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ASM-0004LMS · TRN-0310Packaging

GMP training current for packaging line 2 operators

All 14 operators hold in-date GMP and line-specific training.

Open inspection evidence pack ↗

AI assessment

Simulated AI
B2
Risk level 2 · Formality B · RPN 8
Level 2 · AI review
Risk — severity × occurrence × detection
Severity2
Occurrence2
Detection2
RPN 8 → level 2
Formality — uncertainty + importance + complexity
Uncertainty1
Importance1
Complexity0
Formality B
AI confidence92%
The AI must be at least 75% confident to clear an item without a human.

AI’s reasoning (clear): 100% of required training is in date. No gaps found against the training matrix.

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 92%.
  • ✓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-HR-004 v6.0 §3.4 Annual refresh
    GMP training is refreshed annually. Overdue training removes the person from unsupervised GMP tasks until it is completed.
  • SOP-HR-004 v6.0 §3.1 Training before tasks
    No person performs a GMP task unsupervised until training on the relevant procedures is complete and recorded. Until then they work under the direct supervision of a trained person, and the supervision is recorded.

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-HR-004 GMP Training21 CFR 211.25 · EU GMP Ch.2

History

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

  1. Oct 26, 11:10 AMconnector.lms#19
    Record TRN-0310 pulled from LMS
  2. Oct 26, 11:10 AMai.simulated#20
    AI proposed a grade of B2 (RPN 8, 92% confident) — Level 2
  3. Oct 26, 11:10 AMassurance#21
    Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks
  4. Oct 26, 11:10 AMsystem#22
    Cleared automatically at Level 2 — no human needed