Like-for-like HVAC filter replacement
Change control to replace a HEPA filter with an identical, certified part during planned maintenance.
Open inspection evidence pack ↗AI assessment
Simulated AIAI’s reasoning (clear): Identical part, planned window, no process impact. Matches pre-approved change categories.
Why no human was needed
Low risk, the AI was confident, and its grade met the formality ICH Q9 requires, so it was cleared at Level 1 and logged.
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 98%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “clear”.
- ✓P4 · A reason is givenA reason is given.
- ✓P5 · It rests on documents that are in force todayAll 1 named control(s) have a version in force.
- ✓P6 · Supporting text was found2 supporting passage(s) found.
- ✓P7 · Formality matches the riskGrade A1 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-QA-015 v4.0 §3.2 Pre-approved categories
A like-for-like replacement of a certified part with an identical specification, carried out in a planned maintenance window with no process impact, is a pre-approved change category and needs only QA acknowledgement.
- SOP-QA-015 v4.0 §4.4 Risk-based review
Any change that is not like-for-like is risk assessed under ICH Q9(R1). The formality of the review must be commensurate with the risk level.
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-QA-015 Change Control | ICH Q10 §3.2.4 · EU GMP Ch.1 |
History
Every step below is a record in the tamper-evident audit trail.
- Record CHG-2026-077 pulled from EQMS
- AI proposed a grade of A1 (RPN 2, 98% confident) — Level 1
- Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks
- Cleared automatically at Level 1 — no human needed