HACCP Book

&

CRITICAL CONTROL POINT SYSTEMS

SUPER

MARKET

N. Charisis Athens, Greece 2004

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

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

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

1.

A

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.

HAZARD ANALYSIS AND CRITICAL CONTROL

POINT

SYSTEMS

( H A C C P )

2.

F

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

CRITICAL CONTROL POINT SYSTEM(HACCP): CONCEPTS AND APPLICATIONS, held in Teramo, Italy, 4-11 December 2000. That Course was hosted by the WHO/FAO Collaborating Center on Research and Training in Veterinary Epidemiology and Management, Istituto Zooprofilattico Sperimentale, dell Abruzzo e dell Molise, Teramo, Italy. During the course, presentation materials were made available to the participants as photocopies of the presenters’ charts and graphs and/or from the transparencies and slides and as a CD containing almost all material; however, there was no actual expository text in these presentations materials making the review of the training course a quite difficult task. At that time, the Mediterranean Zoonoses Control Centre Athens, had been assigned by WHO to work out a document containing every possible bit of information given in the ITC of Teramo in combination with salient and complementary points from relevant international literature as well as that from the WHO publications on the subject. It soon became evident, that due to the abundance of material contained in the original Teramo ITC handouts it would not be necessary to reproduce them, but rather expand on those materials in order to facilitate the reading and comprehension of charts, exercises and tables. Little by little, other colleagues were invited to contribute with their skills and experience in a joined effort to make the present document useful, not only to the trainees of similar ITCs but also to every person seeking information on HACCP systems. Therefore we consider the present book a “tool” for the training of beginners and the “enlightening” of experts in most common fields of HACCP.

3.

H

(HACCP)

3.1. H

HACCP

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

(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.

Egypt

Voluntary (more than 10 out of 200

industries)

Thailand

HACCP system in canned food products for exportation

Chilly

A draft low is been prepared

Bolivia,Colombia,Ecu

ador, Peru,

Venezuela (think about

it)

6

Morocco

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

New Zealand

voluntary HACCP system-based Food Safety program

Malaysia

HACCP system in 27 Fishery industries for exports to EU,

USA, Australia

Uruguay

HACCP system in meat industries for exports to USA.

Until 1995, the term, “HAZARD ANALYSIS CRITICAL CONTROL

POINT” was used originally throughout the industry. This was changed after a proposal

from WHO/Geneva Consultation in 1995 to: “HAZARD ANALYSIS AND

CRITICAL CONTROL POINTsystems”.

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.

1970 1975 1980 1985 1990 1995 estimate 0 10 20 30 40 50

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.

Graph 1.: HACCP growth curve from 1970 - 1995

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

4.

T

_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 1995)

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?

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.

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.

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(?)

4.1. T

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 0 5 0 1 0 0 1 5 0 2 0 0 2 5 0 1 9 85 19 86 1 98 7 1 9 88 19 8 9 1 99 0 1 99 1 19 9 2 1 99 3 1 99 4 1 9 95 19 9 6 1 9 97 19 98 In c id e n c e ( c as e s/100000) E s t o n i a L i t h u a n i a L a t v i a A u s t r i a G e r m a n y R u s s i a n F e d . S w i t z e r l a n d C y p r u s U K

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 Wales 103 115 87 120 124 108 UK Scotland - - 13 11 6 13

5.

T

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.

6.

E

.

6.1. T

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 premises.

6.2. E

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.

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.

7.

T

HACCP

7.1. C

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).

To assure that measures are carried out as determined, all-important actions are described and personnel is trained to carry them out. Actions have to be implemented without exception. To ensure that they are carried out correctly and to provide evidence of this, the results should be recorded. At the same time those records also provide a basis for improvement.

7.2. O

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

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.

Prevention of foodborne illness

Reduction of losses due to product recalls More efficient quality assurance system Reduction of costs of food analysis

Experience from the Canning Industry demonstrated that control over processing conditions was much more efficient and reliable than end-product testing.

7.3. A

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

behaviour.

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.

7.4. D

I

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}

actions).

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

11 _{See principles of HACCP.}

12 _{The 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 etc.).

To understand how a product is manufactured, and to have a disciplinary approach in the study, it is important to construct a flow diagram covering all steps where product safety could be affected. In many food production and preparation establishments, different areas or rooms have different hygiene levels, and barriers, such as walls or air curtains separating them.

It is important to inspect the site and the practices applied during all hours of operation (even night shifts, weekends etc) as well as the cleaning procedures and validate their efficacy. During this inspection all potential hazards should be listed and a Hazard Analysis of the production and process should be performed by establishing Critical Limits for each Critical Control Point. (for more information see HACCP system principles of this document)

Let’s now suppose that a specific plant is working under strict HACCP conditions. In that case of course there is no need to perform microbiological examinations in any stage of production in order to verify that the product is free from pathogens. Still, pathogens may enter the premises on the raw material or in the potable water. It is therefore important for the manufacturer of the final product to make sure that every raw material or substance entering his plant is safe in any sense and meaning. In order to achieve this, the manufacturer of the final product should ask from the supplier of raw materials (especially for the edible ones), to provide written specifications for any ingredient they contain. Furthermore the manufacturer may conduct audits to validate the status of the vendor’s certification program. This activity certifies that every substance entering the plant has been manufactured, produced, or transported under GMP regulations and there is no need to proceed with microbiological or other tests in order to use it. In any case that the manufacturer of the final product can’t audit the supplier’s plant (i.e. because of the distance-some exotic material may come from aboard), he always can ask the supplier to provide an assurance that the ingredients meet the specifications of the international standards. In this case the supplier should accompany his product with a GMP certificate attesting not only the concerned product but also the particular batch. This certificate should accompany the batch upon arrival in the plant or entry into the country.

Under the circumstances, one may say that even the potable water used for the manufacturing of the products should have a GMP certificate. This is not absolutely necessary because it is generally expected that, public water typically, maintain high quality standards for chemical and microbiological content. Considering, however, that water is used both in many food processes, such as to wash foods, to clean and sanitise facilities, utensils and equipment, to make ice as well as food ingredient, food processors should perform monitoring analyses to confirm the quality and store the results in their periodic control records.

7.5. B

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

7.6. D

B

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 auditing.

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.

8.

T

HACCP

F

H

F

S

8.1. F

H

F

S

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).

2nd_{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

Today’s approach to food safety assurance is based on a combination of compliance with GMP/GHP/SSOP18 _{and one may say that HACCP, GMP, GHP and} SSOP are the foundations of the food safety assurance system.

Normally, foods produced according to what is called GMP are safe. In most cases where foods have been incriminated in foodborne diseases, deviations from GMP occurred, or incidents happened, that where not detected in time. This means that many aspects of food production are covered by measures and controls, which form part of GMP.

HACCP underscores these practices, which are critical in ensuring a product’s safety. It may also play a complementary role to GMP, as during the HACCP study some control measures specific to the food and line of production may additionally be identified.

Good Manufacturing Practices (GMP) and Good Hygienic Practices (GHP) are necessary but not always sufficient. Today, it is well known that the Codex Alimentarius guidelines provide general requirements without considering the specificity of the food or process in question and its related potential hazards. Furthermore, they do not provide a mechanism for identifying those measures, which are essential for food safety. They do not provide monitoring mechanisms to ensure that measures necessary for safety are implemented and carried out correctly. They don’t provide proof that the products were prepared according to the established requirements and of course, they do not make provisions for corrective measures if the process gets out of control.

Therefore, HACCP is preferred because we need:

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.

FOOD

SAFETY ASSURANCE

General principles of food hygiene Food-related hygienic requirements

In the new concept of food control with HACCP, the “farm-to-fork” principle in assessing food safety is a perfect fit. Government inspectors do less policing and more advising and discussing.

With HACCP, the emphasis is on shared responsibility among professional food handlers and government inspectors. Accordingly, responsibility for the production and preparation of safe food is in the hands of professional food handlers and the final enforcement of the regulation of food safety is in the hands of government inspectors.

9.

Q

9.1. D

It is not easy to define quality because the term means different things to different people. It is a term used arbitrary by many. Traditionally, luxury, beauty, high value meant quality. However, according to the use and requirements of the user, high quality can be attributed to different parameters. Therefore meeting the agreed requirements of the customer is a useful definition. One can define quality as the total parameters and characteristics of the product or service, which satisfies consumer desires and needs (agreed or presumed), or the price a customer is ready to pay for a product.

The American Society for Quality Control (ASQC, 1987) specifies that quality is “the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs”.

Nevertheless, in addition to those “classical’’ demands, from the part of the consumer, and therefore for quality attributes, in the recent years, new parameters, having a limited relation with “actual’’ quality, (i.e. animal welfare during production procedures and environmental protection), have been incorporated as quality attributes, especially in livestock production. As a matter of fact, there is a new concept, which could be addressed as the “new quality’’. It is a general requirement introducing, in the relation between consumer and producer, the dimension of imposing no harm to third parties. In other words, production should not only satisfy the demands and needs of the consumer, but it should also assure safety from the public health point of view - and - it should do that without injury to any third party. This injury or harm may concern the animals for example or the environment. These parameters, known as “other legitimate factors’’, play an important role in production and in prescribing food regulations. They don’t relate directly the production process with the consumer demands for a certain product. But they are requirements, which are projecting a quality profile based on ethical concerns. In other words a new “ethical dimension” is introduced in quality.

Quality, therefore, could be the “degree to which a set of inherent characteristics fulfils requirements’’, with emphasis on the customer both as a consumer and a human being, as well as human environment in general. Likewise, quality control is a “mechanism or technique or procedure or process” ensuring that each product attains a minimum objective standard as this is defined in practical written protocols.

Under this concept, quality can be seen from different angles:

From a consumers’ point of view prevails the Organoleptic quality, the Functional quality (e.g. rheologic properties, convenience, keepability), the Nutritional quality, the Hygienic quality (safety)

From a public health point of view what it counts more is the Hygienic quality (safety). It follows the Nutritional quality and of course the compliance with the regulations.

According to the English Oxford Dictionary, quality is the “Degree of Excellence”. We can also demonstrate it as the peculiar or essential character or the inherent feature of a specific product. Additionally quality may be defined by the entire constant

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).

9.2. I

Q

,

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 view

Consumer/industry point of view Public health point of view organoleptic quality

functional properties

keepability Compliance with regulations

“freshness”

nutritional nutritional

safety safety (hygienic quality)

Value of money

Graph 5.: The role of safety

Foodhyg 9

Safety

Public health Industry

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.

10. Q

A

F

S

A

P

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.

19 _{(ISO/UNCTAD/GATT)}