Traceability Test Record (Free)

Record – Traceability Test

Routine traceability tests keep the system sharp between real incidents – a quick drill, timed, with the result recorded. Little and often beats one heroic annual exercise.

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

1. Test details

• Date: [YYYY-MM-DD] | Tester: [Name]
• Product category:
• Previous test date: [YYYY-MM-DD]
• Unannounced test? [Y/N]
• Test type: [Backward / forward]
• Starting point: [finished lot / raw material lot]:
• Test scenario description:
• Systems used: [paper / ERP / other]:
• Personnel involved: [Names]
• Target time:

2. Results

Time it honestly, warts and all. A test that ‘would have been faster if…’ is telling you exactly where the system is weak – write that down, don’t explain it away. Vary the starting points across tests so you exercise the whole system, not just the well-worn path. If the same bottleneck appears twice, fix the system – usually it’s a missing link between goods-in records and production lots.

• Time taken: | Target met? [Y/N]
• Records legible and complete? [Y/N]
• System used: [paper / electronic]
• Bottlenecks identified:
• Trace completed fully? [Y/N – gaps: ]
• Mass balance: [reconciled / variance %]
• Issues found:

3. Follow-up

• Corrective actions (refs):
• Test witnessed by: [Name]
• Report filed: [location]
• Next test due: [YYYY-MM-DD]
• Reviewed by QA: [Name / date]

Approval and control

Keep completed forms for Retain [5 years]. at [defined location] – and make sure someone besides you knows where that is.