Audit – Labelling
The labelling audit checks the last thing the consumer sees – and the thing behind most recalls. Artwork control, line checks, and finished-pack verification all get tested here.
Audit against what you see, not what you hope. Mark each clause C, NC or N/A on evidence – and write the evidence down; ‘looked fine’ isn’t evidence. Every NC gets a corrective action.
1. Audit details
| Field | Details |
|---|---|
| Audit title | Audit – Labelling |
| Audit no. | [AUD-YYYY-###] |
| Date(s) | [YYYY-MM-DD] |
| Auditor(s) | [Name(s)] |
| Area / process audited | [Area] |
| Auditee(s) | [Name(s) / Title(s)] |
2. Audit criteria
Reword the clauses to match your standard if you need to – but keep the numbering stable so you can trend findings over time.
| Ref | Requirement | C / NC / N/A | Evidence seen | Corrective action ref |
|---|---|---|---|---|
| 1.1 | Artwork approval process includes QA sign-off and version control. | |||
| 1.2 | Label specifications match current product formulations. | |||
| 1.3 | Allergen declarations on labels match the allergen matrix. | |||
| 2.1 | Start-up label checks verify correct label, date mark, and lot code. | |||
| 2.2 | Reel/label roll changes are checked and recorded. | |||
| 2.3 | Date mark format and accuracy are verified against production records. | |||
| 3.1 | Finished pack checks confirm label accuracy (sampling). | |||
| 3.2 | Obsolete labels are controlled and destroyed. | |||
| 3.3 | Label printers/scales are controlled; price and weight accuracy verified. | |||
| 4.1 | Customer-specific labelling requirements are met. | |||
| 4.2 | Regulatory label changes are tracked and implemented on time. |
3. Summary
- Total clauses checked:
- Compliant: Non-compliant: N/A:
- Overall result: [Pass / Conditional pass / Fail – define your scoring rule here]
- Key strengths:
- Priority corrective actions: [list CAR references]
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.