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capa-officer

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

1.06x
Quality

100%

Does it follow best practices?

Impact

99%

1.06x

Average score across 6 eval scenarios

SecuritybySnyk

Passed

No known issues

SKILL.md
Quality
Evals
Security

Evaluation results

100%

5%

Manufacturing Defect Investigation — Cardiac Monitor Housing

RCA method selection and Fishbone analysis

Criteria
Without context
With context

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%

100%

16%

Corrective Action Plan — Recurring Catheter Labeling Nonconformance

CAPA action planning and verification

Criteria
Without context
With context

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%

100%

5%

CAPA Program Management Review — Quarterly Status Report

CAPA metrics reporting with tracker tool

Criteria
Without context
With context

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%

100%

Unverified Material Release — CAPA Investigation

5-Why analysis and CAPA investigation workflow

Criteria
Without context
With context

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%

100%

6%

Infusion Pump Alarm Failure — Safety Incident Investigation

Fault Tree Analysis for safety-critical failures

Criteria
Without context
With context

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%

98%

4%

Recurring Assembly Error — Re-investigation Required

Ineffective CAPA re-investigation and Human Factors Analysis

Criteria
Without context
With context

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%

Repository
alirezarezvani/claude-skills
Evaluated
Agent
Claude Code
Model
Claude Sonnet 4.6

Table of Contents

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