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The IS0 9000 series and its implications for HACCP

W. F. Harrigan

The IS0 9000:1987 series of standards for quality systems concentrates on the contractual relationship beween supplier and customer, and the conformity to customer specifications. The hazard analysis critical control point (HACCP) concept, although its origins also lie in a supplier-customer relationship, emphasizes the need to produce food that could be assured to be safe. Both of these approaches have been adopted within the food industry. Modern food legislation will frequently provide for the possibility of a defence of due diligence by a food manufacturer, supplier, retailer or caterer. The adoption of HACCP or certification under IS0 9001 or IS0 9002 is seen by many companies as an appropriate step providing for a due diligence defence. In thk context, the two approaches have some significant differences. However, it is more important for a company to be motivated towards achieving quality, with the intention of preventing the possibility of prosecution, rather than merely to provide a defence in the event of prosecution.

Keywords: HACCP; IS0 9001/2; microbiological quality; quality management; TQM

INTRODUCTION

The apparent dates of the IS0 9000 series (1987) and of the statement (in 1971) of the formal procedures of the hazard analysis critical control point (HACCP) system (FDA, 1973) suggest that HACCP predated quality systems standards by more than a decade. However, this is the result of the rather parochial view often found in the food industry (and a few other industries) as the food industry only became generally aware of the quality management system (QMS) standards through the publication of the IS0 series in 1987.

The IS0 9000 series

In 1979, the British Standards Institution (BSI) published BS 5750 on quality systems (QS). This

Department of Food Science and Technology, University of Reading, Reading, RG6 2AP, UK. Plenary paper presented at ‘Food Quality and Safety: from Manufacturers to Con- sumers’, a joint symposium of the Singapore Society for Microbiology and the Singapore Institute of Food Science and Technology, 12-13 May, 1992, Concord Hotel, Singapore

standard grew out of the DEFSTANs of the British Ministry of Defence from the 1960s and 197Os, and the AQAP series of standards of the North Atlantic Treaty Organization (NATO), which in turn had originated in similar procedures in the USA. Hendra (Hendra, 1992) has contended that the AQAP series owed most of their development to the US NASA Apollo project. Thus the electrical and electronic industries have been accustomed to this type of QMS standard since the 1950s.

The International Standards Organization (ISO), during its development of an appropriate standard for QS, asked member countries already having a national standard to submit these standards to IS0 for discus- sion and consideration. The British and Canadian standard came closest to ISO’s needs and were used as the basis for the IS0 9000 series.

The foundation standards in the IS0 9000 series were published in 1987, and the BSI simultaneously published a revised BS 5750 identical with the IS0 9000 series. These foundation documents are:

IS0 9000-1987 ‘Quality management and quality assurance standards - guidelines for selection and use’ [Singapore equivalent SS 308 Part 0, 1988;

0956-7135/93/020105-07 @ 1993 Butteworth-Heinemann Ltd Food Control 1993 Volume 4 Number 2 105

IS0 9000 and HACCP: W. F. Harrigan

British equivalent BS 5750 Part 0 Section 0.1, 19871 IS0 9001-1987 ‘Quality systems - model for quality assurance in design/development, production, installation and servicing’ [Singapore equivalent SS 308 Part 1, 1988; British equivalent BS 5750 Part 1, 19871 IS0 9002-1987 ‘Quality systems - model for quality assurance in production and installation’ [Singapore equivalent SS 308 Part 2, 1988; British equivalent BS 5750 Part 2, 19871 IS0 9003-1987 ‘Quality systems - model for quality assurance in final inspection and test’ [Singapore equivalent SS 308 Part 3, 1988; British equivalent BS 5750 Part 3, 19871 IS0 9004-1987 ‘Quality management and quality system elements - guidelines’ [Singapore SS 308 Part 4, 1988; British equivalent BS 5750 Part 0 Section 0.2, 19871.

The emphasis of the application of the IS0 9000 series is on the contracts and relationships between customers and suppliers (thus demonstrating the standards’ origins in defence contracts between govern- ments and manufacturers), rather than on the internal operation of a QMS. Indeed, Sayle (Sayle, 1991) has maintained that certain of the requirements of IS0 90011213 may tend to be in conflict with the QMS of a company intent on operating within a total quality management (TQM) environment. One of the con- sequences of this emphasis is that in order for a customer to be assured of a supplier’s conformance to the appropriate standard, an assessment of the supplier’s QS against the standard can be performed by a third party, which then issues a certificate of conformance. It has been claimed (Hendra, 1991) that third party certification is not a modern phenomenon of the 1980s and later, but that third party certification has been occurring for at least 150 years. Nevertheless, the fact remains that the 1980s and 1990s have seen a tremendous growth in third party certification even in the engineering, electrical, electronic and software industries, and its first introduction into other industries such as the food industry.

In order that quality managers in different companies and in different countries have a commonality of approach to these QS standards, it is necessary to agree on the definitions of the terms used. To this end, a standard vocabulary has been produced (IS0 8402, or BS 4778 Part 1). Unfortunately many key words and phrases of the IS0 9000 series have not been defined in either IS0 8402 or in the IS0 9000 series themselves. Amongst the terms and phrases not defined are: design, document, establish, maintain, procedure, process, product, quality manual, record, test.

Furthermore, many of the clauses in IS0 9001/2/3 are either ambiguous or in conflict with other clauses in the same standard (Sayle, 1991). Consequently, in order to achieve a consistent interpretation within an industry, guidelines need to be produced for that industry. Such guidelines may be produced by a national standards institution (e.g. the BSI), by an organization represent- ing the manufacturers (e.g. the British Food and Drink Federation, FDF) or by the body of professionals involved in quality assurance within the industry (e.g. the Institutes of Food Science and Technology (IFSTs) in Singapore, or the UK). An example of outline guidelines is the document published by BSI

Quality Assurance (BSI, 1991) which was produced by a committee containing, inter alia, representatives of the FDF, IFST and the relevant research associations. The advantage of the national Standards Institutions or the national IFSTs being involved directly in producing such guidelines is that not only can national uniformity be achieved, but also these bodies can then work towards international uniformity through the IS0 and the International Union of Food Science and Technology (IUFoST), respectively.

The HACCP system

There are two major traditional approaches to achieving quality. One is the examination of samples of the product to determine conformity to specification. The other is the use of inspection of the processing environment and the installation of facilities for the monitoring of process parameters.

In some countries, microbiological specifications for end-products have been built into legislation and have tended to take precedence over in-factory inspection by representatives of the regulatory agencies. In other countries there has been a tradition of inspection of the processing environment, with legislation being built around a factory inspectorate/environmental health inspectorate. The UK has tended to be in the latter category, and only very recently has it started to incorporate simple microbiological specifications into the legislation, and so far only in respect of a very few food products.

The two approaches have their own advantages and shortcomings. It is well known that examination of samples from batches to determine whether they meet an end-product specification cannot ensure that the consumer is protected against receiving product below specification, unless 100% inspection can be employed. Whereas metal detection is a non-destructive procedure, all microbiological and most chemical analyses are destructive, so that only a small proportion of the total batch can be examined. Nevertheless, end- product specifications are useful for carrying out acceptance sampling plans, e.g. when a country wishes to control the import of unwholesome foods, but has no direct access for inspection of, or authentic and adequate data about, the production facilities in the exporting country.

Inspection of production facilities should be able to ensure that manufacturing and processing follows appropriate codes of good manufacturing practice. However, in most countries the activities of the inspectors in their in-factory assessments of the hazards and of the steps taken to control those hazards have tended to be left to individual interpretation.

In 1971, at the first US National Food Protection Conference, a new formalized procedure - the HACCP concept - was introduced (Bauman, 1986). The HACCP system was jointly developed by the US National Aeronautics and Space Administation (NASA), the US Army Natick Laboratories and the Pillsbury Company (Bauman, 1974). The principal advance was in formalizing a logical procedure for identifying: (i) hazards; (ii) the steps needed to control these hazards; and (iii) the monitoring of these controls (see Figure I).

106 Food Control 1993 Volume 4 Number 2

IS0 9000 and HACCP: W.F. Harrigan

DEFINE THE PROCESS - - - -1

FLOW-CHART OF PROCESS - - -

IDENTIFY HAZARDS

j G t

/ I

DETERMINE CCPs DOWN ; TO PRIORITY LIMIT

t

I

EVALUATE POTENTIAL CONTROL CRITERIA : I

t

, I

SPECIFY CONTROL CRITERIA AT CCPs, _ _;

MONITOR CONTROLS

t / 4 ! q

I’ 3 VALIDATION AND VERIFICATION j_ ??_: f

Figure 1 Summary of HACCP procedure

Since then, the advantages of having a formal procedure have been widely recognized, and the HACCP system has been adopted by food microbiologists in many countries (ICMSF, 1988). In the Euro- pean Community (EC) a proposed Council Directive (EC Council, 1992) recognizes and requires the use of HACCP by food business operators. However, it is true to say that, worldwide, the major form of adoption so far is by large food companies themselves, who have seen HACCP as a means of particularising quality management techniques to microbiological hazards and food hygiene. The HACCP approach has been

especially welcomed by multinational companies because it facilitates the introduction of similar (microbiological) quality management procedures in factories of subsidiary companies in different countries.

In the UK, there is a very large number of small companies operating in the food industry and many of these have not yet adopted HACCP or any other formal QMS. This is also true of most other countries at the present time.

Implementation of HACCP and certification under IS0 9001/2

In Section 21 of the UK’s Food Safety Act 1990, there was introduced the possibility of a defence of due diligence being offered in prosecutions brought under the Act or under Regulations arising therefrom. This legislation has accelerated the introduction of HACCP, of total quality management (TQM) systems, and/or certification of premises under IS0 9001 (BS 5750 Part 1) or IS0 9002 (BS 5750 Part 2), as food manufacturers, retailers, etc. see these steps as helping to support the plea that they have been exercising due diligence. A booklet providing guidelines on the statutory defence of due diligence (FDF, 1991) was accordingly prepared by the joint efforts of the Food and Drink Federation, the Institute of Environmental Health Officers, the Local Authorities Coordinating body on Trading Standards (LACOTS), the National Consumer Council, the National Farmers Union, and the Retail Consortium. Interestingly, some UK supermarket chains are requiring the suppliers/ manufacturers of the supermarket own-label products to have in place a HACCP system, whereas other supermarket chains have chosen to require the suppliers of own-label products to have obtained (or be in the process of obtaining) certification under BS 5750. Since relatively few food factories in the UK have so far achieved certification, and this process may take six months to a year, at present the supermarket companies taking the latter course have couched their requirements in terms of intent (e.g. a requirement for the supplier ‘to be working towards having achieved certification by December 1993’).

An organization may implement a quality system, e.g. introduce HACCP, TQM, or become certificated under IS0 9001/2 for the following reasons:

(i) to improve the efficiency of their operations and the quality of their products;

(ii) to satisfy a requirement from their customers/ purchasers;

(iii) to provide a due diligence defence in legal actions;

(iv) to keep up with their competitors.

Except in the case of the first reason, the company may not have a genuine desire and commitment to improve quality. For example, if a company is particularly concerned about meeting a customer requirement as a precondition of a new or renewed contract, or having the possibility of a due diligence defence against prosecution, that company may consider that the priority is in achieving IS0 9001/2 certification as quickly as possible. If the company then perceives there to be differences between assessments and approval rates of different certification bodies (accredited third party assessors), it may seek certification from the

Food Control 1993 Volume 4 Number 2 107


certification body thought to require least effort and least expenditure.

In addition, there is a widely held belief that it is far easier to achieve certification under IS0 9002 than under IS0 9001. The differences between the two standards lie in the inclusion in IS0 9001 of Section 4.4 ‘Design Control’ and Section 4.19 ‘Servicing’. In the food industry, Section 4.19 will rarely be relevant, but product design and new product development will often be part of a factory’s activities, in which case certification under IS0 9001 is more appropriate than certification under IS0 9002. Jennings (Jennings, 1992) has argued strongly that assessment and certification under IS0 9002 of organizations/factories which have design departments is a major misuse of the standard. He suggests that design may be the most critical activity in the production of a product. If the concept or design is wrong, then even a perfect system of production and perfect documentation of the QM procedures will not correct the defect. For example, some years ago (and before the recently introduced more rigorous temperature regulations in the UK) the writer encountered a case in which a bakery making cakes and fruit pies had decided to diversify into meat products produced in the same factory. The bakery had an ambient temperature delivery system to small retailers. Not only were meat pies distributed by the bakery vans to shops where the meat products were put on display at ambient tempera- tures, but the company even developed a precooked fried beefburger which was packaged in a single- layered cardboard box and stored in the shops at ambient temperature alongside cakes and biscuits! As can be imagined, this product was not only not microbiologically shelf-stable, but also was not stable by any other criterion. The oil soaked through the cardboard carton, disfiguring the full-colour presenta- tion on the outside and causing disintegration of the carton. The product was withdrawn within a week or two, with the loss of considerable development costs.

A HACCP evaluation should be incorporated into new product design. Recently, a UK manufacturer, experienced in producing canned fruit and fruit purees for the food manufacturing industry, decided to diversify into canned nut purees, which could be provided to manufacturers of flavoured yoghurts. Unfortunately, the thermal processing given to this low-acid product was not adjusted from the mild heat treatment adequate for canning fruit purees and surviving Clostridium botulinurn spores were able to develop in the canned product. This product was supplied to another company and toxin-containing hazelnut puree was incorporated into yoghurt, which then proceeded to cause an outbreak of botulism (O’Mahoney et al., 1990). A proper HACCP evaluation at the outset would have prevented this disaster.

In addition, modifications to a manufacturing process involving an established product may be made by inadequately trained persons. This can readily lead to a corruption of product quality. A well-known example is of the survival of Clostridium botulinum spores in canned mushrooms produced in the USA. In one case the company had been accustomed to canning whole button mushrooms, in which heat penetration to the heating centre of the can was achieved by a mixture of conduction and convection, but primarily by convection in the brine. The introduction of vibratory fillers

led to the cans being more solidly packed so that convection contributed to heat penetration to a lesser extent. The personnel concerned had not realized that this modification would necessitate a re-evaluation of the F-value calculation. Another reason for needing to evaluate the thermal processing is the change from canning small, whole button mushrooms to packing larger, sliced mushrooms, again leading to a more solid pack, and a lesser contribution of convection to heat penetration.

Could these incidents have occurred had the factories concerned been certificated under IS0 9002 (or even IS0 9001)? Unfortunately, I believe that it is possible. It is becoming the view of a number of quality consultants (Sayle, 1991; Jennings, 1992) that compliance with, and certification under, IS0 9001/2 has often been judged on the basis of the factory’s or company’s quality of management of its documentation, rather than on the basis of the efficacy of the QMS in achieving an assured quality of product. In this respect it should be noted that whereas a certification agency or an independent consultant quality assessor may be able to judge on the appropriateness of the quality system as a system, unless they have also been trained as food scientists, food technologists or food microbiologists they are not necessarily professionally competent to judge the effect of the application of that system. The training of a food scientist, food technolo- gist or food microbiologist will take a minimum of two years to diploma level and a minimum of three years to degree level. This represents the minimum training required to make a competent HACCP evaluation. However, the training in the principles of assessing a QMS within the confines of IS0 9001/2, can be obtained in 3 to 5 days, particularly if the training course is orientated to the food industry. Even though the assessors and lead assessors in certification agencies must have appropriate experience as assessors and lead assessors to be properly registered, that experience may be obtained by assessing a range of manufacturing and servicing establishments without the experience resulting in the development of more than a superficial knowledge of food science or food technology.

Thus, it is important for companies to retain the services of qualified scientists and technologists, rather than to imagine that the company’s only quality advisers can be trained solely in generalized QM techniques. I believe that it is a valuable and sound investment for a food company to send their food scientists/technologists/microbiologists on an IS0 OOl/ 9002 Assessors’ Course, particularly if it is run by one of the appopriate certifcation bodies, and especially if that course is specifically designed for the food industry. The standards (IS0 9001, Sections 4.17 and 4.18; IS0 9002, Sections 4.16 and 4.17) require that internal auditing activities be carried out by appropriately trained staff. The more general internal auditing of QM procedures, of document control, etc. can be performed by staff who have attended the courses for assessors or auditors to which I have just referred. The insights thus gained into document control, procedures and documentation for inspection, monitoring, calibra- tion and verification will prove invaluable in developing and implementing an HACCP system which is properly documented with appropriate records ensuring traceability of materials, process and product. Scientific


knowledge and experience on the other hand will be the main determinant of the extent to which the application of the HACCP system will ensure an appropriately high quality of product.

In a TQM environment there is a more important form of auditing which is more directly related to product quality rather than the quality management quality; this is often described as ‘self-auditing’ or ‘self- assessment’ and it refers to the ability of an operative to judge both the efficiency of the operations for which he or she is responsible and the extent to which an appropriate output quality is being maintained.

The general steps in the procedure for a HACCP evaluation have been outlined by Harrigan and Park (1991) as follows.

Phase 1: Construction of a flow-chart of the entire process (including distribution, warehousing and retail operations, as appropriate). The actual flow- chart to be constructed should not only be product- specific, but also factory-specific, showing the types of equipment and their spatial arrangement (see Harrigan and Park, 1991).

Phase 2: Identification of hazards and the location of these, recorded at the appropriate points on the flow- chart. The identification of these hazards requires considerable knowledge of the microbial ecology of the starting materials and of the microbiological effects of all aspects of handling, storage and processing.

Phase 3: Identification of critical control points (CCPs), located on the flow-chart, followed by a

TOTAL QUALITY MANAGEMENT REQUIRES:

1. ACTIVE COLLABORATION AND PARTICIPATION OF ALL

2. QUALITY MANAGEMENT AND VERIFICATION OF PRODUCT DESIGN

3. RECOGNITION OF al CUSTOMER REQUIREMENTS

bl THE VALUE OF CUSTOMER FEEDBACK

4. EVALUATION OF PROCESSING AND PRODUCTION

5. OPERATIVES TO BE INVOLVED IN THE WRITING OF

a) THEIR OWN SECTION OF THE QUALITY MANAGEMENT

b) THEIR WORK INSTRUCTIONS

6. THE VALUE OF MONITORING TO BE APPRECIATED BY OPBRATIVES AS WELL AS LAB. STAFF (‘SELF-AUDIT’)

7. THE IMPORTANCE OF CLERICAL AND MAINTENANCE STAFF TO BE RECOGNIZED

8. RECOGNITION THAT QUAUTY POUCIES ADD TO PROFITS (PRODUCTION QUOTAS SHOULD NOT BE ALLOWED TO OVERRIDE QUALITY CONSIDERATIONSJ

Figure 2 Total quality management

1.

2.

3.

4.

5.

6.

7.

6.

9.


RECOGNIZE THE IMPORTANCE OF QUALITY (From Chief Executive down)

DEFINE CUSTOMER EXPECTATIONS

FIT THESE WITH COMPANY REQUIREMENTS AND ABILITIES

INVOLVE THE WHOLE WORKFORCE IN ACHIEVING QUALITY

ARRANGE APPROPRIATE STAFF TRAINING

MONITOR/INSPECT RAW MATERIALS PRODUCTION/PROCESSING PACKAGING PRODUCT STORAGE DISTRIBUTION

CHECK MONITORING SYSTEMS

INTRODUCE AND IMPLEMENT DOCUMENTATION OF ALL THE ABOVE

REVIEW Figure 3 Steps in quality management consistent with IS0 !%OO series

re-evaluation of the interaction between hazards and CCPS.

Phase 4: Listing and evaluation of the monitoring and QA procedures to be used to ensure continuing efficacy of control at the CCPs; and listing of the documentation of the monitoring required.

The full sequence is shown in Figure I. The accuracy of the flow-chart and the hazards need

to be ascertained and verified by an on-site study of the production process whilst the production line is in operation. This is necessary in order to determine the relative importance of the production steps defined in the flow-chart and only such a study may reveal unexpected hazards. For example, a mismatch in equipment capacities may lead to undesirable bottle- necks in the process. A can-filling and sealing machine may have a much faster throughput than the retorts used to heat-treat the cans, leading to a build-up of racks of cans awaiting retorting - if these cans are then put in a cold store until retorted and are then immediately heat-treated on removal from the cold store, this could lead to their not receiving a botulinum cook (Harrigan and Park, 1991).

It is important to realize that the operation of adequate food hygiene, cleaning and disinfection to a standard specified by an appropriate Code of Hygienic Practice or Code of GMP should be installed before HACCP evaluation. It is necessary to particularize the hygiene, cleaning and disinfection procedures to the factory, equipment and products, and not just to rely on the documentation of a generalized Code of Practice published by government or professional institute. However, to include normal hygiene and sanitation



precautions in a single HACCP evaluation would overcomplicate the issue. The same HACCP procedures can be employed, however, to specify the hygienic and sanitation measures to be installed - thus having a hygiene and cleaning HACCP followed by a subsequent HACCP to cover production, processing, storage and distribution.

One or two examples of the types of hazards involved should suffice to demonstrate the need for a compre- hensive knowledge of food microbiology. A factory buying in materials such as milk powder, fruit or nut purees that have derived from another food manufacturing process in another factory might import a hazard. What are the control opportunities for these materials?

The pasteurization of the ice cream mix is regarded usually as a CCPl, the terminology used by the ICMSF (1988) to indicate a CCP which will eliminate the specified hazard. This was regarded by the ICMSF as contrasting with a CCP2, which was defined as being able to reduce a microbiological hazard without entirely eliminating it. This distinction can be extremely misleading and may even lead to the HACCP system being unfairly discredited (Buchanan, 1990). While national food legislations have often regarded the pasteurization step as being capable of eliminating food poisoning hazards, we can easily envisage food poisoning hazards not controlled by this heat treatment, since it really only provides control over heat-sensitive (particularly Gram-negative) bacteria present in the mix ingredients. Milk powder (from another manufacturer) may be incorporated in the mix. This milk powder could contain staphylococcal enterotoxin and, if so, this heat-stable toxin would not be denatured by pasteurization. A buying specification might require that staphylococcal enterotoxin is undetectable by an enzyme-linked immunosorbent

FIVE LEVELS OF QUALITY DOCUMENTA TION ARE REQUIRED:

1.

2.

3.

4.

5.

THE COMPANY QUALITY POLICY (and Company Quality Manual)

THE FACTORY QUALITY MANUAL

DEPARTMENTAL PROCEDURES

INDIVIDUAL WORK INSTRUCTION SHEETS [e.g. in Production on

a) cleaning, disinfection, etc.. .

b) operating the equipment]

MONITORING AND INSPECTION RECORDS STORES RECORDS DESPATCH RECORDS, etc.. .

Figure 4 Quality documentation, reproduced from Harrigan and Park, 1991

INSTRUCTIONS FOR MONITORING SHOULD S TA TE:

1.

2.

3.

4.

5.

WHO IS RESPONSIBLE FOR EACH MONITORING OPERATION

UNDER WHAT CIRCUMSTANCES ACTION IS TO BE TAKEN

THE THRESHOLD VALUES DERIVED FROM THE MONITORING AT WHICH ACTION MUST BE TAKEN

THE NATURE OF THE ACTION

THE DOCUMENTARY OR OTHER PROCEDURES BY WHICH THE ACTION IS REPORTED

Figure 5 Monitoring

assay (ELISA) capable of detection in the order of rig/g,, or be less than a specified concentration within the sensitivity of the ELISA technique. Since the milk powder is readily bulked, this would seem to be a possible solution to the problem.

If the ice-cream manufacturer produces a nut ice- cream, using a purchased canned coarse-chopped nut puree, would there be a possibility of the presence of botulinum toxin? If so, note that the toxin, although in this case heat-labile, may not be inactivated by the pasteurization process, because the puree may be incorporated into the ice cream mix after the pasteurization step. There will be no adequate quality assurance (QA) provided by opening one can of puree and looking for botulinum toxin by ELISA. Should the ice-cream manufacturer go to the considerable expense of extending ELISA inspection to every can? It is far more sensible for the ice-cream manufacturer to have, as part of the buying specification, a requirement that the supplier is also using a HACCP system or some similar QM tool, to have an assurance that the canned low-acid food material is put into good quality cans without defective seams or seals and properly receives a botulinum cook.

Thus in these two cases, the pasteurization step is an irrelevance. Even more notable is that bacterial endospores may not merely survive the pasteurization but may even be heat-activated into early germination. To prevent growth and toxin production by Bacillus cereus, it is imperative that there is rapid cooling after pasteurization and that the storage interval before freezing is carefully monitored and restricted to prevent development of psychotrophic spore-formers. Recently, in the UK, there was an outbreak of Bacillus cereus food poisoning caused by ice cream as a result of the process not preventing germination, multiplication and toxin production after the pasteurization of the mix.

It is obviously over-simple and misleading to describe



the pasteurization step as a CCPl without reference to the specific hazard it is intended to control.

Need for HACCP to be operated in a TQM environment

The traditional management structure in the food industry is hierarchical and authoritarian. In this situation, QA procedures have tended to be confronta- tional. The QA manager, or the QA scientist, will usually inform an operative that he/she is not setting the process parameters properly, or not observing the appropriate hygienic precautions, or is producing product which is not of the appropriate microbiological quality (without necessarily explaining the reasons for the defect)! This type of negative advice engenders a ‘them and us’ attitude on the part of both processing operatives and the separate QA staff. The people involved in the actual manufacturing process do not see themselves as active participants in the quality system.

A QS needs to be able to operate effectively without the presence of members of the QA department. This is the basis of TQM (Oakland, 1989), in which everybody in an organization is fully committed to achieving quality. The principal tenets of TQM are illustrated in Figure 2.

The steps to be undertaken to establish the QMS are shown in Figure 3. In the UK, there has been an inadequate commitment in the food industry to staff training. A recent report from the UK Audit Commis- sion (Audit Commission, 1990) identified poor staff training, lack of awareness of food hygiene and poor management practices as major risk factors in much of the UK food industry. One of the most important set of regulations being introduced under the UK Food Safety Act 1990 is that providing a requirement for adequate food hygiene training of staff.

Appropriate staff training (in all aspects of the job, and not just in hygiene) is a requirement of IS0 9001/2. This training needs to be related to both the responsibi- lities and the skills/abilities of the operative. If estab- lishing HACCP within a TQM environment, part of this training will occur informally ‘in-house’, when the HACCP evaluators form a team with the process operatives in order to decide jointly on the procedures and monitoring to be adopted in respect of a given CCP.

Another important aspect of a QMS, and one which is central to the concept of ‘traceability’ found in the IS0 9000 series, is that there should be adequate documentation of all stages (Figure 3). The various levels of quality documentation are shown in Figure 4 (Harrigan and Park, 1991). Although HACCP will require certain types of documentation, these will relate particularly to the monitoring stages (Figure 5) (Harrigan and Park, 1991), whereas IS0 9OO1/2 has a requirement for a much wider range of doucmentation.

Thus, we can see that HACCP can be installed as part of a TQM system, or as part of a QM system that is certificated under the IS0 9000 series, whereas to obtain certification under the IS0 9000 series it is not necessary to carry out a hazard analysis. A company that uses HACCP effectively should find it relatively straightforward to adopt the same type of management approach across the whole range of activities in order to work towards IS0 9001/2 certification, and a number of

UK food companies have found that their experience of operating HACCP has helped them in their approach to the QMS necessary to achieve IS0 90001/2 certification.

REFERENCES

Audit Commission (1990) Environmental Health Survey of Food Premises HMSO, London

Bauman, IKE. (1974) The HACCP concept and microbiological hazard categories. Food Technol. 28, 30, 32, 34, 74

Bauman, H.E. (1986) The hazard analysis critical control point concept. In: Food Protection Technology C.W. Felix ed., Lewis Publishers, Chelsea, MI, pp. 175-179

BSI Committee (1991) Guidance Notes for the Application of IS0 9002iEN 29002lBS 5750: Part 2 to the Food and Drink Industry. BSI Quality Assurance, Milton Keynes

Buchanan, R.L. (1990) HACCP: a re-emerging approach to food safety. Trends Food Sci. Technol 1, 104-106

EC Council (1992) Proposal for a Council Directive on the hygiene of foodstuffs. Official Journal of the European Communities C&I,31 January, pp. 11-16

FDA (Food and Drug AdministrPtion) (1973) Hazard analysis and critical control point inspection. In: Compliance Programs Guidance Manual FDA, Washington, cited by Tisler, 1991

FDF (Food and Drink Federation) (1991) Food Safety Act 1990: Guidelines on the Statutory Defence of Due Diligence Food and Drink Federation, London

Food Safety Act 1990 (1990) Chapter 16, HMSO, London

Harrigan, W.F. and Park, R.W.A. (1991) Making Safe Food Academic Press, London

Hendra, I. (1991) Third party certification - a response. Quality News 17, 359-360

Hendra, I. (1992) The origins of IS0 9000. Quality News 18, 4-5

ICMSF (International Commission for Microbiohqical Speciflcatkms for Foods) (1988) Microorganisms in Foods. 4. Application of the Hazard Analysis Critical Control Point (HACCP) System to Ensure Microbiological Safety and Quality Blackwell, Oxford

IS0 9000 (1987) Quality Management and Quality Assurance Standards - Guidelines for Selection and Use [Singapore equivalent SS 308 Part 0, 1988; British equivalent BS 5750 Part 0 Section 0.1, 19871

IS0 9001 (1987) Quality Systems - Model for Quality Assurance in Design/Development, Production, installation and Servicing [Singapore equivslent SS 308 Part 1, 1988; British equivalent BS 5750 Part 1, 19871

IS0 !I002 (1987) Quality Systems - Model for Quality Assurance in Production and Installation [Singapore equivalent SS 308 Part 2, 1988; British equivalent BS 5750 Part 2, 19871

IS0 9003 (1987) Quality Systems - Model for Quality Assurance in Final Inspection and Test [Singapore equivalent SS 308 Part 3, 1988; British equivalent BS 5750 Part 3, 19871

IS0 9004 (1987) Quality Management and Quality System Elements - Guidelines [Singapore equivalent SS 308 Part 4, 1988; British equivalent BS 5750 Part 0, Section 0.2: I9871

Jennings, GM. (1992) IS0 9001/9002 - use, misuse and abuse. Quality Forum 18, 33-35

O’Mahoney, M.O. et al. (1990) An outbreak of foodborne botulism associated with contaminated hazelnut yoghurt. Epidemiol. Infect. 104, 389-395

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Received 5 October 1992 Revised 26 November 1992 Accepted 27 November 1992


the is0 9000 series and its implications for haccp - aua.gr105... · as the food industry only...

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