Generated 2026-10-26 14:50:41 UTC · assembled from the live audit trail, not a template
| Source system | LIMS · ENV-26-0933 |
|---|---|
| Process stage | Manufacturing |
| Summary | Particle counts exceeded the action limit twice in one shift in the filling suite. |
| Current disposition | Flagged, waiting for the auditor |
The AI proposes the factors below. The grade and the routing are computed by fixed rules (ICH Q9(R1)), never by the AI.
| Severity | 4 of 4 |
|---|---|
| Occurrence | 3 of 4 |
| Detection | 2 of 4 |
| Uncertainty | 2 of 2 |
| Importance | 2 of 2 |
| Complexity | 2 of 2 |
| RPN (S × O × D) | 24 |
| Computed grade | D4 — risk level 4, formality D (commensurate with risk) |
| AI confidence | 83%, recommendation: escalate (engine: simulated) |
| AI reasoning | Repeated excursions in a Grade B area adjacent to aseptic filling threaten sterility assurance and need an immediate human decision. |
| Routing | Level 3 — a human was required because:
|
Fixed rule set version 1.0.0, checked on 2026-10-26. Overall: passed.
| Rule | Result | Detail |
|---|---|---|
| P1 · Scores are on the defined scales | Passed | All six scores are whole numbers inside their scales. |
| P2 · Confidence is a real percentage | Passed | Confidence is 83%. |
| P3 · Recommendation is one the platform allows | Passed | The recommendation is “escalate”. |
| P4 · A reason is given | Passed | A reason is given. |
| P5 · It rests on documents that are in force today | Passed | All 2 named control(s) have a version in force. |
| P6 · Supporting text was found | Passed | 2 supporting passage(s) found. |
| P7 · Formality matches the risk | Passed | Grade D4 is formal enough for the risk. |
| P8 · The AI did not try to lower the bar | Passed | The AI’s recommendation does not try to go below what the fixed rules require. |
| 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) |
No signature on this assessment.
Each record is hash-chained to the one before it and cannot be edited or deleted. Record numbers refer to the platform-wide trail.
| # | Time (UTC) | Who | Event | Hash |
|---|---|---|---|---|
| 63 | 2026-10-26 12:55:18 UTC | connector.lims | Record ENV-26-0933 pulled from LIMS | 273c600f1df1… |
| 64 | 2026-10-26 12:55:19 UTC | ai.simulated | AI proposed a grade of D4 (RPN 24, 83% confident) — Level 3 | 6d856ac4e40c… |
| 65 | 2026-10-26 12:55:19 UTC | assurance | Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks | fb9684f799f6… |
| 66 | 2026-10-26 12:55:19 UTC | system | Flagged for a human: Risk level 4 (RPN 24) is at or above the QA threshold; The AI recommends escalation | 08dca67f35ca… |