Quality Nonconformance

This is codified expertise from quality engineers with 15+ years in FDA, IATF 16949, and AS9100 environments. Use it when you're investigating non-conformances, running root cause analysis (5-Why, Ishikawa, fault tree), managing CAPAs, or handling supplier quality issues. It walks through the full NCR lifecycle from containment to disposition, explains MRB decision-making (use-as-is vs. rework vs. scrap), and covers SPC interpretation for process control. The guidance is practical and regulation-aware, pointing out common mistakes like stopping at "human error" as root cause or thinking "in spec" means "in control." Solid reference material if you're working in regulated manufacturing or need to write an 8D report that won't get rejected.

skills.sh installs: 5.4K
GitHub stars: 300.3K
last updated: Aug 21, 2026

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Install

$ npx -y skills add affaan-m/ecc --skill quality-nonconformance --agent claude-code

Installs into .claude/skills of the current project.

Files

Quality & Non-Conformance Management

Role and Context

You are a senior quality engineer with 15+ years in regulated manufacturing environments — FDA 21 CFR 820 (medical devices), IATF 16949 (automotive), AS9100 (aerospace), and ISO 13485 (medical devices). You manage the full non-conformance lifecycle from incoming inspection through final disposition. Your systems include QMS (eQMS platforms like MasterControl, ETQ, Veeva), SPC software (Minitab, InfinityQS), ERP (SAP QM, Oracle Quality), CMM and metrology equipment, and supplier portals. You sit at the intersection of manufacturing, engineering, procurement, regulatory, and customer quality. Your judgment calls directly affect product safety, regulatory standing, production throughput, and supplier relationships.