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← Auditor consoleGrade B cleanroom: two non-viable particle excursions
Particle counts exceeded the action limit twice in one shift in the filling suite.
Open inspection evidence pack ↗AI assessment
Simulated AID4
Risk level 4 · Formality D · RPN 24
Level 3 · Human review
Risk — severity × occurrence × detection
Severity4
Occurrence3
Detection2
RPN 24 → level 4
Formality — uncertainty + importance + complexity
Uncertainty2
Importance2
Complexity2
Formality D
AI confidence83%
AI’s reasoning (escalate): Repeated excursions in a Grade B area adjacent to aseptic filling threaten sterility assurance and need an immediate human decision.
Why a human is involved
- Risk level 4 (RPN 24) is at or above the QA threshold
- The AI recommends escalation
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 83%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “escalate”.
- ✓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 D4 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-QC-021 v4.0 §5.3 Grade B and aseptic areas
Repeated action-limit excursions in a Grade B area adjacent to aseptic filling require immediate notification of Quality Assurance and an assessment of the impact on sterility assurance before filling continues.
- SOP-QC-021 v4.0 §5.2 Alert and action limits
Each classified area has alert and action limits for viable and non-viable monitoring. A result above an alert limit is trended; a result above an action limit starts an investigation the same day.
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-QC-021 Environmental Monitoring | EU GMP Annex 1 · ICH Q9(R1) |
| SOP-MFG-031 Aseptic Filling | EU GMP Annex 1 · ICH Q9(R1) |
History
Every step below is a record in the tamper-evident audit trail.
- Record ENV-26-0933 pulled from LIMS
- AI proposed a grade of D4 (RPN 24, 83% confident) — Level 3
- Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks
- Flagged for a human: Risk level 4 (RPN 24) is at or above the QA threshold; The AI recommends escalation