Audit – Production Line
The production line audit happens while the line is running – that’s the point. Controls, behaviour, and records get checked under real conditions, not in a quiet room afterwards.
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 – Production Line |
| 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 | Pre-operational inspection is completed and passed before start-up. | |||
| 1.2 | Correct materials, recipe, and labels are verified at start-up. | |||
| 1.3 | CCP monitoring is performed at the defined frequency by trained staff. | |||
| 1.4 | In-process checks (weights, temperatures, visual) are recorded. | |||
| 2.1 | Personnel hygiene and GMP are followed on the line (observed). | |||
| 2.2 | Foreign body controls (sieves, magnets, detectors) are checked per schedule. | |||
| 2.3 | Glass and brittle material controls are in place. | |||
| 3.1 | Allergen changeover procedures are followed and verified. | |||
| 3.2 | Rework handling follows procedure with traceability. | |||
| 3.3 | Waste is removed without contaminating product or the line. | |||
| 4.1 | Deviations during the run are recorded and dispositioned. | |||
| 4.2 | Line clearance between products is effective. |
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.