Form – Corrective Action Request (CAR)
The CAR form is where a problem becomes a project: what happened, why it really happened, what you’re changing, and how you’ll know it worked. A well-written CAR prevents the next incident; a vague one just files it.
Fill this in as you go, not from memory at the end of the shift – records reconstructed later are where the errors creep in. Replace [bracketed] guidance with your site’s detail.
1. Document control
| Field | Details |
|---|---|
| Document title | Form – Corrective Action Request (CAR) |
| Document no. | [QA-FORM-001] |
| Version | [1.0] |
| Effective date | [YYYY-MM-DD] |
| Prepared by | [Name / Title / Date] |
| Approved by | [Name / Title / Date] |
| Review date | [YYYY-MM-DD] |
1. Nonconformance details
- CAR no.: [CAR-YYYY-###]
- Date raised: [YYYY-MM-DD] | Raised by: [Name]
- Source: [Audit / complaint / deviation / inspection / other]
- Description of the nonconformance (facts only):
- Requirement not met (procedure/clause/spec):
- Product/lot affected: | Quantity:
- Immediate correction taken (containment):
- Product disposition: [Use as is / rework / downgrade / dispose – with justification]
2. Root cause analysis
Don’t settle for the first plausible cause. We’ve seen ‘operator error’ written on CARs where the real cause was a procedure nobody could follow at line speed.
- Assemble the facts: what, when, where, who, how much.
- Ask why repeatedly (5 Whys) or use fishbone – record each level.
- Separate the direct cause from the systemic root cause.
- Check whether the same root cause could affect other products, lines, or shifts.
- Agree the root cause statement with the process owner – not just QA.
- Record evidence supporting the root cause conclusion.
3. Corrective action plan
| Action | Owner | Due date | Completed (date) | Evidence |
|---|---|---|---|---|
| [Correct the immediate nonconformance] | ||||
| [Fix the root cause] | ||||
| [Prevent recurrence elsewhere (horizontal)] | ||||
| [Update documents/training if needed] |
4. Verification of effectiveness
- Effectiveness check method: [Re-audit / data review / observation – define it]
- Check date (after suitable period): [YYYY-MM-DD]
- Result: [Effective / Not effective – evidence]
- If not effective: new CAR reference:
- CAR closed by: [Name / signature / date]
Approval and control
| Role | Name | Signature | Date |
|---|---|---|---|
| Prepared by | [Name] | [Signature] | [Date] |
| Reviewed by (QA) | [Name] | [Signature] | [Date] |
| Approved by | [Name] | [Signature] | [Date] |
Keep completed forms for Retain [3 years] minimum; longer for CARs linked to recalls or regulatory action. at [defined location] – and make sure someone besides you knows where that is.