4.2. CAPA (Corrective and Preventive Action)
Corrective Action: Action taken to eliminate the cause of a nonconformity and prevent recurrence. There can be more than one cause for a nonconformity. Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence.
Preventive Action: Action taken to eliminate the cause of a potential nonconformity or other potential undesirable situation.
Process for applying corrective and/or preventive actions, and for subsequently monitoring implemented actions to ensure their suitability, adequacy and effectiveness for the Quality Management Systems and medical device safety and performance.
Process to identify, evaluate, correct and/or remove product from commercial distribution where a potential or verified nonconformance in the product or product processing has occurred.
Process for how product-related complaints are evaluated, investigated, documented, trended and closed in a consistent and effective manner for commercially released product only.
Note:
Complaint refers to any written, electronic, or oral communication that. alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or. performance of a device after it is released for.