Professional Documents
Culture Documents
&
SUPER MARKET
N. Charisis
Athens, Greece 2004
1. Abbreviations ___________________________________________________________ 6
2. Forward _______________________________________________________________ 7
3. Hazard analysis and critical control points (HACCP)___________________________ 7
3.1. Historical overview and present status of HACCP ______________________________ 7
3.1.1. Historical overview _____________________________________________________________ 7
3.1.2. Present status __________________________________________________________________ 8
4. The need for the HACCP system __________________________________________ 10
4.1. The incidence of diarrhoeas ________________________________________________ 12
5. The challenge of emerging and reemerging foodborne diseases _________________ 13
6. Economic consequences of foodborne diseases. ______________________________ 14
6.1. The economic challenges today _____________________________________________ 14
6.2. Experience in industrialised and developing countries __________________________ 14
7. The HACCP systems ____________________________________________________ 15
7.1. Concept ________________________________________________________________ 15
7.2. Objectives ______________________________________________________________ 16
7.3. Areas of application ______________________________________________________ 17
7.4. Development and Implementation __________________________________________ 17
7.5. Benefits ________________________________________________________________ 18
7.6. Difficulties and Barriers in the implementation _______________________________ 20
8. The relation of HACCP with Food Hygiene and Food Safety ___________________ 22
8.1. Food Hygiene and Food Safety _____________________________________________ 22
9. Quality of food _________________________________________________________ 24
9.1. Definitions of quality _____________________________________________________ 24
9.2. Importance of Quality for the consumer, industry and public health ______________ 25
10. Quality Assurance and Food Safety Assurance Programme ____________________ 26
11. Quality management systems ISO 9000 series – EN 29000 _____________________ 27
12. Traditional food control _________________________________________________ 29
13. Traditional food production and control ____________________________________ 29
14. Total Quality Management (TQM)_________________________________________ 30
15. Quality Control System __________________________________________________ 31
16. Hazards Analysis, Critical Control Points and Control Measures ________________ 33
16.1. Hazard Analysis _________________________________________________________ 33
16.2. Classification of Hazard according to the risk and severity (Hazard
Index). _________________________________________________________________ 35
16.3. Assessment of risk in Hazard Analysis _______________________________________ 35
3
BY DR. N. CHARISIS (WHO/MZCP)
1. ABBREVIATIONS
CAC FAO/WHO/Codex Alimentarius Commission
CCFH Codex Committee on Food Hygiene
CCFICS Codex Committee on Food Import and Export Inspection and Certification Systems
CCP Critical Control Point
CM Control Measures
FAO Food and Agriculture Organization of the United Nations
FDA Food and Drug Administration (USA)
GAP Good Agriculture Practices
GHP Good Hygienic Practices
GMP Good Manufacturing Practices
HACCP Hazard Analysis and Critical Control Point
QMS Quality Management Systems
ICMSF International Commission for Microbiology Specification of Food
ISO International Organization for Standardisation
PFD Process Flow Diagram
PRP Prerequisite Programme
SLDB Small and/or Less Developed Business
SPS Sanitary and Phytosanitary Measures
SSOP Sanitation Standard Operational Procedures
TQM Total Quality Management
UNIDO United Nations Industrial Development Organization
WHO World Health Organization
WTO World Trade Organization
MZCP/WHO Mediterranean Zoonoses Control Programme/World Health Organization
MZCC Mediterranean Zoonoses Control Centre
Notice: Most diagrams and tables are selected from HACCP Principles and Practice, Teacher’s handbook.
A WHO/ICD Training manual in collaboration with FAO. WHO/SDE/PHE/FOS/99.3.
WHO, Geneva.
7
BY DR. N. CHARISIS (WHO/MZCP)
2. FORWARD
The present document was based initially, on materials presented at the
WHO/MZCP1 International Training Course on HAZARD ANALYSIS AND
CRITICAL CONTROL POINT SYSTEM(HACCP): CONCEPTS AND
APPLICATIONS, held in Teramo, Italy, 4-11 December 2000. That Course was
hosted by the WHO/FAO Collaborating Center on Research and Training in Veterinary
Epidemiology and Management, Istituto Zooprofilattico Sperimentale, dell Abruzzo e
dell Molise, Teramo, Italy. During the course, presentation materials were made available
to the participants as photocopies of the presenters’ charts and graphs and/or from the
transparencies and slides and as a CD containing almost all material; however, there was
no actual expository text in these presentations materials making the review of the
training course a quite difficult task. At that time, the Mediterranean Zoonoses Control
Centre Athens, had been assigned by WHO to work out a document containing every
possible bit of information given in the ITC of Teramo in combination with salient and
complementary points from relevant international literature as well as that from the
WHO publications on the subject. It soon became evident, that due to the abundance of
material contained in the original Teramo ITC handouts it would not be necessary to
reproduce them, but rather expand on those materials in order to facilitate the reading
and comprehension of charts, exercises and tables. Little by little, other colleagues were
invited to contribute with their skills and experience in a joined effort to make the
present document useful, not only to the trainees of similar ITCs but also to every
person seeking information on HACCP systems. Therefore we consider the present
book a “tool” for the training of beginners and the “enlightening” of experts in most
common fields of HACCP.
(NASA) and the U.S. Army Laboratories at Natick, in order to ensure the safety of
astronauts’ food.
In 1973, the Pillsbury Company published Food Safety through the Hazard Analysis
and Critical Control Point System, which was the first document on HACCP concepts and
techniques. Twenty years later, this system was internationally recognised and accepted
for food safety assurance, including, not only microbiological safety of foodstuffs but
also chemical and physical hazards. Since then and for many years HACCP systems have
been applied on a voluntary basis in many food industries.
Systematic implementation of a HACCP system-based approach to food safety
assurance throughout the developing world shouldn’t be expected for the near future,
because of the lack of expertise and training on the subject. However, meeting food
export requirements has always been a strong motivation to introduce HACCP systems.
In Morocco, for instance, there has been an incentive to revise and update fish
inspection legislation and to include a mandatory HACCP system based on food safety
assurance with the aim of obtaining European Union acceptance of Moraccan fish,
because these systems have been made the legal and mandatory requirement in the
European Union.
6
Malaysia Bolivia,Colombia,Ecu
ador, Peru,
Morocco HACCP system in 27 Fishery
industries for exports to EU, Venezuela (think about
revise and update fish USA, Australia it)
inspection legislation including a
mandatory HACCP system
Uruguay
New Zealand HACCP system in meat
voluntary HACCP system- industries for exports to USA.
based Food Safety program
Egypt
Chilly Thailand
Voluntary (more than
10 out of 200
industries)
A draft low is been prepared
HACCP system in canned food
products for exportation
Until 1995, the term, “HAZARD ANALYSIS CRITICAL CONTROL
POINT” was used originally throughout the industry. This was changed after a proposal
from WHO/Geneva Consultation in 1995 to: “HAZARD ANALYSIS AND
CRITICAL CONTROL POINT systems”.
In 1997, the Codex Alimentarius Commission adopted officially the proposed term in
order to ease its translation into other languages.
recognition and application. The following schematic figure shows the growth and
sudden increase in application of HACCP.
50
40
30
20
10
es timate
0
1970 1975 1980 1985 1990 1995
Today, HACCP based food safety assurance systems, rather than voluntary codes,
have been made the legal and mandatory requirement in some countries2, such as the
member states of the European Union. Thus, recognising its importance, food and
public health authorities world-wide have promoted HACCP.
The World Health Organization for example, has recognised the importance of HACCP
for the prevention of foodborne diseases and has played a significant role in the
development and implementation of HACCP.
In 1995 the FAO/WHO Codex Alimentarius Commission adopted guidelines for the
application of HACCP in basic texts (a collection of internationally adopted food standards
presented in a uniform manner). The Codex Alimentarius also includes provisions of an
advisory nature in the form of codes of practice, guidelines and other recommended
measures to assist in achieving its purposes. The Codex Alimentarius3 on general principles
of food hygiene has been revised in 1997 in order to include recommendations for the
application of HACCP guidelines. The description in the Codex guidelines gives a
structure that makes HACCP likely to be accepted by other parties such as food
inspectors and trade partners.
In due course, all food quality assurance guidelines will include HACCP. Sector-specific
guides to Good Hygienic Practice (GHP) and guides to HACCP have been developed
2 In the EU, the Food Hygiene Directives (EC Directives 93/43) include 5 principles of HACCP in the
requirements for Food Hygiene and until 2005 is expected that all principles should be included!
3 Ever since its application, HACCP was recommended by the Codex Alimentarius Commission of General
Principles on Food Hygiene and other specific codes. This means that HACCP has become the international
reference system for food safety assurance.
10
BY DR. N. CHARISIS (WHO/MZCP)
for a considerable range of business types within the food industries such as wholesale,
processing and retail sectors (e.g. caterers, butchers and bakery traders, markets and fairs).
When and where there are legal requirements for HACCP or HACCP-based food safety,
than management control guides can be the “means” of achieving compliance. However,
depending on their scope, target sector, local legal requirements, and other local
conditions, guides may vary in content; they may address GHP, the application of the
principles of HACCP, food microbiology, or staff training but they may not address all
the concerns of food safety nor provide for adequate training in the best food safety
assurance system.
Even though the concept of HACCP was presented in 1971 by industry in the
United States to food inspectors, it took many years before HACCP received world-wide
recognition and application.
Table 1 - Significant dates in the history of HACCP
1959 Pillsbury Company develops the HACCP concept for use by NASA
1971 Concept presented in USA
1980 WHO/ICMSF4 report on HACCP
1983 WHO recommends HACCP
1985 NRC5 in USA recommends HACCP
1988 ICMSF Book on HACCP
1991 Codex includes HACCP in codes
1993 Codex issues HACCP guidelines
1993, 1994, 1995 WHO and FAO consultations
1997 Codex issues revised document
1998 FAO/WHO provide guidance for regulatory assessment of HACCP
This table gives a historical overview of HACCP from 1959 when Pillsbury Co. developed the
concept, until 1998 when FAO/WHO provided guidance for regulatory assessment of HACCP
aware of the need to move to a system such as HACCP. Until that need is acknowledged, it is unlikely that a
commitment at any level can be expected (Report of a WHO Consultation on HACCP Concept and Application, June
1995)
11
BY DR. N. CHARISIS (WHO/MZCP)
condition. Therefore in the relatively modern HACCP system, “hazard”7 is exactly this
condition of the food that may represent any threat to the consumer by causing
symptoms ranging from any detectable discomfort, to severe illness, injury or death.
However, adverse effects on health are not only due to biological, but also to physical,
chemical or radio nuclear hazards. From this point of view HACCP system is the latest
and most developed food safety assurance method in the world, protecting the
contamination and/or growth of bacteria in food as well as it contamination by
poisonous chemicals, foreign bodies etc., and consequently the development of a serious
situation for both manufacturers and consumers. – But, what was the
situation before HACCP?
The need for an effective food safety assurance system goes back to the
beginning of civilisation. Ever since time immemorial, texts indicate that kings
or emperors were concerned about protecting their subjects from foodborne
diseases, and/or food adulteration.
7 The borders of hazard are not strictly confined. There are variations depending on many factors such as the
infective dose, the age, the general health, the pregnancy, the immune competence of the individual e.t.c.
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BY DR. N. CHARISIS (WHO/MZCP)
widespread health problem in the world and was an important cause of reduced
economic productivity. According to national and sentinel studies conducted from 1985
to 1995, foodborne diseases represent a widespread public health problem. From these
studies, for instance, it has been estimated that currently the incidence of foodborne
diarrheas per year is four billion cases(?)
250
E sto n ia
Incidence (cases/100000)
200 L ith u a n ia
L a tvia
150 A u str ia
G erm any
100 R u ssia n F e d .
S w i t ze r l a n d
50 C yprus
UK
0
198 5
198 6
198 7
198 8
198 9
199 0
199 1
199 2
199 3
199 4
199 5
199 6
199 7
199 8
Ireland - - 4 125 7 4
Italy 48 31 29 40 68 45
Netherlands 14 24 31 22 21 29
Spain 24 26 25 21 19 16
Sweden 35 34 34 23 18 32
UK England and 103 115 87 120 124 108
Wales
UK Scotland - - 13 11 6 13
processing line under control. Experience from the canning industry demonstrated that
keeping control over processing conditions was much more efficient and reliable than
end product testing. The time and temperature employed guaranteed safety of the
product (even significant under-processing can seldom be detected by end product testing).
To assure that measures are carried out as determined, all-important actions are
described and personnel is trained to carry them out. Actions have to be implemented
without exception. To ensure that they are carried out correctly and to provide evidence
of this, the results should be recorded. At the same time those records also provide a
basis for improvement.
7.2. OBJECTIVES
No matter the role and the importance of Governments in the implementation of
HACCP, it should not be overlooked that HACCP was introduced by the food industries
to obtain greater assurance for food safety. Therefore it becomes clear that it is in
industry’s best interest to produce safe food. If people become ill after eating a product,
the company will certainly lose its customers and its good reputation as well as large
amounts of money. So the HACCP system is not meant to be an additional regulatory
burden, but rather, a tool for ensuring safety and preventing foodborne illnesses.
The Codex Alimentarius Commission guidelines describe how a HACCP study could
be performed. These guidelines give a certain universal structure to a study, which will
make it more likely to be accepted by other parties (food inspectors and trade partners).
However, the 7 principles of HACCP should be applied taking into account specific
conditions of size, sophistication of the process and the level of the food safety
management system. These 7 principles are the minimum mandatory requirements in the
application of the HACCP system. But before reporting the 7 principles, all steps leading
to the Hazard Analysis should be followed. Appointment of the HACCP team will go
ahead with the appropriate activities. (for more information see at HACCP-team, section of this
document). One of the first activities of this team is to describe the product (i.e. raw
materials used, suppliers, parameters influencing safety, processing conditions, packaging performance,
characteristics of the packaging materials). Next, the intended use of the product should be
defined (i.e. for caterings, hospitals, general population, exportation specific groups of the population
etc.).
To understand how a product is manufactured, and to have a disciplinary approach
in the study, it is important to construct a flow diagram covering all steps where
product safety could be affected. In many food production and preparation
establishments, different areas or rooms have different hygiene levels, and barriers, such
as walls or air curtains separating them.
It is important to inspect the site and the practices applied during all hours of
operation (even night shifts, weekends etc) as well as the cleaning procedures and
validate their efficacy. During this inspection all potential hazards should be listed and a
Hazard Analysis of the production and process should be performed by establishing
Critical Limits for each Critical Control Point. (for more information see HACCP system
principles of this document)
Let’s now suppose that a specific plant is working under strict HACCP conditions. In
that case of course there is no need to perform microbiological examinations in any stage
of production in order to verify that the product is free from pathogens. Still, pathogens
may enter the premises on the raw material or in the potable water. It is therefore
important for the manufacturer of the final product to make sure that every raw material
or substance entering his plant is safe in any sense and meaning. In order to achieve this,
the manufacturer of the final product should ask from the supplier of raw materials
(especially for the edible ones), to provide written specifications for any ingredient they
contain. Furthermore the manufacturer may conduct audits to validate the status of the
vendor’s certification program. This activity certifies that every substance entering the
plant has been manufactured, produced, or transported under GMP regulations and
there is no need to proceed with microbiological or other tests in order to use it. In any
case that the manufacturer of the final product can’t audit the supplier’s plant (i.e. because
of the distance-some exotic material may come from aboard), he always can ask the supplier to
provide an assurance that the ingredients meet the specifications of the international
standards. In this case the supplier should accompany his product with a GMP certificate
attesting not only the concerned product but also the particular batch. This certificate
should accompany the batch upon arrival in the plant or entry into the country.
Under the circumstances, one may say that even the potable water used for the
manufacturing of the products should have a GMP certificate. This is not absolutely
necessary because it is generally expected that, public water typically, maintain high
quality standards for chemical and microbiological content. Considering, however, that
water is used both in many food processes, such as to wash foods, to clean and sanitise
facilities, utensils and equipment, to make ice as well as food ingredient, food processors
should perform monitoring analyses to confirm the quality and store the results in their
periodic control records.
7.5. BENEFITS
As already stated the HACCP system is a scientific, rational and systematic
approach to identification, assessment and control of hazards during production,
processing, manufacturing, distribution, preparation and use of food, to ensure that food
is safe when consumed. With the HACCP system, food safety control, presently based
on end product testing, is from now on integrated into the design of the process. Due to
this sophisticated integration, HACCP systems:
19
BY DR. N. CHARISIS (WHO/MZCP)
are applicable to the whole food chain, from production of raw materials to the
end product (e.g. growing, harvesting, processing, manufacturing, transport and distribution,
preparation and serving)
have few of the limitations of traditional approaches to food safety control13.
have the potential to identify all conceivable, reasonably to be expected hazards,
even when failures have not previously been experienced. Are therefore,
particularly useful for new operations.
Are capable of accommodating changes introduced, such as progress in equipment
design, improvements in processing procedures, and technological developments
related to the product.
help to target or manage resources at the most critical part of the food operation.
aid the relationships between food processors, inspectors and consumers.
promote international trade by providing for equitable food safety control systems
everywhere in the world.
increase confidence in food safety as they reduce detention, confiscation, and
destruction of contaminated food shipments and
can be easily integrated into quality management systems such as ISO systems.
Therefore, HACCP provides a foodborne disease prevention system and a cost-
effective approach to food safety14. But except for the general benefits of HACCP
system, which are referred above, one may focus to its specific benefits for the
consumers, the industry and the governments.
a. Benefits to consumers
- Reduced risk of foodborne diseases
- Increased awareness of basic hygiene
- Increased confidence in the food supply and
- Improved quality of life (health and socio-economic)
b. Benefits to industry
- Increased consumer and/or government confidence
- Reduced legal and insurance costs
- Increased market access
- Reduced production costs (reduced recall/waste of food)
- Improved product consistency
- Improvements of management commitment to food safety and
- Decreased business risk and liability
c. Benefits to governments
- Improved public health
- More efficient and targeted food control
- Reduced public health costs
- Trade facilitation (import/export)
13 Collecting and examining sufficient number of samples, high cost, time, and identification of problems
without understanding the causes, limitations of snapshot inspection.
14 Experiences gained in some countries indicate that application of HACCP systems leads to more efficient
prevention of foodborne diseases. In the U.S.A, only, application of HACCP by the fish processors alone is
estimated to avert some 20-60% of cases of sea-foodborne illnesses.
20
BY DR. N. CHARISIS (WHO/MZCP)
Experts and technical support are necessary in the food industry. The most
important human barrier for the implementation of HACCP is the lack of
management commitment and understanding of HACCP systems. Therefore
during the early stages of the HACCP plan development, businesses need to
commit additional staff time and resources, for experts and technical support.
Moreover the new food safety roles and responsibilities need to be explicitly
identified and handled. For guidance on training and model curricula, reference is
made to the WHO document entitled “Training Aspects of the Hazard Analysis Critical
Control Point System15”
Appropriate infrastructure and facilities within the business itself and within
the community are necessary for the implementation of HACCP. It is clear that
no HACCP or GHP/GMP system can ever be implemented without roads,
electricity and a safe water supply. It is the role of government to ensure that the
appropriate infrastructure is in place before issuing a licence for a food business
operation. Likewise business should ensure that premises, work surfaces and
15 Training Aspects of the Hazard Analysis Critical Control Point System (HACCP). Report of a WHO
Costs versus benefits: Although the economic constraints are a serious barrier
for the implementation of HACCP systems, the government and especially the
22
BY DR. N. CHARISIS (WHO/MZCP)
industry, should take under consideration the long term savings from reduced
public health costs, lawsuits due to food safety failures, and spoilage due to
improved handling, storage etc. Therefore the costs to business to implement
HACCP must be weighed against the possible losses due to food safety failures
when HACCP is not in place.
Management must be prepared for the initial costs and for the day-to-day
operations of the HACCP plan for that particular industry.
A team of experts will be acquired to make the plan and train the employees. There
may be expenses in purchasing equipment and material, and making changes
throughout as necessary. Both government and business will appreciate the long-
term savings from reduced public health costs.
Food safety assurance starts at the “farm”, the primary agricultural or fishery level. At all
steps of the food chain, particular attention is given to potential food safety problems
and how they could be prevented or controlled. In recent decades, food industries and
public health authorities realised the limitations of this approach. They also realised that
GMP and GHP provide necessary and basic guidance for producing safe food; but by
themselves, they are not always sufficient.
However, improvements in food safety and in animal and plant health will not be
achieved without a cost. They require significant human and institutional capacity.
To assure food safety, three levels of hygienic measures can be implemented:
1st Level: application of the General Principles of Food Hygiene, (as stipulated by the Codex
Alimentarius Commission).
nd
2 Level: application of the food-related hygienic requirements (as expressed by the Good
Manufacturing/Hygienic Practice).
3rd Level: application of HACCP.
HACCP can be applied in order to achieve a greater assurance that the
produced, processed or manufactured food is safe. It identifies what is needed
to make food safe and makes sure that what is planned is correctly
implemented. Therefore today HACCP is part of food hygiene, or the food
safety assurance system. Food hygiene can itself be placed in the context of
food quality assurance programmes.
FOOD
SAFETY ASSURANCE
HACCP system
Food-related hygienic requirements
General principles of food hygiene
Today’s approach to food safety assurance is based on a combination of
compliance with GMP/GHP/SSOP18 and one may say that HACCP, GMP, GHP and
SSOP are the foundations of the food safety assurance system.
Normally, foods produced according to what is called GMP are safe. In most cases
where foods have been incriminated in foodborne diseases, deviations from GMP
occurred, or incidents happened, that where not detected in time. This means that many
aspects of food production are covered by measures and controls, which form part of
GMP.
HACCP underscores these practices, which are critical in ensuring a product’s safety. It
may also play a complementary role to GMP, as during the HACCP study some control
measures specific to the food and line of production may additionally be identified.
Good Manufacturing Practices (GMP) and Good Hygienic Practices (GHP) are
necessary but not always sufficient. Today, it is well known that the Codex Alimentarius
guidelines provide general requirements without considering the specificity of the food
or process in question and its related potential hazards. Furthermore, they do not
provide a mechanism for identifying those measures, which are essential for food safety.
They do not provide monitoring mechanisms to ensure that measures necessary for
safety are implemented and carried out correctly. They don’t provide proof that the
products were prepared according to the established requirements and of course, they do
not make provisions for corrective measures if the process gets out of control.
Therefore, HACCP is preferred because we need:
Hygiene requirements (control measures) specific to each facility, particular food
and process, and specific to the associated potential hazards
Prioritised control measures
Effective implementation of essential procedures.
Corrective measures included in a plan of checks, verification and validation.
Monitoring of the process parameters to be able to control safety at all times
encompasses many aspects of plant and personnel operations, whether SSOP are procedures helping to
accomplish the goal of maintaining GMP in the food production.
24
BY DR. N. CHARISIS (WHO/MZCP)
In the new concept of food control with HACCP, the “farm-to-fork” principle in
assessing food safety is a perfect fit. Government inspectors do less policing and more
advising and discussing.
With HACCP, the emphasis is on shared responsibility among professional food
handlers and government inspectors. Accordingly, responsibility for the production and
preparation of safe food is in the hands of professional food handlers and the final
enforcement of the regulation of food safety is in the hands of government inspectors.
9. QUALITY OF FOOD
9.1. DEFINITIONS OF QUALITY
It is not easy to define quality because the term means different things to different
people. It is a term used arbitrary by many. Traditionally, luxury, beauty, high value
meant quality. However, according to the use and requirements of the user, high quality
can be attributed to different parameters. Therefore meeting the agreed requirements of
the customer is a useful definition. One can define quality as the total parameters and
characteristics of the product or service, which satisfies consumer desires and needs
(agreed or presumed), or the price a customer is ready to pay for a product.
The American Society for Quality Control (ASQC, 1987) specifies that quality is
“the totality of features and characteristics of a product or service that bear on its ability to satisfy stated
or implied needs”.
Nevertheless, in addition to those “classical’’ demands, from the part of the consumer,
and therefore for quality attributes, in the recent years, new parameters, having a limited
relation with “actual’’ quality, (i.e. animal welfare during production procedures and environmental
protection), have been incorporated as quality attributes, especially in livestock production.
As a matter of fact, there is a new concept, which could be addressed as the “new quality’’.
It is a general requirement introducing, in the relation between consumer and producer,
the dimension of imposing no harm to third parties. In other words, production should
not only satisfy the demands and needs of the consumer, but it should also assure safety
from the public health point of view - and - it should do that without injury to any third
party. This injury or harm may concern the animals for example or the environment.
These parameters, known as “other legitimate factors’’, play an important role in production
and in prescribing food regulations. They don’t relate directly the production process
with the consumer demands for a certain product. But they are requirements, which are
projecting a quality profile based on ethical concerns. In other words a new “ethical
dimension” is introduced in quality.
Quality, therefore, could be the “degree to which a set of inherent characteristics fulfils
requirements’’, with emphasis on the customer both as a consumer and a human being, as
well as human environment in general. Likewise, quality control is a “mechanism or
technique or procedure or process” ensuring that each product attains a minimum objective
standard as this is defined in practical written protocols.
Under this concept, quality can be seen from different angles:
From a consumers’ point of view prevails the Organoleptic quality, the Functional quality
(e.g. rheologic properties, convenience, keepability), the Nutritional quality, the Hygienic quality
(safety)
From a public health point of view what it counts more is the Hygienic quality (safety). It
follows the Nutritional quality and of course the compliance with the regulations.
According to the English Oxford Dictionary, quality is the “Degree of Excellence”.
We can also demonstrate it as the peculiar or essential character or the inherent feature
of a specific product. Additionally quality may be defined by the entire constant
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BY DR. N. CHARISIS (WHO/MZCP)
Table 4.: Quality from a consumer/industry and from a public health point of
view
Consumer/industry point of view Public health point of view
organoleptic quality
functional properties
keepability Compliance with regulations
“freshness”
nutritional nutritional
safety safety (hygienic quality)
Value of money
Consumer
Safety
Foodhyg 9
26
BY DR. N. CHARISIS (WHO/MZCP)
Among the different components of quality, safety is most important for all parties
i.e. industry, consumer and public health authorities. Nevertheless, it is this feature of the
food, which is most often overlooked. This is because one is aware of safety only when
it is no longer there. It is only after a succession of important and sometimes fatal
foodborne disease outbreaks in the industrialised countries, as well as a raising awareness
campaign of the WHO during recent years, that food safety has gained importance
among consumers, public health authorities and industry.
19 (ISO/UNCTAD/GATT)
20 Total Quality Management
27
BY DR. N. CHARISIS (WHO/MZCP)
Standards for certified quality assurance systems have been internationally accepted, like
ISO 9001: 2000, EN 29000, ANS/ -Q91.
In summary, the ISO 9000 standards are used to evaluate the food quality
assurance programmes, but give no guidance on technical requirements to achieve the
required quality. The objective of a quality assurance programme is to suggest
appropriate actions and ensure that they are carried out. Food hygiene is part of the food
quality assurance programme. Its objective is to ensure that the food, which is produced,
processed or manufactured is safe and fit for human consumption. HACCP should be
considered as part of food hygiene and a method of food safety assurance, which
complements the general aspects of a total quality management culture as well as specific
principles of food hygiene, and ensures that essential safety measures are implemented.
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BY DR. N. CHARISIS (WHO/MZCP)
In more modern times the food safety assurance system relied on two types of measures
called actions.
The first actions were undertaken during procurement of raw material, processing and
manufacturing, transport and distribution including design, layout and cleaning of
premises, to produce safe food. These actions were usually those prescribed in the Codes
of Manufacturing or Hygienic Practice.
The second actions were undertaken to ensure that food, which was produced, was
indeed safe. For this purpose, industries tested the end product for contamination, and
food control authorities inspected the premises and carried out independent testing.
The traditional system of food safety assurance in industry was based on applying codes
of GMP/GHP in food production and processing. Confirmation of safety and
identification of potential problems were obtained by end product testing.
Inspectors in food control agencies checked for compliance with GMP/GHP codes and
also analysed the food for compliance with regulations and identification of unsafe food.
Since GMP and GHP are the bases of food hygiene, it was possible to achieve a great
degree of assurance in food safety with this approach.
setting precise goals, implementing positive preventive steps and corrective actions to
problems, and continuously improving quality, a company will be prepared for future
changes as dictated by economics and customer needs (Webb et al, 1995).
Sashkin and Kiser (1993), have stated that “TQM” means that the “organisation’s
culture is defined and supports the constant attainment of customer satisfaction through
an integral system of tools, techniques and training’’. This involves the continuous
improvement of organisational processes, resulting in turn in continuous higher quality
products and services. It is because, by final product inspection, you may eliminate
defected products to reach the customer, but quality is not improved. Final product
inspection alone does not influence the process of production, which may continue to
produce defected products.
In fulfilling the principle of customer satisfaction, each step in the production flow
diagram, should be addressed as a customer of the previous step and, at the same time, as
supplier of the next. On the other hand, quality, in the various steps of production, is the
only parameter, which can be improved and influence the cost of production, since all
other parameters of production that is raw materials, employees’ income and company’s
profit cannot be suppressed.
Investment in effort, time and money to quality improves the end result and the
working conditions. In this respect, the term “total’’ (in TQM) signifies that, for
supporting quality, all personnel and resources of a business activity are implicated.
The TQM concept, although was theoretically developed in the West Coast of the
USA, it was practically employed by Japanese. They were anxious, after World War II to
study the American economy and draw lessons for improving their competitiveness.
They realised that, while theoreticians were suggesting preventive measures for
improving quality, business in the West were involved in expensive final product quality
control, without decreasing the number of defected products. The Japanese, instead,
turned to preventive actions for improving quality, created products according to the
demands of their customers, suppressed the number of their suppliers for a more
effective control, adjusted, in line with the above, the thinking of their employees and
developed specific systems for quality control. To day all are imitating the Japanese.
days market conditions increased the quality requirements. The customers expect better
and constant quality. Standards, regulations and consumer protection define margins,
within which the producer is expected to operate. Competition increased, due to the
increase of exchanges and better communications. Therefore, a study of the processes,
by which the customers’ demands will be met, and how these processes can be defined,
measured, controlled, for assuring a certain standard to the end product or service is
needed.
The inspection system has many weaknesses. Among others it is based on a snapshot
inspection, and not on what happened during a longer period of time. End-product
testing performed by the industry itself as a means of self-control or by food inspectors
is costly, time consuming and not reliable as a food safety assurance tool.
Basic elements of a Quality Control System are its structural and control factors. The
Structural factors include the organisation structure and the human resources whether
the Quality control factors are focusing into controlling the operational process through
visual inspections, equipment trials, laboratory tests etc.
Today, with food technology at its height, food could be safe all over the world.
Safe food is assured when traditional food safety assurance systems have been integrated
with HACCP. An industry would start from the very beginning of every food operation
with the design of the process of the product. Then the industry managers would
continue with the proper selection of raw material, the process control, the GMP and
GHP, and finally the good commercialisation and use practices. HACCP would be
integrated into each of these steps to identify potential food safety problems. Therefore,
when we talk about food safety assurance today we include traditional hygienic
precautions taken in the production of food and the systematic application of the Hazard
Analysis and Critical Control Points system. Simply stated, HACCP indicates what needs
to be done to make food safe and it ensures that what is planned is correctly. If HACCP
is applied properly from the primary producer to the final consumer, then food safety is
assured, thus making better use of resources, enabling more timely response to problems,
aiding official inspections and promoting international trade.
The implementation of the HACCP CONTROL SYSTEM can be integrated in
the implementation of the QUALITY SYSTEM because in a company, the former can
be considered a part of the later.
Biological agents include bacteria, viruses, moulds, parasites and toxin, whereas
chemical agents may be various paints, or poisons used as pesticides or insecticides or
the inner coating of cooking utensils. Foreign material such as pieces of glass, cork,
wire, or clothes may be considered hazards, which escaped into the food during the
processing, or packaging and they may cause perforation of the guts or suffocation in
babies and children.
use; for microbes these are under development.
Potentially harmful agents are present in many raw materials, usually in very low
levels. They become dangerous when their level, or the level of the toxins they produce,
increases to a point where they may cause disease. Viruses and parasites do not multiply
in food; the same is true for many natural toxins and chemicals. However there are also
situations where chemical reactions may continue to occur; for example nitrosamine
formation, which could present a hazard. To prevent this, the conditions leading to
increase would be kept under control. If an agent is at a high level and processing is
meant to decrease the level to an acceptable one, the conditions during processing should
assure that the acceptable level is actually reached.
The HACCP system is very dynamic. During a HACCP study, only the existing
situation or the situation as it is expected to exist can be taken into account. Every
change can introduce the hazard; thus, every change has to induce the hazard analysis
reflex. It should be understood that once a HACCP plan has been established, it needs
continuous “maintenance”. Every new raw material may bring a new hazard. Therefore
potential new hazards have to be analysed during and directly after industrialisation.
Hazard analysis determines which agents could be present in the food study.
Epidemiological data have linked foods with particular foodborne pathogens, chemical
or physical hazards, (for example, canned food and Clostridium botulinum, eggs and Salmonella,
milk and the Mycobacterium bovis responsible for tuberculosis). These agents may be present in
the raw material, but their levels may not be high enough to cause disease. To decide
whether the presence of an agent in the raw material is a significant hazard, we have to
know the levels at which it may cause disease. We also have to know which conditions
can cause a pathogen to increase to an unacceptable level, the severity or magnitude of a
health effect caused by this pathogen, and, finally the likelihood of its occurrence.
ferment food and drinks and their presence is desirable or even recommended in order
to improve the taste of food (i.e. yoghurt). Bacteria and moulds are most familiar to us
since we can either see them (e.g. mouldy fruit), or we can see their activities (e.g. spoiled
meat). Viruses and parasites are less evident but, as with bacteria, we are aware of their
effects when we suffer from an infection.
The table below shows some of the contaminants listed on the basis of risk
severity.
Physical Hazards
As physical hazards are considered all foreign material slipping accidentally into the
food, such as metal, glass, bone, feathers, teeth, hair, nails, nut-shell, eggshell, rodents
dead bodies, insects, parasite eggs, grit, sand, and rarely medical or cleaning equipment
needles, wire, thermometers, bottles, or even personal equipment (rings, hairpins).
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BY DR. N. CHARISIS (WHO/MZCP)
In order to protect the product from the above hazards entering the premises
through the raw material, one should take different steps for each hazard. For chemical
and biological hazards a GMP certificate should accompany all products and raw material
entering the plant. This way we can be sure that everything entering the plant is safe and
it should remain safe during the process. In order to verify that all raw materials are safe
we may perform a formal inspection in the source of every raw material and check the
implementation of the HACCP.
For physical hazards beyond the GMP certificate, a visual inspection upon the
entrance, metal detectors, magnets and filters depending on the substance may be of
great help. However from the point of entrance and after, the responsibility lies on the
owner of the plant who should insure that there is a creditable HACCP system working
24 hours per day.
product is stored in the correct temperature and position according to his HACCP
system papers.
By the end of this procedure, the first step has been successfully completed – the
raw material is clean, safe, and properly stored. The second step is the process of the
product until the attainment of the final product. The third step is the proper marking of
each batch, the proper storage and finally the transportation to the final point (whether this
is a supermarket or a restaurant). Unloading the final product in the Super market and
signing the papers of acceptance conclude the HACCP system of the Plant. From now
on the responsibility of the safety lies on the Super market or the Restaurant or farther
more the final consumer who is responsible for the storage, handling and cooking of the
product according to directions on the label.
Usually hazards exercise slight and undetected adverse health effects to the
consumers, but sometimes they may cause serious health problems or even death to
individuals or to a large number of people, depending on the case. In general we may
list these adverse health effects as following:
Fever
Chronic illness: Chronic infections
Damage of various organs
Some Cancers
Damage of
organs
Death
surfaces with jet sprays carry pathogens from unclean areas into foods. Condensation
droplets falling down from cold overhead pipes do the same. Infected food handlers
infect food with their hands. Foods that are often insufficiently cooled or not held at hot
enough temperatures, so the pathogens are allowed to multiply, are the sources of many
epidemics of foodborne diseases as well.
In developing countries, a significant proportion of cases occur usually after eating food
purchased from street vendors. There are of course many outbreaks of undetermined
origin.
When using the verb “control”26, we mean taking actions (direct, regulate, command),
in order to ensure and maintain compliance with the criteria established by the specific
HACCP plan.
When we use the noun “control”, we mean “under control” or otherwise that we
have the things under control (because the correct procedures are being followed and criteria set by
the HACCP plan are being met). Accordingly we can use the word control (noun or verb) in
order to specify the “Hazard Control” that has been taken already (noun) or are been
taken now (verb) in order to prevent or eliminate a food hazard or reduce it to an
acceptable level (i.e. prevent the product from contamination, prevent the increase of the hazard over
the acceptable level, decrease the hazard to/or beyond the acceptable level, prevent from recontamination,
prevent of dissemination of the hazard to adjacent or other working grounds).
In order to achieve the “control of a hazard”, one should perform a “Hazard
Analysis” which is the process of collecting and interpreting information on hazards and
conditions leading to their presence. Under this process, one may decide which hazards
or conditions leading to specific hazards are significant and therefore should be
addressed in the HACCP plan.
A Hazard Analysis should be performed during:
product development
industrialisation of a new product
when specific hazards emerge
when new raw material are used
when formulation is changed
when equipment is changed
when a new production area is used
The likely occurrence of hazards and the 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
Quality of raw materials
Conditions leading to the above and identification of control measures
A. Ingredients
1. Does the food contain any sensitive ingredients that may present microbiological
hazards (e.g. Salmonellae, Staphylococcus aureus), or chemical hazards (e.g. aflatoxin, antibiotic or
pesticide residues) or physical hazards (e.g. stones, glass, metal)?
2. Is potable water used in formulating or in handling in food?
B. Intrinsic Factors
6. What are the physical characteristics and composition (e.g. pH, type of acidulents,
fermentable carbohydrate, water activity27, preservatives) of the food during and after
processing?
7. Which intrinsic factor of the food must be controlled in order to assure food safety?
8. Does the food permit survival or multiplication of pathogens and/or toxin formation
in the food during processing?
9. Are there other similar products in the market?
10. What has been the safety record for these products?
27 Microorganisms need available water to grow, which is not bound with other molecules in the food. The
term water activity (Aw) describes the available water needed for the microbial growth and ranges between 0 –
1.0. The lowest Aw at which a harmful bacteria can grow is 0.85 (the most favour Aw is between 0.97 and 0.99).
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BY DR. N. CHARISIS (WHO/MZCP)
14. Is it likely that the food will contain viable sporeforming or non-sporeforming
pathogens?
15. What is the normal microbial count of the food?
16. Does the microbial population change during the normal time the food is stored
prior to consumption?
17. Does the subsequent change in microbial population alter the safety of the food, pro
or con?
E. Facility design
18. Does the layout of the facility provide an adequate separation of raw materials from
ready-to-eat food?
19. Is positive air pressure maintained in packaging areas? Is this essential for product
safety?
20. Is the traffic pattern for people and moving equipment a significant source of
contamination?
F. Equipment design
21. Will the equipment provide the time-temperature control that is necessary for safe
food?
22. Is the equipment properly sized for the volume of food that will be processed?
23. Can the equipment be sufficiently controlled so that the variation in performance will
be within the tolerances required to produce a safe food?
24. Is the equipment reliable or prone to frequent breakdowns?
25. Is the equipment designed so that it can be cleaned and sanitised?
26. Is there a chance of product contamination with hazardous substances (e.g. glass)?
27. What product safety devices are used to enhance consumer safety? (metal detectors,
sifters, filters, screens, thermometers, de-boners)
G. Packaging
28. Does the method of packaging affects the multiplication of microbial pathogens
and/or the formation of toxins?
29. Is the package clearly labelled “Keep refrigerated” if this is required for safety?
30. Does the package include instructions for the safe handling and preparation of the
food by the end user?
31. Is the packaging material resistant to damage thereby preventing the entrance of
microbial contamination?
32. Does each package and case contain the proper label and code?
H. Sanitation
33. Can sanitation impact upon the safety of the food that is being processed?
34. Can the facility and equipment be cleaned and sanitised to permit the safe handling
of food?
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BY DR. N. CHARISIS (WHO/MZCP)
35. Is it possible to provide sanitary conditions consistently and adequately to assure safe
foods?
K. Intended use
41. Will the food be heated by the consumer?
42. Will there likely be leftovers?
L. Intended consumer
43. Is the food intended for the general public?
44. Is the food intended for consumption by a population with increased susceptibility to
illness (e.g. infants, the aged and the immunocompromised individuals)?
28The difference between CCP1 or CCPe (=elimination) ,CCPp (=prevention) , CCPr (=reduction) does no longer exist.
29Step in HACCP is a point, procedure, operation or stage in the food chain, including raw materials, from
primary production to final consumption.
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BY DR. N. CHARISIS (WHO/MZCP)
16.9. MONITORING
Monitoring should aim to detect any deviation from the established criteria. It
usually depends on observations as well as physical or chemical measurements (e.g.
temperature, pH, concentration of salt).
Monitoring is an essential element of “controlling hazards” and it has to be carried out by
the operator who is in charge of the control measure at the specific CCP.
In other words monitoring means the regular measuring and recording of values at
predetermined intervals. These values are the parameters used to assure that a situation is
under control. As a consequence the hazard is reduced to a level where no unacceptable
growth occurs and therefore, every contamination is prevented.
Monitoring of critical control points is essential to ensure that specific criteria are being
met. Foods can be monitored in many ways depending on the type of control point and
the instruments and equipment available.
In order to monitor, we need to set critical limits and determine the methods that can be
used to check whether a CCP is under control. When critical limits are exceeded, then
corrective actions have to be taken; these actions must be described in the HACCP plan.
Through the monitoring system the team establishes the method or the equipment to be
used in this CCP, the intervals or the frequency of checking, and finally the interpretation
of the results and the actions to be taken.
Normally, the milk is heated at 73°C for 15 seconds. This temperature treatment assures
that levels of pathogens such as Mycobacterium bovis, Salmonella, Listeria monocytogenes and
Campylobacter are reduced sufficiently to guarantee that the product is safe. When the
temperature drops a few tenths of a degree, the number of microorganisms will still be
reduced sufficiently; there is a safety margin. But at a certain point, the deviation
becomes too large and safety is not assured. This unacceptable deviation determines the
critical limit. Milk produced with a temperature lower than the critical limit should not
reach the consumer.
This is an easy example because it deals with thermal treatments of known bacteria in an
easy-to-control situation. Many other situations are less easy to control (for instance re-
contamination) and determining a deviation from "normality" is much more difficult.
16.13. DEVIATION
A deviation is a failure to meet a critical limit. According to the Codex Alimentarius
terminology, deviation means a loss of control. For the purposes of this book however,
the word deviation will be used for any situation, which is not "normal".
The last question to be asked for each CCP and each hazard is “what the appropriate
reaction to a deviation should be”? This will help to define corrective actions.
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.
Various corrective actions may be necessary. There is still some ambiguity in the use of
the terminology “corrective actions”, but the final result should be that safe products reach
the consumer.
Ideally, corrective actions should readjust deviations before they become unacceptable.
They should ensure that the product produced during a situation that is out of control
does not reach the consumer, and they should also prevent reoccurrence of the event.
This may mean that the process has to be redesigned, or that a monitoring frequency
method or a target level has to be changed; in other words, the HACCP plan should be
improved.
The above sheets list all CCPs and their associated hazards, the control measures,
the parameters assuring the control, the critical limits and target values which need to be
monitored, as well as the monitoring procedures and the corrective actions. Therefore it
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BY DR. N. CHARISIS (WHO/MZCP)
gives auditors and inspectors a quick insight into the decisions made during the HACCP
study.
In order to collect objective evidence, Auditors should proceed in the examination of
records maintained by the company. The information achieved will be useful for the
auditor to determine if the HACCP system is being implemented as described and is
effective on a continuous basis.
In a HACCP plan we should establish a record30 keeping and documentation
concerning:
Minutes of HACCP study meetings, (decisions made and their reasons)
Records of monitoring
Records of verification
Records of deviations and corrective actions
Records of modifications to the HACCP plan
In other words, issuing a HACCP plan (documenting the analysis of risks, defining control
points and relevant control methods, etc) is not enough; a description of the firm’s organisation
and its basic “working rules” connected to the production process control is also necessary.
The structure of system documentation must be chosen on a “case by case” basis,
according to the firm’s real needs. Main criteria used are:
45. Company Complexity and Number of Products: The HACCP Control System must
suit the firm’s dimensions and guarantee its effectiveness in all cases. System’s
documentation needed for a small firm producing only one type of product will be
minimal, while, for a large industrial Company, documentation will be more complete
and detailed for the various products/process.
46. Existence of the quality system: A quality system developed according to ISO 9000
standards includes a complete documentation, structured on 4 levels:
a) Quality system manual,
b) Operational procedures,
c) Work instructions,
d) Worksheets for quality records.
Such documentation already covers some elements of the HACCP Control
System. Therefore the problem is to integrate the HACCP control System into
the Quality System. This applies especially to medium and large firms wanting
to develop a complete Quality System according to ISO 9000 Standards and
wanting to integrate the HACCP Control System into this Quality System.
30 Records are operative sheets regarding: Incoming materials (raw material, ingredients), Process parameters
(temperature, time), Finished product, Cleaning and sanitising, Pest control, Employee Training as well as
Other record-keeping document such as microbiological/chemical test results, calibration certificate,
complaints documents, finished products rejected, hours for equipment maintenance and results of
internal/external audits
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BY DR. N. CHARISIS (WHO/MZCP)
SECTION 4 --
WORKSHEETS
17.3. PREREQUISITES
Prerequisites are the practices and conditions needed prior to and during the
implementation of HACCP, which are essential for food safety, as described in the Codex
Alimentarious Commission’s General Principles of Food Hygiene and other Codes of
Practices.
Safe food was already produced a long time before HACCP was developed. If
food caused a case or an outbreak of foodborne illness, the causative factors were
analysed and practices put in place to prevent re-occurrence. The practices thus
developed were called Good Manufacturing Practices (GMP) as was previously
explained. Many activities are carried out in the production and preparation of food to
prevent foodborne diseases. Examples are pest control, preventive maintenance, training
of the personnel, etc. All these activities are described in general terms in the Codex
Alimentarius document on the Principles of Food Hygiene.
HACCP assures that GHPs are indeed carried out, anticipates potential problems
and tries to prevent or control them. However application of HACCP alone is not
enough to ensure food safety problems; prerequisites should be in place as well. These
prerequisites may be:
a. Premises (including the structure of the organisation and its description, the
sanitation programme, the pest and insect control programmes implied together with the
maintenance of the buildings),
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BY DR. N. CHARISIS (WHO/MZCP)
In the following table we can see most of the benefits deriving from the
implementation of a HACCP system to processors and inspectors as well as the only
field of disagreements (in red letters).
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BY DR. N. CHARISIS (WHO/MZCP)
Table 16.: Cost and Benefit analysis of a HACCP system for processors and
inspectors.
Food Processors Food Inspectors
Internal advantages
- continuous, problem solving process - identification of the food establishment
as the final party responsible for ensuring the safety
of the food it produces.
- increased productivity - focalisation of the efforts on the more critical phases.
(lower waste, better resources efficiency)
- procedure formalisation - ability to face the increasing need to assure the food
safety for human consumption.
- all human resources involvement in the common -more comprehensive determination of establishment’s
final target (food safety); level of compliance.
Using conventional inspection techniques, the
official Authority can determine conditions during
the time of inspection, which provide a “snapshot” of
conditions at the moment of the inspection.
However, by adopting a HACCP approach, both
current and past conditions can be determined.
When regulatory Authorities review HACCP
records, they have, in fact, a look back through time.
Therefore, the regulatory Authorities can better
ensure that processes are under control.
- continuous self-inspection
External advantages
- customer claims reduction
- product trustiness in the market (competitive
advantage)
- ability for the food processors to prove food safety in
official audits
Costs
- manual development
- human resources training
- new equipment
- system management
- expertise
Problems
- limited final resources
- limited human resources availability
- disagreement between internal HACCP responsible person and official Authorities with regards to number and
nature of CCPs to be managed (every CCP increases the cost of production).
Schedule
It depends on: Food plant size
Quality system existence
GMP Manual existence
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BY DR. N. CHARISIS (WHO/MZCP)
Whenever a change occurs, a new hazard analysis has to be carried out, because a
change might induce a new hazard. Clearly the results of this hazard analysis as well as
the effectiveness of new control measures (if any) have to be validated. So Validation in
this case is part of the maintenance of the system.
17.6.2. Verification
Obviously, it is necessary to obtain evidence that the HACCP system is really
working. For this purpose, verification procedures have to be established. Verification is
the application of methods, procedures, tests and other evaluations in addition to
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BY DR. N. CHARISIS (WHO/MZCP)
B. Records
- of the observations and measurements,
- results of the verification activities,
32 94/356/EC: The Commission Decision of 20 May 1994 is laying down detailed rules for the application of
Council Directive 91/493/EEC, as regards to its own health checks on fishery products (Text with EEA
relevance), Official journal NO. L 156 , 23/06/1994 P. 0050 – 0057, Article 1
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- reports and written accounts of decisions relating to corrective action taken in the past
18. AUDIT
18.1.1. The Audit and it’s role
Audit is a systematic and functionally independent examination in order to
determine whether activities and related results comply with planned objectives (Codex
Alimnentarius1997).
The term “Audit” is used for a variety of activities. Normally, independent auditors
perform an audit which involves an in-depth examination of the production site and of
how the HACCP plan was established and implemented. This definition is given because
the word audit is frequently used in the context of verification or regulatory assessment.
33 The word “conformity” is used in reference to industrial activities; the word “confirmation” refers to a
regulatory situation.
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BY DR. N. CHARISIS (WHO/MZCP)
The business management and the competent authorities are responsible, each for his
own competence, to guarantee the efficacy and efficiency of the check system
implemented.
Specifically the role of the industry is to develop, implement and maintain prerequisite
programmes and HACCP plans, to maintain the necessary records and ensure an
appropriate training programme for the staff.
On the other hand the competent authorities should verify the compliance34 with
planned measures and their efficiency to assure the safety of food. By doing so, the audit
target is to evaluate the effectiveness of the measures described in HACCP plans and
their efficiency to achieve the objective.
An official reference about a regulatory system audit that explains in details, how to
develop own-checks system verification does not exist. The European Union has not
elaborated any procedures for “Auditory field activities” and has not defined any tools to
gather and record information during an own checks system verification.
34 In definitions both of conformity and compliance, it is mentioned that they refer not only to HACCP, but
also to its prerequisites. Foods in international trade have to be produced according to General Principles of
Hygiene and HACCP. Even for foods, which are intended for domestic use, GHP should be the basis;
HACCP is complementary to the system, but cannot stand-alone. For this reason the word “prerequisites” has
been introduced.
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18.1.4. Auditor35
An auditor generally should be a person with abilities and deep knowledge on the
subject. It is important that he will be able to show tact and ability to put Auditees at
ease. He should also be a good listener and aware questioner. From the technical point of
view he should have a suitable technical background to really understand the process
being audited and of course some knowledge of quality management.
The above specifications rarely come together in one person. Therefore it’s
necessary a - on job - training together with a specific training course in order to achieve
the necessary familiarity with the audit system.
The best HACCP plan in the world will not work if the people who implement it
are not properly trained. Training is very important for people responsible for the
development of the HACCP plan, as well as people who have to assess its
implementation and maintenance.
documentation to facilitate the auditor’s work and to document and record all results
must include:
Check list36 to evaluate HACCP system elements and elaborate a specific
segment of the system;
forms to record all findings collected;
forms to document the objective evidence in order to support the auditors
final conclusion
36 Checklist is a tool commonly used for its peculiar characteristics. It permits to standardise the audit procedure,
Record review
All monitoring activities (deviations and the resulting corrective actions) are
recorded and signed by the person doing the monitoring on a timely basis. They are up-
to-date and complete for this CCP. Records show that the monitoring procedures are
carried out as described in the written programme and that they are effective.
18.1.10. Results
The data provided by audit, need to be analysed in order to discover trends and
confirm improvements, to highlight difficulties in the application of procedures or in
particular activities or step of the process, and finally to give right information on what
types of corrective actions have being carried out and how long corrective actions take to
be implemented
In relation to the types and number of non-conformities it is possible to point out
the need for a more frequent or specific training of employees (on technical aspects or
on food hygiene principles).
It is always necessary evaluating the impact of non-conformities on consumer
health in order to decide immediate corrective actions.
Subjects
The subjects of a regulatory audit are numerous including every part of the plant
where a Critical Control Point can be established. In general we can classify these
subjects under 4 major categories, human, machinery, premises and used material. In
particular the regulatory audit is dealing with:
Premises (working areas, storehouses, storage areas, bathrooms etc);
Offices, Plant surrounding, Means of Transport, Machinery and Equipment;
Raw Materials, Ingredients, Technological aids;
Semi-finished products;
Finished products;
Materials and articles intended to come in contact with foodstuffs;
Cleaning and maintenance products and processes (pesticides/detergents);
Processes used for the manufacture or processing of foodstuffs.
Therefore the aim of competent authority is to verify the compliance with planned
measures and their efficiency to assure the safety of food. By doing so, the audit target is
to evaluate the effective implementation of the measures described in HACCP plans and
their efficiency to achieve the objective.
Actual situation
An official reference about a regulatory system audit that explains, in details, how
to develop own-checks system verification does not exist. The European Union has not
elaborated any procedures for “field activities” and has not defined any tools to gather and
record information during own-checks system verification. For these reasons, ISO model
is still a point of reference within the European Union
Therefore HACCP is an
instrument that allows to obtain
the hygienic aspects of food
HACCP quality.
GOOD MANUFACTURING
GMP/GHP PRACTICES
HYGIENIC PRACTICES
and GOOD
PREREQUISITES
Premises (Structure and organization
description, Sanitation program, Pest
PREREQUISITES control program, Maintenance).
Equipment and tools (Equipment
description, Sanitation program,
Maintenance)
Production process (Raw material
supply, Storage, Producing and
Distribution process, Waste disposal,
Water supply).
Personnel (Personnel hygiene and
Training)
problems), identify the products’ intended use, construct a flow diagram specific for each
processing step, list all potential hazards, conduct a hazard analysis (determining how and
where hazards can be controlled or presented), consider control measures, lay down the means
for the provision of resources, equipment, etc., describe what to do for the training of
the personnel, and finally, be responsible for the proper implementation, verification and
improvement – in other words - be responsible for the follow-up of the whole plan.
It is considered very important at this point that the team should succeed in the
commitment of the management and shall issue documents (fill-out forms) specific for
each step of the food processing chain. These forms or records should be easy for the
personnel to understand and to complete in a given time (daily or weekly depending on the
case), because this is the only way to follow-up the success of the HACCP system
implementation in the plan.
might have an influence on the safety of the product. Then the team lists the hazards
associated with each step, conducts a Hazard Analysis and considers any measures to
control identified hazards.
19.1.5. Duty and responsibilities of the co-ordinator, the technical secretary and of
the management
The team co-ordinator should assure that the team composition fits the study
needs. He/she should also assure that the working plan is correctly realised, divide work
and responsibilities, ensure that the study goal is reached, chair the team meeting, resolve
possible conflicts between group members, assure communication of defined decisions,
and act as a link between team and management.
The technical secretary should organise meetings and record the decisions defined during
the meetings.
The management should provide the resources necessary for the study; in particular
should provide time for the meetings, money for training, documents essential for the
working group, admittance to the labs as well as admittance to all information sources.
1st Example – HACCP plan of refrigerated meats in an enterprise, which has
implemented regulations of ISO 9000 series.
Responsible of quality assurance (co-ordinator)
HACCP responsible (technical secretary)
Responsible of meat division
Expert veterinarian (external expertise)
Expert on quality system (external expertise)
Official authority
2nd Example – HACCP plan of cheese in a small and/or less developed dairy.
Owner
Expert veterinarian (external expertise – co-ordinator)
Expert on quality system (external expertise)
Official authority
Table 18.: Product Description Form for Mechanically Separated Meat (Chicken)
1. Product Name(s) 1. Mechanically Separated Meat (Chicken)
2. Mechanically Separated Meat Cured Chicken Meat
2. Important Product Characteristics Fresh (pH 6-7)
(aw, pH, Salt, preservatives,..) Frozen
Sodium Nitrite 100 to 200 pmm (cured)
3. How it is to be used For further processing
4. Packaging Wax-lined cartons
5. Shelf Life Frozen – 1 year at –180 C (in house guideline)
Fresh - “X” hours at close to 00 C
Cured – “Y” days at close to 00 C
6. Where it will be sold Registered and non-registered plants for further processing.
7. Labelling Instructions Keep Frozen/Refrigerated
Ingredient –Sodium Nitrite (in cured)
8. Special Distribution If shipped Fresh, temperature close to 00 C
If shipped Frozen, -180 C
Shipped in refrigerated vehicle at a temperature to maintain fresh or frozen
requirements.
Table 19.: List of Product Ingredients and Incoming Materials for Mechanically
Separated
Meat (Chicken)
bacteria, such as Salmonella, contamination of the raw material (i.e. meat) at the
agricultural level cannot be prevented. Thus if the processing does not include any killing
step, the only CCP which can render the product safe is the adequate heat treatment
during preparation.
INSPECTION:
This symbol represents an inspection or decision. Material is
examined for identification or is verified.
DELAY:
D This symbol represents a delay to material when conditions do not
permit the immediate performance of the next planned step. This
does not include any planned change to its physical or chemical
characteristics.
STORAGE:
A storage where material is kept in an unchanged form and
protected against unauthorised removal.
TRANSPORT:
A transportation occurs when a material is moved from one place
to another, except when such movements are part of an operation,
or are caused by an operator at a workstation during an operation
or inspection.
COMBINED ACTIVITY:
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BY DR. N. CHARISIS (WHO/MZCP)
Example of a flow Diagram for the production of Frozen Cooked Beef Patties
Receiving beef
Grinding
Mixing
Distributing Reheating
Serving
The likely occurrence of hazards and the severity of their adverse effects.
The qualitative and quantitative evaluation of hazards
The survival or multiplication of microorganisms in concern
The production or persistence in foods with toxins, chemicals or physical
agents
The quality of raw material
The conditions leading to the above and identification of control measures.
Hazard analysis is a key element in developing a HACCP plan. It is essential that
this process be conducted in an appropriate manner, as application of subsequent
principles involves tasks, which utilize the results of the hazard analysis. Thus, hazard
analysis represents the foundation for building a HACCP plan.
To exemplify the term “hazards and conditions leading to their presence”, the
enterotoxin of Staphylococcus aureus is an example of a hazard, whereas “a condition leading to
the presence of this hazard” would be the exposure during production or storage of a product
to reach a temperature at which Staphylococcus can grow and produce enterotoxins.
For simplicity, the hazard analysis procedure is divided into the following activities41:
1. Review incoming material for potential hazards
2. Evaluate processing operations for hazards
3. Observe actual operating practices
4. Take measurements
5. Analyse the measurements
A decision tree* included in the Codex Alimentarius, Hazard Analysis and Critical
Control Point (HACCP) System and Guidelines for its Application.
YES NO
Is the step specifically designed to eliminate or Is control at this step necessary for safety?
reduce the likely occurrence of a hazard to an acceptable level?
YES NO
NO YES
YES NO Stop
42 Risk Analysis is a process consisting of 3 components : Risk Assessment, Risk Management and Risk
Communication.
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BY DR. N. CHARISIS (WHO/MZCP)
Another example; The critical limit for acidification in order to control bacterial
pathogens is 4.6 (e.g. to control C. botulinum). Therefore the operator should be alarmed
and take over when the acidification level increases over the pH 4.3).
Table 20.: Examples of critical limits in the field43
does have a role in HACCP verification. When critical limits are established for the
elimination of pathogens or their reduction to an acceptable level, microbiological testing
can be used to verify the HACCP plan’s effectiveness and to ensure that the identified
microbiological limits have not been exceeded. In this instance, the length of time
involved in the analytical procedures does not create operational difficulties44.
Target values are used in monitoring. Even if the value is slightly higher or lower
than the target value, it is still acceptable as long as it remains within the critical limits;
otherwise, the product is considered unacceptable and cannot be released.
Monitoring procedures need to be rapid, as they relate to on line processes, which
in general do not leave time for lengthy analytical testing. For this reason, physical and
chemical measurements (temperature, time, pH, moisture level and water activity) or visual
observations, which may be done rapidly, are often preferred to microbial testing.
The purposes of monitoring include the following:
54. To measure the performance level of the operation at the CCP (trend analysis)
55. To determine when the performance level of the system results in a loss of control at
the CCP (e.g. when there is deviation from a critical limit); and
56. To establish records reflecting the performance level of the system’s operation.
Accurate monitoring procedures and associated records provide information to the
operator and allow for decisions to be made on the acceptability of the lot at a particular
stage in the process. For the monitoring procedures it is essential that all monitoring
equipment is always properly calibrated for accuracy.
Responsibilities for monitoring should be clearly defined, and individuals must be
adequately trained in the monitoring procedures for the CCP for which they are
responsible.
The monitoring specifications for each CCP should be written on the proper form.
They should give information on:
57. What will be monitored (i.e. measurement of the cold-storage temperature, of the pH, of the Aw
etc)
58. How critical limits and preventive measures will be monitored (i.e. physical or chemical
measurements instead of microbiological testing)
59. Who will monitor (individuals assigned to monitor CCP’s may include line personnel, equipment
operators, supervisors, maintenance personnel and quality assurance personnel).
Any corrective measures undertaken with regard to a specific step should be easily
understood and – of course - implemented by the employee performing the activities.
Any corrective action taken should be documented and communicated to management
in order for the system to be modified, if necessary, and reoccurrence of the problem
prevented. The diversity of possible deviations at each CCP means that more than one
corrective action may be necessary at each CCP. When a deviation occurs, it will most
likely be noticed during the routine monitoring of the CCP.
The producer should control the deviations as follow:
60. He should have a specific -for each product- mechanism in place, to identify
deviations as soon as possible
61. He must be able to spot and isolate all affected products manufactured during this
deviation
62. He should cooperate with experts on different fields in order to evaluate a specific
deviation (e.g. with a microbiologist to examine and evaluate a deviation from microbiological
standards in order to detect if this deviation is a possible source of a hazard).
After the evaluation of a deviation a corrective action should be taken in order to
prevent the production of unsafe products. Corrective action procedures are necessary to
determine the cause of the problem, to prevent recurrence and to follow up with
monitoring and reassessment to ensure that the action taken is effective. The producer’s
corrective action programme should include:
(1) investigation to determine the cause of the deviation,
(2) effective measures to prevent recurrence of the deviation and
(3) verification of the effectiveness of the corrective action taken.
The operator notices the deviation and believes that the product has an
excessive bacterial contamination. He informs the supervisor according to the
deviation procedure and the suspected product is withheld and subjected to
microbial testing.
The employee responsible for equipment cleaning is questioned according to
the written procedures and is retrained if necessary.
HACCP and which are essential for food safety, as described in the Codex General Principles of Food Hygiene
and other Codes of Practice.
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BY DR. N. CHARISIS (WHO/MZCP)
which are intended for domestic use, GHP should be the basis whereas HACCP is
complementary to the system, but cannot stand-alone. For this reason the word
“prerequisites” has been introduced.
Although there is not yet international agreement on what verification should
encompass, it is universally accepted as “checking for the implementation and effectiveness of the
HACCP system”. Therefore it is carried out to determine if the HACCP system is working
correctly and eventually to highlight deficiencies that should be rectified. Verification
may also be initiated for other reasons, e.g. changes in the process with potential safety
consequences.
Verification may –and– should also be performed by someone other than the
person who is responsible for performing the activities specified in the plan. According
to the abovementioned definitions for Verification, we can say that it may be conducted
by:
Business personnel,
External personnel,
Governmental organizations,
Inspection services,
Private organizations,
Quality control laboratories,
Trade associations,
Consumer associations,
Buyers,
Importing country authority
HACCP team.
The verification may be done:
(a) After each HACCP plan elaboration,
(b) As part of a continuous revision, established by the program in order to
demonstrate that the HACCP plan is efficient,
(c) When there is any change that affects hazard analysis or changes HACCP in any
way.
Accordingly it can be applied in each step of the HACCP plan, in the HACCP plan of
each product (including each step) and when there is any change in the process or
materials used, affecting hazard analysis.
Verification comprises of “checking system conformity” and “confirmation of effectiveness”49 of the
system.
expected.
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BY DR. N. CHARISIS (WHO/MZCP)
20.6.2. Review
Review means a retrospective view or survey of past events, experiences etc. A
review should show whether unacceptable deviations were followed up and/or whether
CCPs were kept under control. The review of consumer complaints can demonstrate that
deviations were not detected, and thus that things have to be changed: the system did not
deliver what was expected. If the review shows that CCPs were not always monitored as
foreseen, or that instruments used for monitoring were not accurate, the system or its
implementation has to be improved.
End product testing may provide some evidence that the plan was effective, and
that objectives were achieved, but especially as regards to the control of pathogens it is a
poor verification tool.
65. Documentation of methods and procedures used. They clearly relate to the safety of
the product and therefore they should be maintained for possible auditing by the
regulatory authorities.
66. Records of employee training programs (employees are trained to understand the appropriate
procedures/methods and actions in order to intervene when critical control limits are threatened).
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BY DR. N. CHARISIS (WHO/MZCP)
Verification is one of the seven principles of HACCP, that’s why it’s associated activities
are established during the HACCP study.
Validation(see bellow), on the other hand is mentioned in the Codex Alimentarius guidelines
on the application of the seven HACCP principles, but the Codex does not describe how
to do it. \
knowledge of and experience with HACCP and its application; knowledge and
experience in assessing prerequisites to HACCP; ability to assess the effectiveness of
methodologies for controlling hazards and of HACCP plan verification; knowledge of
auditing methodologies; of relevant industrial codes of practice; legal requirements;
guidelines and standards and finally recognized qualifications in food science or
equivalent disciplines desirable for the assessor or the assessing team.
23. CONCLUSIONS
The HACCP system is an effective tool for a food safety assurance. Its application
for the prevention of foodborne diseases is of tremendous value, and in international
food trade its application has become indispensable. Progress in its implementation
varies from country to country and depends on the commitment and recognition of
policy makers as well as their funds, which are made available for the specific purpose. In
developing countries, lack of expertise and resources for training are two major
weaknesses to progress in its implementation, and most of the progress made has been
with regard to food for international trade. Paradoxically these countries are those, which
have the greatest need for this system, because of the high prevalence of foodborne
diseases and lack of sources to meet the high costs of traditional approaches. HACCP is
evolving. World-wide the interest in the application of HACCP in the food industry is
growing, and regulatory agencies are being adapted to make their inspection systems
compatible with the industry based on the HACCP system. Both progress and problems
encountered in the implementation of the HACCP system must be monitored on a
regular basis, and guidance on this subject should be updated.
It is very important for the governments to develop an implementation strategy,
which reflects the needs of the country, and which is time and resources-realistic. Before
the implementation, there should be enough time to allow opportunities for training of
the people to be involved (in private and government sector). It is expected that in the
initial stages, the implementation of the HACCP system would require enormous
resources in terms of qualified personnel, technical support facilities and financial inputs,
particularly to ensure the necessary training.
Training in HACCP for food inspectors and personnel in food businesses will be a
key to its successful implementation, provided that the training is standardised so that a
common understanding is developed between food businesses and food inspectors.
Therefore both the private sector and the government should contribute to mobilising
the necessary resources for the appropriate training and all other requirements that can
set the start point for the implementation of a HACCP system in a specific country.
It seems that, at the moment, the whole of the Meat Industry, is changing to a
customer and market oriented production and distribution system, in which quality is
prevailing over quantity. For a more efficient and effective management system, to this
end, application of Total Quality Management (TQM), and quality assurance certified
systems (ISO 9000 Standards, HACCP, Integrated Quality Control) are vehicles for
transparently projecting the level of safety and quality of meat and meat products the
industry is supplying to the consumer. It is hoped that this is, also, a way to restore the
industry’s credibility, after suffering the consequences of last year’s food safety crisis.
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BY DR. N. CHARISIS (WHO/MZCP)
24. EXPERIENCES
The HACCP system has been proven as a powerful tool in identifying and
assessing hazards in food as well as establishing necessary central measures
(FAO/WHO). Moreover it can lay the foundations for the application of improved food
born surveillance programmes (WHO Document WHO/FSF/FOS/97.3), although at
the moment, the existing comparative statistical studies are not sufficient to demonstrate
this improvement through surveillance programmes.
However, where epidemiological surveillance of foodborne diseases is weak, application
of the HACCP, to food processing and food preparation can be an effective alternative
and/or complementary measure, for the identification of faulty or high-risk practices.
In any case, apart from the recommendation of international organisations, the regulating
authorities or the governments are feeling confident enough to promote the HACCP
system, as a mandatory programme to be applied by the food industry, for assuring food
safety for their products. Leading among these governments is the European Union and
the United States of America.
The “Codex Committee on Food Hygiene”50, in 1963, prescribed codexes of GHPs instead of
end-product microbiological standards.
It was against this background that later (1993) CAC adopted, through the same
Committee the “Guidelines for the Application of Hazard Analysis Critical Control Point
(HACCP)’’, recognising the validity of applying preventive approaches for securing food
safety, rather than relying on end-product control (CAC, Basic Texts on Food Hygiene). The
revised, “Recommended International Code of Practice – General Principles of Food
Hygiene’’ [CAC/RCP 1-1969, Rev. 3 (1997)], were adopted by CAC in 1997.
In the E.U., Directive 93/43/EEC originally established that HACCP application
should be mandatory for all food industry in the Union. Further to it, and in view of the
recent food emergencies in Europe(BSE, dioxins), the E.U.Commission published a White
Paper on Food Safety, which eventually, and in a relatively short period of time, had lead
to the creation of a “European Union Central Agency for Food”. In this respect, and
among others, the concepts of HACCP application and the integrated approach to food
safety “from stable to table’’ were adopted. The HACCP system was proposed also for feed
manufacturing and Good Hygiene Practices were applied to all activities involved in food
production from the field to the consumer’s table. Now Regulations51, are rather
proposed in the E. Union instead of Directives, going to a detailed description for the
HACCP application and certification in the primary production, while HACCP system is
required for activities starting from slaughtering down to the selling points.
In the USA, HACCP application is also required in the food industry. In 1995,
FDA established HACCP for the seafood industry and incorporated it in its Food Code,
which is a general regulation, guiding and serving as model legislation for state and
territorial agencies, for food services establishments, retail food stores and vending
operations. In 1998, FDA proposed requiring HACCP controls for fruit and vegetable
juices, and now is considering expanding through the rest of food industry, including
domestic and imported food products. The USDA has established HACCP for meat and
poultry processing plants requiring compliance by January 1999 and for the very small
plants by January 25, 2000.
In conclusion, one could observe that, at the moment, the use of the HACCP
system for food safety is expanding to new areas. It is almost universally accepted as the
method of our and future times. Preliminary experiences are that, it is highly effective, if
properly used and its application is based on certain preconditions, referring to the
facility, construction and functionality, and more specifically in relation to good hygiene
practices application. Nevertheless, it will take some time, before we will be able to fully
assess the impact that HACCP will have, particularly in the long range, on food safety at
the World level.
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BY DR. N. CHARISIS (WHO/MZCP)
25. GLOSSARY
This glossary provides a list of definitions of terms used in this report as well as
additional definitions found in other relevant reports, dictionaries or the international
bibliography.
Acceptable level Is a criterion whose probability to cause an unacceptable risk for human health is not
relevant.
Acceptance No deficiencies that can lead to a loss of food safety control have been identified.
Accreditation This is the procedure by which a governmental agency having jurisdiction formally
recognises the competence of an inspection and/or certification services.
Audit Is a tool through which the operations of the HACCP system are formally monitored
and conformance with the documented system is assured.
Findings: A statement of fact made during an audit and substantiated by objective
evidence
Objective evidence: Factual and verifiable information describing an audit finding.
Non conformity: A failure to meet specified requirements
Best-before-date: Is the date recommended for best flavour or quality. It is not a purchase or safety date.
Certification Procedure by which official certification bodies or officially recognised bodies provide
written or equivalent assurance that foods or food control systems conform to
requirements.
Checklist A list that contains points/elements that may be considered during assessment. It is used
as an aide-memoir to promote uniformity in assessment.
Cleaning Is the removal of soil, food, residue, dirt grease or other objectionable matter.
Compliance Compliance means that the HACCP plan and prerequisites and their implementation
meet regulatory requirements.
Conformity Conformity means that the industrial activities are carried out according to the
established procedures, e.g. HACCP plan and prerequisites.
Contaminant Any biological or chemical agent, foreign matter, or other substances not intentionally
added to food, which may compromise food safety or suitability.
Contamination The introduction or occurrence of a contaminant in food or food environment.
Control (noun) The state wherein correct procedures are being followed and criteria are being met.
Control (or preventive) Any action and activity that can be used to prevent or eliminate a food safety hazard or
Measure reduce it to an acceptable level.
Control (verb) To take all necessary actions to ensure and maintain compliance with criteria established
in the HACCP plan
Control point A point in a specific food system at which loss of control does not produce an
unacceptable health risk.
Correction Refers to, rework or adjustment in the report
Corrective action Any action to be taken when the results of monitoring at the CCP indicate a loss of
control.
Critical Control Point (CCP) A point at which control can be applied and is essential to prevent or eliminate a food
safety hazard or reduce it to an acceptable level.
Critical limit A criterion, which separates acceptability from unacceptability.
or
The maximum or minimum value to which a physical, biological or chemical parameter
must be controlled at a CCP to minimise the risk that the identified food safety hazard
may occur.
Deviation Failure to meet a critical limit.
Disinfection The reduction by means of chemical agents and/or physical methods, of the numbers of
microorganisms in the environment, to a level that does not compromise food safety or
suitability.
Disposition of Any action to be taken to eliminate the negative effects without removing the causes.
nonconformity
Establishment Any building or area in which food is handled and the surroundings are under control of
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BY DR. N. CHARISIS (WHO/MZCP)
Sell-by-date: Tells the store how long to display the product for sale.
Severity The degree of seriousness of the adverse health effects of a specific hazard.
Step Is a point, procedure, operation or stage in the food chain including raw materials, from
primary production to final consumption.
System A group of elements (parts or components) joined by interdependent relations.
Third party auditor An independent auditor be it a person or an Organization with competence to assess
HACCP.
Validation Obtaining evidence that the elements of the HACCP plan are effective.
It is the responsibility of the industry and should be undertaken initially and as needed
thereafter.
Verification The application of methods, procedures, tests and other evaluations, in addition to
monitoring to determine compliance with the HACCP system This is primarily an
industry responsibility however some verification activities can also be undertaken
during regulatory assessments.
Wholesome food Wholesome food shall mean food, which is fit for human consumption as far as hygiene
is concerned.
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BY DR. N. CHARISIS (WHO/MZCP)
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From F. L. Bryan (1992). Hazard Analysis Critical Control Point Evaluations. A Guide to Identifying Hazards and
52
Assessing Risks Associated with Food Preparation and Storage. World Health Organization, Geneva
103
BY DR. N. CHARISIS (WHO/MZCP)
From F. L. Bryan (1992). Hazard Analysis Critical Control Point Evaluations. A Guide to Identifying Hazards and
53
Assessing Risks Associated with Food Preparation and Storage. World Health Organization, Geneva
104
BY DR. N. CHARISIS (WHO/MZCP)
of cooked product
Air-chilling Measure size of product and time-temperature exposure
Water chilling Measure residual and free chlorine levels and pH of water
Canning/retorting Vegetables, Retorting Observe operation of retorts; measure temperature after exhausting,
meat, fish observe filling of cans, determine whether size of can and type of
product appropriate for process, record time – temperature
distribution and pressure; measure product pH; observe can-
handling equipment
Cooling Measure residual and free chlorine levels and pH of water
Fruits (high Heat-processing Observe operation of retorts; record time temperature exposure and
acid) pressure; measure product temperature after exhausting; observe
filling practices; observe can-handling equipment.
Cooling Measure residual and free chlorine levels and pH of water.
Canning/retorting Luncheon Heat processing Observe operation of retorts, water baths or ovens; measure time-
of products meats temperature exposure and pressure;
containing added
salt and nitrite
Formulation Check pH, aw, concentration of NaCl or NaNO2 (as appropriate)
Cooling Measure residual and free chlorine levels and pH of water; observe
cans for damage during cooling and drying.
Drying Milk/eggs Pre-heating and Measure time-temperature exposure; observe indicator thermometer
pasteurisation and recording charts; evaluate function of flow diversion valves;
collect samples and test for phosphatase
Environment Collect samples from air filters, sweepings, dust collectors, tailings
and test for salmonellae.
Packaging Check integrity of package
Holding of final Collect samples and test for salmonellae, measure aw
product
A HACCP Checklist54
HACCP Checklist
Principle
Preparation What evidence is there of management commitment to HACCP use?
HACCP Team
-Who was on the team?
- Are all appropriate disciplines represented?
- What is the likely knowledge level of the individuals? (Evidence of training, qualifications, experience
etc.)
- Has external expertise been sought where necessary?
- What is the decision-making leverage of the HACCP team leader?
HACCP System
- How does the system fit with the overall food safety control programme?
- Does the company have a food safety policy?
- Has the scope been clearly defined?
- How is the system structured?
From F. L. Bryan (1992). Hazard Analysis Critical Control Point Evaluations. A Guide to Identifying Hazards and
54
Assessing Risks Associated with Food Preparation and Storage. World Health Organization, Geneva
107
BY DR. N. CHARISIS (WHO/MZCP)
- Have changes been made since the PFD was drawn up?
- How does the HACCP Team get notified of changes to the process or product parameters?
- How were the changes recorded and approved?
- Were any changes discussed with the HACCP Team before implementation?
Have appropriate control measures (CMs) been identified for each hazard?
- Will the CMs control the hazards and how was this validated?
- Are all the CMs in place at the plant level?
How are the hazards that are not controlled by CCPs addressed?
Are monitoring personnel and their deputies properly identified and trained?
- How was the training undertaken?
- Are the monitoring records being reviewed by designated appropriate reviewers?
Principle 5 Have the corrective actions been properly defined such that control is regained?
"Establish the - What evidence is there to demonstrate that this is being done in the event of a CCP deviation?
corrective action to be - Has corrective action been recorded and how is the effectiveness being verified?
taken when
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BY DR. N. CHARISIS (WHO/MZCP)
monitoring indicates How has the authority for corrective action been assigned?
that a particular
CCP is not under How is non-conforming product controlled and is this clearly recorded?
control"
Are there clear disposition actions listed?
How is the data from HACCP being used to improve the system?
How is consumer complaint data being used within the verification system?
DATE / /
OPERATOR…………………………………………
Conform = visible absence of dirt, of oily surfaces and of unpleasant odours.
Not conform = absence of conformity characteristics.
Mark using an ‘x’ in the proper column.
Facilities
Conform Not conform
Dining room
Kitchen
Storing rooms
Washrooms
Equipment
Conform Not conform
Mixer
Slicing machine
Mincing machine
Scales
Electric oven
Oven
Cooker
Fan
Freezer
Refrigerator
Boiler
Working surfaces/tools
Conform Not conform
Sinks
Working surfaces
Pans
Containers
Dishes and tools
Notes:……………………………………………………………………………………………………
…………………
Corrective actions:
Less than 3 non-
conformities: Cleaning and sanitising activities must be repeated on facilities, tools or piece
of equipment showing non conformity.
3 non conformities: All cleaning and sanitising activities must be repeated on all facilities, equipment
and tools before starting work.
Manager signature
55 HACCP Principles and Practice, Teacher’s handbook. A WHO/ICD Training manual in collaboration with
56 HACCP Principles and Practice, Teacher’s handbook. A WHO/ICD Training manual in collaboration with
Storage 2 Physical Store as specified, i.e. No physical, Automatic temperature Daily Hold and Warehouse
of raw contamination cream < 5°C, egg for chemical recorder. checks – inform QA Manager
material , biological specified max. time. contamination. Visually inspect label to continue Manager and
growth Keep covered Maintain temp. < ensure stock rotation during use. Operator
5°C Every batch
Bake 3 Survival of Bake sponge at Bake at 70°C for Automatic chart Continuous Stop Operator
sponge vegetative specified 2 min. minimum recorder production.
through pathogens time/temperature core temperature Reject faulty
oven product.
Adjust oven
temp./time
Metal 4 Metal Metal detector Absent – ferrous Metal detection check Every 30 Stop line, QA
detect contamination 2.0 mg, non- using test pieces. min. recalibrate, Inspector
ferrous 2.5 mg Calibrate metal detector notify QAM. Line
Hold stock Engineer
Daily manufacture
d since
previous
check
Dispatch 5 Growth of Low temperature 0-5°C Continuous chart Daily Hold, inform Warehouse
pathogens during storage and recorder– warehouse review QAM, Manager
distribution and distribution sample and Transport
vehicle. Check recorder test product Manager
calibration Monthly Warehouse
Manager
57 HACCP Principles and Practice, Teacher’s handbook. A WHO/ICD Training manual in collaboration with FAO.
58 Annex 7 and Annex 8 are adopted by HACCP: Essential Tool for Food safety. Panamerican Institute for
Food Protection Division of Disease Prevention and Control, PAHO/INPPAZ- WHO, USA 2001
113
Physical NO
Filtration of Biological NO Milk can bring physical The filter will separate YES
milk Chemical NO hazards these hazards
Physical YES
Cooling Biological YES Microbial proliferation. Control cooling time and YES
Chemical NO temperature.
Physical NO
119
Food should never be stored in the same place with other material (disinfectants,
colours, brushes, ropes etc). All storage areas with refrigerators should dispose a proper
ventilation system that can remove the vapours from the area before they overlay on the
product, especially when this product is raw on uncovered (unpackaged).
(e). Proper careful cleaning and extra disinfection of all places and equipment
in case of suspect animals, which have been slaughtered in the
establishment.
(f). Storerooms with adequate refrigeration for the maintenance of carcasses
before transportation.
(g). The construction of the slaughtering process should be made in such a
way that it permits the removal of the skin when the carcass is already
suspended from the ceiling. That means that soon after the
anaesthetisation the carcass is removed from the floor and never touches
it again.
(h). All personnel with raw meat should wear clean head covers, light
coloured uniforms and boots. They should clean their hands always after
the use of toilets in the beginning of their shift and after intermissions for
lunch or toilet. Hands should also washed properly when they come in
contact with suspect or sick animals. Ring, bracelets and hand watches
should be better removed before work and smocking should be
prohibited in working areas (including loading and unloading posts).
(i). Unauthorised personnel should not enter the premises.
(j). All food handlers should present with a health certificate before
employment.
(k). Sick food handlers should not enter the working areas.
(l). The entrance of other animals except the animals to be slaughtered in the
premises (or even backyard) of the slaughterhouse should be prohibited.
(m). The control of rodents and insects should be intensive and effective.
(n). The dispersal of sawdust or of any other material destined to keeping the
floor dry should be prohibited.
Storehouses
Raw meat should be refrigerated immediately after the slaughtering and the
subsequent inspection (in some cases the inspection takes place little after the
slaughtering). Carcasses are preserved in 70C, and viscera in 30C. A deviation is permitted
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only for transportation is butcheries no more than one hour away from the
slaughterhouse.
Meat destined to be preserved in deep freeze should be processed immediately
after slaughtering in approved establishments. The internal temperature of this meat
should be –120 C and no more.
Transportation
Tracks transporting meat should be designed to keep up a stable temperature
during travel. Their inner walls should be from a smooth material that can be easily
cleaned and disinfected without corruption. This material should not corrupt by the
contact of carcass and should not transfer poisonous or toxic substances to the meat.
They should also be water, dust, rodent and insect proof.
Carcasses or raw meat should be suspended from the sealing or the wall in a way
that they don’t touch the floor. Tracks destined to transport raw meat should not carry
living animals or any other material that can contaminate meat. Packed meat should not
be transported together with unpacked.
Viscera, heads, and limbs should not be transported with unpacked meat unless
they have been cleaned, dehaired and scalded. Loading process and transportation
vehicles are checked by the responsible veterinarian.
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SH A R E D R E SP O N SIB IL IT Y