capa-officer
CommunityMaster CAPA for medical device QMS.
AuthorFantasia1999
Version1.0.0
Installs0
System Documentation
What problem does it solve?
This Skill streamlines the management of Corrective and Preventive Actions (CAPA) within a medical device Quality Management System (QMS), ensuring compliance and driving continuous improvement.
Core Features & Use Cases
- Systematic CAPA Management: Guides users through the entire CAPA lifecycle, from investigation to closure.
- Root Cause Analysis (RCA): Provides structured methods like 5-Why and Fishbone diagrams to identify true root causes.
- Action Planning & Verification: Facilitates the creation of effective corrective and preventive actions and their subsequent validation.
- Use Case: A critical customer complaint arises regarding a device malfunction. This Skill will guide the CAPA officer through investigating the complaint, performing a root cause analysis, implementing corrective actions, and verifying their effectiveness to prevent recurrence.
Quick Start
Initiate a CAPA investigation for a critical customer complaint by following the CAPA Investigation Workflow.
Dependency Matrix
Required Modules
capa_tracker.py
Components
scriptsreferences
💻 Claude Code Installation
Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.
Please help me install this Skill: Name: capa-officer Download link: https://github.com/Fantasia1999/claude-skills-zh/archive/main.zip#capa-officer Please download this .zip file, extract it, and install it in the .claude/skills/ directory.
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