HACCP Book

HAZARD ANALYSIS &

CRITICAL CONTROL POINT SYSTEMS

WHO/MZCCTel.: +30-1-3814 703, Fax: +30-1-3814 3

SUPER MARKET

N. Charisis

Athens, Greece 2004

, Stournari 24, 106 82, Athens, Greece. 40, e-mail: [email protected], Web-Site: www.mzcp-zoonoses.gr

mailto:[email protected]

http://www.mzcp-zoonoses.gr/

BY DR. N. CHARISIS (WHO/MZCP) 2

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


1. ABBREVIATIONS

CAC FAO/WHO/Codex Alimentarius Commission CCFH Codex Committee on Food Hygiene CCFICS Codex Committee on Food Import and Export Inspection and Certification Systems CCP Critical Control Point CM Control Measures FAO Food and Agriculture Organization of the United Nations FDA Food and Drug Administration (USA) GAP Good Agriculture Practices GHP Good Hygienic Practices GMP Good Manufacturing Practices HACCP Hazard Analysis and Critical Control Point QMS Quality Management Systems ICMSF International Commission for Microbiology Specification of Food ISO International Organization for Standardisation PFD Process Flow Diagram PRP Prerequisite Programme SLDB Small and/or Less Developed Business SPS Sanitary and Phytosanitary Measures SSOP Sanitation Standard Operational Procedures TQM Total Quality Management UNIDO United Nations Industrial Development Organization WHO World Health Organization WTO World Trade Organization MZCP/WHO Mediterranean Zoonoses Control Programme/World Health Organization MZCC Mediterranean Zoonoses Control Centre Notice: Most diagrams and tables are selected from HACCP Principles and Practice, Teacher’s handbook.

A WHO/ICD Training manual in collaboration with FAO. WHO/SDE/PHE/FOS/99.3. WHO, Geneva.


HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEMS

( H A C C P )

2. FORWARD

The present document was based initially, on materials presented at the WHO/MZCP1 International Training Course on HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEM(HACCP): CONCEPTS AND APPLICATIONS, held in Teramo, Italy, 4-11 December 2000. That Course was hosted by the WHO/FAO Collaborating Center on Research and Training in Veterinary Epidemiology and Management, Istituto Zooprofilattico Sperimentale, dell Abruzzo e dell Molise, Teramo, Italy. During the course, presentation materials were made available to the participants as photocopies of the presenters’ charts and graphs and/or from the transparencies and slides and as a CD containing almost all material; however, there was no actual expository text in these presentations materials making the review of the training course a quite difficult task. At that time, the Mediterranean Zoonoses Control Centre Athens, had been assigned by WHO to work out a document containing every possible bit of information given in the ITC of Teramo in combination with salient and complementary points from relevant international literature as well as that from the WHO publications on the subject. It soon became evident, that due to the abundance of material contained in the original Teramo ITC handouts it would not be necessary to reproduce them, but rather expand on those materials in order to facilitate the reading and comprehension of charts, exercises and tables. Little by little, other colleagues were invited to contribute with their skills and experience in a joined effort to make the present document useful, not only to the trainees of similar ITCs but also to every person seeking information on HACCP systems. Therefore we consider the present book a “tool” for the training of beginners and the “enlightening” of experts in most common fields of HACCP.

3. HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)

3.1. HISTORICAL OVERVIEW AND PRESENT STATUS 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.

EgyptVoluntary (more than

10 out of 200 industries)

ThailandHACCP system in canned food

products for exportation

ChillyA draft low is been prepared

Bolivia,Colombia,Ecuador, Peru, Venezuela (think about it)

6

Moroccorevise and update fish inspection legislation including a mandatory HACCP system

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 Zealandvoluntary HACCP system-

based Food Safety program

MalaysiaHACCP 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 POINT systems”. 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

estimate0

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. THE NEED6 FOR THE HACCP SYSTEM

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:

Foodborne diseases remain one of the most widespread public health problems.

Emerging foodborne pathogens, e.g. Listeria monocytogenes, verotoxin producing E. coli, Campylobacter spp, foodborne trematodes, e.t.c., are in the increase.

Modern technology permits the detection of minute amounts of food contaminant, calling thus, for a more vigilant inspection.

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.

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.

Urbanisation leads to a longer and more complex food chain, and accordingly to greater possibilities for food contamination.

Tourism and international trade in foodstuffs has increased.

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. THE INCIDENCE OF DIARRHOEAS

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

1985

198 6

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

Inci

denc

e (c

ases

/100

000) E s t o n i a

L i t h u a n i aL a t v i aA u s t r i aG e r m a n yR u s s i a n F e d .S w i t ze r l a n dC y p r u sU 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 -

Graph 2.: Incidence of Salmonellosis in some European countries


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. THE CHALLENGE OF EMERGING AND REEMERGING FOODBORNE

DISEASES8

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.


6. ECONOMIC CONSEQUENCES OF FOODBORNE DISEASES.

6.1. THE ECONOMIC CHALLENGES TODAY

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. EXPERIENCE IN INDUSTRIALISED AND DEVELOPING COUNTRIES10

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.

7. THE HACCP SYSTEMS

7.1. CONCEPT

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. OBJECTIVES

No matter the role and the importance of Governments in the implementation of HACCP, it should not be overlooked that HACCP was introduced by the food industries to obtain greater assurance for food safety. Therefore it becomes clear that it is in industry’s best interest to produce safe food. If people become ill after eating a product, the company will certainly lose its customers and its good reputation as well as large amounts of money. So the HACCP system is not meant to be an additional regulatory burden, but rather, a tool for ensuring safety and preventing foodborne illnesses.

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. AREAS OF APPLICATION

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:

In food production, processing, manufacturing and preparation it is applied as a method of food safety assurance.

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.

In education it is used to study food preparation practices and to identify hazardous behaviour.

In the investigation of foodborne disease outbreaks it is important to identify the cause of the outbreak.

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. DEVELOPMENT AND IMPLEMENTATION

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. BENEFITS

As already stated the HACCP system is a scientific, rational and systematic approach to identification, assessment and control of hazards during production, processing, manufacturing, distribution, preparation and use of food, to ensure that food is safe when consumed. With the HACCP system, food safety control, presently based on end product testing, is from now on integrated into the design of the process. Due to this sophisticated integration, HACCP systems:


are applicable to the whole food chain, from production of raw materials to the end product (e.g. growing, harvesting, processing, manufacturing, transport and distribution, preparation and serving)

have few of the limitations of traditional approaches to food safety control13.

have the potential to identify all conceivable, reasonably to be expected hazards, even when failures have not previously been experienced. Are therefore, particularly useful for new operations.

Are capable of accommodating changes introduced, such as progress in equipment design, improvements in processing procedures, and technological developments related to the product.

help to target or manage resources at the most critical part of the food operation.

aid the relationships between food processors, inspectors and consumers.

promote international trade by providing for equitable food safety control systems everywhere in the world.

increase confidence in food safety as they reduce detention, confiscation, and destruction of contaminated food shipments and

can be easily integrated into quality management systems such as ISO systems. Therefore, HACCP provides a foodborne disease prevention system and a cost-

effective approach to food safety14. But except for the general benefits of HACCP system, which are referred above, one may focus to its specific benefits for the consumers, the industry and the governments.

a. Benefits to consumers - Reduced risk of foodborne diseases - Increased awareness of basic hygiene - Increased confidence in the food supply and - Improved quality of life (health and socio-economic) b. Benefits to industry - Increased consumer and/or government confidence - Reduced legal and insurance costs - Increased market access - Reduced production costs (reduced recall/waste of food) - Improved product consistency - Improvements of management commitment to food safety and - Decreased business risk and liability c. Benefits to governments - Improved public health - More efficient and targeted food control - Reduced public health costs - Trade facilitation (import/export)

13 Collecting and examining sufficient number of samples, high cost, time, and identification of problems without understanding the causes, limitations of snapshot inspection. 14 Experiences gained in some countries indicate that application of HACCP systems leads to more efficient prevention of foodborne diseases. In the U.S.A, only, application of HACCP by the fish processors alone is estimated to avert some 20-60% of cases of sea-foodborne illnesses.


- Increased confidence of the community in the food supply

7.6. DIFFICULTIES AND BARRIERS IN THE IMPLEMENTATION

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. THE RELATION OF HACCP WITH FOOD HYGIENE AND FOOD

SAFETY

8.1. FOOD HYGIENE AND FOOD SAFETY

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). 2ndLevel: 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:

Hygiene requirements (control measures) specific to each facility, particular food and process, and specific to the associated potential hazards

Prioritised control measures

Effective implementation of essential procedures.

Corrective measures included in a plan of checks, verification and validation. Monitoring of the process parameters to be able to control safety at all times

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

HACCP system


In the new concept of food control with HACCP, the “farm-to-fork” principle in assessing food safety is a perfect fit. Government inspectors do less policing and more advising and discussing. With HACCP, the emphasis is on shared responsibility among professional food handlers and government inspectors. Accordingly, responsibility for the production and preparation of safe food is in the hands of professional food handlers and the final enforcement of the regulation of food safety is in the hands of government inspectors.

9. QUALITY OF FOOD

9.1. DEFINITIONS OF QUALITY

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

The American Society for Quality Control (ASQC, 1987) specifies that quality is “the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs”. Nevertheless, in addition to those “classical’’ demands, from the part of the consumer, and therefore for quality attributes, in the recent years, new parameters, having a limited relation with “actual’’ quality, (i.e. animal welfare during production procedures and environmental protection), have been incorporated as quality attributes, especially in livestock production. As a matter of fact, there is a new concept, which could be addressed as the “new quality’’. It is a general requirement introducing, in the relation between consumer and producer, the dimension of imposing no harm to third parties. In other words, production should not only satisfy the demands and needs of the consumer, but it should also assure safety from the public health point of view - and - it should do that without injury to any third party. This injury or harm may concern the animals for example or the environment. These parameters, known as “other legitimate factors’’, play an important role in production and in prescribing food regulations. They don’t relate directly the production process with the consumer demands for a certain product. But they are requirements, which are projecting a quality profile based on ethical concerns. In other words a new “ethical dimension” is introduced in quality. Quality, therefore, could be the “degree to which a set of inherent characteristics fulfils requirements’’, with emphasis on the customer both as a consumer and a human being, as well as human environment in general. Likewise, quality control is a “mechanism or technique or procedure or process” ensuring that each product attains a minimum objective standard as this is defined in practical written protocols. Under this concept, quality can be seen from different angles: From a consumers’ point of view prevails the Organoleptic quality, the Functional quality (e.g. rheologic properties, convenience, keepability), the Nutritional quality, the Hygienic quality (safety) From a public health point of view what it counts more is the Hygienic quality (safety). It follows the Nutritional quality and of course the compliance with the regulations.

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


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. IMPORTANCE OF QUALITY FOR THE CONSUMER, INDUSTRY AND

PUBLIC HEALTH

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

Consumer


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. QUALITY ASSURANCE AND FOOD SAFETY ASSURANCE PROGRAMME

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:

Documentation is used as a Standard aid-memoir.

It helps the continuation of processing without problems even when there are changes of personnel.

It is the best basis for training.

Is used as a standard guidance.

It helps as a common basis for communication.

It helps controlling of the system that is applied.

It can be used as the basis for further improvement.

19 (ISO/UNCTAD/GATT) 20 Total Quality Management


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

11. QUALITY MANAGEMENT SYSTEMS ISO 9000 SERIES – EN 29000

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 (inspection, measuring and test equipment)

Nonconformity (control of nonconforming product)

Corrective action Handling and post-production functions (handling, storage, packaging and delivery)

After-sales servicing Quality documentation and records (Document control)

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.


12. TRADITIONAL FOOD CONTROL

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 %

probability

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 following:

- 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.

13. TRADITIONAL FOOD PRODUCTION AND CONTROL

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.

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.

14. TOTAL QUALITY MANAGEMENT (TQM)

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

Before HACCP foods were consumed before irregularities were detected.


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.

15. QUALITY CONTROL SYSTEM

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 consumer.

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 needed. The inspection system has many weaknesses. Among others it is based on a snapshot inspection, and not on what happened during a longer period of time. End-product testing performed by the industry itself as a means of self-control or by food inspectors is costly, time consuming and not reliable as a food safety assurance tool. Basic elements of a Quality Control System are its structural and control factors. The Structural factors include the organisation structure and the human resources whether the Quality control factors are focusing into controlling the operational process through visual inspections, equipment trials, laboratory tests etc.

Graph 6.: Safe food for all


Table 7 - The evolution of Traditional Quality

Before After From considering quality a technical activity “QUALITY” (assessment and control) was an activity assigned to certain individuals

To considering quality a Firm’s management tool “QUALITY” is part of today’s Management strategies

From adjectives Words and slogans were used: Good Quality products, Quality services provided.

To numbers The levels of Quality are measured with real numbers and proper indicators so they can be kept under constant control

From improvised decisions Actions and their consequences were not always planned: “Let’s start doing something and then we’ll look at the existing needs”.

To planned decisions Clearly plan and schedule activities before executing them.

From responding to emergencies “When problems arise react quickly”…..

To preventing emergencies Identify causes of ‘non-conformity” to quality and remove them. Prevention instead of treatment.

From oral tradition Purchase, sales, production were based on unwritten rules, consolidated by their use

To documented rules All rules regulating firm’s activities are written in procedures and standards and distributed to operators.

From …doing “What was important was to do things well”

To doing and recording 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.

16. HAZARDS ANALYSIS, CRITICAL CONTROL POINTS AND CONTROL

MEASURES

16.1. HAZARD ANALYSIS

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

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)

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.


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.

16.2. CLASSIFICATION OF HAZARD ACCORDING TO THE RISK AND

SEVERITY (HAZARD INDEX).

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 Medium likelihood = 3-4 Minimum likelihood = 1-2

Lethal hazard = 5 Severe hazard = 3-4 Minimum hazard = 1-2

Maximum value = 25 Medium value = 9-16 Minimum value = 1-4

Hazard Index = risk x severity

16.3. ASSESSMENT OF RISK IN HAZARD ANALYSIS

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.

16.4. BIOLOGICAL (MICROORGANISMS AND PARASITES), CHEMICAL, AND

PHYSICAL HAZARDS

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 severity.

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, Phytohemagglutinin

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 transportation).

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.

Acute illness: Choking Vomiting Abdominal cramps Diarrhoea Nausea Fever Chronic illness: Chronic infections

Damage of various organs Some Cancers

Death

16.5. FACTORS CONTRIBUTING TO FOODBORNE ILLNESS

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

Fever

Damage of organs

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:


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 origin.

16.6. CONTROLLING GROWTH OF MICROBES – CONTROL MEASURES

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:

product development

industrialisation of a new product

when specific hazards emerge

when new raw material are used

when formulation is changed

when equipment is changed

when a new production area is used 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!


The likely occurrence of hazards and the severity of their adverse health effects

The qualitative and/or quantitative evaluation of the presence of hazards

Survival or multiplication of microorganisms of concern

Production or persistence in foods of toxins, chemicals or physical agents

Quality of raw materials

Conditions leading to the above and identification of control measures

16.7. QUESTIONS TO BE CONSIDERED IN A HAZARD ANALYSIS

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 processing?

7. Which intrinsic factor of the food must be controlled in order to assure food safety?

8. Does the food permit survival or multiplication of pathogens and/or toxin formation in the food during processing?

9. Are there other similar products in the market?

10. What has been the safety record for these products?

C. Procedure used for processing

11. Does the process include steps destroying pathogens (both vegetative cells and spores)?

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 pathogens?

15. What is the normal microbial count of the food?

16. Does the microbial population change during the normal time the food is stored prior to consumption?

17. Does the subsequent change in microbial population alter the safety of the food, pro or con?

E. Facility design

18. Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat food?

19. Is positive air pressure maintained in packaging areas? Is this essential for product safety?

20. Is the traffic pattern for people and moving equipment a significant source of contamination?

F. Equipment design

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

22. Is the equipment properly sized for the volume of food that will be processed?

23. Can the equipment be sufficiently controlled so that the variation in performance will be within the tolerances required to produce a safe food?

24. Is the equipment reliable or prone to frequent breakdowns?

25. Is the equipment designed so that it can be cleaned and sanitised?

26. Is there a chance of product contamination with hazardous substances (e.g. glass)? 27. What product safety devices are used to enhance consumer safety? (metal detectors,

sifters, filters, screens, thermometers, de-boners)

G. Packaging

28. Does the method of packaging affects the multiplication of microbial pathogens and/or the formation of toxins?

29. Is the package clearly labelled “Keep refrigerated” if this is required for safety?

30. Does the package include instructions for the safe handling and preparation of the food by the end user?

31. Is the packaging material resistant to damage thereby preventing the entrance of microbial contamination?

32. Does each package and case contain the proper label and code?

H. Sanitation

33. Can sanitation impact upon the safety of the food that is being processed?

34. Can the facility and equipment be cleaned and sanitised to permit the safe handling of food?


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

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 temperature?

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)?

16.8. CRITICAL CONTROL POINTS (CCPS)

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.

28 The difference between CCP1 or CCPe (=elimination) ,CCPp (=prevention) , CCPr (=reduction) does no longer exist. 29 Step in HACCP is a point, procedure, operation or stage in the food chain, including raw materials, from primary production to final consumption.


16.9. MONITORING

Monitoring should aim to detect any deviation from the established criteria. It usually depends on observations as well as physical or chemical measurements (e.g. temperature, pH, concentration of salt). Monitoring is an essential element of “controlling hazards” and it has to be carried out by the operator who is in charge of the control measure at the specific CCP. In other words monitoring means the regular measuring and recording of values at predetermined intervals. These values are the parameters used to assure that a situation is under control. As a consequence the hazard is reduced to a level where no unacceptable growth occurs and therefore, every contamination is prevented. Monitoring of critical control points is essential to ensure that specific criteria are being met. Foods can be monitored in many ways depending on the type of control point and the instruments and equipment available. In order to monitor, we need to set critical limits and determine the methods that can be used to check whether a CCP is under control. When critical limits are exceeded, then corrective actions have to be taken; these actions must be described in the HACCP plan. Through the monitoring system the team establishes the method or the equipment to be used in this CCP, the intervals or the frequency of checking, and finally the interpretation of the results and the actions to be taken.

16.10. CONTINUOUS MONITORING

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.

16.11. CRITICAL LIMIT

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 milk!


Normally, the milk is heated at 73°C for 15 seconds. This temperature treatment assures that levels of pathogens such as Mycobacterium bovis, Salmonella, Listeria monocytogenes and Campylobacter are reduced sufficiently to guarantee that the product is safe. When the temperature drops a few tenths of a degree, the number of microorganisms will still be reduced sufficiently; there is a safety margin. But at a certain point, the deviation becomes too large and safety is not assured. This unacceptable deviation determines the critical limit. Milk produced with a temperature lower than the critical limit should not reach the consumer. This is an easy example because it deals with thermal treatments of known bacteria in an easy-to-control situation. Many other situations are less easy to control (for instance re-contamination) and determining a deviation from "normality" is much more difficult.

16.12. MICROBIOLOGICAL PROCESS CONTROL

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

16.13. DEVIATION

A deviation is a failure to meet a critical limit. According to the Codex Alimentarius terminology, deviation means a loss of control. For the purposes of this book however, the word deviation will be used for any situation, which is not "normal".

The last question to be asked for each CCP and each hazard is “what the appropriate reaction to a deviation should be”? This will help to define corrective actions.

16.14. 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.

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 packaging

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 0157:H7

Proper holding and cooling temperatures of foods; 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 SOPs.

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 knives

Staphylococcus aureus Proper fermentation and pH control; proper heat treatment and post-process product handling practices; reduced water activity

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.


Specific corrective actions must be developed for each CCP in the HACCP system in order to deal with deviations when they occur. The actions must ensure that the CCP has been brought under control. Actions taken must also include proper disposition of the affected product. Deviation and product disposition procedures must be documented in the HACCP record keeping. Various corrective actions may be necessary. There is still some ambiguity in the use of the terminology “corrective actions”, but the final result should be that safe products reach the consumer. Ideally, corrective actions should readjust deviations before they become unacceptable. They should ensure that the product produced during a situation that is out of control does not reach the consumer, and they should also prevent reoccurrence of the event. This may mean that the process has to be redesigned, or that a monitoring frequency method or a target level has to be changed; in other words, the HACCP plan should be improved.

17. HACCP PLAN

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 folowing:

assessing the compliance with product/process description,

processing flow diagram,

assessing and identifying the most significant hazards,

correcting identification of all hazard sources,

identifying all Critical Control Points,

monitoring the programme (frequency, methods, equipment etc), and

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

Monitoring Raw materials

CCP

No

Hazard to be controlled

Control measures

Critical limits Procedure Frequency

Corrective actions

Responsiperson(s)

Incoming raw material

Flour

1.1 Aflatoxin Obtain Certificates of Analysis from suppliers

Aflatoxin <10 mg/kg

Inspect Certificate of Analysis

Every batch

Reject batch

Incoming Goods Cl

Supply QAManager

Mains water

1.2 Chemical

contamination

Carry out on-site micro checks and obtain Certificate of local sample-Water Authority

Chemical contamination

Regulatory Compliance

Testing for toxic substances Giardia, Cryptosporidium,

Inspect Certificates of Analysis from water Authority

Weekly Contact water Authority

QA mana

Jam 1.3 Pesticide residues

Certificates of Analysis from the approved supplier

Within legal limits

Inspect Certificate

Supplier’s QA Audit

Annually

Annually

Contact Purchasing Manager

QA mana

Cream 1.4 Salmonella and Listeria

Supplier Quality Assurance System

Approved supplier

Absent/25 g

Inform purchasing

Laboratory tests for

Listeria, Salmonella,

Supplier’s QA audit

Every delivery

monthly

Reject batch

QA Mana

QA Mana


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

Monitoring Process step

CCP

No


Control measures

Critical limits Procedure Frequency

Corrective actions

Respoble person

Storage of raw material

2 Physical contamination, biological growth

Store as specified, i.e. cream<50 C egg for specified max. time. Keep covered

No physical, chemical contamination.

Maintain temp. <50 C

Automatic temperature recorder. Visually inspect label to ensure stock rotation

Daily checks-continue during use.

Every batch

Hold and inform QA Manager

WarehoManagand Operat

Bake sponge through oven

3 Survival of vegetative pathogens

Bake sponge at specific time/temperature

Bake at 700 C for 2 min. minimum core temperature

Automatic chart recorder

Continuous

Stop production Reject faulty product. Adjust oven temp/time

Operat

Metal detect

4 Metal contamination

Metal detector

Absent-ferrous 2.0 mg, non-ferrous 2.5 mg

Metal detection check using test pieces.

Calibrate metal detector

Every 30 min.

Daily

Stop line, recalibrate, notify QAM. Hold stock manufactured since previous check.

QA Inspect

Line Engine

Dispatch

5 Growth of pathogens

Low temperature during storage and distribution

0-50 C Continuous chart recorder – warehouse and distribution vehicle.

Check recorder calibration

Daily review

Montly

Hold, inform QAM, Sample and test product

WarehoManagTranspManag

WarehoManag

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 study. In order to collect objective evidence, Auditors should proceed in the examination of records maintained by the company. The information achieved will be useful for the auditor to determine if the HACCP system is being implemented as described and is effective on a continuous basis.

In a HACCP plan we should establish a record30 keeping and documentation concerning:

Minutes of HACCP study meetings, (decisions made and their reasons)

Records of monitoring

Records of verification

Records of deviations and corrective actions

Records of modifications to the HACCP plan In other words, issuing a HACCP plan (documenting the analysis of risks, defining control

points and relevant control methods, etc) is not enough; a description of the firm’s organisation and its basic “working rules” connected to the production process control is also necessary. The structure of system documentation must be chosen on a “case by case” basis, according to the firm’s real needs. Main criteria used are:

45. Company Complexity and Number of Products: The HACCP Control System must suit the firm’s dimensions and guarantee its effectiveness in all cases. System’s documentation needed for a small firm producing only one type of product will be minimal, while, for a large industrial Company, documentation will be more complete and detailed for the various products/process.

46. Existence of the quality system: A quality system developed according to ISO 9000 standards includes a complete documentation, structured on 4 levels:

a) Quality system manual,

b) Operational procedures,

c) Work instructions,

d) Worksheets for quality records.

Such documentation already covers some elements of the HACCP Control System. Therefore the problem is to integrate the HACCP control System into the Quality System. This applies especially to medium and large firms wanting to develop a complete Quality System according to ISO 9000 Standards and wanting to integrate the HACCP Control System into this Quality System.

30 Records are operative sheets regarding: Incoming materials (raw material, ingredients), Process parameters (temperature, time), Finished product, Cleaning and sanitising, Pest control, Employee Training as well as Other record-keeping document such as microbiological/chemical test results, calibration certificate, complaints documents, finished products rejected, hours for equipment maintenance and results of internal/external audits


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

CONTROL SECTION 0 – THE COMPANY AND ITS ORGANIZATION

SECTION 1 – HACCP PLAN + QUALITY SYSTEM

SECTION 2 – OPERATIONAL PROCEDURES

SECTION 3 – WORK INSTRUCTIONS SECTION 4 -- WORKSHEETS

17.1. THE OPERATIONAL PROCEDURES OF A HACCP PLAN

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 areas. 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

17.2. PRODUCT /PROCESS ANALYSIS

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.

17.3. PREREQUISITES

Prerequisites are the practices and conditions needed prior to and during the implementation of HACCP, which are essential for food safety, as described in the Codex Alimentarious Commission’s General Principles of Food Hygiene and other Codes of Practices.

Safe food was already produced a long time before HACCP was developed. If food caused a case or an outbreak of foodborne illness, the causative factors were analysed and practices put in place to prevent re-occurrence. The practices thus developed were called Good Manufacturing Practices (GMP) as was previously explained. Many activities are carried out in the production and preparation of food to prevent foodborne diseases. Examples are pest control, preventive maintenance, training of the personnel, etc. All these activities are described in general terms in the Codex Alimentarius document on the Principles of Food Hygiene.

HACCP assures that GHPs are indeed carried out, anticipates potential problems and tries to prevent or control them. However application of HACCP alone is not enough to ensure food safety problems; prerequisites should be in place as well. These prerequisites may be:

a. Premises (including the structure of the organisation and its description, the sanitation programme, the pest and insect control programmes implied together with the maintenance of the buildings),


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.

17.4. GOOD MANUFACTURING PRACTICES (GMP) AND SANITATION

STANDARD OPERATIONAL PROCEDURES (SSOP)

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 Manual

GOOD HYGIENIC PRACTICE MANUAL

HACCP System MANUAL

Consultative, didactic Prescribing Generic (refers to one kind of product or process)

Specific (refers to the product or process system of a specific plan)

Prepared by the sector associations Validated by the Ministry of Health

Prepared by the Company Approved and signed by the company management Validated by the local official Authorities

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

QUALITY System MANUAL

HACCP System MANUAL

Its goals are defined by customer’s requirements.

IMPLEMENTATION VOLUNTARY

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

IMPLEMENTATION MANDATORY

17.5. IMPACT OF HACCP ON FOOD PROCESSORS AND FOOD

INSPECTORS

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 inspectors.

Food Processors Food Inspectors Internal advantages

- continuous, problem solving process - identification of the food establishment as the final party responsible for ensuring the safety of the food it produces.

- increased productivity (lower waste, better resources efficiency)

- focalisation of the efforts on the more critical phases.

- procedure formalisation - ability to face the increasing need to assure the food safety for human consumption.

- all human resources involvement in the common final target (food safety);

-more comprehensive determination of establishment’s level of compliance. Using conventional inspection techniques, the official Authority can determine conditions during the time of inspection, which provide a “snapshot” of conditions at the moment of the inspection. However, by adopting a HACCP approach, both current and past conditions can be determined. When regulatory Authorities review HACCP records, they have, in fact, a look back through time. Therefore, the regulatory Authorities can better ensure that processes are under control.

- continuous self-inspection External advantages

- customer claims reduction - product trustiness in the market (competitive advantage)

- ability for the food processors to prove food safety in official audits

Costs - manual development - human resources training - new equipment - system management - expertise

Problems - limited final resources - limited human resources availability - disagreement between internal HACCP responsible person and official Authorities with regards to number and

nature of CCPs to be managed (every CCP increases the cost of production). Schedule

It depends on: Food plant size Quality system existence GMP Manual existence


17.6. VALIDATION AND VERIFICATION OF A HACCP PLAN

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.

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

Validation is a responsibility of the industry!

It should be undertaken initially and as needed thereafter


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. AUDIT

18.1.1. The Audit and it’s role

Audit is a systematic and functionally independent examination in order to determine whether activities and related results comply with planned objectives (Codex Alimnentarius1997). The term “Audit” is used for a variety of activities. Normally, independent auditors perform an audit which involves an in-depth examination of the production site and of how the HACCP plan was established and implemented. This definition is given because the word audit is frequently used in the context of verification or regulatory assessment.

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:

confirm that the written procedures (prerequisite programme and HACCP plans) are up to date;

to review the HACCP system for its conformity33 with the written procedures (implemented as described);

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 objectives”.

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 implemented. Specifically the role of the industry is to develop, implement and maintain prerequisite programmes and HACCP plans, to maintain the necessary records and ensure an appropriate training programme for the staff. On the other hand the competent authorities should verify the compliance34 with planned measures and their efficiency to assure the safety of food. By doing so, the audit target is to evaluate the effectiveness of the measures described in HACCP plans and their efficiency to achieve the objective. An official reference about a regulatory system audit that explains in details, how to develop own-checks system verification does not exist. The European Union has not elaborated any procedures for “Auditory field activities” and has not defined any tools to gather and record information during an own checks system verification.

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 department.

(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 horizontal.

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

systems

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. Examples:

- 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 Examples:

- 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. Examples:

- 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:

Check list36 to evaluate HACCP system elements and elaborate a specific segment of the system;

forms to record all findings collected; forms to document the objective evidence in order to support the auditors

final conclusion

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 plan. 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 equipment/machinery. 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”).

Characteristics 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.


Subjects The subjects of a regulatory audit are numerous including every part of the plant

where a Critical Control Point can be established. In general we can classify these subjects under 4 major categories, human, machinery, premises and used material. In particular the regulatory audit is dealing with:

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

Therefore the aim of competent authority is to verify the compliance with planned measures and their efficiency to assure the safety of food. By doing so, the audit target is to evaluate the effective implementation of the measures described in HACCP plans and their efficiency to achieve the objective.

Actual situation An official reference about a regulatory system audit that explains, in details, how

to develop own-checks system verification does not exist. The European Union has not elaborated any procedures for “field activities” and has not defined any tools to gather and record information during own-checks system verification. For these reasons, ISO model is still a point of reference within the European Union

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

FOOD SAFETY

E.U has not passed any guidelines for the conduct of inspections

THEREFORE

the Auditor can use his own methods of Inspection!

But not exaggerate


HACCP

Therefore HACCP is an instrument that allows to obtain the hygienic aspects of food quality. GOOD MANUFACTURING PRACTICES and GOOD HYGIENIC PRACTICES 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. PREREQUISITES Premises (Structure and organization description, Sanitation program, Pest control program, Maintenance). Equipment and tools (Equipment description, Sanitation program, Maintenance) Production process (Raw material supply, Storage, Producing and Distribution process, Waste disposal, Water supply). Personnel (Personnel hygiene and Training)

19. HACCP SYSTEM (PRELIMINARY PHASES)

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.

GMP/GHP

PREREQUISITES


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. PHASE 1. ASSEMBLE THE HACCP TEAM

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 site.

19.1.2. Competencies and professional figure of the TEAM

The team must have specific knowledge referring to: characteristics and intended use of examined product phases of productive process equipment characteristics technological aspects practical aspects of productive activities microbiological principles of examined product possible chemical or mechanical hazards HACCP principles. 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:

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.

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.

Responsible of quality assurance (co-ordinator)

HACCP responsible (technical secretary)

Responsible of meat division

Expert veterinarian (external expertise)

Expert on quality system (external expertise)

Official authority

2nd Example – HACCP plan of cheese in a small and/or less developed dairy.

Owner

Expert veterinarian (external expertise – co-ordinator)

Expert on quality system (external expertise)

Official authority

19.2. PHASE 2. PRODUCT DESCRIPTION (PRODUCTIVE PLANS) 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

Greenland” 3. Important final product characteristics

List characteristics that affect product safety, especially those that influence 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 -used

State how the final product is to be prepared for serving, especially whether it 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 (aw, pH, Salt, preservatives,..)

Fresh (pH 6-7) Frozen Sodium Nitrite 100 to 200 pmm (cured)

3. How it is to be used For further processing 4. Packaging Wax-lined cartons 5. Shelf Life Frozen – 1 year at –180 C (in house guideline)

Fresh - “X” hours at close to 00 C Cured – “Y” days at close to 00 C

6. Where it will be sold Registered and non-registered plants for further processing. 7. Labelling Instructions Keep Frozen/Refrigerated

Ingredient –Sodium Nitrite (in cured) 8. Special Distribution If shipped Fresh, temperature close to 00 C

If shipped Frozen, -180 C Shipped in refrigerated vehicle at a temperature to maintain fresh or frozen requirements.

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

Meat Products Restricted Ingredients Packaging Materials

Chicken Portions (Necks, Backs, Racks, Wings) BCP

Sodium Nitrite Cure (Prague Powder) Waxed Carton C 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 needs.

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:

Section 1: General description (name, execution time, etc)

Section 2: Description of all ingredients, listed in order of decreasing weight/volume. 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)}

Section 3: Representation, through a flow chart, of the main process phases. Description for each phase, of activities and main process parameters (time and temperature). 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

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:

Types 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)

Processes 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.

Definitions: Expiry date (Use-by-date): is the date after which the product should not be

consumed Sell-by-date: tells the store how long to display the product for

sale. Best-before-date: is the date recommended for best flavour or

quality. It is not a purchase or safety date.

19.3. PHASE 3. INTENDED USE

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.

19.4. PHASE 4.- DEVELOPMENT OF FLOW DIAGRAM AND PLAN LAY-OUT

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.

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.

A flow diagram is a “map” of the process


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 process

It indicates a decision point in the productive process

It indicates flow direction

19.4.3. Flow process chart symbols

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

DELAY: This symbol represents a delay to material when conditions do not permit the immediate performance of the next planned step. This does not include any planned change to its physical or chemical characteristics. STORAGE: A storage where material is kept in an unchanged form and protected against unauthorised removal. TRANSPORT: A transportation occurs when a material is moved from one place to another, except when such movements are part of an operation, or are caused by an operator at a workstation during an operation or inspection. COMBINED ACTIVITY:

D


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

Grinding Mixing

Cooking Freezing Boxing

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

Receiving beef


Distributing Reheating

Serving

19.5. PHASE 5. ON SITE CONFIRMATION OF FLOW DIAGRAM AND PLANT

LAY-OUT

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 hours.

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 documents.


20. HACCP SYSTEM PRINCIPLES

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

20.1. PRINCIPLE 1: CONDUCT A HAZARD ANALYSIS

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


The likely occurrence of hazards and the severity of their adverse effects. The qualitative and quantitative evaluation of hazards The survival or multiplication of microorganisms in concern The production or persistence in foods with toxins, chemicals or physical

agents The quality of raw material The conditions leading to the above and identification of control measures.

Hazard analysis is a key element in developing a HACCP plan. It is essential that this process be conducted in an appropriate manner, as application of subsequent principles involves tasks, which utilize the results of the hazard analysis. Thus, hazard analysis represents the foundation for building a HACCP plan.

To exemplify the term “hazards and conditions leading to their presence”, the enterotoxin of Staphylococcus aureus is an example of a hazard, whereas “a condition leading to the presence of this hazard” would be the exposure during production or storage of a product to reach a temperature at which Staphylococcus can grow and produce enterotoxins.

For simplicity, the hazard analysis procedure is divided into the following activities41: 1. Review incoming material for potential hazards 2. Evaluate processing operations for hazards 3. Observe actual operating practices 4. Take measurements 5. Analyse the measurements

20.2. PRINCIPLE 2. DETERMINE THE CRITICAL CONTROL POINTS

(CCPS)

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


Stop

Not a CCP

YES

Critical Control Point

NO

Will a subsequent step eliminate identified hazard(s) orreduce likely occurrence to an acceptable level?

YES NO

Is the step specifically designed to eliminate orreduce the likely occurrence of a hazard to an acceptable level?

YES

Stop

Not a CCP

NO

Modify step, Process or Product

YES

Is control at this step necessary for safety?

NO

Do control preventive measure(s) exist?

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

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

YES NO SNot a CCP


20.3. PRINCIPLE 3. ESTABLISH CRITICAL AND OPERATING LIMITS

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:

Scientific publications/research data

Regulatory requirements and guidelines

Experts studies (e.g. thermal process authorities, consultants, food scientists, microbiologists, equipment manufacturers, sanitation specialists, academics)

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 develop.

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


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

seconds 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

product 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.

20.4. PRINCIPLE 4: ESTABLISH A SYSTEM TO MONITOR CONTROL OF THE

CCP.

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



does have a role in HACCP verification. When critical limits are established for the elimination of pathogens or their reduction to an acceptable level, microbiological testing can be used to verify the HACCP plan’s effectiveness and to ensure that the identified microbiological limits have not been exceeded. In this instance, the length of time involved in the analytical procedures does not create operational difficulties44.

Target values are used in monitoring. Even if the value is slightly higher or lower than the target value, it is still acceptable as long as it remains within the critical limits; otherwise, the product is considered unacceptable and cannot be released.

Monitoring procedures need to be rapid, as they relate to on line processes, which in general do not leave time for lengthy analytical testing. For this reason, physical and chemical measurements (temperature, time, pH, moisture level and water activity) or visual observations, which may be done rapidly, are often preferred to microbial testing. The purposes of monitoring include the following:

54. To measure the performance level of the operation at the CCP (trend analysis) 55. To determine when the performance level of the system results in a loss of control at

the CCP (e.g. when there is deviation from a critical limit); and

56. To establish records reflecting the performance level of the system’s operation. Accurate monitoring procedures and associated records provide information to the

operator and allow for decisions to be made on the acceptability of the lot at a particular stage in the process. For the monitoring procedures it is essential that all monitoring equipment is always properly calibrated for accuracy.

Responsibilities for monitoring should be clearly defined, and individuals must be adequately trained in the monitoring procedures for the CCP for which they are responsible.

The monitoring specifications for each CCP should be written on the proper form. They should give information on:

57. What will be monitored (i.e. measurement of the cold-storage temperature, of the pH, of the Aw etc)

58. How critical limits and preventive measures will be monitored (i.e. physical or chemical measurements instead of microbiological testing)

59. Who will monitor (individuals assigned to monitor CCP’s may include line personnel, equipment operators, supervisors, maintenance personnel and quality assurance personnel).

20.5. PRINCIPLE 5. ESTABLISH THE CORRECTIVE ACTIONS TO BE TAKEN

WHEN MONITORING INDICATES THAT A PARTICULAR CCP IS NOT

UNDER CONTROL.

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.



Any corrective measures undertaken with regard to a specific step should be easily understood and – of course - implemented by the employee performing the activities. Any corrective action taken should be documented and communicated to management in order for the system to be modified, if necessary, and reoccurrence of the problem prevented. The diversity of possible deviations at each CCP means that more than one corrective action may be necessary at each CCP. When a deviation occurs, it will most likely be noticed during the routine monitoring of the CCP. The producer should control the deviations as follow:

60. He should have a specific -for each product- mechanism in place, to identify deviations as soon as possible

61. He must be able to spot and isolate all affected products manufactured during this deviation

62. He should cooperate with experts on different fields in order to evaluate a specific deviation (e.g. with a microbiologist to examine and evaluate a deviation from microbiological standards in order to detect if this deviation is a possible source of a hazard).

After the evaluation of a deviation a corrective action should be taken in order to prevent the production of unsafe products. Corrective action procedures are necessary to determine the cause of the problem, to prevent recurrence and to follow up with monitoring and reassessment to ensure that the action taken is effective. The producer’s corrective action programme should include:

(1) investigation to determine the cause of the deviation, (2) effective measures to prevent recurrence of the deviation and (3) verification of the effectiveness of the corrective action taken. Examples of deviation procedures for different products45.

Canned Vegetables: “The scheduled thermal process is not met because of a loss in steam pressure”!

The operator notices the deviation before the product is released and refers immediately to the written deviation procedures.

According to the deviation procedures the operator adds an additional processing time.

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 condemnation.

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” The operator notices the deviation before the product is unloaded from the

truck and refers immediately to the written deviation procedures. 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 frequency.”



The operator notices the deviation and believes that the product has an excessive bacterial contamination. He informs the supervisor according to the deviation procedure and the suspected product is withheld and subjected to microbial testing.

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

20.6. PRINCIPLE 6. VERIFICATION/ESTABLISH VERIFICATION

PROCEDURES.

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 industry. 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 consequences.

Verification may –and– should also be performed by someone other than the person who is responsible for performing the activities specified in the plan. According to the abovementioned definitions for Verification, we can say that it may be conducted by:

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

The verification may be done: (a) After each HACCP plan elaboration, (b) As part of a continuous revision, established by the program in order to

demonstrate that the HACCP plan is efficient, (c) When there is any change that affects hazard analysis or changes HACCP in any

way.

Accordingly it can be applied in each step of the HACCP plan, in the HACCP plan of each product (including each step) and when there is any change in the process or materials used, affecting hazard analysis. Verification comprises of “checking system conformity” and “confirmation of effectiveness”49 of the system.

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 examination. The verification activities are mentioned more detailed below:

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 expected.


Scientifically evaluate all hazards, Analyse deviations of critical limits, Analyse corrective actions taken for each deviation in the past, Guarantee that all CCP are under control, Guarantee -through calibration- that all measuring equipment are working

properly Perform laboratory analysis to guarantee that the critical limits are well

established, and 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.

20.7. PRINCIPLE 7. ESTABLISH DOCUMENTATION CONCERNING ALL

PROCEDURES AND RECORDS RELEVANT TO THE HACCP

PRINCIPLES AND THEIR APPLICATION.

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 records. 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. \

21. ROLE OF INDUSTRY AND ROLE OF THE AUTHORITIES

21.1. ROLE OF INDUSTRY

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: provide the consumer with food, which is safe and suitable for consumption,

and ensure that the average consumer shall have clear understanding on the

information written on the labels in how to store/preserve, cook, prepare or handle the specific

product. 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. ROLE OF COMPETENT AUTHORITY (GOVERNMENT)

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:

protect consumers from food or waterborne diseases. provide assurance that, any food or water in the market (locally produced or

imported), is suitable for human consumption. 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 below:

Enforcing relevant legislation and regulations Applying sanctions in case of non-compliance Engaging in international relations Conducting research, risk assessment Publicising requirements


Providing technical assistance Training (governmental and industrial people) 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.

22. REGULATORY ASSESSMENT (GOVERNMENTAL ACTIVITIES IN

ASSESSING HACCP)

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 place.

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:

HACCP management HACCP plan development Hazard analysis Control measures Business’s verification procedures Documentation 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 systems.

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 taken.

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:

Description of the product and its intended use; Flow diagram; Location of CCP’s; HACCP worksheet; List of verification activities; Results of monitoring and verification; 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.


23. CONCLUSIONS

The HACCP system is an effective tool for a food safety assurance. Its application for the prevention of foodborne diseases is of tremendous value, and in international food trade its application has become indispensable. Progress in its implementation varies from country to country and depends on the commitment and recognition of policy makers as well as their funds, which are made available for the specific purpose. In developing countries, lack of expertise and resources for training are two major weaknesses to progress in its implementation, and most of the progress made has been with regard to food for international trade. Paradoxically these countries are those, which have the greatest need for this system, because of the high prevalence of foodborne diseases and lack of sources to meet the high costs of traditional approaches. HACCP is evolving. World-wide the interest in the application of HACCP in the food industry is growing, and regulatory agencies are being adapted to make their inspection systems compatible with the industry based on the HACCP system. Both progress and problems encountered in the implementation of the HACCP system must be monitored on a regular basis, and guidance on this subject should be updated.

It is very important for the governments to develop an implementation strategy, which reflects the needs of the country, and which is time and resources-realistic. Before the implementation, there should be enough time to allow opportunities for training of the people to be involved (in private and government sector). It is expected that in the initial stages, the implementation of the HACCP system would require enormous resources in terms of qualified personnel, technical support facilities and financial inputs, particularly to ensure the necessary training.

Training in HACCP for food inspectors and personnel in food businesses will be a key to its successful implementation, provided that the training is standardised so that a common understanding is developed between food businesses and food inspectors. Therefore both the private sector and the government should contribute to mobilising the necessary resources for the appropriate training and all other requirements that can set the start point for the implementation of a HACCP system in a specific country.

It seems that, at the moment, the whole of the Meat Industry, is changing to a customer and market oriented production and distribution system, in which quality is prevailing over quantity. For a more efficient and effective management system, to this end, application of Total Quality Management (TQM), and quality assurance certified systems (ISO 9000 Standards, HACCP, Integrated Quality Control) are vehicles for transparently projecting the level of safety and quality of meat and meat products the industry is supplying to the consumer. It is hoped that this is, also, a way to restore the industry’s credibility, after suffering the consequences of last year’s food safety crisis.


24. EXPERIENCES

The HACCP system has been proven as a powerful tool in identifying and assessing hazards in food as well as establishing necessary central measures (FAO/WHO). Moreover it can lay the foundations for the application of improved food born surveillance programmes (WHO Document WHO/FSF/FOS/97.3), although at the moment, the existing comparative statistical studies are not sufficient to demonstrate this improvement through surveillance programmes. However, where epidemiological surveillance of foodborne diseases is weak, application of the HACCP, to food processing and food preparation can be an effective alternative and/or complementary measure, for the identification of faulty or high-risk practices. In any case, apart from the recommendation of international organisations, the regulating authorities or the governments are feeling confident enough to promote the HACCP system, as a mandatory programme to be applied by the food industry, for assuring food safety for their products. Leading among these governments is the European Union and the United States of America. The “Codex Committee on Food Hygiene”50, in 1963, prescribed codexes of GHPs instead of end-product microbiological standards. It was against this background that later (1993) CAC adopted, through the same Committee the “Guidelines for the Application of Hazard Analysis Critical Control Point (HACCP)’’, recognising the validity of applying preventive approaches for securing food safety, rather than relying on end-product control (CAC, Basic Texts on Food Hygiene). The revised, “Recommended International Code of Practice – General Principles of Food Hygiene’’ [CAC/RCP 1-1969, Rev. 3 (1997)], were adopted by CAC in 1997.

In the E.U., Directive 93/43/EEC originally established that HACCP application should be mandatory for all food industry in the Union. Further to it, and in view of the recent food emergencies in Europe(BSE, dioxins), the E.U.Commission published a White Paper on Food Safety, which eventually, and in a relatively short period of time, had lead to the creation of a “European Union Central Agency for Food”. In this respect, and among others, the concepts of HACCP application and the integrated approach to food safety “from stable to table’’ were adopted. The HACCP system was proposed also for feed manufacturing and Good Hygiene Practices were applied to all activities involved in food production from the field to the consumer’s table. Now Regulations51, are rather proposed in the E. Union instead of Directives, going to a detailed description for the HACCP application and certification in the primary production, while HACCP system is required for activities starting from slaughtering down to the selling points.

In the USA, HACCP application is also required in the food industry. In 1995, FDA established HACCP for the seafood industry and incorporated it in its Food Code, which is a general regulation, guiding and serving as model legislation for state and territorial agencies, for food services establishments, retail food stores and vending operations. In 1998, FDA proposed requiring HACCP controls for fruit and vegetable juices, and now is considering expanding through the rest of food industry, including domestic and imported food products. The USDA has established HACCP for meat and

50 Is part of Codex Alimentarius Commition, 51 A 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.


25. GLOSSARY

This glossary provides a list of definitions of terms used in this report as well as additional definitions found in other relevant reports, dictionaries or the international bibliography. Acceptable level Is a criterion whose probability to cause an unacceptable risk for human health is not

relevant. Acceptance No deficiencies that can lead to a loss of food safety control have been identified. Accreditation This is the procedure by which a governmental agency having jurisdiction formally

recognises the competence of an inspection and/or certification services. Audit Is a tool through which the operations of the HACCP system are formally monitored

and conformance with the documented system is assured.

Findings: A statement of fact made during an audit and substantiated by objective evidence

Objective evidence: Factual and verifiable information describing an audit finding.

Non conformity: A failure to meet specified requirements Best-before-date: Is the date recommended for best flavour or quality. It is not a purchase or safety date. Certification Procedure by which official certification bodies or officially recognised bodies provide

written or equivalent assurance that foods or food control systems conform to requirements.

Checklist A list that contains points/elements that may be considered during assessment. It is used as an aide-memoir to promote uniformity in assessment.

Cleaning Is the removal of soil, food, residue, dirt grease or other objectionable matter. Compliance Compliance means that the HACCP plan and prerequisites and their implementation

meet regulatory requirements. Conformity Conformity means that the industrial activities are carried out according to the

established procedures, e.g. HACCP plan and prerequisites. Contaminant Any biological or chemical agent, foreign matter, or other substances not intentionally

added to food, which may compromise food safety or suitability. Contamination The introduction or occurrence of a contaminant in food or food environment. Control (noun) The state wherein correct procedures are being followed and criteria are being met. Control (or preventive) Measure

Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Control (verb) To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP plan

Control point A point in a specific food system at which loss of control does not produce an unacceptable health risk.

Correction Refers to, rework or adjustment in the report Corrective action Any action to be taken when the results of monitoring at the CCP indicate a loss of

control. Critical Control Point (CCP) A point at which control can be applied and is essential to prevent or eliminate a food

safety hazard or reduce it to an acceptable level. Critical limit A criterion, which separates acceptability from unacceptability.

or The maximum or minimum value to which a physical, biological or chemical parameter must be controlled at a CCP to minimise the risk that the identified food safety hazard may occur.

Deviation Failure to meet a critical limit. Disinfection The reduction by means of chemical agents and/or physical methods, of the numbers of

microorganisms in the environment, to a level that does not compromise food safety or suitability.

Disposition of nonconformity

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 requirements.

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 HACCP plans

These are examples of HACCP plans developed for a food commodity or process that 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 SYSTEM

Is: Organization, Resources, Processes and Procedures working together to guarantee 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 HACCP plan

The ongoing execution and maintenance of the 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

HACCP. Validation Obtaining evidence that the elements of the HACCP plan are effective.

It is the responsibility of the industry and should be undertaken initially and as needed thereafter.

Verification The application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the HACCP system This is primarily an industry responsibility however some verification activities can also be undertaken during regulatory assessments.

Wholesome food Wholesome food shall mean food, which is fit for human consumption as far as hygiene is concerned.


26. BIBLIOGRAPHY

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, Geneva.

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.


27. FURTHER READING

80. American Meat Institute. The Shift from the Traditional Federal Meat and Poultry Inspection System to a new HACCP-Based System. http://www.meatami.org/HACCP/backgrounder.htm

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. MeatNews.com. Article – [469]. http://www.meatnews.com/Articles/view.Article.cfm

84. Borgdorff, M. W., Y. Motarjemi (1997). Food Safety Issues. Surveillance of Foodborne diseases: What are the options? WHO Document: WHO/FSF/FOS/97.3.

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). http://europa.eu.int/eur-lex/el/com/dat/2000/el_500PC0438_01.html




91. EUR-Lex. Document 500PC0438(05). http://europa.eu.int/eur-lex/el/comdat/2000/el_500PC0438_05.html

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. http://www.meatpoultry.com/haccp/7steps.htm

96. US, FDA, HACCP : A State-of-the-Art Approach to Food Safety. http://vm.cfsan.fda.gov/~lrd/bghaccp.html


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 WHO/SDE/PHE/FOS/99.7. http://www.who.int.fsf

99. WHO. 53rd World Health Assembly. Eight Plenary Meeting. Agenda item 12.3. 20-5-2000, A53/VR/8. WHO Document 53.15. http://www.who.int/fsf/WHA%2053_15e.pdf

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 Symposium.

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.


28. ANNEX 1 - HAZARDS, CRITICAL CONTROL POINTS AND

MONITORING PROCEDURES FOR COMMON FOOD SERVICE

OPERATIONS52

This table gives examples of hazards associated with some common food service operations, together with appropriate control actions and monitoring procedures. Operation/critical

control point Hazards Control measures Monitoring procedures

Purchase/receipt Pathogens on raw foods; foods obtained from unsafe sources

Obtain foods from safe source Set purchase specifications and check for 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 high or duration of storage too long; Cross-contamination.

Maintain cold temperature; rotate stock Observe condition of food; measure food and unit temperature, observe storage practices; measure duration of storage; look for potential routes of contamination

Dry storage Break in package; high moisture; poisons stored near foods; sewage backflow or drippage from pipes; vectors

Maintain low temperatures and humidity; store poisons elsewhere; protect foods from contamination

Observe storage practices

Thawing Bacterial growth; contamination of area by thaw water; incomplete thawing

Thaw at temperatures and within times that do not permit multiplication of common pathogenic bacteria

Observe thawing practice; feel whether product is completely thawed

Reconstitution (rehydration)

Contamination during rehydration; bacterial growth

Use safe water and clean utensils and containers; use food promptly or refrigerate in small volumes

Observe practices

Preparation Cross-contamination from raw products; contamination from food-handlers and dirty equipment and utensils

Avoid handling raw foods and then cooked foods; avoid touching foods that are not to be heated subsequently

Observe practices

Cooking Pathogens survive inadequate time-temperature exposure; spores survive

Adequate time-temperature exposure Measure temperature at geometric centre of food

Handling of foods that are not subsequently heated

Cross-contamination from raw products; contamination from hands, equipment or utensils

Avoid handling raw foods and then cooked foods; avoid touching foods that are not to be heated subsequently; exclude ill persons from working with food; ensure personal hygiene of food service workers

Observe practices observe personnel for signs of illness; receive reports of illness or significant symptoms

Holding at room or warm outside temperatures

Bacterial growth Limit time of such holding; hold hot or cool

Observe practices; measure time of holding

Hot-holding Bacterial growth Hold foods at temperatures at which pathogenic bacteria do not multiply

Measure temperature of foods at intervals

Cooling Pathogenic bacteria multiply Cool foods rapidly in shallow containers or use other method of rapid cooling; store as close to freezing as feasible

Measure depth of food; measure temperature of food after cooling; observe storage practices

Reheating Microbial pathogens may survive; heat stable toxins will survive

Adequate time-temperature exposure Measure temperature at completion of reheating

Cleaning of equipment and utensils

Failure to remove pathogens from surfaces

Wash, rinse, disinfect Observe practices; measure concentration of disinfectant solution and conduct time

52 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


29. ANNEX 2 – COMMON CRITICAL CONTROL POINTS AND EXAMPLES

ON MONITORING PROCEDURES FOR PROCESSING OPERATIONS53

Process Food Critical control point

Monitoring procedures

Receipt of raw product

Fruit and vegetables

Fertilisation Observe swage disposal practices and whether faeces are used as fertiliser

Irrigation Observe practices to determine whether sewage reaches irrigation water

Washing and freshening

Conduct sanitary survey of water source

Meat, poultry, eggs

Receipt Observe/smell for signs of spoilage

Cleaning of equipment

Observe for possibility of cross-contamination; Observe effectiveness of cleaning procedures

Chilling and cold storage

Measure size of batch, time of cooling, temperature of chilled 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

storage Measure temperature of product and time of storage

Cleaning of equipment

Observe of possibilities of cross-contamination; Observe effectiveness of cleaning procedures

Shellfish Harvesting of waters free of pollution and with low levels of indicator organisms

Sample water and test for faecal indicator organisms; Survey for sewage outflows

Freezing Fruits, vegetables

Blanching Measure temperature and time

Freezing Measure time-temperature exposure during freezing; Observe whether product is frozen

Storage of thawed product

Measure temperature of product and time held after thawing

Meat, poultry Freezing Measure time, temperature exposure during freezing; Observe whether product is frozen



Fish and shellfish

Freezing Measure time-temperature exposure during freezing and observe whether product is frozen



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, filling

Inspect cleanliness of equipment; take swabs from contact surfaces; inspect valves; collect samples and test for coliforms

Cold storage Measure temperature of product and time of storage Roast beef,

turkey Pasteurisation Measure time-temperature exposure

Slicing, packaging

Observe for possibility of cross-contamination from raw to cooked product via personnel, equipment, cleaning cloths; observe handling



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,

meat, fish Retorting Observe operation of retorts; measure temperature after exhausting,

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

acid) Heat-processing Observe operation of retorts; record time temperature exposure and

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 of products containing added salt and nitrite

Luncheon meats

Heat processing Observe operation of retorts, water baths or ovens; measure time-temperature exposure and pressure;

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

pasteurisation Measure time-temperature exposure; observe indicator thermometer 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

product Collect samples and test for salmonellae, measure aw

Coconut Pasteurisation Measure time-temperature exposure; observe indicator thermometer

and recording chart Grating and

shredding Observe operations for possibility of contamination

Packing Check integrity of package Holding of final

product Collect samples and test for salmonellae, measure aw

Chocolate Raw product Collect samples and test for salmonellae Roasting of

beans Measure time-temperature exposure

Environment Collect environmental samples and test for salmonellae; observe moisture control

Holding of final product

Collect samples of product and test for salmonellae

Dry-blended infant formula

Ingredients Collect samples and test for salmonellae

Environment of blending and packaging areas

Collect environmental samples and test for salmonellae

Holding of final product

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

facilities. 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

room Vegetables, fish Formulation Check concentration of NaCl Final product Measure pH, aw; check appearance of product Milk, cheese,

yoghurt Pre-heating or pasteurisation

Measure time-temperature exposure; observe indicator thermometer 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


30. ANNEX 3 - CORE HACCP ASSESSMENT CHECKLIST

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 Principle

Checklist

Preparation What evidence is there of management commitment to HACCP use? HACCP Team -Who was on the team? - Are all appropriate disciplines represented? - What is the likely knowledge level of the individuals? (Evidence of training, qualifications, experience

etc.) - Has external expertise been sought where necessary? - What is the decision-making leverage of the HACCP team leader? HACCP System - How does the system fit with the overall food safety control programme? - Does the company have a food safety policy? - Has the scope been clearly defined? - How is the system structured?

Principle 1 "CONDUCT A HAZARD ANALYSIS"

Has the product been properly described? - Are intrinsic control measures identified? 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?



- 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 "Determine the Critical Control Points (CCPs)"

How were the CCPs identified? - By expert judgement? - By the use of a decision tree? (has the decision tree been used correctly?) - 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 “Establish critical limits”

How were the critical limits established? - Is there evidence (experimental data, literature references etc.)? - 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 "Establish a system to monitor the control of the CCP"

Have realistic monitoring schedules been established? - Do they cover all CCPs? - Has the reliability of monitoring procedures been assessed where appropriate? - 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 "Establish the corrective action to be taken when

Have the corrective actions been properly defined such that control is regained? - What evidence is there to demonstrate that this is being done in the event of a CCP deviation? - Has corrective action been recorded and how is the effectiveness being verified?


monitoring indicates that a particular CCP is not under control"

How has the authority for corrective action been assigned? How is non-conforming product controlled and is this clearly recorded? Are there clear disposition actions listed?

Principle 6 "Establish procedures for verification to confirm that the HACCP system is working effectively"

Have verification procedures been clearly and appropriately established? - How are these procedures communicated through the business? - Have responsibilities for verification procedures been allocated? - Are they being carried out effectively? - Are all CCPs covered by the verification programme? - 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 "Establish documentation concerning all procedures and records appropriate to these Principles and their application"

What format is being used to document the system? - Does the documentation cover all of the HACCP system operation? - How is the documentation controlled with regard to update and issue etc.? - Are the records accessible? - Are the HACCP records clearly identified by unique reference numbers? - Are all documents accurate and current? - Are verification procedures documented? - How is change control managed?


31. ANNEX 4 – CLEANING/SANITISING VERIFICATION OPERATIVE

FORM55

OPERATIVE FORM Edition: 01 CLEANING/SANITISING VERIFICATION FORM Date: 25/09/00

DATE / / OPERATOR…………………………………………

Conform = visible absence of dirt, of oily surfaces and of unpleasant odours.

Not conform = absence of conformity characteristics. Mark using an ‘x’ in the proper column. Facilities

Conform Not conform Dining room Kitchen Storing rooms Washrooms Equipment

Conform Not conform Mixer Slicing machine Mincing machine Scales Electric oven Oven Cooker Fan Freezer Refrigerator Boiler Working surfaces/tools

Conform Not conform Sinks Working surfaces Pans Containers Dishes and tools Notes:……………………………………………………………………………………………………

…………………

Corrective actions: Less than 3 non- conformities: Cleaning and sanitising activities must be repeated on facilities, tools or piece

of equipment showing non conformity. 3 non conformities: All cleaning and sanitising activities must be repeated on all facilities, equipment

and tools before starting work. Manager signature

55 HACCP Principles and Practice, Teacher’s handbook. A WHO/ICD Training manual in collaboration with FAO. WHO/SDE/PHE/FOS/99.3. WHO, Geneva (1999).


32. ANNEX 5 – CLEANING/DISINFECTING FREQUENCY OUTLINE56

AREAS/TOOLS BEING CLEANED/DISINFECTED

ORDINARY CLEANING AND DISINFECTION

M O D A L I T I E S

DINING ROOM Floors and walls Windows and ceiling lamps Tables

Daily Monthly Monthly Daily (more than once a day)

Detergent/disinfectant in hot water with specific grease remover, then rinsing. Specific detergent Detergent/disinfectant and glass shiner Detergent disinfectant

KITCHEN Floors and walls

Daily Monthly

Detergent/disinfectant Special detergent

Windows and ceiling lamps Monthly Detergent/disinfectant and a special detergent Sinks Daily

Weekly Bleach and grease remover, by hand Filters cleaning Marl removing using acids

Mincing machine Daily Washing by hand after disassembling (according to manual) and dipping disassembled parts Cleaning/disinfection

Scales Daily Cleaned and disinfected by hand. Mixers Daily Washing by hands after disassembling (according to manual) and dipping

disassembled parts. Cleaning/disinfecting

Ovens Weekly Weekly

By hand after removing grids 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 Cleaning/disinfecting

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

Every 3 months Cleaning without detergents Emptied and cleaned with detergent/disinfectant Cleaning and disinfection

Storing rooms Weekly Monthly Every 3 months

Washing with water and vinegar, then drying Specific disinfectant Detergent/disinfectant

Bins and Discarded parts Weekly By hand and by dipping Cleaning, disinfecting

Washrooms Daily Weekly

By hand, using detergent/disinfectant Marl removal

Changing rooms Weekly Using detergent/disinfectant after dusting Drains and Tubes When necessary Pressure washing using probes and acids


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33. ANNEX 6 – EXAMPLE OF HACCP DATA SHEET57

Process step

CCP

No.


Control measures Critical limits Procedure Frequency Corrective actions

Responsible person(s)

Incoming raw material Flour

1.1 Aflatoxin Obtain Certificates of Analysis from suppliers

Aflatoxin: < 10 mg/kg

Inspect Certificate of Analysis

Every batch Reject batch Incoming Goods Clerk, Supply QA Manager

Mains water

1.2 Chemical contamination

Carry out on-site micro checks and obtain Certificate of Analysis of local sample-Water Authority

Chemical contamination Regulatory Compliance

Testing to include toxic substances, Giardia, Cryptosporidium. Inspect Certificates of Analysis from Water Authority

Weekly Contact Water Authority

QA manager

Jam 1.3 Pesticide residues

Certificates of Analysis from approved supplier

Within legal limits

Inspect Certificate SQA Audit

Annually Annually

Contact Purchasing Manager

QA Manager QA Manager

Cream 1.4 Salmonella and Listeria

Supplier Quality Assurance System Approved supplier

Absent/25 g Inform purchasing

Laboratory tests Listeria, Salmonella, Procedure (No s xxx) SQA audit

Every delivery 6-monthly

Reject batch QA Manager QA Manager

Storage of raw material

2 Physical contamination, biological growth

Store as specified, i.e. cream < 5°C, egg for specified max. time. Keep covered

No physical, chemical contamination. Maintain temp. < 5°C

Automatic temperature recorder. Visually inspect label to ensure stock rotation

Daily checks – continue during use. Every batch

Hold and inform QA Manager

Warehouse Manager and Operator

Bake sponge through oven

3 Survival of vegetative pathogens

Bake sponge at specified time/temperature

Bake at 70°C for 2 min. minimum core temperature

Automatic chart recorder

Continuous Stop production. Reject faulty product. Adjust oven temp./time

Operator

Metal detect

4 Metal contamination

Metal detector Absent – ferrous 2.0 mg, non-ferrous 2.5 mg

Metal detection check using test pieces. Calibrate metal detector

Every 30 min. Daily

Stop line, recalibrate, notify QAM. Hold stock manufactured since previous check

QA Inspector Line Engineer

Dispatch 5 Growth of pathogens

Low temperature during storage and distribution

0-5°C Continuous chart recorder– warehouse and distribution vehicle. Check recorder calibration

Daily review Monthly

Hold, inform QAM, sample and test product

Warehouse Manager Transport Manager Warehouse Manager


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34. ANNEX 7 – BASIC KNOWLEDGE NECESSARY TO FOOD

PROCEDURES (PRIMARY PRODUCTION)58

CEREAL PRODUCERS

The main sources of pathogenic microorganisms transmitted to/or existing in cereals which are potentially causing foodborne diseases The role of spoilage organisms which may cause food deterioration The influence of temperature and other factors in food quality and safety

MEAT/POULTRY and MILK PRODUCERS/TRADERS/HANDLERS

Basic livestock feeding and hygienic principles, in particular for 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 slaughterhouse) 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 eggs) The role of temperature and moisture in the storage of food of animal origin

VEGETABLE PRODUCERS/HANDLERS

Basic principles of Good Agriculture Practices (GAP) Indicators of deterioration at harvesting Contamination control measures during harvesting Adequate handling techniques to minimise damage Transport and storage of vegetable products

SEAFOOD PRODUCERS/ TRADERS/HANDLERS

Influence of water quality on pathogenic microorganisms and 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

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35. ANNEX 8 – BASIC KNOWLEDGE NECESSARY FOR FOOD

PERSONNEL

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 PERSONNEL

Sources of microorganisms, their importance as foodborne pathogens and 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 technicians 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 products Adequate process and storage methods and consequences of inadequate practices 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

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36. ANNEX 9 – PRACTICAL EXAMPLES

36.1. HAMBURGER

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

potential hazards

introduced, controlled or enhanced at

this step

Are any potential food safety hazards

significant? YES/NO

Justify your decision for previous column

What control measures can be applied to

prevent the significant hazards?

Is this step a critical

control point (YES/NO)

Preparation of the meat (logs)

Biological Chemical Physical

YES

NO NO

Contamination or multiplication of microorganisms

Set refrigeration. GMP: personnel, equipment, facilities and training.

NO

Weighed/ground Biological Chemical Physical

NO NO YES

Contamination with fragments of metals from grinder.

Metal detector, Grinder maintenance.

YES

Mix with condiments and preservatives


YES

NO NO

Contamination and/or multiplication of microorganisms.

Refrigerated atmosphere. GMP: select the ingredients, Personnel training, Equipment.

NO

Formed Biological Chemical Physical

YES

NO NO

Contamination and/or multiplication of microorganisms.

Refrigerated atmosphere. GMP: select the ingredients, Personnel training, Equipment.

NO

Freezing Biological Chemical Physical

YES

NO NO

Multiplication of microorganisms.

Freeze quickly. Control of the temperature of the tunnel or refrigerating room. Refrigerating room with alarm light and or sound in the event of a faillure

NO

Packed Biological Chemical Physical

YES

NO NO

Contamination and/or multiplication of pathogenic microorganisms

GMP: equipment, operational training of personnel. Refrigerated atmosphere.

NO

Storage Biological Chemical

YES

NO

Multiplication of pathogenic microorganisms.

Control of the time and storage temperature. GMP: appropriate storage conditions. Refrigerating

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Physical NO room with alarm light and/or sound in the event of failure.

36.2. ULTRAHIGH TEMPERATURE (UHT) MILK

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

step Identify potential

hazards introduced,

controlled or enhanced at this

step

Are any potential

food safety hazards

significant? YES/NO




Is this step a critical control point

(YES/NO)

Raw milk reception


YES

YES

YES

Growing of high numbers of pathogenic bacteria. Milk may have residual antibiotic. Hairs, etc.

Control achieved at farm level. Quality should be checked before reception. – GMP -

NO

Standardise Biological Chemical Physical

NO NO NO

NO

Clarify Biological Chemical Physical

NO NO NO

NO NO NO

Homogenise Biological Chemical Physical

NO NO NO

NO NO NO

Heating Biological Chemical Physical

YES

NO NO

Presence of active vegetative and spore forming pathogens.

Heating for approved temperature time

YES

NO NO

Cooling Biological Chemical Physical

YES NO NO

Prevent recontamination

Monitoring physical condition of plant

NO NO NO

Filling and packing


YES NO NO

Cross-contamination Pre-sterilisation of plant. Installation of filler in “clean” area with control of air flow and pressure

NO

Storage and Distribution


NO NO NO

NO

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36.3. PASTEURISED FRUIT JUICE

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.


step Identify potential hazards

introduced, controlled or enhanced at

this step

Are any potential

food safety hazards

significant? YES/NO


What control measures can be applied to prevent the significant hazards?


(YES/NO)

Reception of raw material


NO YES YES

Chemical residuals of agricultural products

Quality assurance of the raw material Quality assurance of the raw material

YES

Weighed Biological Chemical Physical

NO NO NO

NO

Pre-washed Biological Chemical Physical

NO NO NO

NO

Selection Biological Chemical Physical

NO NO NO

NO

Washed Biological YES Contamination by pathogenic microorganisms.

Hyperchlorinated water. Minimum 10 ppm of residual chlorine

NO

Cut into logs the fruit


NO NO NO

NO

Fruit pulp extraction


NO NO NO

NO

Pasteurisation Biological Chemical Physical

NO NO NO

NO


NO NO NO

NO

Addition of preservatives


NO YES NO

Preservatives amount that exceed established limits

Use of the appropriate concentration of the preservatives. Appropriate control of the weight.

YES

Packed Biological Chemical Physical

NO NO YES

Fragments of metals, glasses in the bottles.

Wash bottles. Turn down the containers. Suitable supplier. Put out

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possible fragments with compressed air.

Storage Biological Chemical Physical

NO NO NO

NO

36.4. ROW MILK COLLECTION IN THE FARM (MILKING PROCESS)

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 immunocompromised.

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)


step Identify potential hazards

introduced, controlled or

enhanced at this step

Are any potential

food safety hazards

significant? YES/NO





(YES/NO)

Preparation for milk


NO NO NO

The hazards are controlled with GMP

Hazards controlled by cleaning and sanitation (GMP)

NO

Conduction (handling) of the animals


NO NO NO

NO

Rationing the feed


YES NO NO

Moulds, Preservatives, Dust.

Good practices when placing the portion. Portion of good quality.

NO

Washing of udders


YES NO NO

Soil, manure, etc. GMP No

Drying of udders


YES NO NO

Spread of contamination. Use paper towels NO

Discard of first jets/Black Fund Test and CMT


YES NO NO

This test identifies animals with mastitis and avoids the use of possibly contaminated milk.

Apply Black Fund test and CMT

YES

Milk Biological Chemical Physical

YES NO NO

Milker and equipment may contaminate milk

GMP/GAP NO

Post-dipping Biological Chemical Physical

NO NO NO

NO

Cleaning after milking

Biological Chemical

NO NO

Hazards are controlled with GMP

GMP NO

118

Physical NO Filtration of milk


NO NO YES

Milk can bring physical hazards

The filter will separate these hazards

YES


YES NO NO

Microbial proliferation. Control cooling time and temperature.

YES

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37. ANNEX 10 - PREMISES – THE FIRST STEP IN THE

IMPLEMENTATION OF HACCP/GMP

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 from any contamination source.

Processing rooms located close to dirt roads 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 roofed spaces in order to avoid environmental contamination during windy or rainy days.

Otherwise, the surrounding space – especially where cars are moving - should be paved in order 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 plant. The construction of buildings should prevent the entrance of insects/rodents in the first place. However sometimes it is necessary to perform some food processing operations, or unloading out in the open. In these cases it is important to reduce the numbers of mosquitoes, flies and arthropods.

Dirty water should be carried away properly into covered canals. Oil application in stagnant waters destroys mosquito’s larvae. Housefly is considered the most important from the standpoint of human health. They are breeding in almost any warm organic material (garbage, manure, etc). Fly control in the surroundings involves: 1) Environmental sanitation measures (elimination of insanitary privies, garbage should be stored in flytight

120

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 plant

Proper sanitation with emphasis to adequate 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 buildings usually prevents the entrance of insects and rodents in the premises. Floor and foundation construction should be made in such a way as to prevent the entrance of rodents and arthropods. Screens over windows, doors and ventilators prevent the entrance of rodents or insects.

In case of accidental entrance of insects or rodents in food processing areas the use of traps is mostly suggested because poisonous material may contaminate the food.

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.

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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.

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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.

Stable 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.

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

(f). Storerooms with adequate refrigeration for the maintenance of carcasses before transportation.

(g). The construction of the slaughtering process should be made in such a way that it permits the removal of the skin when the carcass is already suspended from the ceiling. That means that soon after the anaesthetisation the carcass is removed from the floor and never touches it again.

(h). All personnel with raw meat should wear clean head covers, light coloured uniforms and boots. They should clean their hands always after the use of toilets in the beginning of their shift and after intermissions for lunch or toilet. Hands should also washed properly when they come in contact with suspect or sick animals. Ring, bracelets and hand watches should be better removed before work and smocking should be prohibited in working areas (including loading and unloading posts).

(i). Unauthorised personnel should not enter the premises.

(j). All food handlers should present with a health certificate before employment.

(k). Sick food handlers should not enter the working areas.

(l). The entrance of other animals except the animals to be slaughtered in the premises (or even backyard) of the slaughterhouse should be prohibited.

(m). The control of rodents and insects should be intensive and effective.

(n). The dispersal of sawdust or of any other material destined to keeping the floor dry should be prohibited.

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. Storehouses

Raw meat should be refrigerated immediately after the slaughtering and the subsequent inspection (in some cases the inspection takes place little after the slaughtering). Carcasses are preserved in 70C, and viscera in 30C. A deviation is permitted

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

Meat destined to be preserved in deep freeze should be processed immediately after slaughtering in approved establishments. The internal temperature of this meat should be –120 C and no more. Transportation

Tracks transporting meat should be designed to keep up a stable temperature during travel. Their inner walls should be from a smooth material that can be easily cleaned and disinfected without corruption. This material should not corrupt by the contact of carcass and should not transfer poisonous or toxic substances to the meat. They should also be water, dust, rodent and insect proof.

Carcasses or raw meat should be suspended from the sealing or the wall in a way that they don’t touch the floor. Tracks destined to transport raw meat should not carry living animals or any other material that can contaminate meat. Packed meat should not be transported together with unpacked.

Viscera, heads, and limbs should not be transported with unpacked meat unless they have been cleaned, dehaired and scalded. Loading process and transportation vehicles are checked by the responsible veterinarian.

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38. ANNEX 11 - THE CONCEPT OF SHARED RESPONSIBILITY

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.

FOOD

LEGISLATION AND ENFORCEMENT

EDUCATED

AND KNOWLEDGEABLE

PUBLIC

GOOD PRACTICES

BY PRIMARY PRODUCERS

AND DISTRIBUTORS

ADVICE FOR

INDUSTRY/TRADE

DISCRIMINATING AND

SELECTIVE CONSUMERS

QUALITY ASSURANCE AND

CONTROL OF

PROCESSED FOOD CONSUMER EDUCATION

SAFE FOOD PRACTICES IN THE

HOME

APPROPRIATE PROCESSES

AND TECHNOLOGY

INFORMATION GATHERING

AND RESEARCH

COMMUNITY PARTICIPATION

TRAINED MANAGERS AND

FOOD HANDLERS

PROVISION OF

FOOD-RELATED SERVICES

ACTIVE CONSUMER GROUPS

INFORMATIVE LABELLING

AND CONSUMER EDUCATION

GOVERNMENT

CONSUMER

INDUSTRY/TRADE

NATIONAL COMMITMENT TO FOOD SAFETY

WHO LEADERSHIP FOR INTERNATIONAL CONSENSUS ON FOOD SAFETY ISSUES, POLICIES, AND ACTIONS

SCIENCE, RESEARCH AND DEVELOPMENT

The importance of food safety for human nutrition (FAO/WHO international Conference on Nutrition, 1992)

SAFE FOOD FOR ALL

S H A R E D R E S P O N S I B I L I T Y

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Acknowledgments are expressed to: 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.

Prof. K. Genigiorgis for the revision of the document

Dr. A. Seimenis, Director of the WHO/MZCC in Athens for the revision of the document.

HACCP Book

Documents

Transcript of HACCP Book