Corrective and preventive action, or CAPA, is a controlled process for removing the cause of an identified problem and addressing conditions that could create similar problems. Terminology and formal requirements vary by quality system.
How should a business apply Corrective and Preventive Action (CAPA)?
Contain affected goods first. Then establish cause, action, owner, deadline, verification method and the scope of products or processes that may share the issue.
What records support Corrective and Preventive Action (CAPA)?
Keep the problem statement, evidence, containment, root-cause work, action plan, implementation and effectiveness check.
Corrective and Preventive Action (CAPA): control and evidence
| Area | What the record should show |
|---|---|
| Control | Contain affected goods first. Then establish cause, action, owner, deadline, verification method and the scope of products or processes that may share the issue. |
| Evidence | Keep the problem statement, evidence, containment, root-cause work, action plan, implementation and effectiveness check. |
| Tradeoff | Closing a task when the supplier submits a plan is premature. Closure should follow evidence that the action worked. |
What should buyers verify about Corrective and Preventive Action (CAPA)?
Closing a task when the supplier submits a plan is premature. Closure should follow evidence that the action worked.
