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Title: Diapositivo 1


1
Implementation and Management of Safety Systems
2
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

3
Implementation and Management of Safety Systems
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.

4
Implementation and Management of Safety Systems
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)

5
Implementation and Management of Safety Systems
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.

6
Implementation and Management of Safety Systems
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.

7
Implementation and Management of Safety Systems
4. The HACCP Methodology
  • The HACCP methodology is normally described in
    12 steps

1. The HACCP team 2. Product description/characte
rization 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.
8
Implementation and Management of Safety Systems
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.

9
Implementation and Management of Safety Systems
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.

10
Implementation and Management of Safety Systems
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.

11
Implementation and Management of Safety Systems
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
  • 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.

12
Implementation and Management of Safety Systems
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.

13
Implementation and Management of Safety Systems
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.

14
Implementation and Management of Safety Systems
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

15
Implementation and Management of Safety Systems
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.

16
Implementation and Management of Safety Systems
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.

17
Implementation and Management of Safety Systems
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.

18
Implementation and Management of Safety Systems
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.

19
Implementation and Management of Safety Systems
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.

20
Implementation and Management of Safety Systems
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).

21
Implementation and Management of Safety Systems
Fig. 1 - The decision tree
22
Implementation and Management of Safety Systems
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 teams 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).

23
Implementation and Management of Safety Systems
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 arent and could not be put in place,
    then you must consider whether control is
    necessary at this point for food safety.
  • If control isnt necessary here then a CCP is
    not required and you should move on to the next
    hazard and start the decision tree again.

24
Implementation and Management of Safety Systems
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.

25
Implementation and Management of Safety Systems
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?

26
Implementation and Management of Safety Systems
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.

27
Implementation and Management of Safety Systems
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.

28
Implementation and Management of Safety Systems
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.

29
Implementation and Management of Safety Systems
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.

30
Implementation and Management of Safety Systems
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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Implementation and Management of Safety Systems
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.

32
Implementation and Management of Safety Systems
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.

33
Implementation and Management of Safety Systems
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.

34
Implementation and Management of Safety Systems
4.10. Establishment of Corrective Actions
  • The defined corrective action procedures are
    added to the HACCP Control Chart which should
    detail
  • 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.

35
Implementation and Management of Safety Systems
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.

36
Implementation and Management of Safety Systems
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).

37
Implementation and Management of Safety Systems
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.

38
Implementation and Management of Safety Systems
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
  • 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.

39
Implementation and Management of Safety Systems
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.

40
Implementation and Management of Safety Systems
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
  • 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.

41
Implementation and Management of Safety Systems
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.

42
Implementation and Management of Safety Systems
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

43
Implementation and Management of Safety Systems
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.
44
Implementation and Management of Safety Systems
5. Operation of the HACCP System
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Implementation and Management of Safety Systems
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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Implementation and Management of Safety Systems
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 non-conforming.

47
Implementation and Management of Safety Systems
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
    non-conforming 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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Implementation and Management of Safety Systems
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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Implementation and Management of Safety Systems
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.

50
Implementation and Management of Safety Systems
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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Implementation and Management of Safety Systems
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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Implementation and Management of Safety Systems
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 this might be for the
    purpose of internal verification
  • second party audit to audit suppliers
  • third party audit to carry out external
    audits for the purpose of some type of
    consultancy or external validation
  • fourth party audit 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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Implementation and Management of Safety Systems
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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Implementation and Management of Safety Systems
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.

55
Implementation and Management of Safety Systems
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 above-mentioned requirements.

56
Implementation and Management of Safety Systems
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.

57
Implementation and Management of Safety Systems
6.1. DS 3027 E2002
  • 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.

58
Implementation and Management of Safety Systems
6.1. DS 3027 E2002
  • 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.

59
Implementation and Management of Safety Systems
6.1. DS 3027 E2002
  • 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.

60
Implementation and Management of Safety Systems
6.1. DS 3027 E2002
  • 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.

61
Implementation and Management of Safety Systems
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.

62
Implementation and Management of Safety Systems
6.2. ISO 22000
Fig.2 - Communication along the food chain
(Source ISO/ CD 2200 2003)
63
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.

64
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 with agreed customer requirements
    through communication
  • Show compliance with regulatory requirements as
    regard to food safety
  • Assure itself of its conformance with it is
    stated food safety policy

65
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.

66
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.

67
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
90012000 and ISO 140001996 provide
communication of HACCP concepts internationally.
68
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.

69
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.

70
Implementation and Management of Safety Systems
6.2. ISO 22000
  • The structure will include
  • Policy
  • Realization of safe products
  • Operations
  • Performance assessment
  • Improvement
  • Management review.

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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 organizations
    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.

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Implementation and Management of Safety Systems
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.

73
Implementation and Management of Safety Systems
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.

74
Implementation and Management of Safety Systems
6.2. ISO 22000
  • Management review
  • The top management shall review the
    organizations 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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