Form – Supplier Process Validation Review
When you rely on a supplier’s process – their heat treatment, their kill step, their sorting – you’re relying on their validation. This form reviews whether that reliance is justified.
Be specific and honest in every field; vague records help nobody during an investigation. If a field doesn’t apply, write N/A rather than leaving it blank.
1. Document control
| Field | Details |
|---|---|
| Document title | Form – Supplier Process Validation Review |
| Document no. | [QA-FORM-050] |
| Version | [1.0] |
| Effective date | [YYYY-MM-DD] |
| Prepared by | [Name / Title / Date] |
| Approved by | [Name / Title / Date] |
| Review date | [YYYY-MM-DD] |
1. Supplier process
- Supplier: | Material:
- Supplier’s process relied upon: [e.g., heat treatment, metal detection]
- Hazard it controls:
- Date of review: [YYYY-MM-DD] | Reviewer: [Name]
2. Validation evidence
| Evidence required | Provided? (Y/N) | Adequate? (Y/N) | Comments |
|---|---|---|---|
| Validation study/protocol and results | |||
| Critical limits and their basis | |||
| Monitoring and corrective action procedures | |||
| Verification activities (e.g., calibration, testing) | |||
| Change control notification agreement |
3. Decision
If the supplier can’t show validation, you have three options: help them get it, validate it yourself on receipt (rarely practical), or find a supplier who can. ‘We’ve used them for years’ is not the fourth option.
- Reliance justified? [Y/N – conditions]
- Risk if supplier process fails:
- Ongoing verification: [audits, COAs, testing – frequency]
- Next review due: [YYYY-MM-DD]
- Approved by QA: [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 per supplier file requirements. at [defined location] – and make sure someone besides you knows where that is.