Implementation and Management of Safety Systems

Report
Implementation and Management of
Safety Systems
Implementation and Management of
Safety Systems
1. Prerequisites to HACCP
• Prerequisite is the term used to describe systems that must be in place in
order to support the HACCP (Hazard Analysis and Critical Control Point) System.
• Prerequisites include, where appropriate:
cleaning and sanitation;
maintenance;
personnel hygiene and training;
pest control;
premises and structure;
plant and equipment;
Implementation and Management of
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1. Prerequisites to HACCP
– services (e.g. compressed air, ventilation, water, etc.);
– storage, distribution and transportation;
– waste management;
– physical separation of activities to prevent potential food
contamination.
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2. The HACCP Concept
• Systematic approach of identifying and controlling hazards that could pose a
danger to the preparation of safe food.
• HAACP is a method of ensuring food safety by examining every step in a food
operation, identifying the steps that are critical to food safety and implementing
effective control and monitoring procedures at these steps.
• In 1985 HACCP was first taken into consideration for general implementation
in the food industry by the National Academy of Science (NAS);
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2. The HACCP Concept
• In 1988, the International Commission on Microbiological Specification for
Foods (ICMSF) suggested the use of systems HACCP as a base to quality
control;
• In the European Union, the Council Directive on the Hygiene of Foodstuffs
no. 93/43/EEC, sets out the general hygiene principles and conditions for
foodstuffs to apply throughout the food chain.
• Among numerous requirements it states the necessity for each food business
to apply the principles of HACCP.
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3. The HACCP Principles
• The practical implementation of a HACCP System normally follows a
methodology based on seven Principles:
Principle 1 - Hazards analysis;
Principle 2 - Identification of the critical control points;
Principle 3 – Establishment of critical limits;
Principle 4 – Establishment of a monitoring system;
Principle 5 – Establishment of the corrective actions;
Principle 6 – Establishment of verification, validation and review;
Principle 7 – Documentation and records.
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4. The HACCP Methodology
• The HACCP methodology is normally described in 12 steps:
1. The HACCP team;
2. Product description/characterization;
3. Identification of the intended use f or the product;
4. Flow diagram construction;
5. On-site verification of the flow diagram;
6. Identification and hazards analysis;
7. Identification of Critical Control Points (CCPs);
8. Establishment of Critical Limits;
9. Establishment of a monitoring system;
10. Establishment of corrective actions;
11. Establishment of verification procedures, validation and review;
12. Documentation and records.
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4. The HACCP Methodology
• In this 12 steps are included the seven principles of HACCP.
• When the decision is taken to use HACCP within an organization, it is important
there to avoid the inclination that often occurs to charge ahead and start doing
something without taking the time to consider the best approach: the use of the
HACCP methodology.
• HACCP system must not be carried out by one person alone but as the result of
a multi-disciplinary team effort – the HACCP Team.
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4.1. The HACCP Team
• It is recommended that as a minimum the core HACCP team consists of experts
from the following areas:
–Quality Assurance/ Technical;
–Operations or Production;
–Engineering;
–Additional expertise.
•The leader will have a key role in the success of the HACCP systems and he or
she is likely to become the company HACCP expert and be regarded as such.
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4.2. Product Description/Characterization
• The HACCP team skills in relation to technical issues are important here. A full
understanding of the product and the process is necessary.
• At this stage a product description must be constructed for two reasons:
– It is essential that HACCP Team is fully familiarized with the products and
process technologies to be covered by the HACCP Plan.
– The product description acts as an introduction and point of historical
reference to the HACCP Plan.
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4.2. Product Description/Characterization
• All raw materials, substances and food contact materials shall be described to
the extent necessary for the identification and assessment of hazards, including
as appropriate the following:
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Chemical, biological and physical characteristics;
Composition including additives and processing aids;
Origin and method of production;
Delivery method, packaging and storage conditions;
Preparation before use;
Acceptance criteria.
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4.3. Identification of the Intended Use For the Product
• The intended use of the end product shall be described.
• Users and consumers shall be identified for each product/ product category
and consumer groups known to be especially vulnerable to hazard shall be
considered.
• Children, older persons and illness people are normally considered as group of
risk as their immunological system is not totally developed or is debilitated.
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4.4.Flow Diagram Construction
• The flow diagrams shall be prepared for the products/product categories
covered by the safety management system.
• A process flow diagram is simply a diagrammatic representation of the stages
involved in producing a product. Is used as the basis of the hazard analysis and
must therefore contain sufficient technical detail for the study to progress.
• The simplest type of flow diagram is a linear process step diagram.
• Effectively, it is a description of how a product is produced chronologically,
broken into logical stages.
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4.4.Flow Diagram Construction
• The following types of data should be included:
– Details of all raw materials and product packaging, including reception
and storage conditions;
– Details of all process activities, including the potential for any delay stages.
– Temperature and time for all stages. This will be particular important
when analyzing microbiological hazards as it is vital to assess the
potential for any present pathogens to grow to hazardous levels;
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4.4.Flow Diagram Construction
– Types of equipment and design features;
– Details of any reworking or recycling loops;
– Floor plan with details of segregated areas and personnel routing;
– Distribution/ customer issues.
When the process flow diagram is complete it must be verified by the HACCP
team prior to the hazard assessment stage.
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4.5. On-site Verification of the Flow Diagram
• The HACCP team should endeavor to ensure that the diagrammatic
representation is true to the practice on the facilities floor.
• This can be done by following the product through and by seeking verification
from staff members involved in the particular line.
• Once this is completed, only then should the diagram be verified and passed as
a live document for progression to later stages.
• This should be the date record on the example above. If the walk through
indicates variances then these must not be ignored, but should form the basis
of an updated flow diagram.
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4.6. Identification and Hazards Analysis
• A hazard is something that has the potential to cause harm, it may be physical,
chemical or biological.
• Within the HACCP study we need to take a logical, practical approach to risk
assessment.
• At the end of the hazard identification step, the HACCP team will have a list of
potential hazards that might occur in the raw materials or during the process.
• Risk assessment involves the evaluation of the potential hazards on this list, to
establish the realistic or significant hazards that the HACCP system must control.
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4.6. Identification and Hazards Analysis
• Some useful definitions are: the probability or likelihood that an adverse health
effect will be realized and its severity.
• Following on from the identification of hazards, the process of risk assessment
involves three additional steps:
– exposure assessment;
– hazard characterization;
– risk characterization.
• Hazard characterization is an evaluation of the nature of the adverse effects or
severity associated with the hazard.
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4.6. Identification and Hazards Analysis
• Risk characterization is the estimation of the adverse effects likely to occur in
the population.
• Several different approaches to risk assessment can be adopted by the HACCP
team.
• They include qualitative and quantitative techniques. Both the severity and the
probability of the occurrence should be considered.
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4.7. Identification of Critical Control Points
• A Critical Control Point is a point, step or procedure where a food safety hazard
can be prevented, eliminated or reduced to acceptable levels.
• To assist in finding where the correct CCPs should be, is available a tool known
as the CCP Decision Tree.
• A decision tree is a logical series of questions that are asked for each hazard.
• The questions in the tree should be asked for each hazard at each process step.
• The following decision tree is based on the one in Codex Alimentarius but with
some simplifications and amendments (Fig.1).
Q1) Is there a significant hazard at this process step?
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Yes
No
Proceed to next step
Q2) Do control measure(s) exist?
Yes
Modify step, process or
product
No
Is control at this step necessary for
safety?
No
Yes
Not a CCP
Stop
Q3) Is the step designed to eliminate or reduce the hazard to an acceptable
level?
Yes
No
Q4) Could contamination with identified hazard(s) occur in excess of acceptable level(s) or
could these increase to unacceptable levels?
Yes
No
Not a CCP
Stop
Q5) Will a subsequent step eliminate identified hazards or reduce likely occurrence to an
acceptable level?
Yes
Critical Control Point
No
Fig. 1 - The decision tree
Not a CCP
Stop
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4.7. Identification of Critical Control Points
Q1 – Is there a hazard at this process step?
• This first question will seem obvious but it helps to focus the HACCP team’s
minds on the specific process step in question. If there is no significant hazard
there is nothing that needs control, and this process step is not a CCP.
• If there is a hazard then you should move on to question two (Q2).
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4.7. Identification of Critical Control Points
Q2 – Do control measures exist for the identified hazard?
• Here you need to consider the measures you already have in place along with
what could be implemented.
• If the answer to this question is yes, then you should move straight on to
question three (Q3).
• If, however, the answer is no and control measures aren’t and could not be put
in place, then you must consider whether control is necessary at this point for
food safety.
• If control isn’t necessary here then a CCP is not required and you should move
on to the next hazard and start the decision tree again.
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4.7. Identification of Critical Control Points
Q3 – Is the step specifically designed to eliminate or reduce the likely occurrence
of the hazard to an acceptable level?
• If a process step is designed to remove a hazard or reduce it so that it is not
hazardous, this is obviously a CCP.
• If the step is not so designed, we have to progress to see if the hazard will be
removed later in the process.
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4.7. Identification of Critical Control Points
Q4 – Could contamination occur at or increase to unacceptable level (s)?
• This question can require a significant level of technical expertise, and
consultation with experts may be required. It has to be appreciated, may be
cumulative and thus numerous process steps need to be considered to make a
judgment.
• The answer should be largely obvious from the hazard analysis but make sure
that you have covered the following issues:
 Is the immediate environment likely to include the hazard(s)?
 Is cross-contamination possible via personnel?
 Is cross-contamination possible from another product or raw material?
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4.7. Identification of Critical Control Points
Q4 – Could contamination occur at or increase to unacceptable level(s)?
 Could composite time/ temperature conditions increase the hazard?
 Could product build up in deal-leg spaces and increase the hazard?
 Are any other factors or conditions present which could cause
contamination to increase to unacceptable levels at this step?
 If the answer to question four (Q4) is yes, move on to the decision tree
with the next hazard or process step.
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4.7. Identification of Critical Control Points
Q5 – Will a subsequent step or action eliminate or reduce the hazard to an
acceptable level?
• This question is designed to allow the presence of a hazard or hazards at a
particular process stage if they will be controlled either later in the process or by
consumer action.
• In this way it minimizes the number of process steps which are considered to
be Critical Control Point (CCP) and focuses on those steps which are crucial for
product safety.
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4.8. Establishment of Critical Limits
• A critical limit is the monitored limit which if exceeded means the CCP will not
be effective, and thus the identified hazard may occur. Critical limits must also,
as far as possible, be exact and monitored.
• The HACCP team must therefore fully understand the criteria governing safety
at each CCP in order to set the appropriate critical limit.
• In other words, you must have detailed knowledge of the potential hazards,
along with a full understanding of the factors that are involved in their
prevention or control.
• Each CCP may have a number of different factors which need to be controlled
to ensure product safety, and each of these factors will have an associated
critical limit.
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4.8. Establishment of Critical Limits
• In order to set the critical limits, all the factors associated with safety at the
CCP must be identified. The level at which each factor becomes the boundary
between safe and unsafe is then the critical limit.
• It is important to note that the critical limit must be associated with a
measurable factor that can be monitored routinely by test or observation.
• In addition to critical limits you may find it advantageous to have another layer
of control to help manage the process.
• The critical limits can be used as an additional measure to indicate drift in the
process, and you can then adjust the process to maintain control before the CCP
actually deviates from its critical limits.
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4.9. Establishment of a Monitoring System
• Monitoring is the scheduled measurement or observation at a CCP to ensure
compliance with target levels and that the process is in control.
• The specific monitoring procedure for each individual CCP will depend on the
critical limits, and also on the capabilities of the monitoring device or method.
• It is essential that the chosen monitoring procedure must be able to detect loss
of control at the CCP, as it is on the basis of monitoring results that decisions are
made and action is taken.
• The nature and frequency of the monitoring will therefore be variable,
depending on the production method and the nature of the hazard.
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4.9. Establishment of a Monitoring System
• The final consideration in relation to monitoring is the means of recording. Not
only is documentation a principle of HACCP, but also the monitoring serves as
an essential aspect of a “due diligence” approach.
• There should also be clearly indicated on any documentation or training
materials the required corrective action to be taken if the monitoring exceeds
the indicated critical limit; and this takes us to the next HACCP principle.
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4.10. Establishment of Corrective Actions
• HACCP principle 5 requires that a corrective action must be taken when the
monitoring results show a deviation from the critical limit(s) at a CCP.
• Ideally any corrective action should be planned to correct any deviation from
the specified tolerances before they are exceeded and control is lost.
• Practically this cannot always be achieved while the process is out of control,
and which therefore may represent a safety hazard.
• HACCP plan is therefore likely to have two levels of corrective action, i.e.,
actions to prevent deviation and actions to correct following deviation.
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4.10. Establishment of Corrective Actions
• Corrective action procedures should be developed by the HACCP team and
should be specified on the HACCP control chart.
• This will minimize any confusion or disagreements which might otherwise have
occurred when the action needs to be taken. It is also important to assign
responsibility for corrective action both to prevent and correct deviations.
• It is important that detailed records are kept of all stages. It is essential that
you investigate the cause of the deviation, and take appropriate steps to
ensure that it does not happen again.
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4.10. Establishment of Corrective Actions
• The defined corrective action procedures are added to the HACCP Control Chart
which should detail:
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What is to happen to the suspect product;
How the process /equipment is to be adjusted;
Who is to do what;
Who is to be informed.
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4.11. Establishment of Verification Procedures, Validation
and Review
• In order to confirm that the an HACCP procedure is working correctly, a system
of verification should be set up.
• This may involve internal audit, additional microbiological or other testing of
finished or intermediate product, or more detailed testing around specific CCPs.
• Its aims are to verify that the original HACCP procedure is still appropriate, and
that specific monitoring procedures and corrective actions are still being
properly applied.
• There are three key things to consider here: verification, validation, and review.
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4.11. Establishment of Verification Procedures, Validation
and Review
Verification
• In relation to HACCP, therefore, this is the step that we take to make sure that
what is laid down in the HACCP documentation accurately reflects what is
occurring in reality.
• Verification shall be planned. The planning shall include:
– purpose, method, frequency,
– responsibility,
– records.
• Verification results shall be recorded and shall be communicated to the food
safety team (HACCP team).
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4.11. Establishment of Verification Procedures, Validation
and Review
Validation
• Is the means of establishing the effectiveness of the HACCP system and is
technically a part of verification. This would normally be the use of routine
testing or sampling to confirm that the control the HACCP provides is effective.
• Alternatively it might involve auditing the HACCP system to provide a measure
of its effectiveness.
• Validation activities shall include actions to confirm that:
 The established critical limits for CCPs are capable of achieving the
defined levels;
 The efficacy of the control measure constituting the control system;
 The combination of control measure to assure adequate control of the
identified hazards to obtain end products that meet the defined
acceptable levels.
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4.11. Establishment of Verification Procedures, Validation
and Review
Validation
• Food safety management system validation is an assessment carried out at
planned intervals to confirm that the overall performance of the systems
ensures food safety.
• The food safety management systems validation shall include:
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Results of verifications to assess whether identified hazards are in control;
Results of internal audits to show that the planned activities are taking place;
Evaluation of potential unsafe products and of corrections;
Complaints related to food safety.
• The output of the validation shall outline the necessity of reviewing the hazards
analysis and the configuration of the control measure system.
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4.11. Establishment of Verification Procedures, Validation
and Review
Review
• Is usually taken to mean the setting of dates and a formal procedure to verify
and validate the HACCP system, for example, every six months.
• There are also numerous situations under which review should be triggered
prior to a review date.
• Review programs should be formalized as the HACCP program is completed;
with most premises an absolute maximum period of six months is required,
although it is usual that the HACCP team regularly conduct reviewing of the
HACCP.
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4.11. Establishment of Verification Procedures, Validation
and Review
Review
• The HACCP team shall periodically assess complaints related to food safety,
audit reports, and results of verification analyses.
• The necessity of reviewing the hazard analysis and the configuration of the
control measure system shall then be considered.
• The input for the updating activities shall be:
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Communication with the HACCP team;
Other information concerning efficiency of the food management system;
Output from the food safety management system validation;
Output from management review.
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4.12. Documentation and Records
• The key purposes of HACCP documentation are to ensure product safety
and to illustrate that all seven principles have been followed.
• Documentation serves to illustrate legal compliance to the other principles, it
makes review easier, it provides a marketing advantage and it serves to
contribute to “due diligence”, either in court or to an enforcement officer.
• HACCP principle seven requires that effective record-keeping procedures are
established to document the HACCP system.
• Records may be kept of all areas which are critical to product safety, as written
evidence that the HACCP plan is in compliance, i.e., verification that the system
has been working correctly.
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4.12. Documentation and Records
• The types of HACCP records which might be retained are as follows:
The HACCP plan - as the critical document in the HACCP system the current
HACCP plan should be kept. This will mean the process flow diagram and
HACCP control chart, details of the HACCP team, any CCP deviations and
corrective action details;
Critical control points (CCP) monitoring records – this should clearly detail the
CCP number, critical limits, indicate any deviations and corrective actions
taken and persons involved;
Training records – should include HACCP training, auditor training, food
hygiene training and so on;
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4.12. Documentation and Records
Audit records;
Meeting records;
The HACCP system procedures – may wish to consider producing an HACCP
procedural document for your company as a way of drawing together all
activities associated with the HACCP programme.
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5. Operation of the HACCP System
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5.1. Manage and Review Complaints
• The first thing to appreciate about customer complains is that if all complains
are investigated a significant number will either never be understood or be
due to events that are outside the control of the producer.
• It is therefore impossible to achieve zero complaints, and impractical to
suggest all complaints should trigger HACCP review.
• Therefore, the company needs to establish what customer complaints mean;
what is unusual and what level or type of complaint requires action.
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5.2. Control of Non-Conforming Product
• The organization shall establish documented procedures, which ensure that no
potentially unsafe products are supplied to the customer.
• A documented procedure shall be established and maintained to define how it
is ensured that the handling and control or disposal of products manufactured
while a critical control point (CCP) deviated from the critical limits, preventing
the non-conformity from presenting a hazard to food safety.
• Each product batch affected should be evaluated for possible clearance as safe
for distribution. Clearance of the product may occur, where any of the conditions
apply (ISO 22000).
• Linked to traceability is the issue of what happens to products that do not
meet specifications or other critical limits and are thus deemed to be nonconforming.
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5.2. Control of Non-Conforming Product
• Obviously such products need to be controlled to ensure they are not confused
with conforming products. When non-conformance is identified the nonconforming product should be specified and the fault and extent of the fault
recorded.
• The product should then be clearly identified.
• Assuming the product is not safety reworkable or cannot otherwise be used,
then disposal should be recorded and supervised.
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5.3. Maintaining HACCP System
• HACCP should at this juncture be integral to the way food safety is controlled.
• HACCP should be seen as a way of life throughout the entire company from the
moment that the initial studies are completed and the implementation is under
way.
• These include:
– the HACCP audit,
– microbiological and chemical testing,
– analysis of data,
– awareness of new emerging hazards, and keeping the HACCP plan up to
date. This is the final key stage of HACCP.
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5.3. Maintaining HACCP System
• The HACCP system must include verification procedures to provide assurance
that the HACCP plan has been implemented effectively and that it is complied
with on a day-to-day basis.
• Maintaining the HACCP system involved various stages:
– Defined standards and regular audit;
– On-going maintenance;
– Data analysis;
– Corrective and preventative action;
– HACCP plan re-validation;
– Documentation – controlled update.
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5.3. Maintaining HACCP System
• The HACCP plan will need to be updated and amended periodically to ensure
that it remains current. This is only really common sense – an HACCP plan
which was drawn up a year ago is unlikely to reflect current activities accurately.
• The HACCP audit may also provide reasons for change but remember that the
audit is only a sampling exercise, an indicator of whether the HACCP plan is
being complied with and is correct.
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5.4. Auditing the HACCP System
• HACCP audit is a systematic examination to determine whether the activities of
the HACCP system and the related results are corrects with planned
arrangements and whether these arrangements are implemented effectively
and are suitable to each the objectives.
• Auditing is effectively in-depth inspection against a know standard.
• A HACCP audit requires technical assessment and much more visual inspection,
for we are also examining compliance with current knowledge of safety.
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5.4. Auditing the HACCP System
• It is common that anyone involved in HACCP will at some juncture be involved
in the auditing of a HACCP systems:
first party audit
second party audit
third party audit
fourth party audit
this might be for the purpose of internal verification;
to audit suppliers;
to carry out external audits for the purpose of some
type of consultancy or external validation;
for enforcement purposes.
• Knowledge of HACCP is evidently required, but the approach is different from
that of someone establishing a system within their own organization.
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5.4. Auditing the HACCP System
• The audit then becomes the systematic examination, evaluation and finally,
reporting on objective evidence found as to the compliance or non-compliance
with the given standard.
• The type of audit will to a large degree determine the depth to which the
auditor will wish to go into the detail of the operation.
• In general, the facility to enter and inspect any part of the building or process
relevant to the product/ process should be available, but unless there is a firm
intention to trade, the auditee may quite correctly exclude the auditor from
other areas of the business where competitive advantage may be compromised.
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5.4. Auditing the HACCP System
Audit Report
• Reporting the audit is very important, both to the relationship between the two
parties. The report must reflect areas where performance is good, as well as
those where problems exist.
• The purpose of an audit is to place on record the findings.
• In addition to the processes being audited, the report should include any other
observations and deficiencies which have been noted.
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6. Food Safety Management Systems
• One of the greatest challenges of our age is the production and delivery of safe
food. In the last few decades, opportunities for food contamination have
increased.
• Organizations which produce, handle, supply or deliver food products recognize
the need to demonstrate and document the control of conditions which have
impact on food safety. This also applies to their suppliers.
• The sheer numbers of regulations and controls, as well as the increasing
demands of customers, have made the position of food manufactures more
and more uncomfortable.
• Consequently, they turned to their standardization bodies and requested them
to develop such voluntary standards as could help them to meet all the abovementioned requirements.
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6. Food Safety Management Systems
• The idea of harmonizing the relevant national standards on the international
level was mooted by the Danish Standardization body (DS).
• They submitted it as a new work item proposal to the secretariat of ISO/TC 34 Food products, early in 2001. The majority of the members of the technical
committee supported the idea.
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6.1. DS 3027 E:2002
• DS 3027 E: 2002 – Management of food safety based on HACCP (Hazard
Analysis and Critical Control Points) – Requirements for a management system
for food producing organizations and their suppliers.
• Organizations are subject to regular supervision by authorities and customers.
There is an increasing desire in the food industry to be able to set up
management systems for standardized control of food safety.
• This standard specifies requirements for a HACCP management system
consisting of the three main elements:
 Management;
 HACCP system;
 GMP – Good Manufacturing Practice.
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6.1. DS 3027 E:2002
• For an HACCP system to function effectively and obtain the support of the
organization management, it needs to be designed, operated and maintained
within the framework of a structured management system.
• This standard is based on the internationally recognized HACCP principles.
• The objective of the HACCP system is to help organizations focus on the
hazards that affect food safety and on the systematic identification and
implementation of critical control points.
• As part of the HACCP system, the organization is required to implement GMP
measures to address internal conditions and conditions relating to the
organization.
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6.1. DS 3027 E:2002
• To facilitate application of this standard, it has been worded as requirements.
• The fundamental consideration was to leave the choice of method to fulfill
these requirements to the individual organization.
Scope
• This standard describes the requirements that apply to a management
systems for the control of food safety.
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6.1. DS 3027 E:2002
• The standard is intended for food producing companies and their suppliers
throughout the entire food chain.
• This standard is applicable to any organization who wish and maintain an
HACCP management system with a view to demonstrating food safety and, if
appropriate, applying for certification of the HACCP management system.
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6.2. ISO 22000
• This international standard aims to harmonize the requirements for food safety
management in food and food related business on a global level.
• Organizations within the food chain, who produce, handle or supply food,
recognize an increasing need to demonstrate and provide adequate records of
the control of all conditions, which have an impact on food safety.
• This requirement increasing applies to all persons involved in the food chain,
including subcontractors and distributors.
• The scope of this international standard applies to all types of organizations
within the food ranging from e.g. feed producers and producers of equipment
through to distribution and retail outlets.
Implementation and Management of
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6.2. ISO 22000
Producers of ingredients
Feed producers
Primary food producers
Producers of equipment
Regulatory authorities
Food processors
Transport and storage operators
Distributors
Producers of cleaning
agents
Retailers
Producers of packaging
materials
Others
Consumer
Fig.2 - Communication along the food chain (Source: ISO/ CD 2200; 2003)
Implementation and Management of
Safety Systems
6.2. ISO 22000
• This international standard, it has been developed as an auditable standard.
The fundamental consideration leaves the individual organization the choice of
method to fulfill these requirements.
• This international standard describes the requirements for operating an
effective food safety management system integrating the use of the hazard
analysis and critical control point (HACCP) technique and defined prerequisites
for the safe production of food products.
Implementation and Management of
Safety Systems
6.2. ISO 22000
• This International Standard specifies requirements for a food safety
management system, to enable an organization to:
 Develop, implement, execute, maintain and improve a food safety
management system aimed at providing safe food products for the
consumer;
 Show compliance
communication;
with
agreed
customer
requirements
through
 Show compliance with regulatory requirements as regard to food safety;
 Assure itself of its conformance with it is stated food safety policy;
Implementation and Management of
Safety Systems
6.2. ISO 22000
 Demonstrate such conformance to other organizations;
 Make a self-declaration of conformance with this International Standard;
 Seek certification/ registration of its food safety management system by
an external organization.
 The requirements are applicable to operators along the food chain wishing
to design and implement an effective food safety management system.
Implementation and Management of
Safety Systems
6.2. ISO 22000
• This includes organizations directly or indirectly involved in one or more steps
of the food chain.
• The requirements of this International standard are intended to be
incorporated into any food safety management system.
• The extent of the application will depend on such factors as the food safety
policy of the organization, the nature of its activities and the conditions in
which it operates.
Implementation and Management of
Safety Systems
6.2. ISO 22000
• The ISO 22000 has the following objectives:
compliance with the Codex Alimentarius HACCP principles;
harmonize the voluntary international standards;
provides an auditable standard that can be used either for internal
audits;
self-certification or third party certification; the structure is aligned
with ISO 9001:2000 and ISO 14000:1996;
provide communication of HACCP concepts internationally.
Implementation and Management of
Safety Systems
6.2. ISO 22000
• The standard is intended to be used by any organization within the food chain
“to seek a more focused, coherent and integrated food safety system” than
normally required by food processing rule and regulation.
• The important advantage of ISO 22000 is that it will be possible to use it
throughout the chain. It will be internationally accepted and cover almost all of
the requirements of retailer standards.
• The most important difference with standards like British Retail Consortium
(BRC) and International Food Standard (IFS) is that ISO 22000 will not have a
detailed list of requirements for good practices.
• ISO 22000 will require the implementation of good practices and expects
organizations to define the practices that are appropriate to them.
Implementation and Management of
Safety Systems
6.2. ISO 22000
•As a result the standard makes references to several internationally
recognized codes of practice relating to the Codex Alimentarius.
•The standard has three parts:
 requirements for good manufacturing practices or pre-requisite programs;
 requirements for HACCP according to the HACCP principles of the Codex
Alimentarius;
 requirements for a management system.
Implementation and Management of
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6.2. ISO 22000
• The structure will include:
 Policy
 Realization of safe products
 Operations
 Performance assessment
 Improvement
 Management review.
Implementation and Management of
Safety Systems
6.2. ISO 22000
• Policy
– The top management of the organization shall define, document and
communicate its policy.
– The top management shall ensure that the food safety policy is related to
the organization’s role in the food chain.
– The food safety policy shall be in compliance with the business goals of the
organization, the food safety requirements of customers, and regulatory
requirements;
– The food safety policy shall be supported by measurable objectives.
Implementation and Management of
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6.2. ISO 22000
• Realization of safe products
– As a for the hazard analysis all relevant information related to product
realization and use shall be collected and maintained as controlled
documents.
• Operations
– The organization shall ensure that the integrity of the food safety
management system is maintained at all times also when changes are
planned and implemented.
Implementation and Management of
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6.2. ISO 22000
• Performance assessment
– The evaluation of the performance of the HACCP based on the assessment
of system indicators. This assessment has to be supported by data and
information gathered that through comparison with the indicators target
allow the verification of the HACCP system performance.
• Improvement
– As result of the use of the data and information gathered and through it
comparative analysis with target indicators it possible to support the
definition and the implement of actions and measures with the objective of
improving the efficiency and effectiveness of the HACCP system.
Implementation and Management of
Safety Systems
6.2. ISO 22000
• Management review
– The top management shall review the organization’s food safety
management system, at planned intervals, to ensure its continuing suitably,
adequacy and effectiveness. The management review process shall ensure
that the necessary information is collected to allow the top management to
carry out this evaluation.

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