A CAPA record has one job: show that a quality problem was understood, fixed at its root and prevented from coming back. Most inspection findings on CAPA come from the same few weaknesses — root causes that describe a symptom, actions with no owner or date, silent due-date changes and effectiveness checks that were never defined.
What the template covers
- Identification — CAPA number, source record, product and classification.
- Problem statement — facts, quantified.
- Investigation and root cause — method, team, root cause and category, other batches affected.
- Actions — corrective and preventive, each with an owner, due date and evidence.
- Extensions — new date, justification and approval, so changes are never silent.
- Verification and effectiveness — a criterion defined before the check, the data reviewed and the result.
- Approvals and closure.
Tips
- Write the effectiveness criterion when you open the CAPA, not when you close it.
- If the root cause is “human error”, keep asking why the system allowed it.
- Link every CAPA back to its source and forward to its evidence.