Generated 2026-10-26 14:50:47 UTC · assembled from the live audit trail, not a template
| Source system | ERP · SO-55120 |
|---|---|
| Process stage | Distribution |
| Summary | A shipment is booked on a lane whose summer thermal qualification is still in progress. |
| 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 | 3 of 4 |
|---|---|
| Occurrence | 2 of 4 |
| Detection | 2 of 4 |
| Uncertainty | 1 of 2 |
| Importance | 1 of 2 |
| Complexity | 1 of 2 |
| RPN (S × O × D) | 12 |
| Computed grade | B2 — risk level 2, formality B (commensurate with risk) |
| AI confidence | 70%, recommendation: clear (engine: simulated) |
| AI reasoning | Risk looks moderate, but the qualification status in the source data is ambiguous, so confidence is low. |
| 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 70%. |
| 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 | 1 supporting passage(s) found. |
| P7 · Formality matches the risk | Passed | Grade B2 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-DIST-002 Cold Chain Distribution | EU GDP Ch.9 · 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 |
|---|---|---|---|---|
| 52 | 2026-10-26 11:10:36 UTC | connector.erp | Record SO-55120 pulled from ERP | 2bcecb69e4a3… |
| 53 | 2026-10-26 11:10:36 UTC | ai.simulated | AI proposed a grade of B2 (RPN 12, 70% confident) — Level 3 | 03c9b38319a6… |
| 54 | 2026-10-26 11:10:36 UTC | assurance | Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks | fb0d822d8f8f… |
| 55 | 2026-10-26 11:10:36 UTC | system | Flagged for a human: AI confidence 70% is below the 75% needed to clear it alone | f9f379bb9306… |