CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
99
100%
Does it follow best practices?
Impact
99%
1.06xAverage score across 6 eval scenarios
Passed
No known issues
RCA method selection and Fishbone analysis
Fishbone method selected
100%
100%
Man category addressed
100%
100%
Machine category addressed
100%
100%
Method category addressed
87%
100%
Material category addressed
100%
100%
Measurement category addressed
100%
100%
Environment category addressed
100%
100%
Evidence cited per cause
80%
100%
Problem statement specifics
100%
100%
Root cause validation
85%
100%
Cause prioritization
100%
100%
CAPA action planning and verification
Containment action present
100%
100%
Correction action present
50%
100%
Corrective action present
100%
100%
Preventive action present
100%
100%
Action responsible parties
100%
100%
Due dates in YYYY-MM-DD format
100%
100%
Success criteria per action
100%
100%
Implementation timeline milestones
100%
100%
Approval section present
100%
100%
Verification wait period compliant
20%
100%
Verification method appropriate
80%
100%
SMART effectiveness criteria
83%
100%
CAPA metrics reporting with tracker tool
Valid JSON schema
100%
100%
Tracker script invoked
100%
100%
Cycle time metric reported
62%
100%
Overdue rate reported
100%
100%
Effectiveness rate reported
75%
100%
Aging analysis with 4 buckets
100%
100%
Source analysis included
100%
100%
Overdue list with owners
100%
100%
Severity distribution included
100%
100%
Actionable recommendations
100%
100%
5-Why analysis and CAPA investigation workflow
CAPA required determination
100%
100%
Investigation team for severity
100%
100%
Problem statement specifics
100%
100%
Timeline documented
100%
100%
Records reviewed
100%
100%
Personnel interviews
100%
100%
Related prior events referenced
100%
100%
5-Why method selected
100%
100%
WHY/BECAUSE/EVIDENCE format
100%
100%
At least 4 why-levels
100%
100%
Root cause validation checklist
100%
100%
Root cause is systemic
100%
100%
Fault Tree Analysis for safety-critical failures
CAPA required for safety
100%
100%
Critical severity classification
100%
100%
5-person Critical team
50%
100%
FTA method selected
100%
100%
Top event identified
100%
100%
AND gates used
100%
100%
OR gates used
100%
100%
Node types distinguished
100%
100%
Minimal cut sets identified
100%
100%
Single points of failure
100%
100%
Critical path analysis
75%
100%
Recommendations prioritized correctly
100%
100%
Ineffective CAPA re-investigation and Human Factors Analysis
CAPA determined ineffective
100%
100%
Reopen — do not close
100%
100%
Containment for recurrence
100%
100%
Management notification required
100%
100%
Root cause re-evaluation structure
77%
100%
Second-attempt escalation
71%
71%
Human Factors method selected
100%
100%
HFACS four levels addressed
100%
100%
Human error type classified
100%
100%
Systemic root cause identified
100%
100%
Correct wait period for Major
77%
100%
SMART effectiveness criteria
100%
100%
Appropriate verification method
100%
100%
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Table of Contents
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