedures......................................................................... Models of recording documents of the measured values, used within the framework of the monitoring procedures.............................................................. Duration....................................................................................................... Temperature................................................................................................. pH................................................................................................................ Aw............................................................................................................... measurement of quantities: volume, weight, and formulation ........................... Plan of calibration of the measuring instruments..................................................

Measuring instruments calibration

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Task number 10 10.1 Draft of corrective actions to implement in the event of loss of control (deviation of the monitored values)

Table of correspondence between the observed deviations and the corrective action type that must be implemented................................................................... Operational procedures manual of corrective actions ..........................................

10.2 Ensure the follow-up of the batches subjected to corrective actions

Model of monitoring sheet of batches subjected to corrective action (traceability of these batches) Plan of analysis of products (raw materials, in production or finished products): .............................................................................................................................. sampling plan (number and frequency of samples)............................................... types and standards of the microbial flora of the products.................................... report of bacteriological analysis of products ....................................................... Microbiological analysis plan of equipment surfaces ........................................... sampling plan (number and frequency of samples)............................................... types and standards of equipment surfaces microbial flora.................................. report of bacteriological analysis of equipment surfaces ...................................... Audit reports (in house or external) ......................................................................

Task number 11 11.1 Establish verification procedures microbiological analysis of the finished products................................................... simulations of deviations or losses of control......................................................... recordings audit ...................................................................................................... checking of compliance with the implemented corrective actions ......................... validation of good cleaning practices ..................................................................... 11 .2 Define practical methods of checking............................................................ Task number 12 12.1 Establish documentation and records keeping

The whole of the documents taken into account at the preceding steps................

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Annexure-4 Routine evaluation of the real and effective implementation of an HACCP plan in the company
This fourth part is a documentary review. The documents relating to the good practices of hygiene are examined first. Then those relating to HACCP method are examined (in particular those which refer to the control of the CCP) Considered criteria Documents associated to these criteria 13 Implementation of GHP and GMP: real and effective 13.1 Supplies monitoring........................................................................................ 13.2 Cleaning plan validation 13.3 Pests control plan............................................................................................ 13.4 Medical follow-up of the staff 13.5 Staff training 13.6 Maintenance of buildings and equipment 13.7 Upholding of the conformity and provisioning of the washstands (observation in the course of visit) 13.8 Upholding of the conformity and provisioning of the boots/shoe washstands (observation in the course of visit) 14 HACCP plan , CCPs control 14.1 CCP monitoring.............................................................................................. Recording relating to CCPs monitoring : temperature recordings of the cold stores ............................................................. Individual staff training certificates Maintenance daybook correctly kept Raw material delivery checklists correctly and immediately kept........................ Satisfactory water analyses reports Checklists of cleaning tasks execution correctly and immediately completed... .............................................................................................................................. Satisfactory results of microbiological analysis of surfaces.................................. Intervention forms of pest control service correctly filled ................................... Staff medical certificates correctly updated

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records of inventory control (respect of consumption deadlines) ........................ records of heat treatment couple "duration / temperature", schedules of sterilization, pasteurization, cooking ..................................................................... measurement records of pH (dairy products, dry salted meats) ............................ measurement records of water activity (Aw) ........................................................ measurement records of weights, volumes, formulation rates .......................... reports of calibration (in house or official way) of measuring instruments (scales, Monitoring sheets of corrective actions correctly and progressively filled until the departure of concerned batches............................................................................ 14.2 Corrective action followup............................................................................ 14.3 Finished products conformity 14.4 Traceability..................................................................................................... 14.5 Simulations of incidents ................................................................................. thermometers…) ................................................................................................... Analysis reports of raw materials or in production or finished products ............. .............................................................................................................................. Simulations of upstream and downstream traceability realized randomly at the time of the visit ..................................................................................................... Recordings of simulations of incidents / or simulation of incident during the audit session...................................................................................................................

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Annexure-5 Audit Report Template

Name of the Establishment: Address: met: Phone number: employees: Fax Number: production: e-mail: Inspection note number: Page number:

Industry: Staff member Number of Volume

Grid reference Observation

Document

Short comings

Possible solutions

Conclusions:

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Annexure-6 Hazards (Hazard Examples) Chemical Hazards: Raw Materials Pesticides Growth regulators Antibiotics Heavy metals Natural toxins Microbial toxins Allergens Packaging Plasticizers Ink/adhesive Metals Physical hazrads The list is endless, including foreign objects of all kinds. The food industry tends to take special care over some types that easily cause damage if eaten by people, such as glass9 prerequisite- a glass management policy and management system) and metals (prerequisite – good maintenance management). However, in this latter case, metal detection also in use and is normally treated as a CCP. This of course, means that the correct term is metal rejection- simply to detect metal is clearly not the object of the activity. Microbiological Hazards Pathogenic bacteria Parasites and protozoa Viruses and algae Moulds During Process Cleaning agents incorrect ingredient concentrations Hydrocarbon lubricants Refrigerants Pest control agents Allergens Fumes/dust

Presence contamination survival growth

the organism or its toxic products.

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Annexure-7 Calibration Measuring equipment used to monitor Critical Control points (CCPs) (and also product legality factors, such as fill volumes or average weights) shall be calibrated and where possible, traceable to a recognized national standard. Where a national standard is not applicable, the nature of the basis of the calibration shall be described. All too often, companies establish calibration methods involving routine use of subcontractors, or regular internal systems whereby instruments are calibrated very frequently with a very accurate method. This is not always necessary- calibration is required to keep systems in control, but this can be maintained with simpler methods that are referred back to a national standard on a less frequent basis. What matters is that the frequency and the accuracy of calibration is appropriate to ensure that instrument variations are identified before they take the instrument out of allowed tolerance. Weight scales, for example can be calibrated against a reference set of brass weights preserved by the company in a good condition, (perhaps normally locked away in the Quality managers’ office). This reference set need calibration to national standards only, for example, every five years or so, unless damaged. Thermocouple probe thermometers are notorious for going out of calibration. A frequent rapid method of checking is required to maintain good measurement systems, coupled with a less frequent reference back to a national standard.

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Annexure-8 HACCP Certification HACCP Certification- Warnings A frequently defined objective for developing an HACCP system is to obtain recognition by an expert body in the form of certification from a third party audit (perhaps required due to customer pressure). This practice has value in providing extra verification of validity and effectiveness of the system, but it does present a risk. The award of certification does not mean that the system is faultless. No auditor is perfect- the illusion of excellence provided by a certificate can lead to situations where a business may believe that it operates a flawless HACCP system. It may well then not maintain effectiveness of its own certification (auditing) processes. Companies should beware of HACCP certification that is offered as a route to enable a company to export into other countries. In all cases the authorization for exports will be delivered only by the National Competent Authority, which approves the food establishments, involved. Demonstration of good practice with an HACCP certificate will only provide part of any evidence required and is a good route to demonstrating committed management, but other approvals are also needed at national level, such as use of accredited laboratories.

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Annexure-9 Correlation with other standards ISO 22000: 2005- Food safety management systems-requirements As its title suggests this standard sets out a systematic approach to food safety, combining two approaches into an effective tool for management. These approaches are: • the management system approach, as normally understood in ISO 9001:2000 except that ISO 22000 looks at the customer requirement of food safety ONLY and not at all the other requirements that are expressed as customer requirements. For companies that use management systems, this means that an ISO 22000 approach can fit food safety very easily into this pattern. • ISO 22000 is almost exclusively based on HACCP, with less attention to GHP, GMP or other prerequisites (which it terms as supportive safety measures). With this attention to HACCP, it provides a flow diagram demonstrating linkages between the twelve tasks of HACCP and its own sections.

The Global Food Safety initiative (GFSI) This is a comprehensive private initiative for food safety resulting from cooperation between major European food retail super and hypermarket chains. Because of their need to demonstrate due diligence the protocol is comprehensive. Its specifications go beyond, but include those of this GHP, GMP, and HACCP guide. It is much more prescriptive in setting its requirements.

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Annexure-10 Food chain steps There are different steps in the food chain Every step must be covered by specific standards to ensure a high level of food safety. The whole food chain must be monitored. This includes also the environment as there is no seafood in a poisoned sea and there are no crops in a dead landscape. The aim is to link failed productions with their causes so auditing can find failures of the existing food safety systems and avoid harm.

The different steps in the food chain are: Agrarian origin, Transportation, Storage Industrial processing, handling by the consumer. Food safety depends on: 1. Basic knowledge in farming, industrial know-how, transport and storage. 2. Ethical behaviour 3. Controls: HACCP, ISO 9001:2000, GMP, HALAL What to take care of in order to ensure food safety a - Biological hazards: Bacterial infections (Salmonella, Shigella, Campylobacter, Aspergillus), virus infections (Hepatitis, Creuzfeld-Jacobs-Disease) b - Parasites: Such as nematodes in herring and other relevant worms. c - Chemical contaminants: Herbicides, pest control substances and other chemicals such as mercury in Japan.

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d - Bacterial poisoning: Natural toxins can harm people even after the agent has been removed or killed. (Staphyloccocine, botulism and other poisons) e - Physical hazards: Ground Glass, metal or plastic fragments. f - Radioactive contaminants: Radioactive fall-out of nuclear tests such as Brazil nuts with Strontium 90 due to fall-out of nuclear tests coming down in the rain forest of the Amazon region, or fall-out from the catastrophe of Tschernobyl. g - Wrong industrial food processing and bad kitchen habits: High Temperature on backing and frying. Just to mention acrylamid in french fries, crisp bread and breakfast cereals. h - Wrong nutritional habits: Under- or oversupply of vitamins and trace elements, insufficient supply of dietary fiber. History of HACCP The HACCP concept had its origin in the USA and stands for "Hazard Analysis Critical Control Point". Chronology of its development: 1958- Foundation of the NASA (National Aeronautics and Space Administration) 1959- Development of the HACCP concept to assure one hundred percent safety of food to be used in space. 1971- The HACCP system was published and documented in the USA. 1985- The National Academy of Science (NAS) recommended the use of the system.

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Worldwide the system became used and the FAO/WHO Codex Alimentarius (Food and Agriculture Organisation/World Health Organisation) cited the system in the Codex. 1993- The European regulation 93/43 EG from 14.7.93 provides the use of the system for the production of food. 1998- With coming into force on the august the 8th of 1998 the Hygiene Verordnung (German hygiene Rule) demands the use of the HACCP system in Germany. The HACCP-concept The European hygiene rule defined in the paper 94/356/EG demands for an HACCPconcept which can be integrated in a quality management system This HACCP concept has to be developed for all products of every factory. The five basic ideas of HACCP-concept are: 1. Make a hazard analysis 2. Determine the critical points (CPs) which might be of hazard in the production of the food. 3. Determine the CPs which may be CCPs being of high importance to the safety of the food and which may be controlled safely using simple checks named "Controlling". For the controlling define the specifications of the product. 4. Define a control system of the critical points, using tests which can be carried out during production in order to interfere in case of wrong production. "Monitoring". Introduce a documentation in order to record every happening.

Define the corrections to be made in case of critical point being out of control. 5. Define the way of verification to confirm that the HACCP-system works."Verification”.

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Timetable to install an HACCP System 1. The head of the enterprise names the QS Manager who is responsible for the installation of the HACCP System 2. The QS Manager names the members of the team which shall work out the HACCP system. The team should be composed of members of the production line, members of the bacteriological control, members of the quality control, members of the development. There should be persons with knowledge of food bacteriology, food hygiene, food technology. If there are not such persons in the factory, external aid should be taken in the phase of installing the system. 3. The team determines what products can be handled together "Valid for.." 4. Come together of the team to make a "Description of the Products". It should contain: A short description of the product. List of regulations and laws which regulate the food. The list of the ingredients . Important specifications of the product such as chemical and bacteriological limits Temperatures, Packaging of glass, tin can, PP, PE, paper or aluminium wrapping Shelf life ,Instructions of use and storage conditions. 5. Come together of the team to make the "Flow Diagrams of the Products". 6. The team checks all documents to make corrections of possible errors. 7. The team marks all CPs on the flow diagrams. CPs are all points were a hazard for health of the consumer might occur. 8. The team identifies and marks all CCPs on the flow diagrams, trying to have a low number of critical control points. CCP is a Critical Point were the hazard can be avoided, eliminated or reduced to an acceptable level. How to identify a CCP ?

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At any point of the production line ask the question: - Is this point a hazard to the health of the consumer ?

9. IF NO go to the next point. IT IS NOT A CP IF YES . The hazard is put under control at this point and it is reduced to an insignificant tolerable danger with the correct activity or it is totally eliminated.It IS A CCP and is put under control - Are the control activities sufficient to avoid, eliminate or reduce the danger to an acceptable level? NO, the technology of the production should be changed. YES, the CCP is marked in the flow diagram. and the controls are enumerated how often they have to be done and what specifications have to be observed. 10. For every CCP there should be made a list containing the following informations: The place were the CCCP is situated (heater, packing line, Storage), What kind of controls should be made ( chemical bacteriological), What kind of instruments are necessary (thermometers, culture agar, microscope) ,Instructions how to handle the instruments and detailed description of the laboratory methods ,How often shall the controls be made? Who makes the controls ? (Name the personal and the substitutes who have to make the controls) 11. The team determines the tests to be made at the CCPs (temperature, pH, acidity, filter, metal detector etc. The team marks the intervals between these tests. 12. The team determines the corrections to be made in case of fail production. The team determines who is responsible to execute the corrections 13. The team determines the methods used to control the CPs

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14. The QS Manager verifies if the system works or not and if the internal audits are made in time HACCP is a living system. After installing the system it should be rechecked periodic. The work on the basic documents will never end.

Don't forget to answer in your documents the following questions: Who controls? When? How the controls are made? Where the controls are made? Make a drawing of the building enumerating the rooms 1. Make a drawing of the machines enumerating them 2. Make a diagram of the production line with including the material flow 3. Make a drawing of the rooms containing all water tabs, enumerating them 4. Make a drawing of the way the personal has to walk, starting from the entrance to the room where they may change clothes, the way to their working place, the way they have to go during work and the way back to change clothes. 5. Make a drawing of the sewage system 6. Make a plan of progressive education of the personal. This plan should include informations about new machines, new products, hand washing and disinfection, informations about shelf life of the products. Fingernail colours make an inspection of clean nails difficult. Therefore it should not be allowed. 7. Make a cleaning and disinfection plan 8. Make a plan to control the cleaning and disinfection 9. Plan of the controls of water used in production 10. Plan of pest control Industrial hygiene is teamwork. Everyone engaged in production of food must cooperate. There must be a detailed description of every work. The procedural rules should be available at the place where work takes place. The quality and the safety of the end

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product depends on interventions at all stages of agricultural production or harvesting through manufacture, processing,storage and transport to the final consumer. The main concern is to avoid contaminations originated from:

Biological factors :

• •

Bacteria, such as Salmonella, pathogen Escherichia coli, Clostridium botulinum, Viral infections or BSE. The biological factors can be avoided through cleaning and disinfection activities. They must be supervised by a controlling person making periodic surface contact cultures and cultures from different points of the production line.Bioluminescence ATP tests are also performed with good results.

On market there are test stripes which indicate after some minutes the presence of proteins signalising bad cleaning.
• • • •

Introduce a documentation in order to record every happening. The Hygiene rule 93/43/EWG demands also for a hygiene training of the staff. Chemical factors: Residues of cleaning agents, insecticides and other chemicals. Very important is to make sure that all residues of cleaning and disinfection agents are eliminated before product processing starts. This is done with rinsing with clean drinking water. There should be a daily cleaning and disinfection plan.

• •

Physical factors: Splinters of metal, glass, bones, wood, stones and other materials. System to avoid the risk of physical factors are filters, X-ray scanners and metal 285

detectors are widely used. Other materials can hardly be detected. So every effort should be undertaken to avoid splinters of glass, wood and plastics into the food. The bottles should be turned overhead and blown out with a flush of compressed air before filling. All the way to the filling should be covered, so splinters cannot get into the glass. Start a "Glass damage book" where damage of Glass is registered telling the name of the product, the filling machine, the name of the operator, date and the time of damage.

All handling and controlling of the production of food should be conform to the system of "Good Manufacturing Practice ( GMP ). Risks which might endanger the health of consumer The health of the consumer may be endangered by following factors:
• • •

Contamination and recontamination of food by pathogen bacteria Parasites or chemical substances Survival of heat processing of pathogen bacteria, her later multiplication under favourable conditions and formation of undesired chemical reactions Formation or undesired, toxic substances and formation of bacterial toxins

Hazard Analysis and Critical Control Point (HACCP) The HACCP - Concept is now introduced by the Hygiene Rules 93/43/EWG in the production line of food in Europe. It bears the main ideas from the worldwide accepted HACCP-System of the FAO/WHO Codex Alimentarius. The HACCP is a system demanded by the EG Hygiene Directives and avoids the hazards to the health of the consumer. Everything which is not a hazard to the health of the consumer is not covered by the system. Hazard

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With hazard every risk of the health of the consumer are meant. Excluded are all events which are not related to health. This is the difference of the Quality Management of ISO 9.000 which covers every events of quality. Critical Point It is every point in the production of Food where risks of the health of the consumer can be present. Critical Control Point A Critical Control Point ( "CCP" ) is a point in the production line where a risk of hygiene may be put under control or eliminated. With appropriate measures at that point the risk can be:

• • •

avoided eliminated or reduced to an acceptable level

Examples of critical control Points (CCPs) are:
• • •

Income of raw materials Storage and cooling of food Recipes, handling and processing of food

• • • • • •

Defrost, heating, warm hold phase and cooling Distribution of food in restaurant, fast-food pH of food Correct separation between clean and unclean sectors Cleaning and disinfection Hygiene of the surroundings and hygiene of the stuff

In case of deviations of the specifications it is proceeded as follows:
• • • • •

The product is given to rework The product is mixed with another charge in order to bring the analytic to acceptable values The customer is informed about the deviation and accepts the product When no rework is possible and the customer does not agree with the deviation a selling to other customers at reduced price is to be considered When above procedures are not indicated the product must be rejected

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Planing HACCP To plan HACCP proceed as follow: Prepare the following tables: Detailed description of every product A detailed schematic description for every product should contain:
• • • •

Definitions: Explain used terminologies and abbreviations Cite the different foods which belong to the described group Characteristics: like flavour, smell, consistency, etc Ingredients: All ingredients should be listed

• • • • • • •

Chemical and physical properties: Important analytical values such as pH, acidity, viscosity should be established as specification. Maximum and minimum of the deviations should be included in this table Purchasing department Processing: such as pasteurisation,sterilisation etc should be mentioned. Packing:glass ,tin can ,PP , PE etc Storage:Specification of the storage temperature,moisture etc. Shelf life. Indication for consumer for final preparation of the food before eating. Special informations for specific consumer groups such as diabetics.

Description of processing Prepare a table with a complete information about the production containing:
• • • •

Incoming of raw materials. Description of the processing. Temperatures,heating time, pressures. Temperature maximum time for storage.

The description of processing must be completed with a process flow diagram of the whole proceeding with the marked CCPs, the target values and tolerances and the corrective action should the product fall out of specification. Static hygiene conditions: Building The building where food is being handled according to hygiene rules must be in a condition to avoid negative influence during processing. Cleaning and disinfection of the

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rooms must be possible. Necessary temperatures for handling,processing and storage must be available. The building must be clean and the maintenance must have been done. The floor must be easy to clean and to disinfect. It should be watertight. The walls are to be covered with watertight material, easy to clean and to disinfect. The ceiling should be covered wit watertight material avoiding condensation water, dirt and molds. There must be a sufficient number of hand washers with spender of liquid soap and disinfection based on alcohol. There must be a sufficient natural and artificial illumination of all rooms. There must be a facility for the personal to change cloth. Windows must have fly screens. The rooms are not to be used for other activities. The surface of tables and other surfaces which come in contact with food must be easy to clean and to disinfection. To wipe there should be used only one-way towels ,not using it more then a day. Buckets and other cleaning utensils should be of different colour in order do avoid cross contamination from one place to another. Machines and other utensils for processing of food : All surfaces must be easy to clean and to disinfect. Everything should be of

stainless steel. Plastic parts should be made of polyester heat resistant to 130 C . The wire used to hold brushes together should be of stainless steel.Brushes should be made of polyester. They should be of different colour in order to avoid toilet brushes or highly contaminated places be used in the kitchen. All parts and utensils should be free of cadmium. Toilets: There must be a sufficient number of toilets with water flushing. Toilets should not have a direct communication with the processing rooms. The hand washers in the toilet room should provide liquid soap an disinfection based on alcohol being operated automatically or by arm, (not by hand !) One way paper towels should be used. There must be cold and warm water. The toilet room must have an air exhauster . Dynamic hygiene conditions: Cleaning, disinfection and maintenance of the building,hygienic handling of food. The building must be cleaned and disinfected properly. Maintenance of the building includes painting of walls and ceilings to avoid molds. Change broken coverings of walls and close all unnecessary holes. Control the handling through all phases of the production, from income control, from production to storage and transportation. Incoming control: Raw products and ingredients should not be accepted when there is evidence for the presence of pest,pathogen microorganism or there is evidence that the products are spoiled. If necessary the products must be changed to adequate containers, or changed from wood pallets over to plastic pallets. All products should be labelled with:

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Name of the producer. Date of delivery. Expiration date. Storage and handling of raw materials: Raw materials must be stored and handled under well defined conditions. Production, improve the technical processing: Use good manufacturing practice principles handling food during processing.Make a separation of "dirty" and "clean" areas making sure that the routes of transportation of "dirty" and "clean" material does not cross each other (For example: keeping cooked meat and uncooked meat together in one refrigerator or one cooling room. this must be avoided)Avoid crossing unpacked food with already packed food. Avoid people working in "dirty areas" to get to "clean areas". This can be controlled by different hair coverings:

Red for dirty areas and green or white for clean areas. Wood utilities should be avoided as they bear pathogen moulds, bacteria and virus.This includes Tables, doors and environment: Health condition or the staff which comes in contact with food Medical inspection of all people handling food is to be periodic repeated and documented. This includes clinical inspection, bacteriological examination of faeces with regard to Salmonella bacteria, daily control of the personal to avoid purulent wounds, persons with diarrhoea and other problems to come in contact with food. These persons should be engaged in areas were they cannot come in contact with open unpacked food. Diseases which are spread by food. Persons with the diseases mentioned below should not come in contact with unpacked food. Cholera, Enteritis infectiosa, paratyphoid, dysentery, tuberculosis, dermatosis, salmonellosis and shigellosis. Pest control The rules related to hygiene in handling with food demands to avoid any negative affecting of food. Pest and their excrement affects food in this way. The measures to control the affecting should be integrated in the HACCP system. Hazard analysis of pest control Possible Pest in a food factory
• •

Insects: cockroaches, moths, ants, beetles, flies, wasps,mites and spiders Rodents: rats, mice.

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Dissemination of pest Dissemination of pest can happen through:
• •

Dissemination with the product itself- such as banana spiders. Dissemination with the packing Such as bacteria and moulds on cardboard boxes such as seen on a piece of cardboard on nutrient media: Dissemination with the transport devices, such as pallet giving places for mice and rats to hide. Pallets can also transmit insects like wood spoilage : Dissemination from one place of the plant to another, such as the transport from storage of raw material at open air facilities.

There are many ways of affecting food by pest:
• • • • • •

Transmission of bacteria. Damage of product and packing material. negative affecting of Taste and smell. Modification of appearance. Spoiling. Attack by secondary pest at the point of packing damage.

Determination of critical points in relation to Pest control (CCPS) There should be made a flow diagram, of the product to be analysed and a diagram of the building where the production and the storage of the raw material, packing material and end product is taken place.In this diagram the CCPS should be marked. Factors which can facilitate pest dissemination
• • •

Possible food for pest like garbage,empty tin cans with rests of food, open drainpipes etc. Temperature of the different surroundings:Warm rooms and hot places facilitate the multiplication of pest. Humidity:High humidity intensifies not only yeasts and molds but also the multiplication of pests

Neglected or abandoned rooms or environment can act as biotope for pests which can migrate to other parts of the building used for the actual production.

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The whole building and his environment should be considered as one. The best place is as good as the worst place is. Categories of effects of pest attack,according to Voigt
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Catastrophic: When the health of the population is endangered Critical: When the food is not suitable or when it is spoiled Small: When consumption is restricted Insignificant: When the consumer does not notice the failure.

General considerations about pest control Contamination caused by rodents and insects produces loss of material and is a way of transmission of diseases. The Hygiene rules demand to keep food free of influence of pest and pesticides and repulsive modifications as well all hazards for the health of the consumer.

Rodents Rats and mice They generally live near garbage and drainpipes.As these animals live in places with high contamination with bacteria they bear on the hairs of their coat dirt and pathogen bacteria and contaminate the food with which they come in contact. Rats and mice feed themselves with garbage and deteriorated food contaminating itself with bacteria which are eliminated in their faeces and urine. When rats and mice die the fleas abandon the corps an can attack human transmitting diseases or cause allergies. The teeth of rodents grow continuously. In order to keep them short they have to gnaw hard objects such as electrical wires, causing electrical shorts and fire. Rats and mice should therefor be exterminated. Extermination of rats and mice Combat of rats and mice are made with anticoagulants. In the surroundings of food only approved products of are allowed. As babies of rats and mice can feed by itself after 17 days of lactation it is necessary to proceed with the lay out of poison for at least 14 days after the death of adult animals. The new generation can leave their nest in that time. Rats and mice are reservoir of Borrelia, which is transmitted to humans by ticks. Bacteria transmitted by rodents, according Hoffmann 1986 Bacteria transmitted by rodents according to Hoffmann 1986
• • • • •

Salmonella, cause salmonllosis, paratyphi and salmonellosis of cattle Shigella, cause shigelosis Yersinia enterocolytica Yersinia pseudotuberculosis Francisella tularensis, cause tularemie

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• • • • • • • • • • • • • • •

Listeria monocytogenes, cause listeriosis Pseudomonas pseudomallei, causes melioidosis Streptobacillus moniliformis, causes rat-bite fever and complications Clostridium botulinum Leptospira interrogans, it is pathogenicindexLeptospira interrogans Leptospira interrogans,serogroup Icterohaemorrhagiae, cause Weilsch disease Leptospira interrogans, serogroup Grippotyphosa, cause hay-fever Leptospira interrogans, serogroup Pomosa,causes pig breeders disease Leptospira interrogans, serogroup Canicola,cause dogs disease Spirillum minus, cause rat-bite fever and "Sodoku" Coxiella burnetii, cause Q fever Erysipelothrix rhusiopathiae cause pig epidemic Mycobacterium tuberculosis, cause tuberculosis Vibrio cholerae, cause cholera Borrelia sp., cause borreliosis

Viruses transmitted by rodents
• • •

Pig pest Rabies Virus of encephalitis

Molds transmitted by rodents
• •

Tricophyton quinckeanum Trichophyton schoenleinii

Nematodes transmitted by rodents
• • •

Trichinella spiralis Hymenolepis nana Hymenolepis diminuta

Echinococcus multiocularis

Cockroaches They like damp and hot places eating all kind of food, including spoiled garbage.They make therefore the transport of bacteria. They contaminate food with their legs, faeces and vomits.

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Bacteria transmitted by cockroaches.According to Hoffmann, 1985
• • • • • • • • • • • • • • •

Salmonella Shigella Escherichia coli Proteus Klebsiella pneumoniae Enterobacter Serratia marcescens Vibrio cholerae Vibrio parahaemolyticus Yersinia pestis Pseodomonas aeruginosa Streptococcus sp Staphylococcus aureus Listeria monocytogenes Bacillus anthracis

• • •

Chlostridium welchii type A Mycobacterium tuberculosis Mycobacterium leprae

Viruses transmitted by cockroaches. According to Hoffmann, 1985
• • • •

Hepatitis virus B Poliomielitis virus type1 Cocksackie virus type B5 abd A12 ECHO virus type 6

Yeast and molds transmitted by cockroaches. According to Hoffmann, 1985
• • •

Candida albicans Aspergillus Trichophyton rubrum

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Protozoa and nematodes transmitted by cockroaches. According to Hoffmann, 1985
• • • • • •

Balantidium coli Entamoeba hystolytica Giardia intestinalis Toxoplasma gondii Taenia sp Ascaris and other nematodes

Flies Flies like the house fly Musca domestica and Fannia canicularis make the transport of bacteria like Salmonella. Bluebeettle The genus Calliphora sp. and Lucilia sp. inhabit contaminated places such as latrines garbage etc.They enter buildings carrying diseases and putrefaction agents. Contact of food with bluebottle can be avoided keeping food in refrigerator or covering food with a covering bell or plastic coverings, the doors and windows should be closed with fly lattice. Indoor electrical devices with blue light should be used which kill insects using high voltage. Larvae should be killed with insecticides and keeping theenvironment clean and free of garbage, deteriorated meat and carcases. Interior and surroundings of the

buildings should be free of garbage and carcases. Insecticides should not come in to drain pipes as they may kill small animals which are part of the food chain for other animals. Bacteria transmitted by flies. According to Hoffmann 1985,Steinbrink 1989
• • • • • • • • • • • • •

Salmonella Shigella Escherichia coli Proteus vulgaris Vibrio cholerae Brucella abortus Brucella suis Streptococcus sp Staphylococcus aureus Erysiopelothrix rhusiopathiae Bacillus anthracis Clostridium botulinum Mycobacterium tuberculosis

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Bird control Interior and surroundings of food storage, market halls and stores, food processing buildings the presence of birds are not acceptable. Common bird which try to built their nests in the interior of buildings are pigeons, starlings and sparrows. Bird control should be done by removing their nests and avoid reinvasion. Shooting is not always effective and should not collide with rules of animal protection. Pest control tries to avoid pests, early detection and control. Important are tight doors, smooth surface of walls and floors and good air conditioning. Fumigation: Methyl bromide Methyl bromide is being used as a method of fumigation for raw materials such as wheat, semolina and flour to ensure effective eradication of insect pests. Chemical fumigation however is banned. Natural solutions are therefore being searched, such as heat and controlled humidity. Phosphine Phosphine is the most frequently used alternative to methyl bromide for durable commodities. It is widely used to kill pests in cereals, legumes, dried fruits, nuts and other commodities. Phosphine requires a long exposure period (5 to 15 days) and usually temperatures of over 15oC to release phosphine from its tablet form, making its use not practicable in cold climate. It can be used in transit. Phosphine gas is generated by the reaction of metallic phosphide such as aluminium phosphide or magnesium phosphide granules and tablets with atmospheric moisture. Other systems use compressed gas cylinders mixed with carbon dioxide, or by reacting phosphide granules with water and carbon dioxide (Horn Generator). Used on its own initial dosages of 900 to 1200 ppm and

final concentrations of 200 to 400 ppm for 36 to 48 hours. Corrosion, however, should be kept in mind as it endangers electrical equipment. Resistance of pests to phosphine develop under frequent use with poor sealing of structures. Heat, phosphine, Carbon dioxide treatment Combination of heat(30 to 38oC), phosphine (150 to 500 ppm) and carbon dioxide (3 to 7%) increase respiration in insects, allowing reduced concentration of phosphine and reduces the potential for corrosion. These values compare to temperatures over 50oC for a heat treatment alone, or an initial dosage of phosphine of 900 ppm or more when used on its own. Irradiation Irradiation can be used to disinfect packaged or bulk products. In Canada irradiation is allowed only for wheat and wheat flower, spices, herbs and vegetable seasonings. High-speed centrifugal impact High-speed centrifugal impact machines (Entoleters) are useful to destroy any insects that may be in flour. This procedure is less useful for semolina as it tends to break up the larger particles.

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Diatomaceous earth (DE) The fossilized diatoms are amorphous silicon dioxide which works as an insecticide by adsorbing to the wax coatings on insect bodies, leading to death by drying. It is used on grain, in grain storage and transport containers, and in food processing plants and flour mills. It is primarily used in specific areas as a spot treatment or surface treatment of containers. It can also be applied inside electrical and control panels and in dead spaces behind walls before they are closed up. Personnel items A separate area should be provided for personal items such as coats, shoes and lunches that are brought into the plant as they might be a root of pests. Good Sanitation Practices The importance of cleaning and sanitation must be emphasized to all staff. In particular, cooperation among cleaning crews, quality control officials, and a pest control service will be beneficial. In case of faulty food injured people have rights of recourse.If the producer of the faulty food has a valid HACCP concept with written results of his controls the injured person must provide the evidences that the failure was originated during during handling and treatment of a specific producer. If the produce does not have the written results of his controls or the frequency of the controls are not sufficient he has to prove that the failure has not been originated under his responsibility. The HACCP system is therefore a practical instrument of protection against unjustified accusations. However if he fails to proof that the failure could not be originated during his responsibility the producer has to assume the liability.

Waste control There should be a document with informations about: Type of waste. Place where waste and garbage is collected. How the waste is transported and to where it should go. Date and signature. Garbage and waste cannot be collected and stored in the store where food is being sold, stored or handled. Containers should have a lid and they should always be closed. Pest control should avoid rats and insects to get to the garbage. Own experiences with pipelines have shown leaking valves between product line and pipes being cleaned in place, so that CIP solutions got into the product. Don't underestimate the value of pipeline diagram. Engineers like to talk it down because of the trouble to make the initial drawing and to keep it update. Only with complete diagrams hazards like lealing valves placed between product and CIP lines operated simultaneously can be made visible. Total Quality Management Total Quality Management TQM can be installed after ISO 9000. The system tries to unite all the different phases of the activities of a company beginning from the financial 297

control down to production and technical details. With growing international business the enterprises have to integrate modifications in the basic structure concerning the rapid changing international market. ISO 9000 is the basic activity which supports Total Management. Characteristics and ability of the Total Management staff The staff according A.Borning should have:

• • • •

International communicability. The ability to create and guide international teams Intercultural sensibility Knowledge of the differences between the nations as basis of negotiations

In the past quality control and quality improvement was considered as being in the responsibility of one department or a part of an enterprise. In Total Management Quality has to concern every part of the enterprise. The whole personal staff is responsible for the quality management of the enterprise. To coordinate internal processes and external demands of customers Business Process Management BMP can be used. It is a structured, methodical enterprise specific handling of the transaction. The relation from supplier to customer is in BMP of great importance. The different goals of the TQM should be:

• • • • • • • • •

Continuous improvement of processes Information and coordination of the staff in case of innovations Complete basic activities before begin of an innovation Delegation through description of the position and jobs of every employee. Time Management Rules of meeting Education and training Target to be achieved Opinion poll

The integration of manager and the way of thinking of different continents and cultures must be kept always in mind to solve international problems.Therefore are opinions and conferences with a multinational staff extremely important. The main question which rules all activities of Total Quality Management is: What can be improved ? The target of the Total Quality Management is: The most important targets are: High capital rentability Team spirit, culture of the enterprise directed to Total Quality Management resulting in

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success on long terms. Targets must be arranged according to their priority in order not to create conflict situations between employees responsible for the execution of the different sections. In case of necessary changes in the structure of the organisation the international manager staff should have flexibility to overcome difficulties related to:
• • • • • • • • •

Isolated business groups Market Oriented Profitcenter Joint Venture fusions Decentral Diversification Activities Outsourcing Horizontal Networklike Project Organisation like Matrixstructures Creation of Experimental Units Modifications resulting from Common Cost-Analysis Lean Management

Rotation of the Management between branches inland as well as branches from abroad with the main head is very useful to create a common feeling and fortify the unit of the enterprise. Loyalty The career of managers with many changes of jobs between enterprises should be analysed very skeptical.They show little care about the flag they serve and the destiny of the enterprises. Their goal is their own career. They have no identification with the

history and with the future of the enterprise. In bad times they go and take the know how and company secrets to bargain with it for a new job. Quality Management Manual The Quality Management Manual contains all topics concerning Quality Management QM having a description of all standards of the QM system.All other documents are subordinated to the Quality Management Manual. When the whole enterprise is organised according to the principles of ISO 9000 it is certified during a period of 3 years. During this period the certifying company makes audits each year External audits The external audits are made by the company which had certified the enterprise. The external audit controls the actual work to be accord to the established rule of the Quality Management Manual.The duration of an external audit is approximately one day.The external auditor may negate the certificate when serious faults are found. ISO 22000: 200x Food Safety Management Standard

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ISO 22000 will be international and will define the requirements of a food safety management system covering all organisations in the food chain from farmers to catering, including packaging. In recent times there has been a worldwide proliferation of third party HACCP and Food Safety Standards developed both by national standards organisations and industry groups including the UK's own BRC. The idea of harmonising the relevant national standards on the international level was initiated by the Danish Standards Association (DS). ISO 22000 aims to harmonise all of these standards. The standard has the following objectives: 1.Comply with the Codex HACCP principles. 2.Harmonise the voluntary international standards. 3.Provide an auditable standard that can be used either for internal audits, selfcertification or third-party certification. 4.The structure is aligned with ISO 9001:2000 and ISO 14001:1996. 5.Provide communication of HACCP concepts internationally. The ISO 22000 gives definitions on related terms, describes a food management system including: 1.General system requirements. 2.Definition of the management responsibility and commitment. 3.Documentation requirements. 4.Definition of responsibility and authority. 5.Calling for a food safety team, communication, contingency preparedness and response. 6.Gives a review on management, resource management, provision of resources, human

resources, realization of safe products, product and process data, hazard analysis, design of the CCP plan, design of the SSM programmes, operation of the food safety management system, control of monitoring and measuring devices, measurement, analysis and updating of the FSM system. 7.System verification,validation and updating. 8.Correspondence between ISO 22000:200x and ISO 9001:2000. ISO 9001:2000 The ISO 9000 series turnbed out to be the best international quality management system. The ISO-9001:2000 can be used for internal application by organisations, certification, or contractual purposes. The ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 family of standards have been consolidated into a single revised ISO 9001:2000 which contains a single quality management requirements standard that is applicable to all organisations, products and services aiming to:

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Address customer satisfaction. Meet customer and applicable regulatory requirements. Enable internal and external parties to assess the organisation?s ability to meet these requirements. The ISO-9001:2000 quality system aims to enhance customer satisfaction. This includes the processes for continual improvement of the quality system and the assurance of conformity to the customer and applicable regulatory requirements. In global business the certification according ISO 9000 turned out to be an imperative duty. The HACCP concept should be integrated in the quality system fulfilling hygiene regulations. The ISO 9000 was first released in 1987, a first revision was published in 1994 and in 2000 the modification to ISO 9001:2000 was released. Since then only three main standards subsisted: ISO 9000:2000: Includes a description approach to quality Management as well a revised vocabulary. ISO 9001:2000: Includes the quality management system, requirements. ISO 9004:2000: Includes guidelines for performance improvement moving toward Total Quality Management. It is not intended for certification or contractual use. They rely on the following eight principles: 1.Customer focused organisation 2.Leadership 3.Involvement of people 4.Process approach 5.System approach to management 6.Continual improvement 7.Factual approach to decision making 8.Mutually beneficial supplier relationship Documentation of the system should include: 1.Quality Manual. 2.Specific statement regarding quality policy and quality objectives.

3.Documented procedures that describe the sequence of processes necessary to ensure the conformity of the product. 4.Documented instructions to ensure the effective operation and control of the processes. 5.Quality records. Control of documents: A procedure for the control of documents should include: 1.Controlled distribution of documents. 2.Approval of documents prior to issue. 3.Review and updating and re-approval of documents. 4.Identifying the current revision status of documents.

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5.Ensuring that only relevant versions of applicable documents are available at points of use. 6.Insuring that documents remain legible, readily identifiable and retrievable. 7.Identifying, distributing and controlling documents from an external source. 8.Controlling obsolete documents. Control of records should include: Maintenance 1.Identification 2.Storage 3.Retrieval 4.Protection 5.Retention time 6.Disposition of all quality records. Management commitment: 1.Conduct regular management reviews 2.Ensure the availability of necessary resources 3.Ensure that everyone is aware of the importance of meeting customer, regulatory and legal requirements. Customer focus: 1.Customer needs and expectations must be determined. 2.They must be converted into requirements 3.The requirements must be fulfilled. Quality policy: The quality policy of the organisation should be communicated and understood by everyone. It should be capable of continual improvement and regularly reviewed. Quality management system planning:

Quality planning should be documented including quality objectives and resource. Responsibility, authority and communication: The administration of the QMS covering the responsibilities and authorities, function, relationship and the internal communication must be documented. Review input from: 1.Earlier management reviews such as follow-up actions. 2.Previous internal and external audits. 3.Customer feedback. 4.Process performance. 5.Product conformance. 6.Preventive and corrective actions. 7.Changes that could affect the QMS and recommendations for improvement. 302

Review output: 1.Improves the overall QMS and its process. 2.Improves the product. 3.Enhances customers satisfaction. 4.Confirmes the resources required. Resource management includes: 1.Human resources on regard of competence, awareness and training. 2.Provision of resources. 3.Work environment. 4.Infrastructure. Specifications Specifications are essential technical requirements for items, material, or services, including the procedures to be used to determine wether the requirements have been met. Specifications may also include requirements for preservation, packaging, packing and marking. Without proper specifications it is impossible to expect a manufacturer or supplier to produce an article, equipment or system that completely satisfies the customer. Types of specifications Three types of specifications can be used to settle product requirements: 1. General specifications: Are overall specifications of the product written by the purchaser. It requires a detailed description of the article. Suitable, appropriate, conventional harmless or healthy should not be used as they open loopholes in case of complaints. It should contain the whole formula for food, ingredients and packaging. 2. Overall performance specifications: These Specifications have vague contents. They leave everything up to the manufacturer. Later complaints are almost impossible. 3. Standard specification: Here a detailed description of every ingredient is given. Lists

of the National Standards Organisations NSOs of parts commonly used by manufacturers, or The British Standards Institution (BSI) lists such as BS 9000, CENELEC and IECQ and CECC as well as standards and regulations such as Codex Alimentarius and other organisations can be used. HACCP programmes: 1. Good practices: Assessment and Implementation of Prerequisites • Compare the situation of the company with a scheme of Comprehensive Hygiene Management for SMEs. • Identify the items of the scheme which have not, or have only been partially satisfied amongst those which have been fully implemented, by answering the following questions 303

Item 1 o are the buildings and equipment in compliance with regulations and standards? o does a contractual relationship with raw material suppliers exist? o does an effective pest control plan exist? item 2 o is a policy of staff health control defined and applied? item 3 o are the rules of hands washing and personal hygiene defined and applied? o does a cleaning plan of the buildings and equipment exist and is it effectively applied? item 4 o do control procedures of the different "time/temperature" couples implemented in the company exist? o is there a control of the products formulation constancy? item 5 o does a sampling and analysis plan of the finish products exist? training o is staff training ensured and regularly updated? 2. First phase of the HACCP method (tasks 1 to 8)3: the HACCP Study • HACCP method analysis, task-by-task, without being allowed to pass to the next task until the preceding one is entirely carried out; • Audit by the use of grid 2 /4 (relating to the preliminary analysis phase of HACCP method) to check that each task carried out is completely and correctly fulfilled; • With the help of the explanatory booklet, assurance that the criteria of audit grid 2/4 are entirely fulfilled, before being allowed to proceed to implementation of HACCP method second phase (devoted to HACCP plan design). 3. Second phase of the HACCP method (tasks 9 to 12): design of the HACCP plan • HACCP method implementation, task-by-task, without being allowed to pass to the next task until the preceding one is entirely carried out;

• Audit by the use of grid 3/4 (relating to HACCP plan design) to check that each task has been carried out is completely and correctly fulfilled; • With the help of the explanatory booklet, assurance that the criteria of audit grid 3/4 are entirely fulfilled, before being allowed to start operating the HACCP plan. Third phase: Routine evaluation of the operating HACCP plan • With the help of the explanatory booklet, make sure that the criteria of the audit grid 4/4 (relating to the real and effective operation of the HACCP plan) are entirely fulfilled; • If all of the criteria of audit grid 4/4 are not fulfilled, return to stages 3, 2 or even 1 (above). Management scheme: 1 Building Standards, Suppliers Control, Pest Control Plan 2 Personnel Health Policy 304

3 Hand Washing Rules & Cleaning Plan 4 Hot & Cold Technologies + Foodstuffs Formulation 5 Finish Products Analysis Management scheme: 1 Building Standards, Suppliers Control, Pest Control Plan 2 Personnel Health Policy 3 Hand Washing Rules & Cleaning Plan 4 Hot & Cold Technologies + Foodstuffs Formulation 5 Finish Products Analysis 1.2. Building Standards, Suppliers Control, Pest Control Plan Buildings and Environment Conformity The design of new buildings, or the improvement of the existing buildings and equipment, should respect the following principles: General principles • The plant should have at least four doors: • one door for the entry of raw materials • one door for the entry of production staff • one door for the shipment of finished products • one door for waste disposal • The onward flow principle. Successive production operations should ensure a forward progression of products, without back return, from the lowest level of development towards the highest one, from the least healthy condition towards the healthiest one, from the least susceptible condition towards the most susceptible one. In order not to flout this rule, operators should not move from place to place - they should maintain work at the station at which they are placed. • No production line criss-cross. Two (or more) production lines should not crisscross. They can be connected (e.g. assembly of composed products put into a previously washed package) or split (e.g. manufacturing lines of by-products obtained during the preparation of the main product).

• Separation of cool and warm zones. Zones where hot foodstuffs are treated shall be clearly differentiated from those where old ones are treated in order to avoid their thermal pollution. • Separation of clean and dirty areas. Waste produced with each stage of manufacture should be removed in the most direct way possible towards its treatment location(s) (e.g. dishwashing) or storage (e.g. waste handling). Construction Regulation and Standards

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• Floors shall be: smooth and impermeable washable, non-skid not subject to rot, hardwearing • Walls shall be: smooth light colored, washable not subject to rot, ‘shock-resistant’ (up to 2 meters high) bonded to the floor by semicircular joints, with no nooks or crannies, to allow easy cleaning and drainage of wash and rinse water (see diagram below) • Ceilings shall be: light colored, washable, smooth • Passive or mechanical ventilation devices must ensure the elimination of steam and smoke • Lighting shall be: bright, neutral in color (so as not to modify the foodstuff colors) Equipment conformity • Equipment shall be: smooth not subject to rot, stainless, washable (without nooks and crannies that are inaccessible for cleaning). Compliance with these rules prohibits the use of undressed wood, cardboard or tapes for the manufacture of furniture (or their use in temporary repairs). Equipment should not be placed adjacent to walls so as to allow for proper cleaning and for proper pest and cleaning inspection. • Materials used to manufacture tables shall be: Smooth not subject to rot, light colored hardwearing, washable impermeable. The compliance with these rules prohibits the use of undressed wood or cardboard, and porous or rough materials like undressed concrete. The materials most often used are stainless steel, plastics and glazed earthenware tiles. • Tools shall be: inalterable in all parts. The compliance with this principle prohibits the use of wood even for the handles of tools. The materials most often used are stainless steel, aluminum (which may not be allowed by some food control authorities, in the US for example) and plastics.

• Machines shall be: not subject to deterioration, preferably stainless, definitely non-corrosive. easily dismantled. washable (without nooks and crannies that are inaccessible for cleaning). Pest Control Plan Pests generally taken into account are rodents and insects (and, in S.E. Asia, some small amphibians). In certain sectors (e.g. hypermarkets or other large spaces) birds may settle in the superstructures of the buildings or cats (e.g. in slaughter-houses) can soil the environment whilst attacking stored foodstuffs.

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Passive control, surroundings and outbuildings keeping In order not to allow the settlement of pests on the plant surroundings, (i.e. not to provide those places of refuge and feed resources) it is necessary to maintain a non-attractive environment that includes: • Isolated storage of unutilized materials, pallets and machines, without contact with the walls of the buildings. • Design and maintenance of external spaces, including: - The elimination of holes and spaces in wasteland with high vegetation. - The regular short shearing of grass lawns. - The absence of rags, papers, plastic films and other detritus abandoned on the ground (sources of materials for the construction of rodent nests). • Keeping of interior surfaces (racks, tops of furniture pieces) clean so as not to leave feed sources for rodents and insects. • Tidying and cleaning of technical buildings (machine shop, boiler room) so as not to support rodent settlement. • Installation of mosquito nets at windows and suitable screens on access doors. • Rigorous management of waste containers that shall include: - Frequent washing so as not to attract insects. - Storing on a clean and easily washable surface (water tap and floor drainage of waste water). - Kept closed (to prevent use as a feed source by all types of pests). - Filling without overflowing (not to drop food waste on the ground). Active control Pest’s detection • Insects: - Search for dead insects. - Search for alive insects in places of refuge (drawers). - Search and careful removal of bodies in electric insects trap collectors. • Rodents: • Search for rodents dropping or traces of urine.

• Search for attacks on foodstuffs (biting traces) or attractive conditions (torn open bags). - Presence of traces of grease of rodents on the usual passing through points. - Search for nests of rodents. Rodents control plan This plan is composed of a complete (set of) document(s), defining actions to be implemented, and including: • Technical cards of rodent poisons utilized. • Procedure and time tabling of rodent control operations, including the checking and renewal of distributed poison baits. • Timetabling and procedure for identification, evaluation and elimination of possible rodent infestation.

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• Implementation procedure of additional treatment in the event of a residual infestation. • Factory plans on which the locations of poison baits are identified. • Identification on walls of the premises in order to locate poison baits. Insect control plan. This plan is composed of a complete (set of) document(s), defining actions to be implemented, and including: • Technical cards of insecticides utilized. • Time tabling and procedure of insect control operations (walls insecticides, paint application and renewal, premise insecticide spraying). • Factory plan on which are localized the poison baits devoted to crawling insects. • Factory plan on which the locations of electric insect traps are identified. • Timetabling and procedure for traps emptying and trapped insects monitoring in order to evaluate infestation levels. Contractual Relationship with Suppliers and Deliveries Control Raw materials specification. In order to have a sound basis for deliveries’ control, the characteristics of ordered raw materials need to be specified precisely with suppliers. The conditions of acceptance / rejection of batches also needs to be clearly defined. Raw materials specifications should include: • Cards of specification of raw materials. • Formulation defining physico-chemical composition, presentation, particle or chunk size and variability, constants (e.g. pH, Aw, salt or sugar concentration, viscosity of the liquids). • Condition defined by type, volume, and shape. • Labeling (in particular with food safety official marks and elements of traceability). • Bacteriological standards (lawful or contractual) (possibly including contractual access to results of bacteriological control plans set up by suppliers). • Purity criteria, including absence of, or allowed levels of, foreign bodies (plastic, glass, metals) or residues (heavy metals, pesticides,).

• Condition for and responsibilities in case of inspection failure (removal, replacement etc). Preferential choice of suppliers benefiting from: • Certification (e.g. ISO 9001, ISO 22000), • or of a national or international approval (e.g. EEC and USA approvals), • or of other approvals (Halal, Kosher, vegetarian, GM free, retailer promoted assurance schemes, etc), • or of an accreditation or a referencing by a recognized customer. Preferential choice of suppliers accepting customer visits of their production site. Recording cards of deliveries check. These cards shall allow for minimum control of the following criteria: • Delivery temperature of the product (see Appendix – Calibration). • Use-by date or deadline of optimal use.

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• Labeling conformity and, in particular, official food safety marks. • Appending of batch identification marks necessary to operate any upstream and downstream traceability system. • Free from packaging damage. • Cleanliness of delivery vehicles. Details of parameters checked / inspected on deliveries may be recorded in a variety of ways, perhaps either on check cards or by use of an inspection grid, printed from ink pad, on the reverse of delivery orders. Receiving (into storage) procedures for raw materials following delivery checks, and any initial decontamination operations. Some care must be taken during introduction of raw materials into storage: • Maximum time duration following arrival of raw materials into temperature controlled storage (chill rooms and cold rooms) shall be defined and respected. • Soiled packaging (outer cardboard boxes, wooden pallets or supports, etc) shall be eliminated before placing raw materials in clean stores. • If fruits or vegetables undergo a decontamination treatment by steeping in disinfectant solution (chlorination, ozonisation,) the concentration of disinfectant and process time (max and / or min) shall be defined and controlled for each batch. Rejection. Procedures. The application of a rejection procedure must correspond to the clauses drawn up by contract with the supplier. The following needs to be recorded on rejection cards: • Reference(s) of the rejected batch (identification, constitution). • The reason for rejection by reference to conditions defined in the supply contract. • Signatures of the conveyer and the receiver. 1.3. Personnel Health Policy Enforcement of staff (and management) health policy depends theoretically on food factory occupational health care. It is nevertheless necessary to recommend the following provisions: • An annual medical consultation of every operator concerned in handling or manufacturing of foodstuffs.

• The systematic monitoring of staff for lesions caused by staphylococcus through clinical examinations of arms, hands, face, throat and other exposed skin, to be carried out by a medical practitioner of appropriate food handling experience. • The systematic monitoring of staff for potential Salmonella carriers (probably subject to frequent bouts of diarrhea) by conversing with a medical practitioner from industrial medicine. • Enforcement of detection procedures for operators likely to carry Staphylococcus or Salmonellas, by way of bacteriological analysis. Medical treatment for those diagnosed positive with one of these two microorganisms (without penalty so as to ensure staff confidence in the scheme). Hand Washing Rules and Cleaning Plan Hand Hygiene 309

The hands, frequently in direct contact with foodstuffs, need to be considered as the first operational tool. For this reason, detailed attention must be given to their cleanliness (just as with any equipment placed at the operator’s disposal) and to their washing regime. It should be noted that the hands, if not subjected to strict hygiene rules, constitute the first vector of contamination of food stuffs, by germs (pathogens) passed on from the operator. The implementation of training to demonstrate the proper technique for hand washing and drying is recommended. Hand wash sinks Hand wash sinks shall conform to the following principles: • Water flow shall not be operated by hand, but by foot or knee or by an automatic presence detector. • Liquid (or foam) soap shall be bactericidal but not a skin irritant (thereby excluding toilet soaps without bactericidal effect). • Soap dispensers shall be placed in a position adjacent to the wash sinks. • A second dispenser reserved for a disinfecting solution (e.g. of alcohol solution) can be associated with the liquid soap dispenser. • The device devoted to hand drying must be of single use (paper towels being practically the only possible solution). • Nailbrushes complete the wash-stand equipment. They should be made entirely from synthetic matter (handle and bristles) and need to be kept in a dilute clean disinfectant solution, renewed for each work period. Hand washing procedure • Wetted, liquid soap-smeared hands must be rubbed for 20 seconds (the operator counting: 101 . . . 102 . . . 103 . . . up to 120). • The rinsing of hands, which are rubbed under running water, must last a minimum of 10 seconds (counting…). • Wiping of the hands is not systematic, not being necessary for certain types of activities. • If a disinfectant solution is used, it shall be allowed to dry naturally on the hands. Hand washing frequency With effective hand washing taking a long time, strict definition of the frequency and

circumstances of this procedure are needed. Hands must be effectively washed whenever and wherever their contamination is practically certain. This washing, carried out immediately after dirty operations, will restore hands to satisfactory cleanliness and will prevent any points in contact with hands from gross contamination. If these contact points are themselves grossly contaminated, hand hygiene is not possible because, as work continues, they are immediately decontaminated. Complete hand washing after dirty operations (or dirty situations) (Practically the same in all branches of the food industry) • Arrival at the workstation. • Passing through and / or using toilets or changing rooms. • After nose blowing. • After dustbin handling.

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• After handling cardboard boxes from delivery (cardboard box bases are often very dirty). • After handling shell eggs (frequent contaminated by salmonellae). • After handling non-cleaned vegetables direct from the soil. • After handling game or poultry ‘in fur or feather’. • while passing from raw food production areas to cooked food product areas (i.e. from low risk to high risk areas). • In this case materials used (cutting boards, knives, etc…) must similarly be changed or correctly cleaned. Quick hand washing before conducting clean operations There is a multiplicity of clean operations, each specific to a branch of the food industry (e.g. cooked meat cutting, assembly of pastry making...). Whilst remaining at work within the confines of an appointed process, only a quick hand wash procedure is necessary, so long as operators systematically care about washing their hands after previous dirty operations and if contact point hygiene control is maintained. Hands contact point’s hygiene • Hands contact points shall be listed (handles of refrigerators or doors, kitchen utensil handles, machines, electric switches, etc). • These contact points must be the object of meticulous daily cleaning (or even a teach restart at the workstation or with a change of operator). Additional rules • No smoking at the work station, in the work place or whenever wearing work clothes. • No food tasting involving hand-to-mouth. • No nail varnish (or perfume - this is not a hygiene concern, but is one of potential food taint). • Maintaining neat short finger nails. • No rings, jewellery or watches to be worn (even if wearing work gloves). • The washing of gloved hands must be carried out with the same régime as for bare hands. • No reuse of disposable gloves after removal.

Work Clothing Hygiene In agro-food industries, clothing can be a major vector involved in food contamination. Work clothing, when not clean, can be a source of contamination for hands, whenever it is used to wipe them. In certain sectors, such as butchery, clothing is in direct contact with handled carcasses, (e.g. in shouldering carcasses when loading delivery vehicles). Work clothing management must respect some specific principles: • It is of a standard type and is provided by the company. • It is put in a locker (or a compartment of cupboard), physically separated from personal clothing (the locker shall be maintained in a clean manner). • Its color, or the color of one of its elements (cap, overall), may be specific to a work station or a zone of assignment of operators. • It includes a cap or net which covers all hair – this includes snoods for moustaches and 311

beards (head covering may also be devoted to other purposes, such as shock proof helmets). • It includes shoes (crush proof and non-skid) which are only worn in the factory (foot wear shall not contaminate work wear in a locker). • It is laundered by the company or under its responsibility (e.g. by contract with an industrial laundry – in this case the wash method shall be defined to ensure that laundry is not cross contaminated from dirty clothing from other sources). • It is: - hard-wearing to mechanical actions (tear) and frequent washing, - ignition proof. • permanent devices (boots/shoes washstands) or movable ones (trays), containing a disinfecting solution, must allow cleaning/disinfection of shoes or boots before getting into the production zone. Premise Hygiene – The Cleaning Plan Good hygiene of buildings and equipment involves the enforcement of a cleaning plan. There are at least two copies of the cleaning plan in the factory: • A complete version of the document, held and updated by the department of quality management, and to which technical cards of cleaning and disinfection products used are attached, as well as directions for use of machines used in cleaning processes; • A divided version, allowing each cleaning operative of the cleaning plan to have the part(s), which relates to her/his duty. • In the cleaning plan file, tasks checklists are included, as well as expected results of surface bacteriological tests.

The execution of cleaning tasks must be followed up by recorded checks by the operative, immediately monitoring its effectiveness. • Conducting microbiological analyses of surfaces makes it possible to check the effectiveness of the cleaning plan. IMPORTANT The method known as ‘W.W.W.W.W.H.’ (mnemonic - five Wives and one Husband) makes it possible to draft a suitable cleaning plan. These letters stand for six questions (when? who? what? where? why? and how?) that direct the development of the plan. The choice of the first question (asked from When? or Who? or What?) defines the process of organizing tasks in the cleaning plan: • ‘When?’ – cleaning tasks will be organized by day, by week, by month (by schedule) • ‘Who?’ – cleaning tasks will be assigned by operator, by team… • ‘What? – cleaning tasks will be organized according to building, department

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and equipment. 1.6. Finish Products Analysis – Bacteriological Tests Products Bacteriological testing carried out on finished products is generally characterized by a relatively long response time. As a result, it is not possible to await the receipt of tests results to affect production control, nor even to wait for them for product release. Consequently, tests on finished products have an assessment function on GHP, as well as on the operating HACCP plan. Unfavorable results do not make it possible to employ corrective actions on finished product, but must lead to re-evaluation and improvement of GHP implementation, as well as of the HACCP plan. Within the framework of risk analysis, carried out in an HACCP study, bacteriological tests on product at different production stages, makes it possible to evaluate the impact of each process activity/step, in terms of risk reduction or increase. For analysis results to be interpretable, they must be compliant with specific rules of coherence based on the relative weighting of total bacterial populations and component populations. Surfaces Bacteriological tests carried out on tools or equipment surfaces are characterized by a relatively long response time. As a result, it is not possible to await the receipt of tests results to affect production control, nor even to wait for them for product release. Consequently, tests on tool or equipment surfaces have an assessment function on GHP, as well as on operating HACCP plan. Unfavorable results do not make it possible to employ corrective actions on finished product, but must lead to re-evaluation and improvement of the factory-cleaning plan. Interpretation of the Flora • Total aerobic mesophilic flora: - is a reflection of total contamination;

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reaches high values in any case of failure of the hot or cold thermal process chains (refrigeration, delayed hot distribution, cooling,)

- the return to normal values will be obtained by reinforcement of thermal storage chain control. • Total coli forms: - is witness to a possible fæcal contamination? - to correct such a variance, it is necessary to seek out and control the sources of fæcal contamination (e.g. dirty operators' hands, animal gut contents, ground spread manure contaminating green vegetables, egg shells…). • Fæcal coli form: - is witness to definite fæcal contamination? - to correct such a variance, it is necessary to seek out and control the sources of fæcal contamination (e.g. dirty operators' hands, animal gut contents, ground spread manure contaminating green vegetables, egg shells…). 313

• Staphylococcus aureus: - is responsible for food poisoning incidents; - is particularly of human origin, often in partnership with fæcal coli forms; - to correct such a variance, it is necessary to seek out and control the sources of human origin contamination (e.g. dirty operators' hands…). • Clostridium perfringens (anaerobic sulphite reducing bacteria): - is responsible for food poisonings incidents; - is of fæcal or ground origin and is frequently in spore form; - to correct such a variance, it is necessary to seek out and control the sources of fæcal contamination (e.g. dirty operators' hands, animal gut contents, ground spread manure contaminating green vegetables, egg shells…). • Salmonellae: - are responsible for serious food poisoning incidents; - are of fæcal origin and most of the times associated to poultry/egg and related products; - to correct this anomaly it is necessary to seek and control the sources of fæcal contamination (dirty operators' hands, animal gut contents, ground manure contaminating green vegetables, egg shells…). 1.7. Staff Training The following simple principles can be followed to plan, design and implement staff training. Sequence to be followed • Analyze the training needs, taking into account the specific context of the enterprise and the different public to be addressed. • Establish a training plan with clearly defined objectives and indicators. For example: “Train all the seasonal personnel in hygiene before they are sent to production”. The indicator in this case is the number of persons who have followed

the session and the different skills to be acquired. Design and organize the session. This is where the training tools and materials are prepared and the logistical arrangements made. • Carry-out the training. • Assess the effects. A few tips for trainers • 2 weeks before the session: confirm the implementation conditions, i.e.: dates, list of• participants, room…1 week before: is the equipment and material to be distributed available? • 1 day before: - is the equipment in place? - is the room ready to receive the trainees? - is the material to be distributed ready ? 314

• 15 minutes before the training: verify that the equipment is working and the materials available for the trainees. • In the beginning of the training: - welcome the trainees; - present the programme and schedule of the day. • Every morning (if the session lasts several days): make a synthesis of the previous day, answer questions, present the programme of the day. • During the session: alternate the functions (producer, regulator, facilitator), explain difficult points, have exercises done by the trainees, listen carefully to the trainees answer all questions. Assessment of the training • Evaluate if the trainees have acquired the necessary skills and/or competences. • Measure deviations using the indicators defined in the beginning. CHAPTER 2: HACCP Study 2.1 Transition to HACCP The version of the HACCP method to which this guide refers is the official version published in the ‘Codex Alimentarius’6. In the following lines of this guide, HACCP tasks are described in a summarized form, limited to some words or to short sentences. It is accepted that use of this guide cannot be considered without reference to the Codex version. Particular tasks will be studied from the practical point of view, in order to facilitate the implementation of the method under field conditions. Prerequisites Enforcement of Good Hygiene Practice (GHP) and Good Manufacturing Practice (GMP) constitute essential prerequisites for the transition to the implementation of HACCP methodology. IMPORTANT In order to make sure of real and effective implementation of these good practices, it is necessary to refer to the audit grid 1/4 ‘Assessment of implementation of prerequisites’

attached to this document. (To use all audit grids, it is necessary to refer to the explanatory booklet that is attached to them). Success in implementing this HACCP process will depend on a thorough application of each task in sequence and of the real and effective application of its requirements. Jumping one or more task, or being satisfied with incomplete implementation, may well lead to a situation of failure, with potential dangerous conditions within an apparently safe system. Procedures of implementation of HACCP – via each product or via manufacturing operations A HACCP scheme can be easily approached product by product in companies which manufacture only one product or a restricted range of products. On the other hand, for companies that offer a larger range of products (often-small firms in canning or in delicatessen product manufacture), specific application of HACCP to each product will constitute an insurmountable obstacle. 315

It should be noted, in this second case, that the large variety of products is obtained by the use of a limited number of basic technologies of manufacture (cooking, cooling, etc.), always the same ones, but combined in different ways. Under these conditions, all that is required is to choose a proper application of HACCP methodology to each one of these basic operations. For any complete product, association of each basic operation involved, properly managed by HACCP application, allows risk control to be established on the production line. 2.2 The HACCP Method • The HACCP process sets out two missions (two main processes to be carried out, each with definable results). • The HACCP method is the application of seven defined principles. The HACCP method defines twelve tasks for analysis, effective control implementation and system review. HACCP – The 2 missions 1. Hazard analysis (Objective – determination of CCPs – Critical Control Points). 2. Control of CCPs (Objective – effective implementation of food safety control at CCPs). HACCP – The 7 principles 1. Conduct a Hazard Analysis. a - Identify the hazards associated with food production at all the stages of this process. b - Evaluate the probability of appearance of these hazards c - Identify the necessary preventive measures 2. Determine the Critical Control Points (CCPs) of these hazards. 3. Establish critical limit(s). (Which must be met to ensure that each CCP is under? control) Establish operational criteria (limiting values, target levels, tolerances). 4. Establish a system to monitor control of the CCPs. Establish a monitoring system to affirm real and effective control of the CCPs •

5. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control. 6. Establish procedures for verification to confirm that the HACCP system is working effectively. 7. Establish documentation concerning all procedures and records appropriate to these principles and their application. 2.3 The HACCP 12 Tasks7 Task 1: Select the HACCP Team • Constitution of the team: internal and external competences, flow chart; • Training of the team in HACCP; • Organization of the team; - Functional mode - Organizer, secretary, team leader

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• Definition of the necessary resources; - Office devices (computer, photocopier,) - Budget • Collection of information; - Data: historical, causes of food borne disease, epidemiologic, clinical - Normative and lawful data - Technological data • Planning of activities; - Timetable and duration of team work sessions - Programme of the implementation of successive HACCP stages • Definition of the field of study (e.g. product, group of products, hazards under study, full product process or part(s) of process, etc.) Full food safety control for any product will only be complete when every process that goes towards its manufacture has been included, but practical and time restraints frequently lead to a division into realistic parts). Task 2: Describe the Product • Collect data on the finished product (and possibly in-process product) - General characteristics: denomination, composition, volume, structure, - Physical-chemical characteristics: pH, Aw, red ox potential (Eh), preservatives, - Modified atmosphere, - Packing, - Labeling, - Conditions of storage and lifespan, - Storage and distribution network conditions. • Collect data on raw materials - Definitions, - Presentation: volume, type of packaging, - Formulation (% of each raw material used), - Physicochemical characteristics: pH, Aw, Eh, viscosity, - Concentration rate of the solutions and additives rate,

- Temperature of storage, - Lifespan, - Treatment, preparation, manufactured, use/purpose. Task 3: Identify Intended Use • Identification of the intended methods of use: - Lifespan, - Methods of preparation, - Instructions of use, - Foreseeable deviations, - Storage, - Intended target groups of consumers. • Examination of the adequacy between product and its instructions of use. Task 4: Construct a Flow Diagram 317

• Identification of elementary operations/steps. Collection of additional information on each elementary operation/step - Nature, function, - Process, method, parameters, - Inputs (raw materials and packaging), - Buildings, equipment, environment, - Flow, - Operators, - GHP (cleaning, disinfection, maintenance), - Instructions. Task 5: On-Site Verification of the Flow Diagram • On-site checking of flow diagram for different periods of production: - Regular. -High production rate. - Low production rate. - Different shifts. • Modification of the flow diagram, or drafting of several versions of the diagram: - according to real conditions observed on production site; - or according to specific organization during different production rates. Task 6: List all Potential Hazards Associated with Each Step, Conduct a Hazard Analysis, and consider any Measures to Control Identified Hazards • Analyze causes of hazards to each operation/step. • List causes of hazards (physical, chemical, microbiological) (see Text Box below). • for microbiological hazards, causes are of three types: - contamination by germs of spoilage or pathogenic flora - multiplication of the germs/pathogens - survival of the germs/pathogens to a decontaminating treatment (heat, ionization,) • Qualitative and quantitative hazard evaluation: Calculation of hazard criticality, subsequently used in risk evaluation, Hazard grading.

• Definition of the preventive measures. • Formalize preventive measures (control means, procedures, instructions, and records). Task 7: Determine Critical Control Points DEFINITION Critical Control Point (CCPs): A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. For each elementary operation, determine if it constitutes a CCP. You can use 3 different approaches to do so: 1. by use of a decision tree, or 2. by the application of INTUITIVE REASONING (using common sense), or 3. by carrying out Hazard Analysis on the Flow Diagram by an alternative method. Task 8: Establish Critical Limits for each CCP 318

DEFINITION Critical Limit (CL): A criterion (target value + tolerance) that separates acceptability from unacceptability. • For any CCP, the critical limit represents the value beyond which the control of the identified hazard is no longer guaranteed. It makes sense to bring the process back to tight control before this value is reached or breached. Therefore, for safety (and economic) reasons, a target value more rigorous than the critical limit needs to be enforced. • A target value needs a tolerance that ensures that, when intervention occurs, the critical limit is not exceeded. • Identification for each CPP, based of the identified hazards, leads to characteristics to be controlled and appropriate preventive measures. • For each characteristic, defined critical limits have to be respected in order to ensure CCP control. Task 9: Establish a Monitoring System for each CCP DEFINITI ON Monitoring: A planned sequence of observations or measurements of CCP control measures. The records of monitoring provide evidence for future use in verification that the CCP is under control. • Monitoring provision: plan, method, device necessary to carry out the observations, tests or measurements employed to ensure that the critical limits of each CCP are respected. • Define the monitoring provisions for each CCP. • Formalize the monitoring provisions (responsibilities, procedures, instructions, records...). Task 10: Establish Corrective Actions DEFINITION Corrective Action: Any action to be taken when the results of monitoring at the CCP indicates a loss of control or trend towards loss of control. Corrective actions include:

• provisions to ensure the return to CCP control, and • the management of any affected products. Task 11: Establish Verification Procedures DEFINITION Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine compliance with the HACCP plan. Definition of all provisions for confirming an effective HACCP operating plan is needed. These provisions may include: • Tests on products. • Monitoring of target values. • Implementation and concerned batches follow up. • Simulation of incidents. • Auditing of the HACCP system. • Review of records – deviation review – trend analysis. 319

All checking provisions shall be formalized into the HACCP system. It shall include Verification of all parts of the HACCP system, including its records Task 12: Establish Documentation and Record Keeping Documentation: Collection of documents which describes the provisions of the HACCP system, including records that prove its real and effective implementation. • Report of HACCP study (stages 1 to 8) • Design of HACCP plan (stags 9 to 12) - HACCP plan elements, - Specifications, - preventive measures, - critical limits and CCP monitoring system, - corrective actions, - document management, - verification methods, - checks, - reviews of the system, - records. GMP, GHP & HACCP AUDIT GUIDE Presentation of the Audit Guide The complete audit document consists of four evaluation grids. The first one is devoted to pre-requisites and the following three to the HACCP method, (preliminary study, HACCP plans implementation, validity and effectiveness of the plan). Two columns in each grid are reserved for noting observations taken at the time of audit: • as appropriate, the observation will give a satisfactory (sa), acceptable (ac) or not satisfactory (ns) result; • in other cases the observation makes it possible to note an absence (ab), good practice not implemented or documentation not appearing in the file;

• finally, an audit grid item available for observation may not be applicable in the context of the particular food process (na). Assessment of the Implementation of Pre-requisites Conformity of the buildings: general organization Examination of the plans of premises makes it possible to examine matters of the fundamental principles of organization, often better than on the field, such as • observance of the ‘onward flow’ principle on production lines • separation of clean and unclean sectors • no criss-cross of production lines • separation of hot and cold zones. Immediate surroundings must contain no source of contamination, such as a garbage dump or wet unhygienic zones. Passageways and parking areas must be paved or cemented. Lawns must be cut regularly to avoid high vegetation constituting a refuge for pests. The plans provided in the file shall make it possible to identify each room and to locate each work station, each significant material, as well as water mains (or other supplies) and hand washing points. Wastewater and clean water circulations are also to 320

take into account. Finally, the plans make it possible to locate entrances and exits of various flows (production, waste, operators . . .) as well as their circulation within the physical plant. Conformity of the buildings: construction and materials The descriptive booklet, either within the framework of a project, or associated with observations on the ground (at the time of the visit to the premises), makes it possible to control the conformity of materials and methods implemented in building the plant. The covering of the floor and the walls, the way in which they are joined, the devices used to collect water for floor washing, (the principles of which are stated in #1.2 of the guide), must conform to regulation. Passive or mechanical ventilation devices must ensure the elimination of steam and smoke. Lighting must be bright and neutral in color (so as not to modify the foodstuff colors) Conformity of the premises: equipment, materials and furniture The technical documentation of these elements, associated to ground observations carried out at the time of the visit to the premises, make it possible to check their conformity with the regulation. Lawful or normative conformity The elements of conformity of the buildings presented under the former points can be controlled and confirmed within the framework of an official approval or a certification. Upholding the condition of buildings, maintenance Ageing and decay, by continued use of the establishments, can cause the loss of condition of the buildings. The implementation of regular maintenance, together with appropriate immediate remedial action for sudden breakage, confirmed by the keeping of a maintenance daybook (register of requests with records of repair), helps uphold the condition of buildings and equipment. Supplies Contractual relationship with suppliers The criteria of acceptance for delivered consignments, with corrective actions required

according to the significance of any noted variance, must be defined in advance and included in a contractual document drawn up between the producer and his suppliers. Specification of raw materials • of composition: this plays a significant role in the tendency of the product to deteriorate (water content) or in its stability (sugar or salt content). Also it guarantees the accuracy of the composition of the finished product as defined on final product labeling. • of microbiological standards guarantees the safety of food by limiting the presence of pathogenic germs and of toxic metabolites (microbial toxins, histamine . . .). • of the maximum allowed content of residues, covering such substances as heavy metals, antibiotics, pesticides. • of packaging: ensuring by its characteristics protection of delivered raw material. By its volume it influences parameters such as duration of defrosting time or the utilization period after opening. 321

• the condition of preservation is generally related to temperature and shelf life. These two measurable parameters can be the subject to monitoring for each consignment and are thus favorable to the introduction of CCPs. • organization of stock turnover: it should comply with FIFO principles (First In / First Out). Control of deliveries Inspection of delivery checklists makes it possible to control the conformity of certain major specifications of raw materials. Observation of variations in these specifications indicates a loss of hazards control and will result in the use of pre-established corrective actions. Observations and measurements must be carried out at the time of delivery, and the checklists must be checked at the same time. When a variance is noted, the ‘customer/supplier’ agreement must include the signature of a type-approval certificate or a card of anomaly specifically drafted for this purpose, by the supplier or his representative (delivery person). If immediate inspection is not possible, (such as for large mixed palletized loads, or if a long term check is involved, such as for microbiological counts), then the customer / supplier agreement must be clear on the procedure adopted for inspection and on actions to be taken in the light of failure. Potability of water Water is a nutritious raw material and also a cleaning agent. Considering this double use, confidence in its microbiological quality, as well as its chemical quality, is of prime importance. Analysis reports can be easily obtained from water suppliers. However, manufacturers using private water sources (well, borehole.) will have to employ their own water quality control plan. Implementation of a system of traceability A system of traceability makes it possible to manage any food safety crisis by going back to the origin of the products implicated. It also makes it possible to identify all the outlets

where they have been sold. A traceability system also allows, using the HACCP flow charts, to find those production batches that will be subject to corrective action, i.e. all batches that have been produced since CCP monitoring indicates the last time that the system was known to be still in control. Frequently, (and particularly when computerized systems of traceability are implemented by specialist providers), those responsible for food product traceability do not know the configuration of the traceability system; they are simply trained how to use it. Under these conditions, it is good practice to submit this system to a simulation trial, rather than rely on a system audit. Simulation results allow the auditor to judge the efficacy of the traceability system and the capability of staff in its use. System of upstream traceability A simulation of upstream traceability needs to be able, for any real substance chosen randomly from within raw materials stocks, to divulge all information on its source, 322

origin, batch, and delivery date. The system of traceability must be able to provide an answer to these questions. Examination of delivery checklists, supplier invoices and records of raw material stocks can all help to understand the system of traceability. System of downstream traceability A simulation of downstream traceability needs to be able, for a product chosen randomly in finished products stocks, to divulge all information on recipients of any other parts of this batch, as well as batches of raw materials that were used for its manufacture. The system of traceability must be able to provide an answer to these questions. The examination of purchase orders, copies of clients’ invoices and registers of finished product stocks, can also help understand the system of traceability. Pest control Implementation of a pest control plan The presence of pests in a factory can be noted during a visit to the premises by the presence of dead insects or droppings / urine of rodents. A plan of rodent extermination must be implemented. The file must include a plan of the factory where the poison baits are located, and the technical cards of rodent poisons being used. Storage outside the buildings (equipments and materials) must not be placed next to the walls but kept as far from them as possible and must allow a minimum space of at least two meters. This arrangement makes it possible to avoid the settling of pests directly against the walls, their penetration and their establishment inside the plant. Management of waste materials must prevent their overflow and the presence of any food waste on the ground that could attract pests. A plan of insects control must also be implemented. The file must include the schedule of operations and technical information cards of insecticides. The implementation of the programme of pests control operations must be recorded on appropriate checklists. Control of human sources of contamination Medical monitoring of the operators Monitoring is proven by the delivery of an annual medical certificate of fitness for foodstuffs handling to each operator. In the event of a stoppage caused by a severe

infectious condition, or presenting a significant risk of transmission via food, such a certificate may well be required for a return to work. Staff training to the principles of hygiene and good manufacturing practices The company must implement a plan of staff training. As with medical monitoring, appropriate certificates of training shall be delivered for each successfully trained member of staff. Professional clothing hygiene • The documents relating to the internal system of management of professional clothing (clean or soiled) must makes it possible to check that it is provided and cleaned by the company (or under its responsibility). Moreover each member of the staff must use two cupboards in the cloakroom (or one single cupboard with two compartments), to ensure the separate storage of working garments and everyday wear. Permanent devices (boots/shoes washstands) or movable ones (trays), 323

containing a disinfecting solution, must allow cleaning/disinfection of shoes or boots before getting into the production zone Respect of the good hygiene practices and good manufacturing practice Due to training and to the provision of guides of good hygiene practices and guides of good manufacturing practices, staff is able and is obliged to respect these good practices. Hands cleaning and material cleaning Hands Visits to premises make it possible to check that conforming washstands (non-manual taps, disinfectant liquid soap dispenser, disposable hands wiping system) are made available to operators in sufficient numbers. These washstands must be located near working stations, cloakrooms and toilets. Contamination by hands, regarded as the ‘first tool of the operators’, is controlled by the training received and by the posting of handwashing instructions near the washstands. Material and buildings The control of contamination of equipment and buildings requires the introduction of a cleaning plan, drafted by applying the problems resolution method known as ‘the W.W.W.W.H.W method‘(Who? What? Where? When? How? Why?) Written procedures of cleaning, together with technical cards of cleaning products, are gathered in this cleaning plan. Each operator (production operator or member of the cleaning team) has a copy of the part that corresponds to his cleaning tasks. The good execution of this cleaning plan can be assured by checking with appropriate records. • control of good execution of tasks using a check-grid completed as the work progresses • control of visual cleanliness of surfaces using a weekly (or higher frequency) check-grid • microbiological control plan of surfaces, valuable for validation of the cleaning plan, and resulting in analysis reports for appropriate action. Assessment of preliminary HACCP study step After evaluation of the implementation of pre-requisites in the former grid, this second grid approaches HACCP itself. This method is structured in twelve Tasks that are taken in order, one after the other. Grid 2/4 takes into account steps 1 to 8 inclusive.

Task 1 Management commitment This commitment testifies to the sincere resolve of the management to apply HACCP methodology involves a letter addressed individually to each member of the staff of the company. Set up of the HACCP team The HACCP team organization chart (organogram) should be the basis for specifying functions and responsibilities for each member. These functions and responsibilities need to be described on individual job specifications for the HACCP programme. Resources The resources available to the HACCP team (computer, photocopier, budget etc.) shall be clearly defined and recorded in the HACCP file. 324

HACCP team management Organization is planned around the scheduling of activities, setting out the frequency and duration of team working sessions. The plan defines time limits for the implementation of HACCP stages. With objectives being predicted for completion by specific dates, any delay needs to be justified. Each working session starts with a statement of work completed since the former meeting and ends in the allocation of the tasks to be realized for the following meeting. Each working session must be recorded in a report. Task 2 Description of the product The product description file, completed by the execution of stage n° 2, collates all relevant information on the product including (but not restricted to): • composition (ingredients, nutrition) • volume, nature, storage, packaging, labeling, • raw materials specifications (composition, proportion in the product, physicochemical characteristics, conservation, pre-processing, microbiological standards). Task 3 Identification of expected use This stage results in the drafting of documented instructions for use. The information provided by labeling of the product (storage temperature, shelf life . . .) also depends on the conclusions of this step. This study on expected use needs to take into account the expected groups of consumers involved (e.g. children, older people). It also needs to include a study on potential foreseeable deviations of use and on any dangers that could result from these. Task 4 Draft the flow diagram Task 5 Verify the flow diagram The flow diagram is the base for hazards analysis, so it must closely correspond to the real field conditions for all products or all families of products (as appropriate to the

study), for all the production periods. In certain sectors of production (catering, pastry baking), flow diagrams will relate to basic operations (oven cooking, fast cooling . . .). Combinations of these flow diagrams then make it possible to carry out study of all types of production schemes. When each one of these basic operations is controlled, the whole of the production can then be regarded as controlled. It should be noted that the same product can present conditions for more than one flow diagram if the conditions of production change, for example between slack and busy periods. In this example, the number of operators, and hence also work organization, may change. During inspection or audit, some sequences of production need to be compared with the flow diagram appearing in the file in order to assess its validity. Task 6 Hazards analysis Using the flow diagram and the list of potential hazards already in the file, the analyst now needs to evaluate the significance of hazards: 325

• by checking that no hazard has been overlooked; • by checking that all hazards identified by using the flow diagram are collated in a summary (table, list . . .); • by checking that the calculation of the criticality index (specified on a separate document) provides a valid evaluation and hence a correct rating of risks; • by checking through the calculation of the criticality index, that identified risks are real (and thus excluding any risks with a zero index value) A list of preventive measures, each specific to each identified hazard as applied in the particular establishment, with procedures for implementation, must appear in the file. Task 7 Determine critical points The use of the HACCP flow diagram, together with a CCP decision method (CODEX decision tree, or the intuitive method), allows for identification of CCPs, which are gathered into a summary (table, list, etc…).The identification of a parameter, indicating maintained safety control or otherwise of each CCP, that can be monitored, allows differentiation from standard production operation control. This measurement needs to be timely so as to maintain production∗, and at low cost. Auditors need to verify that a measurable parameter is associated with each identified CCP. Task 8 Establish critical limits for each CCP By examination of the file documents, the limits of the criteria, which separate acceptability from non-acceptability, need to be the assessed. Each criterion, together with its possible justifications, is evaluated using: • limits of performances of the available equipment . . . • quantified data (from data sources) on the microbial flora (temperature, pH and Aw, growth limits . . .); • results of ageing tests; • lawful or normative obligations. ∗ if results take too long to come back, production will be held up awaiting them, or expensive large stores of working- process or final product will be required

Assessment of the drafted HACCP plan This third grid relates to the evaluation of the last four tasks of HACCP method. These are devoted to the drafting of the hazard control plan. Task 9 Establish a monitoring system for each CCP Initially, the significance and appropriateness of all monitoring procedures need to be evaluated. Then the framework of parameters for monitoring, (T°, Temps, Aw, pH, weight, volumes) and their recording, needs to be established and validated to ensure that any loss of control is immediately identified. Calibration plan of measuring instruments Any instruments involved in monitoring of CCPs need to be included in calibration plans and the calibration plans need to be implemented.

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(If an instrument is found to be out of calibration, an action plan needs to be in place, particularly indicating actions for all products that have been produced since the last time that the instrument can be confirmed as being correctly calibrated). Task 10 Establishment of corrective actions The HACCP plan needs to define the corrective actions implemented in the event of loss of control (i.e. observation of a deviation of values being monitored for control). To this aim the documentary system must fulfill certain constraints: • to establish appropriate levels of corrective action to be implemented corresponding to the gravity of observed CCP deviation • to define application of operational procedures of for the various corrective actions selected Ensuring the follow-up of batches of products for corrective action(s) The company must set up a system of monitoring sheets, based on traceability, to follow up the batches that need to be subject to corrective actions. Task 11 Establish verification procedures The inspector (or the auditor) controls the implementation of validation methods and documents for HACCP plan or for the implementation of GHP and GMP. The details of implementation means may include (but not be restricted to): An analytical control plan (microbiological and chemical) of the finished product, (defining the finished product standards) including: • sampling plan (number, size, frequency of samples) • microbiological standards for different (types, groups of) products • residue standards for such as: growth factors, pesticides, antibiotics, and heavy metals • standard analysis model report • keys for interpretation of analyses Analytical control plan of surface cleanliness: • sampling plan (number and frequency of samples) • microbiological standards for surfaces • standard analysis model report • keys for interpretation of analyses

Field verification Confirmation of the verity rests on the execution of a documentary review or audits (by external or internal people) of the risks control system (GHP/GMP and / or HACCP). If this step does not allow for satisfactory observation of results, it will lead to revising the set-up of the hazard control system. Task 12 Establish documentation and record keeping The inspector (or the auditor) needs to check that the HACCP system documentation effectively includes all documents (commitment, objectives and system establishment, procedures, analysis reports, outside technical data, checklists, etc . . .) as defined in the eleven steps of the HACCP outlined above or in the Pre-requisites section (- and for the control of this twelfth step) 327

Routine evaluation of the real and effective implementation of an HACCP plan in the company This last grid is intended to be employed at the time of routine visits carried out in companies whose complete HACCP system has already been inspected (or audited), and has already received an official approval or a certification Implementation of the GHP Supplies control The inspector (or the auditor) needs to confirm that raw material delivery checklists are correctly kept. He needs to ensure, by examining preceding weeks’ checklists, that corrective actions are actually implemented based on documented delivery controls, such as: • documented warnings to the suppliers • rejection of raw materials batches Available analysis reports also enable him to check that water used for production (as an ingredient or as a cleaning medium) is potable. Validation of the cleaning plan The inspector (or the auditor) needs to confirm that checklists of task implementation are correctly and immediately completed at the time of cleaning completion He must also check the validity of results of microbiological cleanliness analyses for equipment and surfaces. In the event of nonconformity of the results, he must make sure that the company has taken appropriate action, such as bolstering its cleaning procedures or changing its cleaning / disinfection products (if contaminating microbiological flora have become resistant). Validation of the pest control plan The inspector (or the auditor) needs to confirm that any intervention forms of the pest control company are correctly filled out for each visit. During the visit of the premises, he must also seek out signs of pests: • droppings and urine of rodents • damage to foodstuffs bags (rice, pasta, beans…) caused by rodents • Insect’s bodies • droppings of birds nesting / nests in the superstructures of buildings Medical follow-up of the staff

This medical follow-up is validated by the presence of a medical certificate of aptitude to foodstuffs work, in the personal file of each operator employed by the company. Staff training The implementation of the continual training plan is confirmed by the presence of certificates delivered for each training course, in the personal file of each staff member. The inspector (or the auditor) can also have informal conversations, (without breaking principles of hygiene), with operators posted on the lines of production, in order to evaluate their level of awareness and competence. Maintenance of buildings and equipment

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In addition to the visual observations that can be made during the visit to evaluate premises maintenance, the inspector (or the auditor) must check on the upkeep of the maintenance daybook Upholding of the conformity and provisioning of the washstands This part of the audit mainly depends on visual observations carried out during the visit to the production premises. Upholding of the conformity and provisioning of the boots/shoes washstands This part of the audit mainly depends on visual observations carried out during the visit to the production premises HACCP plan, CCP monitoring CCP monitoring The implementation of this step (n° 9) of the method is validated by the records relating to the CCP monitoring. Assurance in the discipline in their keeping and their use is an essential point of the audit of any implemented HACCP plan. Without such rigor being applied to the keeping and use of these records, no real and effective HACCP plan can be implemented. Any loss of control indicated by a deviation of the measured values, needs to be checked and coupled with necessary corrective action. Recordings need to be dated and signed after reading and before archiving. A (non exhaustive) list of records relating to the monitoring of CCPs • records of cold store temperatures (chill and frozen) and of air-conditioned production areas • records of inventory control (in respect of deadlines for use) • records of the heat treatment pair of parameters ‘duration / temperature’ • schedules of sterilization, pasteurization, cooking • monitoring recordings of pH (dairy products, dry salted meats . . .) • measurement recordings of water activity values (Aw) • weighing, volume measurement of product ingredients, during recipe build Follow-up of the corrective actions The inspector (or the auditor) needs to confirm that monitoring sheets of corrective actions are correctly and progressively filled, until the effective reworking, removal or destruction of any affected batches Conformity of the finished products Conformity of finished products to microbiological and toxicological standards must be validated by analysis reports held by the company. Any observation of analysis

report not in accordance with standards, must lead to reconsideration, and subsequently to, improvement of the entire current system of hazard control. (GHP, GMP and HACCP plan) Traceability The inspector (or the auditor) needs to check simulations of upstream and downstream traceability at the time he is visiting the establishment – either on raw materials, or in production, or finished products randomly taken. Simulations of incidents The simulation of incidents is a method which can be used to check the validity and 329

effectiveness of monitoring systems. Warning lights signals losses of control or hooters (cold stores, metal detectors . . .) such simulations of incidents can be periodic recorded events, which the auditor will be able to reports to trace from records. They may also be carried out at the request of the inspector (or the auditor) at the time of visit.

Sanitation and Hygiene Practices of Employees in Food Safety
Human beings are involved at all stages of food chain i.e. production, harvesting, packaging, transportation, loading, unloading, handling, etc. They are source of contamination. Illnesses associated with foods are primarily those transmitted by the faecal-oral route. Although raw produce can serve as a source of a variety of food borne organisms, such as viruses, bacteria, protozoa, fungi, and parasitic worms, yet one should be gravely concerned about the presence of pathogenic bacteria, such as E. coli 0157:H7. Methods directed towards reducing food safety risks in food production, harvesting and distribution operations must start with good sanitation and hygiene practices. The application of a good sanitation and hygiene programme should focus on the employees, environment, facilities, and transportation of fresh foods. Employees: Microbial Hazard Worker's health and hygiene play a critical role in the controls for minimizing microbial contamination of food. Faecal-oral diseases are the primary microbiological concerns that have been associated with food. Workers during growing, harvesting, sorting, processing, and packing food can spread these diseases. Infected food Industry workers/employees have been implicated as the source of several food borne outbreaks of gastro-enteritis, involving salads, cold food items, and ice. Proper hand washing minimizes the spread of pathogenic bacteria and other microbial hazards, limiting the potential for contamination of produce.

Control of Potential Hazards Personal Health of Employees •Good hygienic practices by all personnel (incl. Senior Managers) who are involved in the harvesting, packing, and distribution of food are essential in the control of microbial and other biological hazards. Any individual in the agricultural environment (farm,

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packing areas and transportation chain) who contacts food or equipment used in contact with food in agricultural areas presents a potential contamination risk. •All personnel, including those indirectly involved in food operations (such as, pest control operators), must comply with established hygienic practices. Infectious diseases, ill health accompanied by diarrhea, open lesions (including boils, sores, or infected wounds), and other ailments are a source of microbial contamination that could contaminate food, water supplies, and other workers. •Some microbial pathogens that can be transmitted by food contaminated by infected individuals include, but are not limited to, the following: 1. Salmonella species, 2. Shigella species, 3. Staphylococcus aureus, 4. Streptococcus pyrogenes, 5. E. coli, 6. Giardia lamblia, 7. Hepatitis A virus, 8. and many others. Symptoms associated with infections by these pathogens may include diarrhea, fever, vomiting, jaundice, and sore throat with fever. An employee suffering from any of these symptoms presents an increased risk of transmitting food borne illness. Unfortunately most of the food companies do not practice regular medical check-up of their employees to prevent such incidences. It is suggested that: •Operators train employees to report to the person in charge any information about their health or activities as they relate to diseases that are transmissible through food. Because of the high infectivity (ability to invade and multiply) and virulence (ability to produce severe disease) of Salmonella typhi, Shigella species, E. coli 0157:H7, or hepatitis A virus, any worker diagnosed with an active case of illness caused by any of these pathogens should be restricted from work assignments that involves contact with food or produce handling equipment.

•The supervisor, or the person in charge, should consider ways to monitor the health of their employees and take steps to reduce the chance of food borne illness. For example, disposable rubber or similar gloves, leak-proof band aids, or other corrective measures for minor cuts should be provided for use as necessary to the personnel who may have contact with produce.

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More importantly, the person in charge should ensure that workers with diarrhea disease are not working with food or any equipment used in the harvesting and processing of food.

•Workers should be taught to report symptoms caused by illness, infection, or other source that is associated with acute gastrointestinal illness such as: diarrhea, fever, vomiting, jaundice, or sore throat with fever, a lesion containing pus such as a boil or infected wound that is open or draining and that is located on parts of the body that might have contact with food or produce harvesting and processing equipment. Prevention is better •Role and attitude of senior managers is very crucial. Many time senior managers ignore the need of training and re-training of employees. Such shortsighted managers are doing disservice to their companies because poor quality and unhygienic food is eroding their companies' good will in market place. • All employees, including supervisors, full time, part time and seasonal personnel should be trained in good hygienic practices. Computer can be used to train people either through animation films of video films.

•Processors or growers may want to consider establishing a training programme that would include a system to monitor and evaluate compliance with established sanitary practices. The operators should also consider follow-up training sessions to encourage adherence to good hygienic practices. •The biggest challenge is to change the mindset of employees and facilitate the learning of new techniques. Well Designed Programme The focus of any training programme should include, but is not limited to, the following:

•The importance of good hygiene. •All personnel should understand the impact of poor personal cleanliness and unsanitary practices on food safety. •Smoking or eating in areas where food is present can contaminate the produce because of the potential that the hands and food-contact surfaces may become contaminated.

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Unsanitary personal practices such as scratching the head, placing the fingers in or about the mouth or nose, and indiscriminate and uncovered sneezing or coughing may contaminate food or any handling equipment. Within packinghouses, hair can be a direct and indirect vehicle of contamination. Workers may contaminate their hands by touching their hair. For enclosed facilities, operators may want to consider the use of hair restraints to keep dislodged hair from ending up in food and to deter employees from touching their hair.

•Thorough hand washing after each absence from the workstation, after using the bathroom, before and after eating, and before commencing work is very important. Many of the diseases that are transmissible through food may be harbored in the employee's intestinal tract and shed in the faeces. Thorough washing of hands with soap and warm water helps to stop the spread of germs. Employees should be taught proper hand washing techniques that include: hand washing with warm water (if available); proper use of soap; and thorough scrubbing (including cleaning under finger nails and between fingers), rinsing, and drying of the hands. •The importance of using sanitation facilities. All employees should be encouraged to use on-site latrines and to avoid eliminating wastes outside of these facilities. The use of well maintained sanitation facilities for waste elimination helps reduce the potential for cross contaminating fields, produce, other workers, and water supplies, and increases the likelihood that employees will wash their hands after using such facilities. •Employee must feel proud and help colleagues in achieving sanitation and hygienic standards. Please remember, employees are not machines but more important than machine. Respect their individuality and build on their strengths. In competitive business environment, good knowledgeable employees are the most important assets. You take care of them they will take care of your business interests.

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