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| CAPA no. | |
| Source (NCR / audit / complaint / trend) | |
| Date opened | |
| Owner | |
| Affected product / process |
Describe the nonconformity or potential nonconformity: what, where, when, how detected, and extent.
Actions taken to contain the effect (quarantine, sort, stop-ship, customer notification) and their status.
Determine the true root cause using a structured method (5-Why, Ishikawa / fishbone, fault tree). State the root cause and the escape point (why it was not detected).
- Why? …
- Why? …
- Why? …
- Why? …
- Root cause: …
| Action | Owner | Due date | Status |
|---|---|---|---|
| [Corrective action] | [Owner] | [Date] | [Open / Closed] |
Actions to prevent recurrence across similar products / processes (systemic fixes, controls, documentation updates).
Objective evidence that the corrective action was implemented and is effective, with the verification method and date.
| Verification date | |
| Verified by |
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