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  1. 1. 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: mzcc@ath.forthnet.gr, Web-Site: www.mzcp-zoonoses.gr
  2. 2. 2 BY DR. N. CHARISIS (WHO/MZCP)1. Abbreviations ___________________________________________________________ 62. Forward _______________________________________________________________ 73. Hazard analysis and critical control points (HACCP)___________________________ 7 3.1. Historical overview and present status of HACCP ______________________________ 7 3.1.1. Historical overview _____________________________________________________________ 7 3.1.2. Present status __________________________________________________________________ 84. The need for the HACCP system __________________________________________ 10 4.1. The incidence of diarrhoeas ________________________________________________ 125. The challenge of emerging and reemerging foodborne diseases _________________ 136. Economic consequences of foodborne diseases. ______________________________ 14 6.1. The economic challenges today _____________________________________________ 14 6.2. Experience in industrialised and developing countries __________________________ 147. 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 _______________________________ 208. The relation of HACCP with Food Hygiene and Food Safety ___________________ 22 8.1. Food Hygiene and Food Safety _____________________________________________ 229. Quality of food _________________________________________________________ 24 9.1. Definitions of quality _____________________________________________________ 24 9.2. Importance of Quality for the consumer, industry and public health ______________ 2510. Quality Assurance and Food Safety Assurance Programme ____________________ 2611. Quality management systems ISO 9000 series – EN 29000 _____________________ 2712. Traditional food control _________________________________________________ 2913. Traditional food production and control ____________________________________ 2914. Total Quality Management (TQM)_________________________________________ 3015. Quality Control System __________________________________________________ 3116. Hazards Analysis, Critical Control Points and Control Measures ________________ 33 16.1. Hazard Analysis _________________________________________________________ 33 16.2. Classification of Hazard according to the risk and severity (Hazard Index). _________________________________________________________________ 35 16.3. Assessment of risk in Hazard Analysis _______________________________________ 35
  3. 3. 3 BY DR. N. CHARISIS (WHO/MZCP) 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 ________________________________________________________ 4617. 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 __________________________________________________________________ 5618. 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”). _________________________ 6419. HACCP System (preliminary phases)_______________________________________ 66 19.1. Phase 1. Assemble the HACCP team ________________________________________ 67 19.1.1. HACCP Team ________________________________________________________________ 67 19.1.2. Competencies and professional figure of the TEAM___________________________________ 67 19.1.3. Team’s activities ______________________________________________________________ 67 19.1.4. Size and composition of the team _________________________________________________ 68 19.1.5. Duty and responsibilities of the co-ordinator, the technical secretary and of the management__________________________________________________________________ 69 19.2. Phase 2. Product Description (Productive Plans) _______________________________ 69 19.2.1. Product Description Form for Raw Material/Ingredient (examples) _______________________ 69
  4. 4. 4 BY DR. N. CHARISIS (WHO/MZCP) 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_________________ 7620. 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. _________________ 8621. 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 __________________________________________________ 8822. Regulatory Assessment (Governmental activities in assessing HACCP) ___________ 89 22.1.1. Assessing the HACCP management _______________________________________________ 90 22.1.2. Assessing the HACCP plan development ___________________________________________ 90 22.1.3. Assessing the HACCP analysis ___________________________________________________ 90 22.1.4. Assessing the effectiveness of control measures ______________________________________ 91 22.1.5. Assessing the verification procedures ______________________________________________ 91 22.1.6. Assessing the documentation_____________________________________________________ 91 22.1.7. Assessing the implementation ____________________________________________________ 91 22.1.8. Competencies of assessors_______________________________________________________ 91 22.1.9. Assessment’s evaluation ________________________________________________________ 9223. CONCLUSIONS _______________________________________________________ 9324. Experiences ___________________________________________________________ 9425. GLOSSARY ___________________________________________________________ 9626. BIBLIOGRAPHY ______________________________________________________ 9927. FURTHER READING _________________________________________________ 10028. ANNEX 1 - Hazards, Critical Control Points and Monitoring Procedures for Common Food Service Operations _____________________________________ 102
  5. 5. 5 BY DR. N. CHARISIS (WHO/MZCP)29. ANNEX 2 – Common Critical Control Points and Examples on Monitoring Procedures for Processing Operations ___________________________ 10330. ANNEX 3 - Core HACCP Assessment Checklist _____________________________ 10631. ANNEX 4 – Cleaning/Sanitising Verification Operative Form _________________ 10932. ANNEX 5 – Cleaning/Disinfecting Frequency Outline________________________ 11033. ANNEX 6 – Example of HACCP Data Sheet________________________________ 11134. ANNEX 7 – Basic Knowledge Necessary to Food Procedures (primary production)___________________________________________________________ 11235. ANNEX 8 – Basic Knowledge Necessary for Food Personnel __________________ 11336. 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_____________________________________________________ 11737. ANNEX 10 - Premises – The first Step in the Implementation of HACCP/GMP ________________________________________________________ 11938. ANNEX 11 - The concept of shared responsibility ___________________________ 125
  6. 6. 6 BY DR. N. CHARISIS (WHO/MZCP)1. ABBREVIATIONSCAC FAO/WHO/Codex Alimentarius CommissionCCFH Codex Committee on Food HygieneCCFICS Codex Committee on Food Import and Export Inspection and Certification SystemsCCP Critical Control PointCM Control MeasuresFAO Food and Agriculture Organization of the United NationsFDA Food and Drug Administration (USA)GAP Good Agriculture PracticesGHP Good Hygienic PracticesGMP Good Manufacturing PracticesHACCP Hazard Analysis and Critical Control PointQMS Quality Management SystemsICMSF International Commission for Microbiology Specification of FoodISO International Organization for StandardisationPFD Process Flow DiagramPRP Prerequisite ProgrammeSLDB Small and/or Less Developed BusinessSPS Sanitary and Phytosanitary MeasuresSSOP Sanitation Standard Operational ProceduresTQM Total Quality ManagementUNIDO United Nations Industrial Development OrganizationWHO World Health OrganizationWTO World Trade OrganizationMZCP/WHO Mediterranean Zoonoses Control Programme/World Health OrganizationMZCC Mediterranean Zoonoses Control CentreNotice: Most diagrams and tables are selected from HACCP Principles and Practice, Teacher’s handbook. A WHO/ICD Training manual in collaboration with FAO. WHO/SDE/PHE/FOS/99.3. WHO, Geneva.
  7. 7. 7 BY DR. N. CHARISIS (WHO/MZCP) HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEMS (HACCP)2. FORWARD The present document was based initially, on materials presented at theWHO/MZCP1 International Training Course on HAZARD ANALYSIS ANDCRITICAL CONTROL POINT SYSTEM(HACCP): CONCEPTS ANDAPPLICATIONS, held in Teramo, Italy, 4-11 December 2000. That Course washosted by the WHO/FAO Collaborating Center on Research and Training in VeterinaryEpidemiology and Management, Istituto Zooprofilattico Sperimentale, dell Abruzzo edell Molise, Teramo, Italy. During the course, presentation materials were made availableto the participants as photocopies of the presenters’ charts and graphs and/or from thetransparencies and slides and as a CD containing almost all material; however, there wasno actual expository text in these presentations materials making the review of thetraining course a quite difficult task. At that time, the Mediterranean Zoonoses ControlCentre Athens, had been assigned by WHO to work out a document containing everypossible bit of information given in the ITC of Teramo in combination with salient andcomplementary points from relevant international literature as well as that from theWHO publications on the subject. It soon became evident, that due to the abundance ofmaterial contained in the original Teramo ITC handouts it would not be necessary toreproduce them, but rather expand on those materials in order to facilitate the readingand comprehension of charts, exercises and tables. Little by little, other colleagues wereinvited to contribute with their skills and experience in a joined effort to make thepresent document useful, not only to the trainees of similar ITCs but also to everyperson seeking information on HACCP systems. Therefore we consider the presentbook a “tool” for the training of beginners and the “enlightening” of experts in mostcommon fields of HACCP.3. HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)3.1. HISTORICAL OVERVIEW AND PRESENT STATUS OF HACCP3.1.1. Historical overview The concept of pre-HACCP is attributed to W.E. Deming, who developed in1950s the leading theory of a Total Quality Management system (TQM). First theJapanese tested this system with great success, thus improving greatly their products. Inbetween, the TQM system paved and prepared the way for the appearance of an almostfull-developed HACCP system in 1960s. But let’s see in more details, what exactlyhappened at that time. The original acronym HACCP was conceived in 1959 and developed by thePillsbury Company together with the National Aeronautics and Space administration1 World Health Organization/Mediterranean Zoonoses Control Programme
  8. 8. 8 BY DR. N. CHARISIS (WHO/MZCP)(NASA) and the U.S. Army Laboratories at Natick, in order to ensure the safety ofastronauts’ food. In 1973, the Pillsbury Company published Food Safety through the Hazard Analysisand Critical Control Point System, which was the first document on HACCP concepts andtechniques. Twenty years later, this system was internationally recognised and acceptedfor food safety assurance, including, not only microbiological safety of foodstuffs butalso chemical and physical hazards. Since then and for many years HACCP systems havebeen applied on a voluntary basis in many food industries. Systematic implementation of a HACCP system-based approach to food safetyassurance 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 foodexport requirements has always been a strong motivation to introduce HACCP systems.In Morocco, for instance, there has been an incentive to revise and update fishinspection legislation and to include a mandatory HACCP system based on food safetyassurance with the aim of obtaining European Union acceptance of Moraccan fish,because these systems have been made the legal and mandatory requirement in theEuropean 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 Bolivia,Colombia,Ecu ador, Peru, Morocco HACCP system in 27 Fishery industries for exports to EU, Venezuela (think about revise and update fish USA, Australia it) inspection legislation including a mandatory HACCP system Uruguay New Zealand HACCP system in meat voluntary HACCP system- industries for exports to USA. based Food Safety program Egypt Chilly Thailand Voluntary (more than 10 out of 200 industries) A draft low is been prepared HACCP system in canned food products for exportation Until 1995, the term, “HAZARD ANALYSIS CRITICAL CONTROLPOINT” was used originally throughout the industry. This was changed after a proposalfrom WHO/Geneva Consultation in 1995 to: “HAZARD ANALYSIS ANDCRITICAL CONTROL POINT systems”.In 1997, the Codex Alimentarius Commission adopted officially the proposed term inorder 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 theUnited States to food inspectors, it took many years before it received world-wide
  9. 9. 9 BY DR. N. CHARISIS (WHO/MZCP)recognition and application. The following schematic figure shows the growth andsudden increase in application of HACCP. Graph 1.: HACCP growth curve from 1970 - 1995 50 40 30 20 10 es timate 0 1970 1975 1980 1985 1990 1995 Today, HACCP based food safety assurance systems, rather than voluntary codes,have been made the legal and mandatory requirement in some countries2, such as themember states of the European Union. Thus, recognising its importance, food andpublic health authorities world-wide have promoted HACCP.The World Health Organization for example, has recognised the importance of HACCPfor the prevention of foodborne diseases and has played a significant role in thedevelopment and implementation of HACCP.In 1995 the FAO/WHO Codex Alimentarius Commission adopted guidelines for theapplication of HACCP in basic texts (a collection of internationally adopted food standardspresented in a uniform manner). The Codex Alimentarius also includes provisions of anadvisory nature in the form of codes of practice, guidelines and other recommendedmeasures to assist in achieving its purposes. The Codex Alimentarius3 on general principlesof food hygiene has been revised in 1997 in order to include recommendations for theapplication of HACCP guidelines. The description in the Codex guidelines gives astructure that makes HACCP likely to be accepted by other parties such as foodinspectors and trade partners.In due course, all food quality assurance guidelines will include HACCP. Sector-specificguides to Good Hygienic Practice (GHP) and guides to HACCP have been developed2 In the EU, the Food Hygiene Directives (EC Directives 93/43) include 5 principles of HACCP in therequirements 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 GeneralPrinciples on Food Hygiene and other specific codes. This means that HACCP has become the internationalreference system for food safety assurance.
  10. 10. 10 BY DR. N. CHARISIS (WHO/MZCP)for a considerable range of business types within the food industries such as wholesale,processing and retail sectors (e.g. caterers, butchers and bakery traders, markets and fairs).When and where there are legal requirements for HACCP or HACCP-based food safety,than management control guides can be the “means” of achieving compliance. However,depending on their scope, target sector, local legal requirements, and other localconditions, guides may vary in content; they may address GHP, the application of theprinciples of HACCP, food microbiology, or staff training but they may not address allthe concerns of food safety nor provide for adequate training in the best food safetyassurance system. Even though the concept of HACCP was presented in 1971 by industry in theUnited States to food inspectors, it took many years before HACCP received world-widerecognition 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 HACCPThis table gives a historical overview of HACCP from 1959 when Pillsbury Co. developed theconcept, until 1998 when FAO/WHO provided guidance for regulatory assessment of HACCP4. THE NEED6 FOR THE HACCP SYSTEM Before we analyse the need for the implementation of a food safety system, weprobably should first define something we all - more or less – know: the HAZARDS.According to the Codex Alimentarius Commission hazards are biological, physical, orchemical properties that may cause a food to be unsafe for human consumption. Inaccordance with the above definition and still expressed differently, the ICMSF definesthe hazard as: the unacceptable contamination of food by bacteria, or of the growth orsurvival of bacteria in food that may affect food safety or quality (spoilage), or theunacceptable production or persistence in food of substances such as toxins, enzymes orproducts of microbial metabolism. This contamination or growth can lead to a critical4 International Commission for Microbiology Specification of Food5 National Research Council (USA)6 To successfully implement HACCP in the food supply, authorities responsible for food safety must first beaware of the need to move to a system such as HACCP. Until that need is acknowledged, it is unlikely that acommitment at any level can be expected (Report of a WHO Consultation on HACCP Concept and Application, June1995)
  11. 11. 11 BY DR. N. CHARISIS (WHO/MZCP)condition. Therefore in the relatively modern HACCP system, “hazard”7 is exactly thiscondition of the food that may represent any threat to the consumer by causingsymptoms 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 latestand most developed food safety assurance method in the world, protecting thecontamination and/or growth of bacteria in food as well as it contamination bypoisonous chemicals, foreign bodies etc., and consequently the development of a serioussituation for both manufacturers and consumers. – But, what was thesituation 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 greatlyconcerned for safe foods. The reasons for this are: Foodborne diseases remain one of the most widespread public health problems. Emerging foodborne pathogens, e.g. Listeria monocytogenes, verotoxin producing E. coli, Campylobacter spp, foodborne trematodes, e.t.c., are in the increase. Modern technology permits the detection of minute amounts of food contaminant, calling thus, for a more vigilant inspection. Industrialisation together with mass production lead to increased risks of food contamination and to considerably larger numbers of people affected in foodborne diseases outbreaks as a result. Changing lifestyles demand from a vast number of people, to eat outside the home every day in food service or catering establishments, at street food stalls, or in fast- food restaurants. Urbanisation leads to a longer and more complex food chain, and accordingly to greater possibilities for food contamination. Tourism and international trade in foodstuffs has increased. Increased contamination of the environment. Therefore in order to understand why HACCP is so important for the foodindustry and to the safety of foods, we must keep in mind the tremendous challengesthat public health authorities face today especially in whatever concerns the emerging andre-emerging foodborne diseases.Public health authorities have come to realise that foodborne diseases are a much morewidespread public health problem than previously believed. Even as early as 1983 thejoint FAO/WHO reported that illness due to contaminated food was perhaps the most7 The borders of hazard are not strictly confined. There are variations depending on many factors such as theinfective dose, the age, the general health, the pregnancy, the immune competence of the individual e.t.c.
  12. 12. 12 BY DR. N. CHARISIS (WHO/MZCP)widespread health problem in the world and was an important cause of reducedeconomic productivity. According to national and sentinel studies conducted from 1985to 1995, foodborne diseases represent a widespread public health problem. From thesestudies, for instance, it has been estimated that currently the incidence of foodbornediarrheas 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 thepopulation may be affected each year by a foodborne disease. Incidence reports indicatethat foodborne diseases are not only widespread but, despite the efforts made by thepublic health authorities, they are on the increase, at least in some countries. This trendindicates that efforts of public health authorities over the past two decades have beenineffective in the prevention of foodborne diseases. Table 2.: Incidence of Diarrheas in some industrialised countries Country Percentage Source Sweden (1995) 7% National survey Netherlands (1991) 15% Sentinel study New Zealand (1993) 9% National survey UK (1995) 7% National survey Canada (1985) 8% Estimation USA (1985) 10% Estimation Graph 2.: Incidence of Salmonellosis in some European countries 250 E sto n ia Incidence (cases/100000) 200 L ith u a n ia L a tvia 150 A u str ia G erm any 100 R u ssia n F e d . S w i t ze r l a n d 50 C yprus UK 0 198 5 198 6 198 7 198 8 198 9 199 0 199 1 199 2 199 3 199 4 199 5 199 6 199 7 199 8 Table 3.: Reported cases of Listeriosis in some European countries COUNTRY 1993 1994 1995 1996 1997 1998 Belgium 36 32 38 50 45 42 Bulgaria - 2 - - 2 1 Denmark 27 23 29 39 33 41 Iceland 3 6 4 1 2 -
  13. 13. 13 BY DR. N. CHARISIS (WHO/MZCP) Ireland - - 4 125 7 4 Italy 48 31 29 40 68 45 Netherlands 14 24 31 22 21 29 Spain 24 26 25 21 19 16 Sweden 35 34 34 23 18 32UK England and 103 115 87 120 124 108 Wales UK Scotland - - 13 11 6 135. 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 oninfectious diseases and to cause the re-emergence of old ones. These diseases are referredto as “emerging” either because they have been newly identified (e.g. infections due to E. coli015: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 1991reached the Latin American region. Some diseases are increasing because productionsystems are changing. For example, foodborne trematodes is an emerging problembecause, for instance, aquaculture production is increasing. Responsible governmental services and agencies, research centres andepidemiologists around the world are witnesses to the emergence and re-emergence offoodborne diseases. According to Dr. D. Heymann, Executive Director of WHO,Geneva, “Emerging and re-emerging infections reflect the constant struggle of micro-organisms to survive, primarily by finding breaks in barriers which normally protecthuman beings from infection.The most known emerging and re-emerging pathogens are the following: Verotoxinproducing 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.
  14. 14. 14 BY DR. N. CHARISIS (WHO/MZCP)6. ECONOMIC CONSEQUENCES OF FOODBORNE DISEASES.6.1. THE ECONOMIC CHALLENGES TODAY At the end of the 19th century, contaminated milk, meat and other foods led tolarge outbreaks and many sporadic cases of foodborne diseases, often with fatalcomplications. The revolution in sanitation and hygiene for food and water, early in the20th century, brought about great improvements in food safety. The scientificcommunity had been lead to the illusion, that foodborne disease was no longer a seriousthreat to public health. Today, however, awareness has increased: research and modernmethods of reporting disease make it clear that foodborne diseases can have cripplingeffects and, in some cases, can even be fatal. Foodborne disease is serious in its effect onhealth and economy. A foodborne disease outbreak might lead to an increase in medicalcare costs, to decreased productivity and to the waste of large amounts of suspectedfood, which is either recalled or condemned. Tourism could be adversely affected.Furthermore the foodborne outbreak would jeopardise the reputation of a company andor an entire industry – or even a country (see BSE). Given that an outbreak of foodbornedisease can have devastating financial consequences, the consumer, - more aware thanever before - demands safety from the beginning of the food production process tohis/her table.Standing on that ground, we might say with certainty that HACCP is the only system thatprotects the “public” from foodborne diseases. Therefore, whether the people knows itor 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 wouldinclude a consideration not only of emerging and re-emerging pathogens but should beable to consider and deal with new and ever evolving food processing and handlingtechniques, methods and materials. A modern system of food safely would also haveprovisions for informing the consumer about appropriate food handling, storage andcooking. Reliability for the long run would be important because the food industry mustinvest in such a food safety system and its application, and HACCP is such a reliablesystem 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 onthe 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 thepremises.6.2. EXPERIENCE IN INDUSTRIALISED AND DEVELOPING COUNTRIES10 Many countries, particularly industrialised ones, have an extensive food controlinfrastructure, including food legislation that is updated regularly, as well as effectiveenforcement mechanisms. However experience from these countries shows that acomprehensive and well-funded regulatory system alone cannot prevent foodbornediseases. The high and increasing incidence of foodborne diseases in industrialisedcountries is evidence of this. On the other hand, we should take under consideration thatthe combination of regulatory and educational measures have been proven to be themost effective way in reducing foodborne disease. A good example is the action taken inthe United Kingdom and USA to prevent listeriosis. This is evidence that combinedregulatory and educational measures can be successful in reducing the incidence of9 In 1993, the Codex Alimentarius Commission endorsed the HACCP system as the most cost-effectiveapproach devised to date for ensuring the safety of food.10 Adapted from “Foodborne disease” a focus for health education, WHO, Geneva, 2000.
  15. 15. 15 BY DR. N. CHARISIS (WHO/MZCP)foodborne diseases significantly. But unfortunately, examples of a combined regulatoryand educational approach are scarce and most of the countries still rely solely, on aregulatory approach for the prevention of foodborne diseases.In developing countries, most efforts to prevent diarrhoea causing diseases have beenfocused on improving the water supply and sanitation. Regrettably in many instances theprovision of safe water and sanitation has been an end in itself and has not beencombined 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 facilitiesin the control of diarrhoeal diseases among young children has shown that, even underthe most favourable conditions, the rate of morbidity was reduced by only 27%.Therefore, such measures are unquestionably essential to food safety and health, buttheir efficiency in reducing diarrhoeal disease would be much enhanced, if they werecombined with a food hygiene education programme that included education in the safeuse and storage of water and efficient hand washing prior to food preparation.Nevertheless, diarrhoeal diseases in infants and children remain a major cause ofmorbidity and mortality in many developing countries. On the other hand it should berealised that in industrialised countries with increased international travel and trade,national regulatory measures would not be sufficient to protect populations from globallyemerging and re-emerging foodborne diseases. Therefore, taking under considerationthese emerging and re-emerging foodborne zoonotic diseases mostly in the developingcountries, it is expected an increase of medical care costs, a loss of money because ofdecreased productivity, wasted food and perhaps a decrease in tourism, which is vital forthe economy of these countries.It should be also noted here that the economic impact is estimated to be more severe forthe food industry because food contamination may lead to recall and loss ofcontaminated food. Consequently it will jeopardise the reputation of the company andlead to reduction in food trade.Public health authorities are increasingly recognising that some groups of the populationare more susceptible to foodborne diseases - either because they may acquire the diseasesmore easily, or because they may suffer more severely from these diseases than othernon-sensitive groups.In order to confront the serious economic consequences of foodborne diseases thegovernments should rely on the implementation of a HACCP system. With the HACCPsystem food safety control is integrated into the design of the process rather than the oldineffective system of end product testing. Therefore the HACCP system provides apreventive and thus a cost-effective approach to food safety.However Food Safety is not only the responsibility of Governments but of a large varietyof factors, including industry, NGO’s, International organizations and especially theconsumer. All persons, whether they prepare food or consume it, are part of the foodchain. As such they share responsibility with the government and the food industry inensuring the safety of food.7. THE HACCP SYSTEMS7.1. CONCEPT The hazard analysis critical control point concept is a systematic approach to theidentification, assessment and control of hazards. It is very simple because it onlyidentifies potential food safety problems and determines where they could be controlledand prevented. At first it was a management tool used in food industry to keep the
  16. 16. 16 BY DR. N. CHARISIS (WHO/MZCP)processing line under control. Experience from the canning industry demonstrated thatkeeping control over processing conditions was much more efficient and reliable thanend product testing. The time and temperature employed guaranteed safety of theproduct (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 aredescribed and personnel is trained to carry them out. Actions have to be implementedwithout exception. To ensure that they are carried out correctly and to provide evidenceof this, the results should be recorded. At the same time those records also provide abasis for improvement.7.2. OBJECTIVES No matter the role and the importance of Governments in the implementation ofHACCP, it should not be overlooked that HACCP was introduced by the food industriesto obtain greater assurance for food safety. Therefore it becomes clear that it is inindustry’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 largeamounts of money. So the HACCP system is not meant to be an additional regulatoryburden, but rather, a tool for ensuring safety and preventing foodborne illnesses. Graph 3.: Objectives of application of the HACCP system Prevention of foodborne illness More efficient Reduction of losses due Reduction of costs quality of food analysis to product recalls assurance system Therefore, HACCP’s main objective is to enhance assurance in the food safety inorder to prevent foodborne illnesses more efficiently. Additionally it will reduce the costsof control and wasted food and it will protect the reputation of the food processor andits entire industry.
  17. 17. 17 BY DR. N. CHARISIS (WHO/MZCP)7.3. AREAS OF APPLICATION Application of the seven HACCP principles11 means in practice that a HACCPteam performs a HACCP study. Originally HACCP was a tool used in food industries ona 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, thesystem has also been used in health education, and in food safety programmemanagement. 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 commitmentare needed. In addition to the final costs necessary for training, there may be alsoadditional 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 couldbe performed. These guidelines give a certain universal structure to a study, which willmake 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 specificconditions of size, sophistication of the process and the level of the food safetymanagement system. These 7 principles are the minimum mandatory requirements in theapplication of the HACCP system. But before reporting the 7 principles, all steps leadingto the Hazard Analysis should be followed. Appointment of the HACCP team will go11See principles of HACCP.12The Codex Alimentarius Commission text does not give guidance on how to put the results of the HACCPstudy into practice. Therefore some industrial practices are provided.
  18. 18. 18 BY DR. N. CHARISIS (WHO/MZCP)ahead with the appropriate activities. (for more information see at HACCP-team, section of thisdocument). One of the first activities of this team is to describe the product (i.e. rawmaterials used, suppliers, parameters influencing safety, processing conditions, packaging performance,characteristics of the packaging materials). Next, the intended use of the product should bedefined (i.e. for caterings, hospitals, general population, exportation specific groups of the populationetc.). To understand how a product is manufactured, and to have a disciplinary approachin the study, it is important to construct a flow diagram covering all steps whereproduct safety could be affected. In many food production and preparationestablishments, different areas or rooms have different hygiene levels, and barriers, suchas walls or air curtains separating them. It is important to inspect the site and the practices applied during all hours ofoperation (even night shifts, weekends etc) as well as the cleaning procedures andvalidate their efficacy. During this inspection all potential hazards should be listed and aHazard Analysis of the production and process should be performed by establishingCritical Limits for each Critical Control Point. (for more information see HACCP systemprinciples of this document)Let’s now suppose that a specific plant is working under strict HACCP conditions. Inthat case of course there is no need to perform microbiological examinations in any stageof production in order to verify that the product is free from pathogens. Still, pathogensmay enter the premises on the raw material or in the potable water. It is thereforeimportant for the manufacturer of the final product to make sure that every raw materialor 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 theycontain. Furthermore the manufacturer may conduct audits to validate the status of thevendor’s certification program. This activity certifies that every substance entering theplant has been manufactured, produced, or transported under GMP regulations andthere is no need to proceed with microbiological or other tests in order to use it. In anycase that the manufacturer of the final product can’t audit the supplier’s plant (i.e. becauseof the distance-some exotic material may come from aboard), he always can ask the supplier toprovide an assurance that the ingredients meet the specifications of the internationalstandards. In this case the supplier should accompany his product with a GMP certificateattesting not only the concerned product but also the particular batch. This certificateshould 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 themanufacturing of the products should have a GMP certificate. This is not absolutelynecessary because it is generally expected that, public water typically, maintain highquality standards for chemical and microbiological content. Considering, however, thatwater is used both in many food processes, such as to wash foods, to clean and sanitisefacilities, utensils and equipment, to make ice as well as food ingredient, food processorsshould perform monitoring analyses to confirm the quality and store the results in theirperiodic control records.7.5. BENEFITS As already stated the HACCP system is a scientific, rational and systematicapproach to identification, assessment and control of hazards during production,processing, manufacturing, distribution, preparation and use of food, to ensure that foodis safe when consumed. With the HACCP system, food safety control, presently basedon end product testing, is from now on integrated into the design of the process. Due tothis sophisticated integration, HACCP systems:
  19. 19. 19 BY DR. N. CHARISIS (WHO/MZCP) are applicable to the whole food chain, from production of raw materials to the end product (e.g. growing, harvesting, processing, manufacturing, transport and distribution, preparation and serving) have few of the limitations of traditional approaches to food safety control13. have the potential to identify all conceivable, reasonably to be expected hazards, even when failures have not previously been experienced. Are therefore, particularly useful for new operations. Are capable of accommodating changes introduced, such as progress in equipment design, improvements in processing procedures, and technological developments related to the product. help to target or manage resources at the most critical part of the food operation. aid the relationships between food processors, inspectors and consumers. promote international trade by providing for equitable food safety control systems everywhere in the world. increase confidence in food safety as they reduce detention, confiscation, and destruction of contaminated food shipments and can be easily integrated into quality management systems such as ISO systems. Therefore, HACCP provides a foodborne disease prevention system and a cost-effective approach to food safety14. But except for the general benefits of HACCPsystem, which are referred above, one may focus to its specific benefits for theconsumers, the industry and the governments. a. Benefits to consumers - Reduced risk of foodborne diseases - Increased awareness of basic hygiene - Increased confidence in the food supply and - Improved quality of life (health and socio-economic) b. Benefits to industry - Increased consumer and/or government confidence - Reduced legal and insurance costs - Increased market access - Reduced production costs (reduced recall/waste of food) - Improved product consistency - Improvements of management commitment to food safety and - Decreased business risk and liability c. Benefits to governments - Improved public health - More efficient and targeted food control - Reduced public health costs - Trade facilitation (import/export)13 Collecting and examining sufficient number of samples, high cost, time, and identification of problemswithout understanding the causes, limitations of snapshot inspection.14 Experiences gained in some countries indicate that application of HACCP systems leads to more efficientprevention of foodborne diseases. In the U.S.A, only, application of HACCP by the fish processors alone isestimated to avert some 20-60% of cases of sea-foodborne illnesses.
  20. 20. 20 BY DR. N. CHARISIS (WHO/MZCP) - Increased confidence of the community in the food supply7.6. 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 requiredfor mandatory implementation. At the business level, training, new equipment andtechnology must be funded. At the consumer level, buyers may be resistant tounnecessary changes in national customs and habits. Once governments, businesses andconsumers understand what is needed to assure food safety, each can then be a supporterof the HACCP systems. The following points address the objections and barriers to theimplementation 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 and15 Training Aspects of the Hazard Analysis Critical Control Point System (HACCP). Report of a WHOWorkshop on training in HACCP. WHO/FNU/FOS/96.3. WHO doc, Geneva, 1999.
  21. 21. 21 BY DR. N. CHARISIS (WHO/MZCP)equipment are designed, constructed and maintained to facilitate cleaning and tominimise any possibility of cross contamination. In functioning, GHP is aprecondition for an effective HACCP system implementation.Customer and business demand is a very important force for encouragingbusinesses to implement the HACCP system. Customers purchase food fromreliable suppliers, transporters and retailers who have a food safety managementsystem 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 theircustomers to others who can answer the demands of the well-informed buyer.Therefore, businesses should ensure that they purchase food from appropriatesuppliers, transporters and retailers who implement food safety managementsystems. This, together with a better-informed consumer creates a demand for theapplication of HACCP systems.Costs versus benefits: Although the economic constraints are a serious barrierfor the implementation of HACCP systems, the government and especially the
  22. 22. 22 BY DR. N. CHARISIS (WHO/MZCP) industry, should take under consideration the long term savings from reduced public health costs, lawsuits due to food safety failures, and spoilage due to improved handling, storage etc. Therefore the costs to business to implement HACCP must be weighed against the possible losses due to food safety failures when HACCP is not in place. Management must be prepared for the initial costs and for the day-to-day operations of the HACCP plan for that particular industry. A team of experts will be acquired to make the plan and train the employees. There may be expenses in purchasing equipment and material, and making changes throughout as necessary. Both government and business will appreciate the long- term savings from reduced public health costs.8. THE RELATION OF HACCP WITH FOOD HYGIENE AND FOOD SAFETY8.1. FOOD HYGIENE AND FOOD SAFETY Food Hygiene includes all conditions and measures necessary to ensure thesafety, suitability and wholesomeness of food at all stages of the food chain16. Accordingto 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 measuresnecessary to ensure the safety and wholesomeness of foodstuffs. Food Safety is the assurance that, food will not cause harm to the consumer whenit is prepared and/or consumed according to its intended use17. Therefore, food safety isthe level of security we achieve by ensuring food hygiene.Food safety assurance starts at the “farm”, the primary agricultural or fishery level. At allsteps of the food chain, particular attention is given to potential food safety problemsand how they could be prevented or controlled. In recent decades, food industries andpublic health authorities realised the limitations of this approach. They also realised thatGMP and GHP provide necessary and basic guidance for producing safe food; but bythemselves, they are not always sufficient.However, improvements in food safety and in animal and plant health will not beachieved 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). nd2 Level: application of the food-related hygienic requirements (as expressed by the Good Manufacturing/Hygienic Practice).3rd Level: application of HACCP. HACCP can be applied in order to achieve a greater assurance that the produced, processed or manufactured food is safe. It identifies what is needed to make food safe and makes sure that what is planned is correctly implemented. Therefore today HACCP is part of food hygiene, or the food safety assurance system. Food hygiene can itself be placed in the context of food quality assurance programmes.16 Term applied by the Codex Alimentarius Commission (CAC).17 Term applied by the Codex Alimentarius Commission (CAC).
  23. 23. 23 BY DR. N. CHARISIS (WHO/MZCP) In conclusion, HACCP should be considered as a combination of measures andmethods used in the field of Food Safety, which complements the general aspects of atotal quality management as well as specific principles of food hygiene, and ensures thatessential 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 ofcompliance with GMP/GHP/SSOP18 and one may say that HACCP, GMP, GHP andSSOP are the foundations of the food safety assurance system.Normally, foods produced according to what is called GMP are safe. In most caseswhere foods have been incriminated in foodborne diseases, deviations from GMPoccurred, or incidents happened, that where not detected in time. This means that manyaspects of food production are covered by measures and controls, which form part ofGMP.HACCP underscores these practices, which are critical in ensuring a product’s safety. Itmay also play a complementary role to GMP, as during the HACCP study some controlmeasures specific to the food and line of production may additionally be identified.Good Manufacturing Practices (GMP) and Good Hygienic Practices (GHP) arenecessary but not always sufficient. Today, it is well known that the Codex Alimentariusguidelines provide general requirements without considering the specificity of the foodor process in question and its related potential hazards. Furthermore, they do notprovide a mechanism for identifying those measures, which are essential for food safety.They do not provide monitoring mechanisms to ensure that measures necessary forsafety are implemented and carried out correctly. They don’t provide proof that theproducts were prepared according to the established requirements and of course, they donot 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 times18 Good Manufacturing Practice/Good Hygienic Practice/Sanitation Standard Operating Procedures. GMPencompasses many aspects of plant and personnel operations, whether SSOP are procedures helping toaccomplish the goal of maintaining GMP in the food production.
  24. 24. 24 BY DR. N. CHARISIS (WHO/MZCP)In the new concept of food control with HACCP, the “farm-to-fork” principle inassessing food safety is a perfect fit. Government inspectors do less policing and moreadvising and discussing.With HACCP, the emphasis is on shared responsibility among professional foodhandlers and government inspectors. Accordingly, responsibility for the production andpreparation of safe food is in the hands of professional food handlers and the finalenforcement of the regulation of food safety is in the hands of government inspectors.9. QUALITY OF FOOD9.1. DEFINITIONS OF QUALITY It is not easy to define quality because the term means different things to differentpeople. It is a term used arbitrary by many. Traditionally, luxury, beauty, high valuemeant quality. However, according to the use and requirements of the user, high qualitycan be attributed to different parameters. Therefore meeting the agreed requirements ofthe customer is a useful definition. One can define quality as the total parameters andcharacteristics 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 statedor 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 limitedrelation with “actual’’ quality, (i.e. animal welfare during production procedures and environmentalprotection), 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 shouldnot only satisfy the demands and needs of the consumer, but it should also assure safetyfrom the public health point of view - and - it should do that without injury to any thirdparty. 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 productionand in prescribing food regulations. They don’t relate directly the production processwith the consumer demands for a certain product. But they are requirements, which areprojecting a quality profile based on ethical concerns. In other words a new “ethicaldimension” is introduced in quality.Quality, therefore, could be the “degree to which a set of inherent characteristics fulfilsrequirements’’, with emphasis on the customer both as a consumer and a human being, aswell as human environment in general. Likewise, quality control is a “mechanism ortechnique or procedure or process” ensuring that each product attains a minimum objectivestandard 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). Itfollows 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 featureof a specific product. Additionally quality may be defined by the entire constant
  25. 25. 25 BY DR. N. CHARISIS (WHO/MZCP)attributes or characteristics of a product or a service, which allow to satisfy specified orimplicit 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 andGHP, is not the safety of food but rather the quality of it.Components of quality: - Nutritional characteristics (conciseness in proteins, carbohydrates, fats, vitamins), - Sensorial characteristics (taste, smell, colour), - Finished product characteristics (packaging, visual aspect, etc).9.2. IMPORTANCE OF QUALITY FOR THE CONSUMER, INDUSTRY AND PUBLIC HEALTH From the consumer’s point of view, all these features of the food as well as theprice-quality relationship are equally important.From the Industry’s point of view “the consumer is always right” and should be satisfiedaccording to demands in all aspects.However, from the Public health point of view, it is primary the hygienic and secondarythe nutritional quality of the food that counts.Other qualities of food are important only to the extent that they affect acceptance of thefood 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 isnot 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 addressnew customs and new definitions of quality. Table 4.: Quality from a consumer/industry and from a public health point of viewConsumer/industry point of view Public health point of vieworganoleptic qualityfunctional propertieskeepability Compliance with regulations“freshness”nutritional nutritionalsafety safety (hygienic quality)Value of money Graph 5.: The role of safety Consumer Safety Public health Industry Foodhyg 9
  26. 26. 26 BY DR. N. CHARISIS (WHO/MZCP) Among the different components of quality, safety is most important for all partiesi.e. industry, consumer and public health authorities. Nevertheless, it is this feature of thefood, which is most often overlooked. This is because one is aware of safety only whenit is no longer there. It is only after a succession of important and sometimes fatalfoodborne disease outbreaks in the industrialised countries, as well as a raising awarenesscampaign of the WHO during recent years, that food safety has gained importanceamong 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 systematicactions necessary to provide adequate confidence that a product or a service will satisfy givenrequirements”19. To achieve this desired quality, many industries try to establish a qualityassurance system that may include a wide range of actions. There is a similarity of thisdefinition with the definition of food hygiene. When the requirements in terms of qualityrelate to hygienic properties of the food, the programme is referred to as “Food SafetyAssurance Programme”. The quality assurance examines the system under which a service or a product issupplied. Or, to put it another way, quality assurance is an objective mechanism,technique, procedure or process that is used to quantitatively assess that minimumstandards are met. Quality assurance is, therefore, based on an integrated managementsystem, which secures that all obligations and targets of a company are fulfilled. In orderto obligate all personnel working in a company, to contribute to the quality assurance, itshould be given to everybody, the appropriate tools (information, training etc). It should alsoexplained to them clearly what is expected from each one. They should know andunderstand that everybody in the company is contributing to the end result and finallythat 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, wedo what we plan and finally we document everything we do.Some of the most important reasons we document everything we do, are the following: Documentation is used as a Standard aid-memoir. It helps the continuation of processing without problems even when there are changes of personnel. It is the best basis for training. Is used as a standard guidance. It helps as a common basis for communication. It helps controlling of the system that is applied. It can be used as the basis for further improvement.19 (ISO/UNCTAD/GATT)20 Total Quality Management
  27. 27. 27 BY DR. N. CHARISIS (WHO/MZCP)Standards for certified quality assurance systems have been internationally accepted, likeISO 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 ofstandards on quality systems known as the ISO 9000 series. In view of globalisation of trade, andthe need for a uniform method for assessing quality assurance systems, these standards havegained importance in industry. Suppliers of goods and services use them to provide objectiveevidence that their quality assurance systems enable them to consistently meet their standards. Some standard organizations use the ISO standards without modification; others haveadopted their own numbering systems while keeping the text identical to those of the ISOstandards. 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 andISO 9003, provide standards for quality assurance systems. The main ISO requirements ondocuments 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 20requirements. The standard establishes requirements for what should constitute theelements of a quality assurance system. However it doesn’t establish what the desiredquality is, or the technical aspects of achieving it. The ISO 9001 and ISO 9002 and to some extend ISO 9003 stipulate the need forproduct safety and liability. Certain elements (e.g. verification) reinforce some aspects ofHACCP. It should be mentioned here that some of the terminology used in the ISO9000 series is different from the HACCP system. The quality system elements are the most stringent quality assurance model, with20 requirements. The standard establishes requirements for what should constitute the“elements” of a quality assurance system. However it doesn’t establish what the desiredquality is or the technical aspects of achieving it. Nevertheless, ISO 9000 standards are compatible with HACCP programmes, andmany of their elements support or reinforce the implementation of HACCP.21 Reviewing the documents contents.22 Authorised for use.
  28. 28. 28 BY DR. N. CHARISIS (WHO/MZCP) Table 5.: Requirements of ISO 9000 Series 1Management responsibility Quality in procurement (Purchasing)Quality system principles Quality in production (Process control)Auditing the quality system (internal) Control of productionEconomics – Quality related cost considerations Material control and tractability (product identification and traceability)Quality in marketing (contract review) Control of verification status (Inspection and testing)Quality in specification and design (Design control) Product verification (Inspection an testing) Series 2Control 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) In summary, the ISO 9000 standards are used to evaluate the food qualityassurance programmes, but give no guidance on technical requirements to achieve therequired quality. The objective of a quality assurance programme is to suggestappropriate actions and ensure that they are carried out. Food hygiene is part of the foodquality 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 beconsidered as part of food hygiene and a method of food safety assurance, whichcomplements the general aspects of a total quality management culture as well as specificprinciples of food hygiene, and ensures that essential safety measures are implemented.
  29. 29. 29 BY DR. N. CHARISIS (WHO/MZCP)12. TRADITIONAL FOOD CONTROLEnd product testing proved to be time consuming, costly and not reliable foridentification of contaminated foods. Testing foods for the presence of contaminantsoffers 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 perunit of 250g is analysed, and if negative result is obtained for all 60 samples, this stillmeans that there is a 30% probability (one out of 3) of accepting a lot in which 800 unitscontain Salmonella. This interpretation assumes a homogenous distribution of Salmonellathrough the lot, or a random sampling procedure, which is usually not the case. Table 6.: Salmonella testing of milkpowderSampling scheme : 60 units / lotExamined : 25g / unit of 250gLot size : 10 tonsAssumption : homogeneous distribution of SalmonellaConfidence : Lots with 800 units containing Salmonella are accepted with 30 % probability Today traditional food control is based on observation and testing of samples aswell as in the detection of spoilage “e.g. unhealthy food” and fraud. It is basically performedthrough “snap-shot” inspection for the compliance with GHP/GMP + End producttesting. However, regulations with GMP are using very often, vague terms such as:“appropriate” or “when necessary”. Consequently, there may be very little distinction betweentrivial and important matters concerning safety. Additionally, the traditional food controlsystem is retroactive and provides little health protection, particularly regarding topathogenic organisms. In general the shortcomings of the traditional inspectional approach are thefollowing: - 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 withGHP/GMP + end product testing.13. TRADITIONAL FOOD PRODUCTION AND CONTROL Early food production concentrated on keep ability (shelf life) and organolepticquality because preserving food was essential to survival. Production methods werebased upon domestic experience; household methods were scaled up without anyscientific experimentation to validate the safety of the product thus obtained. Safety wasoften taken for granted (cause and effect were not known, especially with regard to foodborne diseasescaused by microorganisms).
  30. 30. 30 BY DR. N. CHARISIS (WHO/MZCP) Traditionally, government food inspectors checked samples on the market todetermine if the goods were spoiled, regarded as “unhealthy”, and to detect fraud. Thiscontrol system was usually retroactive. Often foods were consumed before irregularitieswere detected. Punishment was regarded as an effective control measure, because itwould 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 measurescalled actions.The first actions were undertaken during procurement of raw material, processing andmanufacturing, transport and distribution including design, layout and cleaning ofpremises, to produce safe food. These actions were usually those prescribed in the Codesof Manufacturing or Hygienic Practice.The second actions were undertaken to ensure that food, which was produced, wasindeed safe. For this purpose, industries tested the end product for contamination, andfood control authorities inspected the premises and carried out independent testing.The traditional system of food safety assurance in industry was based on applying codesof GMP/GHP in food production and processing. Confirmation of safety andidentification of potential problems were obtained by end product testing.Inspectors in food control agencies checked for compliance with GMP/GHP codes andalso 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 greatdegree 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 themeans for continuous amelioration to meet the competition. Quality in general is astrategic target for any enterprise, taking into account the need for continuousimprovement 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 thequality of the product. The method is to “embody’’ and define quality in each step of theproduction line. “Embodiment’’ of quality means all employees and all processes add inquality at any particular step in production line or service delivering. In order to achieveit, a good communication with all employees is required. We need to explain to and trainall personnel on what we are trying to do, for eliminating defects. The end target is toisolate as early as possible, in the process line, any defect that may appear in the finalproduct. 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 topmanagement personnel. Nevertheless, once the commitment to quality is made, rewardsare manifested by greater employee motivation, improved uniformity in finishedproducts or services, greater profits and, usually, increased customer satisfaction. By
  31. 31. 31 BY DR. N. CHARISIS (WHO/MZCP)setting precise goals, implementing positive preventive steps and corrective actions toproblems, and continuously improving quality, a company will be prepared for futurechanges as dictated by economics and customer needs (Webb et al, 1995). Sashkin and Kiser (1993), have stated that “TQM” means that the “organisation’sculture is defined and supports the constant attainment of customer satisfaction throughan integral system of tools, techniques and training’’. This involves the continuousimprovement of organisational processes, resulting in turn in continuous higher qualityproducts and services. It is because, by final product inspection, you may eliminatedefected products to reach the customer, but quality is not improved. Final productinspection alone does not influence the process of production, which may continue toproduce defected products. In fulfilling the principle of customer satisfaction, each step in the production flowdiagram, should be addressed as a customer of the previous step and, at the same time, assupplier of the next. On the other hand, quality, in the various steps of production, is theonly parameter, which can be improved and influence the cost of production, since allother parameters of production that is raw materials, employees’ income and company’sprofit cannot be suppressed. Investment in effort, time and money to quality improves the end result and theworking conditions. In this respect, the term “total’’ (in TQM) signifies that, forsupporting quality, all personnel and resources of a business activity are implicated. The TQM concept, although was theoretically developed in the West Coast of theUSA, it was practically employed by Japanese. They were anxious, after World War II tostudy the American economy and draw lessons for improving their competitiveness.They realised that, while theoreticians were suggesting preventive measures forimproving quality, business in the West were involved in expensive final product qualitycontrol, without decreasing the number of defected products. The Japanese, instead,turned to preventive actions for improving quality, created products according to thedemands of their customers, suppressed the number of their suppliers for a moreeffective control, adjusted, in line with the above, the thinking of their employees anddeveloped 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 maintainingstandards in production or in a product, especially, until recently, by inspecting samplesof the product. Postproduction inspection, or final product inspection, was thetraditional way of conducting quality control. But, defects are always expected in the finalproduct 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 wrongwith the final product or service, without due respect to what might be wrong with theprocess. Moreover ensuring quality by inspecting the final product is very expensive andwhen it is carried out, the only way to remedy a defect is to prevent it for reaching thecustomer. 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 tocustomers, their production cannot be restrained. We should take under considerationthat a defected product reaching the consumer is in fact a 100% defected product for thisconsumer. The last but not the least is the fact that quality assurance creates a false securityfeeling to the personnel working in the processing line; they think that someone in theend inspects the final product, thus becoming less attentive in their work. In addition, to-