capa-officer

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Tool: SKILL.md [1/3] Description: --- name: capa-officer description: CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics.

Tool: SKILL.md [2/3] Description: Purpose | Timeline | Example | |------|---------|----------|---------| | Containment | Stop immediate impact | 24-72 hours | Quarantine affected product | | Correction | Fix the specific occurrence | 1-2 weeks | Rework or replace affected items | | Corrective | Eliminate root cause | 30-90 days | Revise procedure, add controls | | Preventive | Prevent in other areas | 60-120 days | Extend solution to similar processes | ### Action Plan Components ``` ACTION PLAN

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Tool: references/effectiveness-verification-guide.md [1/2] Description: # Effectiveness Verification Guide CAPA effectiveness assessment procedures, verification methods, and closure criteria.

Malicious tool definition detected

--- ## Table of Contents - [Method Selection Matrix](#method-selection-matrix) - [5 Why Analysis](#5-why-analysis) - [Fishbone Diagram](#fishbone-diagram) - [Fault Tree Analysis](#fault-tree-analysis) - [Human Factors Analysis](#human-factors-analysis) - [Failure Mode and Effects Analysis](#failure-mode-and-effects-analysis) - [Selecting the Right Method](#selecting-the-right-method) --- ## Method Selection Matrix ### When to Use Each Method | Method | Use When | Problem Type | Team Size | Time

Tool: references/rca-methodologies.md [3/3] Description: | 72 | [Action] | RPN THRESHOLD: Actions required for RPN > [threshold] HIGH SEVERITY RULE: Actions required for S >= 9 regardless of RPN ACTION PRIORITIZATION: 1.

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Malicious tool definition detected

Exiting.") return tracker = CAPATracker(capas) metrics = tracker.calculate_metrics() aging = tracker.get_aging_report() print(" " + format_text_output(metrics, aging)) def main(): parser = argparse.ArgumentParser( description="CAPA Tracking and Metrics Tool" ) parser.add_argument( "--capas", type=str, help="JSON file with CAPA data" ) parser.add_argument( "--output", choices=["text", "json"], default="text", help="Output format" ) parser.add_argument( "--interactive", action="store_true", help="