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.

Install to Claude Code

npx -y skills add davila7/claude-code-templates --skill capa-officer --agent claude-code