Section 149.38. Corrective action for quality system and quality control samples.

 

(1)  The laboratory shall take corrective action when:

(a) Departures from established policies and procedures in the quality system are identified or become apparent.

(b) Quality control samples, including proficiency testing samples, fail established acceptance limits or evaluation criteria.

(2)  The corrective action shall identify the source of the problem, correct the problem, and have a mechanism to verify the action has had the desired effect.

(3)  The laboratory shall document corrective action taken to address the nonconformance and any other changes resulting from corrective action investigations. Changes taken to address failures of quality control samples to meet established acceptance criteria shall be those that resolve or address the failure in an expeditious manner before affected results are released or reported by a laboratory.

(4)  The laboratory shall monitor the effectiveness of implemented corrective action changes and take additional corrective action when initial and or subsequent corrective action fails to resolve the nonconformance.

History: CR 06-005 : cr. Register April 2008 No. 628 , eff. 9-1-08.