Determining Control Measures in HACCP Page 1

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Determining Control Measures in HACCP

CONTENTS SUMMARY

1. Introduction

2. What are control measures?

2.1 Critical Control Point (CCP)

2.2 Prerequisite Programme (PRP)
2.3 Operational Prerequisite
Programme (oPRP)
2.4 Control Point (CP)
This whitepaper is essential
2.5 Quality Control Point (QCP)
for anyone responsible for
risk assessment and deter-
3. Determining Control Measures mination of control meas-
ures within a HACCP plan.
3.1 Requirements for determining The whitepaper will demys-
control measures tify much of the language
3.2 Risk assessments and “Significance” and complex logic normally
associated with risk assess-
3.3 Determination models
ment models and decision
trees, which prevent many
4. Definitions food companies from obtain-
ing their objective of produc-
ing robust HACCP plans.
5. References

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1. Introduction not mystifying on occasion.

Since its inception, HACCP has always To put it simply, the basic principle is to
been a risk assessment and management install within the process and operation
tool designed to help food companies some control measures which are
identify specific hazards within their appropriate for the specific hazards and
process, determine their significance and the risk they pose to the final consumer.
develop appropriate controls to ensure HACCP requires the user to identify these
they do not reach the consumer. Over the potential hazards. Next, the user determines
decades numerous food safety standards, the significance of these hazards by
codes of practice, and regulatory directives applying risk assessment techniques, the
have adopted the principles of HACCP output of which is a measure of risk which
and in the process put their own unique then allows us to put in place appropriate
interpretation on how exactly these control measures. Over the decades,
principles are effected. various standards have attempted to
define how this should be done and in the
The almost ubiquitous adoption of process have introduced their own unique
HACCP as the risk tool of choice by the terms, language, scope, methodology and
food industry is a testament to its enduring workflows. Some of these have been good
scientific approach. It has facilitated the and helped the user meet requirements
development of a safer food supply chain but much of the work has served only to
and provided food safety practitioners with confuse the user leading to HACCP plans
a common work-flow, logic and language which are unnecessarily complex and hinder
from which to work and communicate. the effective management of food safety.
It has also provided one of the essential
ingredients required for objective auditing This whitepaper will breakdown much of
– a Standard. As is the case in many other the confusion and inherent weaknesses
industries, the food sector has found present in many food safety standards
an important and valuable friend in risk surrounding the determination of control
assessment and more specifically HACCP. measures in HACCP. It will take the
reader through the basic logic behind the
However as with any good, lifelong friend methodology and build from a basic model
we become aware more than others of up to a more detailed one covering all types
their inherent character uniqueness and of control measures after which a better
challenges. It does not prevent us benefiting insight and understanding of this area will
from the relationship but it can often be achieved.
make things confusing. When we speak of
HACCP it is clear that risk assessment and
determination of control measures is an
aspect which many users find difficult if

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2. What are Control There are others; however, the above

Measures? represent the main ones used widely in the
food industry.
Before examining the methods for
determining the appropriate control 2.1 Critical Control Point (CCP)
measure to apply for a particular hazard,
The CCP is perhaps the most commonly
it is essential to have a clear understanding
known of all the control measures. The
of the various control measures typically
ISO defines it as a step at which control
referred to in food safety standards.
can be applied and is essential to prevent or
In the context of food safety, the eliminate a food safety hazard or reduce it
International Standards Organisation (ISO) to an acceptable level.
has defined a control measure as an action
You will note that the definition is very
or activity that can be used to prevent or
similar to the general definition of a control
eliminate a food safety hazard or reduce
measure; however, a CCP differs in the
it to an acceptable level. This definition is
fact that it relates specifically to a step in
general and can be used to describe virtually
the process e.g. cooking, cooling, freezing
any action, step, activity, job, task, process
and not a general activity or action. The
or procedure which has the intention of
definition also states that a CCP is a step at
addressing a food safety hazard. As we look
which control can be applied. Therefore, if
closer at the main food safety standards
a CCP cannot by definition apply control it
we can see that control measures become
cannot be a CCP.
categorised according to their nature, direct
relationship with the process and the level This might come into play where the
of risk to the consumer should the control control is subjective and cannot be
measure fail. In recent years the following measured accurately. In this case control
categories of control measures have is hard or impossible and would not lend
emerged: well as a critical point of control. Another
factor relating to CCP’s is the risk posed
• Critical Control Point (CCP)
by the hazard should the control not be
• Prerequisite Programme (PRP) exercised. For example, a salmonella in
cooked meat would pose a significant risk
• Operational Prerequisite to the consumer if cooking is not carried
Programme (oPRP) out to an adequate temperature and time
specification. In this case control is critical
• Control Point (CP) and designed specifically to control the
hazard.
• Quality Control Point (QCP)

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• management of purchased materials

2.2 Prerequisite Programme (PRP) (e.g. raw materials, ingredients,
chemicals and packaging), supplies
The ISO defines a PRP as the basic (e.g. water, air, steam and ice),
conditions and activities that are necessary disposals (e.g. waste and sewage)
to maintain a hygienic environment and handling of products (e.g.
throughout the food chain and are suitable storage and transportation)
for the production, handling and provision
of safe end products and safe food for • measures for the prevention of cross
human consumption. contamination

There are a wide variety of PRPs depending • cleaning and sanitizing

on the particular product and process.
They are often described in certain sectors • pest control
of the industry as Good Agricultural
• personnel hygiene
Practice (GAP), Good Veterinarian Practice
(GVP), Good Manufacturing Practice The key point in regard to PRP’s is that
(GMP), Good Hygienic Practice (GHP), they are usually general to the process
Good Production Practice (GPP), Good and not focused on any particular step in
Distribution Practice (GDP) and Good the process. For example, cleaning and
Trading Practice (GTP). Examples of sanitizing are activities which can apply to
PRP’s in a food manufacturing environment all steps, rooms, items and building fabric.
highlighted in the ISO 22000 standard
would be: They also have the character that their
failure does not necessary lead to an
• construction and lay-out of immediate and imminent food safety risk.
buildings and associated utilities Generally, time and repeated failure is
required to create a critical change in the
• lay-out of premises, including
safety of the product. Stated another way,
workspace and employee facilities
they usually manage more general and lower
• supplies of air, water, energy and risk hazards.
other utilities
2.3 Operational Prerequisite
• supporting services, including waste Programme (oPRP)
and sewage disposal
The ISO defines an oPRP as a control
• the suitability of equipment and measure identified by the hazard analysis as
its accessibility for cleaning, essential in order to control the likelihood
maintenance and preventative of introducing food safety hazards and/or
maintenance the contamination or proliferation of food

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safety hazards in the product(s) or in the is that it is not an intrinsic step required
processing environment. for the production of safe cooked ham.
It can be removed from the process and
As a concept of control it was introduced the company can practically still produce
by the ISO in their food safety management relatively safe products. Nonetheless,
standard ISO 22000. What is striking about its presence may be deemed essential to
this control measure and its definition is reducing the likelihood of the hazard and
the almost universal confusion users have therefore an oPRP. It is important to realise
in differentiating it from CCP’s and PRP’s. that this is simply one possible definition
The variation in the focus of the control of an oPRP which provides some working
measures appears to be based on a subtle understanding for users. It may not be the
difference in the description of hazards full definition or scope as intended by the
and risks. Users have found it hard to ISO.
understand the nature of oPRP’s and given
that that standard provides no specific 2.4 Control Point (CP)
examples, it has remained the subject of
some debate in the food safety community. A Control Point is used by some standards
to describe an oPRP. The IFS Food
In an attempt to clarify what exactly Standard for auditing quality and food
an oPRP is, it has been described as a safety of food products Version 6, for
specific action relating to the process example, defines a CP as being identical to
while not being critical for food safety; it an oPRP found in the ISO 22000.
is essential in reducing the likelihood of a
specific hazard occurring. For example, a 2.5 Quality Control Point (QCP)
cooking step in a process may be critical to
A Quality Control Point is a control
controlling the risk of a specific pathogen
measure essential in order to control quality,
surviving e.g. E. coli. This is an intrinsic
service and business risks.
step in the process for producing a cooked
product. Its removal from the process It is used in various standards including
is not possible and therefore its correct the Woolworths Standard (WQA) for
control is critical. Therefore, the control Manufactured Foods V8. In this standard,
applied at this step can be considered quality risks are provided almost equal
critical and therefore a CCP. importance as food safety.
Alternatively, we can take the same process
and look at metal detection. It too is a
specific step in the process designed to
reduce the likelihood of a hazard reaching
the consumer and arguably could be a
CCP also. However, the key difference

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3. Determining Control 3.1 Requirements for Determining

Measures Control Measure

In order to determine which control Various Standards set out requirements

measure is appropriate for the identified for determining control points. The
hazard, you need to employ a specific following table summarizes some of these
methodology encompassing risk assessment requirements as they relate to control
followed by a decision tree. measures.

Standard Requirements
ISO 22000 7.4.4 Selection and assessment of control measures

Based on the hazard assessment of 7.4.3, an appropriate combination of

control measures shall be selected which is capable of preventing, eliminating
or reducing these food safety hazards to defined acceptable levels. In this
selection, each of the control measures as described in 7.3.5.2 shall be
reviewed with respect to its effectiveness against the identified food safety
hazards. The control measures selected shall be categorized as to whether
they need to be managed through operational PRP(s) or by the HACCP plan.
The selection and categorization shall be carried out using a logical approach
that includes assessments with regard to the following:

a) its effect on identified food safety hazards relative to the strictness applied;
b) its feasibility for monitoring (e.g. ability to be monitored in a timely manner
to enable immediate corrections);
c) its place within the system relative to other control measures;
d) the likelihood of failure in the functioning of a control measure or significant
processing variability;
e) the severity of the consequence(s) in the case of failure in its functioning;
f) whether the control measure is specifically established and applied to
eliminate or significantly reduce the level of hazard(s);
g) synergistic effects (i.e. interaction that occurs between two or more
measures resulting in their combined effect being higher than the sum of their
individual effects).

Control measures categorized as belonging to the HACCP plan shall be

implemented in accordance with 7.6.

Other control measures shall be implemented as operational PRPs according

to 7.5. The methodology and parameters used for this categorization shall be
described in documents, and the results of the assessment shall be recorded.

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Standard Requirements
ISO 22000 7.5 Establishing the operational prerequisite programmes (PRPs)

The operational PRPs shall be documented and shall include the following
information for each programme:

a) food safety hazard(s) to be controlled by the programme (see 7.4.4);

b) control measure(s) (see 7.4.4);
c) monitoring procedures that demonstrate that the operational PRPs are
implemented;
d) corrections and corrective actions to be taken if monitoring shows that the
operational PRPs are not in control (see 7.10.1 and 7.10.2, respectively);
e) responsibilities and authorities;
f) record(s) of monitoring.

Woolworths Determine the Critical Control Points – for each significant hazard the Vendor
Standard (WQA) shall determine which of the control measures developed is the critical point for
Version 8 control of the hazard, including significant quality hazards/regulatory issues.

Establish a system to monitor control of the CCP and QCP – procedures for
monitoring the critical limits shall be developed, documented, implemented and
reviewed. These shall include details of what is being measured or monitored,
how this is to be carried out, the frequency at which measurements will be
undertaken, where the monitoring activity is to be undertaken and who is to be
responsible for monitoring. Monitoring activities shall be undertaken regularly so
any deviations can be detected in-line and corrected immediately.

Tesco Food Prerequisite Programmes

Manufacturing
Standard (TFMS) All environmental and operational controls that are necessary to produce safe
and legal food products must be in place. These cover good manufacturing
practices throughout the site. The control measures and monitoring procedures
for the prerequisite programme must be clearly identified and documented.

Hazard Analysis

The HACCP team must conduct a hazard analysis to identify hazards which need
to be prevented, eliminated or reduced to acceptable levels. The hazard analysis
must include:

• Likely occurrence and severity

• Survival or multiplication of micro-organisms
• Presence or production of toxins, chemicals or foreign bodies and allergens
• Potential for adulteration/deliberate contamination

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Standard Requirements
Tesco Food Control Measures
Manufacturing
Standard (TFMS) The HACCP team must assess whether an existing prerequisite adequately
controls the hazard identified.

The HACCP team must also consider what control measures (if any exist) for
the remaining hazards can be applied to prevent, eliminate or reduce the risk
to acceptable levels. If no control measures have been identified the product/
process must be modified so a control measure can be applied.

Determination of CCPs

The Codex decision tree or equivalent must be used to determine if control

measures are CCPs (Critical Control Points).

BRC Standard For each hazard that requires control, control points shall be reviewed to identify
Food 6 those that are critical. This requires a logical approach and may be facilitated by
use of a decision tree. CCPs shall be those control points which are required in
order to prevent or eliminate a food safety hazard or reduce it to an acceptable
level. If a hazard is identified at a step where control is necessary for safety but
the control does not exist, the product or process shall be modified at that step,
or at an earlier or later step, to provide a control measure.

IFS Food CP – Control point

Standard for
auditing quality Identified by the hazard analysis as essential in order to control the likelihood
and food safety of introducing or proliferation of food safety hazard in the product and/or the
of food products environment. A CP can be considered as an OPRP (Operational Prerequisite
Version 6 Program), as defined in ISO 22000. The basis of the company’s food safety
control system shall be a fully implemented, systematic and comprehensive
HACCP system, based upon the Codex Alimentarius principles.

It shall take into account any legal requirements of the production and
destination countries which may go beyond such principles. The HACCP system
shall be implemented at each production site.

The determination of relevant critical control points (CCP’s) shall be facilitated by

the application of a decision tree or other tool(s), which demonstrates a logical
reasoned approach.

For all steps which are important for food safety, but which are not CCP’s, the
company shall implement and document control points (CP’s). Appropriate
control measures shall be implemented.

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In general the methods now universally The benefit of this is ensuring that limited
employed in the global food industry are resources are deployed mainly to control
based on risk assessment followed by high risk hazards.
CCP determination. They are based on a
principle that not all hazards are significant 3.2 Risk Assessment and
to food safety and therefore do not need ‘Significance’
to be controlled in a rigorous manner.
The term Significant Hazard is used widely
Conversely, some hazards are significant
but often poorly understood. This is not
and may be critical to food safety. These
helpful when we set about developing
by definition require tighter control. This
HACCP plans which are capable of
methodology can be summarized in the
controlling hazards in an appropriate
following steps:
manner. The term significance is used
Figure 1: Simple model for the simply to describe those hazards which
determination of control measures present a real risk of impacting on the
consumer. It is used to separate those
hazards which require tight control from
those requiring lesser control. It may
be said that significance is essentially an
expression of Risk.

In food safety, risk (R) is a measure of the

combined severity of impact (S) from a
hazard and its probability of occurrence
(P).

R=SxP
The above model is centred on HACCP.
However, it is important to note that In its simplest form, risk is expressed as
HACCP does not clearly define this being High, Medium or Low. When it
approach which is a weakness of the comes to defining if a hazard is significant,
system. risk is usually used. For example, you can
say that any risk deemed to be high and
In the first stage, the specific hazards
medium are significant. While low risk
at specific steps are identified and
hazards are deemed to be non-significant.
characterized. This is followed by a risk
This is the basic purpose of risk assessment
assessment to determine which hazards if
in food safety and HACCP. The following
any are ‘significant’. Significant hazards are
is a simple model for risk assessment of a
then applied to a decision tree to determine
food safety and quality hazard:
if they should be controlled as a CCP, PRP,
oPRP, CP or QCP.

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Probability Rating

Severity Rating

Risk Rating

Figure (above): Simple risk assessment The model is based on 3 basic questions.
model The first is whether there is in fact an
identified hazard at this step relating to
3.3 Determination Models food safety. If not, it is assumed to be a
quality issue and controlled as such. If the
We can now take the above and develop
answer to question 1 is “Yes” then a risk
further our model for determining control
assessment is conducted on the hazard
measures. In the more advanced model
to determine if it is significant. If the
below we can see clearly the role played by
hazard is deemed to be non-significant it is
risk assessment in defining the significance
then controlled as a PRP or other control
of the hazard. Non-significant hazards
measure. Note the model below does not
are controlled by definition as PRP’s
provide any guidance as to whether a non-
and oPRP’s while significant hazards are
significant hazard should be controlled as a
progressed to a CCP determination phase.
PRP or operational PRP.

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Figure (above): Model for determining There are large numbers of decision trees
control measures employed and cited in various standards.
Below we have set out the more detailed
If the hazard may be deemed to be example of the decision tree found in the
significant it does not automatically follow CODEX standard for HACCP.
that it will be controlled as a CCP. This
must be determined and here our model You will notice that this decision tree
needs development. It must first go through focuses on determining whether the
a decision tree to determine if it meets hazard should be controlled as a CCP or
the criteria for a CCP. This is because not not. It does not attempt to assist the user
every hazard identified as significant can be in determining what type of control shall
controlled in a manner defined as a CCP in be employed where ‘Not a CCP’ is the
many standards. outcome. This makes it limited for most
modern food businesses seeking to develop
It may only be possible to control them a robust food safety plan.
through some other means and this may
explain why oPRP have emerged in an
effort to maintain the importance of the
control failing its suitability as a CCP.

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Figure 4: CODEX Hazard Analysis and Critical Control Point (HACCP) system and
Guidelines for its application, Annex to CAC/RCP 1-1969, Rev. 3 (1997) CCP Decision Tree

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In order to fully address the requirements Q2. Do control measure(s) exist for
(both implicit and explicit) and the the identified hazard(s)?
business needs of the company, a more
robust decision tree is required to clearly In this question the user is asked if control
and logically identify which control is measures have been identified. Where NO,
appropriate for any significant hazards. Q3 is answered which may lead to revisions
to the process or product. If YES, then the
The following model is an example of a user will progress to Q4.
more detailed approach to determining
the type of control measure which should Q3. Is control necessary at this step
be employed for a significant hazard. You for food safety?
will see that it covers both food safety
hazards and quality issues. When used, it If control is required then revision should
can provide a solid and logical approach to be made to the process or product.
determine control measures and will clearly
Q4. Is this step specifically designed
show an auditor how you arrived at your
to eliminate or reduce the likely
decisions.
occurrence of the hazard to an
acceptable level?
The model pictured on the following page
employs an eight question decision tree
In this question the user is asked whether
which is designed to take you through
the step is specifically designed to eliminate
the logic step by step to determine if the
or reduce the occurrence of the hazard. If
hazard should be controlled as a CCP,
YES, it will be determined as a CCP. If NO,
oPRP, PRP or QCP. You will see it builds
Q5 is asked next in the sequence.
upon the Codex model but now brings
into the decision process the other control Q5. Could contamination occur or
measures covered in other food safety increase to an unacceptable level?
standards.
If NO, it is deemed not to be a CCP and
Q1. Is there a food safety hazard(s) the process STOPS. If YES, then the user
at this step? progresses to Q6.
In this question we are again simply Q6. Will a subsequent step eliminate
confirming the fact that a hazard has been or reduce the hazard to an
identified or not. Where the answer is NO acceptable level?
it is assumed it is a quality issue and is
controlled as a QCP. If YES, then the user If YES, then the determination is NOT
progresses to Q2. A CCP and the process stops since some
control later in the process will address the
hazard. If NO, then the user progresses to
Q7.

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Q7. Will a subsequent action 4 Definitions

eliminate or reduce the hazard
to an acceptable level? Action – An action is any activity, task,
job, or procedure which is designed to
In this question we now see the shift of measure or control an aspect of the process
the decision tree away from STEPS (which or the production environment.
are relevant only for CCP’s) to ACTIONS
which are more relevant for PRP’s. If QCP - Quality Control Point – A process
NO, then this step is deemed to be the step at which control is required to prevent
controlling step and therefore a CCP. If or eliminate a quality defect or reduce it to
YES, then the user will progress to Q 8 an acceptable level.

Q8. Is the action a monitoring or HACCP - A system which identifies,

measuring action, specific for evaluates, and controls hazards which are
this step? significant for food safety.

The decision tree is attempting to Control Measure - Food safety action

determine if the action is general or more or activity that can be used to prevent or
specific to the step. If YES, then it is eliminate a food safety hazard or reduce it
controlled as an oPRP and No as a general to an acceptable level.
PRP.
Prerequisite Programme (PRP)
Figure (previous page): Detailed model - basic conditions and activities that
for determination of Control Measures are necessary to maintain a hygienic
including CCP’s, PRP’s, oPRP’s, CP’s and environment throughout the food chain
QCP’s and are suitable for the production,
handling and provision of safe end
products and safe food for human
consumption.

Operational Prerequisite
Programme (oPRP) - identified by
the hazard analysis as essential in order to
control the likelihood of introducing food
safety hazards to and/or the contamination
or proliferation of food safety hazards
in the product(s) or in the processing
environment.

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Critical Control Point (CCP) - step 5 References

at which control can be applied and is
essential to prevent or eliminate a food ISO 22000:2005 Food safety management
safety hazard or reduce it to an acceptable systems - Requirements for any
level organization in the food chain

Control Point (CP) - any step at which CODEX Hazard Analysis And Critical
biological, chemical, or physical factors can Control Point (HACCP) System and
be controlled. Guidelines for Its Application Annex to
CAC/RCP 1-1969, Rev. 3 (1997)
Hazard - A biological, chemical, or
physical agent that is reasonably likely to BRC Standard for Food Issue 6
cause illness or injury in the absence of its
control. IFS Food Standard for auditing quality and
food safety of food products Version 6
Hazard Analysis - The process of
collecting and evaluating information Woolworths Standard (WQA) for
on hazards associated with the food Manufactured Foods V8
under consideration to decide which are
significant and must be addressed in the
HACCP plan.

Step - A point, procedure, operation or

stage in the food system from primary
production to final consumption.

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