HAZARD ANALYSIS &
CRITICAL CONTROL POINT SYSTEMS
SUPER MARKET
N. Charisis Athens, Greece 2004 WHO/MZCC, Stournari 24, 106 82, Athens, Greece. Tel.: +30-1-3814 703, Fax: +30-1-3814 340, e-mail:
[email protected], Web-Site: www.mzcp-zoonoses.gr
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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. 3.1.2.
4.
Historical overview _____________________________________________________________ 7 Present status __________________________________________________________________ 8
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
7.
8.
6.1.
The economic challenges today _____________________________________________ 14
6.2.
Experience in industrialised and developing countries __________________________ 14
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
The relation of HACCP with Food Hygiene and Food Safety ___________________ 22 8.1.
9.
Food Hygiene and Food Safety _____________________________________________ 22
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
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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. 19.1.2. 19.1.3. 19.1.4. 19.1.5.
HACCP Team ________________________________________________________________ 67 Competencies and professional figure of the TEAM___________________________________ 67 Team’s activities ______________________________________________________________ 67 Size and composition of the team _________________________________________________ 68 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
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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. 22.1.2. 22.1.3. 22.1.4. 22.1.5. 22.1.6. 22.1.7. 22.1.8. 22.1.9.
Assessing the HACCP management _______________________________________________ 90 Assessing the HACCP plan development ___________________________________________ 90 Assessing the HACCP analysis ___________________________________________________ 90 Assessing the effectiveness of control measures ______________________________________ 91 Assessing the verification procedures ______________________________________________ 91 Assessing the documentation_____________________________________________________ 91 Assessing the implementation ____________________________________________________ 91 Competencies of assessors_______________________________________________________ 91 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
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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
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ABBREVIATIONS
CAC CCFH CCFICS CCP CM FAO FDA GAP GHP GMP HACCP QMS ICMSF ISO PFD PRP SLDB SPS SSOP TQM UNIDO WHO WTO MZCP/WHO MZCC
Notice:
FAO/WHO/Codex Alimentarius Commission Codex Committee on Food Hygiene Codex Committee on Food Import and Export Inspection and Certification Systems Critical Control Point Control Measures Food and Agriculture Organization of the United Nations Food and Drug Administration (USA) Good Agriculture Practices Good Hygienic Practices Good Manufacturing Practices Hazard Analysis and Critical Control Point Quality Management Systems International Commission for Microbiology Specification of Food International Organization for Standardisation Process Flow Diagram Prerequisite Programme Small and/or Less Developed Business Sanitary and Phytosanitary Measures Sanitation Standard Operational Procedures Total Quality Management United Nations Industrial Development Organization World Health Organization World Trade Organization Mediterranean Zoonoses Control Programme/World Health Organization Mediterranean Zoonoses Control Centre
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.
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HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEMS
(HACCP) 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. 3.1.
HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP) 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
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(NASA) and the U.S. Army Laboratories at Natick, in order to ensure the safety of astronauts’ food. In 1973, the Pillsbury Company published Food Safety through the Hazard Analysis and Critical Control Point System, which was the first document on HACCP concepts and techniques. Twenty years later, this system was internationally recognised and accepted for food safety assurance, including, not only microbiological safety of foodstuffs but also chemical and physical hazards. Since then and for many years HACCP systems have been applied on a voluntary basis in many food industries. Systematic implementation of a HACCP system-based approach to food safety assurance throughout the developing world shouldn’t be expected for the near future, because of the lack of expertise and training on the subject. However, meeting food export requirements has always been a strong motivation to introduce HACCP systems. In Morocco, for instance, there has been an incentive to revise and update fish inspection legislation and to include a mandatory HACCP system based on food safety assurance with the aim of obtaining European Union acceptance of Moraccan fish, because these systems have been made the legal and mandatory requirement in the European Union. 6
Indeed, the implementation of HACCP in the developing world cannot be expected because of lack of money. However, food export requirements has always been a strong motivation to introduce HACCP system
Malaysia Morocco revise and update fish inspection legislation including a mandatory HACCP system
HACCP system in 27 Fishery industries for exports to EU, USA, Australia
New Zealand voluntary HACCP systembased Food Safety program
Chilly A draft low is been prepared
Bolivia,Colombia,Ecu ador, Peru, Venezuela (think about it)
Uruguay HACCP system in meat industries for exports to USA.
Thailand HACCP system in canned food products for exportation
Egypt
Voluntary (more than 10 out of 200 industries)
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
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recognition and application. The following schematic figure shows the growth and sudden increase in application of HACCP. Graph 1.: HACCP growth curve from 1970 - 1995
50 40 30 20 10 0 1970
es timate 1975
1980
1985
1990
1995
Today, HACCP based food safety assurance systems, rather than voluntary codes, have been made the legal and mandatory requirement in some countries2, such as the member states of the European Union. Thus, recognising its importance, food and public health authorities world-wide have promoted HACCP. The World Health Organization for example, has recognised the importance of HACCP for the prevention of foodborne diseases and has played a significant role in the development and implementation of HACCP. In 1995 the FAO/WHO Codex Alimentarius Commission adopted guidelines for the application of HACCP in basic texts (a collection of internationally adopted food standards presented in a uniform manner). The Codex Alimentarius also includes provisions of an advisory nature in the form of codes of practice, guidelines and other recommended measures to assist in achieving its purposes. The Codex Alimentarius3 on general principles of food hygiene has been revised in 1997 in order to include recommendations for the application of HACCP guidelines. The description in the Codex guidelines gives a structure that makes HACCP likely to be accepted by other parties such as food inspectors and trade partners. In due course, all food quality assurance guidelines will include HACCP. Sector-specific guides to Good Hygienic Practice (GHP) and guides to HACCP have been developed
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. 2
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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 International Commission for Microbiology Specification of Food 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) 4 5
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condition. Therefore in the relatively modern HACCP system, “hazard”7 is exactly this condition of the food that may represent any threat to the consumer by causing symptoms ranging from any detectable discomfort, to severe illness, injury or death. However, adverse effects on health are not only due to biological, but also to physical, chemical or radio nuclear hazards. From this point of view HACCP system is the latest and most developed food safety assurance method in the world, protecting the contamination and/or growth of bacteria in food as well as it contamination by poisonous chemicals, foreign bodies etc., and consequently the development of a serious situation for both manufacturers and consumers. – But, what was the situation before HACCP? The need for an effective food safety assurance system goes back to the beginning of civilisation. Ever since time immemorial, texts indicate that kings or emperors were concerned about protecting their subjects from foodborne diseases, and/or food adulteration.
Today, governments, regulatory agencies, industries, and consumers are greatly concerned for safe foods. The reasons for this are: 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 fastfood 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 The borders of hazard are not strictly confined. There are variations depending on many factors such as the infective dose, the age, the general health, the pregnancy, the immune competence of the individual e.t.c.
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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 Sweden (1995) Netherlands (1991) New Zealand (1993) UK (1995) Canada (1985) USA (1985)
Percentage 7% 15% 9% 7% 8% 10%
Source National survey Sentinel study National survey National survey Estimation Estimation
Graph 2.: Incidence of Salmonellosis in some European countries
Incidence (cases/100000)
250 E sto n ia L ith u a n ia L a tvia A u str ia G erm any R u ssia n F e d . S w i t ze r l a n d C yprus UK
200 150 100 50
199 8
199 7
199 6
199 5
199 4
199 3
199 2
199 1
199 0
198 9
198 8
198 7
198 6
198 5
0
Table 3.: Reported cases of Listeriosis in some European countries COUNTRY Belgium Bulgaria Denmark Iceland
1993 36 27 3
1994 32 2 23 6
1995 38 29 4
1996 50 39 1
1997 45 2 33 2
1998 42 1 41 -
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Ireland Italy Netherlands Spain Sweden UK England and Wales UK Scotland
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48 14 24 35 103
31 24 26 34 115
4 29 31 25 34 87
125 40 22 21 23 120
7 68 21 19 18 124
4 45 29 16 32 108
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THE CHALLENGE OF EMERGING AND REEMERGING FOODBORNE 8
DISEASES
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 microorganisms 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.
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ECONOMIC CONSEQUENCES OF FOODBORNE DISEASES. 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.
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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. 7.1.
THE HACCP SYSTEMS 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
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processing line under control. Experience from the canning industry demonstrated that keeping control over processing conditions was much more efficient and reliable than end product testing. The time and temperature employed guaranteed safety of the product (even significant under-processing can seldom be detected by end product testing).
Experience from the Canning Industry demonstrated that control over processing conditions was much more efficient and reliable than end-product testing.
To assure that measures are carried out as determined, all-important actions are described and personnel is trained to carry them out. Actions have to be implemented without exception. To ensure that they are carried out correctly and to provide evidence of this, the results should be recorded. At the same time those records also provide a basis for improvement.
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 Prevention of foodborne illness
Reduction of costs of food analysis
More efficient quality assurance system
Reduction of losses due to product recalls
Therefore, HACCP’s main objective is to enhance assurance in the food safety in order to prevent foodborne illnesses more efficiently. Additionally it will reduce the costs of control and wasted food and it will protect the reputation of the food processor and its entire industry.
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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 See principles of HACCP. 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. 11 12
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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:
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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 costeffective 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) 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. 13
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- 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.
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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
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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 longterm savings from reduced public health costs.
8. 8.1.
THE RELATION OF HACCP WITH FOOD HYGIENE AND FOOD SAFETY 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). nd 2 Level: application of the food-related hygienic requirements (as expressed by the Good Manufacturing/Hygienic Practice). 3rd Level: application of HACCP. HACCP can be applied in order to achieve a greater assurance that the produced, processed or manufactured food is safe. It identifies what is needed to make food safe and makes sure that what is planned is correctly implemented. Therefore today HACCP is part of food hygiene, or the food safety assurance system. Food hygiene can itself be placed in the context of food quality assurance programmes.
16 17
Term applied by the Codex Alimentarius Commission (CAC). Term applied by the Codex Alimentarius Commission (CAC).
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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
FOOD SAFETY ASSURANCE HACCP system Food-related hygienic requirements General principles of food hygiene
Today’s approach to food safety assurance is based on a combination of compliance with GMP/GHP/SSOP18 and one may say that HACCP, GMP, GHP and SSOP are the foundations of the food safety assurance system. Normally, foods produced according to what is called GMP are safe. In most cases where foods have been incriminated in foodborne diseases, deviations from GMP occurred, or incidents happened, that where not detected in time. This means that many aspects of food production are covered by measures and controls, which form part of GMP. HACCP underscores these practices, which are critical in ensuring a product’s safety. It may also play a complementary role to GMP, as during the HACCP study some control measures specific to the food and line of production may additionally be identified. Good Manufacturing Practices (GMP) and Good Hygienic Practices (GHP) are necessary but not always sufficient. Today, it is well known that the Codex Alimentarius guidelines provide general requirements without considering the specificity of the food or process in question and its related potential hazards. Furthermore, they do not provide a mechanism for identifying those measures, which are essential for food safety. They do not provide monitoring mechanisms to ensure that measures necessary for safety are implemented and carried out correctly. They don’t provide proof that the products were prepared according to the established requirements and of course, they do not make provisions for corrective measures if the process gets out of control. Therefore, HACCP is preferred because we need: Hygiene requirements (control measures) specific to each facility, particular food and process, and specific to the associated potential hazards Prioritised control measures Effective implementation of essential procedures. Corrective measures included in a plan of checks, verification and validation. Monitoring of the process parameters to be able to control safety at all times 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.
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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. 9.1.
QUALITY OF FOOD DEFINITIONS OF QUALITY
It is not easy to define quality because the term means different things to different people. It is a term used arbitrary by many. Traditionally, luxury, beauty, high value meant quality. However, according to the use and requirements of the user, high quality can be attributed to different parameters. Therefore meeting the agreed requirements of the customer is a useful definition. One can define quality as the total parameters and characteristics of the product or service, which satisfies consumer desires and needs (agreed or presumed), or the price a customer is ready to pay for a product. The American Society for Quality Control (ASQC, 1987) specifies that quality is “the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs”. Nevertheless, in addition to those “classical’’ demands, from the part of the consumer, and therefore for quality attributes, in the recent years, new parameters, having a limited relation with “actual’’ quality, (i.e. animal welfare during production procedures and environmental protection), have been incorporated as quality attributes, especially in livestock production. As a matter of fact, there is a new concept, which could be addressed as the “new quality’’. It is a general requirement introducing, in the relation between consumer and producer, the dimension of imposing no harm to third parties. In other words, production should not only satisfy the demands and needs of the consumer, but it should also assure safety from the public health point of view - and - it should do that without injury to any third party. This injury or harm may concern the animals for example or the environment. These parameters, known as “other legitimate factors’’, play an important role in production and in prescribing food regulations. They don’t relate directly the production process with the consumer demands for a certain product. But they are requirements, which are projecting a quality profile based on ethical concerns. In other words a new “ethical dimension” is introduced in quality. Quality, therefore, could be the “degree to which a set of inherent characteristics fulfils requirements’’, with emphasis on the customer both as a consumer and a human being, as well as human environment in general. Likewise, quality control is a “mechanism or technique or procedure or process” ensuring that each product attains a minimum objective standard as this is defined in practical written protocols. Under this concept, quality can be seen from different angles: From a consumers’ point of view prevails the Organoleptic quality, the Functional quality (e.g. rheologic properties, convenience, keepability), the Nutritional quality, the Hygienic quality (safety) From a public health point of view what it counts more is the Hygienic quality (safety). It follows the Nutritional quality and of course the compliance with the regulations. According to the English Oxford Dictionary, quality is the “Degree of Excellence”. We can also demonstrate it as the peculiar or essential character or the inherent feature of a specific product. Additionally quality may be defined by the entire constant
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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:
9.2.
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Nutritional characteristics (conciseness in proteins, carbohydrates, fats, vitamins),
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Sensorial characteristics (taste, smell, colour),
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Finished product characteristics (packaging, visual aspect, etc).
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 organoleptic quality functional properties keepability “freshness” nutritional safety Value of money
Public health point of view Compliance with regulations nutritional safety (hygienic quality)
Graph 5.: The role of safety Consumer
Safety
Public health Foodhyg 9
Industry
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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 20
(ISO/UNCTAD/GATT) Total Quality Management
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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 22
Reviewing the document's contents. Authorised for use.
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Table 5.: Requirements of ISO 9000 Series 1 Quality in procurement (Purchasing) Quality in production (Process control) Control of production Material control and tractability (product identification and traceability) Quality in marketing (contract review) Control of verification status (Inspection and testing) Quality in specification and design (Design control) Product verification (Inspection an testing) Series 2 Control of measuring and test equipment Nonconformity (control of nonconforming product) (inspection, measuring and test equipment) Corrective action Handling and post-production functions (handling, storage, packaging and delivery) After-sales servicing Quality documentation and records (Document control) Management responsibility Quality system principles Auditing the quality system (internal) Economics – Quality related cost considerations
In summary, the ISO 9000 standards are used to evaluate the food quality assurance programmes, but give no guidance on technical requirements to achieve the required quality. The objective of a quality assurance programme is to suggest appropriate actions and ensure that they are carried out. Food hygiene is part of the food quality assurance programme. Its objective is to ensure that the food, which is produced, processed or manufactured is safe and fit for human consumption. HACCP should be considered as part of food hygiene and a method of food safety assurance, which complements the general aspects of a total quality management culture as well as specific principles of food hygiene, and ensures that essential safety measures are implemented.
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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 : Examined : Lot size : Assumption : Confidence :
60 units / lot 25g / unit of 250g 10 tons homogeneous distribution of Salmonella 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).
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Traditionally, government food inspectors checked samples on the market to determine if the goods were spoiled, regarded as “unhealthy”, and to detect fraud. This control system was usually retroactive. Often foods were consumed before irregularities were detected. Punishment was regarded as an effective control measure, because it would prevent reoccurrence. In reality this system offered little health protection, particularly in terms of preventing foodborne diseases. Before HACCP foods were consumed before irregularities were detected.
In more modern times the food safety assurance system relied on two types of measures called actions. The first actions were undertaken during procurement of raw material, processing and manufacturing, transport and distribution including design, layout and cleaning of premises, to produce safe food. These actions were usually those prescribed in the Codes of Manufacturing or Hygienic Practice. The second actions were undertaken to ensure that food, which was produced, was indeed safe. For this purpose, industries tested the end product for contamination, and food control authorities inspected the premises and carried out independent testing. The traditional system of food safety assurance in industry was based on applying codes of GMP/GHP in food production and processing. Confirmation of safety and identification of potential problems were obtained by end product testing. Inspectors in food control agencies checked for compliance with GMP/GHP codes and also analysed the food for compliance with regulations and identification of unsafe food. Since GMP and GHP are the bases of food hygiene, it was possible to achieve a great degree of assurance in food safety with this approach.
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
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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-
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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
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Table 7 - The evolution of Traditional Quality Before From considering quality a technical activity “QUALITY” (assessment and control) was an activity assigned to certain individuals From adjectives Words and slogans were used: Good Quality products, Quality services provided. 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”. From responding to emergencies “When problems arise react quickly”….. From oral tradition Purchase, sales, production were based on unwritten rules, consolidated by their use From …doing “What was important was to do things well”
After To considering quality a Firm’s management tool “QUALITY” is part of today’s Management strategies To numbers The levels of Quality are measured with real numbers and proper indicators so they can be kept under constant control To planned decisions Clearly plan and schedule activities before executing them. To preventing emergencies Identify causes of ‘non-conformity” to quality and remove them. Prevention instead of treatment. To documented rules All rules regulating firm’s activities are written in procedures and standards and distributed to operators. 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.
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Definition of hazard analysis23: Hazard analysis is the process of collecting and interpreting information on hazards and conditions leading to their presence in order to decide which are significant for food safety and should be addressed in that particular industry’s HACCP plan. Hazards to food safety can originate from the raw materials, the line environment, and the personnel handling the food, but even if they enter the final product, this does not mean that their levels are always dangerous. Therefore, hazard analysis is a process of deciding whether potential hazards are significant and if they need to be controlled. During this process the hazard will be determined to be significant depending upon the levels present, the sizes or the doses of the hazardous agent. Furthermore, the effect of the agent varies with the food in which it is found and the susceptibility of the person ingesting it. Some agents, for example, are more dangerous than others and there is a great variety in the severity of the effect. However there is always a level below which the presence of an agent is considered to be acceptable. For most chemicals, a maximum residue level (MRL) has been established. For the establishment of acceptable levels for chemicals, risk assessment protocols have been in Biological agents include bacteria, viruses, moulds, parasites and toxin, whereas chemical agents may be various paints, or poisons used as pesticides or insecticides or the inner coating of cooking utensils. Foreign material such as pieces of glass, cork, wire, or clothes may be considered hazards, which escaped into the food during the processing, or packaging and they may cause perforation of the guts or suffocation in babies and children. use; for microbes these are under development. Potentially harmful agents are present in many raw materials, usually in very low levels. They become dangerous when their level, or the level of the toxins they produce, increases to a point where they may cause disease. Viruses and parasites do not multiply in food; the same is true for many natural toxins and chemicals. However there are also situations where chemical reactions may continue to occur; for example nitrosamine formation, which could present a hazard. To prevent this, the conditions leading to increase would be kept under control. If an agent is at a high level and processing is meant to decrease the level to an acceptable one, the conditions during processing should assure that the acceptable level is actually reached. The HACCP system is very dynamic. During a HACCP study, only the existing situation or the situation as it is expected to exist can be taken into account. Every change can introduce the hazard; thus, every change has to induce the hazard analysis reflex. It should be understood that once a HACCP plan has been established, it needs continuous “maintenance”. Every new raw material may bring a new hazard. Therefore potential new hazards have to be analysed during and directly after industrialisation. Hazard analysis determines which agents could be present in the food study. Epidemiological data have linked foods with particular foodborne pathogens, chemical or physical hazards, (for example, canned food and Clostridium botulinum, eggs and Salmonella, milk and the Mycobacterium bovis responsible for tuberculosis). These agents may be present in the raw material, but their levels may not be high enough to cause disease. To decide whether the presence of an agent in the raw material is a significant hazard, we have to know the levels at which it may cause disease. We also have to know which conditions can cause a pathogen to increase to an unacceptable level, the severity or magnitude of a health effect caused by this pathogen, and, finally the likelihood of its occurrence.
23
Codex Alimentarius Commission definition of Hazard Analysis (1997)
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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 ) Maximum likelihood = 5 Medium likelihood = 3-4 Minimum likelihood = 1-2 Hazard Index = risk x severity
Severity ( S ) Lethal hazard = 5 Severe hazard = 3-4 Minimum hazard = 1-2
Hazard Index ( HI ) Maximum value = 25 Medium value = 9-16 Minimum value = 1-4
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 nonhazardous 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
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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 Severe hazards Clostridium botulinum types A,B,E and F Shigella dysenteriae Salmonella typhi; S. paratyphi A, B Hepatitis A, E Brucella abortus; B. suis
Vibrio cholerae 0, 1, Vibrio vulnificus Taenia solium, Trichinella spiralis Moderate hazards (Extensive spread) Listeria monocytogenes Salmonella spp., Shigella spp. Enteovirulent E. coli (EEC) Streptococcus pyogenes
Rotavirus Norwalk virus group Entamoeba histolytica Diphylobothrium latum Ascaris lubricoides 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
Chemicals Naturally occurring chemicals Mycotoxins (e.g. aflatoxin) Scombrotoxin (histamine), Ciguatoxin Mushroom toxins Shellfish toxins - Paralytic shellfish poisoning (PSP) - Diarrheic shellfish poisoning (DSP) - Neurotoxic shellfish poisoning (NSP) - Amnesic shellfish poisoning Pyrrolizidine alkaloids, Phytohemagglutinin Polychlorinated biphenyls (PCBs)
Added chemicals Agricultural chemical Pesticides, fungicides, fertilisers, insecticides, antibiotics, heavy metals, ink from seals and labels, PCG’s, packaging materials, pigments, disinfectants, cleaners, growth hormones Toxin elements and compounds - Lead, zinc, arsenic, mercury and cyanide Food additives Direct – allowable limits under GMPs legal restrictions Preservatives (nitrite and sulphating agents) Flavour enhancers (monodium glutamate) Nutritional additives (niacin) Colour additives Plan chemicals (e.g. lubricants, cleaners, sanitises, cleaning compounds, coating and paint) Maintenance materials ……surface paints ……machine lubricants Chemicals intentionally added (sabotage)
Physical Hazards As physical hazards are considered all foreign material slipping accidentally into the food, such as metal, glass, bone, feathers, teeth, hair, nails, nut-shell, eggshell, rodents dead bodies, insects, parasite eggs, grit, sand, and rarely medical or cleaning equipment needles, wire, thermometers, bottles, or even personal equipment (rings, hairpins).
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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.
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product is stored in the correct temperature and position according to his HACCP system papers. By the end of this procedure, the first step has been successfully completed – the raw material is clean, safe, and properly stored. The second step is the process of the product until the attainment of the final product. The third step is the proper marking of each batch, the proper storage and finally the transportation to the final point (whether this is a supermarket or a restaurant). Unloading the final product in the Super market and signing the papers of acceptance conclude the HACCP system of the Plant. From now on the responsibility of the safety lies on the Super market or the Restaurant or farther more the final consumer who is responsible for the storage, handling and cooking of the product according to directions on the label. Usually hazards exercise slight and undetected adverse health effects to the consumers, but sometimes they may cause serious health problems or even death to individuals or to a large number of people, depending on the case. In general we may list these adverse health effects as following:
Acute illness:
Choking Vomiting Abdominal cramps Diarrhoea Nausea Fever
Fever Chronic illness:
Chronic infections Damage of various organs Some Cancers
Death
Damage of organs
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
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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.
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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: 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! 25
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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).
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14. Is it likely that the food will contain viable sporeforming or non-sporeforming pathogens? 15. What is the normal microbial count of the food? 16. Does the microbial population change during the normal time the food is stored prior to consumption? 17. Does the subsequent change in microbial population alter the safety of the food, pro or con? E. Facility design 18. Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat food? 19. Is positive air pressure maintained in packaging areas? Is this essential for product safety? 20. Is the traffic pattern for people and moving equipment a significant source of contamination? F. Equipment design 21. Will the equipment provide the time-temperature control that is necessary for safe food? 22. Is the equipment properly sized for the volume of food that will be processed? 23. Can the equipment be sufficiently controlled so that the variation in performance will be within the tolerances required to produce a safe food? 24. Is the equipment reliable or prone to frequent breakdowns? 25. Is the equipment designed so that it can be cleaned and sanitised? 26. Is there a chance of product contamination with hazardous substances (e.g. glass)? 27. What product safety devices are used to enhance consumer safety? (metal detectors, sifters, filters, screens, thermometers, de-boners) G. Packaging 28. Does the method of packaging affects the multiplication of microbial pathogens and/or the formation of toxins? 29. Is the package clearly labelled “Keep refrigerated” if this is required for safety? 30. Does the package include instructions for the safe handling and preparation of the food by the end user? 31. Is the packaging material resistant to damage thereby preventing the entrance of microbial contamination? 32. Does each package and case contain the proper label and code? H. Sanitation 33. Can sanitation impact upon the safety of the food that is being processed? 34. Can the facility and equipment be cleaned and sanitised to permit the safe handling of food?
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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.
The difference between CCP1 or CCPe (=elimination) ,CCPp (=prevention) , CCPr (=reduction) does no longer exist. Step in HACCP is a point, procedure, operation or stage in the food chain, including raw materials, from primary production to final consumption. 28 29
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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 indepth 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!
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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 recontamination) 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.
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Table 10.: Examples of processing control methods to prevent Biological Hazards
Pathogen
Bacillus cereus
Campylobacter jejuni Clostridium botulinum
Clostridium perfrigens Escherichia coli 0157:H7 Listeria monocytogenes
Salmonella spp.
Staphylococcus aureus Yersinia enterocolytica
Preventive Measure or Control Proper holding and cooling temperatures of foods. Thermal processing of shelf-stable canned food Proper pasteurisation or cooking; avoiding cross contamination of utensils, equipment, freezing, atmospheric packaging 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 Proper holding and cooling temperatures of foods; Proper cooking times and temperatures Proper holding and cooling temperatures of foods; Proper cooking times and temperatures 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. 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 Proper fermentation and pH control; proper heat treatment and post-process product handling practices; reduced water activity Proper refrigeration; heat treatments; control of salt and acidity, prevention of cross-contamination.
* The above measures usually fit to more than one pathogens.
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.
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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)
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Table 11: Example of a HACCP data sheet – raw material Raw materials
CCP Hazard to be controlled No
Incoming 1.1 raw material
Aflatoxin
Flour Mains water
Jam
Cream
1.2
Chemical contamination
1.3
1.4
Pesticide residues
Salmonella and Listeria
Control measures
Critical limits
Obtain Certificates of Analysis from suppliers
Aflatoxin
