AiVACO · Inspection evidence pack

ASM-0006 — New excipient supplier introduced without qualification on file

Generated 2026-10-26 14:50:43 UTC · assembled from the live audit trail, not a template

Audit trail integrity: Intact. 68 records verified at generation time.

1. Record

Source systemERP · PO-88213
Process stageQuality System
SummaryA purchase order was raised with Northfield Excipients Ltd, which has no supplier qualification record in the system.
Current dispositionWaiting for information from the team

2. AI proposal and the rules applied

The AI proposes the factors below. The grade and the routing are computed by fixed rules (ICH Q9(R1)), never by the AI.

Severity4 of 4
Occurrence3 of 4
Detection2 of 4
Uncertainty2 of 2
Importance2 of 2
Complexity2 of 2
RPN (S × O × D)24
Computed gradeD4 — risk level 4, formality D (commensurate with risk)
AI confidence62%, recommendation: request input (engine: simulated)
AI reasoningNo qualification record was found, but it may exist outside the connected systems. The team can confirm quickly.
RoutingLevel 3 — a human was required because:
  • 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

Assurance Layer check on the AI proposal

Fixed rule set version 1.0.0, checked on 2026-10-26. Overall: passed.

RuleResultDetail
P1 · Scores are on the defined scalesPassedAll six scores are whole numbers inside their scales.
P2 · Confidence is a real percentagePassedConfidence is 62%.
P3 · Recommendation is one the platform allowsPassedThe recommendation is “request_input”.
P4 · A reason is givenPassedA reason is given.
P5 · It rests on documents that are in force todayPassedAll 1 named control(s) have a version in force.
P6 · Supporting text was foundPassed2 supporting passage(s) found.
P7 · Formality matches the riskPassedGrade D4 is formal enough for the risk.
P8 · The AI did not try to lower the barPassedThe AI’s recommendation does not try to go below what the fixed rules require.

3. Controls and the regulations they satisfy

Company controlRegulation / guideline
SOP-PUR-006 Supplier QualificationEU GMP Ch.7 · ICH Q9(R1)

4. Controlled documents relied on

SOP-PUR-006 v4.0 §4.1 · Supplier Qualification — 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 · Supplier Qualification — 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.

5. Signature

No signature on this assessment.

6. Audit trail for this record

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)WhoEventHash
272026-10-26 11:10:34 UTCconnector.erpRecord PO-88213 pulled from ERP7d2cbb82f31c…
282026-10-26 11:10:34 UTCai.simulatedAI proposed a grade of D4 (RPN 24, 62% confident) — Level 351c15bd9aec2…
292026-10-26 11:10:34 UTCassuranceAssurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks62840924009c…
302026-10-26 11:10:34 UTCsystemFlagged 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 team719a6922ac36…
312026-10-26 11:10:34 UTCai.simulatedAsked Supplier Quality: Has a supplier qualification audit or questionnaire been completed for Northfield Excipients Ltd? If yes, please give the reference.69a7bd971688…