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|Both ISO9000 and
ISO 17025 suggest that its not enough to identify a problem, investigate the
root cause and make the required change to the system, but that the
implemented corrective active must be reviewed at a later date to ensure
that the change was effective – has the change to the system prevented the
problem from occurring again ?
Before the CA can be closed out a relevant staff member must review the change and verify its effectiveness.
If the nonconformance was minor and was not required to be rectified urgently the verification follow up may be included in an internal audit. If the nonconformance was major a ‘mini’ audit should be conducted to check the CA effectiveness.
This verification must be recorded on the CAR.
If the CA was effective and prevented the problem from occurring again without affecting the QMS then the Quality Manager can close out the CAR. The CAR log must be updated and the CAR filed appropriately.
If the change to the system did not resolve the problem or caused another problem within the QMS, then the CA must be reinvestigated and a new CA developed.