The Hazard Analysis and Critical Control Point System(HACCP) –
Guidelines for its Application
Principles
The HACCP system consists,of the following seven principles,
Principle 1
Conduct a hazard analysis,
Principle 2
Determine the Critical Control Points (CCPs),
Principle 3
Establish critical limit(s),
Principle 4
Establish a system to monitor control of the CCP,
Principle 5
Establish the corrective action to be taken when monitoring indicates that a particular
CCP is not under control,
Principle 6
Establish procedures for verification to confirm that the HACCP system is working
effectively,
Principle 7
Establish documentation concerning all procedures and records appropriate to these
principles and their application,
Guidelines for the Application of the HACCP System
Prior to application of HACCP to any sector of the food chain,that sector should be
operating according to the Codex General Principles of Food Hygiene,the appropriate
Codex Codes of Practice,and appropriate food safety legislation,Management
commitment is necessary for implementation of an effective HACCP system,During
hazard identification,evaluation,and subsequent operations in designing and applying
HACCP systems,consideration must be given to the impact of raw materials,ingredients,
food manufacturing practices,role of manufacturing processes to control hazards,likely
end-use of the product,categories of consumers of concern,and epidemiological
evidence relative to food safety,
The intent of the HACCP system is to focus control at CCPs,Redesign of the operation
should be considered if a hazard which must be controlled is identified but no CCPs are
found,HACCP should be applied to each specific operation separately,CCPs identified
in any given example in any Codex Code of Hygienic Practice might not be the only ones
identified for a specific application or might be of a different nature,
The HACCP application should be reviewed and necessary changes made when any
modification is made in the product,process,or any step,
It is important when applying HACCP to be flexible where appropriate,given the context
of the application taking into account the nature and the size of the operation,
Application
The application of HACCP principles consists of the following tasks as identified in the
Logic Sequence for Application of HACCP (Diagram 1),
1,Assemble HACCP team
The food operation should assure that the appropriate product specific knowledge and
expertise is available for the development of an effective HACCP plan,Optimally,this
may be accomplished by assembling a multidisciplinary team,Where such expertise is
not available on site,expert advice should be obtained from other sources,The scope of
the HACCP plan should be identified,The scope should describe which segment of the
food chain is involved and the general classes of hazards to be addressed (e.g,does it
cover all classes of hazards or only selected classes),
2,Describe product
A full description of the product should be drawn up,including relevant safety information
such as,composition,physical/chemical structure (including Aw,pH,etc.),microcidal/static
treatments (e.g,heat-treatment,freezing,brining,smoking,etc.),packaging,durability
and storage conditions and method of distribution,
3,Identify intended use
The intended use should be based on the expected uses of the product by the end user
or consumer,In specific cases,vulnerable groups of the population,e.g,institutional
feeding,may have to be considered,
4,Construct flow diagram
The flow diagram should be constructed by the HACCP team,The flow diagram should
cover all steps in the operation,When applying HACCP to a given operation,
consideration should be given to steps preceding and following the specified operation,
5,On-site confirmation of flow diagram
The HACCP team should confirm the processing operation against the flow diagram
during all stages and hours of operation and amend the flow diagram where appropriate,
6,List all potential hazards associated with each step,conduct a hazard
analysis,and consider any measures to control identified hazards (see Principle 1)
The HACCP team should list all of the hazards that may be reasonably expected to occur
at each step 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,
The team must then consider what control measures,if any,exist which can be applied
for each hazard,
More than one control measure may be required to control a specific hazard(s) and more
than one hazard may be controlled by a specified control measure,
7,Determine Critical Control Points (see Principle 2)'1
There may be more than one CCP at which control is applied to address the same
hazard,The determination of a CCP in the HACCP system can be facilitated by the
application of a decision tree,e.g,Diagram 2,which indicates a logic reasoning
approach,Application of a decision tree should be flexible,given whether the operation is
for production,slaughter,processing,storage,distribution or other,It should be used for
guidance when determining CCPs,This example of a decision tree may not be applicable
to all situations,Other approaches may be used,Training in the application of the
decision tree is recommended,
1 Since the publication of the decision tree by Codex,its use has been implemented many times for training
purposes,In many instances,while this tree has been useful to explain the logic and depth of understanding
needed to determine CCPs,it is not specific to all food operations,e.g,slaughter,and therefore it should be
used in conjunction with professional judgement,and modified in some cases,
If a hazard has been identified at a step where control is necessary for safety,and no
control
measure exists at that step,or any other,then the product or process should be modified
at that step,or at any earlier or later stage,to include a control measure,
8,Establish Critical Limits for each CCP (see Principle 3)
Critical limits must be specified and validated if possible for each critical control point,In
some cases more than one critical limit will be elaborated at a particular step,Criteria
often used include measurements of temperature,time,moisture level,pH,AW,available
chlorine,and sensory parameters such as visual appearance and texture,
9,Establish a Monitoring System for Each CCP (see Principle 4)
Monitoring is the scheduled measurement or observation of a CCP relative to its critical
limits,The monitoring procedures must be able to detect loss of control at the CCP,
Further,monitoring should ideally provide this information in time to make adjustments to
ensure control of the process to prevent violating the critical limits,Where possible,
process adjustments should be made when monitoring results indicate a trend towards
loss of control at a CCP,The adjustments should be taken before a deviation occurs,
Data derived from monitoring must be evaluated by a designated person with knowledge
and authority to carry out corrective actions when indicated,If monitoring is not
continuous,then the amount or frequency of monitoring must be sufficient to guarantee
the CCP is in control,Most monitoring procedures for CCPs will need to be done rapidly
because they relate to on-line processes and there will not be time for lengthy analytical
testing,Physical and chemical measurements are often preferred to microbiological
testing because they may be done rapidly and can often indicate the microbiological
control of the product,All records and documents associated with monitoring CCPs must
be signed by the person(s) doing the monitoring and by a responsible reviewing official(s)
of the company,
10 Establish Corrective Actions (see Principle 5)
Specific corrective actions must be developed for each CCP in the HACCP system in
order to deal with deviations when they occur,
The actions must ensure that the CCP has been brought under control,Actions taken
must also include proper disposition of the affected product,Deviation and product
disposition procedures must be documented in the HACCP record keeping,
11,Establish Verification Procedures (see Principle 6)
Establish procedures for verification,Verification and auditing methods,procedures and
tests,including random sampling and analysis,can be used to determine if the HACCP
system is working correctly,The frequency of verification should be sufficient to confirm
that the HACCP system is working effectively,Examples of verification activities include,
Review of the HACCP system and its records
Review of deviations and product dispositions
Confirmation that CCPs are kept under control
Where possible,validation activities should include actions to confirm the efficacy of all
elements of the HACCP plan,
12,Establish Documentation and Record Keeping (see Principle 7)
Efficient and accurate record keeping is essential to the application of a HACCP system,
HACCP procedures should be documented,Documentation and record keeping should
be appropriate to the nature and size of the operation,
Diagram 1
Logical Sequence for Application of HACCP
1 Assemble the HACCP team
2 Describe the Product
3 Identify Intended Use
4 Construct Flow Diagram
5 On-site Confirmation of Flow
Diagram
6 List All Potential Hazards
Conduct a Hazard Analysis
Determine Control Measures
7 Determine CCCPs See Diagram 2
8 Establish Critical Limit for each
CCP
9 Establish a Monitoring System for
each CCP
10 Establish Corrective Action for
Deviation that May Occur
11 Establish Verification Procedures
12 Establish Documentation and
Record Keeping
Diagram 2
Example of Decision Tree to Identify CCPs
(answer questions in sequence)
Q1 Do control measure(s) exist
Yes No Modify step,process or product
Is control at this step necessary for safety Yes
No Not a CCP Stop*
Q2 Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level Yes
No
Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable levels2
Yes No Not a CCP Stop*
Q4 Will a subsequent step eliminate identified hazard(s) or reduce likely accurence to an acceptable level?
Yes No CRITICAL CONTROL POINT
Not a CCP Stop*
* Proceed to next identified hazard in the described process
2Acceptable and unacceptable levels need to be defined within the overall objectives in identifying
the CCPs of the HACCP plan,
Diagram 3
Example of HACCP Worksheet
1,Describe Product
2,Diagram Process Flow
3,List
Step Hazard(s) Control Measure(s) CCPs Critical Limits Monitoring Procedure(s) Corrective Action(s) Record(s)
4,Verification
Guidelines for its Application
Principles
The HACCP system consists,of the following seven principles,
Principle 1
Conduct a hazard analysis,
Principle 2
Determine the Critical Control Points (CCPs),
Principle 3
Establish critical limit(s),
Principle 4
Establish a system to monitor control of the CCP,
Principle 5
Establish the corrective action to be taken when monitoring indicates that a particular
CCP is not under control,
Principle 6
Establish procedures for verification to confirm that the HACCP system is working
effectively,
Principle 7
Establish documentation concerning all procedures and records appropriate to these
principles and their application,
Guidelines for the Application of the HACCP System
Prior to application of HACCP to any sector of the food chain,that sector should be
operating according to the Codex General Principles of Food Hygiene,the appropriate
Codex Codes of Practice,and appropriate food safety legislation,Management
commitment is necessary for implementation of an effective HACCP system,During
hazard identification,evaluation,and subsequent operations in designing and applying
HACCP systems,consideration must be given to the impact of raw materials,ingredients,
food manufacturing practices,role of manufacturing processes to control hazards,likely
end-use of the product,categories of consumers of concern,and epidemiological
evidence relative to food safety,
The intent of the HACCP system is to focus control at CCPs,Redesign of the operation
should be considered if a hazard which must be controlled is identified but no CCPs are
found,HACCP should be applied to each specific operation separately,CCPs identified
in any given example in any Codex Code of Hygienic Practice might not be the only ones
identified for a specific application or might be of a different nature,
The HACCP application should be reviewed and necessary changes made when any
modification is made in the product,process,or any step,
It is important when applying HACCP to be flexible where appropriate,given the context
of the application taking into account the nature and the size of the operation,
Application
The application of HACCP principles consists of the following tasks as identified in the
Logic Sequence for Application of HACCP (Diagram 1),
1,Assemble HACCP team
The food operation should assure that the appropriate product specific knowledge and
expertise is available for the development of an effective HACCP plan,Optimally,this
may be accomplished by assembling a multidisciplinary team,Where such expertise is
not available on site,expert advice should be obtained from other sources,The scope of
the HACCP plan should be identified,The scope should describe which segment of the
food chain is involved and the general classes of hazards to be addressed (e.g,does it
cover all classes of hazards or only selected classes),
2,Describe product
A full description of the product should be drawn up,including relevant safety information
such as,composition,physical/chemical structure (including Aw,pH,etc.),microcidal/static
treatments (e.g,heat-treatment,freezing,brining,smoking,etc.),packaging,durability
and storage conditions and method of distribution,
3,Identify intended use
The intended use should be based on the expected uses of the product by the end user
or consumer,In specific cases,vulnerable groups of the population,e.g,institutional
feeding,may have to be considered,
4,Construct flow diagram
The flow diagram should be constructed by the HACCP team,The flow diagram should
cover all steps in the operation,When applying HACCP to a given operation,
consideration should be given to steps preceding and following the specified operation,
5,On-site confirmation of flow diagram
The HACCP team should confirm the processing operation against the flow diagram
during all stages and hours of operation and amend the flow diagram where appropriate,
6,List all potential hazards associated with each step,conduct a hazard
analysis,and consider any measures to control identified hazards (see Principle 1)
The HACCP team should list all of the hazards that may be reasonably expected to occur
at each step 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,
The team must then consider what control measures,if any,exist which can be applied
for each hazard,
More than one control measure may be required to control a specific hazard(s) and more
than one hazard may be controlled by a specified control measure,
7,Determine Critical Control Points (see Principle 2)'1
There may be more than one CCP at which control is applied to address the same
hazard,The determination of a CCP in the HACCP system can be facilitated by the
application of a decision tree,e.g,Diagram 2,which indicates a logic reasoning
approach,Application of a decision tree should be flexible,given whether the operation is
for production,slaughter,processing,storage,distribution or other,It should be used for
guidance when determining CCPs,This example of a decision tree may not be applicable
to all situations,Other approaches may be used,Training in the application of the
decision tree is recommended,
1 Since the publication of the decision tree by Codex,its use has been implemented many times for training
purposes,In many instances,while this tree has been useful to explain the logic and depth of understanding
needed to determine CCPs,it is not specific to all food operations,e.g,slaughter,and therefore it should be
used in conjunction with professional judgement,and modified in some cases,
If a hazard has been identified at a step where control is necessary for safety,and no
control
measure exists at that step,or any other,then the product or process should be modified
at that step,or at any earlier or later stage,to include a control measure,
8,Establish Critical Limits for each CCP (see Principle 3)
Critical limits must be specified and validated if possible for each critical control point,In
some cases more than one critical limit will be elaborated at a particular step,Criteria
often used include measurements of temperature,time,moisture level,pH,AW,available
chlorine,and sensory parameters such as visual appearance and texture,
9,Establish a Monitoring System for Each CCP (see Principle 4)
Monitoring is the scheduled measurement or observation of a CCP relative to its critical
limits,The monitoring procedures must be able to detect loss of control at the CCP,
Further,monitoring should ideally provide this information in time to make adjustments to
ensure control of the process to prevent violating the critical limits,Where possible,
process adjustments should be made when monitoring results indicate a trend towards
loss of control at a CCP,The adjustments should be taken before a deviation occurs,
Data derived from monitoring must be evaluated by a designated person with knowledge
and authority to carry out corrective actions when indicated,If monitoring is not
continuous,then the amount or frequency of monitoring must be sufficient to guarantee
the CCP is in control,Most monitoring procedures for CCPs will need to be done rapidly
because they relate to on-line processes and there will not be time for lengthy analytical
testing,Physical and chemical measurements are often preferred to microbiological
testing because they may be done rapidly and can often indicate the microbiological
control of the product,All records and documents associated with monitoring CCPs must
be signed by the person(s) doing the monitoring and by a responsible reviewing official(s)
of the company,
10 Establish Corrective Actions (see Principle 5)
Specific corrective actions must be developed for each CCP in the HACCP system in
order to deal with deviations when they occur,
The actions must ensure that the CCP has been brought under control,Actions taken
must also include proper disposition of the affected product,Deviation and product
disposition procedures must be documented in the HACCP record keeping,
11,Establish Verification Procedures (see Principle 6)
Establish procedures for verification,Verification and auditing methods,procedures and
tests,including random sampling and analysis,can be used to determine if the HACCP
system is working correctly,The frequency of verification should be sufficient to confirm
that the HACCP system is working effectively,Examples of verification activities include,
Review of the HACCP system and its records
Review of deviations and product dispositions
Confirmation that CCPs are kept under control
Where possible,validation activities should include actions to confirm the efficacy of all
elements of the HACCP plan,
12,Establish Documentation and Record Keeping (see Principle 7)
Efficient and accurate record keeping is essential to the application of a HACCP system,
HACCP procedures should be documented,Documentation and record keeping should
be appropriate to the nature and size of the operation,
Diagram 1
Logical Sequence for Application of HACCP
1 Assemble the HACCP team
2 Describe the Product
3 Identify Intended Use
4 Construct Flow Diagram
5 On-site Confirmation of Flow
Diagram
6 List All Potential Hazards
Conduct a Hazard Analysis
Determine Control Measures
7 Determine CCCPs See Diagram 2
8 Establish Critical Limit for each
CCP
9 Establish a Monitoring System for
each CCP
10 Establish Corrective Action for
Deviation that May Occur
11 Establish Verification Procedures
12 Establish Documentation and
Record Keeping
Diagram 2
Example of Decision Tree to Identify CCPs
(answer questions in sequence)
Q1 Do control measure(s) exist
Yes No Modify step,process or product
Is control at this step necessary for safety Yes
No Not a CCP Stop*
Q2 Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level Yes
No
Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable levels2
Yes No Not a CCP Stop*
Q4 Will a subsequent step eliminate identified hazard(s) or reduce likely accurence to an acceptable level?
Yes No CRITICAL CONTROL POINT
Not a CCP Stop*
* Proceed to next identified hazard in the described process
2Acceptable and unacceptable levels need to be defined within the overall objectives in identifying
the CCPs of the HACCP plan,
Diagram 3
Example of HACCP Worksheet
1,Describe Product
2,Diagram Process Flow
3,List
Step Hazard(s) Control Measure(s) CCPs Critical Limits Monitoring Procedure(s) Corrective Action(s) Record(s)
4,Verification