Generated 2026-10-26 15:24:33 UTC · assembled from the live audit trail, not a template
| Source system | EQMS · CHG-2026-077 |
|---|---|
| Process stage | Manufacturing |
| Summary | Change control to replace a HEPA filter with an identical, certified part during planned maintenance. |
| Current disposition | Cleared automatically by the AI under the routing rules |
The AI proposes the factors below. The grade and the routing are computed by fixed rules (ICH Q9(R1)), never by the AI.
| Severity | 2 of 4 |
|---|---|
| Occurrence | 1 of 4 |
| Detection | 1 of 4 |
| Uncertainty | 0 of 2 |
| Importance | 0 of 2 |
| Complexity | 0 of 2 |
| RPN (S × O × D) | 2 |
| Computed grade | A1 — risk level 1, formality A (commensurate with risk) |
| AI confidence | 98%, recommendation: clear (engine: simulated) |
| AI reasoning | Identical part, planned window, no process impact. Matches pre-approved change categories. |
| Routing | Level 1 — cleared without a human |
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 98%. |
| P3 · Recommendation is one the platform allows | Passed | The recommendation is “clear”. |
| P4 · A reason is given | Passed | A reason is given. |
| P5 · It rests on documents that are in force today | Passed | All 1 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 A1 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-QA-015 Change Control | ICH Q10 §3.2.4 · EU GMP Ch.1 |
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 |
|---|---|---|---|---|
| 57 | 2026-10-26 12:55:04 UTC | connector.eqms | Record CHG-2026-077 pulled from EQMS | 3aa4de64ca09… |
| 58 | 2026-10-26 12:55:04 UTC | ai.simulated | AI proposed a grade of A1 (RPN 2, 98% confident) — Level 1 | 89c054b93d56… |
| 59 | 2026-10-26 12:55:04 UTC | assurance | Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks | 7f4d4b288e7e… |
| 60 | 2026-10-26 12:55:04 UTC | system | Cleared automatically at Level 1 — no human needed | cbd4f29b1fda… |