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← Auditor consoleBatch record missing a second-person verification
Batch 24-0888 weigh-and-dispense step has one signature; a second-person check is required.
Open inspection evidence pack ↗AI assessment
Simulated AIC3
Risk level 3 · Formality C · RPN 18
Level 3 · Human review
Risk — severity × occurrence × detection
Severity3
Occurrence3
Detection2
RPN 18 → level 3
Formality — uncertainty + importance + complexity
Uncertainty2
Importance1
Complexity1
Formality C
AI confidence86%
AI’s reasoning (review): A required independent verification is absent. This is a documentation and data-integrity gap a QA reviewer must resolve.
Why a human is involved
- Risk level 3 (RPN 18) is at or above the QA threshold
- The AI recommends a human review
These reasons come from fixed rules, not from the AI. The AI can add reasons for a human to look but can never remove them.
Checked by the Assurance Layer
Checked, passedAll 8 Assurance checks on this proposal
- ✓P1 · Scores are on the defined scalesAll six scores are whole numbers inside their scales.
- ✓P2 · Confidence is a real percentageConfidence is 86%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “review”.
- ✓P4 · A reason is givenA reason is given.
- ✓P5 · It rests on documents that are in force todayAll 2 named control(s) have a version in force.
- ✓P6 · Supporting text was found2 supporting passage(s) found.
- ✓P7 · Formality matches the riskGrade C3 is formal enough for the risk.
- ✓P8 · The AI did not try to lower the barThe AI’s recommendation does not try to go below what the fixed rules require.
Rule set v1.0.0, judged on 2026-10-26. See the rules
Before the AI’s proposal is used, fixed rules check it. A failed blocking rule means the AI cannot clear the item by itself.
Grounded in the controlled documents
- SOP-MFG-014 v7.0 §6.2 Second-person verification
Critical steps, including weighing and dispensing, require a second-person verification signed in the batch record at the time of the operation. A missing verification is a deviation and the batch is held until it is resolved.
- SOP-QA-030 v3.0 §3.4 Independent verification
Where a procedure requires independent verification, the verifier is a different person from the operator and signs contemporaneously. A missing verification is treated as a data integrity gap.
Only approved, effective versions are quoted, and only documents this record is mapped to. The assistant cites the same sections.
Controls and the regulations they satisfy
| Company control | Regulation / guideline |
|---|---|
| SOP-MFG-014 Batch Record Review | 21 CFR 211.188 · EU GMP Ch.4 |
| SOP-QA-030 Data Integrity | 21 CFR Part 11 · EU GMP Annex 11 |
History
Every step below is a record in the tamper-evident audit trail.
- Record MES-MFG-0288 pulled from MES
- AI proposed a grade of C3 (RPN 18, 86% confident) — Level 3
- Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks
- Flagged for a human: Risk level 3 (RPN 18) is at or above the QA threshold; The AI recommends a human review