Setup & Installation
Or with the ClawHub CLI, for registry-managed skill folders outside a full OpenClaw workspace:
Version History
v2.1.1: optimization, reference splits
What This Skill Does
Manages Corrective and Preventive Action (CAPA) processes within medical device Quality Management Systems. Guides investigation from trigger event through root cause determination, action planning, and effectiveness verification. Tracks CAPA metrics and supports compliance with ISO 13485 and FDA 21 CFR 820.100.
Instead of consulting separate RCA guides, compliance references, and tracking spreadsheets, decision trees, regulatory mappings, and action templates are available in one workflow.
When to use it
- Investigating a recurring nonconformance with 5-Why analysis
- Building a fishbone diagram for a complex audit finding
- Tracking open CAPAs and flagging overdue items
- Verifying corrective action effectiveness after implementation
- Generating a CAPA status report for management review
Example Workflow
Here's how your AI assistant might use this skill in practice.
User asks: We've had three calibration failures this month from the same equipment group. How do I investigate this as a CAPA?
- 1Confirms CAPA is required based on the recurring nonconformance rule (same NC type occurring 3 or more times)
- 2Recommends 5-Why analysis given the linear causation pattern
- 3Steps through each Why level with evidence prompts, tracing from overdue calibration back to a missing procedure update requirement
- 4Produces a corrective action plan with containment, correction, and systemic corrective actions, each with an assigned owner and due date
- 5Defines effectiveness verification criteria and schedules a 60-day post-implementation review
A complete CAPA investigation package with root cause statement, action plan with measurable success criteria, and a verification schedule ready for QA review