~ . . . . . . . . . . . . . . . . . . .

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.
f o o d a f e t y a n d q u a l i t y , 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! , whi c h
| ~ , e velop.ment,
T. Mayes production, installation and servicing. ISO9000 is the
guide to selection and use of the standards and ISO
Management systems of f er t he f ood industry a structured
f ramework around whi c h companies can def i ne and i mpl e-
ment measures t o enable the consistent manufacture o f pr od-
ucts o f the required saf et y and qual i t y standards. Such sys-
tems can offer significant advantages t o the f ood i ndust ry and
consumers over t radi t i onal methods used f or the cont r ol o f
product safety and qual i t y. This mi ni - r evi ew concentrates on
the appl i cati ons and benefits o f three management systems t o
f ood product safety and qual i t y.
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.
M a n a g e m e n t sy st e ms
I SO 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 t i l e 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, i n summary, I S 0 9 0 0 0 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 o f Ihe In te rn a tio n a l Standards
Orga n iza tio n (ISO) system and corresponding components o f the
British Sta n d a rd (BS) and European No rm (EN) systems
ISO n u mbe r BS n u mber EN n u mber
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
t O ~ l q q ~. [ I , e x l e r ~ t l t , n t e P u h l i , , h e r , , L t d . q i .; k t I 1 q 2 4 - 2 2 4 4 ! q I / S ( I h . ( l i l
Trends in Food Science & Technology July 1993 IVol. 41
Ta bl e 2. Ma n a ge me n t sy ste m re q u i re me n t s a n d sta ge s i n HACCP a ppl i ca t i o n a
ISO 9 0 0 0 BS 7750 HACCP
4.1 Management responsibility
4.2 Qual i t y system
4.3 Contract review
4.4 Desi gn control
4.5 Document control
4.6 Purchasing
4.7 Purchaser-supplied product
4.8 Pr oduct 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 del i very
4.16 Qual i t y records
4.17 Internal qual i t y audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
4.1 Management system
4.2 Envi ronmental pol i cy
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 f l ow diagram
6 On-site verification of f l ow diagram
7 Li st al l hazards associated wi t h each process step
and al l measures to control the hazards
8 Appl y 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 7 7 5 0 s t a n d a r d
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 Tabl e2.
Certification to BS7750 is likely to involve a similar
route to that for ISO9000.
H a z a r d a n a l y s i s a n d c r i t i c a l c o n t r o l p o i n t s ( H A C C P )
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 Jul y 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.
A p p l i c a t i o n s t o f o o d s af et y a n d q u a l i t y
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,
Bo x 1, The se ve n pri n ci pl e s o f a HACCP pro gra mme '
I , Identify potential hazard(s)associated wi t h food production
at a l l stages, from growth, processing, manufacture and
di st ri but i on u n t i l the poi nt of consumption. Assess the
l i k el i hood 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 mi ni mi ze 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 moni tor control of the CCPs by scheduled
testing or observations.
5. Establish the corrective action to be t aken 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 pr ocedur es 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 '~.
Co n clu sio n s
B o t h I S O 9 0 0 0 a n d H A C C P a r e r a p i d l y b e c o m i n g
e s t a b l i s h e d i n t h e f o o d i n d u s t r y , i n b o t h t h e U S A a n d
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, F i . (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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