This is a ready-to-use checklist. Run it against each finding before the audit report issues, and use the same items in calibration sessions. Replace every <<FILL: ...>> placeholder, mark each item Pass, Fail, or N/A, and resolve every Fail before issue. A filled specimen follows. This content is educational reference, not legal or regulatory advice; verify cited requirements against the current source.
Checklist control
| Field | Entry |
|---|---|
| Checklist title | Audit Finding Defensibility and Grade Calibration |
| Checklist number | <<FILL: FRM-ID, e.g. FRM-QA-021-02>> |
| Parent SOP | <<FILL: SOP-ID for finding classification>> |
| Finding under review | <<FILL: finding ID>> |
| Reviewer | <<FILL: name / role>> |
| Date | <<FILL: date>> |
Part A: the four parts are present and sound
| # | Item | Reference | Result (P/F/NA) |
|---|---|---|---|
| A1 | A specific requirement is cited (clause, standard section, or SOP step + version), not a vague principle like “good documentation practice” | <<FILL>> | |
| A2 | The condition is a factual, observed state a second person could go and verify | <<FILL>> | |
| A3 | Objective evidence is recorded as artifacts with identifiers (doc/version, batch/lot, page/line, timestamp, system ID) | <<FILL>> | |
| A4 | The consequence ties the condition to patient/subject safety, product quality, or data reliability | <<FILL>> | |
| A5 | Any verbal evidence was corroborated against a record before being used to support a major or critical grade | <<FILL>> |
Part B: the grade is correct and defensible
| # | Item | Reference | Result (P/F/NA) |
|---|---|---|---|
| B1 | The grade follows from the consequence sentence (the consequence names the tier) | <<FILL>> | |
| B2 | The decision path was applied in order: falsification/patient harm checked before major; systemic/aggregation checked before minor | <<FILL>> | |
| B3 | Spread was assessed (how many sampled, how many affected), not assumed | <<FILL>> | |
| B4 | Aggregation was considered for repeated related minors | <<FILL>> | |
| B5 | The grade is no looser than the regulatory definition for this audit type (a falsification is not graded below critical) | <<FILL>> | |
| B6 | The internal grading matrix, if any, did not downgrade a falsification or a patient-harm finding | <<FILL>> |
Part C: tone, scope, and independence
| # | Item | Reference | Result (P/F/NA) |
|---|---|---|---|
| C1 | The finding is factual and neutral; no speculation about intent beyond what evidence supports | <<FILL>> | |
| C2 | No corrective action or solution is embedded in the finding (the auditee owns the fix) | <<FILL>> | |
| C3 | The finding is one nonconformity, not two distinct issues merged | <<FILL>> | |
| C4 | Critical and major findings were reviewed by QA before issue | <<FILL>> | |
| C5 | The grade was not softened through negotiation with the auditee for tone or relationship | <<FILL>> |
Part D: the reproducibility test
| # | Item | Reference | Result (P/F/NA) |
|---|---|---|---|
| D1 | A second competent auditor, reading only the requirement, condition, evidence, and consequence, would assign the same grade | <<FILL>> | |
| D2 | If D1 is uncertain, the weak point (evidence or consequence) was strengthened before issue | <<FILL>> |
Signoff
| Field | Entry |
|---|---|
| All Fails resolved | <<FILL: yes / list open>> |
| Reviewer signature / date | <<FILL>> |
| QA signature / date (critical/major) | <<FILL>> |
Acceptance criteria
The finding is ready to issue when every applicable item is Pass and no Fail remains open. Any Fail on A1 to A4 or B1, B2, B5 blocks issue until corrected, because those are the items an auditee or regulator uses to challenge the finding.
Filled specimen
Reviewing finding INT-2026-019 (CDS audit trail review documented after disposition, graded Major):
| # | Item | Result | Note |
|---|---|---|---|
| A1 | Specific requirement cited | Pass | Annex 11 para 9 + SOP-QC-114 v4 step 6.2 |
| A2 | Verifiable condition | Pass | Lots and dates named |
| A3 | Objective evidence as artifacts | Pass | Signatures, checklist forms, CDS screen, audit note |
| A4 | Consequence tied to protected interest | Pass | Release control operated after the decision it informs |
| A5 | Verbal evidence corroborated | N/A | No verbal evidence relied on |
| B1 | Grade follows consequence | Pass | ”Not functioning as designed” reads as major |
| B2 | Decision path in order | Pass | Critical ruled out, aggregation not needed, minor ruled out |
| B3 | Spread assessed | Pass | 4 sampled, 3 affected |
| B4 | Aggregation considered | Pass | Single systemic finding, not a roll-up |
| B5 | No looser than regulation | Pass | Consistent with Annex 11 / PIC/S major |
| B6 | Matrix did not downgrade | Pass | No matrix override applied |
| C1 | Neutral, no intent speculation | Pass | States facts only |
| C2 | No embedded solution | Pass | CAPA owns the fix |
| C3 | Single nonconformity | Pass | One issue |
| C4 | QA reviewed | Pass | R. Gomez, 2026-06-06 |
| C5 | Not negotiated soft | Pass | Grade held |
| D1 | Second auditor would agree | Pass | Calibration scenario confirmed |
| D2 | Weak point strengthened | N/A | No uncertainty |
Result: all applicable items Pass, no open Fail. Finding issued.
Common inspection findings this checklist prevents
- Findings issued with a cited principle instead of a breached requirement.
- Grades that do not match the recorded consequence.
- Evidence that could not be relocated when the auditee challenged the finding.
- Missed aggregation of repeated minors into a systemic major.
- Critical and major findings issued without QA review.
How to adapt this checklist
- Set your checklist number and parent SOP in the control block.
- Add a reference column entry pointing to your SOP’s section for each item so reviewers can find the rule.
- Use Parts A to D unchanged in calibration sessions: have auditors grade a common scenario, then compare their checklist results to surface drift.
- Treat any pattern of Fails on the same item across findings as a signal to retrain or to sharpen the SOP’s definitions.