Protocol – Cleaning Validation
Cleaning validation proves the procedure works on the worst soil, in the hardest-to-clean spots – so routine verification (swabs, visual) is just confirming, not hoping.
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 | Protocol – Cleaning Validation |
| Document no. | [QA-FORM-043] |
| Version | [1.0] |
| Effective date | [YYYY-MM-DD] |
| Prepared by | [Name / Title / Date] |
| Approved by | [Name / Title / Date] |
| Review date | [YYYY-MM-DD] |
1. Validation design
- Equipment/area: | Soil type (worst case):
- Cleaning procedure reference:
- Acceptance criteria: [visual + ATP limit + micro limit]
- Sampling points (worst-case locations): [list]
- Trials planned: (minimum 3)
2. Results
| Trial / point | Visual | ATP result | Micro result | Pass / Fail |
|---|---|---|---|---|
| [Trial 1 – point 1] | ||||
| [Trial 1 – point 2] | ||||
| [Trial 2 – point 1] | ||||
| [Trial 3 – point 1] |
3. Conclusion
A validated cleaning procedure still fails if the operator rushes it – validation proves the method, verification proves the execution. You need both, and this protocol is only the first half.
- Overall result: [Pass / Fail]
- Routine verification defined:
- Revalidation triggers:
- Validated by: [Name / signature / date] | QA approval: [Name / 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 for life of the procedure plus [3 years]. at [defined location] – and make sure someone besides you knows where that is.