This is a ready-to-use worksheet for recording the self-audit findings on one computerized system. Complete one worksheet per sampled system and attach it to the overall self-audit report. Replace every <<FILL: ...>> placeholder. A worked filled specimen follows.
Field definitions
Worksheet
Traceability spot-check
Supplier reliance
Change control sample
Periodic review
Findings raised on this system
Instructions for use
- Complete one worksheet per system sampled in the audit cycle; do not combine multiple systems on a single worksheet.
- Perform the traceability spot-check live, at the system or in its documentation, not from memory of how it should work.
- For supplier reliance, insist on a stated conclusion (“full site testing, no reliance” is a legitimate answer); “documentation reviewed” alone is not a passing entry.
- Route every finding through the triage logic in the parent checklist: could this, found by an inspector today, support an objection.
- Attach completed worksheets to the overall self-audit report as the supporting evidence for its conclusions.
Acceptance criteria
- Every sampled system in the audit scope has a completed worksheet.
- The traceability spot-check was performed live and the time taken recorded.
- Every finding on the worksheet is reflected in the overall self-audit report with a priority and a routing decision.
Retention
Retain completed worksheets for not less than <<FILL: retention period, aligned to the parent self-audit report>>, attached to or referenced from the self-audit report they support.
Filled specimen
Traceability spot-check
Supplier reliance
Change control sample
Periodic review
Findings raised on this system
This system passed every sampled area cleanly: a supplier reliance conclusion that actually states what is reduced, a change control record with proportionate testing, and a periodic review that did the substantive work rather than a paperwork pass. Worksheets like this one are what let the overall self-audit report state its conclusion with specific supporting evidence rather than a general impression.
Common inspection findings this worksheet surfaces
- A traceability spot-check that cannot be completed quickly because no RTM ties the sampled requirement to evidence.
- A supplier reliance line with no stated conclusion about what site testing is reduced.
- A change control sample where the testing performed does not match the declared change tier.
- A periodic review current on the calendar but with no audit trail sample or version reconciliation behind it.
How to adapt this worksheet
- Add fields specific to your technology (an AI/ML model version and performance-monitoring status, for example) where the system warrants it.
- Point the finding-routing column at your real deviation, tracked-action, and recommendation categories.
- Set your retention period to match your self-audit report retention.
