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ASM-0007EQMS · CAPA-2026-031Quality System

CAPA-2026-031 effectiveness check closed

Effectiveness check showed no recurrence over the 90-day monitoring period.

Open inspection evidence pack ↗

AI assessment

Simulated AI
B2
Risk level 2 · Formality B · RPN 12
Level 2 · AI review
Risk — severity × occurrence × detection
Severity3
Occurrence2
Detection2
RPN 12 → level 2
Formality — uncertainty + importance + complexity
Uncertainty1
Importance1
Complexity1
Formality B
AI confidence90%
The AI must be at least 75% confident to clear an item without a human.

AI’s reasoning (clear): Monitoring period completed with zero recurrences and the closure evidence is attached.

Why no human was needed

Low risk, the AI was confident, and its grade met the formality ICH Q9 requires, so it was cleared at Level 2 and logged.

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 90%.
  • ✓P3 · Recommendation is one the platform allowsThe recommendation is “clear”.
  • ✓P4 · A reason is givenA reason is given.
  • ✓P5 · It rests on documents that are in force todayAll 1 named control(s) have a version in force.
  • ✓P6 · Supporting text was found2 supporting passage(s) found.
  • ✓P7 · Formality matches the riskGrade B2 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-012 v5.0 §5.2 Effectiveness check
    An effectiveness check is defined at CAPA approval and run after a monitoring period of at least 90 days. A CAPA is closed only when the check shows no recurrence.
  • SOP-QA-012 v5.0 §4.1 Initiation
    A CAPA is raised when a deviation, audit finding or trend shows a systemic cause. Each CAPA names an owner, a due date and a risk rating under ICH Q9.

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-012 CAPAICH Q10 §3.2 · 21 CFR 211.192

History

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

  1. Oct 26, 11:10 AMconnector.eqms#32
    Record CAPA-2026-031 pulled from EQMS
  2. Oct 26, 11:10 AMai.simulated#33
    AI proposed a grade of B2 (RPN 12, 90% confident) — Level 2
  3. Oct 26, 11:10 AMassurance#34
    Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks
  4. Oct 26, 11:10 AMsystem#35
    Cleared automatically at Level 2 — no human needed