AiVACO · Inspection evidence pack

ASM-0001 — Temperature excursion in cold storage room 3

Generated 2026-10-26 14:46:43 UTC · assembled from the live audit trail, not a template

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

1. Record

Source systemEQMS · DEV-2026-0142
Process stageDistribution
SummaryRoom 3 logged 9.4 °C for 47 minutes against a 2–8 °C limit. Stock was quarantined pending impact assessment.
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
Detection2 of 4
Uncertainty1 of 2
Importance2 of 2
Complexity1 of 2
RPN (S × O × D)16
Computed gradeC3 — risk level 3, formality C (commensurate with risk)
AI confidence88%, recommendation: review (engine: simulated)
AI reasoningExcursion exceeded the validated limit and affects product stability. Impact depends on stability data a human should confirm.
RoutingLevel 3 — a human was required because:
  • Risk level 3 (RPN 16) is at or above the QA threshold
  • The AI recommends a human review

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 88%.
P3 · Recommendation is one the platform allowsPassedThe recommendation is “review”.
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 C3 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-QA-007 Deviation ManagementEU GMP Ch.1 §1.4 · ICH Q10
SOP-DIST-002 Cold Chain DistributionEU GDP Ch.9 · ICH Q9(R1)

4. Controlled documents relied on

SOP-QA-007 v6.0 §4.2 · Deviation Management — 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 · Cold Chain Distribution — 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.

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
72026-10-26 11:10:32 UTCconnector.eqmsRecord DEV-2026-0142 pulled from EQMS97f74b97cfec…
82026-10-26 11:10:32 UTCai.simulatedAI proposed a grade of C3 (RPN 16, 88% confident) — Level 37479fd0cd697…
92026-10-26 11:10:33 UTCassuranceAssurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checksa412fe110cd5…
102026-10-26 11:10:33 UTCsystemFlagged for a human: Risk level 3 (RPN 16) is at or above the QA threshold; The AI recommends a human reviewa7d48a9d63f3…