Corrective action: The manufacturer shall take action to eliminate the cause of non-conformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the non-conformities encountered. A documented procedure shall be established to define requirements for— (a) reviewing non-conformities (including customer complaints); (b) determining the causes of non-conformities; (c) evaluating the need for action to ensure that non-conformities do not recur; (d) determining and implementing action needed, including, if appropriate, updating documentation; (e) recording of the results of any investigation and of action taken; and (f) reviewing the corrective action taken and its effectiveness.