CAPA report template: free template for Confluence and Jira
At an ISO 9001 or ISO 13485 audit, the auditor picks a closed CAPA and asks three things: what was the real cause, what did you change, and how do you know it worked? This template follows that order, so every CAPA answers them before it is closed.
CAPA [number]: [short title]
Opened: [date] · Owner: [name] · Source: [complaint / audit / nonconformity / trend] · Risk level: [low / medium / high]
1. Problem description
What happened, where, when, how often, and what evidence shows it: [facts only, no cause yet]. Products or batches affected: [list].
2. Containment
Immediate action to limit the impact while the cause is investigated: [action, who, date]. Is the product already delivered affected? [yes / no, decision].
3. Root cause
Method used: [5 whys / fishbone / fault tree]. Root cause: [one sentence]. Evidence that confirms it: [test, data, record].
4. Action plan
| Action | Type | Owner | Due | Done |
|---|---|---|---|---|
| [action] | [corrective / preventive] | [name] | [date] | [date] |
| [action] | [corrective / preventive] | [name] | [date] | [date] |
Documents or training changed: [procedure, version]. Approved by: [name, date].
5. Effectiveness check
Criterion decided before closing: [measurable criterion, e.g. no recurrence in 3 months]. Planned on: [date]. Result: [met / not met, evidence]. If not met, the CAPA goes back to step 3.
6. Closure
Closed by: [name, date]. Similar products or processes checked: [yes / no, which].
How to use it in Confluence
- Click Copy the template, open a new Confluence page and paste: headings, lists and tables stay as they are.
- Replace the parts in [brackets] and delete what does not apply to you.
- To reuse it, save it as a space template: Space settings › Templates › Create template, then paste.
Three mistakes auditors see most
- The cause is the symptom again. “Operator error” is rarely a root cause: ask why the error was possible.
- The effectiveness check is set after the fact. Decide the criterion when you approve the plan, not when you want to close.
- Closed before the check. A CAPA closed when the actions are done proves the actions were done, not that they worked.
ISO 9001 (clause 10.2) and ISO 13485 (clauses 8.5.2 and 8.5.3) both expect corrective actions in proportion to the effects of the problem, a review of their effectiveness, and records of it.
Related: how to run CAPA in Jira.