Are there automated tools included in this skill?

The skill references Python scripts for CAPA tracking, RCA documentation, metrics dashboarding, and automated trend identification.

What is the primary purpose of the CAPA Officer skill?

The skill is designed to guide users through the Corrective and Preventive Action (CAPA) process, ensuring thorough root cause analysis, effective action planning, and regulatory compliance within a Quality Management System.

Which RCA methodologies are included?

It supports 5 Why Analysis, Fishbone Diagrams, Fault Tree Analysis, Human Factors Analysis, and Failure Mode and Effects Analysis (FMEA).

Does this skill help with regulatory inspections?

Yes, it provides frameworks and documentation standards that align with ISO 13485, FDA 21 CFR 820.100, and EU MDR requirements to ensure inspection readiness.

Enterprise CAPA Officer

Name: Enterprise CAPA Officer
Author: pur3v4d3r

bypur3v4d3r

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Productivity & Workflow

Manages Corrective and Preventive Action (CAPA) workflows and root cause investigations within Quality Management Systems.

About

The Enterprise CAPA Officer skill provides Claude with a comprehensive framework for managing the full lifecycle of Corrective and Preventive Actions, from initial problem identification to effectiveness verification. It integrates industry-standard root cause analysis (RCA) methodologies—such as 5 Whys, Fishbone diagrams, and FMEA—with automated Python scripts for tracking metrics and identifying trends. Designed for quality assurance professionals and system administrators, this skill ensures rigorous investigation protocols and alignment with regulatory standards like ISO 13485 and FDA 21 CFR 820.100, facilitating continuous improvement and systemic risk mitigation.

Key Features

Automated CAPA tracking and metrics reporting scripts
1 GitHub stars
Risk management integration for QMS compliance
Full CAPA lifecycle management from initiation to closure
Multi-methodology Root Cause Analysis (RCA) framework
Systematic trend analysis and management reporting

Use Cases

Executing systematic investigations into quality deviations or non-conformances
Developing and monitoring corrective action plans for regulatory compliance
Automating the generation of CAPA performance dashboards and trend reports

About

Key Features

Automated CAPA tracking and metrics reporting scripts
1 GitHub stars
Risk management integration for QMS compliance
Full CAPA lifecycle management from initiation to closure
Multi-methodology Root Cause Analysis (RCA) framework
Systematic trend analysis and management reporting

Use Cases

Executing systematic investigations into quality deviations or non-conformances
Developing and monitoring corrective action plans for regulatory compliance
Automating the generation of CAPA performance dashboards and trend reports