AiVACO · Inspection evidence pack

ASM-0005 — Packaging line 2 label reconciliation variance

Generated 2026-10-26 14:50:49 UTC · assembled from the live audit trail, not a template

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

1. Record

Source systemMES · MES-PKG-0553
Process stagePackaging
SummaryReconciliation showed 6 labels unaccounted for on batch 24-0902 (limit: zero unaccounted).
Current dispositionFlagged, waiting for the auditor

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
Occurrence2 of 4
Detection3 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 confidence81%, recommendation: escalate (engine: simulated)
AI reasoningUnaccounted labels risk a mix-up reaching the patient. Zero-tolerance limit was breached, so this should not be closed without a human decision.
RoutingLevel 3 — a human was required because:
  • Risk level 4 (RPN 24) is at or above the QA threshold
  • The AI recommends escalation

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 81%.
P3 · Recommendation is one the platform allowsPassedThe recommendation is “escalate”.
P4 · A reason is givenPassedA reason is given.
P5 · It rests on documents that are in force todayPassedAll 2 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-PKG-005 Labelling Reconciliation21 CFR 211.125 · EU GMP Ch.5
SOP-QA-007 Deviation ManagementEU GMP Ch.1 §1.4 · ICH Q10

4. Controlled documents relied on

SOP-PKG-005 v5.0 §5.1 · Labelling Reconciliation — Zero-tolerance reconciliation
Printed labels issued to a line must be reconciled exactly against labels used, rejected and returned. The limit for unaccounted labels is zero. Any variance stops the line and starts a deviation before the batch can proceed.
SOP-PKG-005 v5.0 §5.3 · Labelling Reconciliation — Mix-up risk
Unaccounted labels are treated as a potential mix-up that could reach the patient, and the batch is quarantined until the reconciliation is explained.

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
232026-10-26 11:10:34 UTCconnector.mesRecord MES-PKG-0553 pulled from MES3b1fe88cc38c…
242026-10-26 11:10:34 UTCai.simulatedAI proposed a grade of D4 (RPN 24, 81% confident) — Level 382b1198d130a…
252026-10-26 11:10:34 UTCassuranceAssurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checksa1f14af85b7c…
262026-10-26 11:10:34 UTCsystemFlagged for a human: Risk level 4 (RPN 24) is at or above the QA threshold; The AI recommends escalatione89b6667eca4…