Agent skill · data analytics · affaan-m
quality-nonconformance
Quality control and non-conformance management for regulated manufacturing (FDA 21 CFR 820, IATF 16949, AS9100): NCR lifecycle and disposition, 5-Why/Ishikawa/fault-tree/8D root cause analysis, CAPA systems, SPC interpretation, AQL sampling, and supplier quality audits. Use when investigating non-conformances, performing root cause analysis, managing CAPAs, interpreting SPC data, or handling supplier quality issues.
Why this skill is useful
Provides specific methodologies and frameworks for managing non-conformance and quality control in regulated manufacturing that the AI wouldn't reliably generate on its own.
What it needs
About 11k tokens when loaded. Last updated 2026-08-06. 238,342 stars on the source repository.
What this skill does
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. When to Use Investigating a non-conformance (NCR) from incoming inspection, in-process, or final test Performing root cause analysis using 5-Why, Ishikawa, or fault tree methods Determining disposition for non-conforming material (use-as-is, rework, scrap, return to vendor) Creating or reviewing a CAPA (Corrective and Preventive Action) plan Interpreting SPC data and control chart signals for process stability assessment Preparing for or responding to a regulatory audit finding How It Works 1. Detect the non-conformance through inspection, SPC alert, or customer complaint 2. Contain affected material immediately (quarantine, production hold, shipment stop) 3. Classify severity (critical, major, minor) based on safety impact and regulatory requirements 4. Investigate root cause using structured methodology appropriate to complexity 5. Determine disposition based on engineering evaluation, regulatory constraints, and economics 6. Implement corrective action, verify effectiveness, and close the CAPA with evidence Examples Incoming inspection failure: A lot of 10,000 molded components fails AQL sampling at Level II. Defect is a dimensional deviation of +0.15mm on a critical-to-function feature. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills affaan-m/quality-nonconformance--b0da20