Quality Nonconformance
- 5.2k installs
- 238k repo stars
- Updated August 5, 2026
- affaan-m/everything-claude-code
Quality-nonconformance is an agent skill that codifies regulated manufacturing quality control for NCR investigation, root cause analysis, CAPA management, SPC interpretation, and supplier quality under FDA, IATF, and AS
About
The quality-nonconformance skill encodes senior quality engineering expertise for regulated manufacturing under FDA 21 CFR 820, IATF 16949, AS9100, and ISO 13485. Activate it when investigating NCRs from incoming, in-process, or final inspection, performing root cause analysis with 5-Why, Ishikawa, or fault tree methods, deciding material disposition, drafting or reviewing CAPA plans, interpreting SPC control chart signals, or responding to regulatory audit findings. The six-step workflow covers detection, containment, severity classification, structured root cause investigation, disposition under engineering and regulatory constraints, and corrective action verification with documented closure. Examples walk through incoming AQL failures with supplier SCARs, Western Electric Rule 2 SPC signals where in-spec differs from in-control, and automotive OEM 8D CAPA for field failures. Core knowledge spans the full NCR lifecycle with identification, quarantine, MRB segregation, and traceability tied to eQMS platforms, ERP QM modules, Minitab, and supplier portals.
- Full NCR lifecycle from identification through containment, investigation, disposition, and CAPA closure
- Root cause methods include 5-Why, Ishikawa fishbone, and fault tree analysis for regulated environments
- SPC interpretation covers Western Electric rules when in-spec differs from in-control
- Disposition guidance for use-as-is, rework, scrap, and return-to-vendor under regulatory constraints
- Examples span incoming AQL failures, filling-line control charts, and automotive OEM 8D field-failure CAPAs
Quality Nonconformance by the numbers
- 5,237 all-time installs (skills.sh)
- +219 installs in the week ending Aug 5, 2026 (Skillselion tracking)
- Ranked #114 of 3,282 Productivity & Planning skills by installs in the Skillselion catalog
- Security screen: HIGH risk (skills.sh audit)
- Data as of Aug 5, 2026 (Skillselion catalog sync)
quality-nonconformance capabilities & compatibility
- Capabilities
- ncr lifecycle management from identification thr · root cause analysis with 5 why, ishikawa, and fa · capa creation, review, effectiveness verificatio · spc control chart signal interpretation includin · supplier quality escalation with scar issuance a
- Use cases
- planning · project management
What quality-nonconformance says it does
Includes NCR lifecycle management, CAPA systems, SPC interpretation, and audit methodology.
Use when investigating non-conformances, performing root cause analysis, managing CAPAs, interpreting SPC data, or handling supplier quality issues.
Skipping steps creates audit findings and regulatory risk:
npx skills add https://github.com/affaan-m/everything-claude-code --skill quality-nonconformanceAdd your badge
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| Installs | 5.2k |
|---|---|
| repo stars | ★ 238k |
| Security audit | 3 / 3 scanners passed |
| Last updated | August 5, 2026 |
| Repository | affaan-m/everything-claude-code ↗ |
How do quality engineers investigate non-conformances, determine disposition, and close CAPAs without skipping steps that create audit findings and regulatory risk?
Investigate manufacturing NCRs, run root cause analysis, manage CAPAs, interpret SPC signals, and respond to FDA or IATF audit findings.
Who is it for?
Quality engineers in medical device, automotive, or aerospace manufacturing managing NCRs, CAPAs, SPC alerts, supplier SCARs, and regulatory audit responses.
Skip if: Skip when the task is software unit testing, generic project management, or manufacturing quality outside regulated NCR and CAPA workflows.
When should I use this skill?
User mentions NCR, non-conformance, CAPA, root cause analysis, SPC control chart, supplier SCAR, 8D response, MRB disposition, or FDA IATF AS9100 audit finding.
What you get
Structured NCR workflows, root cause analysis, disposition decisions, CAPA plans, and SPC interpretations grounded in 15+ years regulated manufacturing practice.
- NCR and CAPA workflow designs
- Root cause analysis frameworks
- SPC interpretation guidance
By the numbers
- Version 1.0.0 under Apache-2.0 license
- Informed by quality engineers with 15+ years experience across FDA, IATF 16949, and AS9100
Files
quality-nonconformance - 日本語翻訳進行中
このファイルの翻訳は実装中です。英語版は元のスキルファイルを参照してください。
詳細は：D:/tmp/everything-claude-code/skills/quality-nonconformance/SKILL.md
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Quality Nonconformance has 1 known copy in the catalog totaling 1.4k installs. They canonicalize to this original listing.
- affaan-m - 1.4k installs
How it compares
Pick quality-nonconformance over generic bug-tracking skills when the software must implement regulated NCR, CAPA, and SPC semantics for manufacturing QMS modules.
FAQ
What is the documented NCR workflow?
Detect the issue, contain affected material, classify severity, investigate root cause, determine disposition, then implement and verify corrective action before closing the CAPA with evidence.
When should I stop a line based on SPC signals?
When control charts show assignable cause patterns such as nine consecutive points above center line (Western Electric Rule 2), even if measurements remain within specification limits.
What systems does the skill assume?
eQMS platforms like MasterControl or Veeva, SPC tools such as Minitab, ERP QM modules, CMM metrology, and supplier portals for traceability and notifications.
Is Quality Nonconformance safe to install?
skills.sh reports 3 of 3 security scanners passed. Review the Security Audits panel on this page before installing in production.