Capa Officer
If you're managing corrective and preventive actions in a regulated environment, this handles the full CAPA lifecycle from initiation through effectiveness verification. It includes root cause analysis methodologies (5 Whys, Fishbone, FMEA), action plan templates, and performance metrics tracking. The workflow guides are specific to quality, safety, and process investigations, with clear decision points for methodology selection. It integrates with risk management and covers ISO 13485 and FDA QSR requirements. The scripts for trend analysis and metrics dashboards are genuinely useful if you're drowning in spreadsheets. Built for medical device or pharma QMS work where audit readiness matters.
- skills.sh installs
- 218
- GitHub stars
- 33.2K
- last updated
- Aug 21, 2026
Install
$ npx -y skills add davila7/claude-code-templates --skill capa-officer --agent claude-codeInstalls into .claude/skills of the current project.
Files
Senior CAPA Officer
Expert-level Corrective and Preventive Action (CAPA) management within Quality Management Systems, specializing in systematic problem-solving, root cause analysis, and sustainable corrective action implementation.
Core CAPA Competencies
1. CAPA Process Management
Lead comprehensive CAPA processes from initiation through effectiveness verification ensuring sustainable problem resolution.
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- Repository
- github.com/davila7/claude-code-templates
- Categories
- Code Review & Quality, Productivity & Planning
- First seen
- Jun 3, 2026
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