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      1.7

      Control Measures


      Control measures must beassessed to determine whether they can prevent, eliminate or reduce the risk of all identified hazards to acceptable levels. Where there is no control measure, the product/process must be modified so a control measure can be applied.


      1.7.1

      Control Measures


      The documentation shouldshow links to a specific prerequisite, rather than generic commenti.e.‘Pre-requisite’.

      e.g Glass/Hard Plastic Control

      1.8

      Determination of CCPs


      An effective justification system must be used to decide if controls areCCPs (Critical Control Points).


      1.81

      Determination of CCPs


      A decision tree or equivalent must be used to determine if control measures are CCPs.

      e.g. the Codex decision tree is used (Appendix 3)

      1.9

      Critical Limits

      Critical limits must be defined and validated where relevantto ensure that the product is safe. The process must be capable of operating consistently within the definedlimits. Critical limits must be measurable.

      Critical limits are justified and documented.

      The precision limits andtolerances of the monitoring equipment must be considered when defining limits.

      1.10

      Monitoring

      Procedures &

      Records


      Documented CCP monitoring procedures must be established with clearlydefined frequencies to determine if the criticallimits are achieved. Records mustbe signedby the person doing the monitoring.

      When identified by risk assessment records may need to be verified by

      an authorised individual.


      1.11

      Corrective

      Actions


      When a CCP deviates fromcritical limits the corrective action required must be documented.The corrective actions must identify and isolateall defective materials and ensure that the CCP returns to operating within the critical limits.

      If the safety of the product is in doubt, product or materials must be disposed of.


      1.12

      Verification

      The HACCP/Risk Assessment planmust be verified to confirm that it is effective.

      Verification may include:Internal audits

      ? Review of customer complaints

      ? Review of monitoring results

      1.13

      HACCP/ Risk

      Assessment

      Review


      The HACCP plan / Risk Assessment must be reviewed either annually as a minimum, or prior to any changes of the product formulation or process which may affect product safety or legality.

      Review following changesto:

      1.Process steps

      2.Raw material specifications

      3.Formulation

      4.Packaging, storage or distribution



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