Agent skill · research science · borghei
capa-officer
CAPA system management for medical device QMS, covering root cause analysis, corrective action planning, and effectiveness verification. Use for CAPA investigations, 5-Why and fishbone analysis, and corrective action tracking.
Why this skill is useful
Provides specific methodologies and workflows for CAPA investigations that the AI wouldn't reliably generate on its own.
What it needs
About 11k tokens when loaded. Last updated 2026-07-21. 462 stars on the source repository.
What this skill does
CAPA Officer Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification. --- Table of Contents CAPA Investigation Workflow Root Cause Analysis Corrective Action Planning Effectiveness Verification CAPA Metrics and Reporting Reference Documentation Tools --- Clarify First Before starting a CAPA investigation, confirm these inputs. If any is unknown or vague, ASK — do not assume: [ ] Trigger event and objective evidence — what happened, where/when, and what records exist (drives the problem statement and RCA scope) [ ] Severity classification — Critical, Major, or Minor (sets investigation team composition, action depth, and verification timeline) [ ] Source — complaint, audit finding, recurring NC, or trend (determines whether a CAPA is required and the regulatory linkage) Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the CAPA record. CAPA Investigation Workflow Conduct systematic CAPA investigation from initiation through closure: 1. Document trigger event with objective evidence 2. Assess significance and determine CAPA necessity 3. Form investigation team with relevant expertise 4. Collect data and evidence systematically 5. Select and apply appropriate RCA methodology 6. Identify root cause(s) with supporting evidence 7. Develop corrective and preventive actions 8. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills borghei/capa-officer