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N. Charisis
Athens, Greece 2004

WHO/MZCC, Stournari 24, 106 82, Athens, Greece.

Tel.: +30-1-3814 703, Fax: +30-1-3814 340, e-mail:, Web-Site:

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

16.4. Biological (microorganisms and parasites), Chemical, and Physical

hazards_________________________________________________________________ 35
16.5. Factors contributing to foodborne illness _____________________________________ 38
16.6. Controlling growth of microbes – Control Measures ___________________________ 40
16.7. Questions to be considered in a Hazard Analysis ______________________________ 41
16.8. Critical Control Points (CCPs) _____________________________________________ 43
16.9. Monitoring______________________________________________________________ 44
16.10. Continuous monitoring ___________________________________________________ 44
16.11. Critical limit ____________________________________________________________ 44
16.12. Microbiological process control_____________________________________________ 45
16.13. Deviation _______________________________________________________________ 46
16.14. Corrective actions ________________________________________________________ 46
17. HACCP Plan __________________________________________________________ 47
17.1. The operational procedures of a HACCP plan ________________________________ 51
17.2. Product /process analysis __________________________________________________ 52
17.3. Prerequisites ____________________________________________________________ 52
17.4. Good Manufacturing Practices (GMP) and Sanitation Standard
Operational Procedures (SSOP) ___________________________________________ 53
17.5. Impact of HACCP on Food Processors and Food Inspectors_____________________ 54
17.6. Validation and Verification of A HACCP plan ________________________________ 56
17.6.1. Validation ___________________________________________________________________ 56
17.6.2. Verification __________________________________________________________________ 56
18. Audit_________________________________________________________________ 59
18.1.1. The Audit and it’s role__________________________________________________________ 59
18.1.2. Third part Auditing ____________________________________________________________ 59
18.1.3. Types of Audit ________________________________________________________________ 60
18.1.4. Auditor______________________________________________________________________ 61
18.1.5. Audit procedure _______________________________________________________________ 61
18.1.6. Frequency of auditing __________________________________________________________ 61
18.1.7. Audit preparation ______________________________________________________________ 62
18.1.8. Opening meeting ______________________________________________________________ 63
18.1.9. Gathering information __________________________________________________________ 63
18.1.10.Results ______________________________________________________________________ 64
18.1.11.Closing meeting_______________________________________________________________ 64
18.1.12.Audit report __________________________________________________________________ 64
18.1.13.Principal characteristics and subjects of regulatory audit (according to the
Council Directive 89/397/EEC “Official control of foodstuffs”). _________________________ 64
19. HACCP System (preliminary phases)_______________________________________ 66
19.1. Phase 1. Assemble the HACCP team ________________________________________ 67
19.1.1. HACCP Team ________________________________________________________________ 67
19.1.2. Competencies and professional figure of the TEAM___________________________________ 67
19.1.3. Team’s activities ______________________________________________________________ 67
19.1.4. Size and composition of the team _________________________________________________ 68
19.1.5. Duty and responsibilities of the co-ordinator, the technical secretary and of the
management__________________________________________________________________ 69
19.2. Phase 2. Product Description (Productive Plans) _______________________________ 69
19.2.1. Product Description Form for Raw Material/Ingredient (examples) _______________________ 69

19.2.2. Product Description Form for Restaurants __________________________________________ 71

19.2.3. Product Description Form for Self life _____________________________________________ 72
19.3. Phase 3. Intended Use_____________________________________________________ 72
19.4. Phase 4.- Development of flow diagram and plan lay-out________________________ 73
19.4.1. Flow diagram: ________________________________________________________________ 73
19.4.2. Flow diagrams (symbols) _______________________________________________________ 74
19.4.3. Flow process chart symbols______________________________________________________ 74
19.5. Phase 5. On site confirmation of Flow diagram and plant lay-out_________________ 76
20. HACCP System Principles _______________________________________________ 77
20.1. Principle 1: Conduct a Hazard analysis ______________________________________ 77
20.2. Principle 2. Determine the Critical Control Points (CCPs) ______________________ 78
20.3. Principle 3. Establish Critical and Operating Limits ___________________________ 80
20.3.1. Critical Limits ________________________________________________________________ 80
20.3.2. Operating limits _______________________________________________________________ 80
20.4. Principle 4: Establish a system to monitor control of the CCP. ___________________ 81
20.5. Principle 5. Establish the corrective actions to be taken when monitoring
indicates that a particular CCP is not under control. ___________________________ 82
20.6. Principle 6. Verification/Establish verification procedures. ______________________ 84
20.6.1. Verification activities___________________________________________________________ 85
20.6.2. Review______________________________________________________________________ 86
20.7. Principle 7. Establish documentation concerning all procedures and
records relevant to the HACCP principles and their application. _________________ 86
21. Role of Industry and Role of the Authorities _________________________________ 87
21.1. Role of industry__________________________________________________________ 87
21.2. Role of competent authority (Government) ___________________________________ 88
21.2.1. Inspection____________________________________________________________________ 88
21.2.2. Responsibilities of Governments __________________________________________________ 88
22. Regulatory Assessment (Governmental activities in assessing HACCP) ___________ 89
22.1.1. Assessing the HACCP management _______________________________________________ 90
22.1.2. Assessing the HACCP plan development ___________________________________________ 90
22.1.3. Assessing the HACCP analysis ___________________________________________________ 90
22.1.4. Assessing the effectiveness of control measures ______________________________________ 91
22.1.5. Assessing the verification procedures ______________________________________________ 91
22.1.6. Assessing the documentation_____________________________________________________ 91
22.1.7. Assessing the implementation ____________________________________________________ 91
22.1.8. Competencies of assessors_______________________________________________________ 91
22.1.9. Assessment’s evaluation ________________________________________________________ 92
23. CONCLUSIONS _______________________________________________________ 93
24. Experiences ___________________________________________________________ 94
25. GLOSSARY ___________________________________________________________ 96
26. BIBLIOGRAPHY ______________________________________________________ 99
27. FURTHER READING _________________________________________________ 100
28. ANNEX 1 - Hazards, Critical Control Points and Monitoring Procedures
for Common Food Service Operations _____________________________________ 102

29. ANNEX 2 – Common Critical Control Points and Examples on

Monitoring Procedures for Processing Operations ___________________________ 103
30. ANNEX 3 - Core HACCP Assessment Checklist _____________________________ 106
31. ANNEX 4 – Cleaning/Sanitising Verification Operative Form _________________ 109
32. ANNEX 5 – Cleaning/Disinfecting Frequency Outline________________________ 110
33. ANNEX 6 – Example of HACCP Data Sheet________________________________ 111
34. ANNEX 7 – Basic Knowledge Necessary to Food Procedures (primary
production)___________________________________________________________ 112
35. ANNEX 8 – Basic Knowledge Necessary for Food Personnel __________________ 113
36. ANNEX 9 – Practical Examples __________________________________________ 114
36.1. Hamburger ____________________________________________________________ 114
36.1.1. Flow diagram for hamburger ____________________________________________________ 114
36.1.2. Hazard Analysis Worksheet_____________________________________________________ 114
36.2. Ultrahigh Temperature (UHT) Milk________________________________________ 115
36.2.1. Flow diagram of UHT milk _____________________________________________________ 115
36.2.2. Hazard Analysis Worksheet_____________________________________________________ 115
36.3. Pasteurised Fruit Juice___________________________________________________ 116
36.3.1. Flow diagram for the pasteurised fruit juice ________________________________________ 116
36.3.2. Hazard Analysis Worksheet_____________________________________________________ 116
36.4. Row milk collection in the farm (Milking process) ____________________________ 117
36.4.1. Flow diagram for bovine milk ___________________________________________________ 117
36.4.2. Hazard Analysis Worksheet_____________________________________________________ 117
37. ANNEX 10 - Premises – The first Step in the Implementation of
HACCP/GMP ________________________________________________________ 119
38. ANNEX 11 - The concept of shared responsibility ___________________________ 125

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.



The present document was based initially, on materials presented at the
WHO/MZCP1 International Training Course on HAZARD ANALYSIS 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.


3.1.1. Historical overview
The concept of pre-HACCP is attributed to W.E. Deming, who developed in
1950s the leading theory of a Total Quality Management system (TQM). First the
Japanese tested this system with great success, thus improving greatly their products. In
between, the TQM system paved and prepared the way for the appearance of an almost
full-developed HACCP system in 1960s. But let’s see in more details, what exactly
happened at that time.
The original acronym HACCP was conceived in 1959 and developed by the
Pillsbury Company together with the National Aeronautics and Space administration

1 World Health Organization/Mediterranean Zoonoses Control Programme


(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.

Indeed, the implementation of HACCP in the developing

world cannot be expected because of lack of money.
However, food export requirements has always been a
strong motivation to introduce HACCP system

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
New Zealand HACCP system in meat
voluntary HACCP system- industries for exports to USA.
based Food Safety program
Chilly Thailand
Voluntary (more than
10 out of 200
A draft low is been prepared
HACCP system in canned food
products for exportation
POINT” was used originally throughout the industry. This was changed after a proposal
from WHO/Geneva Consultation in 1995 to: “HAZARD ANALYSIS AND
In 1997, the Codex Alimentarius Commission adopted officially the proposed term in
order to ease its translation into other languages.

3.1.2. Present status

Even though the concept of HACCP was presented in 1971 by the industry in the
United States to food inspectors, it took many years before it received world-wide

recognition and application. The following schematic figure shows the growth and
sudden increase in application of HACCP.

Graph 1.: HACCP growth curve

from 1970 - 1995





es timate
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.

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


Before we analyse the need for the implementation of a food safety system, we
probably should first define something we all - more or less – know: the HAZARDS.
According to the Codex Alimentarius Commission hazards are biological, physical, or
chemical properties that may cause a food to be unsafe for human consumption. In
accordance with the above definition and still expressed differently, the ICMSF defines
the hazard as: the unacceptable contamination of food by bacteria, or of the growth or
survival of bacteria in food that may affect food safety or quality (spoilage), or the
unacceptable production or persistence in food of substances such as toxins, enzymes or
products of microbial metabolism. This contamination or growth can lead to a critical

4 International Commission for Microbiology Specification of Food

5 National Research Council (USA)
6 To successfully implement HACCP in the food supply, authorities responsible for food safety must first be

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

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.

Today, governments, regulatory agencies, industries, and consumers are greatly

concerned for safe foods. The reasons for this are:
ƒ Foodborne diseases remain one of the most widespread public health problems.
ƒ Emerging foodborne pathogens, e.g. Listeria monocytogenes, verotoxin producing E. coli,
Campylobacter spp, foodborne trematodes, e.t.c., are in the increase.
ƒ Modern technology permits the detection of minute amounts of food contaminant,
calling thus, for a more vigilant inspection.
ƒ Industrialisation together with mass production lead to increased risks of food
contamination and to considerably larger numbers of people affected in foodborne
diseases outbreaks as a result.
ƒ Changing lifestyles demand from a vast number of people, to eat outside the home
every day in food service or catering establishments, at street food stalls, or in fast-
food restaurants.
ƒ Urbanisation leads to a longer and more complex food chain, and accordingly to
greater possibilities for food contamination.
ƒ Tourism and international trade in foodstuffs has increased.
ƒ Increased contamination of the environment.
Therefore in order to understand why HACCP is so important for the food
industry and to the safety of foods, we must keep in mind the tremendous challenges
that public health authorities face today especially in whatever concerns the emerging and
re-emerging foodborne diseases.
Public health authorities have come to realise that foodborne diseases are a much more
widespread public health problem than previously believed. Even as early as 1983 the
joint FAO/WHO reported that illness due to contaminated food was perhaps the most

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.

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(?)


Data and surveys from many industrialised countries indicate that up to 15% of the
population may be affected each year by a foodborne disease. Incidence reports indicate
that foodborne diseases are not only widespread but, despite the efforts made by the
public health authorities, they are on the increase, at least in some countries. This trend
indicates that efforts of public health authorities over the past two decades have been
ineffective in the prevention of foodborne diseases.
Table 2.: Incidence of Diarrheas in some industrialised countries
Country Percentage Source
Sweden (1995) 7% National survey
Netherlands (1991) 15% Sentinel study
New Zealand (1993) 9% National survey
UK (1995) 7% National survey
Canada (1985) 8% Estimation
USA (1985) 10% Estimation

Graph 2.: Incidence of Salmonellosis in some European countries

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
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

Table 3.: Reported cases of Listeriosis in some European countries

COUNTRY 1993 1994 1995 1996 1997 1998

Belgium 36 32 38 50 45 42
Bulgaria - 2 - - 2 1
Denmark 27 23 29 39 33 41
Iceland 3 6 4 1 2 -

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
UK Scotland - - 13 11 6 13



Emerging and re-emerging foodborne pathogens call for vigilance. Social,

technological and environmental factors continue to have an important impact on
infectious diseases and to cause the re-emergence of old ones. These diseases are referred
to as “emerging” either because they have been newly identified (e.g. infections due to E. coli
015:H7), or have acquired a new niche in the environment (e.g. salmonellosis due to S.
enteritidis), or have acquired a new geographic region such as cholera, which in 1991
reached the Latin American region. Some diseases are increasing because production
systems are changing. For example, foodborne trematodes is an emerging problem
because, for instance, aquaculture production is increasing.
Responsible governmental services and agencies, research centres and
epidemiologists around the world are witnesses to the emergence and re-emergence of
foodborne diseases. According to Dr. D. Heymann, Executive Director of WHO,
Geneva, “Emerging and re-emerging infections reflect the constant struggle of micro-
organisms to survive, primarily by finding breaks in barriers which normally protect
human beings from infection.
The most known emerging and re-emerging pathogens are the following: Verotoxin
producing E. coli infections, Listeriosis, Salmonellosis (S. enteritidis), Cholera,
Campylobacteriosis, Yersiniosis, Cryptosporidiosis, Clonorchis sinensis infection,
Cyclosporidiosis, Plague, Leptospirosis, Bovine Spongiform Encephalopathy.

8 WHO/MZCC, Information Circular, No.53 – December 2001.



At the end of the 19th century, contaminated milk, meat and other foods led to
large outbreaks and many sporadic cases of foodborne diseases, often with fatal
complications. The revolution in sanitation and hygiene for food and water, early in the
20th century, brought about great improvements in food safety. The scientific
community had been lead to the illusion, that foodborne disease was no longer a serious
threat to public health. Today, however, awareness has increased: research and modern
methods of reporting disease make it clear that foodborne diseases can have crippling
effects and, in some cases, can even be fatal. Foodborne disease is serious in its effect on
health and economy. A foodborne disease outbreak might lead to an increase in medical
care costs, to decreased productivity and to the waste of large amounts of suspected
food, which is either recalled or condemned. Tourism could be adversely affected.
Furthermore the foodborne outbreak would jeopardise the reputation of a company and
or an entire industry – or even a country (see BSE). Given that an outbreak of foodborne
disease can have devastating financial consequences, the consumer, - more aware than
ever before - demands safety from the beginning of the food production process to
his/her table.
Standing on that ground, we might say with certainty that HACCP is the only system that
protects the “public” from foodborne diseases. Therefore, whether the people knows it
or not, its’ health depends upon HACCP systems for effective food safety assurance.
HACCP systems enhance food safety based on the concept of prevention of disease,
rather than on the identification of end product contamination. The system would
include a consideration not only of emerging and re-emerging pathogens but should be
able to consider and deal with new and ever evolving food processing and handling
techniques, methods and materials. A modern system of food safely would also have
provisions for informing the consumer about appropriate food handling, storage and
cooking. Reliability for the long run would be important because the food industry must
invest in such a food safety system and its application, and HACCP is such a reliable
system for the prediction of potential health risks and for the assurance of food safety.
HACCP is also the most cost-effective approach to food safety,9 because it focuses on
the analysis and the identification of the critical control points in the production,
processing and preparation of food, feed and water, before the product ever leaves the


Many countries, particularly industrialised ones, have an extensive food control
infrastructure, including food legislation that is updated regularly, as well as effective
enforcement mechanisms. However experience from these countries shows that a
comprehensive and well-funded regulatory system alone cannot prevent foodborne
diseases. The high and increasing incidence of foodborne diseases in industrialised
countries is evidence of this. On the other hand, we should take under consideration that
the combination of regulatory and educational measures have been proven to be the
most effective way in reducing foodborne disease. A good example is the action taken in
the United Kingdom and USA to prevent listeriosis. This is evidence that combined
regulatory and educational measures can be successful in reducing the incidence of
9 In 1993, the Codex Alimentarius Commission endorsed the HACCP system as the most cost-effective

approach devised to date for ensuring the safety of food.

10 Adapted from “Foodborne disease” a focus for health education, WHO, Geneva, 2000.

foodborne diseases significantly. But unfortunately, examples of a combined regulatory

and educational approach are scarce and most of the countries still rely solely, on a
regulatory approach for the prevention of foodborne diseases.
In developing countries, most efforts to prevent diarrhoea causing diseases have been
focused on improving the water supply and sanitation. Regrettably in many instances the
provision of safe water and sanitation has been an end in itself and has not been
combined with an effective educational programme on the hygienic handling of food,
including water!
A critical review of the impact of improved water supplies and excreta disposal facilities
in the control of diarrhoeal diseases among young children has shown that, even under
the most favourable conditions, the rate of morbidity was reduced by only 27%.
Therefore, such measures are unquestionably essential to food safety and health, but
their efficiency in reducing diarrhoeal disease would be much enhanced, if they were
combined with a food hygiene education programme that included education in the safe
use and storage of water and efficient hand washing prior to food preparation.
Nevertheless, diarrhoeal diseases in infants and children remain a major cause of
morbidity and mortality in many developing countries. On the other hand it should be
realised that in industrialised countries with increased international travel and trade,
national regulatory measures would not be sufficient to protect populations from globally
emerging and re-emerging foodborne diseases. Therefore, taking under consideration
these emerging and re-emerging foodborne zoonotic diseases mostly in the developing
countries, it is expected an increase of medical care costs, a loss of money because of
decreased productivity, wasted food and perhaps a decrease in tourism, which is vital for
the economy of these countries.
It should be also noted here that the economic impact is estimated to be more severe for
the food industry because food contamination may lead to recall and loss of
contaminated food. Consequently it will jeopardise the reputation of the company and
lead to reduction in food trade.
Public health authorities are increasingly recognising that some groups of the population
are more susceptible to foodborne diseases - either because they may acquire the diseases
more easily, or because they may suffer more severely from these diseases than other
non-sensitive groups.
In order to confront the serious economic consequences of foodborne diseases the
governments should rely on the implementation of a HACCP system. With the HACCP
system food safety control is integrated into the design of the process rather than the old
ineffective system of end product testing. Therefore the HACCP system provides a
preventive and thus a cost-effective approach to food safety.
However Food Safety is not only the responsibility of Governments but of a large variety
of factors, including industry, NGO’s, International organizations and especially the
consumer. All persons, whether they prepare food or consume it, are part of the food
chain. As such they share responsibility with the government and the food industry in
ensuring the safety of food.


The hazard analysis critical control point concept is a systematic approach to the
identification, assessment and control of hazards. It is very simple because it only
identifies potential food safety problems and determines where they could be controlled
and prevented. At first it was a management tool used in food industry to keep the

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).

Experience from the Canning Industry demonstrated that control

over processing conditions was much more efficient and reliable
than 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.

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.

Graph 3.: Objectives of application of the HACCP system

Prevention of foodborne illness

More efficient Reduction of losses due

Reduction of costs quality
of food analysis to product recalls

Therefore, HACCP’s main objective is to enhance assurance in the food safety in

order to prevent foodborne illnesses more efficiently. Additionally it will reduce the costs
of control and wasted food and it will protect the reputation of the food processor and
its entire industry.


Application of the seven HACCP principles11 means in practice that a HACCP
team performs a HACCP study. Originally HACCP was a tool used in food industries on
a voluntary basis. However, over the years it has been proved to have many applications.
In addition to its application in food industries and food service establishments, the
system has also been used in health education, and in food safety programme
management. The areas of HACCP application are as following:
ƒ In food production, processing, manufacturing and preparation it is applied as a
method of food safety assurance.
ƒ In food control it is used as an inspection tool to channel the resources to critical
issues. Moreover the assessment of the HACCP plan in a food-producing unit
automatically confirms that this unit is properly designed and effectively operated
and conclusively there is no need to exercise any food control on the final product.
ƒ In education it is used to study food preparation practices and to identify hazardous
ƒ In the investigation of foodborne disease outbreaks it is important to identify the
cause of the outbreak.
ƒ In the management of food safety programmes it may identify those problems,
which are of the greatest risk for the public health and prioritise interventions, which
may have the greatest impact on the prevention of the problem.


Naturally before attempting to do HACCP, management support and commitment
are needed. In addition to the final costs necessary for training, there may be also
additional costs for acquiring necessary expertise, equipment and material.
The stages in developing and implementing HACCP are:
1. Perform a HACCP study during which the elements of the HACCP system in line
with the 7 principles of HACCP are established.
2. Develop a HACCP plan. This is a document that reflects the results of the study.
3. Train personnel in their functions as determined by the HACCP plan.
4. Implement12 (=To carry into effect) the HACCP plan (i.e. monitoring, taking corrective
5. Verify the HACCP plan.

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

11See principles of HACCP.

12The Codex Alimentarius Commission text does not give guidance on how to put the results of the HACCP
study into practice. Therefore some industrial practices are provided.

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
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.

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:

ƒ 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)
ƒ have few of the limitations of traditional approaches to food safety control13.
ƒ 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.
ƒ Are capable of accommodating changes introduced, such as progress in equipment
design, improvements in processing procedures, and technological developments
related to the product.
ƒ help to target or manage resources at the most critical part of the food operation.
ƒ aid the relationships between food processors, inspectors and consumers.
ƒ promote international trade by providing for equitable food safety control systems
everywhere in the world.
ƒ increase confidence in food safety as they reduce detention, confiscation, and
destruction of contaminated food shipments and
ƒ 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.

- Increased confidence of the community in the food supply


There are barriers that impede HACCP’s implementation at the national, business,
and consumer level in each country. At the national level, legislative approval is required
for mandatory implementation. At the business level, training, new equipment and
technology must be funded. At the consumer level, buyers may be resistant to
unnecessary changes in national customs and habits. Once governments, businesses and
consumers understand what is needed to assure food safety, each can then be a supporter
of the HACCP systems. The following points address the objections and barriers to the
implementation of HACCP.
Government commitment is the most important factor in the development and
the implementation of HACCP. Government awareness may be influenced by
epidemiological data on foodborne diseases and food contamination and especially
by the need for food safety and HACCP in order to export foods to other
countries. Advocacy by international organizations, (i.e. Codex Alimentarius
Commission, WHO, FAO and World Trade Organization (WTO)), may also help a
government to commit.
Government intervention and an active help network to provide technical,
scientific and educational support is necessary for success. Legal requirements vary
from country to country. Large food industries in places other than the United
States and the European Union, for example, may introduce HACCP without any
legal backup; most of the time they do it for their profit. But small businesses may
need an active government intervention in order to promote and facilitate the
change from traditional to modern food safety management systems. Moreover,
the government and the trade associations should provide help and support which
may include education for the managers and staff, and/or scientific knowledge.
Whether HACCP is implemented under voluntary or mandatory schemes, the
government should train regulatory authorities in HACCP for proper third part

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

Workshop on training in HACCP. WHO/FNU/FOS/96.3. WHO doc, Geneva, 1999.


equipment are designed, constructed and maintained to facilitate cleaning and to

minimise any possibility of cross contamination. In functioning, GHP is a
precondition for an effective HACCP system implementation.

Customer and business demand is a very important force for encouraging

businesses to implement the HACCP system. Customers purchase food from
reliable suppliers, transporters and retailers who have a food safety management
system in place. As customers become better informed with regard to food safety,
it can be expected that HACCP will be applied, or businesses will loose their
customers to others who can answer the demands of the well-informed buyer.
Therefore, businesses should ensure that they purchase food from appropriate
suppliers, transporters and retailers who implement food safety management
systems. This, together with a better-informed consumer creates a demand for the
application of HACCP systems.

Costs versus benefits: Although the economic constraints are a serious barrier
for the implementation of HACCP systems, the government and especially the

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 Hygiene includes all conditions and measures necessary to ensure the
safety, suitability and wholesomeness of food at all stages of the food chain16. According
to E.U. Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs -
Official Journal L 175, 19/07/1993 p. 0001 – 0011, Food Hygiene means all measures
necessary to ensure the safety and wholesomeness of foodstuffs.
Food Safety is the assurance that, food will not cause harm to the consumer when
it is prepared and/or consumed according to its intended use17. Therefore, food safety is
the level of security we achieve by ensuring food hygiene.

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).
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.

16 Term applied by the Codex Alimentarius Commission (CAC).

17 Term applied by the Codex Alimentarius Commission (CAC).

In conclusion, HACCP should be considered as a combination of measures and

methods used in the field of Food Safety, which complements the general aspects of a
total quality management as well as specific principles of food hygiene, and ensures that
essential safety measures are implemented.
Graph 4.: 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
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:
ƒ Hygiene requirements (control measures) specific to each facility, particular food
and process, and specific to the associated potential hazards
ƒ Prioritised control measures
ƒ Effective implementation of essential procedures.
ƒ 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

18 Good Manufacturing Practice/Good Hygienic Practice/Sanitation Standard Operating Procedures. GMP

encompasses many aspects of plant and personnel operations, whether SSOP are procedures helping to
accomplish the goal of maintaining GMP in the food production.

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.

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
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

attributes or characteristics of a product or a service, which allow to satisfy specified or

implicit requirements.
On the other hand, food safety represents a preliminary requirement of quality.
Therefore we may say that at the top of the structure, above HACCP and GMP and
GHP, is not the safety of food but rather the quality of it.
Components of quality:
- Nutritional characteristics (conciseness in proteins, carbohydrates, fats, vitamins),
- Sensorial characteristics (taste, smell, colour),
- Finished product characteristics (packaging, visual aspect, etc).


From the consumer’s point of view, all these features of the food as well as the
price-quality relationship are equally important.
From the Industry’s point of view “the consumer is always right” and should be satisfied
according to demands in all aspects.
However, from the Public health point of view, it is primary the hygienic and secondary
the nutritional quality of the food that counts.
Other qualities of food are important only to the extent that they affect acceptance of the
food by consumers and they belong to the sphere of industry’s interests.
Of course, meeting the agreed “quality requirements” of the customer is a useful goal.
However, in an ever changing and challenging modern society the definition of quality is
not fixed yet. Those in the food industry, as they try to expect and meet consumers’
notions of quality, must be ready with a system of food safety assurance that can address
new customs and new definitions of quality.

Table 4.: Quality from a consumer/industry and from a public health point of
Consumer/industry point of view Public health point of view
organoleptic quality
functional properties
keepability Compliance with regulations
nutritional nutritional
safety safety (hygienic quality)
Value of money

Graph 5.: The role of safety



Public health Industry

Foodhyg 9

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.


In ISO 8402: 1986, “Quality Assurance” is defined as: “all planned and systematic
actions necessary to provide adequate confidence that a product or a service will satisfy given
requirements”19. To achieve this desired quality, many industries try to establish a quality
assurance system that may include a wide range of actions. There is a similarity of this
definition with the definition of food hygiene. When the requirements in terms of quality
relate to hygienic properties of the food, the programme is referred to as “Food Safety
Assurance Programme”.
The quality assurance examines the system under which a service or a product is
supplied. Or, to put it another way, quality assurance is an objective mechanism,
technique, procedure or process that is used to quantitatively assess that minimum
standards are met. Quality assurance is, therefore, based on an integrated management
system, which secures that all obligations and targets of a company are fulfilled. In order
to obligate all personnel working in a company, to contribute to the quality assurance, it
should be given to everybody, the appropriate tools (information, training etc). It should also
explained to them clearly what is expected from each one. They should know and
understand that everybody in the company is contributing to the end result and finally
that everybody is doing his/hers best for assuring an internal quality.
In the TQM20 systems for quality assurance, we plan what is needed to be done, we
do what we plan and finally we document everything we do.
Some of the most important reasons we document everything we do, are the following:
ƒ Documentation is used as a Standard aid-memoir.
ƒ It helps the continuation of processing without problems even when there are
changes of personnel.
ƒ It is the best basis for training.
ƒ Is used as a standard guidance.
ƒ It helps as a common basis for communication.
ƒ It helps controlling of the system that is applied.
ƒ It can be used as the basis for further improvement.

20 Total Quality Management

Standards for certified quality assurance systems have been internationally accepted, like
ISO 9001: 2000, EN 29000, ANS/ -Q91.


The International Organization for Standardisation (ISO) has formulated a series of
standards on quality systems known as the ISO 9000 series. In view of globalisation of trade, and
the need for a uniform method for assessing quality assurance systems, these standards have
gained importance in industry. Suppliers of goods and services use them to provide objective
evidence that their quality assurance systems enable them to consistently meet their standards.
Some standard organizations use the ISO standards without modification; others have
adopted their own numbering systems while keeping the text identical to those of the ISO
standards. The EU decided to adopt quality systems based on the “EN 29000” series.
The ISO 9000 series include 5 documents. Three of them, i.e. ISO 9001, ISO 9002 and
ISO 9003, provide standards for quality assurance systems. The main ISO requirements on
documents are the following:
- Documents must be classified according to predetermined classes.
- Each document must be univocally identified, verified21 and approved22.
- The rules for issuing the documents must be defined (filling, distribution, updating)
- The documents should always be updated and available
- Changes to documents must be made only according to strict rules.
(It is considered that with the integration of ISO and HACCP, the above documents apply also for
the HACCP system).
The most significant quality assurance model, which is ISO 9001, has 20
requirements. The standard establishes requirements for what should constitute the
elements of a quality assurance system. However it doesn’t establish what the desired
quality is, or the technical aspects of achieving it.
The ISO 9001 and ISO 9002 and to some extend ISO 9003 stipulate the need for
product safety and liability. Certain elements (e.g. verification) reinforce some aspects of
HACCP. It should be mentioned here that some of the terminology used in the ISO
9000 series is different from the HACCP system.
The quality system elements are the most stringent quality assurance model, with
20 requirements. The standard establishes requirements for what should constitute the
“elements” of a quality assurance system. However it doesn’t establish what the desired
quality is or the technical aspects of achieving it.
Nevertheless, ISO 9000 standards are compatible with HACCP programmes, and
many of their elements support or reinforce the implementation of HACCP.

21 Reviewing the document's contents.

22 Authorised for use.

Table 5.: Requirements of ISO 9000

Series 1
Management responsibility Quality in procurement (Purchasing)
Quality system principles Quality in production (Process control)
Auditing the quality system (internal) Control of production
Economics – Quality related cost considerations Material control and tractability (product identification
and traceability)
Quality in marketing (contract review) Control of verification status (Inspection and testing)
Quality in specification and design (Design control) Product verification (Inspection an testing)
Series 2
Control of measuring and test equipment Nonconformity (control of nonconforming product)
(inspection, measuring and test equipment)
Corrective action Handling and post-production functions (handling,
storage, packaging and delivery)
After-sales servicing Quality documentation and records (Document

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.


End product testing proved to be time consuming, costly and not reliable for
identification of contaminated foods. Testing foods for the presence of contaminants
offers little protection even when large numbers of samples are examined. For example,
when a 10-ton batch of milk powder is examined by taking 60 units, and 25 gram per
unit of 250g is analysed, and if negative result is obtained for all 60 samples, this still
means that there is a 30% probability (one out of 3) of accepting a lot in which 800 units
contain Salmonella. This interpretation assumes a homogenous distribution of Salmonella
through the lot, or a random sampling procedure, which is usually not the case.

Table 6.: Salmonella testing of milkpowder

Sampling scheme : 60 units / lot
Examined : 25g / unit of 250g
Lot size : 10 tons
Assumption : homogeneous distribution of Salmonella
Confidence : Lots with 800 units containing Salmonella are accepted with 30 %

Today traditional food control is based on observation and testing of samples as

well as in the detection of spoilage “e.g. unhealthy food” and fraud. It is basically performed
through “snap-shot” inspection for the compliance with GHP/GMP + End product
testing. However, regulations with GMP are using very often, vague terms such as:
“appropriate” or “when necessary”. Consequently, there may be very little distinction between
trivial and important matters concerning safety. Additionally, the traditional food control
system is retroactive and provides little health protection, particularly regarding to
pathogenic organisms.
In general the shortcomings of the traditional inspectional approach are the
- Vague terms in laws
- Laws allow much to discretion
- Failure to distinguish requirements
- Overlooking important safety factors
- Aesthetic vs. safety factors
- Given point in time
On the other side, HACCP systems anticipate inspection for compliance with
GHP/GMP + end product testing.


Early food production concentrated on keep ability (shelf life) and organoleptic
quality because preserving food was essential to survival. Production methods were
based upon domestic experience; household methods were scaled up without any
scientific experimentation to validate the safety of the product thus obtained. Safety was
often taken for granted (cause and effect were not known, especially with regard to foodborne diseases
caused by microorganisms).

Traditionally, government food inspectors checked samples on the market to

determine if the goods were spoiled, regarded as “unhealthy”, and to detect fraud. This
control system was usually retroactive. Often foods were consumed before irregularities
were detected. Punishment was regarded as an effective control measure, because it
would prevent reoccurrence. In reality this system offered little health protection,
particularly in terms of preventing foodborne diseases.
Before HACCP foods were consumed before irregularities were detected.

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.


The strategic goal for any company is to satisfy the customer and provide the
means for continuous amelioration to meet the competition. Quality in general is a
strategic target for any enterprise, taking into account the need for continuous
improvement in a rate faster than the competitors. These needs are served by TQM.
According to the concept, everybody in the enterprise should be responsible for the
quality of the product. The method is to “embody’’ and define quality in each step of the
production line. “Embodiment’’ of quality means all employees and all processes add in
quality at any particular step in production line or service delivering. In order to achieve
it, a good communication with all employees is required. We need to explain to and train
all personnel on what we are trying to do, for eliminating defects. The end target is to
isolate as early as possible, in the process line, any defect that may appear in the final
product. In fact what we need in this respect is a cultural change, which however,
requires a tremendous effort and dedication from all employee levels, including top
management personnel. Nevertheless, once the commitment to quality is made, rewards
are manifested by greater employee motivation, improved uniformity in finished
products or services, greater profits and, usually, increased customer satisfaction. By

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.


As we have already stated, Quality control system is a system for maintaining
standards in production or in a product, especially, until recently, by inspecting samples
of the product. Postproduction inspection, or final product inspection, was the
traditional way of conducting quality control. But, defects are always expected in the final
product or service, a fact which leads to the concept of “accepted quality levels’’.
Therefore, until recently, too much time has been spend, investigating what is wrong
with the final product or service, without due respect to what might be wrong with the
process. Moreover ensuring quality by inspecting the final product is very expensive and
when it is carried out, the only way to remedy a defect is to prevent it for reaching the
customer. Besides, the most experienced people are used as inspectors.
Quality assurance is not full proof, even if 100% inspection takes place. Besides,
although, if rigorously applied may prevent for defected products for delivering to
customers, their production cannot be restrained. We should take under consideration
that a defected product reaching the consumer is in fact a 100% defected product for this
The last but not the least is the fact that quality assurance creates a false security
feeling to the personnel working in the processing line; they think that someone in the
end inspects the final product, thus becoming less attentive in their work. In addition, to-

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
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.

Graph 6.: Safe food for all


Table 7 - The evolution of Traditional Quality

Before After
From considering quality a technical activity To considering quality a Firm’s management tool
“QUALITY” (assessment and control) was an activity “QUALITY” is part of today’s Management strategies
assigned to certain individuals
From adjectives To numbers
Words and slogans were used: Good Quality products, The levels of Quality are measured with real numbers and
Quality services provided. proper indicators so they can be kept under constant control
From improvised decisions To planned decisions
Actions and their consequences were not always planned: Clearly plan and schedule activities before executing them.
“Let’s start doing something and then we’ll look at the
existing needs”.
From responding to emergencies To preventing emergencies
“When problems arise react quickly”….. Identify causes of ‘non-conformity” to quality and remove
them. Prevention instead of treatment.
From oral tradition To documented rules
Purchase, sales, production were based on unwritten rules, All rules regulating firm’s activities are written in procedures
consolidated by their use and standards and distributed to operators.
From …doing To doing and recording
“What was important was to do things well” What is important is to do things well and provide evidence
for this.

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.


Definitions of hazard in the food industry: In 1970 hazard was something we
did not want to happen. In 2000 hazard was developed to represent a biological,
chemical or physical agent, or a condition of food with the potential to cause an adverse
health effect when present at an unacceptable level.

Definition of hazard analysis23: Hazard analysis is the process of collecting and

interpreting information on hazards and conditions leading to their presence in order to
decide which are significant for food safety and should be addressed in that particular
industry’s HACCP plan.
Hazards to food safety can originate from the raw materials, the line environment, and
the personnel handling the food, but even if they enter the final product, this does not
mean that their levels are always dangerous. Therefore, hazard analysis is a process of
deciding whether potential hazards are significant and if they need to be controlled.
During this process the hazard will be determined to be significant depending upon the
levels present, the sizes or the doses of the hazardous agent. Furthermore, the effect of
the agent varies with the food in which it is found and the susceptibility of the person
ingesting it. Some agents, for example, are more dangerous than others and there is a
great variety in the severity of the effect. However there is always a level below which the
presence of an agent is considered to be acceptable.
For most chemicals, a maximum residue level (MRL) has been established. For the
establishment of acceptable levels for chemicals, risk assessment protocols have been in

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.

23 Codex Alimentarius Commission definition of Hazard Analysis (1997)


Potential hazards can be present in raw materials and in ingredients, or may be

introduced or increase during processing. A product formulation may allow a pathogen
to multiply to unacceptable levels, i.e. to become a significant hazard.
Packaging may prevent a food from recontamination but may also create conditions
favouring pathogen growth. Storage and distribution of perishable foods may create
hazards. The growth of pathogens increases significantly at temperatures above 50 and
below 600 C.
Foodborne illness sometimes results from improper preparation and use. Finally the
consumer’s susceptibility influences the severity and the probability of occurrence of a
foodborne disease. When a food product is targeted at the very young, the very old or
people with certain diseases, potential hazards often become significant hazards. For
instance, a healthy person normally can consume low levels of Listeria monocytogenes
without becoming ill; for immuno-suppressed person, these doses may be dangerous.


Priorities must be assigned to address contaminants in a rational and cost-effective
way. These criteria can be used to establish priorities for food safety control activities.
Although food safety emergencies always have highest priority, sound public health
planning must rest on science and on objective assessments of risks and cost-effective
possibilities for their reduction.
One of these criteria, and perhaps the most important from the public health point of
view, is the severity of potential effects of a contaminant on health. Therefore in order to
classify a hazard we should take under consideration its Risk and Severity according to
the following table.

Table 8.: A Hazard Index according to the risk and severity.

Risk ( R ) Severity ( S ) Hazard Index ( HI )
Maximum likelihood = 5 Lethal hazard = 5 Maximum value = 25
Medium likelihood = 3-4 Severe hazard = 3-4 Medium value = 9-16
Minimum likelihood = 1-2 Minimum hazard = 1-2 Minimum value = 1-4
Hazard Index = risk x severity


Evaluating the likelihood of occurrence of the hazard is the most difficult aspect of
Hazard Analysis.
It is possible for instance, that Salmonella is present in any number of raw materials; but is
its presence probable or likely or reasonably expected to occur?
The choice of descriptive wards reflects an assessment of the likelihood of
occurrence, which is one of the elements of the assessment of risks. Another part is the
assessment of whether the reduction of a hazard is adequate, acceptable or unacceptable.


We have already mentioned the word “contaminants”. In the field of safety we say
that all hazardous microorganisms, parasites, viruses, chemicals and physical agents are
contaminants of a food. We should always distinguish between hazardous and non-
hazardous contaminants. We have seen that microorganisms can be dangerous when
present in a food. However some of them are not dangerous at all, but they may spoil
foods and make it unfit for consumption. Moreover some microorganisms are used to

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

Table 9.: Contaminants listed on the basis of severity of risk

Microorganisms and parasites Chemicals
Severe hazards Naturally occurring chemicals
Clostridium botulinum types A,B,E and F Mycotoxins (e.g. aflatoxin)
Shigella dysenteriae Salmonella typhi; S. paratyphi A, B Scombrotoxin (histamine), Ciguatoxin
Hepatitis A, E Mushroom toxins
Brucella abortus; B. suis Shellfish toxins - Paralytic shellfish poisoning (PSP)
- Diarrheic shellfish poisoning (DSP)
- Neurotoxic shellfish poisoning (NSP)
- Amnesic shellfish poisoning
Vibrio cholerae 0, 1, Vibrio vulnificus Pyrrolizidine alkaloids,
Taenia solium, Trichinella spiralis Polychlorinated biphenyls (PCBs)
Moderate hazards (Extensive spread) Added chemicals
Listeria monocytogenes Agricultural chemical
Salmonella spp., Shigella spp. Pesticides, fungicides, fertilisers, insecticides, antibiotics, heavy
metals, ink from seals and labels, PCG’s, packaging materials,
pigments, disinfectants, cleaners, growth hormones
Enteovirulent E. coli (EEC) Toxin elements and compounds - Lead, zinc, arsenic, mercury
and cyanide
Streptococcus pyogenes Food additives
Direct – allowable limits under GMPs legal restrictions
Preservatives (nitrite and sulphating agents)
Flavour enhancers (monodium glutamate)
Nutritional additives (niacin)
Colour additives
Rotavirus Norwalk virus group Plan chemicals (e.g. lubricants, cleaners, sanitises, cleaning
compounds, coating and paint)
Entamoeba histolytica Maintenance materials
……surface paints
……machine lubricants
Diphylobothrium latum
Ascaris lubricoides Chemicals intentionally added (sabotage)
Cryptosporidium parvum
Moderate hazards (Limited spread)
Bacilus cereus, Campylobacter jejuni
Clostridium perfrigens, Staphylococcus aureus
Vibrio cholerae, non-01, Vibrio parahaemolyticus
Yersinia enterocolitica,Giardia lablia
Taenia saginata

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).

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.

Example: Raw meat.

Meat is subject of contamination at the moment of slaughter and evisceration. It is
well known that the digestive tract of all animals and birds as well as their skin and
feathers are the major source of contamination for meat and poultry. This usually
happens when the evisceration is not performed properly and the contents of the
digestive tract are poured on the surface of the carcass. Further washing of the carcass
only helps in the spreading of the contamination to other parts of the carcass or to
adjacent carcasses. Salmonella among a large variety of pathogens is transmitted through
evisceration. Therefore the implementation of HACCP in the slaughterhouses is a matter
of paramount importance24. However it is very difficult to restrain the spread of
pathogens in the slaughterhouse especially in case that, most of the slaughtered animals
are loaded with pathogens! For this reason HACCP is starting at the farm level - and
even before (production of feedstuff, control of water sources etc).
In England, Denmark, and other EU countries are still implemented programs for the
control of Salmonellosis in poultry farms. These programs are considered as a part of the
HACCP system on farm level, which actually starts with the entrance of foodstuff in the
farm (checking of GMP certificates of the producer) and ends with the serological examinations
of animals, little before they will live the farm for the slaughterhouse (including
This practice can reduce the initial load of pathogens and consequently help in the
control of salmonella in the slaughterhouse and beyond. In practice, control of
salmonellosis usually means control of many other pathogens (i.e. Campylobacter jejuni)
causing foodborne diseases, since Salmonella is often used as an indicator for the
confirmation of the effectiveness of HACCP systems.
Let’s suppose that the entering raw product is raw meat (beef, swine or poultry)
arriving either directly from the slaughterhouse or from a storehouse. The responsible
person should check the new batch upon arrival in the plant. First he can perform a
visual inspection of the truck/containers. During this inspection he may “feel” or even
count with a thermometer the temperature of the truck and see with his own eyes the
conditions (cleanliness) during the transportation. In this way he may assure that the raw
material has been transported under the proper conditions and theoretically has not been
contaminated with microorganisms or foreign material. He can also be sure that the
temperature at the arrival was the proper and therefore the existing microorganisms have
not multiplied during the transportation. Then he should check all papers (GMP
certificates) and make sure that this is the proper lot. Finally he can supervise for the
proper transportation and storage of the meat into the plant making sure that the
24 Other pathogens transmitted from the digestive tract to the surface of meat are: Listeria monocytogenes,

Clostridium botulinum, Staphylococcus aureus, Bacillus cereus, E. coli 0157:H7 etc.


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:

Acute illness: Choking

Abdominal cramps

Chronic illness: Chronic infections
Damage of various organs
Some Cancers

Damage of


There are a vast number of factors contributing to foodborne illness. In brief we
mention below only a few of them, such as the factors depending on the pathogen (e.g.
infective dose, virulence of strain, vegetative spores or cells), or the host (e.g. age, immune status, gastric
acidity, Immuno-competence, nature of gut flora, pregnancy), or the nature of the food itself (acidity,
presence of fat, etc).
In the first category there are some other sub-classifications affecting the
pathogenic agent such as the temperature and time of cooking or preserving, the pH, the
water activity, the oxygen tension, the preservatives, or even the microbial interactions.
Unclean equipment is often a source of foodborne pathogens. Raw materials that
are eaten fresh or insufficiently cooked are another source. In other cases pathogens find
their way into food through insects, rodents or other pests. Aerosols from cleaning dirty

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.

Major factors contributing to foodborne illness, in industry and at home.

A large number of foodborne diseases outbreaks are due to mishandling both in

the production sites and the consumer’s home. If we know why these incidents occur, we
can apply control measures.
In industrialised countries, most outbreaks can be traced to food service establishments
(restaurants, institutions) and to the home. Industrially processed foods and retail foods are
less likely to be involved in outbreaks, but when they occur they often involve a large
number of cases.

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


Various biological and chemical agents are usually and even normally present in the
food without causing adverse reactions to health. This happens because they may be in
such a small quantity that can be easily confronted by the biological or mechanical
defences of the host. Therefore if the agent is present in a food at a low, acceptable
level25 the concern of the HACCP plan is to keep it under this level preventing its
increase. If unlikely, the agent present in the food is over the harmless level, then the
HACCP plan should propose a way to assure its reduction to/or beyond the acceptable
level. This “way” is generally called “Control Measures”.
Therefore, “Control Measures” are the actions or activities that can be used to
prevent or eliminate a food safety hazard or reduce it to an acceptable level. At this point
it is very useful to specify the word “Control” when used isolated in a HACCP system.

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:
ƒ product development
ƒ industrialisation of a new product
ƒ when specific hazards emerge
ƒ when new raw material are used
ƒ when formulation is changed
ƒ when equipment is changed
ƒ when a new production area is used

Points that should be considered while performing a hazard analysis include:

25 Some agents are more dangerous than others, and there is a great variety in the severity of the effect. To this
concept, not all levels (or sizes) of all agents are harmful to all individuals under all conditions. Therefore agents
(contaminants) are acceptable as long as their levels remain below a certain maximum.
26 In HACCP, the word “control” does not mean in any way: to check or to test!

ƒ The likely occurrence of hazards and the severity of their adverse health effects
ƒ The qualitative and/or quantitative evaluation of the presence of hazards
ƒ Survival or multiplication of microorganisms of concern
ƒ Production or persistence in foods of toxins, chemicals or physical agents
ƒ Quality of raw materials
ƒ Conditions leading to the above and identification of control measures


The hazard analysis consists of a series of questions, which are appropriate to each
step in a HACCP plan. It is not possible in these recommendations to provide a list of all
the questions, which may be pertinent to a specific food or process. The hazard analysis
should question the effect of a variety of factors upon the safety of the food such as.

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
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?

C. Procedure used for processing

11. Does the process include steps destroying pathogens (both vegetative cells and
12. Is the product subject to recontamination between processing (e.g. cooking, pasteurising)
and packaging

D. Microbial content of the food

13. Is the food commercially sterile ?

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).

14. Is it likely that the food will contain viable sporeforming or non-sporeforming
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
20. Is the traffic pattern for people and moving equipment a significant source of

F. Equipment design
21. Will the equipment provide the time-temperature control that is necessary for safe
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?

35. Is it possible to provide sanitary conditions consistently and adequately to assure safe

I. Employee health, hygiene, education

36. Can employee health or personnel hygiene practices impact upon safety of the foods
being processed?
37. Do the employees understand the process and the factors they must control to assure
the preparation of safe foods?
38. Will employees inform management of a problem, which could impact upon safety
of the food?

J. Conditions of storage between packaging and the end user.

39. What is the likelihood that the food will be improperly stored at the wrong
40. Would an error in improper storage lead to a microbiologically unsafe food?

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)?


The Hazard Analysis will determine the Critical Control Points (CCPs28) of raw
materials in different locations of the process, no matter what the practice or the
procedures used for the development of the product are. A Critical Control Point is a
step29 in the food chain where activities are carried out, or conditions prevail, which can
have an influence on the safety of the product, and where control can be exercised over
one or more factors to prevent or eliminate a food safety hazard or reduce it to an
acceptable level. Therefore the Hazard Analysis by determining the CCPs in the food
chain helps the team to establish Critical Limits for each CCP, or in other words, to
establish criteria, which separate acceptability of the product from unacceptability. The
CCPs are usually Standard Values (such as pH, aw, temperature, time), Maximum Levels (of
contaminants), Limits in Microbial criteria, Levels of Cleanliness, Levels of Chlorine,
Pressure etc.
Then the team establishes a Monitoring system for each CCP in order to observe
and/or measure its functions and parameters and assess whether the specific CCP is
under control.

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.

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.


Ideally, measurement and testing should be done continuously. An example is the
continuous measurement and recording of the acidity or pH obtained during
fermentation. Such a recording shows that small fluctuations always occur. This reflects
the normal treatment variations. In process control terminology, we call the arithmetic
mean of the values the “target level” and two or more standard deviations determine the
upper and lower control level. Under optimal conditions, there should be sufficient
distance between the upper (or lower) control level and the critical limit, to ensure that the
critical limit is not surpassed in normal operational conditions.


The critical limit should not be exceeded; otherwise the safety of the product
cannot be assured. By definition, the critical limit separates acceptability from
unacceptability in terms of risks for the consumer wherever possible.
Critical limits can be all kind of parameters. Physical parameters such as pH, aw,
temperature and time are usually preferred as they can be measured continuously and “in
line”. Critical limits may also be established for other process parameters such as
absorbed radiation dose, level of disinfectant or antimicrobial agents, over-pressure in
heat exchanger, or over-pressure of air in a clean room. However, critical limits can also
be the “Maximum Residue Levels” for pesticides or “Maximum Levels of chemicals” set by
Public Health Authorities and Codex Alimentarius. Also, limits in microbiological criteria
of pathogens or indicators may be taken as critical limit, although they are often of little
practical use.
The selection of parameters for which critical limits have to be established requires an in-
depth understanding of the technologies used for controlling the hazards and the
processing. For instance, for chlorination of water, it is important to monitor not only
the residual chlorine but also the contact time, pH and turbidity of the water.
In order to determine the Critical Limits, let us take the example of pasteurisation of

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.


HACCP was developed in the food processing industry because it was known that
controlling processing conditions gives a better assurance of the product’s safety than
testing the final product. For example, it is more effective to control retorting time and
temperature in canning, because even serious under-processing cannot normally be
detected by microbiologically testing of the end-product. Microbiological process control
means having control over conditions, which may lead to unacceptable events. Such
events are unacceptable growth, survival, and spread or contamination of/with
undesirable microorganisms. The word “unacceptable” is important because some growth,
survival and even spread or contamination can always occur.
Pasteurisation is a good example of processing for safety. When a product such as milk is
heated for a sufficient long period of time at a high enough temperature, levels of
pathogens such as Salmonella and Mycobacterioum bovis are reduced by a factor of more than
106. This assures the safety of the product. Heating time and temperature are monitored
and when a deviation occurs, the milk is automatically returned to the raw milk section
by a flow diversion valve. When controls are in place to control recontamination, no
safety problem will occur. If the temperature shows a tendency to drop, timely
adjustments have to be made and corrective actions should ensure that this situation
does not repeat itself.

Table 10.: Examples of processing control methods to prevent Biological Hazards

Pathogen Preventive Measure or Control

Bacillus cereus Proper holding and cooling temperatures of foods.
Thermal processing of shelf-stable canned food
Campylobacter jejuni Proper pasteurisation or cooking; avoiding cross
contamination of utensils, equipment, freezing, atmospheric
Clostridium botulinum Thermal processing of shelf-stable canned food; addition of
nitrite and salt to cured processed meats;
Refrigeration of perishable vacuum packaged meats;
Acidification below pH 4.6; reduction of moisture below
water activity of 0.93
Clostridium perfrigens Proper holding and cooling temperatures of foods;
Proper cooking times and temperatures
Escherichia coli Proper holding and cooling temperatures of foods;
0157:H7 Proper cooking times and temperatures
Listeria monocytogenes Proper heat treatments; rigid environmental sanitation
programmes; separation of raw and ready-to-eat production
areas and/or product. This may be included in the sanitation
Salmonella spp. Proper heat treatment; separation of raw and cooked
product; fermentation controls; decreased water activity;
withdrawing feed from animals before slaughter; avoiding
exterior of hide contacting carcass during skinning;
antimicrobial rinses; proper scalding procedures; disinfecting
Staphylococcus aureus Proper fermentation and pH control; proper heat treatment
and post-process product handling practices; reduced water
Yersinia enterocolytica Proper refrigeration; heat treatments; control of salt and
acidity, prevention of cross-contamination.
* The above measures usually fit to more than one pathogens.

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.


When a deviation occurs, corrective actions have to be taken. In the latest text of
Codex Alimentarius, corrective actions are only those actions, which are taken when a CCP
is out of control; thus, when a critical limit is exceeded. However here we will use the
term "corrective action" to apply also to situations where critical limits were not exceeded,
and where the corrective action was used only to make minor readjustments.

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


A HACCP plan is a document prepared in accordance with the principles of
HACCP in order to ensure control over hazards, which are significant for food safety in
a segment of the food chain under consideration. The goals of this activity are as
ƒ assessing the compliance with product/process description,
ƒ processing flow diagram,
ƒ assessing and identifying the most significant hazards,
ƒ correcting identification of all hazard sources,
ƒ identifying all Critical Control Points,
ƒ monitoring the programme (frequency, methods, equipment etc), and
ƒ evaluating the quality of information gathered through records.
The term “HACCP plan” has been used several times. The Codex Alimentarius definition
describes what a HACCP plan is. It indicates what needs to be done, when and where. It
is the basis of documentation, which can be shown to food inspectors and auditors.
Normally, a flow chart with CCPs is attached. It is the result of a HACCP study; it is
specific to a production site and product, and must be rigorously implemented. Since the
HACCP plan is specific, each change and its potential impact on safety should be studied
and the HACCP plan should be modified when necessary. The results of a HACCP
study are also presented in a condensed form in a HACCP data sheet. (see below)

Table 11: Example of a HACCP data sheet – raw material

Raw CCP Hazard to be Control Critical Monitoring Corrective Responsi

materials controlled measures limits actions person(s)
No Procedure Frequency
Incoming 1.1 Aflatoxin Obtain Aflatoxin Inspect Every Reject Incoming
raw Certificates <10 mg/kg Certificate batch batch Goods Cl
material of Analysis of Analysis Supply QA
Flour Manager
Mains 1.2 Chemical Carry out Chemical Testing for Weekly Contact QA mana
water on-site contamination toxic water
micro substances Authority
checks and Giardia,
obtain Cryptosporidi
Certificate of Regulatory um,
local sample- Compliance Inspect
Water Certificates
Authority of Analysis
from water
Jam 1.3 Pesticide Certificates Within legal Inspect Annually QA mana
residues of Analysis limits Certificate Contact
from the Supplier’s Purchasing
approved QA Audit Manager
supplier Annually
Cream 1.4 Salmonella and Supplier Absent/25 g Laboratory Every Reject QA Mana
Listeria Quality tests for delivery batch
Assurance Listeria,
System Salmonella,
Inform QA Mana
Approved QA audit
supplier monthly

Table 12.: Example of a HACCP data sheet – processing step

Process CCP Hazard to be Control Critical Monitoring Corrective Respo

step No controlled measures limits Procedure Frequency actions ble
Storage 2 Physical Store as No physical, Automatic Daily Hold and Wareho
of raw contamination, specified, i.e. chemical temperature checks- inform QA Manag
material biological cream<50 C contamination. recorder. continue Manager and
growth egg for Maintain Visually during Operat
specified temp. <50 C inspect use.
max. time. label to Every
Keep ensure batch
covered stock
Bake 3 Survival of Bake sponge Bake at 700 C Automatic Continuo Stop Operat
sponge vegetative at specific for 2 min. chart us production
through pathogens time/temper minimum recorder Reject faulty
oven ature core product.
temperature Adjust oven
Metal 4 Metal Metal Absent- Metal Every 30 Stop line, QA
detect contamination detector ferrous 2.0 detection min. recalibrate, Inspect
mg, non- check using notify QAM.
ferrous 2.5 test pieces. Hold stock
mg manufactured
since Line
previous Engine
detector Daily check.

Dispatc 5 Growth of Low 0-50 C Continuous Daily Hold, inform Wareho

h pathogens temperature chart review QAM, Manag
during recorder – Sample and Transp
storage and warehouse test product Manag
distribution and Wareho
distribution Manag
Check Montly

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

gives auditors and inspectors a quick insight into the decisions made during the HACCP
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
ƒ Minutes of HACCP study meetings, (decisions made and their reasons)
ƒ Records of monitoring
ƒ Records of verification
ƒ Records of deviations and corrective actions
ƒ 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

Graph 7.: Point of integration of a HACCP Plan and a Quality system







They describe the rules and responsibilities of an operational process. The procedures are
generally interfunctional (they often involve more than one organisational function). The choice of
“which” and “how many” procedures to develop depends on the company’s complexity and
size. The following is a possible list of Procedures:
Table 13: Possible list of Procedures of a HACCP plan
1 Document issuing and control
2 Purchasing control: All purchased products, significant from the quality point of view, must be under control. This
control must include: suppliers’ evaluation and selection, clear definition of suppliers’ requirements, and verification
of purchased product.
3 Premises, equipment and tools cleaning and disinfecting: All facilities, equipment and tools involved in the
production process must be cleaned and disinfected. These activities should be proved and documented.
Cleaning = removal of dust, undesired materials or dirt from surfaces, objects, defined surfaces and their
surrounding areas.
Disinfecting = destroying or inactivating pathogen microorganisms from defined surfaces and their surrounding
Sanitising = control and improvement of working environment conditions (e.g. cleaning, disinfecting, pest control,
improvement of temperature, humidity, light, noise etc.)
4 Rat and pest control: The aim of this procedure is to guarantee that all pest and rat control activities carried out on
the Firm’s premises are performed according to specific given indications. The procedure guarantees that all
production steps, all storing activities of food and packaging materials, are performed in a clean working
environment, using clean equipment and tools; the procedure also identifies operators responsible of such activities.
5 Personal hygiene: This instruction applies to all personnel directly involved in production as well as all management
staff occasionally in contact with products being processed. All personnel should have a “health register” recording all
sanitary data, which has to be renewed every year. Health registers are kept in administration in order to keep track of
documents, which have to be renewed. In case of illness (respiratory problems, skin diseases, etc,..) employees are
suspended from work until recovery. Among others, personnel should not be eating, smoking, spitting, or chewing in
the working areas; Overalls or other clothes must not be reused once they have been thrown into dirty clothes bins.
Before starting work, after any interruption and whenever necessary, operators must accurately wash their hands using
hot water and liquid antiseptic soap and then dry them accurately with paper towels.
6 Personal training involves specific technical and technological knowledge relevant to the operators’ tasks. This
education is aimed at the development of capabilities coherent with the assigned position. Personnel have to be
trained on activities performing procedures and modalities in compliance with proper hygienic sanitary procedures.
7 Machinery and equipment maintenance: All machinery involved in the production process must be efficient. It is
required to:
Identify, register and list all equipment and machines.

Define specific maintenance requirements to each equipment or tool.

Define responsibilities.
Prepare a form to each equipment in which to register every preventive and corrective maintenance performed
8 Calibration of measuring equipment: It is essential to guarantee the proper control of the product.
9 Product identification and traceability
To IDENTIFY means to associate to a member of a population a series of Identification Data, which allow to
distinguish it from the other members of the population (if for example we like to identify a live bovine animal then the
identification data should be its European Union identification number which identifies nationality, origin, breed, etc).
To TRACE means to reconstruct the product’s history, identifying all its components and the relevant suppliers, the
processes and the operators involved, the customers, which have bought it.
10 Water supplies: Aim of this procedure is to guarantee that the water used in the firm does not compromise the
product’s hygienic and sanitary aspects. It is applied to all activities relevant to water supplies used in all processing
steps and in cleaning and sanitising activities. The results must be available for audits/inspections by the competent
authority and filed for 2 years period in the Firm’s archives.
11 Processing residues and garbage: All waste produced during processing steps and empty containers of cleaning
products will not become a contamination source for environment and foods. People responsible for these activities
are also identified. This procedure applies to all reception, preparation, service, cleaning, sanitising, pest control
activities performed in the firm, which will produce waste. Waste disposal is managed according to the type of
waste/garbage and the requirements of legislation in force.
12 Control of “non-conforming” product and procedures: Processes and products can sow “non-conformities”. In
such cases we should prevent unwanted use of non-conforming product and trace back and/or recall the product
already distributed. We also should notify non-conformity cases
13 Corrective and preventive actions
14 Internal system audits


If we imagine the entity of “Food Safety” as a building consisted of three floors,
then without no doubt, the first floor starts with the prerequisites needed to lead to the
top of the ladder. In the second floor we find side by side the Good Manufacturing
Practice together with the Good Hygienic Practice and in the third floor we identify
HACCP system.

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
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),

b. Equipment and tools used in the plant (description of the equipment,

sanitation programme and maintenance).
c. Production process (Raw material supply, storage, producing and distribution
process, waste disposal, water supply).
d. Personnel (Personal hygiene and training)
e. Efficient product management.
In other words, the facilities should be constructed and maintained according to
sanitary principles (linear product flow to minimise cross-contamination from raw to cooked materials
or from cleaning to potable water). The supplier of any raw material should certify that he
follows an effective GMP and food safety programs. All equipment should be
constructed, placed and sanitised according to a written schedule and to update sanitary
principles. All employees should strictly follow the updated requirements for personal
hygiene, cleaning and sanitising according to the written schedule that can always be
adjusted by the HACCP team. All raw materials or finished product should be stored
under the best sanitary and environmental conditions in order to maintain their safety
and quality. All materials should be properly coded, so they can be totally recalled (in case
of emergency). And finally that all pest-control programs are in place to secure that there
is no further contamination during processing and storage.


In the “Food Safety Enhancement Programme Manuals”, edited by Agri-Food and
Agriculture, Canada, the data referring to personnel behaviour, sanitation, etc. are
managed out of the HACCP plan, through the Prerequisite Programmes. These
procedures control the environmental production conditions and allow obtaining an
environment fit for safety food production. Compliance with good manufacturing
practices and sanitation requirements are the foundation for safe food production
forming the complex of GMP. In this complex belong the SSOP programs, which
prescribe the daily sanitation procedures implemented by the plant in order to avoid
contamination and/or adulteration.
According to the FDA31 the GMP involves standard sanitary operations and
procedures concerning the General Maintenance (cleaning and sanitising of facilities and
equipment), the Substances used for Cleaning and Sanitising, the Pest Control, the Storage
and Handling of any raw material or finished product circulating into the plant, and
different other factors such as the water supply, plumbing, sewage disposal, toilet
facilities, hand-washing facilities and rubbish disposal etc. Therefore we may say that
SSOP is a part of GMP, in the sense that it is an accumulation of internal written rules,
which are following the international guidelines and are expressed with the product’s
quality representing thus a specific for each plant, and still a worldwide accepted GMP.
Therefore, the “HACCP Plan” development and implementation depends on the
presence, in the enterprise, of an efficient and effective programme; furthermore they
control specific factors, which are not directly linked to the food production, but
represent a “support” to the plan. If these Prerequisite Programmes are absent or ineffective, it
can be necessary to detect and introduce in the HACCP plan more CCPs than those
strictly related to the productive process; this is due to the reduced attention, by the
operator, toward the points “not critical”. However, ideally, the HACCP system should be
implemented only when the Good Hygienic Practices (or the Prerequisite Programmes) are
present. That is in accordance with a specific need of the field operators, i.e. to keep the
CPP number to the essential minimum.

31 Food and Drug Administration


Table 14.: Good Hygienic Practices Manual in comparison with a HACCP

Consultative, didactic Prescribing
Generic Specific
(refers to one kind of product or process) (refers to the product or process system of a specific plan)
Prepared by the sector associations Prepared by the Company
Validated by the Ministry of Health Approved and signed by the company management
Validated by the local official Authorities

Table 15.: HACCP Manual in comparison with Quality System Manual

Its goals are defined by customer’s requirements. Its’ goals are defined by hygienic laws and by the
necessity to guarantee health security to the consumer.


The advantages of HACCP are certainly overwhelming both for processors and
inspectors. In most of the cases the implementation of a HACCP system on a plant is
increasing the prestige of the company surrounding it by a legal frame. At the same time
it simplifies the work for the authorities.

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).

Table 16.: Cost and Benefit analysis of a HACCP system for processors and
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
- ability for the food processors to prove food safety in
official audits
- manual development
- human resources training
- new equipment
- system management
- expertise
- 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).
It depends on: Food plant size
Quality system existence
GMP Manual existence


17.6.1. Validation
Throughout the application of the HACCP system various confirmation activities
are required to validate that the elements of the HACCP system plan are effective. These
activities need to take place at all stages of the HACCP system, for example,
confirmation that critical limits are appropriate and that identified hazards are reduced to
acceptable levels or eliminated. The responsibility for validation will vary depending on
the nature and size of the business and the availability of resources. The expertise for
validation may not exist within a small business. Therefore, this business may need to use
external validated data. These data may be found in legal requirements, national
standards, Codex Alimentarius Standards, or standards recommended by trade associations
or bodies.
The Codex Alimentarius guidelines are mentioning “Validation” on the application of the
seven HACCP principles, but they do not describe the way to perform Validation.
Generally speaking, a HACCP plan validation programme should include review of
hazard analysis, determination of CCPs, justification of critical limits, as well as the
determination of adequacy of monitoring activities, corrective actions, record keeping
and verification procedures
A HACCP plan contains a list of hazards, CCPs, critical limits, monitoring and
verification procedures etc. All these elements were decided by the HACCP team during
the HACCP study. At a certain CCP, specified hazards are controlled with specific
control measures; for instance a heat treatment to achieve a certain effect, which should
ideally be specified, (i.e. a process criterion should be set). To this specific CCP, for example,
Validation ensures that, the heat treatment at 72° C for 12 seconds really reduces
Salmonella a million fold (6D) on the equipment and in the food under consideration.
If a food product should not contain more than a certain level of a hazard at the moment
of consumption, challenge studies should be performed to validate that under the
marketing conditions, and even under slight abuse situations, the hazard levels remain
below a specified level.
Since Validation deals with product formulation, processes, storage conditions,
preparation and use, it should be performed before the results of the HACCP study are
approved and implemented. For this reason Validation requires highly professional skills
and may be costly and time consuming.

Validation is a responsibility of the industry!

It should be undertaken initially and as needed thereafter

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

monitoring, to determine compliance with the HACCP plan. Therefore verification

procedures are intended to check the effectiveness of the HACCP system.
Verification refers to activities undertaken to check compliance with the plan and its
implementation. These activities should be planned ahead, because they should be
approved by the responsible person in the establishment at the same time as all other
results of the HACCP study.
Originally the producer did verification to check the effectiveness of the HACCP
system. However, since HACCP has been incorporated into legislation and
recommended by Codex Alimentarius, the authorities have seen verification as their task.
Although internationally accepted definitions of the tasks of regulators or law
enforcement officers have not been established yet, it is believed that the food handler,
should do verification in accordance with the HACCP plan. That activity doesn’t exclude
necessarily the authorities from checking the verification procedures performed by the
handler in particular or the plan in general.
Taking under consideration that “Food Hygiene” means all measures necessary to
ensure the safety and wholesomeness of foodstuffs, then, “Food Hygiene Monitoring
System” is the main tool to prevent foodborne disease. Secondary, this system permits to
detect and prevent the causes responsible for the spoilage of food. An inefficient
monitoring system leads to economic losses, reduces credit by consumers in food
hygiene control system and also reduces credit in international trades.
In order for the monitoring system to be effective, measures shall cover all stages
after primary production (the latter including, for example, harvesting, slaughter and
milking), during preparation, processing, manufacturing, packaging, storing,
transportation, distribution, handling and offering for sale or supply to the consumer.
According to Article 132, of 94/356/EC: Commission Decision of 20 May 1994, {this can
be achieved by ‘Own-checks’, that means all those actions aimed at ensuring and demonstrating that a
fishery product satisfies the requirements of that Directive. Those actions must correspond to an approach
internal to the establishment; they must be developed and implemented by the persons responsible for each
production unit, or under their management, in accordance with the general principles set out}.
The documentation must include two types of information to be kept for submission
(upon request) to the competent authority:

A. A detailed and comprehensive document including:

- description of the product,
- description of the manufacturing process indicating critical points, identified hazards,
assessment of risks and control measures,
- procedures for monitoring and checking (at each critical point), with indication of critical
limits for parameters that need to be controlled
- corrective action to be taken in case of loss of control,
- procedures for verification and review.

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

- reports and written accounts of decisions relating to corrective action taken in the past

An appropriate document management system must be provided, in particular, for the

easy retrieval of all documents relating to an identified production batch.

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
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.

18.1.2. Third part Auditing

It is good practice to let “another pair of eyes” scrutinise the HACCP study and the
implementation of a HACCP plan. This scrutiny or “audit” can be performed by people
working already at the factory or industry to which the factory belongs, or by
professional auditors working for an independent accredited auditing organisation.
Since most processing lines are quite complicated, both HACCP teams and Audit
“teams” should include members with different expertise. However, the auditors should
have some advantages, which the HACCP team may not have. The reason for this is that
the HACCP team may overlook certain things because of a well known “familiarity
blindness” due to its professional affiliation with the company. Therefore the Audit team
should be able to identify possible week points of the HACCP plan proposed by a
HACCP team.
Very often auditors are acting on behalf of a customer who has specific requirements,
and they may recommend improvements to satisfy their customer’s specific needs.
Taking under consideration that audit is a tool through which the operations of the
HACCP system are formally monitored and conformance with the documented system is
assured, we may say that through audit it is possible to:
ƒ confirm that the written procedures (prerequisite programme and HACCP plans)
are up to date;
ƒ to review the HACCP system for its conformity33 with the written procedures
(implemented as described);
ƒ measure the effectiveness of the HACCP system in meeting the objectives set
in the written procedures. Furthermore audit has to assure uniform and
consistent actions, to guarantee the objectiveness of the evaluation, to
maintain records and enhance their use and maintenance in the plant.
Now taking under consideration that audit is consistent with the ISO 10011 we can apply
to it the following definition:
“Audit is a systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether
these arrangements are implemented effectively and are suitable to achieve
The audit has to assure uniform and consistent actions and objectiveness of the
evaluation. All these information should be kept in records (Audit Records).

33 The word “conformity” is used in reference to industrial activities; the word “confirmation” refers to a

regulatory situation.

The business management and the competent authorities are responsible, each for his
own competence, to guarantee the efficacy and efficiency of the check system
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.

18.1.3. Types of Audit

(a) First party audit
It’s the tool by which the “business” is monitoring adherence to the documented
HACCP system. It provides detailed information about failures of the system and
highlights the potentiality of improvement. The auditors are chosen within the company
but not strictly related to the area, function or procedures being audited.

(b) Second party audit

It is the tool through which the customer can directly evaluate if the
process/product of his supplier satisfies its request. In this case the auditor usually
belongs to the customer’s staff.
Sometimes the supplier can choose one person among the personnel who can act as a
“representative” of the customer. In many cases the customer is hiring an independent
expert to do the Auditing for him.
(c) Third party audit
It is performed by agencies, independent of both customer and suppliers,
recognised as competent to assess system against a standard. For quality management
system, third party audit is carried out by internationally recognised agencies; it’s
volunteer and the company will achieve certification related to the quality standard met.
Regulatory Audit complies with this type of audit.
(d) Vertical audit
It is used to look in depth a particular function or department. It permits to
monitor the use of all relevant procedures as they are used to support this function or
(e) Horizontal audit
It is used to follow a process from the start to the end. This kind of audit would
look at procedures as they support the process itself and is likely to span many different
functions or departments. Audits or assessment leading to certification are likely to be

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.

(f) Partial audit

It consists of an assessment of a part of the system. The partial audit goal may be
focused on:
- selected components or areas of HACCP system;
- follow-up to previous full or partial audit;
- concerns detected through consumer complaints;
- company’s HACCP system changes;
(g) Full audit
It consists of an assessment of both, prerequisite programmes and HACCP

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.

18.1.5. Audit procedure

The audit procedure and the related forms belong to the HACCP system
documents. It will include surveillance activities and checks on monitoring data to assure
the respect of critical limits as well as systematic and independent measures (control and test
on products and processes). The reason for that is to achieve objective evidence that the food
processing plant own-checks-system complies with the standards.
All the results will be filed in order to qualify and assure that the audit will be
conducted on the basis of previously established rules, which will define methods, tools,
frequency, responsibility and proper record keeping.

18.1.6. Frequency of auditing

The frequency of auditing has to assure that the System will not loose efficacy with
time. Therefore special audits out-of-schedule, should take place when there are changes
related to raw material (new supplier for example) or to the product (changes in processing
conditions, purchase of new equipment, new packaging material, extra cleaning and sanitising, etc).
Other reasons for extra (out-of-schedule) audits are: change in storage conditions,
consumer use, receipt of any information on a new hazard associated with the product,
evidence or suspect of non compliance, previous audit findings, etc.
Frequency is strictly related to the risks presented by a product and processes and
to the ability of the establishment to adhere to its HACCP system. The risks of the
establishment can be classified under three categories:
Category I: includes all the factories whose process includes a “kill step” or
other kind of process step, able to reduce or eliminate specific
35 The characteristics of this figure are defined in details in ISO 30011.

microbial contaminants. Many of the products are “ready-to-eat”.

Therefore, the loss of control within these establishments could
mean a significantly high health risk.
- Pasteurisation, heat treatment, drying, freezing dairy products, and
processed eggs
- Thermal processing of low acid /acidified low acid canned food
- Assembling, packaging and cooking of infant food
Category II: includes the establishments whose process generally don’t include
any kill steps. The processing control doesn’t minimise the potential
hazards through proper sanitation or temperature control as in
category I. So the quality of raw product entering has to be
considered a crucial factor and requires a special consideration in
order to permit manipulation without significantly increasing risk.
In category II, specific handling and storage instructions are
required in order to protect the consumer
- Washing, grading, packing shell eggs
- Fresh cutting, modified atmosphere packaging vegetables
- Freezing vegetables
- Cutting, packaging cheese

Category III: consists of establishments preparing products which do not pose

significant health hazards and the food processing to which they are
exposed represents little or no additional risk.
- Thermal processing, aseptic processing high acid foods
- Maple processing
- Honey processing
- Freezing, drying, packaging fruits
- Drying, packaging vegetables

18.1.7. Audit preparation

According to the HACCP plan there are certain activities that lead to a proper
auditing. These activities constitute the “audit plan” and can be summarised as following:
47. Audit scope: There should be always a definition of the boundaries of an audit (i.e.
what is going to be audited). It may depend by factors such as results of previous audits,
establishment profile, consumer complaints and other information.
48. Identification of the Chief auditor and the team members (if it is applicable): The
number of auditors required depends on the size of the company and the diversity of
the functions carried out within the establishment. The audit team members are
selected in relation to specified requirements (training, experiences, etc). They can belong
to the plant staff or to an external structure. The auditors must be independent of the
function and the department being audited. This is absolutely necessary to prevent
conflict of interest.
The plant management should provide the auditor/auditing team with all
documentation at its disposal. Specifically the auditor/auditing team, should review one
or more of the previous audit reports. It is important to highlight the presence of
recurrent non-conformities or if there is any outstanding corrective action request.
In order to avoid the possibility to obtain insufficient or incomplete data, the
auditor/auditing team will choose and elaborate all necessary tools. This necessary

documentation to facilitate the auditor’s work and to document and record all results
must include:
ƒ Check list36 to evaluate HACCP system elements and elaborate a specific
segment of the system;
ƒ forms to record all findings collected;
ƒ forms to document the objective evidence in order to support the auditors
final conclusion

18.1.8. Opening meeting

It is necessary for the members of the audit team to be introduced to the
management representatives so they can review together the key areas of the planned
audit. This meeting allows the establishment of official communication links between the
audit team and the management of the plant and confirms that the resources and
facilities needed are available for the team. Furthermore it is the proper time and place
when all necessary written prerequisite programmes and HACCP plans will be made
available to the team.

18.1.9. Gathering information

The audit is necessary to obtain evidence that procedures, documents and other
information describing HACCP system are kept up to date, are adequate in order to
achieve the required food safety objectives and they meet regulatory requirements. For
this reason, the auditor should conduct a series of activities such as questioning,
observing, examining records etc.
The auditor will record any audit findings and document it on the audit
worksheet. If any audit findings encountered during an audit, have not been audited at
that time, then they will be dealt with in the future in the appropriate manner. For
example, pest control procedures is not included in audit scope. However, if during the
on-site verification pests are seen, the pest control procedure will be added to the audit

Gathering information from on-site verification

On-site verification confirms that the monitoring procedures are carried out as
described in the written programme and that they are effective. Individuals are
interviewed and should be able to demonstrate that they have an understanding of the
critical limits, reason and importance of the monitoring of this CCP and know how to
perform the related monitoring procedures, including record keeping. Information is also
gathered through physical observation of activities carried out by the responsible
employee and conditions found in the selected areas of the plant. The correct records are
being used for this CCP.
Personnel responsible of selected areas will be interviewed in order to establish
that they have access to what they have understood and they are familiar with the written
procedures. A checklist is important to structure the interview. The auditor must be
equipped to ask the right questions in order to get the information required. The
information gathered through the interview, will be tested, by acquiring the same
information from other sources. The auditor will directly observe the plant condition to
verify specific procedures.

Gathering information on Establishment

36 Checklist is a tool commonly used for its peculiar characteristics. It permits to standardise the audit procedure,

avoid partial, insufficient and improvised audit record.


All valuable information for the establishment is gathered by on-site inspection.

This verifies the real and correct application of the rules described in HACCP manual,
which guarantee food wholesomeness and the adequate condition of working areas and

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.

18.1.11. Closing meeting

The auditor will communicate all findings to the HACCP co-ordinator. Prior to
preparing the audit report, the audit team will meet with management representatives and
present the audit findings. In relation to the evaluation of non-conformities identified,
the audit team will propose the Corrective Action request and the timetable to solve
them. The auditor should be sure that the results of the audit are clearly understood.

18.1.12. Audit report

The audit report has to include the scope of the audit, the identification of the
chief auditor and audit members, the identification of the establishment representatives,
the identification of the reference documents against which the audit was conducted and
of course the audit findings.
The audit findings have to be supported by the “evidence”. This means that the
auditor has to report “what” and “where” he detected the non-conformity.

18.1.13. Principal characteristics and subjects of regulatory audit (according to the

Council Directive 89/397/EEC “Official control of foodstuffs”).
Regulatory audit is carried out regularly and where non-compliance is suspected; it
therefore should be simple, and observable in order to guarantee the effectiveness of the
HACCP. It should be carried out in a harmonised way with a frequency more or less
related to the risk associated with the premises. Particular attention of the regulatory
audit should be given to critical control points identified by food businesses in order to
assess whether the necessary monitoring and verification controls are being operated.

E.U has not passed any guidelines for the

conduct of inspections
the Auditor can use his own methods of

But not exaggerate

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:
ƒ Premises (working areas, storehouses, storage areas, bathrooms etc);
ƒ Offices, Plant surrounding, Means of Transport, Machinery and Equipment;
ƒ Raw Materials, Ingredients, Technological aids;
ƒ Semi-finished products;
ƒ Finished products;
ƒ Materials and articles intended to come in contact with foodstuffs;
ƒ Cleaning and maintenance products and processes (pesticides/detergents);
ƒ 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

HACCP is a scientific and

FOOD systematic method, based on
prevention, aimed to assure food
SAFETY safety, from primary production to
final consumer, through
identification, assessment and
control of hazards, significant for the
food safety.

Therefore HACCP is an
instrument that allows to obtain
the hygienic aspects of food
HACCP quality.

and GOOD

Are managed out by the HACCP

plan through the Prerequisite
Programmes in order to control the
environment in the production site
for the benefit of the safety of food.

Premises (Structure and organization
description, Sanitation program, Pest
PREREQUISITES control program, Maintenance).
Equipment and tools (Equipment
description, Sanitation program,
Production process (Raw material
supply, Storage, Producing and
Distribution process, Waste disposal,
Water supply).
Personnel (Personnel hygiene and


A HACCP system is a scientific and systematic method aimed to assure food
safety. This method is based on “prevention” from the stage of primary production to
the final consumer and it is performed through identification assessment and control of
hazards significant for food safety. Otherwise, HACCP is an internationally accepted
instrument that allows obtaining the hygienic aspects of food quality.

According to another relative definition, HACCP system is a scientific, rational and

systematic approach to ensure food safety through identification, assessment and control
of the hazards, significant for food safety, from primary producer to final consumer.
However, prior the application of HACCP to any sector of the food chain, that
sector should be operating according to the Codex Alimentarius General Principles of
Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety
legislation. In the development of a HACCP plan, five preliminary steps need to be
accomplished before applying the HACCP principles to a specific product and process.
These tasks are as follows:
49. Assemble the HACCP team,
50. Describe the food
51. Describe the intended use and consumers of the food
52. Develop a flow diagram which describes the progress
53. Verify the flow diagram


19.1.1. HACCP Team
In order to work out with a HACCP system we should assemble
a HACCP team. The team should be familiar with overall
food operation and the specific production process to be
included in the plan. Therefore the team’s goal and each
member’s responsibilities in reaching that goal must be clearly defined. The first duty of
the team is to gather the information essential to the HACCP plan construction. This
information starts with the products’ description and the identification of its intended
use. Then the team should develop a flow diagram and a plant layout and confirm it on

19.1.2. Competencies and professional figure of the TEAM

The team must have specific knowledge referring to:
ƒ characteristics and intended use of examined product
ƒ phases of productive process
ƒ equipment characteristics
ƒ technological aspects
ƒ practical aspects of productive activities
ƒ microbiological principles of examined product
ƒ possible chemical or mechanical hazards
ƒ HACCP principles.
ƒ Therefore the team should be constituted by a Veterinarian specialised in
food safety aspects and/or an Agronomist, a Biologist, a Chemist, an
Engineer, a Physician, a person responsible of research and development
section and a person responsible of production.

19.1.3. Team’s activities

The activities of the team should focus on Hazard identification in every possible
point of the production, the determination and monitoring of the CCPs and the
validation of the actions implemented at CCP level. Therefore the HACCP team, after
studying the whole operation, should describe the product (identifying potential food safety

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.

19.1.4. Size and composition of the team

The number of people composing the team is dependent on the kind of examined
activity, nature of the hazards to be prevented, and complexity of the control measure to
be arranged. It also depends on the size of the plant and its’ different departments
involved in the production process as well as of the raw materials and the ingredients
used. For instance, in a vegetable processing plant an agronomist is required, whereas in
a meat processing plant a veterinarian should be used. Accordingly in a mixed plant both
professionals should be part of the team. The HACCP team should be composed by:
INTERNAL personnel, which is directly involved in daily activities of the
enterprise and
OUTSIDE expertise, whether the enterprise doesn’t have the competencies
essential to the HACCP plan development.
A HACCP team should include:
ƒ in general: personnel which is directly involved in daily activities of the
enterprise, and outside expertise, where the enterprise doesn’t have the
required competent personnel.
ƒ in particular: a top manager of the factory, a secretary, and private experts in
microbiology, chemistry and food technology. They should be familiar with
overall food operation and the specific production process to be included in
the plan. Therefore the team’s goal and each member’s responsibilities in
reaching that goal must be clearly defined.
External duties of a team
Furthermore the team should assure co-operation with other experts on every field
of food production and processing. In the very beginning the members of the team
define the scope of the study and set priorities according to the intended use of the
product37. Afterwards they study the formulation and the composition of raw materials
and ingredients taking into consideration all parameters influencing their safety during
processing, packaging and distribution. Now having full knowledge of the characteristics
of the product they are ready to construct a flow diagram38 covering all steps, which

37 Whether it is a Food Service Establishment, Caterers, Hospitals, Preparation practices etc.

38 This diagram should include important data such as time and temperature and indicate the specific hygienic
level for each working area or even setting barriers between working areas of different hygienic importance.
The flow diagram should be checked for its correctness of information, and whether this information is
important or overlooked. These checks are performed during all periods of operation (during working hours)
and during idle hours (cleaning, maintaining of equipment etc). At this point the person responsible for the
flow of diagram may discuss with operators, train them theoretically on GHP, GMP and HACCP rules and
help them practically to fill out the given forms.

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.
ƒ Responsible of quality assurance (co-ordinator)
ƒ HACCP responsible (technical secretary)
ƒ Responsible of meat division
ƒ Expert veterinarian (external expertise)
ƒ Expert on quality system (external expertise)
ƒ Official authority

2nd Example – HACCP plan of cheese in a small and/or less developed dairy.
ƒ Owner
ƒ Expert veterinarian (external expertise – co-ordinator)
ƒ Expert on quality system (external expertise)
ƒ Official authority


One of the first activities of the study team is to describe the product (which raw
materials and ingredients are used, and who are the suppliers). Which parameters influence safety
(pH, aw, modified atmosphere packaging, storage temperature and time). What are the processing
conditions, temperature treatment etc? How is the packaging performed, and what are
the characteristics of the packaging material? What are the real conditions during
distribution, warehousing and sales? All these information is described in a specific
“form” called “product Description Form”. Next, the intended use of the product has to
be defined.

19.2.1. Product Description Form for Raw Material/Ingredient (examples)

In the following form are described the origin of the raw material, the percentage of final
product, all chemical-physical characteristics (pH, aw, stickiness, temperature, etc), its

microbiological composition, as well as storage conditions before use, preparation

methods, packaging and finally transport.

Table 17.: Product Description Form for “Frozen halibut steaks”

1. Product name(s) Identify the species and method of processing: e.g., “Frozen halibut steaks”
2. Source of raw material State where it came from: e.g., “Locally caught” or “Imported from
3. Important final product List characteristics that affect product safety, especially those that influence
characteristics pathogens, such as pH level or salt concentration.
4. Ingredients List every substance added during processing: e.g., water, salt. Also list all
ingredients of sauces and batter or crumb coatings.
5. Packaging List all packaging materials: e.g., waxed cardboard, polyethylene wrapping.
Only approved materials may be used.
6. How the end product is to be State how the final product is to be prepared for serving, especially whether it
-used is ready to eat.
7. Shelf life (if applicable) State the date when the product can be expected to begin to deteriorate if
stored according to instructions: e.g., “use within 21 days of shipping”.
8. Where the product will be sold If the product is for export only – that is, it contains an ingredient not
permitted in your country, include this information so that the product goes
only to a market where all its ingredients are permitted.
9. Special labelling instructions List all instructions for safe storage and preparation: e.g., “Keep refrigerated”.
10. Special distribution control List all instructions for safe product distribution: e.g.: “Keep refrigerated”.

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

Table 19.: List of Product Ingredients and Incoming Materials for Mechanically
Meat (Chicken)

Meat Products Restricted Ingredients Packaging Materials

Chicken Portions (Necks, Backs, Sodium Nitrite Cure (Prague Powder) Waxed Carton C
Racks, Wings) BCP Tamper-Evident Tape
Nutrition Facts
Serving Size ½ cup (114g)
Serving Per Container 4
Amount per serving
Calories 90 Calories from Fat 30
% Daily Volume
Total Fat 3g 5%
Saturated Fat 0g 0%
Cholesterol 0mg 0%

Sodium 300mg 13%

Total carbohydrate 13 g 4%
Dietary Fibre 3g 12%
Sugars 3g
Protein 3g
Vitamin A 80% Vitamin C 60% Calcium 4% Iron 4%
Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie
Calories 2,000 2,500
Total Fat Less than 65g 80g
Sat. Fat Less than 20g 25g
Cholesterol Less than 300mg 300mg
Sodium Less than 2,400 mg 2,400mg
Total Carbohydrate 300g 375g
Dietary Fibre 25g 30g
Calories per gram:
Fat 9 - Carbohydrate 4 - Protein 4

19.2.2. Product Description Form for Restaurants

For the product description in the restaurants it is possible to organise the recipe in
the following four sections:
ƒ Section 1: General description (name, execution time, etc)
ƒ Section 2: Description of all ingredients, listed in order of decreasing
Indication for each ingredient, of the weight, in percentage, on all the ingredients
and the weigh loss due to cooking.
In particular situations it is necessary to indicate, for each portion, the nutritional
value {Calories (Kcal), proteins (g), total carbohydrate (g) dietary fibre (g), sugars (g), total fat
(g), cholesterol (mg), saturated fat (g), monounsaturated fat (g), polyunsaturated fat (g), vitamins
(mg), minerals (mg)}
ƒ Section 3: Representation, through a flow chart, of the main process phases.
Description for each phase, of activities and main process parameters (time and
Organization of activities in the following 9 phases:
A. receipt (referring operative instruction)
B. storage (referring operative instruction)

C. preliminary activities (ingredient selection, “best before date” and boxing

integrity verification, package elimination, preservation condition verification, cleaning,
washing, cutting, ingredient assembling)
D. preparation (cooking, cooling/freezing)
E. storage
F. service (making portions etc.)
G. storage
H. heating
ƒ Section 4
Listing of all ingredients responsible of allergic reaction for the consumers.

Recipe types and processes


In restaurants it is possible to group the different recipes in 5 types and 7 processes

as following:
1. Assemble and serve
2. Cook and serve (fresh-fresh)
3. Cook and keep warm (fresh-warm)
4. Cook and keep refrigerated (fresh-refrigerated)
5. Cook and keep frozen (fresh-frozen)
1. Thick foods (more than 5 cm/2-inch)
2. Thin foods (less than 5 cm/2-inch)
3. Sauces and brews
4. Fruits, vegetables and starches
5. Bread and batters
6. Cold combination products
7. Hot combination products

19.2.3. Product Description Form for Self life

Shelf life is the period during which the product maintains its microbiological
safety and sensory qualities, including visual appearance, under expected storage
conditions. The HACCP team has to set the product shelf life, when it is not indicated,
or to validate the safety of the chosen (by the industry) shelf life.
The shelf life is based on identified hazard for the product, heat or other
preservation treatments, inhibiting factors, as well as packaging and storage conditions.
Therefore, in order to set a shelf life of a product or to validate the proposed one, the
HACCP team should rely on microbiological challenge and other studies.
Expiry date (Use-by-date): is the date after which the product should not be
Sell-by-date: tells the store how long to display the product for
Best-before-date: is the date recommended for best flavour or
quality. It is not a purchase or safety date.


As intended use of food (or product in general) is defined the normal expected use of
it (i.e. whether it is ready-to-eat, to drink or ready-to-cook, or should be mixed etc). On the other
hand the same terminology is used to determine the consumer, or otherwise, whether or
not the food is intended for infants, immunocompromised individuals, the elderly,
pregnant women, etc.
The identification of the product’s intended use is following the description of the
product., because this may influence the level of safety to be assured, or the risks which
can be taken. If the product is to be sold to hospitals or groups of the population with
high susceptibility to certain microbes, more safety has to be built in and critical limits
need to be stricter.
The use and preparation practices may also influence the safety of the product. HACCP
is successful only if applied from farm to fork. For certain products such as hamburgers,
the preparation practices determine the final safety for the consumer. For certain

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.


The purpose of a flow diagram is to provide a clear, simple outline of the steps
involved in the process. The scope of the flow diagram must include all steps in the
process, which are directly under the control of the establishment. In addition, the flow
diagram can include steps in the food chain, which take place before and after the
processing that occurs in the establishment.

A flow diagram is a “map” of the process

19.4.1. Flow diagram:

A Flow diagram is a schematic representation of the sequence of steps or operations
used in the production or manufacture of a particular food, from raw materials receipt to
end product sale or service. A Plant layout is a graphic representation of the plant.
To understand how a product is manufactured, and to have a disciplined approach in the
study, it is important to construct a flow diagram covering all steps where product safety
could be affected. In order to do this all information, which should be looked at, should
be gathered. Temperatures in heat treatments should be mentioned as well as time; time
and temperature should also be mentioned for holding the product in buffer tanks,
holding vats etc.
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.
For instance, all Good Manufacturing Practices require a clear separation between raw
materials and prepared foods. For the same reason, it is important to indicate on the
diagram or factory layout sheet, the personnel movements.
In flow diagram the phases should be listed and described considering at least the
following steps: 1) incoming raw material storage, 2) operations before manufacturing, 3)
manufacturing phases, 4) productive process parameters, 5) end-product storage, 6)
packaging, 7) transport.

19.4.2. Flow diagrams (symbols)

It describes the activities in each process phase

It indicates a raw material, an ingredient, a by-product of the


It indicates a decision point in the productive process

It indicates flow direction

19.4.3. Flow process chart symbols

This symbol represents any kind of operation or group of
operations, which results in an intentional change in the form or
arrangement of the material, which brings it nearer to completion.

This symbol represents an inspection or decision. Material is
examined for identification or is verified.

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

A storage where material is kept in an unchanged form and
protected against unauthorised removal.

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.


When it is desired to show activities performed either concurrently

or by the same operator at the same workstation, the symbols for
these activities are combined as shown for a combined operation
and inspection by the circle within the square.

The flow diagram needs not to be as complex as engineering drawings. A block

type flow diagram is sufficiently descriptive. Also a simple schematic illustration of the
facility is often useful in understanding and evaluating product and process flow39.

Example of a flow Diagram for the production of Frozen Cooked Beef Patties

Receiving beef


Cooking Freezing Boxing

39 PAHO/INPAZ 2001/HACCP Essential Tool for Food Safety.


Distributing Reheating



The efficiency of the HACCP plan depends on the expertise used during its
development, and the correctness of the data used. Assessment therefore starts with an
evaluation of these two points. As has been mentioned before, not only should HACCP
be assessed, but also the prerequisites. The accuracy of several data, such as the
correctness of the flow diagram, can only be checked during on-site inspection. Up to
this point, the study is a paper exercise. Clearly, what has been put on paper should be
confirmed by an on-site inspection. This should check the correctness of the information
and ensure that nothing crucial was overlooked. It is important to inspect the site and the
practices applied during all hours (night shifts, weekends etc.) of operation, as well as the idle
Inspection of the cleaning procedures and validation of their efficacy are very
important. Operators often are better informed than Chief Engineers or Production
Managers about practices and the problems encountered during the operation, and may
have information about problems that were not considered in the study.
The used method is the direct observation through the inspection in order to find
out possible discrepancies between documents and reality and to adjust the wrong


It is unanimously accepted that responsibility for producing safe food is in the
hands of producers or providers. It is thus the responsibility of industry to ensure
proper application of the seven HACCP principles and implementation of the HACCP
plan. The Codex Alimentarius text distinguishes principles (which are essential), from
guidelines for their application (which are advisory). Application may differ according to the
product, the size and sophistication of the industry, the country etc., but it is the
responsibility of the industry to ensure that the essentials of HACCP are put into practice
and, when requested, to provide evidence that this was done.
One very important aspect of HACCP has to be repeated here. Each step of the
food chain has its own responsibility. HACCP is effective at ensuring safety only when it
is applied at all steps, from farm to fork. Food safety is a shared responsibility of
farmers, manufacturers and consumers.
HACCP consists of 7 principles, which are the minimum requirements in the
mandatory application of the HACCP system. These principles are the following:
Principle 1: Conduct a hazard analysis
Principle 2: Determine the Critical Control Point (CCP)
Principle 3: Establish critical limits
Principle 4: Establish a system to monitor control of the CCP
Principle 5: Establish the corrective actions to be taken when monitoring
indicates that a particular CCP in not under control
Principle 6: Establish procedures for verification to confirm that the HACCP
system is working effectively
Principle 7: Establish documentation concerning all procedures and records
appropriate to these principles and their application


The team should examine the problems caused by the foodborne diseases in the
specific region or country where the product is produced or raw materials are coming
from and identify the hazards to occur at any step of the process. These can be of
microbiological, chemical or physical nature. Within a HACCP system, there is a
distinction between biological, chemical and physical hazards. In case of physical
hazards (splinters of metal, glass or other foreign material), is required logical thinking and the
knowledge of the technological production procedures. Here, the expertise lies with the
technical staff of the food company. In contrast, the assessment of chemical and
biological hazards requires special expertise for the pathogenesis of human diseases,
which are caused by such hazards. Therefore the development of effective preventive
measures requires comprehensive knowledge of the epidemiological factors, which
threaten the health of the consumer. A hazard analysis carried out for a product or
process should be reviewed if any changes are made in the product or the process (new
raw material, changes in the method of preparation, processing or packaging etc)
Hazards of low probability of occurrence and of a low severity should not be
addressed under the HACCP system but may be addressed through Good Manufacturing
Practice (GMP)40.
Points that should be considered while performing a hazard analysis include:

40 PAHO/INPAZ 2001/HACCP Essential Tool for Food Safety


ƒ The likely occurrence of hazards and the severity of their adverse effects.
ƒ The qualitative and quantitative evaluation of hazards
ƒ The survival or multiplication of microorganisms in concern
ƒ The production or persistence in foods with toxins, chemicals or physical
ƒ The quality of raw material
ƒ 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 CCP is a step in the food chain where activities are carried out, or conditions
prevail which can have an influence on the safety of the product, and where control can
be exercised over one or more factors to prevent or eliminate a food safety hazard or
reduce it to an acceptable level.
The Codex Alimentarius guidelines define a critical control point (CCP) as a step at
which control can be applied and is essential to preventing or eliminating a food safety
hazard or reducing it to an acceptable level.
Critical Control Points are crucial to ensuring product safety. A CCP can be related
to raw materials, processes and practices applied along the food chain. CCPs govern all
factors, which are basic to the prevention of foodborne diseases.
If a hazard has been identified at a step where is necessary for safety and if no
control measure exists at that point or at any other, then the product or process should
be modified at that step, or at any earlier or later stage, to include a control measure for
this hazard.
Determination of critical control points (CCPs) must follow a logical consideration of all
steps where hazards can be controlled. There may be one or more CCPs at which control
can be applied to address the same hazard.
The determination of a CCP in the HACCP system can be facilitated by the application
of a flexible, decision tree according to the type of operation, which indicates a logical
reasoning approach. (e.g. production, slaughter, processing, storage, distribution or other). The next
figure represents a decision tree such as that included in the Codex Alimentarius, Hazard
Analysis and Critical Control Point (HACCP) System and Guidelines for its Application.

41 PAHO/INPAZ 2001/HACCP Essential Tool for Food Safety


A decision tree* included in the Codex Alimentarius, Hazard Analysis and Critical
Control Point (HACCP) System and Guidelines for its Application.

Do control preventive measure(s) exist?


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?


Will a subsequent step eliminate identified hazard(s) or

Not a CCP Modify step, Process or Product
reduce likely occurrence to an acceptable level?


Not a CCP Critical Control Point

Could contamination with identified hazard(s) occur in excess of
acceptable level(s) or could these, increase to unacceptable level?




20.3.1. Critical Limits

Critical limits are defined as criteria that separate acceptability from unacceptability.
A critical limit represents the boundaries that are used to judge whether an operation is
producing safe products.
The critical limits must be specified for each critical control point, be realistic and
especially sufficient to provide the necessary food safety assurances. Measurable and
observable criteria used to set critical limits may include measurements of temperature,
pH, time, available chlorine etc.
The critical limits should meet requirements set out by government regulations and
company standards and most of all should be supported by scientific data. In some case,
food control regulatory authorities provide information on which to establish the critical
limits based on known food hazards and the results of risk analysis42 (e.g. the
time/temperature requirements for thermal processes such as pasteurisation, cooking, retorting, maximum
number and size of physical contaminants, chemical residues etc). It is essential that the person
responsible for establishing critical limits have knowledge of the process and of the legal
and commercial standards required for the product.
Sources of information on critical limits include:
ƒ Scientific publications/research data
ƒ Regulatory requirements and guidelines
ƒ Experts studies (e.g. thermal process authorities, consultants, food scientists, microbiologists,
equipment manufacturers, sanitation specialists, academics)
ƒ Experimental studies (e.g. in-house experiments, contract laboratory studies).
If the information needed to establish critical limits is not available, a conservative
value should be selected or regulatory limits used. Once the critical limits are established,
they are recorded in the proper form together with the description of the process step,
CCP number and hazard description.

20.3.2. Operating limits

If monitoring shows a trend towards lack of control at a CCP, operators can take
action to prevent loss of control of the CCP before the critical limit is exceeded. The
point at which operators take such action is called “the operating limit”. Operating limits
should not be confused with critical limits because they may be almost similar and yet
they are quite different to each other. The explanation is because the operating limit is
more restrictive and it will be reached before the critical limit is violated. For example the
operating limit for drying oven in the table 19 (next page) = 0.80 Aw. At this point the
operator is taking action before the Aw goes over 0.85 were bacterial pathogens may

42 Risk Analysis is a process consisting of 3 components : Risk Assessment, Risk Management and Risk


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

Hazard CCP Critical Limit

Bacterial pathogens non sporulating Pasteurisation 720 C (161.50 F) for at least 15
Metal fragments Metal detector Metal fragments larger than 0.5 mm
Bacterial pathogens Drying oven Aw < 0.84 -0.85 for controlling growth in drying
food products
Excessive nitrite Brining Maximum 200 ppm sodium nitrite in finished
Bacterial pathogens Acidification step Maximum pH of 4.6 to control Clostridium
botulinum in acidified food
Food allergens Labelling Legible label containing all ingredients
Histamine Receiving i.e. maximum of 25 ppm histamine levels in the
evaluation of tuna for histamine*.
* US regulatory action level is 50 ppm, but histamine levels may increase during processing. Therefore,
industry may want to set lower histamine critical limits at receiving.


The Codex Alimentarius Hazard Analysis and Criticl Control Point (HACCP) System and
Guidelines for its Application, defines “monitoring” as the observations or measurements of
control parameters in order to assess whether a CCP is under control.
Therefore “Monitoring” is checking by testing, measuring or observing, whether a
Critical Control Point is under control. It is the tool that will confirm if the HACCP plan
is being followed. It is essential in making sure that critical steps are under control. It
will identify where a loss of control has occurred or if there is a trend towards a loss of
control. It will also identify the corrective actions to the processes to restore or maintain
control. The monitoring procedures must be able to detect loss of control at the CCP.
The monitoring system will be effective only if the owner of the establishment, the
manager and employees are given the knowledge, skills and the responsibility for
preparing safe food.
There are many ways to monitor the critical limits of a CCP. Most commonly
monitoring can be done on a continuous basis (100%) or on an every batch analysis
basis. Among the above, continuous monitoring is preferred, where feasible, because it is
more reliable. The higher the frequency of monitoring (i.e. the less time between each instance
of monitoring), the less product will be affected when there is a loss of control at the CCP.
Field experience has proven that sampling and microbiological testing are usually not
adequate by themselves to ensure food safety. Microbiological testing is seldom effective
for monitoring CCP and cannot be used as a means of process control because of the
“time-consuming” of most analytical procedures and the inability to provide results in real
time. In addition, detection of pathogenic micro organisms can be difficult if
contamination of the product at the CCP is at a low level or is unevenly distributed in the
food sample, necessitating large and numerous samples. However microbiological testing

43 PAHO/INPAZ 2001/HACCP Essential Tool for Food Safety.


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
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
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).


Specific corrective actions must be developed for each CCP. Corrective actions
must specify what should be done to bring the CCP under control and ensure that
potentially unsafe products are not marketed. Corrective actions include steps to correct
the problem and steps to deal with the affected product.
The Codex Alimentarious Hazard Analysis and Critical Control Point (HACCP) System and
Guidelines for its Application defines as “Corrective action”, any action to be taken when the
results of monitoring at the CCP indicate a loss of control. In this concept, loss of
control is considered a deviation from the critical limit of a CCP and deviation is a failure
to meet a critical limit.

44 PAHO/INPAZ 2001/HACCP Essential Tool for Food Safety.


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
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.

Examples of deviation procedures for different products45.

Canned Vegetables: “The scheduled thermal process is not met because of a loss in steam
ƒ The operator notices the deviation before the product is released and refers
immediately to the written deviation procedures.
ƒ According to the deviation procedures the operator adds an additional
processing time.
ƒ However the problem is not completely over! The operator following the
instructions, reports the incident to his superior and they mark the suspected
lot for further inspection by the experts, leading to its authorisation or final
In case that the same problem persists, beyond the above-mentioned detention of the
product for inspection, the processor should examine the underline cause of the
deviation, i.e. he should determine the reason for the loss in steam pressure and the
actions that should be taken to prevent recurrence of the problem.
Milk: “Antibiotics are detected by a rapid screening test”
ƒ The operator notices the deviation before the product is unloaded from the
truck and refers immediately to the written deviation procedures.
ƒ According to the deviation procedure the operator/manager should follow
up with the milk supplier involved. All corrective actions are recorded.
Cooked sausages: “Sausages are sliced with equipment that has not been cleaned at specific

45 PAHO/INPAZ 2001/HACCP Essential Tool for Food Safety.


ƒ 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.
ƒ The employee responsible for equipment cleaning is questioned according to
the written procedures and is retrained if necessary.


The Codex Alimentarius guidelines define “Verification” as the application of
methods, procedures, tests and other evaluations, in addition to monitoring, to determine
compliance with the HACCP plan.
In other words “Verification” refers to all these activities undertaken to check
compliance with the plan and its implementation. These activities should be planned
ahead, because they should be approved by the responsible person in the establishment,
at the same time as all other activities of the HACCP study.
Originally, the producer did verification in order to check out the effectiveness of
the HACCP system. For this reason he was using a qualified individual or individuals
who were capable of detecting deficiencies in the plan or its implementation. However,
since HACCP has been incorporated into legislation and recommended by Codex
Alimentarius, State regulators have seen also verification as their task. However, there are
no “written” internationally accepted definitions of the tasks of regulators or law
enforcement officers.
In this chapter we will use the word verification to include any activity performed by the
food handler, which is in accordance with the HACCP plan, because we should agree
that the food handler is the first person in line that has the opportunity and the
possibility to perform the everyday verification in order to determine conformity46 with
the HACCP plan.
Of course we should define as verification any inspection from the side of the
Authorities, but only when the results of these tests are used for the benefit of the
When during a regulatory assessment books and records are reviewed, this again can be
seen as verification, as long as the results are used by the industry.
If results of assessment activities by regulatory authorities are not communicated to the
industry and used by the industry these activities should not be called verification.

The word “Conformity”47 is used in reference to proper industrial activities whether

“Confirmation” means compliance with State regulations (conformity of a food industry with
GMP, / confirmation of the industry with local Food Legislation).
In definitions both of conformity and confirmation, it is mentioned that they refer not
only to HACCP, but also to its prerequisites48. Foods in international trade have to be
produced according to General Principles of Hygiene and HACCP. Even for foods,

46 PAHO/INPAZ 2001/HACCP Essential Tool for Food Safety.

47 System conformity means that the seven principles have been correctly applied and that the HACCP plan is
correctly and consistently implemented. It is not an approval of the system, i.e. that all the hazards have been
correctly identified, that critical limits have been correctly chosen etc. It only means that the system was
understood and the resulting activities put into action.(for distinction between conformity and confirmation see
par. 20.7)
48 Prerequisites of HACCP are practices and conditions needed prior to and during the implementation of

HACCP and which are essential for food safety, as described in the Codex General Principles of Food Hygiene
and other Codes of Practice.

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
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
ƒ Business personnel,
ƒ External personnel,
ƒ Governmental organizations,
ƒ Inspection services,
ƒ Private organizations,
ƒ Quality control laboratories,
ƒ Trade associations,
ƒ Consumer associations,
ƒ Buyers,
ƒ Importing country authority
ƒ 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

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

20.6.1. Verification activities

Verification is an ongoing activity. A new hazard analysis is necessary after changes
in raw materials, processing conditions, line layout, distribution conditions, preparation
and use etc. The outcome of such an analysis may need to be validated and verified. As a
consequence of trends detected in monitoring results, or results of raw material and end
product testing, changes may be made which need to be verified. External auditors or
government inspectors should keep records of all these verification activities for
The verification activities are mentioned more detailed below:
ƒ Analyse the HACCP plan documents and its registers,
49 Confirmation of Effectiveness means that evidence is sought to confirm that the system delivers what is


ƒ Scientifically evaluate all hazards,

ƒ Analyse deviations of critical limits,
ƒ Analyse corrective actions taken for each deviation in the past,
ƒ Guarantee that all CCP are under control,
ƒ Guarantee -through calibration- that all measuring equipment are working
ƒ Perform laboratory analysis to guarantee that the critical limits are well
established, and
ƒ Evaluate suppliers for quality assurance.

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.


Records are written evidence through which an action is documented. A record
shows the process history, the monitoring, the deviations and the corrective actions that
occurred in the past. Accurate documentation and record keeping is essential to the
application of a HACCP system. They should be appropriate to the nature and size of
the operation. They should also be sufficient to enable the business to be confident that
controls are in place and being maintained. Records document that the critical limits at
each CCP were met or that appropriate corrective actions were taken when the limits
were not met. They can also record that the actions performed were verified. Therefore it
is imperative that the producer maintains complete, current, properly filed and accurate
Four types of records should be used in the HACCP plan:
63. Basic Support Documentation (bibliographical or other data used for the
establishment of control measures, shelf life, critical limits)
64. Records generated by the HACCP system. These records describe all activities and
documentation required to prove adherence of a HACCP system to the originally
designed HACCP plan.

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).

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. \


The food business management and the competent Authorities are responsible,
each for its own competence, to guarantee the efficacy and efficiency of the own-check
system implemented. For this reason it’s important to define the peculiar aspects of the
roles of those figures.
The industry (by all means) should apply all available hygienic practices in order to:
ƒ provide the consumer with food, which is safe and suitable for consumption,
ƒ ensure that the average consumer shall have clear understanding on the
information written on
ƒ the labels in how to store/preserve, cook, prepare or handle the specific
In this way the industry shall maintain confidence not only within the country but
in the international community as well.
In order to succeed in this task the industry should develop, implement and
maintain prerequisite programmes and HACCP plans; maintain the necessary records;
ensure an appropriate training programme for the staff; be complied with all regulatory
aspects. This is the role of an experienced HACCP team, which should develop its own-
checks system’s verification. The first step of the team is to specify the methods and
procedures to be used.
Usable methods may include, in particular, random sampling and analysis,
reinforced analysis or tests at selected critical points, intensified analysis of intermediate
or final products, surveys on actual condition during storage, distribution and sale and on
actual use of the product.
Verification procedures may include: inspection of operations, validation of critical
limits, review of deviations, corrective action and measures taken with regard to the
product, audits of the own-check system and its records. Verification should provide for
confirmation of the suitability of the own-checks system established and ensure,
afterwards, with an appropriate frequency, that the provisions laid down are still being
properly applied.


21.2.1. Inspection
Is the examination of food or of the systems who control it, of raw materials,
processing and distribution (including in-process and finished product testing), in order to verify
that they conform to requirements (Codex 1997). The Codex Committee dealing with
import and export regulations has defined the term inspection. HACCP assessment is
one of the aspects of inspection. According to this definition it is very important for
importing and exporting countries to agree on the "requirements". It should be realised
that this definition should serve all kinds of inspection activities, not only those to assure
the safety of food.
Inspection is performed by the evaluation of hygienic compliance of structures, good
manufacturing practices, and the final products Therefore governments should take all
necessary measures to:
ƒ protect consumers from food or waterborne diseases.
ƒ provide assurance that, any food or water in the market (locally produced or
imported), is suitable for human consumption.
ƒ subsidise relevant education programs for food inspectors and consumers.
However beyond the roles and responsibilities of the industry and the Governments, the
consumer should always be alert in order to follow the written instructions and apply the
basic hygienic measures.

Although HACCP is a food safety management tool used by industry,

governments can or have to play several roles in its use. It is therefore very important
that industries understand the role governments have to play in HACCP, and that
governments understand the intricacies of industrial implementation of HACCP.
Government authorities can play three roles; they can act as facilitators, enforcers
and trainers.
As facilitators, they can help industries understand the goals and scope of HACCP, and
provide expertise during the establishment of a HACCP plan or its verification.
As enforcers, their task is to assess the correct application and implementation of the
seven HACCP principles.
Government authorities can participate in training courses organised by or for
industry, as well as provide training programmes for use in such courses.

21.2.2. Responsibilities of Governments

The responsibilities of governments consist in Strategic and Operative effective
implementation as well as on going-assessment of HACCP.
Strategy means having a plan of how to do certain things or to achieve a pre-set goal.
Before governments are going to implement a mandatory or even a voluntary HACCP
programme, they should have worked out how to do it, foreseen the necessary training,
allocated sufficient resources and communicated this programme to the industry.
Once the programme started it becomes operational and many activities have to be
executed, with several on an on-going basis. The Operative responsibilities are listed
ƒ Enforcing relevant legislation and regulations
ƒ Applying sanctions in case of non-compliance
ƒ Engaging in international relations
ƒ Conducting research, risk assessment
ƒ Publicising requirements

ƒ Providing technical assistance

ƒ Training (governmental and industrial people)
ƒ Regulatory assessment

The above-mentioned responsibilities are self-explanatory. It is evident that,

governmental inspectors have to enforce the legislation, and that sanctions have to be
applied in case of non-compliance. Governments have always had certain relations with
other governments, but their responsibilities as exporters towards importing countries
have been enlarged as a consequence of the WTO/SPS agreement. Another consequence
of this agreement is that food safety criteria such as Food Safety Operations criteria and
microbiological end product criteria have to be based on scientific evidence and where
appropriate, on risk assessment. Conducting scientific research is therefore an operative
responsibility. Results of these studies have to be published and communicated to
interested bodies as part of the transparency policy required by WTO/SPS. Having
scientific knowledge also means that technical assistance can be provided, which is also
part of the training to be given to governmental inspectors and industrial operators.
Regulatory assessment will be discussed in more detail.



Regulatory Assessment refers to governmental activities carried out with the

objective of obtaining evidence that the seven principles have been effectively applied
and the HACCP plan and prerequisites to HACCP correctly implemented and
additionally that the system has been maintained. This definition that expresses clearly
the responsibility of a governmental inspector in assessing HACCP was the result of the
FAO/WHO consultation of June 1998. An important aspect of this definition is the
mentioning of prerequisites to HACCP. It was the unanimous opinion of the experts
that HACCP can only be based on having effective GHPs and other prerequisites in
Although it is the responsibility of food industry to assure the safety of food on the
market, history has shown that overseeing is necessary, as adulteration of food is still
taking place even in developed countries where food laws and regulations have a long
history. Even if governments accept that development of a HACCP plan is the industry’s
responsibility, they still have to ascertain that those HACCP plans lead to the
manufacture and distribution of safe food.
Regulatory assessment should cover various aspects of HACCP. First of all it
should be determined whether hazards have been correctly identified, adequate CCPs
determined, correct control measures were put in place etc. Then evidence should be
sought to assess whether the production of safe food is consistently assured. This
includes reviewing the documentation in order to assess whether the plan was indeed
executed. The assessment should not only cover the development and implementation of
a HACCP plan, but also its maintenance.
HACCP is an on-going and dynamic system. It has to respond to changes, it has to
be improved whenever data indicate that such an improvement is necessary or that the
system can be more efficient or more effective by making certain changes.
Although verification of the HACCP plan has been used in various countries as
the term to deal with governmental assessment of HACCP, in this document the word
“verification” is used also mostly for activities carried out by the industry. The results of
governmental activities such as document review and end product testing can be used for

verification by industries as part of their information gathering. A governmental

assessment report is certainly the type of information which will be examined in detail
and improvements will be made in the HACCP plan, if necessary.
The elements of the regulatory assessment are summarised below:
ƒ HACCP management
ƒ HACCP plan development
ƒ Hazard analysis
ƒ Control measures
ƒ Business’s verification procedures
ƒ Documentation
ƒ Implementation

22.1.1. Assessing the HACCP management

The commitment of management to apply, implement and maintain HACCP is of
utmost importance. Obtaining indications concerning this commitment is therefore one
of the first elements of assessment. If the business never had food safety problems, if all
personnel are well trained to do their jobs, if the overall knowledge of hygiene is
adequate, this already shows that management considers these elements as very
important. If the establishment has technical skills and expertise or when these are
readily available, this shows again that management understands that this is necessary to
assure the safety of its products. In smaller enterprises documentation may not be really
necessary, because personnel know everything “by heart”. When HACCP plans and their
execution are still well documented, this again is an indication of management’s
commitment. An indication of management’s commitment to food safety can be
obtained by checking the compliance history of the business, the level of food hygiene
training and its application, the technical knowledge within or available to the company
and the existence of satisfactory documented procedures and food safety management

22.1.2. Assessing the HACCP plan development

The efficiency of the HACCP plan depends on the expertise used during its
development, and the correctness of the data used. Assessment therefore starts with an
evaluation of these two points. As has been mentioned before, not only should HACCP
be assessed, but also the prerequisites. The accuracy of several data, such as the
correctness of the flow diagram, can only be checked during an on-site inspection.
During this inspection the accuracy of the product and the description of the process is
been evaluated. The accuracy of the flow diagram and the adequacy of the prerequisites
to HACCP are also evaluated.

22.1.3. Assessing the HACCP analysis

For HACCP to be effective, significant hazards, which are inherent to the product
or production line, should not be overlooked. Furthermore products and the way they
are produced may seem similar, but details may be different and a small difference may
have an influence on the outcome of a hazard analysis. For instance, botulism was caused
by a hazelnut yoghurt when the hazelnut paste was produced with an artificial sweetener
instead of sugar. The water activity of the sugar-free paste permitted growth and toxin
formation, where the sugar in the original formula prevented this. The outcome of a
hazard analysis is as good as its input. Sometimes it may be necessary to ask for access to
supporting data. A very important point to be looked at, is the history of the product.
When the product under scrutiny has been produced and consumed during a long period
of time, not much more evidence is needed to assess its safety.

22.1.4. Assessing the effectiveness of control measures

Effective control is only achieved if indeed the CCPs have been identified in every
point of the food processing chain and they are adequate. The critical limits, or otherwise
the criteria which separate acceptability from unacceptability of the product, ensure the
required safety level and finally, the monitoring procedures assure that the system
remains under control, and that if a deviation occurred, adequate corrective actions were

22.1.5. Assessing the verification procedures

Considering that the term “verification” is used for a number of different activities,
these actions can be summarised as obtaining evidence that safety of the product was
assured. Many of these activities and their results can easily be reviewed. It may be more
difficult to find out whether actions were taken in time as a result of new emerging
hazards and whether these actions were adequate. Assessing these aspects of HACCP is
very important because they give a good indication whether verification is indeed an
ongoing activity.

22.1.6. Assessing the documentation

This is mainly a paper activity, which can be carried out before an on-site
assessment is performed. For a proper evaluation of the documentation, the following
documents should be assessed:
ƒ Description of the product and its intended use;
ƒ Flow diagram;
ƒ Location of CCP’s;
ƒ HACCP worksheet;
ƒ List of verification activities;
ƒ Results of monitoring and verification;
ƒ Records necessary to demonstrate the adequacy of prerequisites of HACCP

22.1.7. Assessing the implementation

This means checking whether the HACCP plan and prerequisites have been
adequately implemented, the plan adequately maintained, the operators are sufficiently
trained and the records are in order (monitoring and verification executed as planned and
corrective actions, if any, are taken).
Many of the foregoing points had to do with an assessment of adequacy of the
HACCP plan. It is of equal importance to assess whether HACCP was adequately
implemented. A few of the points to be checked are mentioned above. What is
mentioned in the second and third point should receive particular attention. Even if a
plan is correctly developed and implemented it will not function correctly, if it is not
adequately maintained. If operators are not sufficiently trained to keep their CCPs under
control, HACCP will not be effective, regardless of whether everything on paper is well
looked after.

22.1.8. Competencies of assessors

Small businesses can often be assessed by a single assessor, who is familiar with the
business, knows the basic principles of HACCP, and has the ability to judge the
appropriateness of the control measures. In more sophisticated industries these skills
cannot often be found in one person. For the assessment multi-disciplinary teams may
be required. The members of these teams should have the following competencies:

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.

22.1.9. Assessment’s evaluation

Assessment should result in an evaluation during which the findings are discussed
with the management of the enterprise. The assessor should analyse the information and
evaluate whether the deficiencies, if any, have an impact on the safety of the food,
whether the findings indicate that some of the regulatory requirements were not met, or
whether the product may lead to problems in trade.
It is recommended that the assessor also formulates proposals for improvements
or remedial actions which, again, should be discussed with management. It should be
made very clear to management that they have to make the decisions and to implement
some of the proposals. The assessor has only the right to demand the follow-up of a
proposal when it is clearly based on the regulatory requirement.

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.

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

50Is part of Codex Alimentarius Commition,

51A Regulation is a piece of legal document, which is directly applicable to all E.U. member countries. A
Directive is a general framework, within which the national governments are asked to establish their national
regulations, without exceeding the limits set by the Directive.

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.

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

Acceptable level Is a criterion whose probability to cause an unacceptable risk for human health is not
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
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
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
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.
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
Disposition of Any action to be taken to eliminate the negative effects without removing the causes.
Establishment Any building or area in which food is handled and the surroundings are under control of

the same management.

Evidence Are documents, worksheets and records proving the activities.
Expiry date (Use-by-date): is the date after which the product should not be consumed
Flow diagram A systematic representation of the sequence of steps or operations used in the
production or manufacture of a particular food item.
Food handler Any person who directly handles packaged or unpackaged food, food equipment and
utensils, or food contact surfaces and is therefore expected to comply with food hygiene
Food hygiene All conditions and measures necessary to ensure the safety and suitability of food at all
stages of the food chain.
Food safety Assurance that food will not cause harm to the consumer when it is prepared and/or
eaten according to intended use.
Food suitability Assurance that food is acceptable for human consumption according to its intended use.
Generic These are examples of HACCP plans developed for a food commodity or process that
HACCP plans may be used as guidance for business operators producing such commodities or using
such processes. Generic plans are not appropriate for use until customised for a specific
food and food process.
HACCP A system, which identifies, evaluates, and controls hazards, which are significant for
food safety.
HACCP CONTROL Is: Organization, Resources, Processes and Procedures working together to guarantee
SYSTEM product safety and, as a consequence, consumer health.
HACCP plan A document describing the activities developed in accordance with the principles of
HACCP to ensure control of hazards, which are significant for food safety in the
product under consideration and its intended use.
Hazard A biological, chemical or physical agent in, or condition of, food with the potential to
cause an adverse health effect (to the consumer).
Hazard Analysis The process of collecting and evaluating information on hazards and conditions leading
to their presence to decide which are significant for food safety and therefore should be
addressed in the HACCP plan.
Implementation of the The ongoing execution and maintenance of the HACCP plan.
HACCP plan
Measurability The capacity to detect a specific hazard
Methodology Main activities to be performed in a logical sequence, represented by a Flow Diagram.
Modality Who does What, When, Where and How, for each activity.
Monitor The act of conducting a planned sequence of observations or measurements of control
parameters to assess whether a CCP is under control.
Nonconformity Non fulfilment of a specified requirement concerned with safety (HACCP)
Objective evidence Information, qualitative and quantitative records or findings on the quality of the
product or service, based on verifiable findings, measures and tests.
Prerequisites for HACCP Practices and conditions needed prior to and during the implementation of HACCP and
which are essential for food safety, as described in Codex Alimentarius Commission’s
General Principles of Food Hygiene and other Codes of Practice.
Primary production Those steps in the food chain up to and including, for example, harvesting, slaughter,
milking, fishing.
Quality -Peculiar or essential character, or
- Inherent feature, or
- Degree of excellence (English Oxf. Dict.), or
- The totality of features and characteristics of a product or service that bear on its
ability to satisfy stated or implied needs (ISO/UNCTAD/GATT)
Quality assurance Are all planned and systematic actions necessary to provide adequate confidence that a
product or service will satisfy given requirements for quality (ISO/UNCTAD/GATT)
Quality control Is a system for maintaining standards in production or in a product, especially by
inspecting samples of the product.
Regulatory approval Official confirmation that the regulatory requirements are complied with.
Regulatory assessment A governmental activity to obtain evidence that the seven HACCP principles have been
effectively applied and the HACCP plan and prerequisites correctly implemented and
that the system has been maintained.
Risk An estimate of the likely occurrence of a specific hazard.
Security level Is a criterion, more restrictive than the critical limit, used to reduce the risk of critical
limit overcoming.

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
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
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.

67. Strategies for Implementing HACCP in small and/or Less Developed Business. WHO document
WHO, Geneva, WHO/SDE/PHE/FOS/99.7 (1999).
68. Importance of HACCP for public health and development. The role of the World Health
Organization. PII: S0956-7135(96)00003-5. Food Safety Unit, World Health Organization,
69. Codex Alimentarius. Food Hygiene, Basic Texts. ISSN 0259-2916. Food and Agriculture
Organization, Rome, Italy.
70. Training aspects of the Hazard Analysis Critical Control Point System (HACCP). WHO,
Geneva, WHO/FNU/FOS/96.3 (1996).
71. Application of the Hazard Analysis Critical Control Point (HACCP) System for the
Improvement of Food Safety. WHO, Geneva, WHO/FNU/FOS/93.1 (1993).
72. HACCP: Introducing the Hazard Analysis and Critical Control Point System. WHO, Geneva,
WHO/FSF/FOS/97.2 (1997).
73. Food Safety. An Essential Public Health Issue for the New Millennium. WHO, Geneva,
WHO/SDE/PHE/FOS/99.4 (1999).
74. Bryan F. L.(1992) Hazard Analysis Critical Control Point Evaluations. A Guide to Identifying
Hazards and Assessing Risks Associated with Food Preparation and Storage. World Health
Organization, Geneva.
75. Safe, Quality, Security, and Hygiene in Food Production, Trade, and Consumption. XI
Interamerican Meeting, at the Ministerial Level, on Animal Health Washington, D.C., 13-15
April, 1999.
76. Charissis N.S., Vassalos C.M (2001). Foodborne Diseases. A Guide for a Rapid Review of
Different Infections and Intoxications (Third Edition-Prepublication issue).
77. HACCP Principles and Practice, Teacher’s handbook. A WHO/ICD Training manual in
collaboration with FAO. WHO/SDE/PHE/FOS/99.3. WHO, Geneva (1999).
78. HACCP: Essential Tool for Food safety. Panamerican Institute for Food Protection Division of
Disease Prevention and Control, PAHO/INPPAZ- WHO, USA 2001.
79. Motarjemi Y., Foodborne Disease,“a focus for health education“, WHO, Geneva, 2000.


80. American Meat Institute. The Shift from the Traditional Federal Meat and Poultry
Inspection System to a new HACCP-Based System.
81. An. (1997). The ‘’stable to table’’ approach to animal health, animal welfare and
public health. A policy document, accepted by FVE General Assembly, 17-19 April
1997. WVA Bulletin, 14, 64-72.
82. An. (1998). Food Quality and Safety Systems – A training manual on food hygiene
and the Hazard Analysis and Critical Control Point (HACCP) system, ISBN 92-5-
104115-6, FAO, Rome.
83. An. (2000). More trouble for HIMP. Article – [469].
84. Borgdorff, M. W., Y. Motarjemi (1997). Food Safety Issues. Surveillance of
Foodborne diseases: What are the options? WHO Document:
85. CAC. Basic Texts on Food Hygiene. Document CAC/RCP 1-1969, Rev. 3, 1997.
86. CAC. Hazard Analysis Critical Control Point (HACCP) System and Guidelines for its
Application. Annex to Document CAC/RCP 1-1969, Rev. 3, 1997.
87. EUR-Lex. Document 500PC0438(01).
88. EUR-Lex. Document 500PC0438(02).
89. EUR-Lex. Document 500PC0438(03).
90. EUR-Lex. Document 500PC0438(04).
91. EUR-Lex. Document 500PC0438(05).
92. FAO/WHO. (1997). Introducing the Hazard Analysis and Critical Control Point
System. Geneva, World Health Organisation. Document WHO/fsf/FOS/97.2.
93. FAO/WHO. Guidance on Regulatory assessment of HACCP – The Report of a
Joint FAO/WHO Consultation on the Role of Government Agencies in Assessing
HACCP. Document WHO/FSF/FOS/98.5.
94. Tompkin, R.B. (1995). The use of HACCP for producing and distributing processed
meat and poultry products. In: ‘’HACCP in Meat, Poultry and Fish Processing’’. A.
M. Pearson, T. R. Dutson, edrs. Advances in Meat Research – Volume 10.
95. USDA. Meat and Poultry – HACCP, the Seven Steps to Success.
96. US, FDA, HACCP : A State-of-the-Art Approach to Food Safety.

97. WHO. (1998). Food Safety and Globalisation of Trade in Food. A Challenge to the
Public Health Sector. WHO Document: WHO/FSF/FOS/97.8 Rev.1.
98. WHO. (1999). Strategies for implementing HACCP in Small and/or Less Developed
Businesses. Report of a WHO Consultation. WHO Document
99. WHO. 53rd World Health Assembly. Eight Plenary Meeting. Agenda item 12.3. 20-
5-2000, A53/VR/8. WHO Document 53.15.
100. An. (2001). Meat Processing Global, July-August 2001, 40.
101. CAC (1997). Hazard Analysis Critical Control Point (HACCP) System and
Guidelines for its application. Annex to Document CAC/RCP1-1969 Rev. 3 (1997).
102. Bauman, H. (1990). Food Technology, 44(5), 156-158.
103. Buchanan, R. L. (1990). Trends in Food Science and Technology, 1, 104-106.
104. Crosby, J. M. (1979). Quality free. McGraw-Hill, New York.
105. Golomski, W. A. (1993). Food Technology, 47(5), 74-77.
106. Hollingsworth, R. (1993). Food Technology, 47(5), 81-84.
107. Juran, J. M. (1993). Basic concepts in quality planning and analysis. 3rd edn.
McGraw-Hill, New York, p.p. 1-13.
108. Newman, P. B. (2001). Quality assurance – Asset or Liability. IFFA Meat
109. Logothetis, N. (1993). Managing for total quality; from Deming to Taguchi and
SPC. Prentice Hall. England.
110. Sashkin, M.; K. H. Kiser (1993). Putting Total Quality Management to work.
Berret-Kochler, San Francisco.
111. Schebesta, W. (2000). Seminar on ‘’Redesign and auditing of quality management
systems according to ISO 9000: 2000’’. TUV Austria, Hellas.
112. Webb, N. B., J. L. Marsden (1995). Relationship of the HACCP system to Total
Quality Management. In: Advances in Meat research – Vol. 10, 156-181, Blackie
Academic & Professional, an imprint of Chapman & Hall, Glasgow.
113. Via, R. E. (1990). International Review of the Armed Forces Medical Services.
63, 236-238.
114. HACCP: Essential Tool for Food safety. Panamerican Institute for Food
Protection Division of Disease Prevention and Control, PAHO/INPPAZ- WHO,
USA 2001.


This table gives examples of hazards associated with some common food service
operations, together with appropriate control actions and monitoring procedures.
Operation/critical Hazards Control measures Monitoring procedures
control point
Purchase/receipt Pathogens on raw foods; foods obtained Obtain foods from safe source Set purchase specifications and check for
from unsafe sources compliance on receipt
Frozen storage Microbial growth in thawed goods Maintain frozen until use Observe whether foods are frozen;
measure temperature of freezer
Refrigerated storage Microbial growth if temperatures are too Maintain cold temperature; rotate stock Observe condition of food; measure
high or duration of storage too long; food and unit temperature, observe
Cross-contamination. storage practices; measure duration of
storage; look for potential routes of
Dry storage Break in package; high moisture; poisons Maintain low temperatures and Observe storage practices
stored near foods; sewage backflow or humidity; store poisons elsewhere;
drippage from pipes; vectors protect foods from contamination
Thawing Bacterial growth; contamination of area Thaw at temperatures and within times Observe thawing practice; feel whether
by thaw water; incomplete thawing that do not permit multiplication of product is completely thawed
common pathogenic bacteria
Reconstitution Contamination during rehydration; Use safe water and clean utensils and Observe practices
(rehydration) bacterial growth containers; use food promptly or
refrigerate in small volumes
Preparation Cross-contamination from raw Avoid handling raw foods and then Observe practices
products; contamination from food- cooked foods; avoid touching foods that
handlers and dirty equipment and are not to be heated subsequently
Cooking Pathogens survive inadequate time- Adequate time-temperature exposure Measure temperature at geometric
temperature exposure; spores survive centre of food
Handling of foods Cross-contamination from raw Avoid handling raw foods and then Observe practices observe personnel for
that are not products; contamination from hands, cooked foods; avoid touching foods signs of illness; receive reports of illness
subsequently heated equipment or utensils that are not to be heated subsequently; or significant symptoms
exclude ill persons from working with
food; ensure personal hygiene of food
service workers
Holding at room or Bacterial growth Limit time of such holding; hold hot or Observe practices; measure time of
warm outside cool holding
Hot-holding Bacterial growth Hold foods at temperatures at which Measure temperature of foods at
pathogenic bacteria do not multiply intervals
Cooling Pathogenic bacteria multiply Cool foods rapidly in shallow containers Measure depth of food; measure
or use other method of rapid cooling; temperature of food after cooling;
store as close to freezing as feasible observe storage practices
Reheating Microbial pathogens may survive; heat Adequate time-temperature exposure Measure temperature at completion of
stable toxins will survive reheating
Cleaning of Failure to remove pathogens from Wash, rinse, disinfect Observe practices; measure
equipment and surfaces concentration of disinfectant solution
utensils and conduct time

From F. L. Bryan (1992). Hazard Analysis Critical Control Point Evaluations. A Guide to Identifying Hazards and

Assessing Risks Associated with Food Preparation and Storage. World Health Organization, Geneva



Process Food Critical control Monitoring procedures

Receipt of raw Fruit and Fertilisation Observe swage disposal practices and whether faeces are used as
product vegetables fertiliser
Irrigation Observe practices to determine whether sewage reaches irrigation
Washing and Conduct sanitary survey of water source
Meat, poultry, Receipt Observe/smell for signs of spoilage
Cleaning of Observe for possibility of cross-contamination;
equipment Observe effectiveness of cleaning procedures
Chilling and cold Measure size of batch, time of cooling, temperature of chilled
storage product, time of storage
Packaging Observe whether vacuum is effective;
Observe type of wrap, package
Fish Receipt Observe/smell for signs of spoilage
Chilling and cold Measure temperature of product and time of storage
Cleaning of Observe of possibilities of cross-contamination;
equipment Observe effectiveness of cleaning procedures
Shellfish Harvesting of Sample water and test for faecal indicator organisms;
waters free of Survey for sewage outflows
pollution and
with low levels
of indicator
Freezing Fruits, Blanching Measure temperature and time
Freezing Measure time-temperature exposure during freezing;
Observe whether product is frozen
Storage of Measure temperature of product and time held after thawing
thawed product
Meat, poultry Freezing Measure time, temperature exposure during freezing;
Observe whether product is frozen
Storage of Measure temperature of product and time held after thawing
thawed product
Fish and Freezing Measure time-temperature exposure during freezing and observe
shellfish whether product is frozen
Storage of Measure temperature of product and time held after thawing
thawed product
Pasteurisation Milk Pasteurisation Measure time-temperature exposure; observe indicator thermometer
and recording charts; evaluate function of flow diversion valve;
check pump speed and time flow through holding tubes; check
plates for leaks (high temperature, short time pasteurisation), collect
samples and test for phosphatase
Cooling, holding, Inspect cleanliness of equipment; take swabs from contact surfaces;
filling inspect valves; collect samples and test for coliforms
Cold storage Measure temperature of product and time of storage
Roast beef, Pasteurisation Measure time-temperature exposure
Slicing, Observe for possibility of cross-contamination from raw to cooked
packaging product via personnel, equipment, cleaning cloths; observe handling

From F. L. Bryan (1992). Hazard Analysis Critical Control Point Evaluations. A Guide to Identifying Hazards and

Assessing Risks Associated with Food Preparation and Storage. World Health Organization, Geneva

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

Coconut Pasteurisation Measure time-temperature exposure; observe indicator thermometer

and recording chart
Grating and Observe operations for possibility of contamination
Packing Check integrity of package
Holding of final Collect samples and test for salmonellae, measure aw
Chocolate Raw product Collect samples and test for salmonellae
Roasting of Measure time-temperature exposure
Environment Collect environmental samples and test for salmonellae; observe
moisture control
Holding of final Collect samples of product and test for salmonellae
Dry-blended Ingredients Collect samples and test for salmonellae
infant formula
Environment of Collect environmental samples and test for salmonellae
blending and
packaging areas
Holding of final Collect samples and test for salmonellae, measure aw,
Meat and fish Formulation Check concentration of NaCl
Drying Measure time of drying; measure aw, measure temperature of dryer
Nuts Drying Evaluate rapidity of drying process. Measure humidity of storage
Fermentation Meat products Fermentation Check temperature and humidity of fermentation chamber o room;
observe whether starter culture is used; check frequency of transfer
of culture; test speed of fall in pH
Formulation Check concentration of NaCl, NO2 ,NO3, sugar
Heating Measure product temperature: observe indicator thermometer and
recording chart

Drying Measure time of drying

Final product Measure pH, aw, check appearance of product
Fermentation Measure temperature and humidity of fermentation chamber or
Vegetables, fish Formulation Check concentration of NaCl
Final product Measure pH, aw; check appearance of product
Milk, cheese, Pre-heating or Measure time-temperature exposure; observe indicator thermometer
yoghurt pasteurisation and recording chart
Fermentation Measure product temperature; check type, amount and purity of
starter culture
Ageing Measure duration of ageing
Packaging Observe integrity of package
Acidification Fish Formulation Check concentration and type of acid
Blending Observe thoroughness of blending
Marinating Measure duration of marinating, check effectiveness of mixing,
measure pH
Mayonnaise Formulation Check type and amount of organic acid used
Blending Observe thoroughness of blending
Final product Measure percentage of organic acid and pH


Checklist is a list that contains points/elements that may be considered during
auditing. It is used as an aide-memoir to promote uniformity in assessment. A checklist is
an assessment tool for the entire HACCP application including prerequisites, design,
implementation and maintenance of the plan.
The checklist includes questions on generic or specific and detailed aspects to be
covered during the audit. So it’s necessary to elaborate this document in relation to the
verification goal. It is a useful guide for the auditor and for the auditee. The auditor will
record fully or in short form (i. e. codified answers). By the use of prepared checklist it’s
possible to save time.
Besides being used as an aide-memoir, the list helps to maintain focus and
objectivity, helps to ensure completeness of assessment and acts as a record of
assessment. It also helps to evaluate comparability of different assessments, companies
or assessors and ensures transparency of the assessment process.
If a checklist is improperly designed or used, then it may contain irrelevant or
unnecessary items and therefore restrict the judgement of the assessor. However, the use
of checklists alone will never be sufficient to perform an appropriate assessment.
The checklist on the following pages represents a compilation of commonly used
questions. It does not represent a comprehensive checklist or a checklist, which is
currently in use. It intends to show how a list may look and the sort of questions and
activities, which may lead to an effective assessment.

A HACCP Checklist54
HACCP Checklist
Preparation What evidence is there of management commitment to HACCP use?

-Who was on the team?
- Are all appropriate disciplines represented?
- What is the likely knowledge level of the individuals? (Evidence of training, qualifications, experience
- 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?

Principle 1 Has the product been properly described?

"CONDUCT A - Are intrinsic control measures identified?
ANALYSIS" Is the process flow diagram (PFD) comprehensive?
- How was the PFD verified for accuracy and by whom?
- Are all raw materials and process/storage activities included in the flow diagram? (Rework can be
included as an ingredient.)

- Have all activities been included?

From F. L. Bryan (1992). Hazard Analysis Critical Control Point Evaluations. A Guide to Identifying Hazards and

Assessing Risks Associated with Food Preparation and Storage. World Health Organization, Geneva

- Is the PFD correct?

- 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?

- Are there rework opportunities and have they been included?

How was the hazard analysis conducted?

- Were only significant hazards identified?
- Have all raw materials (including rework) been included?
- Have all process steps been considered?
- Have the hazards been specifically identified by type/source or have they been generalised?
- How did the team assess the likelihood of occurrence?
- What information sources were utilised?

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?

Principle 2 How were the CCPs identified?

"Determine the - By expert judgement?
Critical Control - By the use of a decision tree? (has the decision tree been used correctly?)
Points (CCPs)" - By the use of consultants?

- Have all necessary CCPs been identified?

Did each identified hazard undergo a systematic consideration?

How are the hazards that are not controlled by CCPs addressed?

Principle 3 How were the critical limits established?

“Establish critical - Is there evidence (experimental data, literature references etc.)?
limits” - What validation exists to confirm that the critical limits control the identified hazards?
- Have critical limits been established for each CCP?

How do they differ from operational limits?

Principle 4 Have realistic monitoring schedules been established?

"Establish a system - Do they cover all CCPs?
to monitor the control - Has the reliability of monitoring procedures been assessed where appropriate?
of the CCP" - What is the status of monitoring equipment?
- Is it evidenced as being in place and calibrated appropriately?
- Are the CCP log sheets being used at all CCPs?
- Have CCP log sheets been filled out correctly?
- Is there any evidence that procedures are not being followed consistently?
- Does the frequency of monitoring adequately confirm control?
- Are the sampling plans statistically valid?
- Are statistical process control records being used to demonstrate that the process is in control on a day-
to-day basis?
- Check that records agree with stated activities.

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

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?
Are there clear disposition actions listed?

Principle 6 Have verification procedures been clearly and appropriately established?

"Establish procedures - How are these procedures communicated through the business?
for verification to - Have responsibilities for verification procedures been allocated?
confirm that the - Are they being carried out effectively?
HACCP system is - Are all CCPs covered by the verification programme?
working effectively" - Is the information on the HACCP Control Chart up to date?
- Is there a formal system to trigger amendments?
- Are control parameters being achieved?

Have process capability studies been carried out?

How is the data from HACCP being used to improve the system?

How is consumer complaint data being used within the verification system?

Is there a regular review of CCP failure and product dispositions?

Are prerequisite support systems included within the verification programme?

Principle 7 What format is being used to document the system?

"Establish - Does the documentation cover all of the HACCP system operation?
documentation - How is the documentation controlled with regard to update and issue etc.?
concerning all - Are the records accessible?
procedures and - Are the HACCP records clearly identified by unique reference numbers?
records appropriate to - Are all documents accurate and current?
these Principles and - Are verification procedures documented?
their application" - How is change control managed?



DATE / /
ƒ Conform = visible absence of dirt, of oily surfaces and of unpleasant odours.
ƒ Not conform = absence of conformity characteristics.
Mark using an ‘x’ in the proper column.

Conform Not conform
Dining room
Storing rooms

Conform Not conform
Slicing machine
Mincing machine
Electric oven

Working surfaces/tools
Conform Not conform
Working surfaces
Dishes and tools

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

FAO. WHO/SDE/PHE/FOS/99.3. WHO, Geneva (1999).



Floors and walls Daily Detergent/disinfectant in hot water with specific grease remover, then
Windows and ceiling lamps Monthly Specific detergent
Monthly Detergent/disinfectant and glass shiner

Tables Daily (more than once a Detergent disinfectant

KITCHEN Daily Detergent/disinfectant
Floors and walls Monthly Special detergent
Windows and ceiling lamps Monthly Detergent/disinfectant and a special detergent
Sinks Daily Bleach and grease remover, by hand
Weekly Filters cleaning
Marl removing using acids
Mincing machine Daily Washing by hand after disassembling (according to manual) and dipping
disassembled parts
Scales Daily Cleaned and disinfected by hand.
Mixers Daily Washing by hands after disassembling (according to manual) and dipping
disassembled parts.
Ovens Weekly By hand after removing grids
Weekly By hand after removing grids
Fans Monthly Cleaning and disinfecting by hand, grease remover
Slicing machine Daily Washing by hands after disassembling (according to manual) and dipping
disassembled parts
Working surfaces Daily By hand using a grease remover, then water and bleach rinsing, then soft
cloth drying
Plastic containers, pans daily By hand
Cleaning and disinfection
Dishes Daily Dishwasher machine
Refrigerators Weekly Cleaning without detergents
Every 3 months Emptied and cleaned with detergent/disinfectant
Cleaning and disinfection
Storing rooms Weekly Washing with water and vinegar, then drying
Monthly Specific disinfectant
Every 3 months Detergent/disinfectant
Bins and Discarded parts Weekly By hand and by dipping
Cleaning, disinfecting
Washrooms Daily By hand, using detergent/disinfectant
Weekly Marl removal
Changing rooms Weekly Using detergent/disinfectant after dusting
Drains and Tubes When necessary Pressure washing using probes and acids

56 HACCP Principles and Practice, Teacher’s handbook. A WHO/ICD Training manual in collaboration with

FAO. WHO/SDE/PHE/FOS/99.3. WHO, Geneva (1999).



Process CC Hazard to be Control measures Critical limits Procedure Frequency Corrective Responsibl
step P controlled actions e person(s)
Incoming 1.1 Aflatoxin Obtain Certificates of Aflatoxin: Inspect Certificate of Every batch Reject batch Incoming
raw Analysis from < 10 mg/kg Analysis Goods
material suppliers Clerk,
Flour Supply QA
Mains 1.2 Chemical Carry out on-site Chemical Testing to include toxic Weekly Contact QA
water contamination micro checks and contamination substances, Giardia, Water manager
obtain Certificate of Regulatory Cryptosporidium. Authority
Analysis of local Compliance Inspect Certificates of
sample-Water Analysis from Water
Authority Authority
Jam 1.3 Pesticide Certificates of Within legal Inspect Certificate Annually Contact QA
residues Analysis from limits Purchasing Manager
approved supplier Manager
SQA Audit Annually
Cream 1.4 Salmonella and Supplier Quality Absent/25 g Laboratory tests Every Reject batch QA
Listeria Assurance System Listeria, Salmonella, delivery Manager
Procedure (No s xxx)
Approved supplier Inform SQA audit 6-monthly
purchasing QA

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
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
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

57 HACCP Principles and Practice, Teacher’s handbook. A WHO/ICD Training manual in collaboration with FAO.

WHO/SDE/PHE/FOS/99.3. WHO, Geneva (1999).




CEREAL The main sources of pathogenic microorganisms transmitted

PRODUCERS to/or existing in cereals which are potentially causing foodborne
The role of spoilage organisms which may cause food
The influence of temperature and other factors in food quality
and safety
MEAT/POULTRY and MILK Basic livestock feeding and hygienic principles, in particular for
PRODUCERS/TRADERS/HANDLERS the animal species of concern (Poultry: chickens, ducks, ostriches
etc. Swine, Cattle, Sheep/goats, Rabbits etc)
Influence of animal nutrition on food-borne diseases of animal
origin (i.e. foodborne/waterborne disease of poultry)
Which are the hazardous contaminants (i.e. aflatoxin, Salmonella)
and how they can affect final product (i.e. poultry carcass in the
Sources of milk contamination and control measures (pathogens
affecting and transmitted through milk and milk products)
Risks and benefits of cleaning eggs (pathogens transmitted by
The role of temperature and moisture in the storage of food of
animal origin
VEGETABLE Basic principles of Good Agriculture Practices (GAP)
PRODUCERS/HANDLERS Indicators of deterioration at harvesting
Contamination control measures during harvesting
Adequate handling techniques to minimise damage
Transport and storage of vegetable products
SEAFOOD Influence of water quality on pathogenic microorganisms and
PRODUCERS/ TRADERS/HANDLERS their contamination of aquatic animals
Cleaning, storing and processing of seafood animals
Influence of proper evisceration on seafood safety
Control of deterioration of seafood

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


Personnel Minimal knowledge required
LINE OPERATOR Main sources of microorganisms affecting the product handled by them and
mode of transmission
The role of pathogenic and other microorganisms on foodborne diseases and
food deterioration
The necessity of a good personal hygiene
Importance of reporting systemic (i.e. lung Tuberculosis) or skin diseases
(including wounds and cuts) to supervisor
Importance of properly and frequently cleaning equipment
Nature of required control (on premises, equipment and process)
Practices for registering deviations
Characteristics of normal and abnormal products
Importance of registering conservation
How to monitor the CCP in his/her area of responsibility
QUALITY CONTROL Sources of microorganisms, their importance as foodborne pathogens and
PERSONNEL agents of deterioration and how to control them
How to conduct and interpret biological and physical-chemical analysis
How to investigate and resolve possible causes of process deviation
How to maintain and transmit registers of quality control
MANAGER Microbiological and economical consequences of an out-of-control process
How to determine if the process is under control
The limits of responsibilities of line operators, quality control personnel and
Sources of microorganisms and their role in foodborne disease transmission
and food deterioration
Benefits of food personnel hygiene of line operators
The manager’s responsibility to guarantee that line operators and quality
control operators be trained in GMP and in specific aspects of their functions
STORAGE PERSONNEL Principles of cross-contamination of pathogenic microorganisms responsible
for decomposition
Food safety practices during transportation
Principles of cleaning and sanitation of vehicles
Role of temperature in food safety
Importance of pest control
CONSUMER Practical measures to safety preparation, storage and processing of food
Adequate process and storage methods and consequences of inadequate
Improper practices that permit microbial growth and spore germination
Potentially hazardous foods
The possibility and risks of cross contamination
OFFICIAL INSPECTORS The same level of knowledge as line operators, quality control operators and
managers about foodborne disease and food deterioration
Risk assessment methodology


The hamburger is a product based on meat that is cut in peace of 4X4 cm. The
pieces are grinded and other ingredient are added (condiments and food additives). The
end product is packed in plastic bags and stored to temperatures of –18 C . The product
will be fried before consumption.

36.1.1. Flow diagram for hamburger

Preparation of the meat (logs) → Weighed/ground (CCP) → Mixed with
condiments and preservatives → Formed →Freezing →Packed→Storage (CCP)

36.1.2. Hazard Analysis Worksheet

Processing step Identify Are any Justify your decision What control measures Is this step a
potential potential food for previous column can be applied to critical
hazards safety hazards prevent the significant control point
introduced, significant? hazards? (YES/NO)
controlled or YES/NO
enhanced at
this step
Preparation of the Biological YES Contamination or Set refrigeration. GMP: NO
meat (logs) multiplication of personnel, equipment,
microorganisms facilities and training.
Chemical NO
Physical NO
Weighed/ground Biological NO YES
Chemical NO
Physical YES Contamination with Metal detector, Grinder
fragments of metals maintenance.
from grinder.
Mix with Biological YES Contamination and/or Refrigerated atmosphere. NO
condiments and multiplication of GMP: select the
preservatives microorganisms. ingredients, Personnel
Chemical NO training, Equipment.
Physical NO
Formed Biological YES Contamination and/or Refrigerated atmosphere. NO
multiplication of GMP: select the
microorganisms. ingredients, Personnel
Chemical NO training, Equipment.
Physical NO
Freezing Biological YES Multiplication of Freeze quickly. NO
microorganisms. Control of the
Chemical NO temperature of the tunnel
Physical NO or refrigerating room.
Refrigerating room with
alarm light and or sound
in the event of a faillure
Packed Biological YES Contamination and/or GMP: equipment, NO
multiplication of operational training of
pathogenic personnel.
microorganisms Refrigerated atmosphere.
Chemical NO
Physical NO
Storage Biological YES Multiplication of Control of the time and
pathogenic storage temperature.
microorganisms. GMP: appropriate storage
Chemical NO conditions. Refrigerating

Physical NO room with alarm light

and/or sound in the event
of failure.


UHT milk is heated to a temperature sufficient to kill all vegetative bacteria, and all
but the most heat-resistant spores, and then packaged under aseptic conditions in pre-
sterilised, plastic-coated cardboard. UHT milk is stable for long periods at ambient
temperatures. A process temperature of 1320 C (2700 F) for less than 1 second is
employed, and there are two means of heating-directly by injecting live steam into the
milk and indirect by using plate, or tubular, heat exchangers.

36.2.1. Flow diagram of UHT milk

Raw milk → Standardise → Clarify → Homogenise→ Heating (CCP) → Cooling
→ Filling/packing → Storage and distribution

36.2.2. Hazard Analysis Worksheet

Processing Identify potential Are any Justify your decision What control measures Is this step
step hazards potential for previous column can be applied to a critical
introduced, food safety prevent the significant control
controlled or hazards hazards? point
enhanced at this significant? (YES/NO)
step YES/NO
Raw milk Biological YES Growing of high Control achieved at farm NO
reception numbers of pathogenic level.
Chemical YES Milk may have residual
Physical YES Hairs, etc. Quality should be checked
before reception. – GMP -
Standardise Biological NO NO
Chemical NO
Physical NO
Clarify Biological NO NO
Chemical NO NO
Physical NO NO
Homogenise Biological NO NO
Chemical NO NO
Physical NO NO
Heating Biological YES Presence of active Heating for approved YES
vegetative and spore temperature time
forming pathogens.
Chemical NO NO
Physical NO NO
Cooling Biological YES Prevent Monitoring physical NO
Chemical NO recontamination condition of plant NO
Physical NO NO
Filling and Biological YES Cross-contamination Pre-sterilisation of plant. NO
packing Chemical NO Installation of filler in
Physical NO “clean” area with control
of air flow and pressure
Storage and Biological NO NO
Distribution Chemical NO
Physical NO


The juice is obtained by the removal of the pulp, an operation that will be carried
out in the shortest possible time, in order to avoid the incorporation of air in the product
since this would cause the oxidation of the juice, the acceleration of the enzymatic
reactions and the proliferation of microorganisms that could modify the normal
characteristics of the product.

36.3.1. Flow diagram for the pasteurised fruit juice

Reception of raw material (CCP) → Weighed → Pre-washed → Selection →
Washed → Cut into logs the fruit → Fruit pulp extraction → Pasteurisation → Cooling
→ Addition of preservatives (CCP) → Storage.

36.3.2. Hazard Analysis Worksheet

Processing Identify Are any Justify your decision for What control measures Is this step
step potential potential previous column can be applied to prevent a critical
hazards food safety the significant hazards? control
introduced, hazards point
controlled or significant? (YES/NO)
enhanced at YES/NO
this step
Reception of Biological NO YES
raw material Chemical YES Chemical residuals of Quality assurance of the
Physical YES agricultural products raw material
Quality assurance of the
raw material
Weighed Biological NO NO
Chemical NO
Physical NO
Pre-washed Biological NO NO
Chemical NO
Physical NO
Selection Biological NO NO
Chemical NO
Physical NO
Washed Biological YES Contamination by Hyperchlorinated water. NO
pathogenic Minimum 10 ppm of
microorganisms. residual chlorine
Cut into logs Biological NO NO
the fruit Chemical NO
Physical NO
Fruit pulp Biological NO NO
extraction Chemical NO
Physical NO
Pasteurisation Biological NO NO
Chemical NO
Physical NO
Cooling Biological NO NO
Chemical NO
Physical NO
Addition of Biological NO Preservatives amount that Use of the appropriate YES
preservatives Chemical YES exceed established limits concentration of the
Physical NO preservatives.
Appropriate control of the
Packed Biological NO Fragments of metals, Wash bottles. Turn down
Chemical NO glasses in the bottles. the containers.
Physical YES Suitable supplier. Put out

possible fragments with

compressed air.
Storage Biological NO NO
Chemical NO
Physical NO


Milk is obtained from two milking daily, one at 5:00 o’ clock in the morning and
the other one at 3:00 in the afternoon. The product won’t be consumed “in nature”. It is
used as raw material for the industry of milky products. The consumers of these products
are people of all the ages and conditions of health, including children and

36.4.1. Flow diagram for bovine milk

Conduction of the animals → rationing the food → washing the udders → drying
the udders → Discard of first jets (CCP) (Black Fund Test and CMT) → Milk →
Milk→ Post-dipping → Cleaning after milking → Filtration of milk (CCP) →
Cooling (CCP)

36.4.2. Hazard Analysis Worksheet

Processing Identify Are any Justify your decision for What control measures Is this step
step potential potential previous column can be applied to a critical
hazards food safety prevent the significant control
introduced, hazards hazards? point
controlled or significant? (YES/NO)
enhanced at this YES/NO
Preparation Biological NO NO
for milk Chemical NO The hazards are Hazards controlled by
Physical NO controlled with GMP cleaning and sanitation
Conduction Biological NO NO
(handling) of Chemical NO
the animals Physical NO
Rationing the Biological YES Moulds, Preservatives, Good practices when NO
feed Chemical NO Dust. placing the portion.
Physical NO Portion of good quality.
Washing of Biological YES Soil, manure, etc. GMP No
udders Chemical NO
Physical NO
Drying of Biological YES Spread of contamination. Use paper towels NO
udders Chemical NO
Physical NO
Discard of Biological YES This test identifies animals Apply Black Fund test YES
first Chemical NO with mastitis and avoids and CMT
jets/Black Physical NO the use of possibly
Fund Test contaminated milk.
and CMT
Milk Biological YES Milker and equipment GMP/GAP NO
Chemical NO may contaminate milk
Physical NO
Post-dipping Biological NO NO
Chemical NO
Physical NO
Cleaning Biological NO Hazards are controlled GMP NO
after milking Chemical NO with GMP

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


The evaluation of the premises is the first step for the implementation of HACCP
in a food producing or processing plant. So government should ensure that the
appropriate infrastructure is in place before issuing a licence for a food business
operation. On the other hand business should ensure that premises, work surfaces and
equipment are designed, constructed and maintained appropriately to facilitate cleaning
and to minimise any possibility of cross contamination. However hazards may enter the
premises through the raw material or the water.
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.
The immediate confrontation of hazards in the surroundings of the plant is
perhaps the first impression of any State inspector. Swamps, open ditches, hips of
manure, in the vicinity, rodents nests, swarms of flies in the garden and armies of
cockroaches around the entrance of the plant does not guarantee the safety of food
produced there. Therefore the battle against food- contamination starts in the
surroundings of the plant!
The Hazards in the vicinity and inside the plant and corrective measures
Hazards in the surroundings Corrective measures
Buildings/gardens/parking places should be away Processing rooms located close to dirt roads
from any contamination source. should always have their windows closed in order
to avoid dust potentially contaminated with
pathogenic microorganisms. Nearby pools and
swamps should be drained.
Unloading places should preferably be inside Otherwise, the surrounding space – especially
roofed spaces in order to avoid environmental where cars are moving - should be paved in order
contamination during windy or rainy days. to keep dust on the ground. Cars should move
slowly and when necessary the cement should be
sprayed with water.
Insects in the immediate surroundings of the Dirty water should be carried away properly into
plant. The construction of buildings should covered canals. Oil application in stagnant waters
prevent the entrance of insects/rodents in the first destroys mosquito’s larvae.
place. However sometimes it is necessary to Housefly is considered the most important from
perform some food processing operations, or the standpoint of human health. They are
unloading out in the open. In these cases it is breeding in almost any warm organic material
important to reduce the numbers of mosquitoes, (garbage, manure, etc). Fly control in the
flies and arthropods. surroundings involves: 1) Environmental
sanitation measures (elimination of insanitary
privies, garbage should be stored in flytight

containers), 2) Larvicidal measures (dry conditions

will kill larvae and spreading of manure
immediately upon fields stops breeding. Treating
of manure with insecticides also kills larvae). 3)
Adulticidal methods (outdoor fogging).
Insecticides are also used for the control of
cockroaches and other arthropods.
Rodents in the immediate surroundings of the Proper sanitation with emphasis to adequate
plant garbage storage, collection and disposal is
considered the most effective rat-control measure
available. Other methods are: 1) Use of poisoning
(when there is no danger for domestic animals), 2)
Use of anticoagulants, 3) Trapping, and
4)Fumigation with hydrocyanic acid gas.
Special construction of food storing/processing In case of accidental entrance of insects or rodents
buildings usually prevents the entrance of insects in food processing areas the use of traps is mostly
and rodents in the premises. Floor and foundation suggested because poisonous material may
construction should be made in such a way as to contaminate the food.
prevent the entrance of rodents and arthropods.
Screens over windows, doors and ventilators
prevent the entrance of rodents or insects.
In theory when buildings are insect-and rodent-proof the plant is considered safe. However even in the
best cases some pests may accidentally enter the working areas. Therefore there should be in place a
programme for the surveillance and control of these pests in time before they will contaminate the
food. Taking into consideration that chemicals should be avoided in the food processing and storing
rooms, these measures include mostly traps (for flies, cockroaches and rodents).
Who should perform the control of pests both outside and inside the premises?
Specialized and State authorized companies usually perform the control of pests. Therefore they
provide the plant with papers confirming the works performed and certifying that the premises are
clean of pests.
However in small businesses and sometimes in large establishments it is required that the work should
be performed by assigned personnel. In this case it should be described in the HACCP the specific
programme performed by the plant for the pest control. For the implementation of the programme the
management should appoint a responsible person, which is or should be trained on the subject. It
should be also described in details the method used for the control and the chemicals (if any)
employed. It is self-evident that such material should either be specially designed for the food industry,
or they will never come in contact with food. Furthermore it should be mentioned in the programme
the place were the traps are placed and the bait used, as well as the frequency of inspections and the
efficiency of the used method. The results of the inspections are recorded in specially designed forms
kept in the archives for a long period of time and be available for any State inspection or internal audit.

GMP in the plant

The Good Manufacturing Practice in the Plant prepares the conditions for …and
facilitates greatly the application of HACCP.
Let's suppose that a small number of pests are sneaking in the plant carrying
pathogens. They will contaminate with their excrements, both floors and/or working
areas little before they will be trapped and exterminated. Therefore in order to reduce the
contamination to the less acceptable we should have in place daily mechanisms assuring
most part of the dirt and the pathogens harboured in it will be removed. For this
purpose a thorough cleaning of every surface coming in contact with the food is
designed and prescribed thoroughly in the HACCP system. It is most practical to start
with ceilings and lamps hanging from them, proceed with the walls and shelves starting
from the upper and go on the working surfaces before we finish with the floors. It is
obvious that ceilings, lamps, tubes, pipes, ventilators and upper walls which sometimes
are infested with spider’s nets holding dirt and perhaps pathogens are cleaned only
according to the existing HACCP schedule i.e. every week, month, year etc. On the
contrary working surfaces, lower walls and floors are cleaned necessarily after the end of
a shift or the end of the day, again according to the HACCP schedule. For this they
should be manufactured by a material that can be easily cleaned, and disinfected. In other
wards it should be waterproof, smooth and resistant to disinfectants without holes or
hollow that may hold cleaning water. Otherwise the weathering of the floor should be
perfect. Corners on the floor may obstruct or impede perfect cleaning and should be
avoided. Wooden surfaces are not acceptable in food processing establishments.
Lamps on the ceilings should be covered with wire so in case of accident food will
be protected from falling glasses. The same applies for windows above food processing
areas. Doors (especially in bathrooms) should close automatically because knobs may be
easily contaminated by hands and transmit the contamination to food handlers.
Tubes and ventilators should be checked for leakage especially when they are
above food processing areas.
Cleaning shall start from most clean and continue with more dirty areas, i.e. start in
the food processing rooms and finish in the unloading areas.
The ventilators should work smoothly and the filters replaced or cleaned regularly.
Pipes with potable water should have different colour with those of washing or irrigation
water and should not be intermingled. Pipes with unclean water should be close to the
floor in order to avoid possible leakage in the food processing areas. Garbage boxes
should be closed as much as possible in the premises and necessarily closed outside of
the plan until they will be permanently removed, burned or hygienically buried.
Taps with hot water should be made available where they needed (working rooms,
toilets, storing rooms etc.) for cleaning and disinfecting hands and for cleaning and
disinfecting equipment. The potable water (in all forms, liquid, ice tubes, or vapour)
should be clean circulating in water lines with different colour than those carrying track
washing, grass irrigating of fire extinguishing water.
Equipment should be made of a proper material that can be cleaned with hot water
no less than 820 and disinfected easily without been corroded.
The windows should be located in a such a place as to let the daily light to enter in
the working and especially in the inspection areas, where the personnel is asked to
evaluate the proper colour of the product as a matter of visual inspection. Otherwise it is
needed a proper artificial light.
Containers for raw product should be of such a material that is waterproof and
easy to be cleaned and disinfected by the end of daily work.

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).

GMP in the European slaughterhouse, meat cutting and slicing establishments,

freezers and transportation.
According to the E.U. legislation, beyond the general GMP regulations concerning
a food-processing plan, the basic requirements for the slaughterhouses are the following:
(a). Proper stables for the animals (covered if possible and depending from
the climatic conditions of the country/region). These stables should have
pressure resistant and waterproof floors that can be cleaned and
disinfected easily. The walls should also be of proper material that can be
cleaned and disinfected without corruption. Troughs for the feeding and
water lines for the watering of the animals are necessary. It is also
impervious that the urine and faeces are easily and hygienically removed
by covered canals in especially designed cesspools, in order to protect the
underground waters from contamination and keep the odours from
escaping in the vicinity. Proper stables for quarantine of suspected
animals until the microbiological tests arrive. These animals should be
watered and feed properly until slaughter without any contact with clean
animals. Animals should be inspected by a veterinarian the day of arrival
in the slaughterhouse or just before the slaughtering. Every animal should
bear an identification tag in order to trace back its origin (farm, heard,
flock). The inspection should be performed under the proper light.
Animals sick, suspect, tired, stressed or with obvious malnutrition should
not be slaughtered. Tired or stressed animals should rest for 24 hours
before slaughtering. Suspect animals should be placed in quarantine until
the results of microbiological tests.
(b). Slaughtering rooms should be wide enough for the normal workload and
be different for the swine than the other ruminants taking under
consideration that the work process is different for this species of animals
(dehairing, burning of hair, scalding). Otherwise between the two
slaughtering chains there should be a 5-meter empty space or a 3-meter
high wall.
(c). In establishments where the cleaning and preparation of the intestines of
ruminants is performed manually, there should be an appropriate wide
and specially designed space for this process, which is completely
separated from the place where the carcass meat is processed. The same
applies for the personnel: workers in the meat processing line should not
enter or work in the evisceration room. Meat by-products such as skin,
hooves, horns, hair etc., should be removed immediately or remain in
tight close boxes until been removed from the area.
(d). Proper storerooms for the isolation of suspect carcasses until official
condemnation and destruction.

(e). Proper careful cleaning and extra disinfection of all places and equipment
in case of suspect animals, which have been slaughtered in the
(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
(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.

Meat processing workrooms

Whether the above requirements are going on and on in many details describing
GMP ways in the processing of meat, we consider rather necessary to say few words on
the duties of the official veterinarian who is the person performing the auditing in the
approved meat processing workrooms and freeze storehouses.
State veterinarians inspect these establishments for their compliance with the EU
legislation. They inspect the hygienic conditions of raw meat during entrance, before and
after cutting/slicing and at the point of exit. They also inspect the space, equipment and
personnel’s hygiene
Therefore in this kind of establishment it is mostly the veterinarian who performs
the auditing of HACCP or, at least, of a great part of the HACCP implemented. He is
also responsible for signing the relevant certificate of suitability for raw meat upon its
exit from the plan. This peace of paper actually represents a GMP certificate, and
comprises the passport of this batch of meat for every market in the E.U., without any
other written documentation.

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

only for transportation is butcheries no more than one hour away from the
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.

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.


Foodborne diseases are a major health and economic problem in both
industrialised and developing countries. Policy makers should recognise that the
nutritional well being of the population depends as much on availability of and access to
nutritious food as on food safety.










The importance of food safety for human nutrition (FAO/WHO international

Conference on Nutrition, 1992)

Acknowledgments are expressed to:

ƒ Mrs Micki Genigiorgis for the revision of a great part of the document. Her
particular care to this task will be much appreciated by the readers.
ƒ Prof. K. Genigiorgis for the revision of the document
ƒ Dr. A. Seimenis, Director of the WHO/MZCC in Athens for the revision of the