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HACCP system -hazard analysis and risk assessment, based on ISO 22000:2005
methodology
PII: S0956-7135(16)30231-6
DOI: 10.1016/j.foodcont.2016.05.001
Reference: JFCO 5014
Please cite this article as: Soman R. & Raman M., HACCP system -hazard analysis and risk
assessment, based on ISO 22000:2005 methodology, Food Control (2016), doi: 10.1016/
j.foodcont.2016.05.001.
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1 HACCP System -Hazard Analysis and Risk Assessment, based on ISO 22000:2005
2 Methodology
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4 Department of Food and Nutrition, RVS College of Arts and Science, Sulur, Coimbatore,
5 Tamilnadu, India.
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6 *Corresponding author’s E-Mail: rahulmattathil@gmail.com, Mobile: +91 9497187707
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7 Abstract
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8 Food Safety is a fundamental public health concern, and achieving a safe supply poses major
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9 challenges for organisations involved in the food chain. A vide number of food borne hazards,
10 both familiar and new, pose risks to health and obstructions to international trade in foods. These
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11 risks must be properly analysed, assessed and managed to meet growing and increasingly
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12 complex sets of global food chain. Proper implementation of food hygiene principles across the
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13 food chain in conjunction with Hazard Analysis and Critical Control Point System will ensure
14 food safety. To achieve this, a procedure for hazard analysis and risk assessment based on ISO
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15 22000:2005 methodology has been developed. The hazard assessment, selection and assessment
16 of control measures, Operational prerequisite programme Plan and HACCP Plan have been
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18 Keywords: food safety, hazard, hazard analysis, OPRP, CCP, control measures
19 Introduction
20 Major outbreaks of food borne disease periodically occur on almost every continent and this
21 underline the fact that unsafe food is a worldwide public health problem24. It is a known fact that
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22 more than 200 diseases transmitted through food24. Food borne diseases can cause many adverse
23 health effects ranging from gastroenteritis to life-threatening conditions like cancer, birth defects,
24 and neurological, hepatic and renal syndromes. Also, food borne diseases can have major
25 economic impacts on individuals, food businesses and even countries due to reduced
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26 productivity and expenditure on medical care24, 18.
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27 As stated by the FAO/WHO World Declaration and Nutrition, access to safe and nutritious food
28 is a basic individual right. Article 14 of Regulation (EC) No.178/2002 on ‘General Food Law’
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29 also states that “Food shall not be placed on the market if it is unsafe. Food shall be deemed to be
unsafe if it is injurious to health or unfit for consumption” 2. Therefore, recognizing the need for
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31 safe and nutritious food also requires an understanding of how feasible this can be achieved.
32 Food Safety is a concept that food will not cause harm to the consumer when it is prepared
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33 and/or eaten according to its intended use 20. Food safety is based on a scientific knowledge of
34 crucial linkages between adverse health effects and hazards occurring in food. Since hazards in
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35 food can come across any steps in the food-chain11, 17, it is essential to assure coordinated efforts
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36 for the safety of the food supply9. A hazard can be a biological, chemical or physical agent in, or
37 condition of, food with the potential to cause an adverse health effect. Food safety hazards
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38 include allergens20. The adoption of good manufacturing practices based on Codex General
Principles for Food Hygiene is the first level of defense for food safety18. These general
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39
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40 principles act as a strong foundation for ensuring food hygiene and follow the food chain from
41 primary production till it reaches consumer to final consumption, highlighting the important
42 hygiene controls to be adopted at each step 2. To enhance food safety, a HACCP based approach
43 is necessary wherever possible20, 05, 25. HACCP (Hazard Analysis and Critical Control Point) is a
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44 systematic approach to food safety, which identifies, evaluates, and controls hazards which are
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47 bodies (ISO member bodies) . ISO 22000:2005 (Food Safety Management Systems-
48 Requirements for any Organisation in the Food Chain) is based within the framework of a
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49 structured management system and incorporated into the overall management activities of the
50 organization to establish, implement, monitor and update the most effective food safety systems.
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51 This standard integrates HACCP System and application steps developed by the Codex
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52 Alimentarius Commission. By the application of auditable requirements, it combines the
55 ISO 22000:2005 standard requirements were used for the selection and assessment of control
57 proper planning is required to determine those hazards that need to be controlled, the degree of
58 control required to meet acceptable levels and the combination of control measures that can
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59 deliver this 21. During hazard analysis, this approach makes use of determining the strategy to be
60 used to ensure hazard control by combining the PRP(s), operational PRP(s) and the HACCP
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61 plan.
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63 A science based approach to food safety was founded on understanding the nature of hazards in
64 food, the risks they pose and means for their control. Without this approach, interventions may
65 fail to properly assess the hazards that pose the greatest risks to health1. Hazard analysis is very
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66 important for an effective food safety management system, because conducting hazard analysis
68 measures.
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69 Different types of hazards include biological, chemical and physical hazards. Food borne
70 biological hazards include microbiological organisms such as bacteria, viruses, fungi and
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71 parasites. Physical hazards include glass, metal, stones, wood, plastic, rubber or pests (typically
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72 larger pests). Major sources of chemical hazards include agricultural chemicals (pesticides,
73 insecticides, fungicides, fertilizers, antibiotics, growth stimulators, growth hormones, etc), plant
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74 chemicals (cleaners and sanitizers, materials used in equipment such as PCBs, oils, lubricants,
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75 ammonia, cleaning compounds, sanitizers, pesticides (fogs, baits), paints, printing inks, etc),
76 naturally occurring toxicants (agaric acid, hydrocyanic acid, hypericine, saffrole) and food
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77 chemicals (include preservatives, acids, food additives, suplhating agents, colouring agents/ dyes
78 etc).
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79 All food safety hazards (biological, physical, chemical including allergens) that are reasonably
80 expected to occur in relation to the type of product, type of process and actual processing
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81 facilities should be identified and recorded3. The identification should be based on13, 12, 4
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83 materials, ingredients, product- contact materials and end products, intended use, flow
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• Information from the food chain on food safety hazards that may be relevant for the
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90 safety of the end products, intermediate products and the food at consumption
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91 (Environmental considerations).
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92 When identifying hazards, it is important to consider the steps preceding and following the
93 specified operation, the process equipment, utilities/services and surroundings, and the preceding
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94 and following links in the food chain20.
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95 The acceptable level(s) of the food safety hazard in the end product should be determined
96 whenever applicable for each of the food safety hazards identified. The determined level should
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97 consider established statutory and regulatory requirements, customer food safety requirements,
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98 the intended use by the customer and other appropriate data. The justification for, and the result
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99 of, the determination shall be recorded. The “acceptable level” means the level of a particular
100 hazard in the end product of the organisation that is needed at the next step in the food chain to
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102 A hazard assessment should be conducted (Table 01) to determine, for each food safety hazard
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103 identified whether its elimination or reduction to acceptable levels is essential to the production
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104 of a safe food, and whether its control is required to enable the defined acceptable levels to be
105 met. The key function of hazard assessment is to assess the reasonably expected hazards
106 identified for the products so that those to be controlled by the organisation are identified. The
107 term “hazard” should not be confused with the term ‘risk” which, in the food safety context,
108 means a function of the probability of an adverse health effect (e.g. becoming ill) and the
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109 severity of that effect (death, hospitalization, absence from work, etc) when exposed to a
110 specified hazard. Risk is defined as the combination of the probability of occurrence of harm and
111 the severity of that harm19. Referring food-borne risks, risk assessment is defined as an
112 “evaluation of the potential for adverse effects on human or animal health arising from the
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113 presence of additives, contaminants, toxins, or disease-causing organisms in food, beverages or
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114 feed stuffs” 17.
115 In conducting the hazard assessment, the following parameters should be taken into
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116 consideration08, 07, 23
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117 • The sources of the hazard (e.g. where and how it can be introduced into the product
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118 and/or its environment);
119 • The probability of occurrence of the hazard (e.g. qualitative and/or quantitative
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120 prevalence, such as frequency of occurrence and the typical levels, highest possible
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122 • The nature of the hazard (e.g. ability to multiply, deteriorate and produce toxins);
123 • The severity of the adverse health effects that can be caused by the hazard.
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124 To the extent that the information required conducting the hazard assessment is not available
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125 within the food safety team, additional information should be obtained from scientific literature,
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126 databases, statutory and regulatory authorities, and external competences. Transparency in
127 hazard assessment requires full documentation of the process, including sources of data and their
129 When evaluating the probability of hazard occurrence, consideration should be given to steps
130 preceding and following the specified operation within the same system, the process equipment,
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131 service activities and surroundings, as well as to the preceding and following links in the food
132 chain and measures taken at preceding steps in the food chain (e.g. raw material suppliers,
133 subcontractors). Similarly, relevant society initiatives (e.g. general environmental protection
134 measures) and measures taken at subsequent steps in the food chain (e.g. further processing,
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135 transportation, distribution and consumers) should be taken into account.
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136 The hazard analysis may determine that control of a hazard by the organisation should not be
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137 needed. This may occur when, for example, the introduction or occurrence of an identified food
138 safety hazard meets the defined acceptable level without any further intervention by the
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139 organisation10. This may, for instance, be the case where adequate controls have been
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140 implemented at other stages in the food chain and/or where introduction or occurrence within the
141 organisation is unlikely or so low that the acceptable level will be met anyway8.
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142 A logical approach11 should be used to assess and sort the control measures into three groups
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143 (PRPs, Operational PRPs and CCPs). The Table 01 given below illustrates one method of
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146 The probability of such hazard occurring is measured using the following parameters:
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153 The severity or impact of such hazard on the human health is measured using the following
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154 parameters:
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155 Critical (Death) -5
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156 High (Hospitalization/illness) -4
160 The limit which distinguishes between Significant or Non Significant hazards will be reviewed
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161 by the food safety team during the review of Food Safety Management System as per the defined
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162 frequency.
164 The consequence of the hazard is accepted. There are two types of Acceptance:
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168 Develop Control Measures for significant hazards. These would then be controlled either by
169 OPRP (Operational prerequisite programme) or CCP (Critical Control Programme) monitoring
170 after determining using selection and assessment of control measures as defined in the ISO
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172 iii) Justification of Hazard Assessment:
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173 Significance Rating
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<10 Non-significant Hazards
≥ 10
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174 - Ratings <10 (i.e. Non significant hazards) are controlled by the PRP.
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175 - Ratings ≥ 10 are controlled by either by OPRP or CCP’s based on the assessment
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176 level of the control measures/combinations of control measures using selection and
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177 assessment of control measures as defined in the ISO 22000:2005 Standard as given
179 Assessment and Combination of Control Measures: More than one control measure is often
180 required to control specific food safety hazard(s) and more than one food safety hazard may be
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181 controlled by the same control measure (but not necessarily to the same extent). It is therefore
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182 advisable first to select suitable combinations of control measures for each of the hazards identified,
183 followed by a consequential establishment of the whole range of control measures required to
184 control them all10. Example includes combination of time and temperature in case of pasteurization
185 of milk (Heating at 72 ºC for about 15 seconds) for protection from biological hazard such as
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188 Industry has the primary responsibility to implement food safety controls (meeting both regulatory
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189 and voluntary); many different national legislative arrangements provide for this selection of food
190 safety responsibility8. For some hazards, it will be practically difficult for industry to implement
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191 food control measures at each process steps, for example testing for different types of chemical
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192 residues. Examples include detection of heavy metals (Cadmium, Mercury, Lead, Arsenic etc)
193 presence in cultured shrimp; Presence of antibiotics in milk; Pesticide residues in fruit and vegetable
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194 products; DDT in carbonated water. In such cases, data can be sought from National chemical
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195 residue programmes to ensure that appropriate control of hazards is being achieved.
196 Categorization of Control Measures: The organisation may focus on having as many of the control
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197 measures as possible managed by operational PRPs and only a few managed by the HACCP plan, or
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198 the opposite. It should be noted that, in certain cases, no CCP can be identified, for example because
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200 The selection and categorization of control measures should be carried out using a logical approach
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201 that includes assessments with regards to the following criteria as given in the Table 2.
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202 Based on the above guidance on the scoring parameters for assessment criteria, control measures are
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203 categorized into OPRP’s and HACCP plan by assigning the lowest possible level of affectivity rating
204 and the highest level of affectivity that could be attained. It is clear that the ratings will be between
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207 Values of > 14 rating of effectiveness will be controlled by the HACCP plan
208 Based on the above guidance, the differentiation between OPRPs and CCPs can be logically
209 achieved and can be properly defined using the following Tables such as Table 04, Table 05 and
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210 Table 06.
211 Conclusion
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212 Proper handling of food along the entire food supply is essential to ensure the safety of the food. To
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213 an extent, it is the prime responsibility of the food manufacturing organisation to do this in a
214 systematic fashion. The hazard analysis as detailed in ISO 22000 requires the organisation to
215
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evaluate all of the food safety control measures in a scientific way. Once the hazard analysis is
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216 completed, this may result in the addition of some new PRPs to the system. Also, it may result into
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217 upgrading of some PRPs to the category of operational PRP. Hence, it is the responsibility of the
218 organisation to document these changes, approve them and prepare to implement in a proper manner
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220 References
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221 1. Adams M & Motarjemi Y. (1999). Basic Food Safety for Health Workers. Geneva: WHO, 5-
222 16.
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223 2. Chilled Food Association Limited. (2010). Shelf Life of Ready to Eat Food in Relation to L.
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224 monocytogenes-Guidance for Food Business Operators. (1st ed.). UK: Chilled Food Association
225 Limited, 4.
226 3. Codex Alimentarius Commission. (1997). Principles for the establishment and application of
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228 4. Codex Alimentarius Commission. (1999). Principles and Guidelines for the Conduct of
230 5. Codex Alimentarius Commission. (2003). Basic Texts on Food Hygiene, 3-72..
231 6. FAO. (2009). Good Hygienic Practices in the Preparation and Sale of Street Food in Africa-
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232 Tools for Training. Rome, 98-101.
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233 7. FAO/WHO. (1997). Risk Management and Food Safety-Report of a Joint FAO/WHO
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235 8. FAO/WHO. (2003). Hazard Characterization for Pathogens in Food and Water-Guidelines,
237 9.
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FAO/WHO. (2006). Food Safety Risk Analysis- A Guide for National Food Safety
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238 Authorities. FAO Food and Nutrition Paper 87:1-102.
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240 and/or Less Developed Food Businesses.FAO Food and Nutrition Paper 86: 4-74.
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241 11. FAO/WHO. (2007). Animal Feed Impact on Food Safety- Report of the FAO/WHO Expert
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244 Microbiological Risk Assessment Series No.07. Rome, 11-16, 37-43, 45-49.
245 13. FAO/WHO. (2008). Risk Based Food Inspection Manual. FAO Food and Nutrition Paper 89:
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246 9-12.
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249 15. FAO/WHO. (2010). FAO/WHO Expert Meeting on the Application of Nanotechnologies in
250 the food and agricultural sectors: Potential Food Safety Implications-Meeting Report. Rome, 24-42.
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251 16. Gandhi A.P. (2009). Development of HACCP protocols for the production of soy milk.
253 17. Gruszczynski L.(2006). The Role of Science in Risk Regulation under the SPS Agreement,
254 Department of Law. European University Institute.EUI Law Working Paper No. 2006/03: 13-16.
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255 18. Havelaar AH, Nauta MJ, Mangen MJ, De Koeijer AG, Bogaardt MJ, Evers EG, Jacobs-
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256 Reitsma WJ, Van Pelt W, Wagenaar J, De Wit GA and Van Der Zee H. (2005). Costs and Benefits
257 of Controlling Campylobacter in the Nederland- Integrating Risk Analysis, Epidemiology and
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258 Economics. Bilthoven: National Institute for Public Health and the Environment. Report No:
259 250911009:44-47.
260 19.
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IS/ISO. (2005). Safety Aspects-Guidelines for their Inclusion in Standards (IS/ISO/IEC
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261 Guide 51:2005), 2-5.
20. ISO. (2005). Food Safety Management Systems- Requirements for any Organisation in the
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262
264 21. ISO. (2005). Technical Specification/ Food Safety Management Systems- Guidance on the
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265 Application of ISO 22000:2005. (ISO/TS 22004). .(1st ed.). (2005-11-15): 1-20.
266 22. ISO/ ITC. (2007). ISO 22000 Food Safety Management Systems- An easy to use Checklist
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268 23. National Academy Press. (2001). Food Safety Policy, Science, and Risk Assessment:
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269 Strengthening the Connection: Workshop Proceedings. Food Forum. Washington, D.C: Food and
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272 25. WHO. (2008). Hazard Analysis and Critical Control Point Generic Models for Some
273 Traditional Foods- A Manual for the Eastern Mediterranean Region. Egypt, 7-40.
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Significance Rating:
Quantifying Hazards (Exposure)
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Critical 5 5 10 15 20 25
Significant
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High
4 4 8 12 16 20 ≥ 10 Hazards
Hazard Impact/Severity
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Medium 3 3 6 9 12 15
Non-
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Low Significant
2 2 4 6 8 10 < 10 Hazards
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Negligible 1 1 2 3 4 5
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1 2 3 4 5
Very
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relative to the strictness applied
2. Reduce or control to meet
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acceptable level
3. Reduce to within acceptable level
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or eliminate the hazard completely
b) Control measure feasibility for monitoring (e.g. ability to be
1. No feasibility
monitored in a timely manner to enable immediate corrections)
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AN 2. Has limitation
3. Feasible
c) Control measure place within the system relative to other 1. First
2. Middle
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control measures
3. Final measure
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Table 03. Assessment of control measures are described below
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Assessment of control measures
4. Management &
Categorization
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1. Selected
2. Assessment Criteria 3. Total
Combination of
HACCP
(Level of effectiveness) Score OPRP
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Control Measures
Plan
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A B C D E F G
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Scoring Parameters
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1 1 1 1 1 1 1 7
≤ 14
3 3 3 3 3 3 3 21
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> 14
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3
Process / Step
Control Measure(s)
C Effect on identified food safety
What
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Feasibility / freq. of monitoring
(b)
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Table 04. Assessment of Control Measures
How
Place with in the food chain
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Frequency M system (c)
Monitoring
Likelihood of failure (d)
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Who
Severity in case of failure (e)
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Correction and Is control measure specifically
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Corrective action
Assessment of control measures (cm’s)
designed? (f)
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Synergistic effect (g)
Responsibilities and
Authorities
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Total score = a+b+c+d+e+f+g
4
Records of Monitoring
CCP
Score
Score
> 14 :
≤ 14 :
OPRP
CCP (Process / Step)
Significant hazard
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C Control Measure(s)
Table 06. HACCP Plan Form
Critical Limit (s )
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What
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How
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Monitoring
Frequency
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Who
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Correction and Corrective
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action
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Responsibilities and
Authorities
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Records of Monitoring
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Research Highlights
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