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After the identification of the root cause of the problem, a decision is needed on the nature of the CA required to overcome the problem what will prevent this problem from occurring again ?

If the problem and its resolution is complex the issue may be work-shopped in a problem solving team.

The action proposed to fix the problem must be effective and in harmony with the overall quality system. The resolution must not fix the immediate nonconformance but trigger a problem elsewhere in the system. For this reason, the CA required for a problem identified during an internal audit must be agreed by the auditor and the auditee ( the person responsible for that area).

The following issues should be taken into account before implementing the CA:

  • The significance of the problem in relation to the quality of the test result.
  • The options available for fixing the problem.
  • Possible effects on other areas of the QMS.
  • The time frame in which the action must be completed i.e. if the problem is a major or minor non-conformance.
  • How the effectiveness of the change will be monitored.
  • If the action required to fix a problem will cause a major change to the QMS or another department then management should be consulted.

    After identifying the CAR required to fix the problem the relevant section of the CAR is completed.