Вы находитесь на странице: 1из 126
HAZARD ANALYSIS & CRITICAL CONTROL POINT SYSTEMS SUPER MARKET N. Charisis Athens, Greece 2004 WHO/MZCC,
HAZARD ANALYSIS & CRITICAL CONTROL POINT SYSTEMS SUPER MARKET N. Charisis Athens, Greece 2004 WHO/MZCC,
HAZARD ANALYSIS & CRITICAL CONTROL POINT SYSTEMS SUPER MARKET N. Charisis Athens, Greece 2004 WHO/MZCC,

HAZARD ANALYSIS

&

CRITICAL CONTROL POINT SYSTEMS

HAZARD ANALYSIS & CRITICAL CONTROL POINT SYSTEMS SUPER MARKET N. Charisis Athens, Greece 2004 WHO/MZCC, Stournari
SUPER MARKET N. Charisis Athens, Greece 2004 WHO/MZCC, Stournari 24, 106 82, Athens, Greece. Tel.:
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

BY DR. N. CHARISIS (WHO/MZCP)

1. Abbreviations

6

2. Forward

7

3. Hazard analysis and critical control points (HACCP)

7

3.1.

Historical overview and present status of HACCP

7

3.1.1. Historical overview

7

3.1.2. Present status

8

4. The need for the HACCP system

4.1. The incidence of diarrhoeas

10

12

5. The challenge of emerging and reemerging foodborne diseases

13

6. Economic consequences of foodborne

14

6.1. The economic challenges today

14

6.2. Experience in industrialised and developing countries

14

7. The HACCP systems

15

7.1. Concept

15

7.2. Objectives

16

7.3. Areas of application

17

7.4. Development and Implementation

17

7.5. Benefits

18

7.6. Difficulties and Barriers in the implementation

20

8. The relation of HACCP with Food Hygiene and Food Safety

8.1. Food Hygiene and Food Safety

9. Quality of food

22

22

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

 

35

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

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

64

19. HACCP System (preliminary phases)

19.1. Phase 1. Assemble the HACCP team

66

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

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

20. HACCP System Principles

76

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

81

20.5. Principle 5. Establish the corrective actions to be taken when monitoring indicates that a particular CCP is not under

82

20.6. Principle 6. Verification/Establish verification

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

21. Role of Industry and Role of the Authorities

86

87

21.1. Role of industry

87

21.2. Role of competent authority (Government)

88

21.2.1. Inspection

88

21.2.2. Responsibilities of Governments

88

22. Regulatory Assessment (Governmental activities in assessing HACCP)

89

22.1.1. Assessing the HACCP management

90

22.1.2. Assessing the HACCP plan development

90

22.1.3. Assessing the HACCP analysis

90

22.1.4. Assessing the effectiveness of control measures

91

22.1.5. Assessing the verification procedures

91

22.1.6. Assessing the documentation

91

22.1.7. Assessing the implementation

91

22.1.8. Competencies of assessors

91

22.1.9. Assessment’s evaluation

92

23. CONCLUSIONS

93

24. Experiences

94

25. GLOSSARY

96

26. BIBLIOGRAPHY

99

27. FURTHER READING

100

28. ANNEX 1 - Hazards, Critical Control Points and Monitoring Procedures for Common Food Service Operations

102

5

BY DR. N. CHARISIS (WHO/MZCP)

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

6

BY DR. N. CHARISIS (WHO/MZCP)

1.

ABBREVIATIONS

CAC

FAO/WHO/Codex Alimentarius Commission

CCFH

Codex Committee on Food Hygiene

CCFICS

Codex Committee on Food Import and Export Inspection and Certification Systems

CCP

Critical Control Point

CM

Control Measures

FAO

Food and Agriculture Organization of the United Nations

FDA

Food and Drug Administration (USA)

GAP

Good Agriculture Practices

GHP

Good Hygienic Practices

GMP

Good Manufacturing Practices

HACCP

Hazard Analysis and Critical Control Point

QMS

Quality Management Systems

ICMSF

International Commission for Microbiology Specification of Food

ISO

International Organization for Standardisation

PFD

Process Flow Diagram

PRP

Prerequisite Programme

SLDB

Small and/or Less Developed Business

SPS

Sanitary and Phytosanitary Measures

SSOP

Sanitation Standard Operational Procedures

TQM

Total Quality Management

UNIDO

United Nations Industrial Development Organization

WHO

World Health Organization

WTO

World Trade Organization

MZCP/WHO

Mediterranean Zoonoses Control Programme/World Health Organization

MZCC

Mediterranean Zoonoses Control Centre

Notice: Most diagrams and tables are selected from HACCP Principles and Practice, Teacher’s handbook. A WHO/ICD Training manual in collaboration with FAO. WHO/SDE/PHE/FOS/99.3. WHO, Geneva.

7

BY DR. N. CHARISIS (WHO/MZCP)

HAZARD ANALYSIS AND CRITICAL CONTROL POINT

SYSTEMS

2. FORWARD

(HACCP)

The present document was based initially, on materials presented at the WHO/MZCP 1 International Training Course on HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEM(HACCP): CONCEPTS AND APPLICATIONS, held in Teramo, Italy, 4-11 December 2000. That Course was hosted by the WHO/FAO Collaborating Center on Research and Training in Veterinary Epidemiology and Management, Istituto Zooprofilattico Sperimentale, dell Abruzzo e dell Molise, Teramo, Italy. During the course, presentation materials were made available to the participants as photocopies of the presenters’ charts and graphs and/or from the transparencies and slides and as a CD containing almost all material; however, there was no actual expository text in these presentations materials making the review of the training course a quite difficult task. At that time, the Mediterranean Zoonoses Control Centre Athens, had been assigned by WHO to work out a document containing every possible bit of information given in the ITC of Teramo in combination with salient and complementary points from relevant international literature as well as that from the WHO publications on the subject. It soon became evident, that due to the abundance of material contained in the original Teramo ITC handouts it would not be necessary to reproduce them, but rather expand on those materials in order to facilitate the reading and comprehension of charts, exercises and tables. Little by little, other colleagues were invited to contribute with their skills and experience in a joined effort to make the present document useful, not only to the trainees of similar ITCs but also to every person seeking information on HACCP systems. Therefore we consider the present book a “tool” for the training of beginners and the “enlightening” of experts in most common fields of HACCP.

3.

HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)

3.1.

HISTORICAL OVERVIEW AND PRESENT STATUS OF HACCP

3.1.1.

Historical overview

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

1 World Health Organization/Mediterranean Zoonoses Control Programme

8

BY DR. N. CHARISIS (WHO/MZCP)

(NASA) and the U.S. Army Laboratories at Natick, in order to ensure the safety of astronauts’ food. In 1973, the Pillsbury Company published Food Safety through the Hazard Analysis and Critical Control Point System, which was the first document on HACCP concepts and techniques. Twenty years later, this system was internationally recognised and accepted for food safety assurance, including, not only microbiological safety of foodstuffs but also chemical and physical hazards. Since then and for many years HACCP systems have been applied on a voluntary basis in many food industries. Systematic implementation of a HACCP system-based approach to food safety assurance throughout the developing world shouldn’t be expected for the near future, because of the lack of expertise and training on the subject. However, meeting food export requirements has always been a strong motivation to introduce HACCP systems. In Morocco, for instance, there has been an incentive to revise and update fish inspection legislation and to include a mandatory HACCP system based on food safety assurance with the aim of obtaining European Union acceptance of Moraccan fish, because these systems have been made the legal and mandatory requirement in the European Union.

Indeed, the implementation of HACCP in the developing world cannot be expected because of lack
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
always been a strong motivation to introduce HACCP system Malaysia HACCP system in 27 Fishery industries
always been a strong motivation to introduce HACCP system Malaysia HACCP system in 27 Fishery industries
Malaysia HACCP system in 27 Fishery industries for exports to EU, USA, Australia
Malaysia
HACCP system in 27 Fishery
industries for exports to EU,
USA, Australia
Bolivia,Colombia,Ecu ador, Peru, Venezuela (think about it)
Bolivia,Colombia,Ecu
ador,
Peru,
Venezuela (think about
it)
ador, Peru, Venezuela (think about it) Morocco revise and update fish inspection legislation
ador, Peru, Venezuela (think about it) Morocco revise and update fish inspection legislation
Morocco revise and update fish inspection legislation including a mandatory HACCP system New Zealand voluntary
Morocco
revise and update fish
inspection legislation including a
mandatory HACCP system
New Zealand
voluntary HACCP system-
based Food Safety program
Zealand voluntary HACCP system- based Food Safety program Chilly A draft low is been prepared Uruguay
Chilly A draft low is been prepared
Chilly
A draft low is been prepared
Food Safety program Chilly A draft low is been prepared Uruguay HACCP system in meat industries
Uruguay HACCP system in meat industries for exports to USA. Egypt Voluntary (more than 10
Uruguay
HACCP system in meat
industries for exports to USA.
Egypt
Voluntary (more than
10 out of 200
industries)
Egypt Voluntary (more than 10 out of 200 industries) Thailand HACCP system in canned food products
Thailand HACCP system in canned food products for exportation
Thailand
HACCP system in canned food
products for exportation

Until

1995,

the

term,

HAZARD

ANALYSIS

CRITICAL

CONTROL

POINTwas 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

9

BY DR. N. CHARISIS (WHO/MZCP)

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

estimate

Today, HACCP based food safety assurance systems, rather than voluntary codes, have been made the legal and mandatory requirement in some countries 2 , 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 Alimentarius 3 on general principles of food hygiene has been revised in 1997 in order to include recommendations for the application of HACCP guidelines. The description in the Codex guidelines gives a structure that makes HACCP likely to be accepted by other parties such as food inspectors and trade partners. In due course, all food quality assurance guidelines will include HACCP. Sector-specific guides to Good Hygienic Practice (GHP) and guides to HACCP have been developed

2 In the EU, the Food Hygiene Directives (EC Directives 93/43) include 5 principles of HACCP in the requirements for Food Hygiene and until 2005 is expected that all principles should be included!

3 Ever since its application, HACCP was recommended by the Codex Alimentarius Commission of General Principles on Food Hygiene and other specific codes. This means that HACCP has become the international reference system for food safety assurance.

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 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/ICMSF 4 report on HACCP

1983

WHO recommends HACCP

1985

NRC 5 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 NEED 6 FOR THE HACCP SYSTEM

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

4 International Commission for Microbiology Specification of Food

5 National Research Council (USA)

6 To successfully implement HACCP in the food supply, authorities responsible for food safety must first be aware of the need to move to a system such as HACCP. Until that need is acknowledged, it is unlikely that a commitment at any level can be expected (Report of a WHO Consultation on HACCP Concept and Application, June

1995)

11

BY DR. N. CHARISIS (WHO/MZCP)

condition. Therefore in the relatively modern HACCP system, “hazard7 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?

consumers. – But, what was the situation before HACCP? The need for an effective food safety

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 fast- food restaurants.

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

Tourism and international trade in foodstuffs has increased.

Increased contamination of the environment. Therefore in order to understand why HACCP is so important for the food industry and to the safety of foods, we must keep in mind the tremendous challenges that public health authorities face today especially in whatever concerns the emerging and re-emerging foodborne diseases. Public health authorities have come to realise that foodborne diseases are a much more widespread public health problem than previously believed. Even as early as 1983 the joint FAO/WHO reported that illness due to contaminated food was perhaps the most

7 The borders of hazard are not strictly confined. There are variations depending on many factors such as the infective dose, the age, the general health, the pregnancy, the immune competence of the individual e.t.c.

12

BY DR. N. CHARISIS (WHO/MZCP)

widespread health problem in the world and was an important cause of reduced economic productivity. According to national and sentinel studies conducted from 1985 to 1995, foodborne diseases represent a widespread public health problem. From these studies, for instance, it has been estimated that currently the incidence of foodborne diarrheas per year is four billion cases(?)

4.1. THE INCIDENCE OF DIARRHOEAS

Data and surveys from many industrialised countries indicate that up to 15% of the population may be affected each year by a foodborne disease. Incidence reports indicate that foodborne diseases are not only widespread but, despite the efforts made by the public health authorities, they are on the increase, at least in some countries. This trend indicates that efforts of public health authorities over the past two decades have been ineffective in the prevention of foodborne diseases.

Table 2.: Incidence of Diarrheas in some industrialised countries

Country

Percentage

Source

Sweden (1995)

7%

National survey

Netherlands (1991)

15%

Sentinel study

New Zealand (1993)

9%

National survey

UK (1995)

7%

National survey

Canada (1985)

8%

Estimation

USA (1985)

10%

Estimation

Graph 2.: Incidence of Salmonellosis in some European countries

250 200 150 100 5 0 0 Incidence (cases/100000) 1985 1986 1987 1988 1989 1990
250
200
150
100
5 0
0
Incidence (cases/100000)
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
E stonia L ithuania L atvia A ustria Germany R ussian F ed. S w

E

stonia

L

ithuania

L

atvia

A

ustria

Germany

R ussian F ed.

S w itzerla n d

Cyprus

U K

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

COUNTRY

1993

1994

1995

1996

1997

1998

Belgium

36

32

38

50

45

42

Bulgaria

-

2

-

-

2

1

Denmark

27

23

29

39

33

41

Iceland

3

6

4

1

2

-

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

32

UK England and Wales

103

115

87

120

124

108

UK Scotland

-

-

13

11

6

13

5. THE CHALLENGE OF EMERGING AND REEMERGING FOODBORNE DISEASES 8

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

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

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 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 COUNTRIES 10

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.

15

BY DR. N. CHARISIS (WHO/MZCP)

foodborne diseases significantly. But unfortunately, examples of a combined regulatory and educational approach are scarce and most of the countries still rely solely, on a regulatory approach for the prevention of foodborne diseases. In developing countries, most efforts to prevent diarrhoea causing diseases have been

focused on improving the water supply and sanitation. Regrettably in many instances the provision of safe water and sanitation has been an end in itself and has not been combined with an effective educational programme on the hygienic handling of food, including water!

A

critical review of the impact of improved water supplies and excreta disposal facilities

in

the control of diarrhoeal diseases among young children has shown that, even under

the most favourable conditions, the rate of morbidity was reduced by only 27%. Therefore, such measures are unquestionably essential to food safety and health, but their efficiency in reducing diarrhoeal disease would be much enhanced, if they were combined with a food hygiene education programme that included education in the safe use and storage of water and efficient hand washing prior to food preparation. Nevertheless, diarrhoeal diseases in infants and children remain a major cause of morbidity and mortality in many developing countries. On the other hand it should be realised that in industrialised countries with increased international travel and trade,

national regulatory measures would not be sufficient to protect populations from globally emerging and re-emerging foodborne diseases. Therefore, taking under consideration these emerging and re-emerging foodborne zoonotic diseases mostly in the developing countries, it is expected an increase of medical care costs, a loss of money because of decreased productivity, wasted food and perhaps a decrease in tourism, which is vital for the economy of these countries.

It should be also noted here that the economic impact is estimated to be more severe for

the food industry because food contamination may lead to recall and loss of contaminated food. Consequently it will jeopardise the reputation of the company and lead to reduction in food trade. Public health authorities are increasingly recognising that some groups of the population are more susceptible to foodborne diseases - either because they may acquire the diseases more easily, or because they may suffer more severely from these diseases than other non-sensitive groups. In order to confront the serious economic consequences of foodborne diseases the governments should rely on the implementation of a HACCP system. With the HACCP system food safety control is integrated into the design of the process rather than the old ineffective system of end product testing. Therefore the HACCP system provides a preventive and thus a cost-effective approach to food safety. However Food Safety is not only the responsibility of Governments but of a large variety of factors, including industry, NGO’s, International organizations and especially the consumer. All persons, whether they prepare food or consume it, are part of the food chain. As such they share responsibility with the government and the food industry in ensuring the safety of food.

7.

THE HACCP SYSTEMS

7.1.

CONCEPT

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

16

BY DR. N. CHARISIS (WHO/MZCP)

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).

can seldo m be detected by end product testing ). Experience from the Canning Indu stry

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
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.

17

BY DR. N. CHARISIS (WHO/MZCP)

7.3. AREAS OF APPLICATION

Application of the seven HACCP principles 11 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. Implement 12 (=To carry into effect) the HACCP plan (i.e. monitoring, taking corrective actions).

5. Verify the HACCP plan.

The Codex Alimentarius Commission guidelines describe how a HACCP study could be performed. These guidelines give a certain universal structure to a study, which will make it more likely to be accepted by other parties (food inspectors and trade partners). However, the 7 principles of HACCP should be applied taking into account specific conditions of size, sophistication of the process and the level of the food safety management system. These 7 principles are the minimum mandatory requirements in the application of the HACCP system. But before reporting the 7 principles, all steps leading to the Hazard Analysis should be followed. Appointment of the HACCP team will go

11 See principles of HACCP.

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

18

BY DR. N. CHARISIS (WHO/MZCP)

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:

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 control 13 .

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 safety 14 . But except for the general benefits of HACCP system, which are referred above, one may focus to its specific benefits for the consumers, the industry and the governments.

a.

Benefits to consumers

-

Reduced risk of foodborne diseases

-

Increased awareness of basic hygiene

-

Increased confidence in the food supply and

-

Improved quality of life (health and socio-economic)

b.

Benefits to industry

-

Increased consumer and/or government confidence

-

Reduced legal and insurance costs

-

Increased market access

-

Reduced production costs (reduced recall/waste of food)

-

Improved product consistency

-

Improvements of management commitment to food safety and

-

Decreased business risk and liability

c.

Benefits to governments

-

Improved public health

-

More efficient and targeted food control

-

Reduced public health costs

-

Trade facilitation (import/export)

13 Collecting and examining sufficient number of samples, high cost, time, and identification of problems without understanding the causes, limitations of snapshot inspection.

14 Experiences gained in some countries indicate that application of HACCP systems leads to more efficient prevention of foodborne diseases. In the U.S.A, only, application of HACCP by the fish processors alone is estimated to avert some 20-60% of cases of sea-foodborne illnesses.

20

BY DR. N. CHARISIS (WHO/MZCP)

- 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 System 15

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.

21

BY DR. N. CHARISIS (WHO/MZCP)

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.

precondition for an effective HACCP system implementation. Customer and business demand is a very important force
precondition for an effective HACCP system implementation. Customer and business demand is a very important force
precondition for an effective HACCP system implementation. Customer and business demand is a very important force

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.

creates a demand for the application of HACCP systems. Costs versus benefits: Although the economic constr
creates a demand for the application of HACCP systems. Costs versus benefits: Although the economic constr

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

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 SAFETY

8.1.

FOOD HYGIENE AND FOOD SAFETY

Food Hygiene includes all conditions and measures necessary to ensure the safety, suitability and wholesomeness of food at all stages of the food chain 16 . 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 use 17 . 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:

1 st Level: application of the General Principles of Food Hygiene, (as stipulated by the Codex Alimentarius Commission). 2 nd Level: application of the food-related hygienic requirements (as expressed by the Good Manufacturing/Hygienic Practice). 3 rd 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

BY DR. N. CHARISIS (WHO/MZCP)

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
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/SSOP 18 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.

24

BY DR. N. CHARISIS (WHO/MZCP)

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

9.

QUALITY OF FOOD

9.1.

DEFINITIONS OF QUALITY

It is not easy to define quality because the term means different things to different people. It is a term used arbitrary by many. Traditionally, luxury, beauty, high value meant quality. However, according to the use and requirements of the user, high quality can be attributed to different parameters. Therefore meeting the agreed requirements of the customer is a useful definition. One can define quality as the total parameters and characteristics of the product or service, which satisfies consumer desires and needs (agreed or presumed), or the price a customer is ready to pay for a product. The American Society for Quality Control (ASQC, 1987) specifies that quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs”. Nevertheless, in addition to those “classical’’ demands, from the part of the consumer, and therefore for quality attributes, in the recent years, new parameters, having a limited relation with “actual’’ quality, (i.e. animal welfare during production procedures and environmental protection), have been incorporated as quality attributes, especially in livestock production. As a matter of fact, there is a new concept, which could be addressed as the “new quality’’. It is a general requirement introducing, in the relation between consumer and producer, the dimension of imposing no harm to third parties. In other words, production should not only satisfy the demands and needs of the consumer, but it should also assure safety from the public health point of view - and - it should do that without injury to any third party. This injury or harm may concern the animals for example or the environment. These parameters, known as “other legitimate factors’’, play an important role in production and in prescribing food regulations. They don’t relate directly the production process with the consumer demands for a certain product. But they are requirements, which are projecting a quality profile based on ethical concerns. In other words a new “ethical dimension” is introduced in quality. Quality, therefore, could be the “degree to which a set of inherent characteristics fulfils requirements’’, with emphasis on the customer both as a consumer and a human being, as well as human environment in general. Likewise, quality control is a “mechanism or technique or procedure or process” ensuring that each product attains a minimum objective standard as this is defined in practical written protocols. Under this concept, quality can be seen from different angles:

From a consumers’ point of view prevails the Organoleptic quality, the Functional quality (e.g. rheologic properties, convenience, keepability), the Nutritional quality, the Hygienic quality (safety) From a public health point of view what it counts more is the Hygienic quality (safety). It follows the Nutritional quality and of course the compliance with the regulations. According to the English Oxford Dictionary, quality is the “Degree of Excellence”. We can also demonstrate it as the peculiar or essential character or the inherent feature of a specific product. Additionally quality may be defined by the entire constant

25

BY DR. N. CHARISIS (WHO/MZCP)

attributes or characteristics of a product or a service, which allow to satisfy specified or implicit requirements. On the other hand, food safety represents a preliminary requirement of quality. Therefore we may say that at the top of the structure, above HACCP and GMP and GHP, is not the safety of food but rather the quality of it. Components of quality:

- Nutritional characteristics (conciseness in proteins, carbohydrates, fats, vitamins),

- Sensorial characteristics (taste, smell, colour),

- Finished product characteristics (packaging, visual aspect, etc).

9.2. IMPORTANCE OF QUALITY FOR THE CONSUMER, INDUSTRY AND PUBLIC HEALTH

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

Table 4.: Quality from a consumer/industry and from a public health point of view

Consumer/industry point of view

Public health point of view

organoleptic quality

 

functional properties

 

keepability

Compliance with regulations

“freshness”

 

nutritional

nutritional

safety

safety (hygienic quality)

Value of money

 

Graph 5.: The role of safety

Consumer Safety Public health Industry Foodhyg 9
Consumer
Safety
Public health
Industry
Foodhyg 9

26

BY DR. N. CHARISIS (WHO/MZCP)

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 requirements19 . 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 TQM 20 systems for quality assurance, we plan what is needed to be done, we do what we plan and finally we document everything we do. Some of the most important reasons we document everything we do, are the following:

Documentation is used as a Standard aid-memoir.

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

It is the best basis for training.

Is used as a standard guidance.

It helps as a common basis for communication.

It helps controlling of the system that is applied.

It can be used as the basis for further improvement.

19 (ISO/UNCTAD/GATT)

20 Total Quality Management

27

BY DR. N. CHARISIS (WHO/MZCP)

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, verified 21 and approved 22 .

- The rules for issuing the documents must be defined (filling, distribution, updating)

- The documents should always be updated and available

- Changes to documents must be made only according to strict rules.

(It is considered that with the integration of ISO and HACCP, the above documents apply also for the HACCP system). The most significant quality assurance model, which is ISO 9001, has 20 requirements. The standard establishes requirements for what should constitute the elements of a quality assurance system. However it doesn’t establish what the desired quality is, or the technical aspects of achieving it. The ISO 9001 and ISO 9002 and to some extend ISO 9003 stipulate the need for product safety and liability. Certain elements (e.g. verification) reinforce some aspects of HACCP. It should be mentioned here that some of the terminology used in the ISO 9000 series is different from the HACCP system. The quality system elements are the most stringent quality assurance model, with 20 requirements. The standard establishes requirements for what should constitute the elements” of a quality assurance system. However it doesn’t establish what the desired quality is or the technical aspects of achieving it. Nevertheless, ISO 9000 standards are compatible with HACCP programmes, and many of their elements support or reinforce the implementation of HACCP.

21 Reviewing the document's contents.

22 Authorised for use.

28

BY DR. N. CHARISIS (WHO/MZCP)

Table 5.: Requirements of ISO 9000

 

Series 1

Management responsibility

Quality in procurement (Purchasing)

 

Quality system principles

Quality in production (Process control)

 

Auditing the quality system (internal)

Control of production

 

Economics – Quality related cost considerations

Material control and tractability (product identification and traceability)

Quality in marketing (contract review)

Control of verification status (Inspection and testing)

Quality in specification and design (Design control)

Product verification (Inspection an testing)

 
 

Series 2

Control of measuring and test equipment (inspection, measuring and test equipment)

Nonconformity (control of nonconforming product)

Corrective action

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

After-sales servicing

Quality

documentation

and

records

(Document

control)

In summary, the ISO 9000 standards are used to evaluate the food quality assurance programmes, but give no guidance on technical requirements to achieve the required quality. The objective of a quality assurance programme is to suggest appropriate actions and ensure that they are carried out. Food hygiene is part of the food quality assurance programme. Its objective is to ensure that the food, which is produced, processed or manufactured is safe and fit for human consumption. HACCP should be considered as part of food hygiene and a method of food safety assurance, which complements the general aspects of a total quality management culture as well as specific principles of food hygiene, and ensures that essential safety measures are implemented.

29

BY DR. N. CHARISIS (WHO/MZCP)

12. TRADITIONAL FOOD CONTROL

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

Table 6.: Salmonella testing of milkpowder

Sampling scheme :

60 units / lot

Examined :

25g / unit of 250g

Lot size :

10 tons

Assumption :

homogeneous distribution of Salmonella

Confidence :

Lots with 800 units containing Salmonella are accepted with 30 % probability

Today traditional food control is based on observation and testing of samples as well as in the detection of spoilage “e.g. unhealthy food” and fraud. It is basically performed through “snap-shot” inspection for the compliance with GHP/GMP + End product testing. However, regulations with GMP are using very often, vague terms such as:

appropriate” or “when necessary”. Consequently, there may be very little distinction between trivial and important matters concerning safety. Additionally, the traditional food control system is retroactive and provides little health protection, particularly regarding to pathogenic organisms. In general the shortcomings of the traditional inspectional approach are the following:

- Vague terms in laws

- Laws allow much to discretion

- Failure to distinguish requirements

- Overlooking important safety factors

- Aesthetic vs. safety factors

- Given point in time

On the other side, HACCP systems anticipate inspection for compliance with GHP/GMP + end product testing.

13. TRADITIONAL FOOD PRODUCTION AND CONTROL

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

30

BY DR. N. CHARISIS (WHO/MZCP)

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.

foods were consumed before irregularities were detected. In more modern times the food safety assurance system
foods were consumed before irregularities were detected. In more modern times the food safety assurance system
foods were consumed before irregularities were detected. In more modern times the food safety assurance system

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

31

BY DR. N. CHARISIS (WHO/MZCP)

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-

32

BY DR. N. CHARISIS (WHO/MZCP)

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

the operational process through visual inspections, equipment trials, laboratory tests etc. Graph 6.: Safe food for

33

BY DR. N. CHARISIS (WHO/MZCP)

Table 7 - The evolution of Traditional Quality

Before

Before After
Before After

After

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

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

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

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

From improvised decisions Actions and their consequences were not always planned:

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

“Let’s start doing something and then we’ll look at the existing needs”.

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

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

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

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

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

To doing and recording What is important is to do things well and provide evidence for this.

Today, with food technology at its height, food could be safe all over the world. Safe food is assured when traditional food safety assurance systems have been integrated with HACCP. An industry would start from the very beginning of every food operation with the design of the process of the product. Then the industry managers would continue with the proper selection of raw material, the process control, the GMP and GHP, and finally the good commercialisation and use practices. HACCP would be integrated into each of these steps to identify potential food safety problems. Therefore, when we talk about food safety assurance today we include traditional hygienic precautions taken in the production of food and the systematic application of the Hazard Analysis and Critical Control Points system. Simply stated, HACCP indicates what needs to be done to make food safe and it ensures that what is planned is correctly. If HACCP is applied properly from the primary producer to the final consumer, then food safety is assured, thus making better use of resources, enabling more timely response to problems, aiding official inspections and promoting international trade. The implementation of the HACCP CONTROL SYSTEM can be integrated in the implementation of the QUALITY SYSTEM because in a company, the former can be considered a part of the later.

16.

HAZARDS ANALYSIS, CRITICAL CONTROL POINTS AND CONTROL MEASURES

16.1.

HAZARD ANALYSIS

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

34

BY DR. N. CHARISIS (WHO/MZCP)

Definition of hazard analysis 23 : 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)

35

BY DR. N. CHARISIS (WHO/MZCP)

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 5 0 and below 60 0 C. Foodborne illness sometimes results from improper preparation and use. Finally the consumer’s susceptibility influences the severity and the probability of occurrence of a foodborne disease. When a food product is targeted at the very young, the very old or people with certain diseases, potential hazards often become significant hazards. For instance, a healthy person normally can consume low levels of Listeria monocytogenes without becoming ill; for immuno-suppressed person, these doses may be dangerous.

16.2. CLASSIFICATION OF HAZARD ACCORDING TO THE RISK AND SEVERITY (HAZARD INDEX).

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

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

Risk ( R )

Severity ( S )

Hazard Index ( HI )

Maximum likelihood = 5 Medium likelihood = 3-4 Minimum likelihood = 1-2

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

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

Hazard Index = risk x severity

16.3. ASSESSMENT OF RISK IN HAZARD ANALYSIS

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

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

PHYSICAL HAZARDS

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

36

BY DR. N. CHARISIS (WHO/MZCP)

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