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ASM-0001EQMS · DEV-2026-0142Distribution

Temperature excursion in cold storage room 3

Room 3 logged 9.4 °C for 47 minutes against a 2–8 °C limit. Stock was quarantined pending impact assessment.

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AI assessment

Simulated AI
C3
Risk level 3 · Formality C · RPN 16
Level 3 · Human review
Risk — severity × occurrence × detection
Severity4
Occurrence2
Detection2
RPN 16 → level 3
Formality — uncertainty + importance + complexity
Uncertainty1
Importance2
Complexity1
Formality C
AI confidence88%
The AI must be at least 75% confident to clear an item without a human.

AI’s reasoning (review): Excursion exceeded the validated limit and affects product stability. Impact depends on stability data a human should confirm.

Why a human is involved

  • Risk level 3 (RPN 16) is at or above the QA threshold
  • The AI recommends a human review

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 88%.
  • ✓P3 · Recommendation is one the platform allowsThe recommendation is “review”.
  • ✓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 C3 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-007 v6.0 §4.2 Storage and temperature excursions
    Any storage or temperature excursion outside validated limits requires the affected stock to be quarantined immediately. An impact assessment, using stability data, must be completed within five working days before any stock is released.
  • SOP-DIST-002 v3.0 §3.2 Excursions in storage
    Cold storage areas are monitored continuously against the labelled 2 to 8 degree range. An excursion triggers quarantine of the affected stock and follows the deviation procedure.

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-QA-007 Deviation ManagementEU GMP Ch.1 §1.4 · ICH Q10
SOP-DIST-002 Cold Chain DistributionEU GDP Ch.9 · ICH Q9(R1)

History

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

  1. Oct 26, 11:10 AMconnector.eqms#7
    Record DEV-2026-0142 pulled from EQMS
  2. Oct 26, 11:10 AMai.simulated#8
    AI proposed a grade of C3 (RPN 16, 88% confident) — Level 3
  3. Oct 26, 11:10 AMassurance#9
    Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks
  4. Oct 26, 11:10 AMsystem#10
    Flagged for a human: Risk level 3 (RPN 16) is at or above the QA threshold; The AI recommends a human review