Protocol – Allergen Cleaning Validation
Allergen cleaning validation proves the changeover actually works – not just that it was done. Worst-case product, defined sampling, and a pass/fail line decided before you start.
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 | Protocol – Allergen Cleaning Validation |
| Document no. | [QA-FORM-024] |
| 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/line: | Allergen(s):
- Worst-case product (highest allergen load):
- Cleaning procedure reference:
- Test method: [Protein swab / ELISA – kit and detection limit]
- Acceptance criteria: [e.g., below detection limit at all points]
- Trials planned: (minimum 3 recommended)
2. Sampling plan
| Sample point (worst-case locations) | Trial 1 | Trial 2 | Trial 3 | Pass / Fail |
|---|---|---|---|---|
3. Conclusion
Validation passes the procedure, not the operator’s good intentions. If it fails, fix the procedure (or the equipment design) – don’t just clean harder on the day and call it validated.
- Overall result: [Pass / Fail]
- Corrective actions (if fail):
- Revalidation triggers: [Procedure/equipment/product change]
- Validated by: [Name / signature / date] | Approved by QA: [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.
General use: This template contains no country-specific laws or regulator names and suits any food business — restaurant, catering, food manufacturing, retail, or food service. Adapt temperature limits, legal references, and record-retention periods to your local regulations. Provided by GIFSQ · v1.0 · September 2026