~ . . . . . . . . . . . . . . . . . . . Review

management systems to | | ~ o n . ~ h ' e r e w.asThe componentsan obvious

S | ~ l s interpreted as the | EN 29000 ~ are listed "m Table I. food afety and quality , s o 9 0 0 3 " ~ c i f i c a t i o n s for final | ~ o v e r s specifications | ~ i c . I S O 900!,which | ~ , e velop.ment,

T. Mayes production, installation and servicing. ISO9000 is the guide to selection and use of the standards and ISO

Management systems offer the food industry a structured

framework around which companies can define and imple-

ment measures to enable the consistent manufacture of prod-

ucts of the required safety and quality standards. Such sys-

tems can offer significant advantages to the food industry and

consumers over traditional methods used for the control of

product safety and quality. This mini-review concentrates on

the applications and benefits of three management systems to

food product safety and quality.

The traditional approaches to the control of food safety and quality have been largely based on inspection and sampling/testing regimes. These often fail to discrimi- nate clearly between what is desirable and what is essential, and tend to be very unstructured and primarily retrospective mechanisms providing companies with poor assurance of achieving the required product stan- dards. The introduction of quality management systems has provided companies with a structured framework t'or the definition and implementation of management systems to enable consistent manufacture of products of the required quality. Such systems allow companies to move to a preventative philosophy where product safety and quality standards are achieved by design rather than by inspection and sampling/testing. Many tbod com- panies in the USA and Europe are now implementing ISO9000 (BS5750) and hazard analysis and critical control points (HACCP) into their businesses and are realizing tangible benefits in areas such as compliance with legislation, increased confidence in product safety, consistent product quality standards, and third-party acceptance of pertbrmance. This article reviews the major characteristics of three management systems and their application to ensuring food safety and quality.

Management systems ISO 9000 system

The ISO9000 system is a specification for a quality management system that has its roots in the British Standard BS5750 series I. The origins of the BS5750

T. Mayes is at tile Unilever Research Laboratory. Colworth House, Sharnhrook. UK MK44 1LQ.

9004 is the guide to quality management and quality system elements.

The ISO9000 system-" provides the framework for a quality management system for organizations covering a broad spectrum of activities. Although intended initially to address engineering-based industries it is now ac- cepted as being applicable, with some guidence (e.g. see Ref. 3), to all manufacturing and service industries. ISO 9001 sets out 20 requirements of business management (see Table 2), designed to ensure the quality of prod- ucts, and provides guidance on topics that must be con- sidered and definitions of what is required of the manu- facturer in each section. Specific criteria are not defined in each section; it is up to manufacturers or suppliers to define the criteria they believe will result in goods or services of the desired quality. Assessing companies do, however, issue guidance documents, which outline the need for key control points, critical process variables, etc. to be defined and for food products to be wholesome and free from contamination. Certification to ISO9000 standard requires manufacturers or suppliers to define the criteria by which they intend to operate consistent with the requirements in each section, to document those criteria and operating protocols fully, and to demonstrate to an external assessor that they conlbrm to those criteria, in summary, IS09000 requires naanufac- turers to define their own standards and to demonstrate that they conform to them.

In addition to a clearly defined set of requirements tbr ISO9000, there is a well-defined administrative route ['or companies wishing to gain certification to ISO9000. In summary this involves:

• the preparation of documentation to support the rel- evant ISO 9000 standard;

Table 1. Components of Ihe International Standards Organization (ISO) system and corresponding components of the British Standard (BS) and European Norm (EN) systems

ISO number BS number EN number

ISO 9000 BS 5750 Part 0 §0.1 EN 29000

ISO 9001 BS 5750 Part 1 EN 29001

ISO 9002 BS 5750 Part 2 EN 29002

ISO 9003 BS 5750 Part 3 EN 29003

ISO 9004 BS 5750 Part 0 §0.2 EN 29004

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Table 2. Management system requirements and stages in HACCP application a

ISO 9000 BS 7750 HACCP

4.1 Management responsibility 4.2 Quality system 4.3 Contract review 4.4 Design control 4.5 Document control 4.6 Purchasing 4.7 Purchaser-supplied product 4.8 Product identification 4.9 Process control 4.10 Inspection and testing 4.11 Inspection, measuring and test equipment 4,12 Inspection and test status 4.13 Control of nonconforming product 4.14 Corrective action 4.15 Handling, storage, packaging and delivery 4.16 Quality records 4.17 Internal quality audits 4.18 Training 4.19 Servicing 4.20 Statistical techniques

4.1 Management system 4.2 Environmental policy 4.3 Organization and personnel 4.4 Environmental effects 4.5 Objectives and targets 4.6 Management programme 4.7 Manual and documentation 4.8 Operational control 4.9 Records 4.10 Audits 4.11 Reviews

,i Data taken from Refs 1,4 and 5

1 Define terms of reference 2 Select the HACCP team 3 Describe the produci 4 Identify intended use 5 Construct a flow diagram 6 On-site verification of flow diagram 7 List all hazards associated with each process step

and all measures to control the hazards 8 Apply HACCP decision tree to identify CCPs 9 Establish target levels and tolerance for each CCP

10 Establish a monitoring system for each CCP 11 Establish a corrective action plan 12 Establish record keeping and documentation 13 Verification 14 Review the HACCP plan

• the assessment of both documentation and working practices by an independent external organization accredited for certification;

• documented remedial action on any noncompliance items;

• certification;

• maintenance of the system and reassessment.

BS 7750 standard In recent years concern over the environment has

crept higher and higher up the corporate ladder to the extent that many companies now openly court the en- vironmentally friendly/green image and use this as a posi- tive marketing tool. The concern of organizations ~ver the environment has been spurred by a number oi" inci- dents (Chernobyl, Bhopal, the Braer tanker spillage, etc.), all of which have led to immediate or long-term damage to human, animal and' plant life. Many organ- izations are already attempting to define the effects that environmental concern will have on company policy, structure and activities. In the UK, government depart- ments, local authorities, manufacturing and service- sector companies are among those expressing concern over the need for more environmentally friendly operations, and are instigating environmental audits or reviews as a way of helping progress towards, and judging com- pliance with, environmental goals. However, audits and reviews ale unlikely to provide companies with assur- ance that their performance meets current and projected requirements unless they are carried out in a structured management system.

BS7750:1992 (Ref. 4), which has been prepared under the direction of the Environmental and Pollution Standards Policy Committee, specifies such an en- vironmental management system for ensuring and

demonstrating compliance with stated environmental policies and objectives. The standard is designed to enable all types and sizes of organizations to establish an effective management system as a basis for both sound environmental performance and participation in environmental auditing schemes. The standard shares common management system principles with ISO 9000. The system requirements are given in Table2. Certification to BS7750 is likely to involve a similar route to that for ISO9000.

Hazard analysis and critical control points (HACCP) The hazard analysis and critical control points

(HACCP) system is a systematic approach to the identi- fication and assessment of hazards and risks associated with the manufacture, distribution and use of a particu- lar foodstuff. The HACCP system was developed in the 1960s jointly by the Pillsbury Company, the US Army Laboratories at Natick and the National Aeronautics and Space Administration as part of their development of processes to ensure the elimination of bacterial pathogens and toxins from foods intended for the space programme. Although intended initially to identify microbiological hazards, it is now accepted as the most cost-effective means of controlling foodborne disease 6'7 arising from microbiological, physical or chemical hazards. Although targeted primarily at issues of food safety, HACCP can also be used to identify and control hazards associated with product spoilage. The underlying philosophy inherent in the HACCP approach (to ident- ify potential hazards and implement controls and moni- toring systems to prevent their occurrence) can be used to identify hazards associated with product quality attributes, but it is strongly recommended that in such cases a different terminology be used. Critical control points (CCPs; see below) should be used for product safety hazards only.

Trends in Food Science & Technology July 1993 [Vol. 41 217

HACCP provides a more systematic and reliable approach to the identification of hazards than that achievable by traditional inspection and sampling pro- cedures 8. There are a vast number of publications deal- ing with the application of HACCP to various parts of the food chain ~-~3 using a variety of methodologies, but recent publications 5"~4J~ have all proposed a common approach and have gone a long way towards standard- izing HACCP application. Although recent publications list 12-14 stages in HACCP application (see Table 2), in general terms HACCP involves seven principles (Box 1). Essentially HACCP is a self-assessment system, although reviews and verification could involve external persons.

Applications to food safety and quality In the following discussion the specific issue of food

safety is considered to be part of the overall concept of food quality. In considering their application to food quality the above three systems have a number of points in common, but there are many more points that are spe- cific to only one system. All three systems have clearly defined requirements or stages of implementation (Table 2) and all require significant management commitment to the project and support in terms of the resources required. None of the three systems can be completed 'on the back of an envelope'. Even HACCP, which is the quickest of the three to complete because it is aimed at a specific product and process line, can take 6-8 meetings of 2-3 hours each to complete the HACCP plan. Development of the HACCP plan involves significant operational involvement, and is not just a paper exercise. ISO9000 and BS7750 are management systems targeted at whole organizations,

Box 1, The seven principles of a HACCP programme'

I, Identify potential hazard(s)associated with food production at all stages, from growth, processing, manufacture and distribution until the point of consumption. Assess the likelihood of occurrence of the hazard(s) and identify the preventative measures for their control.

2. Determine the points/procedures/operation steps that can be controlled to eliminate the hazard(s) or minimize its/their likelihood of occurrence - the critical control points (CCPs),

3. Establish critical limit(s) that must be met to ensure each CCP is under control.

4. Establish a system to monitor control of the CCPs by scheduled testing or observations.

5. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.

6. Establish procedures for verification that include supplementary tests and procedures to confirm that the HACCP system is working effectively.

7. Establish documentation concerning all procedures and records appropriate to these principles and their application.

,! Taken from Ref. 15.

businesses, manufacturing facilities, etc. and as such can take 1-3 years to put in place depending on priorities and the size of the task. All systems require ongoing support during use and regular reviews and updates to ensure that they remain relevant.

HACCP is the most specific of the three systems, being targeted solely at the tbod industry and primarily at issues of food safety. ISO 9000 and BS 7750 are not targeted specifically at the food industry but are appli- cable to all manufacturing and service industries. Both ISO9000 and BS 7750 address the whole of the man- agement system and can therefore be considered to be more widely based approaches to food quality than HACCP.

Certification to ISO9000 is being increasingly valued as an indication that organizations will manufacture goods to specified standards of quality - that product quality can be assured. However, ISO9000 does not specifically address product safety, although any product safety requirements in the company specification must be complied with. One of the major differences in terms of output between HACCP and ISO9000 is that HACCP studies require that a company identifies food safety hazards and puts control mechanisms in place to ensure that product is safe and manufactured to stan- dards that are generally agreed internationally, whereas ISO9000 requires that an organization defines its own standards and demonstrates that it can comply with them. In theory this could mean that an organization with specifications for poor quality and/or an unsafe product could still obtain ISO9000 certification pro- vided that it adhered to such specifications. Although this is unlikely to occur, it does nevertheless illustrate one of the current differences in emphasis between ISO9000 and HACCP, and would certainly imply that implementation of HACCP before lSO 9000 is the safest route (in terms of product safety). There is no reason why companies working to ISO9000 should not specify HACCP for product safety either as a pre-study or as a specific component of the main ISO9000. Under such specified conditions ISO9000 could be considered to have covered product safety issues. In the long term, formal integration of the two systems may be appropri- ate (see below).

Other differences between the systems include the fact that, because HACCP is specifically targeted at tbod safety, the identification of CCPs is being increas- ingly required by legislation', whereas the impetus behind ISO9000 and BS5750 is consumer/customer confidence and a desire by manufacturers to be seen to be controlling and improving quality standards at all levels of operation. HACCP is essentially a self- assessment system whereas ISO9000 and BS7750 systems must be certified by an accredited external body. A fully documented HACCP study is proving to be very powerful as part of the defence of 'due diligence' (in the UK only).

Despite the above comments the three systems do have many elements in common ~7. HACCP is often quoted as being complementary to ISO 9000 and there is

218 Trends in Food Science & Technology July 1993 IVol. 41

no doubt that if an organization already has ISO9000 then some of the information required for HACCP will already be available, although because of the differences in emphasis it must not be assumed that all data relating specifically to product safety issues will have been con- sidered by ISO9000 systems. Organizations that have already carried out HACCP will find that the infor- mation can be used to build specific product safety issues into the ISO 9000 system. Completion of HACCP pro- vides a very firm base for the broader ISO 9000. As the pilot scheme for BS 5750 did not end until April 1993 it is perhaps premature to talk about the application of BS 7750 to food quality, but the major thrust of the stan- dard seems to be compliance with broader environmen- tal goals, not adherence to product specific safety or quality attributes. There has already been significant interest in the standard from the manufacturing industry generally, and current problems with the lack of an agency to accredit certification bodies have been high- lighted '~.

Conclusions Both ISO 9000 and H A C C P are rapidly becoming

established in the food industry, in both the U S A and Europe, probably for different reasons for they are tar- geted at different aspects of food quality. Both provide quantifiable benefits. Companies wishing to concentrate on product safety must follow the HACCP approach in preference to ISO 9000. In the long term it would seem sensible to consider the formal incorporation of the HACCP concepts into ISO9000, possibly as part of future ISO updates. This would add value to ISO9000 (specific safety issues would be covered) and HACCP (accreditation, external review, continuous improve- ment, etc.), and would provide a more natural stepping stone from HACCP to ISO9000. It would require ad- ditional expertise from assessing and certifying bodies but would bring together management system structure and product safety specifications into one definitive working document. The benefits of BS7750 for food safety and quality are less tangible. BS7750 does not directly address product safety and quality issues and for that reason uptake in the food industry is likely to

be governed more by corporate policy than by specific product safety or quality issues.

References 1 British Standard Quality Systems (BS 57501 (1987) British Standards

Institution 2 Quality Management and Quality Assurance Standards (Guidelines for

Selectior, and Use) (ISO 9000) (1987) Inlernational Standards Organization

3 Guidance Document to Quality Systems for Use in Food Processing and Allied Industries (QSS 4100) (1988) Lloyds Register Quality Assurance

4 Specification for Environmental Management Systems. BS 7750 (19921 British Standards Institution

5 HACCP: A Practical Guide (Technical Manual 38) (19921Campden Food and Drink Research Association, Chipping Campden, UK

6 Report of a WHO Informal Working Group, Geneva, on Foodborne L isteriosis (WHO/EHE/FOS 88.5)(1988) World Health Organisation, Geneva, Switzerland

7 ConsultationonFoodSafetyinEuropeinthe 1990s:TheHazard Analysis Critical Control Point System as the Tool of Choice for Effective Inspection, Brussels 20-22 Nov. 1989 (EUR/ICP/FOS 018/S) (1990) World Health Organisation, Geneva, Switzerland

8 Baird-Parker, A.C. (1990) Food Control 1, 131-133 9 Bauman, H. (1990) Food TechnoL 44, 156-158

10 Spencer Garrelt, E., III and Hudak-Roos, M. (1990) Food Technol. 44, 159-165

11 Adams, C.E. (1990) Food TechnoL 44, 169-170 12 Pierson, M.D. and Corletl, D.A., Jr, eds (1992) HACCP Principles and

Applications, Van Nostrand Reinhold 13 Bryan, Fi. (1992) Hazard Analysis Critical Control Point Evaluations,

World Health Organisation, Geneva, Switzerland 14 National Advisory Committee on Microbiological Criteria for Foods

(19921 int. J. Food Microbiol. 16, 1-23 15 Report of the 25th Session of the Codex Committee on Food Hygiene,

Washington, D.C. 28 October - 1 November 1991 (Alinorm 93/13 Appendix V175-80)(1991) Codex Alimentarius Commission

16 Council Directive 92/46/EEC 16 June 1992 Laving Down the Health Rules for the Production and Placing on the Market of Raw Milk, Heat Treated Milk and Milk-based Products (1992) Commission of European Communities

17 Jouve, J.L., ed. (1992) HACCP and Quality Systems. Proceedings of the 3rd World Congress on Foodborne Infections and Intoxications 16-19 June 1992 Bedin, pp. 881-883, Institute of Veterinary Medicine, Robert yon Oslertag Institute, Berlin, Germany

18 Institute of Environmental Managers (1992) J. Inst. Environ. Managers 1(1), 5-6

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