This is a ready-to-use finding record. One form per finding. Replace every <<FILL: ...>> placeholder, route it through your audit report and CAPA process, and keep it with the audit file. A field-definition table and a filled specimen follow so both the empty and completed shapes are visible. This content is educational reference, not legal or regulatory advice; verify cited requirements against the current source.
Form control
| Field | Entry |
|---|---|
| Form title | Audit Finding Record |
| Form number | <<FILL: FRM-ID, e.g. FRM-QA-021-01>> |
| Parent SOP | <<FILL: SOP-ID for finding classification, e.g. SOP-QA-021>> |
| Version | <<FILL: version>> |
The finding record
| Field | Entry |
|---|---|
| Finding ID | <<FILL: unique ID, e.g. INT-2026-019>> |
| Audit reference | <<FILL: audit ID / report number>> |
| Audit type | <<FILL: internal / supplier / self-inspection / for-cause>> |
| Date observed | <<FILL: date>> |
| Area / process / system | <<FILL: department, process, or system>> |
| Auditor | <<FILL: name>> |
| Requirement (criteria) | <<FILL: specific clause, standard section, or SOP number + step + version>> |
| Condition (what was found) | <<FILL: factual, verifiable observed state with identifiers>> |
| Objective evidence | <<FILL: artifacts with identifiers: doc/version, batch/lot, page/line, timestamp, system/equipment ID, audit note ref>> |
| Consequence / risk | <<FILL: link to patient/subject safety, product quality, or data reliability>> |
| Spread assessed | <<FILL: number sampled / number affected; isolated or pattern>> |
| Aggregation? | <<FILL: N/A, or references to constituent minor findings rolled up>> |
| Grade | <<FILL: Critical / Major / Minor / Observation>> |
| Grade rationale (decision path) | <<FILL: why this tier and not the ones above/below it>> |
| Auditee acknowledgement of condition | <<FILL: acknowledged / condition corrected to: ...>> |
| CAPA / response reference | <<FILL: CAPA number or N/A>> |
| Response due date | <<FILL: date per grade>> |
| Finding owner (CAPA) | <<FILL: name / role>> |
| Lead auditor review | <<FILL: name, date>> |
| QA review (critical/major) | <<FILL: name, date, or N/A>> |
Field definitions
| Field | Format / rule | Who enters | When |
|---|---|---|---|
| Finding ID | Unique, sequential per program | Auditor | At draft |
| Requirement | Must cite a clause, section, or SOP step + version, not a principle | Auditor | At draft |
| Condition | Factual and relocatable by a second person; no adjectives of judgment | Auditor | At observation |
| Objective evidence | Identifiers sufficient to relocate; verbal statements corroborated before grading major | Auditor | At observation |
| Consequence | Ties to one protected interest; the grade must follow from it | Auditor / SME | At draft |
| Grade | One of the four tiers; no looser than regulatory definition | Lead auditor | At draft, confirmed at review |
| Grade rationale | References the decision path (critical, then major, then minor) | Lead auditor | At draft |
| QA review | Mandatory for critical and major before issue | QA | Before report issue |
Retention: keep with the audit file for not less than <<FILL: retention period>>.
Instructions
- Complete one record per finding. Do not merge two distinct nonconformities into one record.
- Fill the four core fields (requirement, condition, evidence, consequence) before assigning the grade; the grade is the output, not the input.
- Where several related minors aggregate into a major, raise the major on its own record and list the constituent findings in the aggregation field.
- Do not write proposed corrective actions into the condition or consequence; the auditee owns the fix through CAPA.
- Route critical and major records to QA for review before the report issues.
Filled specimen
| Field | Entry |
|---|---|
| Finding ID | INT-2026-019 |
| Audit reference | INT-AUD-2026-04 (QC laboratory) |
| Audit type | Internal |
| Date observed | 2026-06-04 |
| Area / process / system | QC chromatography data system, audit trail review process |
| Auditor | A. Patel |
| Requirement | EU GMP Annex 11 paragraph 9 and site SOP-QC-114 v4 step 6.2 require audit trail review prior to batch disposition. |
| Condition | In 3 of 4 sampled finished-product batch records (lots A231, A239, A241), the CDS audit trail review was documented on a date later than the disposition decision. |
| Objective evidence | Disposition signatures 2026-03-02, 2026-03-09, 2026-03-15; review checklists FRM-114-01 dated 2026-03-04, 2026-03-11, 2026-03-18; confirmed on screen in the CDS audit trail; audit note AN-07. |
| Consequence / risk | A required release control operated after the release decision it informs, across most of the sample; the release-control process is not functioning as designed. No patient harm demonstrated. |
| Spread assessed | 4 sampled, 3 affected; pattern, not isolated. |
| Aggregation? | N/A (single systemic finding, not a roll-up). |
| Grade | Major |
| Grade rationale | No falsification and no direct patient harm shown, so not critical; systemic failure of a release control across the sample, so major; not isolated, so not minor. |
| Auditee acknowledgement | Condition acknowledged by QC Manager at closing meeting. |
| CAPA / response reference | CAPA-2026-0231 |
| Response due date | 2026-07-04 (30 days) |
| Finding owner (CAPA) | QC Manager |
| Lead auditor review | A. Patel, 2026-06-05 |
| QA review | R. Gomez, 2026-06-06 |
The completed record shows a finding that is hard to argue with: every field points at a relocatable artifact, and the grade follows from the consequence. An auditee can fix it; they cannot wave it away.
Common inspection findings this form prevents
- Findings recorded as conclusions (“data integrity concerns”) with no requirement, evidence, or consequence.
- A grade with no rationale, so no one can tell why it was not a tier higher or lower.
- Corrective actions pre-written into the finding, letting the auditee skip a real root cause.
- Verbal assertions graded major without corroboration against a record.
- No QA review of critical and major findings before the report issued.
How to adapt this form
- Set your form number and parent SOP in the control block.
- Match the retention period to your records retention schedule.
- If your CAPA system assigns IDs automatically, align the CAPA reference field to that format.
- Keep the four core fields in this order; the ordering is the discipline that makes the grade defensible.