Food Control 35 (2014) 233e240

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Food Control
journal homepage: www.elsevier.com/locate/foodcont

HACCP e The difculty with Hazard Analysis

Carol A. Wallace a, *, Lynda Holyoak b, Susan C. Powell c, Fiona C. Dykes d
a
International Institute of Nutritional Sciences and Applied Food Safety Studies, School of Sport, Tourism and the Outdoors, University of Central Lancashire,
Preston PR1 2HE, UK
b
School of Psychology, University of Central Lancashire, Preston PR1 2HE, UK
c
Academy for Health and Wellbeing, Manchester Metropolitan University, John Dalton Building, Chester Street, Manchester M1 5GD, UK
d
School of Health, University of Central Lancashire, Preston PR1 2HE, UK

a r t i c l e i n f o

a b s t r a c t

Article history:
Received 15 October 2012
Received in revised form
25 May 2013
Accepted 6 July 2013

HACCP is a key element of modern food safety management practice such that design, implementation,
control and management of HACCP systems are crucial to the production of safe food products. Whilst it
is widely accepted that food companies should apply HACCP, understanding of the factors impacting
successful HACCP application is limited and this knowledge is important to the delivery of systems that
will control all relevant food safety hazards. HACCP principle 1, Conduct a Hazard Analysis, forms a central
pillar of any HACCP plan since hazards need to be identied, analysed and understood before effective
control measures can be specied. However limited guidance is available to HACCP teams on exactly how
to approach the application of this principle. This paper discusses an investigation into the application of
HACCP principle 1 by HACCP teams operating within manufacturing sites of a multinational food company. Using a combination of HACCP knowledge testing and HACCP plan assessment, the study identied
weaknesses in knowledge of signicant hazard identication and errors in the hazard analysis process,
including errors in application of structured risk evaluation methods. Findings suggest that this is an area
of difculty for HACCP teams and that further detailed guidance in the application of this HACCP principle is urgently needed.
2013 Elsevier Ltd. All rights reserved.

Keywords:
Hazard analysis
HACCP
HACCP principle application
Food safety
Risk assessment
HACCP effectiveness

1. Introduction
Food safety management depends on the building blocks of
safe product design, prerequisite programmes and HACCP all being
applied fully and correctly (Wallace, Powell & Holyoak, 2005a).
Focussing on the HACCP building block, achievement of effectiveness depends on the design, implementation, control and management of the HACCP system. This framework for effective HACCP
should achieve safe food production when accompanied by other
building blocks within the food operation, however there is a need
to understand the factors impacting successful HACCP application
such that food companies can design, implement and manage
systems that will control all relevant food safety hazards, i.e.
effective HACCP (Fig. 1).
Abbreviations: Codex, Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission Committee on Food Hygiene; HACCP, the hazard analysis
and critical control point system of food safety management; NACMCF, The United
States National Advisory Committee on Microbiological Specications for Foods.
* Corresponding author. Tel.: 44 1772 893657; fax: 44 1772 892927.
E-mail addresses: cawallace@uclan.ac.uk, drcarolwallace@gmail.com (C.A. Wallace),
lholyoak@uclan.ac.uk (L. Holyoak), S.Powell@mmu.ac.uk (S.C. Powell), fcdykes@
uclan.ac.uk (F.C. Dykes).
0956-7135/$ e see front matter 2013 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.foodcont.2013.07.012

Recent work (Yiannis, 2009; Grifth, Livesey & Clayton, 2010a,

2010b; Powell, Jacob & Chapman, 2011) has focussed on the area
of food safety culture, dened by Grifth et al. (2010a) as the aggregation of the prevailing, relatively constant, learned, shared attitudes, values and beliefs contributing to the hygiene behaviours
used within a particular food handling environment. It is clearly
vitally important for food safety effectiveness that an appropriate
blend of shared attitudes, values and beliefs is in place within food
businesses to ensure the correct behaviours in line with planned
systems and procedures. In HACCP terms this means that the control
procedures specied by a valid HACCP plan will only work in practice where that appropriate blend of attitudes, values and beliefs
exists and, therefore, The HACCP Effectiveness Framework (Fig. 1)
will only operate effectively within a strong business food safety
culture. However, it is still essential that we continue to investigate
the effectiveness of the HACCP system itself, since this plays a crucial
role in dening how food safety hazards need to be controlled in
order to protect public health. Even with a good food safety culture
we are at risk of harming the consumer if there are aws in our
HACCP plans due to technical errors in their construction.
To achieve effective HACCP, successful application of the HACCP
Principles (Codex, 2009) is crucial at the HACCP Design stage.

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C.A. Wallace et al. / Food Control 35 (2014) 233e240

Fig. 1. HACCP effectiveness framework.

Whilst all principles are important, principle 1, Conduct a Hazard

Analysis forms a central pillar of any HACCP plan since hazards need
to be identied, analysed and understood before effective control
measures can be specied. However limited guidance is available to
HACCP teams on exactly how to approach the application of this
principle. Codex (2009) lists some brief points to consider when
performing hazard analysis (Table 1) and NACMCF (1997) also lists a
series of questions to help the HACCP team discuss different hazard
issues, although many of these latter questions are directed towards prerequisite programme issues rather than hazards.
Current thinking is that the HACCP team should consider each
raw material and process activity in turn and list any potential
hazards that might occur, then carry out an analysis to identify the
signicant hazards before identifying suitable control measures
(Mortimore & Wallace, 2013; Wallace, Sperber & Mortimore, 2011).
Closer investigation of the key term denitions from internationally accepted HACCP Guidelines (Codex, 2009; NACMCF, 1997) is
helpful in understanding this hazard analysis process further:
Hazard analysis: The process of collecting and evaluating information on hazards and conditions leading to their presence
to decide which are signicant for food safety and therefore
should be addressed in the HACCP Plan (Codex, 2009).
Hazard: a biological, chemical or physical agent in, or condition
of, food with the potential to cause an adverse health effect
(Codex, 2009).
Table 1
Codex Guidance on Application of HACCP Principle 1.
List all potential hazards associated with each step, conduct a hazard analysis,
and consider any measures to control identied hazards
The HACCP team should list all of the hazards that may be reasonably expected
to occur at each step according to the scope from primary production,
processing, manufacture, and distribution until the point of consumption.
The HACCP team should next conduct a hazard analysis to identify for the
HACCP plan which hazards are of such a nature that their elimination or
reduction to acceptable levels is essential to the production of a safe food.
In conducting the hazard analysis, wherever possible the following should be
included:
- the likely occurrence of hazards and severity of their adverse
health effects;
- the qualitative and/or quantitative evaluation of the presence of hazards;
- survival or multiplication of microorganisms of concern;
- production or persistence in foods of toxins, chemicals or physical agents; and,
- conditions leading to the above.
Consideration should be given to what control measures, if any exist, can be
applied for each hazard.
More than one control measure may be required to control a specic hazard(s)
and more than one hazard may be controlled by a specied control measure
Source: Codex, 2009.

Hazard: a biological, chemical, or physical agent that is

reasonably likely to cause illness or injury in the absence of its
control (NACMCF, 1997).
This latter hazard denition provides a reminder of the need to
evaluate risk to consumer health, should no control be in place.
Hazard analysis, therefore, is a key element of HACCP that, alongside the identication of suitable control measures, will determine
the strength of the resulting HACCP Plan. The Hazard Analysis
needs to be accurate and specic; if it is too brief or general then the
following steps in the HACCP study will be more difcult and the
HACCP Plan is likely to be weak (Wallace, Sperber & Mortimore,
2011).
1.1. Determination of hazard signicance
As shown in Table 1, Codex (2009) requires control of hazards
that are of such a nature that their elimination or reduction to
acceptable levels is essential to the production of a safe food and
states that the process of hazard analysis is intended to identify
those hazards that are signicant for food safety and therefore
should be addressed in the HACCP plan. Although the term signicant hazard is not dened by Codex, the International Life Sciences Institute (ILSI, 1999) has put these two phrases together to
form the denition:
Signicant Hazard: Hazards that are of such a nature that their
elimination or reduction to an acceptable level is essential to the
production of safe foods (ILSI, 1999).
To identify the signicant hazards it is necessary to consider the
likelihood of occurrence of the hazard in the type of operation
being studied as well as the severity of the potential adverse effect.
A signicant hazard, therefore, is one that is both likely to occur and
cause harm to the consumer and identication of signicant hazards needs to be based on sound data.
When considering how to identify signicant hazards, Sperber
(2001) reported that this was generally based on past experience
since most of the hazards you will need to consider are already known
and the relevance, or signicance, to your process is also known.
In line with this thinking, many HACCP teams within food
manufacturing companies assess signicance of hazards using
judgement and experience but structured risk evaluation
methods, where different degrees of likelihood and severity are
weighted, are increasingly being used to help with the signicance
decision. Structured risk evaluation methods often involve signicance assessment tables or matrices which aim to consider the
degree of likelihood and the severity of effect by rating these as, for

C.A. Wallace et al. / Food Control 35 (2014) 233e240

example, high, medium or low or 1e5. This qualitative or semiquantitative approach (Manning & Soon, 2013; Sperber, 2001) aims
to put each individual hazard into one of a range of sub-categories
to assist with the signicance decision. Many risk evaluation tools
are available (Manning & Soon, 2013) and the choice of approach is
down to the preference of each food company, although this may be
inuenced by external stakeholders such as customers or 3rd party
auditors. Any tool for signicance assessment relies on the expertise, judgement and training of the personnel applying it and, along
with correct placement of the hazard in appropriate likelihood/
severity sub-categories, interpretation of the rating tool outcome is
a critical factor in the successful establishments of signicant
hazards, i.e. in any 3  3 or 5  5 matrix which boxes or, where
multiplication of ratings is used, which resulting numbers are taken
to represent signicance.
The perceived complexity of such structured risk evaluation
procedures (Mossel, Weenk, Morris & Struijk 1998) along with the
lack of guidance from Codex on how they might practically be used
within HACCP have led to inconsistencies in their use. Indeed, these
reasons may have contributed to the confusion between the requirements for hazard analyses being performed at individual site
HACCP team level and the risk assessments being performed at national/governmental level (Sperber, 2001) and led to the continued
use of traditional hazard assessment through a simple evaluation
process rather than more detailed, structured approaches (Bertolini,
Rizzi & Bevilacqua, 2007). Nevertheless, whilst some key HACCP
texts include discussion on the use of hazard analysis tools (e.g.
Mortimore & Wallace, 2013, pp. 193e198), there is limited ofcial
guidance from Codex on how to perform the analysis of potential
hazards to establish which are signicant for food safety.
In addition, there is limited literature on HACCP team skills and
ability in the process of HACCP principle application or the effectiveness of approaches employed by HACCP teams in developing
HACCP plans. If there are weaknesses in HACCP team knowledge
about how to apply HACCP principles, it follows that there could be
weaknesses in the HACCP system (Wallace, Holyoak, Powell, &
Dykes, 2012). Since effectiveness of food safety management procedures is highly dependent on the strength of the HACCP system
design, it is therefore important to study the factors involved in
more detail. The research reported here forms one facet of a large
study on factors impacting HACCP effectiveness, where the aims
included the development of recommendations for HACCP training
and support strategy in multinational manufacturing organisations.
It is the goal of this communication to highlight specic ndings of
key importance with regard to successful application of HACCP
principle 1, in particular the need for further guidance and/or tools
to assist in its application.
2. Material and methods
The research reported here was based in a multinational organisation where requirements for HACCP, prerequisite programmes
and quality management systems were mandated at corporate
level, but responsibility for implementation was at local level. Data
on HACCP Principles and their application were collected using a
combination of HACCP knowledge testing and HACCP audit methodology (Wallace et al. 2005a, Wallace, Powell & Holyoak, 2005b).
2.1. HACCP knowledge testing
HACCP knowledge of HACCP Teams and individual team members was tested using the Wallace et al. (2005b) HACCP Knowledge
Questionnaire. This questionnaire tests knowledge of HACCP Principles and their application in the following HACCP Knowledge
areas (Table 2):

235

Table 2
Knowledge areas of the Wallace et al. (2005b) HACCP Knowledge Questionnaire.
HACCP knowledge area
(Wallace et al., 2005b)

Codex principle(s) (2009)

1 Codex preliminary steps

2. Hazard analysis
3. CCP identication and control
4. HACCP implementation

Codex preliminary steps

Principle 1
Principles 2e5
Principle 7 plus application
of work from 1 to 6
Principles 6e7

5. HACCP maintenance

Of particular relevance in the context of this article was HACCP

Knowledge Area 2 e Hazard Analysis, which included the following
questions:
 Explain what is meant by a hazard
 Explain what is meant by a control measure
 Give an example of a hazard from each of the following groups:
B Microbiological
B Chemical
B Physical
 What should the HACCP team do if they have identied a signicant hazard but there is no control measure at that step or
any following step?
 Suggest a control measure that could be used for hazards
associated with raw materials
 Which two factors should be considered when carrying out the
hazard analysis?
Whilst these questions were addressed as part of the full
questionnaire completion, results for hazard analysis only are reported here.
Initial knowledge testing was done on 91 trained individuals at
11 international manufacturing sites (Wallace et al., 2005b) and
further knowledge testing of both HACCP teams and individual
team members (N 75) was done via eldwork at 7 manufacturing
sites spread over 3 countries (Wallace et al., 2012), where HACCP
plan assessment data were also collected.
2.2. HACCP plan effectiveness
HACCP plan effectiveness was assessed using the HACCP Audit
tools developed by Wallace et al. (2005a). This was achieved by
assessing sample HACCP plans that were operating at the case
study sites during the data collection site visits. Whilst assessment
of both the quality of the specied HACCP plan (using tool 1) and of
its effective implementation in practice (using tool 2) were performed and full, this paper focuses on the strength of hazard
analysis in the sample HACCP plans, i.e. assessed using tool 1. All
assessments were performed by an expert HACCP practitioner who
had previously been trained and qualied to Lead Auditor/3rd Party
Auditor standard (ISO and BRC2) and had substantial knowledge
and practice experience in the specic food sector.
The choice of HACCP plans to assess was based on the range of
completed HACCP plans in operation at the site, and therefore
available for assessment, and the availability of manufacturing
processes of similar complexity both within and between sites. It
was the intention to assess at least one operating HACCP plan at
each site to establish a measure of effectiveness of HACCP development and implementation in practice however, where possible,

2
ISO Quality Management Systems and British Retail Consortium Global Standard: Foods Auditing.

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C.A. Wallace et al. / Food Control 35 (2014) 233e240

two HACCP plans were assessed (3/5 sites) to give a deeper understanding of HACCP competence.
For evaluation of the hazard analysis element of the HACCP
plans, section C) Application of HACCP Principles, part 1) Hazard
Analysis (Principle 1) from the Wallace et al. (2005a) assessment
tool 1 was applied. This involved consideration of the key requirements for successful hazard analysis: whether the hazard
analysis has considered all steps in the process; whether all hazards
that can reasonably be expected to occur at each process step in the
given type of food operation have been identied; whether risk
evaluation considering severity and likelihood of occurrence has
been performed to identify signicant hazards (including appraisal
of any tools used and whether the signicant hazards identied are
appropriate to the given food operation); whether the chosen
control measures are sufcient to prevent, eliminate or reduce each
signicant hazard to an acceptable level. This necessitated use of
expert judgement by the assessor with respect to HACCP principle
application and technical knowledge and practice experience
regarding the type of process operation and likely hazards.
The hazard analysis process evaluation included expert judgement comparison of likelihood and severity based on the potential
hazards that had been identied by the team. In addition, the decision records for each HACCP teams hazard signicance decisions
were scrutinised with respect to application of any tools used. This
included evaluation of the placement of potential hazards in, for
example, the specic low, medium and high likelihood and severity
categories of the tool, and the interpretation of those categories by
the team with respect to which hazards were determined as signicant. These decision routes were also compared against the
instructions for use of each specic tool.
Although HACCP plan assessment tool 1 (Wallace et al., 2005a)
provides a scoring system for comparison purposes, scoring was
not used in this case as it was necessary to allow detailed
discrimination between specic ndings on the hazard analysis
process rather than to apply a weighting to the overall application
of HACCP Principle 1. Therefore, detailed auditors notes were
recorded on the tool for each HACCP plan assessed and key ndings
identied are presented below.
3. Results
3.1. Hazard Analysis knowledge
Overall percentage scores for the questions of the Hazard
Analysis knowledge area are presented in Table 3.
The HACCP knowledge results (Table 3) show variable knowledge across the questions of the Hazard Analysis knowledge area
for both sets of data (Wallace et al., 2005b, 2012). Whilst there was
also variation between groups of individuals between different

manufacturing sites (Wallace et al., 2005b, 2012), the summary

data on hazard analysis presented here give an overall indication of
the areas that are less well understood by individuals within HACCP
teams. In both studies best results were seen for ability to identify
an example of a hazard, although individuals in the rst study
group (Wallace et al., 2005b) were less able to identify microbiological hazard examples compared with chemical and physical. This
group also had good ability to dene what was meant by a hazard,
however the second group fared less well with this question. Both
groups showed similar ability to dene what is meant by a control
measure, and both showed signicant weaknesses in ability to
answer the remaining hazard analysis knowledge questions. Of key
interest to the study of hazard analysis is inability to identify the
factors that need to be considered when carrying out hazard
analysis, i.e. likelihood of occurrence and severity of outcome.
3.2. Audit data ndings on application of HACCP Principle 1
Key weaknesses identied in the assessment of HACCP plans are
listed in Table 4.
Whilst these data (Table 4) are the result of the assessment of a
small number of HACCP plans (8), the weaknesses identied were
seen at several manufacturing sites in the HACCP plans developed
by different HACCP teams who had undergone separate HACCP
training sessions. This suggests a general difculty with the application of the hazard analysis principle and, whilst in some cases the
errors resulted in non-signicant hazards being identied as signicant leading to tighter control than might be necessary, in other
cases the errors could have led to the existence of uncontrolled
hazards.
4. Discussion
Wallace et al. (2005b) classied hazard analysis knowledge as
marginal or unsafe for the majority of sites evaluated in a preliminary study. Comparing the hazard analysis knowledge of the
entire original group with that of the second test group (Table 3),
differences can be seen in the proportion of correct answers to the
individual questions between the groups. However the overall
picture that emerges is one of inability to demonstrate understanding of key hazard analysis concepts, suggesting that this is
indeed an area of weakness in trained HACCP team members. It is
striking to note the percentages of HACCP team members able to
correctly identify the two factors that need to be considered as part
of hazard analysis and this is of particular concern for the determination of signicant hazards. This inability to identify likelihood
of occurrence and severity of outcome as factors to be evaluated
when performing hazard analysis is particularly surprising as this
information would normally be included in HACCP training and

Table 3
Individual hazard analysis knowledge of HACCP team members.
Question

Percentage correct within rst

test groupN 91 (Source: Wallace
et al., 2005a)

Percentage correct within second

test group N 75 (Source:
Wallace, 2009)

Explain what is meant by a hazard

Explain what is meant by a control measure
Give an example of a hazard from each of the following groups:

67.0
59.3
56.0
90.1
90.1
18.1

30.0
47.2
73.2
77.6
82.8
30.1

33.3
20.0
2.7

43.1
35.9
28.7

Microbiological
Chemical
Physical
What should the HACCP team do if they have identied a signicant hazard but there is no
control measure at that step or any following step?
Suggest a control measure that could be used for hazards associated with raw materials
Which two factors should be considered when carrying out the
Likelihood of occurrence
hazard analysis?
Severity of outcome

C.A. Wallace et al. / Food Control 35 (2014) 233e240

237

Table 4
Weaknesses in hazard analysis application in the development of HACCP plans e Example issues from the assessment of 8 HACCP plans.
Hazard analysis element

Issue

Outcome

Hazard Identication

Hazard identication done in a general manner, e.g. listing micro

rather than considering specic pathogens that could likely be present.

This had given difculties with signicance assessment and,

even though a structured evaluation method had been used,
the lack of clarity about what the hazards actually were had
resulted in more issues being raised as signicant hazards
than actually necessary.
No microbiological hazard identied for a raw material that
is well known in this sector to be at risk of contamination
with Salmonella spp. and which would be expected to be
of concern to both the raw material/product stream and to
cross contamination possibilities.
Physical contaminants (metal) of a type that would
normally be considered to have high severity were rated
by the HACCP team to be of minor severity although high
likelihood at some steps.

Missed hazard identication.

Hazard Signicance
Evaluation

Inappropriate ruling out of hazards as not signicant. Use of structured

method of signicance assessment (rating severity as critical, serious,
major or minor against low, medium or high risk of occurrence) did not
prevent incorrect judgements of likelihood and/or severity by HACCP
team members, i.e. placement in wrong subcategories.
Fundamental misunderstanding of severity ratings in application of
locally developed risk evaluation method used for determining hazard
signicance. (This tool, if used correctly, would be suitable for
identifying signicant hazards)

Rating of hazards as more likely or more severe than they actually are.
Control Measure (and CCP)
Identication

Hazards established as signicant hazards not followed through with

CCP identication (i.e. application of HACCP Principle 2). This
demonstrated mismatch between application of one principle
and the next.
Inappropriate measures, e.g. verication checks listed as control
measures for the identied hazards showing

could be expected to be considered by HACCP teams in any active

HACCP study. These factors are well established as key to applying
HACCP principle 1 both in guidelines and training syllabi
(Mortimore & Wallace, 1998, 2013; Codex, 2009; RSPH, 2009a,
2009b) and lack of knowledge in this area suggests that the process of hazard analysis is not being fully grasped during HACCP
training and/or during HACCP plan development and, therefore,
trained HACCP teams may have difculty in establishing signicant
hazards.
Key reasons for these issues are believed to be lack of guidance/
tools, training, expertise and experience in the hazard analysis
process. Although Codex HACCP guidelines (Codex, 2009) offer
suggested points to consider when applying HACCP principle 1:
Conduct a Hazard Analysis (Table 1), no specic advice or tools are
provided to help in the determination of signicant hazards, i.e.
those hazards (that) are of such a nature that their elimination or
reduction to acceptable levels is essential to the production of a safe
food (Codex, 2009). This is an area which clearly requires substantial judgement and experience to be applied by HACCP team
members and, whilst previous literature suggests that this qualitative evaluation can be achieved by experienced HACCP teams
(Sperber, 2001), it is questionable whether people working in dayto-day factory roles always have the required knowledge and
experience, or whether they should be expected to take these decisions alone without expert collaboration.
It is true that HACCP studies are normally performed by HACCP
teams working together as a group rather than individuals and,
therefore, it could be argued that individual hazard analysis
knowledge is not as important as the collective knowledge of the
team. However, Wallace et al. (2012) found that HACCP team
knowledge of hazard analysis scored lower than the median of the
individual HACCP team member knowledge scores on 5.6% of occasions and lower than the best individual scores on 15.3% of occasions. This, along with the possibility that some team members,
potentially with poorer knowledge than their colleagues, might

Both pathogens and physical contaminants (metal) had

been identied as likely to occur at different process steps
but rated as low severity whereas, by their very nature,
these issues would normally have been considered high
severity. On questioning, a misunderstanding by the team
of the severity concept was identied.
Additional signicant hazards identied that were not
truly signicant.
In this case the hazards were less signicant than had
been considered by the HACCP team and were actually
under control by existing systems
Confusion between control and monitoring/verication
requirements.

over-ride their colleagues during the HACCP study process, suggests that it is important to understand the levels of knowledge of
all HACCP team members such that HACCP process facilitators can
be identied (Wallace et al., 2012).
From the audit data presented here (Table 4), several weaknesses were identied in the application of HACCP Principle 1:
Conduct a Hazard Analysis, including problems with hazard signicance assessment (resulting in both under-identication and
over-identication of signicant hazards), failure to identify likely
hazards and confusion between control measures for the identied
hazards and monitoring/verication procedures. These ndings tie
in with those of Panisello, Quantick and Knowles (1999) on the
missed hazard principle, where hazards are not identied so
cannot be controlled, and the missed risk principle, where hazards
are identied but risks, particularly likelihood of occurrence, are
not considered; although in this study the lack of understanding of
severity was a further dimension.
Where there is a serious weakness in hazard analysis, e.g.
missing signicant hazard leading to insufcient CCPs in a HACCP
plan, then assessment of whether the documented HACCP plan is
working in practice, e.g. through HACCP audit of control, monitoring and corrective action for specied CCPs, cannot give an
effective measure of food safety since the missing hazard/CCP
could result in harm to the consumer. For example, if a potential
hazard of Salmonella spp. contamination in a raw ingredient is
likely to occur in that ingredient then, due to the nature of
salmonellae as human pathogens, this should automatically be
seen as a signicant hazard (high likelihood and severity) that will
require control via a CCP. If no CCP has been identied then an
uncontrolled hazard could exist and endanger the consumer. In this
example of Salmonella spp. in a raw ingredient, it would be
important to address both the hazard in the ingredient/product
stream, most likely via a CCP, and the potential crosscontamination risk to the factory and other products, likely via
facility design (segregated zones) and/or prerequisite programmes

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C.A. Wallace et al. / Food Control 35 (2014) 233e240

(Mortimore & Wallace, 1998, 2013; Reij, Den Aantrekker & ILSI
Europe Risk Analysis in Microbiology Task Force, 2004). If a heat
process CCP has been identied to eliminate the hazard then
assessment of the monitoring and corrective action systems in
practice, along with associated records for that CCP, will give a view
on its effectiveness. However, if the cross-contamination risk has
not been addressed, then no matter how well managed the heat
process CCP, there will still be a risk of salmonella contamination in
the nal product and the HACCP plan cannot be said to be effective.
This was the situation found at one of the case study sites, which
would seem to have been at the same level of risk as manufacturing
sites previously involved in foodborne disease outbreaks known to
be caused by post-process contamination (Reij et al., 2004). This
nding raises concern for HACCP audit, particularly where
compliance with the documented HACCP plan is the audit model
rather than a wider examination that includes evaluation of the
likely hazards in different types of food operation, i.e. consideration
of HACCP plan validity.
Further issues with hazard signicance assessment seen in this
study involved errors in application of, or inappropriate use of, risk
evaluation tools and fundamental misunderstandings in severity
evaluation for potential hazards identied. This strongly suggests
that the requirement to analyse hazards in HACCP principle 1 is an
area where HACCP teams experience difculty and this may be
because of lack of guidance provided in how to apply the theory of
hazard analysis and/or application of tools chosen by the company,
or due to inadequate training and/or limited experience and
knowledge in both principle application and food safety hazard
control.
It is disappointing to note that, although Panisello et al. highlighted issues with missed hazards, risks and prevention in 1999
and called for further support in this area, similar weaknesses may
still be found in the HACCP work of HACCP teams within food
manufacturing. Since it is a commonly held belief that larger
manufacturers are more likely to be capable of establishing effective HACCP systems, this also gives grave concern over the quality
of HACCP plans being established by smaller food companies.
Whilst it may be true that smaller companies are more likely to
engage external consultants to help with developing HACCP systems, the quality of these systems will also relate to the knowledge
and experience of the chosen consultant (Mortimore & Wallace,
2013, p. 329).
As stated previously and seen in this case study, some companies are using structured risk evaluation frameworks to try to
systematise the judgement-based decision of identifying signicant hazards as they believe these methods will overcome the
difculties with hazard analysis at site level and/or will provide a
standardised approach for consistency between manufacturing
sites. These approaches may be based on published tools (e.g.
NACMCF, 1989), may be developed in-house within the company,
either at site, regional or corporate level, or may be approaches
recommended by consultants or third party food safety auditors. In
fact the case study company had provided such a tool from its
corporate technical centre for use by sites, however the sites
investigated here had used their own site-specic or regionally
developed versions, possibly due to the timing of release of the
corporate model (too late). Although such tools are generally
believed to make signicance assessment more straightforward by
the companies using them, they do still require training in their
application and use of judgement to position the identied hazards
in the correct sub-categories. From the assessments reported here
3/5 sites made errors in applying these tools in the way intended,
either regarding severity/likelihood judgements or due to lack of
clarity in the initial hazard identication making the tool more
difcult to apply. A key issue may be the lack of any standardisation

of the tools being used, thus meaning that there is limited published guidance and training in their application.
Although structured risk evaluation tools were used in the
earlier application of HACCP (NACMCF, 1989), international guidelines (Codex, 1993, 1997, 2003, 2009) have never advocated this
approach. Current tools appear to have their root in the early
publications of the American National Advisory Committee on
Microbiological Criteria for Foods (NACMCF) who published Hazard Analysis and Assignment of Risk Categories in its 1989 version
of the HACCP system. This approach fell out of favour in the USA
and was written out of subsequent versions of the NACMCF HACCP
document (NACMCF, 1992, 1997), mainly because the process was
not found to be helpful, in fact as much a hindrance as a help
(Sperber, pers. comm.) in establishing signicant hazards, since it
was more closely related to microbiological testing requirements
for product intended for sensitive consumer groups (Sperber,
2001). It is interesting, therefore, that companies still cling to
these ideas as a way to facilitate the hazard evaluation process, even
though HACCP teams, perhaps unknowingly, continue to make
errors in applying their tools. This is likely to be because they do not
have enough expertise and/or experience in applying the tools at a
local level and suggests that further assistance is needed by HACCP
teams trying to make decisions about hazard severity and likelihood of occurrence. Perhaps there is a role for a body such as Codex
or the Global Food Safety Initiative (www.mygfsi.com) in providing
an accepted tool with guidance on its application. The reiteration
that these critical judgements need to be made by people with the
sufcient knowledge, expertise and experience would seem to be
an important point to make.
Whilst Codex (2009) does highlight that where expertise to
form a multidisciplinary team does not exist on site that expert
advice should be obtained from other sources, the inference is that
this is most likely to be required in small and/or less developed
businesses rather than the large manufacturing sites of a multinational manufacturer as in this case. In fact the sites investigated
here had all managed to form multidisciplinary HACCP teams that
would meet the expected scope of team disciplines in a HACCP
team (Mortimore & Wallace, 1998; 2013) but a key issue discovered
was the lack of competence in evaluation of hazards to establish
signicance to food safety. This is an area that clearly needs more
focus from standards and guideline setters as well as HACCP
trainers and food companies. In addition, the current version of the
Codex HACCP Principles and Guidelines (Codex, 2009) refers to
training only in general terms, i.e.
The efcacy of any HACCP system will nevertheless rely on
management and employees having the appropriate HACCP
knowledge and skills, therefore ongoing training is necessary for
all levels of employees and managers, as appropriate.
Codex 2009
and
Training of personnel [.] in HACCP principles and applications
[.] are essential elements for the effective implementation of
HACCP.
Codex 2009
Typical training criteria for HACCP team members (e.g. RSPH,
2009a, 2009b; www.haccpalliance.org) clearly identify the need to
train the application of the hazard analysis principle but may not
identify to trainers exactly how this principle should be applied or
trained. More detailed and specic guidance on training needs and
syllabus requirements for hazard analysis and other detailed aspects
of HACCP Principle application would therefore seem prudent. The
development of more appropriate, practical and easy-to-use hazard

C.A. Wallace et al. / Food Control 35 (2014) 233e240

evaluation tools would be a further benecial step to assist HACCP

teams. Whilst there has been some work in this area, this needs
further review and testing such that effective solutions can be recommended to all HACCP teams.
Fielding, Ellis, Clayton & Peters (2011) discuss the evaluation of
process specic information resources aimed at hazard analysis in
small and medium food manufacturing enterprises. This was based
on an information source in booklet form for manufacturers of
chilled and frozen soups and sauces. Whilst Fielding et al. (2011) do
not provide full details of this tool, there are apparent similarities
with simplied approaches to HACCP produced for catering/foodservice operations (e.g. FSA, 2005) where the food business uses best
practice guidance on control and monitoring at different steps rather
than conducting a hazard analysis per se. This evaluation did not
provide evidence that the resource was effective in improving
knowledge, behaviour or attitudes of the participants, however this
may have been affected by sampling issues (Fielding et al., 2011).
Further detail on the resource design along with further evaluation
would be needed to assess if this type of resource could play a
practical role in assisting HACCP teams in performing hazard analysis, and questions remain about whether simple resources such as
these would be suitable in more complex manufacturing operations.
Other authors have suggested what are apparently more complex tools to assist in hazard analysis. Ryu, Park, Yang & Bahk (2012)
suggest that probability distributions may be used to facilitate the
process, however this technique is only applicable to the likelihood
of occurrence part of the signicance evaluation and the authors
state that it still needs further development. Bertolini et al. (2007)
discuss potential use for fuzzy logic and fault tree analysis tools.
This approach appears to add complexity to the hazard analysis
process and, like that of Ryu et al. (2012), seems mainly to cover the
likelihood of occurrence aspect. Whilst the authors (Bertolini et al.,
2007) state that the tools do cover severity and that expert input is
required, this is apparently looking at detectability of hazards
downstream from their point of likely occurrence/control rather
than severity of potential outcome for the consumer.
More promising in the search for practical hazard evaluation
tools that might be employed by factory HACCP teams, several
recent studies outline the development of spread-sheet-based tools
in the agri-food sector. The design of these tools is based on expert
knowledge and literature information on sector hazards and their
severity combined with food business knowledge of likelihood of
occurrence (Soon & Baines, 2012; Soon, Davies, Chadd & Baines,
2012; Soon, Davies, Chadd & Baines, 2013). Results demonstrate
that food business perception and ability to apply these tools are
encouraging, but more work is needed to examine how this
approach might be applied to other food industry sectors.
The above approaches are just some examples of the types of
tools that have been proposed. Manning and Soon (2013) reviewed
methods for assessing food safety risk within food safety plans and
concluded that the choice of food safety risk model is crucial to an
organisation. The eld of HACCP application would benet from
further study of this aspect in practice, with particular focus on
practicality and effectiveness of tools that might be applied at each
stage of the food chain.
Whilst this paper has focussed on hazard analysis knowledge
and the application of HACCP principle 1 by HACCP teams to
identify signicant hazards, this is only one small part of the story
on HACCP effectiveness and HACCP needs to work within a strong
food safety culture for overall effectiveness and public health protection. This means that the tools and infrastructure for making
HACCP work, i.e. management commitment, adequate resources,
technical skills and data, business culture and a proactive approach
are equally crucial to its effectiveness. Management of food companies need to understand that with the advance of product

239

development and innovation, as well as the evolution of their

HACCP systems, there is a need for additional technical skills and
scientic knowledge to plan, develop and implement valid management systems. At the international level, international stakeholders need to facilitate hazard analysis and effective food safety
management systems by sharing best practice approaches for
consistency of application, in addition to providing the guidance
and technical data needed for success.
5. Conclusions and recommendations
The essential process of hazard analysis is weakened by poor
knowledge of how to perform this crucial part of the HACCP study.
This issue is compounded by both use of unproven structured risk
evaluation methods or by inappropriate use of suitable tools by
untrained and inexperienced personnel.
In order to overcome these issues it is important that food
businesses ensure that their HACCP team members have the correct
blend of training, skills and experience to take decisions about food
safety hazard management, in particular the identication of potential hazards and evaluation of their signicance to food safety.
HACCP team limitations in this aspect need to be identied and
external expertise brought in where necessary. It is recommended
that businesses employ caution when deciding to apply structured
risk assessment tools such that steps are taken to ensure that the
chosen tool works in practice, i.e. it is capable of correctly establishing which hazards are signicant for food safety, and that team
members are skilled in its application.
It is recommended that Standard and Guidelines Setters provide
further detailed guidance on how to approach hazard analysis, i.e.
exactly how to evaluate severity and likelihood of occurrence, to
assist food companies in correctly identifying signicant hazards,
since lack of competence was clearly identied in this area. Further
guidance on expertise needed to successfully analyse hazards and
take critical food safety decisions would be highly benecial. In
particular, a strong reminder to food companies that this area does
require technical expertise and judgement would be helpful,
reminding them to recognise HACCP team limitations and seek
expert help where necessary. However the development of standardised evaluation tools to assist HACCP teams could also bring
major improvements. Detailed guidance on specic training needs
and syllabus requirements for training in the application of HACCP
Principles also needs to be provided and it would also be benecial
to establish international standards for qualications, training and
experience needed by HACCP auditors.
Acknowledgements
Thanks to the personnel from the multinational food company
who kindly gave up their time to participate in the elements of
this research, and the Regional and Factory Managers for allowing
access to their sites and personnel.
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