Can it help me perform a Root Cause Analysis?

Yes, it provides structured guidance for 5-Why, Ishikawa (Fishbone) diagrams, Fault Tree Analysis (FTA), and the 8D methodology.

How does it handle material disposition?

It provides a framework for Material Review Board (MRB) decisions, helping you document justifications for use-as-is, rework, repair, or scrap.

Which regulatory standards does this skill support?

The skill is informed by standards including FDA 21 CFR 820 (Medical Devices), IATF 16949 (Automotive), AS9100 (Aerospace), and ISO 13485.

Does it assist with Statistical Process Control (SPC)?

Absolutely. It helps interpret control chart signals using Western Electric Rules and explains capability indices like Cp, Cpk, Pp, and Ppk.

Quality & Non-Conformance Management

Name: Quality & Non-Conformance Management
Author: affaan-m

byaffaan-m

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156,033

•

Analíticas y Monitorización

Guides quality engineers through non-conformance investigations, root cause analysis, and regulatory compliance in manufacturing environments.

This skill transforms Claude into a senior quality engineer with 15+ years of experience across FDA, IATF 16949, and AS9100 regulated environments. It provides structured frameworks for managing the entire non-conformance (NCR) lifecycle, performing deep root cause analysis using 5-Why and Ishikawa methods, and developing robust Corrective and Preventive Action (CAPA) plans. Whether interpreting complex SPC control charts or drafting 8D reports for automotive OEMs, this skill ensures that quality investigations are data-driven, regulatory-compliant, and focused on preventing recurrence rather than just addressing symptoms.

Características Principales

01Regulatory compliance alignment for FDA 21 CFR 820, AS9100, and ISO 13485

02CAPA system guidance for corrective and preventive action planning

03Structured Root Cause Analysis (RCA) using 5-Why, Ishikawa, and FTA

04156,033 GitHub stars

05Statistical Process Control (SPC) interpretation and capability analysis

06End-to-end NCR lifecycle management from identification to disposition

Casos de Uso

01Generating professional 8D response reports for customer field failures

02Analyzing SPC data to identify special cause variation and process instability

03Investigating manufacturing defects and determining material disposition (scrap, rework, or use-as-is)

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add affaan-m/everything-claude-code quality-nonconformance

For use in Claude.ai and ChatGPT

Características Principales

01Regulatory compliance alignment for FDA 21 CFR 820, AS9100, and ISO 13485

02CAPA system guidance for corrective and preventive action planning

03Structured Root Cause Analysis (RCA) using 5-Why, Ishikawa, and FTA

04156,033 GitHub stars

05Statistical Process Control (SPC) interpretation and capability analysis

06End-to-end NCR lifecycle management from identification to disposition

Casos de Uso

01Generating professional 8D response reports for customer field failures

02Analyzing SPC data to identify special cause variation and process instability

03Investigating manufacturing defects and determining material disposition (scrap, rework, or use-as-is)