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Standardised
Development of methods for HACCP
standardised HACCP assessment assessment
Carol A. Wallace and Susan C. Powell
Lancashire School of Health and Postgraduate Medicine, 723
University of Central Lancashire, Preston, UK, and
Lynda Holyoak
Department of Psychology, University of Central Lancashire, Preston, UK

Abstract
Purpose – Assessment of HACCP systems is a key element in assuring the effective management of
food safety. However, there is no accepted approach or common methodology available to HACCP
practitioners, auditors or regulatory bodies. This paper seeks to examine this situation
Design/methodology/approach – This paper reviews previous approaches to HACCP audit and
describes developments in audit and audit methods based on a long-term study of HACCP in a
multinational organisation.
Findings – The proposed audit tools provide a useful method for collection of data on the
effectiveness of HACCP plans and their implementation.
Research limitations/implications – Limitations of using this approach are identified and
discussed.
Originality/value – New audit tools for validation and verification of HACCP effectiveness are
proposed.
Keywords Environmental health and safety, Food safety, Quality management
Paper type Conceptual paper

Introduction
Food safety is an increasingly important public health issue. The World Health
Organisation (WHO) estimates that in 2000 2.1 million people died from diarrhoeal
diseases (WHO, 2002). In this context, governments worldwide are intensifying their
efforts to improve the safety of the food supply. The work of the WHO Food Safety
Programme includes implementing and improving food safety systems, promoting
good manufacturing practices and educating manufacturers, retailers and consumers
about appropriate food handling (WHO, 2002).
The hazard analysis and critical control point system (HACCP) is the internationally
agreed approach to food safety control. The reference standard for implementation of
HACCP is published by the Codex Alimentarius Commission of the joint United
Nations Food and Agriculture Organisation (FAO)/WHO Food Standards Programme
(Codex Committee on Food Hygiene, 1993; Codex Committee on Food Hygiene, 1997).
Hazard Analysis Critical Control Point is designed to control significant food safety
hazards, i.e. those hazards that are likely to cause an adverse health effect when
products are consumed. In order for HACCP to be effective, it is essential that it is
supported by Good Manufacturing Practice (GMP) or Prerequisite Programmes that British Food Journal
Vol. 107 No. 10, 2005
control the general hygiene and environmental conditions in a food processing pp. 723-742
operation (ILSI, 1999; Sperber, 1998;Wallace and Williams, 2001). In a manufacturing q Emerald Group Publishing Limited
0007-070X
operation, food safety management is achieved through the application of system DOI 10.1108/00070700510623513
BFJ “building blocks” – safe product design, prerequisite programmes and HACCP –
107,10 operating under the framework of the overall operations management system
(Figure 1).
The systems of the HACCP “building block” are developed through application of
the internationally agreed HACCP Principles (Codex, 1997). For effective food safety
management, all three “building blocks” need to be adequately designed and their
724 implementation verified. Assessment approaches are needed to demonstrate
effectiveness of the prerequisite programmes, safe product design and HACCP
blocks. This paper focuses on the assessment of HACCP.
The HACCP system will prevent food-borne disease outbreaks only if it is
understood and applied correctly. There are very few records of food-borne disease
outbreaks in which a food company operating with full commitment and
understanding of the HACCP system has been implicated. Hence when the HACCP
system is applied correctly, food-borne disease should not occur. In the outbreaks that
have been reported involving industries that have implemented the HACCP system,
serious flaws could be detected in their HACCP plans or the implementation of HACCP,
reflecting a lack of understanding of, or commitment to the HACCP system (Motarjemi
and Kaferstein, 1999).

Measuring the effectiveness of HACCP


Whilst Motarjemi and Kaferstein (1999) argue that positive results may be expected
when the HACCP system has been applied correctly, it is also necessary to establish
ways of measuring HACCP effectiveness that are not based solely on retrospective
analysis of outbreak data. This need is reinforced by experience with a range of food
companies, which has shown that, although manufacturing sites often consider that
they have implemented HACCP, frequently the outcome is an inadequate or poorly
implemented HACCP System. Sperber (1998) believes that the continued auditing and
verification of a HACCP system is at least as important and perhaps far more
important than the initial development of the HACCP plan.
A WHO consultation in Geneva on the “HACCP System: concept and application”
(WHO, 1995) highlighted that ongoing assessments are essential once a HACCP system
has been implemented. Both internal assessments carried out by food industry and

Figure 1.
Manufacturing food safety
management model
independent assessments carried out by regulators and third-party bodies should be Standardised
undertaken. A further WHO Consultation in Geneva in 1998 considered “The Role of HACCP
Government Agencies in Assessing HACCP” (WHO, 1998) and provided guidance on:
. government roles and responsibilities;
assessment
.
principle activities for regulatory assessment;
.
organisation and planning of assessments; 725
.
the assessment process and its implementation;
.
assessor competencies; and
.
specific problems encountered in assessing HACCP systems.

Although aimed primarily at Government Agencies, this document provided valuable


guidance on how to approach and manage a HACCP assessment process. Previous
publications have also described the roles and approaches taken by government
agencies in different parts of the world in assessing HACCP (Kvenberg et al., 2000;
Gagnon et al., 2000; Torres, 2000; Merican, 2000).
Gagnon et al. (2000) described the position in Canada where the Food Safety
Enhancement Program (FSEP) is voluntary for establishments registered under the
Meat Inspection Act, and the Quality Management Program (QMP) is mandatory for
federally registered fish processors. Both these initiatives are compatible with Codex
HACCP requirements and use similar methods for verification of compliance and
adequacy, including the use of Critical, Major and minor non-conformity ratings.
Kvenberg et al. (2000) described the development of HACCP and regulatory
assessment in the USA, including the FDA and USDA HACCP inspection/verification
programmes. Although regulators and food processors have the same goal of safe food
production, they may have different perspectives on how to measure “effectiveness”.
Therefore, objective and direct measures that have a baseline against which an
assessment can be made and/or a change can be calculated need to be developed
(Kvenberg et al., 2000).
A number of other studies (Torres, 2000; Merican, 2000) have used frameworks that
include checklists and guidance for auditors. However, there is limited consistency and
no internationally agreed approach.
For any assessment programme to generate useful information, criteria to evaluate
the effectiveness of the HACCP Plan and its application need to be established and
assessment methods need to be identified.

HACCP assessment criteria


Mortimore and Wallace (1998) divide the application of HACCP in manufacturing into
four key stages:
(1) Planning and preparation;
(2) HACCP studies and HACCP plan development;
(3) Implementing the HACCP plan; and
(4) Maintaining the HACCP system.

Whilst the planning and preparation stage is important in laying foundations for
HACCP, effectiveness assessment of the HACCP system generally requires evaluation
BFJ of the outcomes from stages 2), 3) and 4) (Mortimore and Wallace, 1998). Similarly, the
107,10 International Life Sciences Institute (ILSI, 1999) describes the assessment of three
phases of HACCP:
(1) Technical evaluation of the process of performing the hazard analysis and
establishing control measures;
(2) Implementation of the resulting HACCP plan, which includes the process of
726 validation; and
(3) Operation of HACCP, which includes the assessment activities of verification
and auditing (Mortimore and Wallace key stages 2), 3) and 4).

Thus, broad criteria for HACCP effectiveness assessment can be established (Table I).

The need for HACCP assessment tools


Both the approach taken by government agencies (Kvenberg et al., 2000) and work
with multinational companies has identified a need for standardised tools for the
assessment of HACCP effectiveness. This is important to allow comparison of progress
across a range of sites. Although previous groups (ISLI, 1999; WHO, 1998; Mortimore
and Wallace, 1998; Mortimore, 2000) have produced auditing practice guidelines and/or
identified key points to cover, few standardised tools have been published.
Sperber (1998) outlined the approach to food safety audit within Cargill
Incorporated, including the provision of a 17-question “Food Safety Effectiveness
Audit Worksheet” for evaluating HACCP procedures on the production floor and a
ten-question “Food Safety Management Worksheet”. Use of these worksheets allows
the implementation of HACCP in production to be verified but they do not cover the
validity of the HACCP Plan. It is also questionable whether the “Food Safety

The HACCP plan must be: Considerations for assessment planning

Valid for control of significant food Validity of the HACCP plan depends on the knowledge and
safety hazards that are likely to occur in skills of the HACCP team in terms of understanding the
the type of operation being studied process, its ingredients and the likely occurrence of hazards;
and ability to understand and apply the Codex HACCP
principles to develop an effective HACCP plan
Implemented into the every-day This is achieved through a hand-over process from the
operation of the food company HACCP team to operations management and line personnel,
where it is important that operations personnel take
ownership for day-to-day operation of the HACCP plan.
Implementation is demonstrated through monitoring of
critical control points, taking corrective action where
necessary and keeping records

Adequately verified and maintained Verification includes audit of the working HACCP system
for compliance with the HACCP plan and review of food
safety records. Maintenance involves ongoing update
Table I. procedures both to evaluate impact of changes in the
HACCP effectiveness operation and to keep up to date on knowledge of food safety
criteria hazards
Effectiveness Audit Worksheet”, as written, would elicit information on the Standardised
effectiveness of corrective action taken at CCPs. HACCP
A number of HACCP Audit Checklists and example questions have been published
on the internet, e.g. the United States National Conference on Interstate Milk Shipments assessment
(NCIMS) Dairy HACCP Audit Report Form (NCIMS, 2004), the Australian Standing
Committee on Agriculture and Resource Management HACCP Plan Audit Checklist
(Standing Committee on Agriculture and Resource Management, 2003; Cooper and 727
Pronk, 1997). The NCIMS Form (NCIMS, 2004) provides a tick-sheet of items to be
covered in assessing both prerequisite programmes and HACCP, while the Australian
Standing Committee checklist gives specific questions to be asked about different
aspects of HACCP plan development and implementation. Cooper and Pronk (1997)
outline methodology that can be used to assess HACCP Plan procedures, e.g. visual
observation and records review, and describe eight questions that can be used to assess
management support for HACCP and three questions for review of the HACCP plan.
Torres (2000) includes a checklist criteria in his discussion of government agency
approaches. He appears to look for presence or absence of HACCP System elements
and does not, as written, challenge the effectiveness of these elements.
Although all of these approaches contain useful guidance on topics/questions to be
covered, it was considered that they do not offer a “complete” approach to the
assessment of HACCP systems.
More recently, (Wilkinson and Wheelock, 2004) published a checklist of questions
used in assessing the effectiveness of HACCP implementation and maintenance in food
production plants on the island of Ireland. This checklist is designed to be applied by
trained auditors. It is a detailed approach, and includes aspects of food safety
management as well as HACCP development, implementation and maintenance.
However, the checklist is written as a series of interview questions and therefore must
be applied at the manufacturing site with assistance from site personnel. Whilst it is
clearly important to verify HACCP implementation and maintenance on-site, it is also
possible to assess the validity of HACCP documentation remotely. This has benefits of
identifying major flaws in the approach without the time and travel expense of a site
visit.
Highly structured sets of interview questions such as those proposed by Wilkinson
and Wheelock (2004) also have the potential to limit auditor flexibility and judgment. It
is therefore important to obtain a balance, including a structured framework whilst still
allowing some subjectivity based on auditor experience. This is consistent with
international guidelines for quality and environmental management systems auditing
(BS EN ISO 19011:2002) which states that “the use of checklists and forms should not
restrict the extent of audit activities, which can change as a result of information
collected during the audit”. Therefore, a checklist framework needs to act as an aide
memoir on the essential points to be assessed, while allowing flexibility to the auditor
in making expert judgements about HACCP status.
Some approaches (Sperber, 1998) use simple scoring systems based on allocating
points to “satisfactory” or “unsatisfactory” ratings whilst others (Gagnon et al., 2000;
Mortimore, 2000; NCIMS, 2004) rely on listing of deficiencies/non-compliances. Cooper
and Pronk (1997) describe scoring systems as a topic of contention, indicating that
some companies find scoring useful to indicate progress whilst others believe that they
are difficult to keep objective. Indeed, this is confirmed by discussions with many food
BFJ safety professionals who are wary of the use of arbitrary scores, particularly
107,10 percentages, since a scoring system could be envisaged where a particular HACCP
Plan achieves a 95 per cent score but still has a major food safety flaw (Palmer, 2005). It
is therefore crucial that any scoring system is carefully designed and that its
limitations are clearly understood.
As part of a research programme investigating the impact of training on the
728 effectiveness of HACCP in a multinational organisation, it was necessary to identify
standard approaches to assess the effectiveness of HACCP Systems. This was to allow
assessment of global data from manufacturing sites that had been collected by trained
HACCP auditors using a consistent checklist format. It was also necessary to identify a
comparative measure of individual manufacturing site HACCP progress so that
priority targets for additional training and HACCP support could be identified.
Therefore a scoring system was considered to be an essential part of the assessment
approach.
The aims of the study pertaining to HACCP assessment were:
.
Establish strategies for the assessment of HACCP effectiveness;
.
Develop and validate tools to measure HACCP effectiveness;
.
Determine the validity of HACCP Plans developed by trained HACCP teams; and
.
Evaluate the implementation, verification and maintenance of HACCP plans;

Methods
The methods described here were developed in 2003 for data collection between
October 2003 and March 2004. At that time, there was no accepted tool that provided a
comprehensive measure of the effectiveness of HACCP system implementation. Hence,
it was important to identify a way of assessing the HACCP systems that had been
developed by the HACCP teams following training. Previously published guidance on
HACCP assessment (WHO, 1998; ILSI, 1999; Mortimore and Wallace, 1998; Mortimore,
2000; Sperber, 1998) was considered and, in order to establish a standardised audit
framework that would cover all required aspects of HACCP assessment, two audit
checklist tools were developed. These two tools provide a step-wise approach to
HACCP Assessment (Figure 2).
The HACCP Audit Tools were designed to assess both the validity of the HACCP
Plan (i.e. will the HACCP Plan control all likely hazards?), and the implementation and
maintenance of the HACCP system (i.e. is the HACCP Plan working in practice in the
factory?). As was recommended practice in previous approaches, the tools were
designed to allow off-site assessment (desk-top audit) of HACCP documentation for
validity as well as on-site assessment of implementation and maintenance
effectiveness. Use of off-site desk-top audit was also important to allow assessment
of a larger sample of sites than could be covered by on-site audit, and thus give an
indication of site positioning for HACCP competence throughout a large
manufacturing group. On-site assessment was necessary to provide more rigorous
assessment of HACCP at a smaller sample of sites.
Tool 1 – A HACCP desk-top audit checklist (Figure 3) was developed by selecting
aspects of HACCP audit that focused on the approach to HACCP plan development and
its validity. Tool 2 – HACCP verification audit checklist (Figure 4) was developed as a
Standardised
HACCP
assessment

729

Figure 2.
Use of audit tools in
HACCP assessment

complementary checklist that would allow verification of implementation and


maintenance at the site.

Tool 1 – HACCP desk-top audit checklist (Figure 3)


In order to assess the validity of HACCP plan documentation, six groups of questions
were developed, relating to the steps in a HACCP study, as follows:
(1) Codex preliminary steps and documentation.
(2) Principle 1 – hazard analysis.
BFJ
107,10

730

Figure 3.
HACCP documentation
desk-top assessment
checklist
Standardised
HACCP
assessment

731

Figure 3.
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107,10

732

Figure 3.
Standardised
HACCP
assessment

733

Figure 3.
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734

Figure 3.

(3) Principle 2 – determination of critical control points.


(4) Principle 3 – critical limits.
(5) Principle 4 – monitoring procedures.
(6) Principle 5 – corrective action.

Questions assessed not only the completeness of the documentation, but also validity
of the content. It was intended that the checklist would be applied by experienced
auditors who had known HACCP expertise. Guidance notes were included, where
appropriate, to ensure consistency of application. Wording of individual questions was
designed to be appropriate to a remote audit of HACCP plan paperwork without access
to further site information.
Questions were not developed for Principles 6 (Verification) and 7 (Documentation)
since, although documentation is considered as part of a desk-top audit, these
principles can only be fully assessed during an on-site audit. They are therefore
included in Tool 2.
In order to produce comparable data from application of the desk-top audit tool, a
scoring system was also developed. Since all the HACCP principles being assessed and
the preparation included in Codex Preliminary steps were deemed equally important to
the development of a valid HACCP system, each of the six question groups was
allocated 20 points. However, weighting of individual questions within each question
Standardised
HACCP
assessment

735

Figure 4.
HACCP verification audit
checklist
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107,10

736

Figure 4.
Standardised
HACCP
assessment

737

Figure 4.
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107,10

738

Figure 4.

group was developed by considering their relative impact on the development of


effective HACCP systems (Figure 3). For example, the relatively minor question:
Is intended use for product stated?
was allocated 0.5 points while the question:
Are listed control measures sufficient to prevent, eliminate or reduce each significant hazard
to an acceptable level?
was allocated six points.
Use of tool 1 – HACCP desk-top audit (Figure 3) Standardised
The tool design includes the overall assessment score at the front (Section 1) for ease of HACCP
comparison between assessments. Questions are designed to have “yes” or “no”
answers, denoting whether the information is present and acceptable or not. If the assessment
auditor considers that the information demonstrates partial coverage/acceptability for
a specific question, the answer is recorded as “marginal”. Scoring is given as full marks
for an acceptable answer and no marks for an incorrect answer of missing information. 739
Where the answer is “marginal”, proportional marks are given based on auditor
judgement.
The desk-top audit is conducted as follows:
Initially, HACCP Plan documentation is read through by the auditor to gain an
impression of the overall approach. At this stage background notes on the HACCP
system and approach are recorded in section 2 (HACCP system approach). The auditor
then works through the groups of question in section 3 (Assessment of HACCP plan
documentation), using the guidance notes and expert judgement to score each question.
At the end of the assessment, the marks for each section are totalled and recorded in
section 1 (Overall assessment of HACCP plan documentation) along with supporting
notes for the overall assessment. The overall marks are not converted into a percentage
value overall, but used as an indication of the strengths and weaknesses in each area of
HACCP development. Depending upon the results of this audit, auditors can choose
whether to implement Tool 2.

Tool 2 – HACCP verification audit checklist (Figure 4)


The HACCP verification audit checklist was designed to work at site level in
conjunction with the HACCP Desk-top Audit Checklist, thus allowing both validity to
be assessed and implementation/maintenance of HACCP to be verified. It consists of
four sections:
(1) Overall assessment of HACCP plans.
(2) Assessment of process flow diagram.
(3) Verification of HACCP implementation.
(4) Verification of maintenance procedures.

For verification of HACCP effectiveness, both tools can be applied together on-site,
requiring the trained auditor(s) to visit the site for 2-3 days to perform the
assessment.

Use of tool 2 – HACCP verification audit checklist


This tool was designed to be used in conjunction with Tool 1, HACCP Desk-top Audit,
to gain an assessment of the effectiveness of HACCP Plans and their
implementation/maintenance. Because Tool 2 was intended to highlight anomalies
and weaknesses specific to manufacturing sites rather than as part of a larger
comparative study, a numerical scoring system was not included in this case. Rather, it
was decided to use the accepted quality systems audit approach of
conformity/non-conformity identification (British Standards Institute, 2002).
However, a weighted scoring system could be envisaged for use in comparative
studies.
BFJ The HACCP Verification Audit is conducted as follows. First the Process Flow
107,10 Diagram (PFD) is verified by following the process through the factory. Any anomalies
are recorded in section 2 (On-site verification of process flow diagrams) and, where
possible, indicated on a photocopy of the PFD. This stage of the audit is also useful in
familiarising the auditor with the process and processing environment.
If not done previously off-site, the auditor then assesses the HACCP plan using
740 Tool 1. If this has been completed previously, any points requiring clarification are
resolved with input from site personnel. The auditor then chooses a sample of CCPs
(normally at least three CCPs) for further investigation in the factory and through
historical records. Findings are recorded in section 3 (HACCP implementation).
HACCP maintenance is then assessed and findings recorded in section 4 (HACCP
maintenance procedures). The auditor forms an overall judgement on HACCP
implementation and maintenance effectiveness, and records this in Section 1,
highlighting any non-conformity to the requirements of the defined HACCP plan and
Codex HACCP principles.
Audit findings are reported back to site management at a closing meeting and a
written report is generated from the checklists.

Pilot study and data collection


Questionnaire design and wording were discussed with three experienced HACCP
auditors and tested against five sample HACCP plans. Any difficulties in application
and interpretation were highlighted and minor modifications were made to the tools. In
the judgement of this group of expert HACCP auditors, the questions were considered
appropriate to measure HACCP validity and effectiveness.
A group of six HACCP auditors was then trained in the application of Tool 1 and its
accompanying scoring system. HACCP Plans were collected from 117 manufacturing
sites and these were assessed by the trained HACCP auditors. A further group of four
HACCP auditors was trained in the application of both Tool 1 and Tool 2 so that they
could be used to assess HACCP implementation and maintenance status in the field. It
was necessary to involve two separate groups of auditors due to company logistical
reasons. Results will be reported separately.

Discussion
Both assessment tools have now been used to collect data on effectiveness of HACCP
plans and their implementation status. This has demonstrated that the tools are a
useful way of collecting information about HACCP progress. Throughout this process
a number of benefits and limitations have been identified.
Limitations of desk-top assessment include that the assessment can only be based
on the paperwork submitted so anything not submitted is not assessed. In this study it
was found that further communication with sites may be necessary to clarify details of
information provided or to obtain missing information. The approach is further limited
in that, as an off-site assessment, it cannot give a complete judgment on the validity of
hazard identification but rather an assessment of the approaches taken and likely
hazards for the product group. However, it is similarly questionable whether on-site
assessment by one to two auditors could give a more complete judgement on hazard
identification validity if they are independent from the site.
The auditor plays a vital role in the assessment of HACCP systems and both their Standardised
HACCP and audit expertise is crucial to success. In this study it was concluded that HACCP
training of auditors in the use of the checklist tools is also important to ensure
consistency of application. assessment
Desk-top audit was found to be a useful way to gain a comparative measure of
HACCP development progress and documentation quality at a large number of sites,
however it is important to remember that this assessment is based on paperwork alone 741
and so needs to be triangulated with on-site assessment data. From this study it was
concluded that the combined use of Tools 1 and 2 by trained HACCP auditors could
give a detailed assessment of HACCP Plan validity along with verification of its
implementation and maintenance.
As described previously, the use scoring systems in HACCP assessment has been a
contentious issue. None of the previously described approaches apply weighted
scoring to the differential importance of specific parts of HACCP documentation and
system application. This could be one way of establishing a pragmatic scoring system
that reflects the consequence of flaws in a HACCP system. It was found that scoring
can be used effectively to monitor progress at a particular manufacturing site or to
allow comparison of progress within a group of sites, however the scoring system must
be carefully designed for its specific use. In this study a scoring system was necessary
for Tool 1 in order to assess and compare progress in HACCP at a large number of
manufacturing sites. It would also be possible to use the tool qualitatively without the
scoring system, to identify lists of weaknesses that need to be addressed for effective
HACCP plans.
It is hoped that the tools described here will provide a resource for industry to
assess the effectiveness of HACCP systems being developed and in operation at
manufacturing sites.

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