New excipient supplier introduced without qualification on file
A purchase order was raised with Northfield Excipients Ltd, which has no supplier qualification record in the system.
Open inspection evidence pack ↗AI assessment
Simulated AIAI’s reasoning (request input): No qualification record was found, but it may exist outside the connected systems. The team can confirm quickly.
Why a human is involved
- Risk level 4 (RPN 24) is at or above the QA threshold
- AI confidence 62% is below the 75% needed to clear it alone
- The AI needs information from the team
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 62%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “request_input”.
- ✓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 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-PUR-006 v4.0 §4.1 Qualification before purchase
A purchase order for a GMP material is not raised with a supplier that has no qualification record. Qualification is by questionnaire and, for critical materials, an audit or documented desk review.
- SOP-PUR-006 v4.0 §4.3 Change of supplier
Introducing a new supplier for an existing material is a change under change control and requires qualification, and where applicable regulatory notification, before first use.
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-PUR-006 Supplier Qualification | EU GMP Ch.7 · ICH Q9(R1) |
History
Every step below is a record in the tamper-evident audit trail.
- Record PO-88213 pulled from ERP
- AI proposed a grade of D4 (RPN 24, 62% 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; AI confidence 62% is below the 75% needed to clear it alone; The AI needs information from the team
- Asked Supplier Quality: Has a supplier qualification audit or questionnaire been completed for Northfield Excipients Ltd? If yes, please give the reference.