Script invocation

JSON input file

Correct JSON schema

High-risk processes identified

Medium-risk processes identified

Correct frequency mapping

All ISO 13485 clauses covered

JSON output format

Auditor independence criteria

Audit program metrics

Previous findings considered

Audit dates included

Requirement/Evidence/Gap format

Specific clause references

Objective evidence in Evidence field

Correct Major classification

Correct Minor classification

Correct Observation classification

Decision tree applied

CAPA timeline for Major

CAPA timeline for Minor

No corrective actions in finding

Neutral language used

Findings not combined

Finding log produced

5-Why or Fishbone for Major

Immediate cause for Minor

Major closure checklist

Closure only after CAPA verified

Closure record template

Evidence references in closure

Major CAPA timeline

Effectiveness verification method

Verification timing for Major

NC-YYYY-XXX finding ID format

Finding log updated

Management review metrics

Opening meeting documented

Documentation reviewed pre-audit

Closing meeting with preliminary findings

5-day report deadline

Document review evidence fields

Interview evidence fields

Observation evidence fields

Record trace evidence fields

Scope validation

Findings supported by evidence

Audit plan produced

All four evidence methods used

All internal audits completed

Findings closed with effective CAPA

Management review with audit input

Documentation readiness checklist

Personnel readiness checklist

Facility readiness checklist

Mock audit uses qualified auditor

Mock audit covers full scope

Mock audit simulates real conditions

Mock findings documented as real audit

Major and Minor findings addressed first

Management briefed on readiness

Personnel briefed on audit protocol

Documentation reviewed for currency

Impact vs. occurrence matrix applied

High-impact always Major

Medium-impact + occurrence escalation

Low-impact administrative findings

Clause 5.6 threshold applied

Clause 8.5 threshold applied

Clause 4.2 threshold applied

Clause 8.2.2 threshold applied

Classification rationale documented

Observation not escalated without evidence

Finding ID format

Severity-appropriate CAPA requirement