Corrective action

Corrective action. (1) The laboratory shall take corrective action in response to any nonconformances including all the following: (a) Departures from established procedures in the quality system are identified. (b) Quality control samples fail, unless immediate reanalysis of the affected sample resolves the issue. (2) The corrective action under sub. (1) shall identify the problem, determine the most probable cause of the problem, implement solutions to correct the problem, and include a mechanism to verify that the action has had the desired effect. (3) The laboratory shall document corrective action taken to address the nonconformance under sub. (1) and any other changes resulting from corrective action investigations. Changes implemented to address failures of quality control samples shall be those that resolve or address the failure. Changes shall be implemented to minimize the number of affected results reported by a laboratory. (4) The laboratory shall monitor the effectiveness of implemented corrective action changes and take additional corrective action when initial or subsequent corrective action fails to resolve the nonconformance. (5) Root cause analysis shall be performed when there is recurrence.