Quality Nonconformance
Manage non-conformances, root cause analysis, CAPA, and supplier quality workflows in regulated manufacturing with an agent that speaks FDA, IATF, and AS9100 language.
Overview
Quality Nonconformance is an agent skill for the Operate phase that guides non-conformance investigation, root cause analysis, CAPA management, SPC interpretation, and supplier quality in regulated manufacturing.
Install
npx skills add https://github.com/affaan-m/everything-claude-code --skill quality-nonconformanceWhat is this skill?
- Full non-conformance lifecycle from incoming inspection through final disposition
- Root cause analysis and CAPA systems aligned with regulated QMS practice
- SPC interpretation guidance for Minitab/InfinityQS-style monitoring contexts
- Supplier quality and audit methodology framed for FDA 21 CFR 820, IATF 16949, AS9100, ISO 13485
- Codified 15+ years quality-engineering judgment for NCR investigation and corrective action
- 15+ years quality-engineering experience encoded
- Covers FDA 21 CFR 820, IATF 16949, AS9100, and ISO 13485 contexts
Adoption & trust: 4.1k installs on skills.sh; 210k GitHub stars; 3/3 security scanners passed (skills.sh audits).
What problem does it solve?
A non-conformance or audit finding landed in your QMS and you need defensible root cause, disposition, and corrective action—not improvised chat advice that won't survive regulatory review.
Who is it for?
Founders or lead engineers in FDA, IATF, AS9100, or ISO 13485 manufacturing who personally drive NCRs, CAPAs, and supplier quality responses.
Skip if: Typical indie software-only products with no physical goods, lot traceability, or formal QMS—use general debugging or issue-triage skills instead.
When should I use this skill?
Investigating non-conformances, performing root cause analysis, managing CAPAs, interpreting SPC data, or handling supplier quality issues in regulated manufacturing.
What do I get? / Deliverables
You get structured NCR and CAPA reasoning, investigation steps, and quality language suitable for documenting containment, correction, and preventive action in a regulated QMS.
- RCA and containment reasoning aligned to NCR workflow
- CAPA structure with corrective and preventive action elements
- Audit-ready narrative for disposition and supplier escalation
Recommended Skills
Journey fit
Operate is the canonical shelf because NCRs, CAPAs, and SPC interpretation are ongoing production-quality operations—not one-time prototype work. Iterate subphase fits continuous corrective action, disposition decisions, and closing the loop on recurring defects and supplier issues.
How it compares
Use for regulated manufacturing NCR/CAPA discipline instead of generic software bug or incident postmortem templates.
Common Questions / FAQ
Who is quality-nonconformance for?
Quality leads and technical founders in regulated manufacturing who manage NCRs, CAPAs, supplier quality, and audit responses alongside production.
When should I use quality-nonconformance?
Invoke when investigating a non-conformance, performing root cause analysis, opening or closing a CAPA, interpreting SPC trends, or escalating supplier material issues during Operate.
Is quality-nonconformance safe to install?
Treat it like any third-party skill: review the Security Audits panel on this Prism page and avoid pasting export-controlled or patient-identifiable data into prompts.
SKILL.md
READMESKILL.md - Quality Nonconformance
# 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. Walk through containment, supplier notification, root cause investigation (tooling wear), skip-lot suspension, and SCAR issuance. - **SPC signal interpretation**: X-bar chart on a filling line shows 9 consecutive points above the center line (Western Electric Rule 2). Process is still within specification limits. Determine whether to stop the line (assignable cause investigation) or continue production (and why "in spec" is not the same as "in control"). - **Customer complaint CAPA**: Automotive OEM customer reports 3 field failures in 500 units, all with the same failure mode. Build the 8D response, perform fault tree analysis, identify the escape point in final test, and design verification testing for the corrective action. ## Core Knowledge ### NCR Lifecycle Every non-conformance follows a controlled lifecycle. Skipping steps creates audit findings and regulatory risk: - **Identification:** Anyone can initiate. Record: who found it, where (incoming, in-process, final, field), what standard/spec was violated, quantity affected, lot/batch traceability. Tag or quarantine nonconforming material immediately — no exceptions. Physical segregation with red-tag or hold-tag in a designated MRB area. Electronic hol