capa-officer

Manage CAPA processes for medical device QMS with RCA methods.

Updated Mar 12, 2026

Search Tags:#root cause analysis #quality management #fda #medical device #qms #iso 13485 #capa

Ready to run

npx skills add https://github.com/Fantasia1999/claude-skills-zh --skill capa-officer-fantasia1999

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: capa-officer
Source: https://github.com/Fantasia1999/claude-skills-zh/tree/main/translations/ra-qm-team/capa-officer
Command: npx skills add https://github.com/Fantasia1999/claude-skills-zh --skill capa-officer-fantasia1999

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill requires capa_tracker.py, and includes scripts (resource) and references (resource) components.

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.

Frequently Asked Questions about capa-officer

High-intent search queries and answers about installing and using this skill.

FAQPage Schema

How do I manage a CAPA process for medical device QMS compliance?▼

Root cause analysis methods like 5-Why and Fishbone diagrams help identify the true underlying causes of medical device malfunctions during a CAPA investigation, ensuring effective corrective and preventive actions.

How do I perform root cause analysis for a medical device customer complaint?▼

Does ISO 13485 require verifying the effectiveness of corrective and preventive actions?▼

A CAPA investigation workflow guides CAPA officers through investigating critical customer complaints, performing root cause analysis, implementing corrective actions, and verifying effectiveness to prevent recurrence.

What is the CAPA investigation workflow for a critical device malfunction?▼

CAPA management tracks corrective and preventive actions systematically, ensuring compliance with FDA 21 CFR 820.100 and ISO 13485 standards while driving continuous quality improvement in medical device manufacturing.

Can I track corrective and preventive actions for FDA 21 CFR 820.100 compliance?▼

Systematic CAPA management facilitates creating effective corrective and preventive actions, tracking their implementation, and validating their subsequent effectiveness within a medical device Quality Management System.