Professional Documents
Culture Documents
CODE OF PRACTICE
No. (6)/2011
Endorsed by BOD
30 October 2011
ADFCA-033-11-2011-01
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I. INTRODUCTION 4
1. HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) SYSTEM 7
1.1 The Codex HACCP reference standard 7
REFERENCES 27
APPENDICES 28
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I. Introduction Figure (1) Relationship between HACCP & Pre-Requisite Programs (PRPS)
HACCP has become synonymous with food safety. It is a worldwide-recognized systematic and preventive approach
that addresses biological, chemical and physical hazards through anticipation and prevention, rather than through
end-product inspection and testing. The system, which is science based and systematic, identifies specific hazards
and measures for their control to ensure the safety of food.
The HACCP system can be applied throughout the food chain from the primary producer to the consumer. Besides
enhancing food safety, other benefits of applying HACCP include more effective use of resources, savings to the food
industry and more timely response to food safety problems.
HACCP enhances the responsibility and degree of control at the level of the food industry. A properly implemented
HACCP system leads to greater involvement of food handlers in understanding and ensuring food safety, thus
providing them with renewed motivation in their work. Implementing HACCP does not mean undoing quality
assurance procedures or good manufacturing practices already established by a company; it does, however, require a
revision of these procedures as part of the systematic approach and for their appropriate integration into the HACCP
plan.
While the application of HACCP to all segments and sectors of the food chain is possible, it is assumed that all sectors
should be operating according to the Codex General Principles of Food Hygiene. The ability of an industry segment or
sector to support or implement the HACCP system depends on the degree of its adherence to these practices.
The successful application of HACCP requires the full commitment and involvement of management and the
workforce. It requires a multidisciplinary approach which should include, as appropriate, expertise in agronomy,
veterinary health, microbiology, public health, food technology, environmental health, chemistry, engineering, etc.
according to the particular situation.
This Code of Practice has been developed to give manufacturers guidance on how food businesses should comply
with the internationally recognized Codex principles for the application of HACCP system In order to meet regulatory
requirements. It assumes that pre-requisite programs to ensure that premises, equipment, transport and employees
do not contribute to or become food safety hazards are already in place. Without these basic principles (e.g. sanitation,
pest control, personnel practices), a risk-based system such as HACCP will fail. As described by Codex prerequisite
programs to HACCP, including training, should be well established, fully operational and verified in order to facilitate the
successful application and implementation of the HACCP system.
II. SCOPE
This Code of Practice shall apply to the implementation of Codex based HACCP principles within the manufacturing
sector. It reflects the requirements of Regulation No (6) 2010 Food Hygiene Throughout the Food Chain, which
requires the implementation of a food safety management system in all food businesses:
The food business operator shall develop, implement and maintain food safety management systems based on the
Hazard Analysis and Critical Control Point (HACCP) principles. (Article 100, Regulation 6)
The Code specifically excludes guidance on pre-requisite programs. It assumes these are already in place and have
been validated, documented and verified routinely. Regulatory requirements for pre-requisites can be found in other
sections of Regulation 6 and related documents.
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Corrective action: Any action to be taken when the results of monitoring at the CCP indicate a loss of 2. THE CODEX TWELVE STEPS FOR THE APPLICATION OF HACCP
control. Figure (2): The Codex Protocol for the Application
Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or eliminate a food
safety hazard or reduce it to an acceptable level
Flow diagram: A systematic representation of the sequence of steps or operations used in the
production or manufacture of a particular food item
HACCP: A system which identifies, evaluates, and controls hazards which are significant for
food safety
HACCP plan: A document prepared in accordance with the principles of HACCP to ensure control
of hazards which are significant for food safety in the segment of the food chain
under consideration
Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to
cause an adverse health effect
Hazard analysis: The process of collecting and evaluating information on hazards and conditions
loading to their presence to decide which are significant for food safety and therefore
should be addressed in the HACCP plan
Step: A point, procedure, operation or stage in the food chain including raw materials,
from primary production to final consumption
Verification: The application of methods, procedures, tests and other evaluations, in addition to
monitoring to determine compliance with the HACCP plan.
Prerequisite programs Steps or procedures that control the general operational conditions within a food
establishment and promote environmental conditions that are favorable for the
production of safe food.
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A typical set of information to place together in order to describe a certain food product would include: 2.4.3 FLOOR PLAN
Product name (common name) or group of product names (the grouping of like products is acceptable as long It is useful to prepare a floor plan (plan schematic) to show product flow and employee traffic patterns within the plant
as all hazards are addressed) for the specific product. This should include the flow of all ingredients and packaging materials from the moment they
are received at the plant, through storage, preparation, processing, packaging, finished product holding and shipping.
Important end-product characteristics: properties or characteristics of the food under review that are required
The personnel flow should indicate employee movement through the plant, including changing rooms, washrooms
to ensure its safety (e.g. Aw, pH/preservatives)
and lunchrooms. The location of hand-washing facilities and footpaths (if applicable) should also be noted.
How the product is to be used (i.e. ready-to-eat/further processing required, heated prior to consumption)
This plan should aid in the identification of any areas of potential cross-contamination within the establishment, and
Type of package, including packaging material and packaging conditions (e.g. modified atmosphere) the floor and equipment layout should be considered in detail and assessed. Data may include but is not restricted to:
Shelf-life, including storage temperature and humidity if applicable Personnel routes
Where the product will be sold (e.g. retail, institutions, further processing) Routes of potential cross-contamination
Labeling instructions (e.g. handling and usage instructions) Area segregation
Special distribution control (e.g. shipping conditions) Flow of ingredients and packaging materials
(See Example in Appendix 3) Location of changing rooms, washrooms, lunchrooms and hand-washing stations
2.3 STEP 3: IDENTIFY THE INTENDED USE 2.5 STEP 5: ON-SITE CONFIRMATION OF THE FLOW DIAGRAM
The HACCP approach allows flexibility in terms of the level of control required within food businesses. This will be Once the process flow diagram has been drafted, it must be confirmed by an on-site inspection for accuracy and
dependent on the position of the company in the food chain and also the end user. For example, whilst vegetables completeness. This will ensure that all the major process operations have been identified. It will also confirm the
which are to be eaten raw may undergo chlorination to reduce the risk of pathogens, this would be a totally unnecessary assumptions made with respect to the movement of product and employees on the premises.
step if the vegetables were intended to be eaten cooked. It is also accepted that some hazards pose a greater risk to
The flow diagram should also be compared with the operation it represents on site. The process should be reviewed
vulnerable groups within the community such as the elderly, the very young or those with low immunity to infection.
at various times throughout the hours of operation to verify that the flow diagram is valid throughout all operational
For example, a factory producing dried milk to be sold for further processing including heat treatment (eg canned rice
periods. All members of the HACCP team should be involved in the flow diagram confirmation. Adjustments should
pudding) may have a lower level of control than a factory producing dried infant milk formula.
be made to the flow diagram, as necessary based on the actual operations observed.
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A hazard analysis must be conducted for each existing product or process type and for each new product. In addition, Each of the process steps identified above should be discussed by the team in order for preventative strategies to be
the hazard analysis done for a product or process type must be reviewed if any changes are made in raw material, implemented. These control measures are described as actions and activities which are implemented to eliminate
product formulation, preparation, processing, packaging and distribution or intended use of the product. hazards or reduce their occurrence to acceptable levels. It is often the case that more than one control measure may
be needed to control a hazard (e.g. low pH/temperature and pressure for Clostridium botulinum control in canned
foods), or alternatively that more than one hazard is controlled by any one measure (e.g. infectious pathogens in
2.6.3 HOW TO CONDUCT A HAZARD ANALYSIS. cooking).
The hazard analysis process is one of the most difficult aspects of HACCP and many operational failures in food safety The process steps at which they are implemented are termed control points (CPs), i.e. points at which biological,
are caused by problems with this step in the process. It is best attempted in a structured way, as presented in the 9 chemical or physical factors can be controlled.
step method below.
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2.7 STEP 7: DETERMINE CRITICAL CONTROL POINTS (PRINCIPLE 2) Table (1): Examples on Critical limits:
The determination of critical control points (CCPs) is the second principle of HACCP and this requires the identification
of steps in the process where control is necessary for product safety. At these critical control points (CCPs) control Hazard CCP Critical limit
measures need to be rigorously monitors and maintained to ensure that the product never fails to meet the required Bacterial pathogens Pasteurization 72C for at least 15 seconds
safety criteria. (non-sporulating)
Careful examination of the context of the hazard, in relation to the complete production process will identify those Metal fragments Metal detector Metal fragments larger than 0.5 mm
steps in the process where: Bacterial pathogens Drying oven Aw<0.85 for controlling growth in
A loss of control at that step would lead to an unacceptable health risk. dried food products
Bacterial pathogens Acidification step Maximum pH of 4.6 to control Clos-
The hazard will not be controlled later in the process.
tridium botulinum in acidified food
Prior to determining CCPs hazards should be reviewed to verify if any of the identified hazards are fully controlled by Food allergens Labeling Label that is legible and contains
the Good Hygienic practices (GHP). Furthermore, an on-site verification must be carried out by the HACCP team to correct list of ingredients
verify if those hazards are in fact controlled by the application of pre-requisite programs. Hazards that are not fully
controlled by pre-programs should be analyzed to determine whether they are CCPs or not. Histamine Receiving Maximum of 25 ppm histamine. To
be evaluated by sensory tests.
There are a number of tools that have been developed to assist HACCP teams in the identification of CCPs. These
include a variety of decision trees (See Appendix 1 and 2), adapted from the original version that is illustrated within
the Codex guidelines, that aims guide the team though a series of logical questions to determine criticality. Whilst
decision trees can be useful (especially in training) most experienced HACCP teams can identify CCPs using their 2.8.2 OPERATIONAL LIMITS
expertise and experience of their food process. Indeed, the decision trees do not apply in all situations and should be If monitoring shows a trend towards lack of control at a CCP, operators can take action to prevent loss of control
seen as only a guide to decision making. of the CCP before the critical limit is exceeded. The point would trigger such action is often called the target or
operating limit. Many food manufacturers will set such limits in addition to critical limits. Whilst critical limits define
the boundaries for safe food these additional limits provide the operator with an early warning that the system is
2.8 STEP 8: ESTABLISH CRITICAL LIMITS FOR CCPS (PRINCIPLE 3) moving out of control.
Operating limits should not be confused with critical limits. Often, the operating limits are more restrictive and are
2.8.1 CRITICAL LIMITS established at a level that would be reached before the critical limit is violated; i.e. they should prevent a deviation
At each CCP critical limits need to be specified. Critical limits are defined as criteria that separate acceptability from from critical limits.
unacceptability. A critical limit represents the boundaries that are used to judge whether an operation is producing An operator may observe a trend towards loss of control, such as the failure of a cooker to maintain the desired
safe product. One or more critical limits may be used to control the identified hazards. Examples of critical limits can temperature consistently. Observing a trend towards loss of control early and acting on it can save product rework
be found in Appendix X. or, worse yet, product destruction. When the critical limit is exceeded, corrective action is required (see section 2.9).
For this reason a processor may choose to operate a CCP at a limit more conservative than the critical limit. Such
Critical limits may relate to operating procedures, for example specific cleaning procedures, parameters such as pH, operating limits may be selected for various reasons.
water activity, salt levels, product characteristics or sensory characteristics such as color change. These parameters, if
maintained within boundaries, will confirm the safety of the product.
Table (2): Examples of Critical and Operating Limits.
The critical limits should meet requirements of government regulations and/or company standards and/or be
supported by other scientific data. In some cases, food control regulatory authorities provide information on which to Process Critical limit Operating limit
establish the critical limits based on known food hazards and the results of scientific studies (e.g. the time/temperature Acidification pH 4.6 pH 4.3
requirements for thermal processes such as pasteurization, cooking, retorting; maximum number and size of physical
contaminants, chemical residues). Many businesses use critical limits based on custom and practice rather than on Drying 0.84 Aw 0.80 Aw
evidence this Step in the HACCP is a good opportunity to validate these practices Hot fill 80C 85C
It is essential for the HACCP team to be aware of legal and commercial standards required for the product and obtain Slicing 2 cm 2.5 cm
the necessary information on which to base decisions. Examples of useful sources of information include:
Scientific publications/research data
Regulatory requirements and guidelines
Experts (e.g. thermal process authorities, consultants, food scientists, microbiologists, equipment manufacturers, 2.9 STEP 9: ESTABLISH A MONITORING SYSTEM (PRINCIPLE 4)
sanitarians, academics)
2.9.1 INTRODUCTION
Experimental studies (e.g. in-house experiments, contract laboratory studies)
The (HACCP) system and guidelines for its application defines monitoring as the act of conducting a planned
If the information needed to establish critical limits is not available, a conservative value should be selected or sequence of observations or measurements of control parameters to assess whether a CCP is under control.
regulatory limits used. The rationale and reference materials for all decisions made concerning critical limits (i.e.
validation data) should be recorded. The materials become part of the support documentation of the HACCP plan. 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. Therefore, it is important to specify fully how, when and
by whom monitoring is to be performed.
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The worst scenario is that in which monitoring procedures indicate that any one of the critical limits is exceeded, Monitoring can be continuous or non-continuous. Where possible, continuous monitoring is preferred; it is possible
which indicates loss of control of a CCP. This lack of control is considered to be a deviation resulting in the production for many types of physical or chemical methods.
of a hazardous or unsafe product. The situation requires immediate identification and control of the affected product Examples of continuous monitoring include:
and corrective action.
Measuring the time and temperature of a pasteurization or retorting process
Responsibility for monitoring should be clearly defined, and individuals must be adequately trained in the monitoring
procedures for the CCP for which they are responsible. They must also fully understand the purpose and importance Checking each package of frozen, mechanically chopped spinach with a metal detector
of monitoring. The individual should have ready access to the monitoring activity, must be unbiased in monitoring Monitoring the container closures on glass jars by passing them under a dud detector
and must accurately report the monitoring activity.
For continuous monitoring to be effective, it is necessary to review the monitoring results periodically and take action
when appropriate. The length of time between checks is important as it is directly related to the amount of product
2.9.2 DESIGN OF A MONITORING SYSTEM involved when there is a deviation from a critical limit.
The control measures identified at Step 5 are intended to control a hazard or hazards at each CCP. The monitoring Where non-continuous monitoring is the chosen system, the frequency of monitoring should be determined from
procedures will determine if the control measures are being implemented and ensure that critical limits are not historical knowledge of the product and process. When problems are detected the frequency of monitoring may
exceeded. need to be increased until the cause of the problem is corrected.
Each monitoring procedure should be fully detailed in the form of a Standard Operating Procedure (SOP) that act as The following questions will help to determine the correct frequency:
an operational and training reference for employees involved in CCP monitoring (see Section 2.12 ) How much does the process normally vary?
The monitoring SOP should include the following: How close is the operating limit to the critical limit?
Name/title of person responsible for the monitoring and evaluation of monitoring results How much product is the processor prepared to risk if there is deviation from the critical limit?
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In developing the HACCP plan consideration should be given to assigning responsibility for monitoring. Individuals Detailed procedures to be followed in the event of a process/product deviation.
assigned to monitor CCPs may include: The detail in the corrective action procedure will vary but should always include:
Line personnel How the affected product will be isolated
Equipment operators The procedure for dealing with the affected product
Supervisors How the process will be brought back under control
Maintenance personnel What must be done to prevent reoccurrence of the problem
Quality assurance personnel Records should be available to demonstrate the control of products affected by the deviation and the corrective
Once assigned, the individual responsible for monitoring a CCP must: action taken. Adequate records permit verification that the producer has deviations under control and has taken
effective corrective action.
Be adequately trained in the CCP monitoring techniques
The following information should be recorded in the deviation and corrective action records:
Fully understand the importance of CCP monitoring
Deviation
Have ready access (be close) to the monitoring activity
Product/code
Accurately report each monitoring activity
Date produced/held/released
Have the authority to take appropriate action as defined in the HACCP plan
Reason for the hold
Immediately report critical limit deviation
Amount of product held
Results of evaluation: amount analyzed, analysis report, number and nature of defects
2.10 STEP 10: ESTABLISH CORRECTIVE ACTIONS (PRINCIPLE 5)
Signature of personnel responsible for hold and evaluation
2.10.1 PROCESS OR PRODUCT DEVIATIONS
Disposition of held product (if appropriate)
The preceding steps have outlined the methodology required to maintain rigorous control of steps in the process that
are critical to consumer safety. However, even the best plans can sometimes fail and HACCP requires an extra level of Signed authorization for disposition
protection: the development of a series of crisis management plans to use in the event of loss of control or deviation Corrective action
- a CCP. Within the context of HACCP these plans are known as corrective actions.
Cause of deviation identified
All deviations must be controlled by taking corrective action(s) to control the non-compliant product and to correct
the cause of non-compliance. Product control includes proper identification, control and disposition of the affected Corrective action taken to correct deficiency immediately (i.e. quick fix)
product. The control and disposition of the affected product and the corrective action(s) taken must be recorded and Investigation to identify why the control measure failed with a appropriate follow up action (e.g. redesign of
filed. control measure, competency assessment of employees involved)
The diversity of possible deviations at each CCP means that more than one corrective action may be necessary at each Date and Signature of person responsible
CCP. When a deviation occurs, it will most likely be noticed during the routine monitoring of the CCP. Deviation and
corrective action procedures are prescribed so that employees responsible for CCP monitoring understand and are
able to perform the appropriate corrective action(s) in the event of a deviation. 2.10.3 ASSESSMENT FOR RELEASE
Process adjustments should also be made when monitoring results indicate a trend towards loss of control at a CCP. Product that fails to meet the critical limits specified in the HACCP Plan should only be released to customers when
Action should be taken to bring the process within the operating limits before a deviation occurs. any of the following conditions apply:
Evidence, other than monitoring data, demonstrates that the CCP has been effective.
2.10.2 CORRECTIVE ACTION PLANS Evidence demonstrates that the combined action of multiple control measures has been effective in reducing
Since the main reason for implementing HACCP is to prevent problems from occurring, corrective action should be the hazard to an acceptable level.
taken to prevent deviation at a CCP. Corrective action should be taken following any deviation to ensure the safety of The results of sampling, analysis and/or other verification activities demonstrate that the affected product
the product and to prevent recurrence of the deviation. meets acceptable levels of the hazard(s) concerned.
Corrective action plans are necessary to determine the cause of the problem, take action to prevent recurrence and The assessment procedures should follow those identified in the corrective action plan and the results of the
follow up with monitoring and reassessment to ensure that the action taken is effective. If the corrective action assessment shall be fully documented.
does not address the root cause of the deviation, the deviation could recur. Reassessment of the hazard analysis or
modification of the HACCP plan may be necessary to eliminate further occurrence.
Each corrective action procedure should be fully detailed in the form of a Standard Operating Procedure (SOP) that 2.10.4 DISPOSAL OF NON-COMPLIANT PRODUCT
acts as an operational and training reference for employees involved in this activity (see Section 2.12) If the results of the assessment for release indicates the product is not acceptable for release to customers it shall be
The corrective action procedure (SOP) should include the following: either:
Name or title of person that has the responsibility and authority to take actions Reprocessed within or outside the establishment (according to regulatory requirements) to ensure the
hazard(s) is reduced to an acceptable level
Detailed instructions for how results are to be recorded.
Destroyed and disposed of in a safe manner.
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The disposition of non-compliant product shall follow procedures established in the corrective action plan and shall The experience of the HACCP team members,
be fully documented. In-house specialists e.g. microbiologists,
Regulations,
2.11 STEP 11: ESTABLISH VERIFICATION PROCEDURES (PRINCIPLE 6) Industry Guides,
2.11.1 INTRODUCTION Research bodies,
Careful preparation of the HACCP plan with clear definition of all the necessary items does not guarantee the plans Suppliers,
effectiveness. Verification is necessary to assess the effectiveness of the plan and to confirm that the HACCP system
adheres to the plan. Trade organizations,
1. Those that are carried out to check if the system is meeting its objective to produce safe food. This is referred
to as validation. 2.11.2.4 DECISIONS RELATED TO CCPS
2. Those that are carried out to ensure that the HACCP plan is followed in practice. This is referred to as Compliance. A clear rationale must be kept for all decisions related to the identification of CCPs. Minutes of HACCP team meetings
should be kept to record the discussions and decisions made at the time. These records will form valuable evidence
during future validation activities.
2.11.2 VERIFYING THAT THE HACCP PLAN IS VALID
Validation is necessary at various stages throughout the life of a HACCP plan. Initially validation occurs as the HACCP
plan is being designed and decisions as to controls and limits are made. This validation can be termed the initial 2.11.2.5 VALIDATING THE CRITICAL LIMITS
validation or validation during design. Once the HACCP plan has been implemented and established it must be
Once the hazard analysis and CCP decisions have been justified the focus then turns to how to control these. When
subject to periodic, scheduled validation. This questions the effectiveness of the plan over time and can be termed
deciding on critical limits it must be proven that the limit selected will be capable of achieving the food safety
revalidation. Validation can and may also be prompted by change. Such a change could occur in the product or
objective, i.e. reduction in pathogen loading or cleaning routine.
process and prompt the controls in the plan to be reassessed. The key aim of these different types of validation
remains the same, i.e., to challenge the elements of the plan. However, the nature and focus of the questions asked When the critical limits are being validated there are two issues which require consideration:
may differ depending on the type of validation. Terms used to describe these different types of validation can vary. Is the critical limit capable of achieving the required food safety objective?
Validation activities can be conducted both internally and externally to the operation.
Can the critical limit be consistently achieved in practice?
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2.11.2.8 VALIDATION BEFORE IMPLEMENTATION plan. An example of a HACCP checklist is included in (Appendix 9).
Even with validation of each decision made during the design of the plan it is a good idea to have a final validation On-site observation may include, for example, visual inspection to ensure that:
immediately before the HACCP plan is implemented. This should be done by someone outside the original HACCP
The product description and flow diagram are accurate
team with HACCP knowledge and an understanding of the product / process. A fresh pair of eyes can sometimes
identify errors which the team has been too closely involved to see. Correcting these errors before implementation Monitoring required by the HACCP plan at the CCPs is performed
can save valuable time. This final validation stage can also give the team the reassurance and confidence they need
Processes are operating within established critical limits
to take the plan forward to implementation and justify the need for resources to make it work in practice. Suitable
people to validate the plan at this stage would be: Records are filled out accurately and at the time observations are made
A member of a HACCP team from a sister site / head office Records to be reviewed during auditing of the HACCP plan include, for example, those demonstrating that:
Someone from within the operation who has had HACCP training but was not involved with the initial design Monitoring activities have been performed at the locations specified in the HACCP plan
of the plan.
Monitoring activities have been performed at the frequencies specified in the HACCP plan
A consultant with experience in the relevant industry sector and HACCP knowledge.
Affected product has been controlled and corrective actions have been taken whenever monitoring has
indicated the occurrence of a deviation from critical limits
2.11.2.9 ONGOING / REVALIDATION OF THE HACCP PLAN Equipment has been calibrated at the frequencies specified in the HACCP plan Audits should occur frequently
enough to ensure that the HACCP plan is being followed continuously. This frequency depends on a number
When the plan has become established it is important that it is subject to scheduled revalidation. The purpose of
of conditions, such as the variability of the process and product.
the revalidation is to ensure the plans effectiveness and accuracy over time. This validation activity re-challenges
the original decisions and assumptions made as to the controls within the plan. After receiving further training and The essential support of HACCP that is provided by pre-requisite programs has already been discussed. As pre-
advice from external sources the team may look back on their original decisions and find they could be improved. requisite program are essential to the success of the HACCP plan it is important that they are also verified. Verification
Revalidation also questions the appropriateness of the plan in the light of changes which may have occurred since of pre-requisite program may be done alongside, or independently, of HACCP verification, however the types of
the plans implementation or last revalidation. Developments in HACCP methodology and application should also be activities and principles of verification remain the same for both of these elements of the food safety management
considered. In essence, revalidation provides an opportunity to reassess the controls within the plan with the valuable system.
benefit of hindsight.
Depending on the scope of the audit, a HACCP audit can also be used to assess the validity of the HACCP systems
as well as to verify compliance with the plan. However, technical specialists are required for this purpose and most
HACCP audits do not include this function.
2.11.2.10 WHEN TO VALIDATE
The type and timing of validation will vary depending on the maturity of the HACCP plan and the nature of the
operation. Once the initial validation has been carried out and the plan is implemented validation should then take 2.11.3.2 VERIFICATION FREQUENCY
place at regular, predetermined intervals and is commonly an annual event. Validation may happen more often than
Verification activities should be performed according to a pre-established schedule described in the HACCP plan or
this in complex operations or those operations which experience frequent changes.
whenever there are indications that the food safety status may have changed.
These indications may include:
2.11.3 VERIFICATION AUDITS TO ASSESS COMPLIANCE
On-line observations that CCPs may not be operating within critical limits
Verification is the term used to describe any activity that seeks to assess the level to which the controls and procedures
Record reviews indicating inconsistent monitoring
prescribed within the HACCP plan are being adhered to in practice. In other words, verification seeks to confirm
compliance with the HACCP plan. Verification usually takes place once the HACCP plan has been developed and Record reviews indicating that CCPs are repetitively operated outside critical limits
implemented and helps to ensure that compliance with the system is assessed and improved as the HACCP plan
matures and develops. Consumer complaints or product rejections by customers
New scientific data
2.11.3.1 THE AUDIT Verification procedures should be scheduled at a frequency that ensures that the HACCP plan is being followed
continuously and that measurements remain accurate within established limits.
Auditing is a well-established technique used to check practical compliance against planned procedures. It is
a standard tool in many areas of business including financial and quality management and has become the main Thus, the length of time between scheduled verification activities should match the level of confidence in the
verification method used by food businesses to check that they are complying with the HACCP Plan. continuous and accurate performance of the HACCP plan.
The activity of auditing involves comparing practice with a documented standard, generally posing the question are The frequency of verification activities may change over time. A history of verification activities indicating that the
we doing what we planned to do? When applied to HACCP this means comparing the actual practices and activities process is consistently in control may support safe reduction of the frequency of verification activities.
that take place within the food operation to the documented practices and activities as set out within the HACCP
plan. From such an assessment conclusions can then be drawn to enable any non-compliance to be corrected and to
ensure that practices reflect the HACCP plan. 2.11.4 TYPES OF AUDIT
A HACCP audit is defined as an systematic and independent examination involving on-site observations, interviews Audits can be carried out either internally or externally and further divided into first, second or third party involvement.
and review of records to determine whether the procedures and activities stated in the HACCP plan are implemented The third party audit is perceived to be the most effective due to the independent nature of the auditor. However,
in the HACCP system. These examinations are usually performed by one or more independent persons who are not with careful selection and training the performance of the internal auditor can be increased significantly and, in some
involved in implementation of the HACCP system. Audits may be performed for individual CCPs and/or for the overall cases, match that of externals.
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Table 3: Audit Activity Classification Regulatory verification can also be used to challenge the HACCP plan in the event of outbreaks of illness or consumer
complaints. Verification in such situations would include review of the company consumer complaint file. New
Type Auditor Status technological information or an industry request for consultation may also result in verification actions by regulatory
Internal Business operator 'First Party' agencies.
External Customer 'Second Party'
Independent 'Third Party' 2.11.8 MICROBIOLOGICAL TESTING IN HACCP VALIDATION AND VERIFICATION
Regulatory Authority 'Third Party'
Sampling and microbiological testing are usually not adequate by themselves to ensure food safety. Microbiological
testing is seldom effective for monitoring CCPs and cannot be used as a means of process control because of
2.11.5 SELECTION OF AUDITOR / AUDIT TEAM. the lengthiness of analytical procedures and the inability to provide results in real time. In addition, detection of
pathogenic microorganisms can be difficult if contamination of the product at the CCP is at a low level or is unevenly
To perform an effective HACCP audit several key skills are required and these should be taken into consideration when
distributed in the food sample, necessitating large and numerous samples.
selecting the person(s) that will carry out the audit. HACCP audit skills include:
Microbiological testing does have a role in HACCP verification, however: when critical limits are established for the
o Qualifications and experience in HACCP methodology
elimination of pathogens or their reduction to an acceptable level, microbiological testing can be used to verify the
o Qualifications and experience in food science directly relevant to the product / process / industry sector HACCP plans effectiveness and to ensure that the identified microbiological limits have not been exceeded. In this
o Qualifications and experience in auditing. instance, the length of time involved in the analytical procedures does not create operational difficulties.
o Independence
It is often the case that it is impossible to select one person who can demonstrate all these skills. This is why effective 2.11.9 OTHER METHODS OF VERIFICATION
HACCP audits, especially if any aspects of technical validation are required, usually requires a team approach. It is A HACCP system will produce significant amounts of data that can be used to assess whether the HACCP system is
necessary to clearly define the objective of the audit (for example: validation or compliance, individual process or being complied with over time, in addition to audit results. This exercise may highlight trends towards a loss of control
whole production line) before auditors are contracted. In the case of external Certification Audits it is the business at certain CCPs, and can be a prompt for investigation or corrective action. Types of data that may be useful include:
owners responsibility to ensure the competence of auditors contracted for this purpose. At the very least, the full
profile of auditors should be requested in advance of an audit visit. CCP records
Process control charts
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HACCP documents also include correspondence with consultants/external experts, as well as documents detailing SOP examples include:
how the HACCP plan was developed, minutes of team meetings and most importantly, the rationale for all decisions Description of the monitoring system for the critical limit of each CCP
made. Plans for corrective actions for critical limit violations or situations resulting in potential hazards
Description of record keeping procedures, including copies of all record forms
Description of verification and validation procedures
2.12.2 HACCP CONTROL CHARTS
The process of identification of CCPs and plans for their control are usually documented in the form of a Control Chart SOPs are only of value if they are written with sufficient detail so that employees can understand the follow them. As
a table containing all the key information related to the CCPs. The template outlined in the Codex HACCP guidelines a guide, SOPs should be:
has become a standard for industry, with adaptation to meet local government requirements or industry preference. Easy to understand (e.g. pictures or diagrams)
(See Appendices 5 & 6). Easy to read (e.g. large, clear lettering)
Not too long (e.g. no unnecessary details)
A Codex style example can be seen in Figure 3 below. This is a simplified HACCP Control Chart of the manufacture of
Cover all the steps required (e.g. nothing important missed out)
potato crisps. The complete chart would have a lot of extra detail (e.g. SOPs, justification, record sheets) to support
Written with employee involvement (e.g. who have practical experience of the procedures)
it. It would also be necessary to cross-reference the process steps against the flow diagram and control measures,
Tested by employees (to ensure they can be followed)
monitoring procedures and corrective actions would be required to be documented as SOPs.
Validated (to make sure they are safe)
Easily accessible (e.g. in the place where they are used)
Figure (3): HACCP Chart example (Hazard: Metal)
Process Step Hazard Control CCP Critical Limit Monitoring Corrective Action 2.12.4 HACCP RECORD KEEPING
Measure procedure HACCP record keeping systems record what actually takes place on a daily basis and forms a history of actual events.
Purchase Presence Safe, No The records are kept to demonstrate adherence of the HACCP system with the HACCP plan. These records are used to
of metal in approved demonstrate, for example, control at CCPs in the food process. By tracking records generated by the HACCP system,
potatoes supplier an operator or manager can become aware that a process is approaching its critical limit. Review of records can be
instrumental in identifying trends and in making operational adjustments. Timely corrective action can be taken if a
Sieving Persistence Correct No
critical limit is violated.
of metal in sieving
flavoring
The records generated by the HACCP system include all activities and documentation required by the plan, as follows:
Metal Persistence 100% metal Yes X mm 100% of If metal detector is activated Monitoring records for all CCPs
detection metal detection (ferrous) product is when there is no test piece, Corrective action records
contamination Y mm (non monitored production must be stopped, Verification records
ferrous) 100% of the last batch of product In-house on-site inspection
metal time with must be removed, sent Equipment testing and evaluation
metal through detector again until Accuracy and calibration of monitoring equipment
detector. metal found and removed. Training of employees
This source of the metal
Metal should be investigated and
detector the problem recorded.
itself is If metal detector is not
3. HACCP SYSTEM MAINTENANCE
The HACCP system, if developed and applied according to the previous 12 steps, will be have the potential to control
monitored activated when test piece
specific food safety hazards and, in combination with pre-requisites, to produce safe food products. However, HACCP
with two goes through, production
requires, like any other management system, actively maintained and reviewed regularly to ensure continuous
test pieces must be stopped and all
improvement.
that are put product since the last check
through the must be removed. This must
machine be tested again in a working REFERENCES
at regular metal detector, and if safe
1. Abu Dhabi Food Control Authority. (2010) Regulation No (6). Food Hygiene throughout the Food Chain. ADFCA:
intervals. can continue. The faulty
Abu Dhabi.
metal detector must be
repaired/replaced and the 2. Standardizations Organization for G.C.C (2007) UAE.S GSO ISO 22000: 2007.Food Safety Management Systems:
problem recorded. requirements for any organization in the food chain. GSO.
3. Standardizations Organization for G.C.C (2005) General Principles of Food Hygiene.1694 / 2005. GSO.
2.12.3 DOCUMENTATION OF FOOD SAFETY PROCEDURES 4. Food & Agricultural Organization (1998) Food Quality and Safety Systems - a Training Manual on Food Hygiene
An essential step in managing food safety is the formalization of food safety procedures and this is a major part of and the Hazard Analysis and Critical Control Point (HACCP) System.FAO: Rome.
any food safety management system, including pre-requisites. This is achieved through the development of clear,
easy to follow instructions for all procedures that affect food safety. These are often referred to as Standard Operating 5. Food & Agricultural Organization (2008) Food Hygiene Basic Texts.FAO: Rome.
Procedures (SOPs) and should relate to the specific business. 6. Canadian Food Inspection Agency (2010) Food Safety Enhancement Program Manual. CFIA: Toronto.
7. Codex (2008). Guidelines for the Validation of Food Safety Control Measures. CAC/GL 69 2008. Codex: Rome.
[http://www.codexalimentarius.net/web/standard_list.do: Accessed Nov 9th 2008
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Ref: Canadian Food Inspection Agency (2010) Food Safety Enhancement Program Manual. CFIA: Toronto.
Ref: Food & Agricultural Organization (2008) Food Hygiene Basic Texts.FAO: Rome.
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APPENDIX 3 - PRODUCT DESCRIPTION: EXAMPLE APPENDIX 4- INGREDIENT AND RAW MATERIAL APPROVAL FORM: EXAMPLE
1. Product name(s) Canned mushroom RAW MATERIAL PACKAGING MATERIAL DRY INGREDIENTS
2. Important product characteristics of end product (e.g. Aw, pH, etc.) pH 4.8 to 6.5 (low acid) Mushrooms Cans Salt
Aw > 0.85 (high moisture) (domestic, white) Ends Ascorbic acid
Citric acid
3. How the product is to be used Normally heated before serving (casseroles, garnishes, etc.) or served
unheated (salads, appetizers, etc.) OTHER
6. Where the product will be sold Retail, institutions and food service. Could be consumed by high-risk
groups (infirm, immune compromised, elderly)
8. Special distribution control No physical damage, excess humidity or temperature extremes DATE: ___________________ APPROVED BY: ____________________
Ref: Food & Agricultural Organization (1998) Food Quality and Safety Systems: Training Manual on Food Hygiene and the Hazard Analysis and Critical
Control Point (HACCP) System.FAO: Rome.
DATE: ___________________ APPROVED BY: ____________________
Ref: Food & Agricultural Organization (1998) Food Quality and Safety Systems: Training Manual on Food Hygiene and the Hazard Analysis and Critical
Control Point (HACCP) System.FAO: Rome.
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Product: Canned Mushroom This is a simplified HACCP Control Chart used to identify any critical controls for pesticides in the chickpeas pur-
chased for the production of humus. The complete chart would have a lot of extra detail (e.g. SOPs, justification,
record sheets) to support it. It would also be necessary to cross-reference the process steps against the flow diagram
MUSHROOM (Raw) EMPTY CANS/ENDS DRY INGREDIENTS WATER (municipal)
and control measures, monitoring procedures and corrective actions would be required to be documented as SOPs.
Receiving Receiving Receiving Intaking
The specific pesticide(s) of concern would also be identified.
Storing Storing Storing
Dumping/Washing Inspecting/Depalletizing Dumping Process Step Hazard Control CCP Critical Limit Monitoring Corrective Action
Measure procedure
Blanching Conveying Mixing
Purchase of Pesticide residues Purchase only from Yes Every batch Operative to check If batch is not from
Conveying/Inspecting Washing chickpeas above approved safe, approved from approved every batch, and approved supplier, put
levels in product supplier with supplier only, only allow through on hold. Investigate to
Slicing/Dicing Brine injecting verifiable GAP. with supporting if on approved list ensure safety.
(ref: supplier documents. and with supporting If documentation
Foreign object removing Filling specification documents is not in place/ not
in relation to in accordance with
Weighing pesticides). specification put on
hold and contact
Water filling supplier to request
further details (if
Head-spacing needed immediately
request faxed copy).
Record all problems in
End feeding/Closing/ Inspecting Chlorinating
corrective action log,
and review supplier
Thermal processing appraisal.
Cooling
Conveying/Drying
DATE: _________________ APPROVED BY: ___________________
Labelling/Storing
Shipping
Ref: Food & Agricultural Organization (1998) Food Quality and Safety Systems: Training Manual on Food Hygiene and the Hazard Analysis and Critical
Control Point (HACCP) System.FAO: Rome.
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APPENDIX 7- HACCP CHART: EXAMPLE 2 APPENDIX 8- HACCP PLAN: EXAMPLE (BOTTLED WATER)
This is an extract from a generic HACCP Chart that identifies the analysis of the chilled storage process step. 8.1 IN-LINE MONITORING OF CCP
Chilled Uncon- CCP2 4C for Temp. readout Stores Every 3 Isolate em-
Storage trolled Chilled Digital hours and perature
tempera- identify Record
ture may -18C for affected
result in Frozen items Audit
multiplica- Items Reports
tion of Re check
pathogen- tempera- Training
ic micro ture of records
organisms food
to unac- Calibra-
ceptable Move to tion Logs
levels another
chiller Mainte-
Repair nance
chiller Reports
Discard
Reverse Osmosis Laboratory / QC supervisor verify the Finished Product Release / Hold Report
(RO) Finished Product Bromate analysis report on (Bromate Analysis)
Bromate analysis report daily
Post Ozonation QA Supervisor verify the Daily post ozone Daily Production Line Monitoring Report
monitoring report on daily.
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8.3 HACCP CHART: EXAMPLE 2 APPENDIX 9- HACCP PLAN AUDITOR CHECKLIST: EXAMPLE
Extract from HACCP PLAN: Critical Limits, Monitoring and Corrective Actions Activity Yes No
Product: Bottled Drinking Water
1. Describe the Product
a. does the HACCP plan include :
Process Step/ CCP Critical Limits Monitoring Procedures Corrective Actions I. The procedure / establishment and the product name?
(Who/What/When/How/ (What & Who) II. The ingredient and raw materials used along with the product receipt or formation?
Where) III. The packaging used?
IV. The temperature at which the product will be prepared for consumption?
b. Has a flow diagram for the product have been developed that is clear, simple and descriptive of the step through the
Reverse Osmosis <10 ppb Who: Lab Technician / HSEQ Immediate: Isolate product, re- process?
(RO) What: Bromate level less than 10 ject load or hold until documen- c. Has the flow diagram been verified for accuracy and completeness against the actual process?
Hazard: Chemical Hazard ppb tation provided.
When: Before releasing the FP to By: Lab technician/ Produc- 2. Conduct a Hazard Analysis
High Bromate in the Finished the market tion supervisor/ Warehouse a. Have all steps in the process been identified and listed where hazards of potential significance occur?
Product How: Analyze the Finished prod- Supervisor b. Have all hazards associated with each identical step been listed?
c. Have safety concerns been differentiated from quality concerns?
uct with Iron Chromatograph
d. Have preventive measures to control the identified hazard have been identified, if they exit and listed?
Where: Laboratory Preventive: Monitoring of RO
performance 3. Identify Critical Control Points
By: Water Treatment Operator a. Has the CCP decision tree been used to help determine if a particular step is a CCP for a previous identified hazard?
b. Have the CCPs been entered on the forms?
Post Ozonation 0.02 ppm to 0.05ppm Who: Water Treatment Operator Immediate: Stop the production c. Have all significant hazards identified during analysis been addressed?
What: Presence of Ozone Level line & Hold the Finished Product 4. Establish Critical Limits
Hazard: Microbiological Hazard When: Every 2 hours from the last inspection time. a. Have critical limits been established for each preventive measure at each CCP?
How: With HACH portable instru- Re-set the Ozone Unit b. Has the validity of the critical limits to control the identified hazard been established?
Ozone presence after filling ment / DPD Tablet Method By: QA Supervisor/ Production c. Were critical limits obtained from the regulation, processing authority, etc?
Where: Near Post Ozone Unit & in Supervisor d. Is documentation attesting to the adequacy of the critical limits maintained on file at the establishment?
the Laboratory Preventive: Proper maintenance 5. Establish Monitoring Procedure
& calibration of Ozone unit a. Have the monitoring procedure been developed to assure that preventive measures necessary for controls at each
By: Maintenance Team & Lab CCP are maintained within the established limits?
Technician b. Are the monitoring procedures continuous or, when continuous Monitoring is not possible, is the frequency of
monitoring sufficiently reliable to indicate that the hazard is under control?
c. Have procedure been developed for systematically recording the monitoring data?
d. Have employees responsible for reviewing monitoring records been identified and trained?
e. Have procedures been developed for using the results of monitoring to adjust the process and maintain control?
6. Establish Corrective Actions
a. Have specific corrective actions been developed for each CCP?
b. Do the corrective actions addressed :
i. Re-establishment of process control?
ii. Disposition of affected product?
iii. Procedure to correct the cause of non-compliance and to prevent the deviation from recurring?
c. Have procedure been established to record the corrective actions?
d. Have procedure been established for reviewing the corrective actions records?
7. Establish Record keeping procedures
a. Have the procedure been established to maintain the HACCP plan on file at the establishment?
b. Do the HACCP records include:
I. Description of the product and its intended use?
II. Flow diagram for the process, indicating the CCPs?
III. Control measures?
IV. Critical limits?
V. Monitoring systems
VI. Corrective action plan for deviation from critical limits?
VII. Record keeping procedure for monitoring?
VIII. Procedures for verification of HACCP system?
8. Establish verification Procedures
a. Have procedure been included to verify that all significant hazards were identified in the HACCP?
b. Plan when it was developed?
c. Have procedures been included to verify that the critical limits are adequate to control the identified hazard?
d. Are procedures in place to verify that the HACCP system is functioning properly?
e. Are procedures in place to reassess the HACCP plan and system on a regular basis whether significant, process or
packaging changes occur?
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APPENDIX 10- VALIDATION PROCEDURES: EXAMPLES b. The control measure (label) will be considered validated if a specified percentage of the population under-
stands the label (i.e., having read it, they can state what they would do if following the label instructions)
and indicates that they plan to follow the instructions.
This document contains examples of several approaches to validating control measures or combinations of control
measures. All of the examples described below are for purposes of illustration only, do not represent actual valida- 4. Assemble relevant validation information:
tion scenarios in a global sense and should not be replicated as presented. Also, the examples below are presented a. Identify target demographic for survey
in a specific format only for consistency and this format is not intended to be a general model for validation. b. Design a statistically-valid survey to determine
In the examples below, it is assumed that the control measures have not been previously validated, that they have a Current consumer practices
decisive impact on the control of the specific hazard, and that they have been prioritized for validation.
Whether the label is understandable
Whether consumers plan to change their current practices, if necessary, based on the label instructions.
EXAMPLE ONE: CONTROL OF METAL FRAGMENTS
5. Analyze the results:
1. Pre-validation Tasks:
a. Determine the percentage of the population that is not currently following the practices described on the
a. Hazard: Metal fragments label.
b. Food Safety Outcome: Less than 1 metal fragment over 2 mm in 100,000 kg of product. b. Determine the percentage of the population that understands the label instructions.
c. Control Measure: Introduction of a sieve into a production line c. Determine the percentage of the population that indicates that they plan to change their current practice
2. Approach: Collection of data during normal operation. and follow the label instructions.
3. Parameters and Decision Criteria: 6. Document and review the validation:
Control measure will be considered validated if a metal detector indicates that production with the sieve will a. Document the development of the survey
allow < 1 metal fragment 2 mm in 100,000 kg of final product. Operational data will be collected for one b. Document the identification of the target demographics for the survey
month and reviewed to determine the size of any metal pieces in products rejected by the metal detector.
c. Document the survey results
4. Assemble relevant validation information.
7. Conclusion
a. Determine the size of metal fragments in products rejected by the metal detector.
The control measure can be implemented because data indicated that because of the label instructions more than
b. Ensure that the metal detector is sensitive enough and calibrated to detect metal pieces of 2 mm or more 25% of the population plan to change their current practice and begin refrigerating eggs at 5C (41F) and, when
in the specific product. appropriate, cooking eggs until the yolk is firm.
c. Ensure that the sieve remains intact during normal operations.
5. Analyze the results EXAMPLE THREE: VALIDATION OF CLEANING AND DISINFECTING PROTOCOLS (Sanitation Standard Operating
Determine the rate at which the sieve allowed fragments of 2 mm or more in the final product. Procedures, SSOPs)
[CAC/GL 69 - 2008 Page 14 of 16 ] 1. Pre-validation Tasks
6. Document and review the validation a. Hazard(s): Generic microbial contaminants
a. Document all findings from the metal detector. b. Food Safety Outcome: Effective sanitation of food-contact surfaces as demonstrated by compliance with
b. Document the integrity of the sieve and the sensitivity and calibration of the metal detector. microbiological criteria.
7. Conclusion c. Control Measure(s): Cleaning and disinfection protocols (SSOPs) within a facility
a. Control measure can be implemented if data indicate that production with the sieve will allow < 1 metal 2. Approach: Collection of scientific data.
fragment 2 mm in 100,000 kg of final product. 3. Parameters and Decision Criteria: SSOPs will be considered to be validated if, after implementation of clean-
b. Validation will likely provide information on monitoring needed to ensure that sieve remains intact. ing and disinfection protocols, food contact surfaces meet microbiological criteria established for aerobic
plate counts or other indicator microorganisms as appropriate.
c. The metal detector can be used after the validation as an ongoing verification activity to ensure that the
sieve is controlling the hazard as intended.
EXAMPLE TWO: VALIDATION OF A SAFE-HANDLING LABEL FOR TABLE EGGS Ref: Codex. Guidelines for the Validation of Food Safety Control Measures. CAC/GL 69 2008
1. Pre-validation Tasks: [ http://www.codexalimentarius.net/web/standard_list.do Accessed Nov 9th 2008 ]
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