SOP: Corrective Action Process (Free)
SOP – Corrective Action
Fixing the immediate problem is only half the job – the other half is making sure it doesn’t come back. This SOP takes you from nonconformance through root cause to the effectiveness check most people skip.
Don’t let this go stale. Review the SOP at least annually and every time the process, equipment or chemicals change – and re-brief the team whenever you do.
1. Document control
| Field | Details |
|---|---|
| Document title | SOP – Corrective Action |
| Document no. | [QA-SOP-024] |
| Version | [1.0] |
| Effective date | [YYYY-MM-DD] |
| Prepared by | [Name / Title / Date] |
| Approved by | [Name / Title / Date] |
| Review date | [YYYY-MM-DD] |
2. Purpose
To ensure nonconformances are corrected and their causes eliminated.
3. Scope
Covers all food safety nonconformances at [site name], from any source (audits, complaints, monitoring failures).
4. Responsibilities
| Role | Responsibility |
|---|---|
| Anyone | Raises nonconformances – no blame for reporting. |
| QA | Assesses; assigns investigation. |
| Action owners | Implement and evidence actions. |
5. Materials and equipment
- Nonconformance / CAR form
- Root cause tools (5 Whys, fishbone)
- CAR tracker
6. Safety precautions
- If the nonconformance affects product safety, quarantine first – paperwork second.
7. Procedure
Follow the steps in order. Steps marked [CHECK] are the ones people skip under pressure – don’t.
- Describe the nonconformance precisely: what, where, when, how found, and what product or lots are affected. [CHECK]
- Take immediate correction: contain the problem and protect product (hold, segregate, stop the line).
- Investigate the root cause – ask ‘why’ until you reach something you can actually fix. ‘Human error’ is not a root cause. [CHECK]
- Plan corrective actions that address the cause, with owners and due dates; get QA approval for the plan.
- Implement and evidence each action – photos, records, training signatures.
- Check effectiveness after [suitable period]: did the problem actually stop recurring? If not, re-investigate. [CHECK]
- Close the CAR only when actions are complete and effective; trend CARs for systemic issues.
8. Records
- CAR log and forms
- Root cause analysis records
- Effectiveness check records
9. Revision history
| Version | Date | Change description | Changed by |
|---|---|---|---|
| 1.0 | [YYYY-MM-DD] | Initial issue | [Name] |
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 [Define retention period, e.g., 2 years beyond shelf life] at [defined location] – and make sure someone besides you knows where that is.