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ASM-0005MES · MES-PKG-0553Packaging

Packaging line 2 label reconciliation variance

Reconciliation showed 6 labels unaccounted for on batch 24-0902 (limit: zero unaccounted).

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AI assessment

Simulated AI
D4
Risk level 4 · Formality D · RPN 24
Level 3 · Human review
Risk — severity × occurrence × detection
Severity4
Occurrence2
Detection3
RPN 24 → level 4
Formality — uncertainty + importance + complexity
Uncertainty2
Importance2
Complexity2
Formality D
AI confidence81%
The AI must be at least 75% confident to clear an item without a human.

AI’s reasoning (escalate): Unaccounted labels risk a mix-up reaching the patient. Zero-tolerance limit was breached, so this should not be closed without a human decision.

Why a human is involved

  • Risk level 4 (RPN 24) is at or above the QA threshold
  • The AI recommends escalation

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 81%.
  • ✓P3 · Recommendation is one the platform allowsThe recommendation is “escalate”.
  • ✓P4 · A reason is givenA reason is given.
  • ✓P5 · It rests on documents that are in force todayAll 2 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-PKG-005 v5.0 §5.1 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 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.

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 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

History

Every step below is a record in the tamper-evident audit trail.

  1. Oct 26, 11:10 AMconnector.mes#23
    Record MES-PKG-0553 pulled from MES
  2. Oct 26, 11:10 AMai.simulated#24
    AI proposed a grade of D4 (RPN 24, 81% confident) — Level 3
  3. Oct 26, 11:10 AMassurance#25
    Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks
  4. Oct 26, 11:10 AMsystem#26
    Flagged for a human: Risk level 4 (RPN 24) is at or above the QA threshold; The AI recommends escalation