Hooker2000 - Two Case Studies of Food Quality Management Systems

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Two Case Studies of Food

Quality Management Systems
a b
Neal H. Hooker & Julie A. Caswell
a
Department of Agricultural and Resource
Economics , Colorado State University , B311 Clark,
Fort Collins, CO, 80523-1112, USA
b
Department of Resource Economics , University
of Massachusetts , 235 Draper Hall, Amherst, MA,
01003, USA
Published online: 12 Oct 2008.
To cite this article: Neal H. Hooker & Julie A. Caswell (2000) Two Case Studies of
Food Quality Management Systems, Journal of International Food & Agribusiness
Marketing, 11:1, 57-71, DOI: 10.1300/J047v11n01_04
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Two Case Studies of Food Quality
Management Systems
Neal H. Hooker
Julie A. Caswell
ABSTRACT. The role of voluntary and mandatory quality management

systems (QMS) is changing in an era of increasing international agri-food
trade. This trade environment requires cooperative activity among nations to
determine the equivalence of domestic regulatory programs, and thereby
facilitate trade. At the same time, voluntary QMS are growing in importance
as a means of certifying quality. This paper focuses on two QMS (mandato-
ry HACCP-based programs and the voluntary ISO 9000 certification series)
currently applied throughout agri-food supply chains. Their independent and
interactive impacts are assessed under this new trade environment. [Article
copies available for a fee from The Haworth Document Delivery Service:
1-800-342-9678. E-mail address: getinfo@haworthpressinc.com <Website: http://
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KEYWORDS. Quality management systems, international agri-food

trade, Hazard Analysis and Critical Control Points (HACCP), Interna-
tional Organization for Standardization (ISO 9000)
INTRODUCTION
The interaction of voluntary and mandatory quality management
systems (QMS) is important in food production. Many voluntary
Neal H. Hooker is Assistant Professor, Department of Agricultural and Resource

Economics, B311 Clark, Colorado State University, Fort Collins, CO 80523-1112 (E-mail:
nhooker@lamar.colostate.edu). Julie A. Caswell is Professor, Department of Re-
source Economics, 235 Draper Hall, University of Massachusetts, Amherst, MA 01003
(E-mail: caswell@resecon.umass.edu).
Address correspondence to Neal H. Hooker at the above address.
This research is based on work funded by USDA National Research Initiative
Competitive Grant #95-37400-1816 to the University of Massachusetts.
Journal of International Food & Agribusiness Marketing, Vol. 11(1) 1999
E 1999 by The Haworth Press, Inc. All rights reserved. 57
58 Journal of International Food & Agribusiness Marketing
third-party certification programs and mandatory systems enhance

product quality via systematic approaches to process control. The use
of such QMS can also facilitate international agri-food trade provided
they are recognized widely and implemented in a ‘harmonized’ man-

ner. Such QMS fit well under recent trade agreements such as the
Uruguay Round of the General Agreement on Tariffs and Trade
(GATT) now managed by the World Trade Organization (WTO) and
the North American Free Trade Agreement (NAFTA). Yet the interac-
tion between voluntary and mandatory systems remains to be better
analyzed. Differently implemented or enforced mandatory regimes
over nations or stages of agri-food supply chains, or divergent inter-
pretation of (or compliance with) voluntary norms can impede trade.
This paper surveys these issues in the context of recent trade agree-
ments using two case studies.
To best address the interaction of QMS two sets of controls current-
ly being adopted in or required of the agri-food industry are consid-
ered. The first is mandatory implementation of HACCP (Hazard Anal-
ysis and Critical Control Points)-based approaches to food safety by a
growing number of countries. The second is an example of a voluntary
private certification program as an alternative means of assuring food
quality. The ISO 9000 series, managed by the International Organiza-
tion for Standardization (ISO) is explored. Such QMS can be voluntar-
ily adopted as a source of viable third-party certification that may
complement or even substitute for government regulation of certain
quality attributes.
These cases provide excellent examples of mandatory and volun-
tary controls, with a narrow (food safety) and broad (quality) focus on
product attributes. Most interestingly the interaction between HACCP
and ISO 9000 applications provides an extension to the cases that is
illustrative of many issues germane to the management and commu-
nication of quality attributes throughout agri-food supply chains. The
broader international trade implications for such cooperative activity
between nations and firms in mandating, implementing, and adopting
these QMS is also discussed.
TARGETS OF QMS
Quality management systems seek to control the overall mix of
characteristics or attributes that determine a product’s performance
Neal H. Hooker and Julie A. Caswell 59
relative to its price. Several important quality attribute subsets can

then be identified for food (see Table 1). The first is safety attributes
including foodborne pathogens, heavy metal and pesticide residues,
food additives, naturally occurring toxins, and veterinary drug resi-

dues. The second set of attributes relates to the nutritional profile of
the product and includes aspects such as content of fat, calories, fiber,
sodium, vitamins, and minerals. A third subset is value attributes
including characteristics of the product itself that are of value to the
consumer but are not food safety or nutrition attributes. Examples are
purity (lack of nonhazardous contaminants), compositional integrity
(lack of economic adulteration), size, appearance, taste, and conve-
nience of preparation. The fourth subset is package attributes, which
includes package materials, labeling, and other information provided.
A fifth subset includes those product attributes that arise from the
manner of production and processing, such as animal welfare and
environmental impacts. Particular quality issues may relate to more
TABLE 1. Quality Attribute Space for Food
Quality Attribute Subsets
1. Food Safety Attributes

Foodborne Pathogens
Heavy Metals
Pesticide Residues
Food Additives
Naturally Occurring Toxins
Veterinary Residues
2. Nutrition Attributes
Fat Content
Calories
Fiber
Sodium
Vitamins
Minerals
3. Value Attributes
Purity
Compositional Integrity
Size
Appearance
Taste
Convenience of Preparation
4. Package Attributes
Package Materials
Labeling
Other Information Provided
5. Process Attributes
Animal Welfare
Biotechnology
Environmental Impact
Pesticide Use
Worker Safety
than one attribute subset. For example, organic products may be

appealing for their food safety, nutritional, value, or process attributes.
The Sanitary and Phytosanitary (SPS) agreements in the Uruguay
Round of GATT and NAFTA were intended to address trade barrier

concerns related to national-level regulation of the first subset of at-
tributes, food safety. They do so by providing a dispute resolution
system and promoting the wider adoption of scientific standards pro-
mulgated by three key international standards bodies: Codex Alimen-
tarius Commission (Codex), the International Plant Protection Con-
vention (IPPC) and its regional affiliates, and the International Office
of Epizootics (OIE). Conversely, the Technical Barriers to Trade
(TBT) parts of these agreements stress the need to be aware of nega-
tive trade impacts that may arise from differences in national-level
standards (both mandatory and voluntary) controlling the remaining
four quality attribute subsets. Clear demarcation of the two areas at
their margins is often difficult (Roberts and DeRemer 1997).
QUALITY MANAGEMENT SYSTEMS

Firms have clear incentives to adopt effective and cost efficient
QMS. These include the need to be in compliance with regulations
regarding the product and process, to have checks in place that avoid
litigation based on product and workplace safety, to minimize internal
and external transactions costs in order to maintain contracts that
increasingly include strict quality management components, to sup-
port product differentiation strategies, and to meet the market-based
pressure to maintain a ‘competitive’ price and/or cost position. The
firms’ quality targets can then be met or missed by the plant- and
company-level QMS.
There is a definite trend toward systematic approaches to control-
ling quality in food processing, frequently in response to regulatory,
technical, and managerial innovations. This trend recognizes short-
comings in using end-point performance testing to assure the quality,
and in particular the safety, of a product. QMS that use end-point
testing merely as a complement to tighter process controls are believed
to offer an holistic approach to quality control (Codex 1996). Of
course, few nations rely solely on end-point testing in their regulatory
programs. They make concerted efforts to dictate a minimum produc-
tion environment by mandating good manufacturing practices (GMP)
and/or standard sanitary operating procedures. However, many con-

sider these measures better suited to the control of chemical and physi-
cal hazards, doing little to address microbiological hazards. Further,
even truly harmonized (i.e., Codex-based) GMPs are only rarely based
on consistent risk analysis techniques that focus on the actual risks to
human health as required by the current SPS agreements (Hathaway
and Cook 1996).
It is in this environment that more stringent and scientifically
grounded quality control and assurance measures that focus on the
whole quality system have been advocated. A standard definition of
quality management is:
All activities of the overall management function that determine
the quality policy, objectives and responsibilities, and implement
them by means such as quality planning, quality control, quality
assurance and quality improvement within the quality system.
(ISO 1996: 8402, p. 1)
The role of quality assurance is key within this definition. When
moving from simple end-point testing of product quality the emphasis
of quality management changes from one of simple quality control to
incorporating a greater appreciation of the process and how it can
influence product quality. Within this environment quality assurance
efforts can more effectively be used to indicate whether a plant is
practicing sufficient control at the key stages of production to enhance
and ensure the final quality of the good. Further, documented evidence
of compliance efforts can be more efficiently validated by the compe-
tent authority, allowing end-point performance testing to be used to
check the effectiveness of upstream controls. Finally, when a QMS is
widely recognized across nations international agri-food trade is facil-
itated as partners are aware of what the QMS dictates of the plant.
Case Study 1: The ISO 9000 Series
ISO is a non-governmental international organization made up of

national standard setting bodies from some 133 countries. It attempts
to harmonize voluntary industrial standards to facilitate trade in a
similar manner to the work of Codex, IPPC, and OIE. However, the
member bodies need not be and often are not government agencies.
The U.S., for example, is represented in ISO by the American National
Standards Institute and not the National Institute of Standards and

Technology, the standard setting division of the U.S. Department of
Commerce.
The ISO 9000 series developed out of the British BS 5750 stan-
dards. It was adapted for wider use in 1987 with the publication of its
first edition. This framework was then amended in 1994. ISO 9000
certification involves a third party (not the ISO) certifying that the
firm’s QMS is in compliance with the appropriate model. Surak clari-
fies the different language often applied to the accreditation process
between North America and Europe (Surak 1995). Essentially we
follow his classification by calling the third party making the assess-
ment of the plant’s QMS the registration company, which then awards
a certificate of conformance. The ISO appointed registration company
plays a role in advising, coordinating and validating the plant-level
QMS. Certification is maintained via a combination of internal and
third party audits to ensure the QMS adheres to the ISO 9000 require-
ments.
The registration company does not need to be from the same coun-
try in which the plant is located. The goal is to promote the consistent
application across countries of conformity assessments, the certifica-
tion process, and costs of obtaining a certificate. However, clearly
firms select a particular registration company based on its reputation
as well as the cost of certification. ISO targeted possible inconsisten-
cies in the accreditation process by introducing a quality system as-
sessment recognition (QSAR) program in 1996 that was intended to
demonstrate the equivalency of certificates regardless of their country
of origin. The system attempts to minimize any potential trade barriers
(perceived or real) due to differently interpreted or implemented ISO
9000 QMS. In 1997 QSAR was reassessed following a survey of
certified firms that identified such trade barrier concerns were un-
founded. Further, a strengthening organization, the International Ac-
creditation Forum, was developed to provide the oversight capabilities
required for the consistent global application of ISO 9000. Validation
of registration companies to ensure consistency across clients and
nations is a continuing concern for ISO and an interesting area of
future research.
The greatest benefit of attaining ISO 9000 certification is seen to be
the increased understanding of the whole quality system that it offers.
However, this benefit comes at a cost. The certification process can be
drawn out, with 19 months suggested as an average time depending

upon the system chosen and the plant’s complexity (Capmany et al.
1998). However, adoption of the QMS may be faster for a food pro-
cessing facility that is already in tight compliance with regulatory

GMPs and that has close links to its suppliers. The average annual cost
reductions attributable to ISO 9000 certification were reported to be
around $200,000 per plant, regardless of whether the QMS was
adopted voluntarily or was required by a supplier (Surak 1995).
Better estimates of the costs and benefits of ISO 9000 are the focus
of several on-going studies. For example, Holleran and Bredahl
(1996) studied the impact of the QMS on transaction costs in the
British food sector. They provide a framework for continued work to
analyze the dynamics of this system’s approach to quality manage-
ment. Holleran and Bredahl (1996) also stress the potential for volun-
tary QMS to act as trade barriers. Capmany et al. (1998) suggest that
the costs of attaining ($101,400) and maintaining ($26,500) ISO 9000
certification were not considered a major hurdle by the U.S. agribusi-
ness firms they surveyed.
One early step along the road to ISO 9000 certification is the selec-
tion of the level to pursue. ISO 9001 is the most complete option
covering all of the 20 clauses listed in Table 2. ISO 9002 excludes 4.4
(design control) and is thus considered best suited to food processing
facilities without research and development divisions. ISO 9003 is the
least restrictive system, intended for operations that demonstrate con-
formance only via final inspection and testing. It is recommended for
commodity suppliers, food distribution and warehousing companies,
and certain retailers (Surak 1995; Golomski 1994).
Figures on the number of ISO 9000 certified plants are available
from the various Mobil surveys. By the end of 1995 at least 127,389
certificates of conformance of QMS to one of the ISO 9000 series
models were noted globally across all industries. Of this number some
8% were U.S. plants (ISO 1996b). There is an increasing trend toward
certification in the food sector. In France, for example, some 330 plants
were certified as of September 1, 1995. Ninety-six percent of these
were certified to 9002, and only three percent to 9001 (Codex 1996).
Holleran and Bredahl (1996) provide more detailed information on
the British experience. They report that over 1,100 British food firms
were ISO 9000 certified in 1994 (almost all to 9002). This compared
to only about 50 of the 10,000 total plants in the U.S. food sector.
TABLE 2. ISO 9001 Requirements
Clause Title and Description

4.1 Management responsibility: Defines the firm’s quality policy, organization, and management review. This step ties that part of
management with ‘‘executive responsibility’’ to the quality system.
4.2 Quality system: Defined as the combination of organizational structure, procedures, process and resources, the quality system
must be fully documented and maintained to meet all ‘‘specified requirements.’’ This step involves the preparation of a quality
manual.
4.3 Contract review: Addresses the capabilities of the firm to meet its contractual requirements.
4.4 Design control: Reviews the design of the product to ensure that all specified requirements can be met. This step follows each
stage of the process through design review, verification, validation, and changes.
4.5 Document and data control: Linking with other clauses, this is the commitment the firm makes to maintain all documents and data
and guarantee these records reflect up-to-date practices.
4.6 Purchasing: Sets-up checks that all products purchased from subcontractors conform to their specified requirements.
4.7 Control of customer-supplied product: Firms that incorporate customer-supplied ingredients or packaging materials into their
end-products should establish and maintain documented procedures for the verification, storage, and maintenance of these
products.
4.8 Product identification and traceability: A system that follows the product through each stage of production, delivery, and
installation should be implemented. This ‘‘trace-back’’ capability is essential for product recalls.
4.9 Process control: That all aspects of the production process (e.g., buildings, plant, equipment, personnel, etc.) must be carried out
under controlled conditions. Further ‘‘where the results of processes cannot be fully verified by subsequent inspection and testing
of the product and where, for example, processing deficiencies may become apparent only after the product is in use, the
processes shall be carried out by qualified operators and/or shall require continuous monitoring and control of process
parameters to ensure that the specified requirements are met’’ (ISO 9001 1994, p. 6).
4.10 Inspection and testing: Procedures to verify that the specific requirements of the inputs, intermediate, and final product are being
met should be initiated.
4.11 Control of inspection, measuring, and test equipment: Those instruments required to comply with 4.10 should be periodically
calibrated.
4.12 Inspection and test status: Some system of identification of the product that indicates if it is in compliance with the tests
performed must be in place.
4.13 Control of nonconforming product: This is then followed-up with an assurance that nonconforming product is not inadvertently
used (such may be reworked and then reinspected depending upon the details of the quality system).
4.14 Corrective and preventative action: There must be an effective system that implements both corrective and preventative action
when required.
4.15 Handling, storage, packaging, preservation, and delivery: The quality of the product should be maintained during the
post-production stages.
4.16 Control of quality records: All quality records should be readily available.
4.17 Internal quality audits: The quality system should undergo periodic internal reviews to determine its effectiveness.
4.18 Training: Training needs should be identified and addressed to ensure qualified personnel are performing those activities that
affect the quality of the product.
4.19 Servicing: Although unlikely to be appropriate for the agri-food industry, provisions for compliance with any after sales servicing
requirements are included.
4.20 Statistical techniques: When statistical techniques are required to establish, control or verify the process capability or product
attributes they should be documented.
Sources: Adapted from ISO (1996a): 9000-1 and Surak and Simpson (1994).
Although adoption rates have clearly risen in both countries in the

interim period, U.S. agribusiness still lags behind the U.K. The British
data vary considerably, with 75% of total sales in the drink sector
coming from ISO 9000 firms compared to less than 5% for meat and
meat products, catering, and transportation. The authors hypothesize
that this variability is directly related to market structure and transac-
tion cost differences for the products. They go on to report that the
heaviest concentration of ISO 9000 certification is found among sec-
ond stage processors (those producing differentiated goods).
Given that certification to ISO 9002 is so much more common

among food processors the exclusion of a design control component
deserves special consideration. This may serve to limit the impact of
ISO 9000 certification in the area of food safety. The exclusion of a

thorough analysis of the product and the ability of the process to
consistently meet all specified requirements can prove significant. The
ISO 9000 series ‘‘focuses on system quality, not product quality’’
(Golomski 1994, p. 58, emphasis in original). Clause 19 of ISO 9004-1
recommends certain preventative measures, but these are limited to
design testing and product recall. Further, ISO 9004-1 is intended to
serve only as an internal guide to developing a QMS. Mortimore and
Wallace (1994) further comment that if part of the process is unsafe
the ISO 9000 focus on consistency will ensure that the resulting prod-
uct will always be unsafe. This has led to criticism of the current
composition of the ISO 9000 series and recommendations to expand it
to incorporate HACCP principles for agri-food applications.
Regardless of the level of the QMS selected, all national-level technical
requirements for the product and technical specifications for the process
remain ‘‘separate and distinct from the applicable ISO 9000 family require-
ments or guidance’’ (ISO 1996a: 9000-1, p. 3). These mandated, and any
other contractual (voluntary) constraints, are grouped under the term ‘spe-
cified requirements’ throughout the ISO 9000 documentation. The QMS
then must ensure 100% compliance with all these requirements.
In summary, the four main incentives to gaining ISO 9000 certifica-
tion can be seen as confidence, consistency, contracts, and competi-
tiveness. The goal of the QMS is to promote confidence in the firm’s
ability consistently to offer a high quality good and thus fulfill its
contractual requirements and install a competitive advantage for fu-
ture transactions.
Case Study 2: Mandated HACCP Regimes
HACCP began as a voluntary QMS in the 1960s but in the 1990s
has been increasingly used as an element in the regulatory programs of
governments (Mortimore and Wallace 1994). HACCP principles were
adopted by the National Advisory Committee on Microbiological Cri-
teria for Foods in the U.S. in 1992, by the European Union for meat
products in 1992 and for all foodstuffs in 1993, and by Codex in 1993.
The seven basic HACCP principles are shown in Table 3. They in-
clude identifying where risks to human heath are likely to occur in a
TABLE 3. HACCP Principles
Principle Description/Activity
1 Identify the 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/operational steps that can be controlled to eliminate the hazard(s) or minimize its likelihood of
occurrence (Critical Control Points (CCP)). A ‘‘step’’ means any stage in food production and/or manufacture including raw
materials, their receipt and/or production, harvesting, transport, formulation, processing, storage, etc.
3 Establish critical limit(s) which must be met to ensure the CCP is under control.
4 Establish a system to monitor control of the CCP 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, which 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.
Source: Adapted from Codex (1995).
processing chain, the critical control points (CCP) for these hazards,
preventative measures to be taken to keep hazards within critical limits
at each CCP, establishment of monitoring procedures, clear responses
to violations of critical limits at each CCP, record keeping, and contin-
ued validation and updating of the HACCP system.
HACCP attempts to assure food safety by focusing on the operation
of the food processing chain. It is based on the view that end product
testing is a less effective method of assuring safety than is close and
continuous attention to food safety at all points in the supply chain.
Like the ISO 9000 series, HACCP lays down an approach to quality
management without specifying particular actions to be taken. As a
voluntary QMS, the goals of a HACCP system are to produce safe
product every time, to demonstrate adequate safety assurance activity
(e.g., as part of a ‘due diligence’ defense), and to support the reputa-
tion of the product in consumer markets. A HACCP system can be a
step toward other types of certification (e.g., ISO 9000) and a cost-ef-
fective technique for updating the QMS system (Mortimore and Wal-
lace 1994).
Alternatively, as a mandatory QMS HACCP-based regulatory re-
gimes are becoming more common. Key examples include HACCP-
based approaches for agri-food supply chains in Canada and Australia;
the U.S. Food and Drug Administration’s (FDA) seafood HACCP rule
(FDA 1995); and the U.S. Department of Agriculture (USDA) Food
Safety and Inspection Service’s Pathogen Reduction and HACCP rule
for meat and poultry slaughtering and processing facilities (USDA
1996). FDA is considering extending the application of HACCP-
based regulatory systems to additional food industries. How the QMS

operates as a mandated regulatory regime depends on how govern-
ments implement it, especially on the degree to which they simply
require a HACCP plan versus specifying particular elements of the

plan (see, e.g., Unnevehr and Jensen 1996). This distinction is often
blurred because governments are implementing HACCP while main-
taining and even strengthening mandated GMPs (Caswell and Hooker
1996).
Hathaway and Cook (1996) discuss weaknesses in HACCP applica-
tions that focus on reducing hazards over individual stages of an
agri-food supply chain rather than targeting the risk to consumers.
They advocate the implementation of HACCP-based principles at all
stages. The authors also raise the point that differently implemented
HACCP-based regimes will need to be evaluated to determine their
equivalence in the international trade arena. This, they suggest, will
most likely require a qualitative comparison of stage-specific food
safety objectives based on prescriptive controls rather than a quantita-
tive risk analysis for the full agri-food supply chain. This contradicts
the systematic intent of the HACCP principles.
THE INTERACTION OF VOLUNTARY

AND MANDATORY QMS
The interaction and even interdependency of voluntary and manda-
tory QMS are important. Plants adopting a mandatory HACCP-based
regime may then find this introduction to QMS a logical first step
towards ISO 9000 certification or vice versa. Further, the review
stages of each QMS can complement each other (e.g., in going over
the HACCP plan one can also identify non-safety attributes whose
control can increase food quality).
All ISO 9000 certified firms must incorporate HACCP when man-
dated via the ‘specific requirements’ language. Also, guarantees of
continuous monitoring of the process may need to be put in place
when considering food safety attributes under process control (clause
4.9, see Table 2). Clause 4.14, corrective and preventative actions, also
interacts closely with HACCP principles 5 and 6 (see Table 4 and
Mortimore and Wallace 1994). However, this control only mandates
compliance to the national-level version of HACCP and not the har-
monized (Codex) model (Codex 1995). Thus the potential conflict
TABLE 4. Interaction of ISO 9001 Requirements and HACCP Principles
ISO 9001 Requirements HACCP Principles

4.1 1-7
4.2 1-3 and 7
4.3 --
4.4 1-7
4.5 1-7
4.6 1-3
4.7 1-3 and 7
4.8 6-7
4.9 4
4.10 2-4
4.11 --
4.12 2-4
4.13 3-5
4.14 5-6
4.15 *
4.16 7
4.17 6-7
4.18 -
4.19 -
4.20 -
* Depends upon the stage to which HACCP is applied.

Source: Adapted from Hathaway (1995).
between differently implemented national-level HACCP-based re-

gimes is not mitigated by the ISO 9000 certification process. Thus
trade barriers may remain even when one or both QMS are in place.
INTERNATIONAL TRADE IMPACTS
Key issues surrounding these QMS remain to be solved in the

international arena. These include the need to demonstrate the equiva-
lency of HACCP-based regulatory regimes, the ability to validate the
safety of the domestic food supply with its increasingly international
origins in an era of limited government budgets, increasing demands
for safer foods, growing awareness of the systematic impacts of con-
trols at each stage of food production and processing (including ship-
ping) on the risk to the consumer, and the key requirement to apply
consistent measures of risk across food groups and controls. These
issues will stretch current QMS and require food processing firms to
adopt more pro-active quality strategies. However, these efforts need
not prove restrictive as an effective QMS with a focus on safety and
general quality improvements can allow a firm to develop a competi-
tive and even comparative advantage, thus promoting increased prod-

uct and process innovation (Maurer and Drescher 1996). Again, the
manner of implementation of mandatory QMS, such as HACCP-based
regimes, is vital. An emphasis on a prescriptive process control meth-

odology can stifle innovation with firms being restricted to a particular
manner of production. In contrast, a flexible ISO 9000 QMS can allow
for greater cost savings by allowing the firm to optimize its process
within the constraints of maintaining its quality system.
The United States has voiced concerns about efforts to extend the
utilization of ISO 9000 QMS into various Codex standard setting
activities (FDA 1996). It believes there are problems associated with
the call for countries to recognize ISO 9000 certificates as evidence of
compliance to national-level food safety standards and with the idea
that this is an efficient and cost effective way to reduce certain inspec-
tion duties. FDA raised concerns over how ISO 9000 standards are set,
for example, in not fulfilling the transparency requirements of the
GATT SPS Agreement. Other issues raised included the lack of
HACCP-based food safety principles, resulting in an inability to dem-
onstrate that scientifically determined controls are in place, and the
need for additional government validation of both the ISO 9000 regis-
tration company and the certified firm. The FDA position paper did,
however, advocate a continued, voluntary role for ISO 9000 certifica-
tion with the potential that:
If safety and/or quality assurance tools (such as ISO 9000) are

used by food businesses, the official inspection and certification
systems should take them into account in determining the level of
inspection. (FDA 1996, p. 3)
Such a linkage would be of interest to many firms as it might reduce

their overall QMS costs.
Finally it should be noted that the GATT SPS Agreement makes no
reference to the ISO. Similarly there is no prescribed role for ISO
under the GATT TBT Agreement. ISO is addressing these issues with
the World Trade Organization, particularly relating to the work of the
Trade and Environment Committee. The ISO 14000 series of environ-
mental management systems may play a role in facilitating the work of
the Committee. Similar voluntary and mandatory interactions will
evolve for the ISO 14000 series as for ISO 9000.
DISCUSSION
If international agri-food trade of quality differentiated products is

to be facilitated, consistent and transparent QMS must be adopted

throughout supply chains. This involves the broader application of
both mandatory and voluntary QMS such as those discussed here.
Differences in mandatory QMS often are not mitigated by voluntary
systems. For example, the lack of HACCP principles in the ISO 9000
series is a central issue limiting an increasing role for it in trade
facilitation. On the other hand, it is argued that incorporating such
principles into the QMS would be redundant of national-level
HACCP-based regimes. Managing this interaction between voluntary
and mandatory QMS is a major challenge and opportunity in the
global food trade.
REFERENCES
Capmany, C., N. H. Hooker, T. Ozuna Jr., and A. van Tilburg. (1998). ISO 9000 - A
U.S. Agribusiness Perspective. Paper presented at the IAMA World Pre-Congress
VIII Building Relationships to Feed the World: Firms, Chains, Blocs. Punta del
Este, Uruguay. June 28-July 2.
Caswell, J. A. and N. H. Hooker (1996) HACCP as an International Trade Standard,
American Journal of Agricultural Economics, 78(3), pp. 775-779.
Codex, (1995) Codex Alimentarius General Principles of Food Hygiene, Alinorm
95/13.
Codex (1996) Report of Codex Committee on Import and Export Food Inspection
and Certification Systems, CX/FICS 96/6, Fourth session, Canberra, Australia,
February 19-23.
FDA (1995) Procedures for the Safe and Sanitary Processing and Importing of Fish
and Fishery Products; Final Rule, Federal Register, 60(242), pp. 65096-65202.
FDA (1996) Position paper for Codex Committee on Import and Export Food Inspec-
tion and Certification Systems, Fourth session, Canberra, Australia, February
19-23.
Golomski, W. A. (1994) ISO 9000-- The Global Perspective, Food Technology,
48(12), pp. 57-59.
Hathaway, S. (1995) Harmonization of International Requirements Under HACCP-
Based Food Control Systems, in report of the Food and Agriculture Organization
Expert Technical Meeting on The Use of Hazard Analysis Critical Control Point
(HACCP) Principles in Food Control, Vancouver, Canada, December.
Hathaway, S. and R. L. Cook (1996) A Regulatory Perspective on the Potential Uses
of Microbial Risk Assessment in International Trade, Paper presented at the
Second International Conference on Predictive Microbiology Power with Preci-
sion, Hobart, Australia, 18-22 February.
Holleran, E. and M. E. Bredahl (1996) Food Safety, Transaction Costs and Institu-
tional Innovation in the British Food Sector, in G. Schiefer and R. Hilbig, Eds.
Quality Management and Process Improvement for Competitive Advantage in
Agriculture and Food. University of Bonn.

Hooker, N. H. and J. A. Caswell (1996) Regulatory Targets and Regimes for Food
Safety: A Comparison of North American and European Approaches, in Econom-
ics of Reducing Health Risk from Food, J. A. Caswell, Ed., Food Marketing Policy
Center, Storrs, CT, pp. 1-15.
ISO (1996a) ISO Standards Compendium-- ISO 9000 Quality Management, 6th edi-
tion, Geneva, Switzerland.
ISO (1996b) ISO 9000 News, November/December, pp. 4.
Maurer, O. and K. Drescher (1996) Industrial Standards as Driving Forces of Corpo-
rate Innovation and Internationalization, in Economics of Innovation: The Case of
Food Industry, G. Galizzi and L. Venturini, Eds., Physica-Verlag, Heidelberg,
Germany, pp. 221-237.
Mortimore S. and C. Wallace (1994) HACCP: A Practical Approach, Chapman &
Hall, London.
Roberts, D. and K. DeRemer (1997) Overview of Foreign Technical Barriers to U.S.
Agricultural Exports, Economic Research Service Staff Paper 9705, U.S. Depart-
ment of Agriculture, March.
Surak, J. G. (1995) ISO 9000 for the Food Processing Industry, Unpublished Manu-
script, Department Food Science, Clemson University, Clemson, SC.
Surak, J. G. and K. E. Simpson (1994) Using ISO 9000 Standards as a Quality
Framework, Food Technology, 48(12), pp. 63-65.
Unnevehr, L. J. and H. H. Jensen (1996) HACCP as a Regulatory Innovation to
Improve Food Safety in the Meat Industry, American Journal of Agricultural
Economics, 78(5), pp. 764-769.
USDA (1996) Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems; Final Rule, Federal Register, 61(144), pp. 38805-38989.
Submitted: July 1998

First Revision: February 1999
Second Revision: July 1999
Accepted: September 1999

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This article was downloaded by: [McMaster University]

On: 23 October 2014, At: 10:39

Journal of International Food &

Two Case Studies of Food

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ABSTRACT. The role of voluntary and mandatory quality management

KEYWORDS. Quality management systems, international agri-food

Neal H. Hooker is Assistant Professor, Department of Agricultural and Resource

third-party certification programs and mandatory systems enhance

they are recognized widely and implemented in a ‘harmonized’ man-

relative to its price. Several important quality attribute subsets can

food additives, naturally occurring toxins, and veterinary drug resi-

TABLE 1. Quality Attribute Space for Food

Quality Attribute Subsets

1. Food Safety Attributes

than one attribute subset. For example, organic products may be

Round of GATT and NAFTA were intended to address trade barrier

QUALITY MANAGEMENT SYSTEMS

and/or standard sanitary operating procedures. However, many con-

Case Study 1: The ISO 9000 Series

ISO is a non-governmental international organization made up of

Standards Institute and not the National Institute of Standards and

drawn out, with 19 months suggested as an average time depending

cessing facility that is already in tight compliance with regulatory

TABLE 2. ISO 9001 Requirements

Clause Title and Description

Although adoption rates have clearly risen in both countries in the

Given that certification to ISO 9002 is so much more common

ISO 9000 certification in the area of food safety. The exclusion of a

TABLE 3. HACCP Principles

Source: Adapted from Codex (1995).

based regulatory systems to additional food industries. How the QMS

require a HACCP plan versus specifying particular elements of the

THE INTERACTION OF VOLUNTARY

TABLE 4. Interaction of ISO 9001 Requirements and HACCP Principles

ISO 9001 Requirements HACCP Principles

* Depends upon the stage to which HACCP is applied.

between differently implemented national-level HACCP-based re-

INTERNATIONAL TRADE IMPACTS

Key issues surrounding these QMS remain to be solved in the

tive and even comparative advantage, thus promoting increased prod-

regimes, is vital. An emphasis on a prescriptive process control meth-

If safety and/or quality assurance tools (such as ISO 9000) are

Such a linkage would be of interest to many firms as it might reduce

If international agri-food trade of quality differentiated products is

to be facilitated, consistent and transparent QMS must be adopted

Agriculture and Food. University of Bonn.

Submitted: July 1998

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