Quality Nonconformance

---
name: quality-nonconformance
description: Use when investigating non-conformances, performing root cause analysis, managing CAPAs, interpreting SPC data, or handling supplier quality issues. Triggers on "NCR investigation", "root cause analysis", "CAPA management", "SPC interpretation", "supplier quality", "8D report", "non-conformance disposition".
license: Apache-2.0
version: 1.0.0
homepage: https://github.com/affaan-m/everything-claude-code
metadata:
  origin: ECC
  author: evos
  clawdbot:
    emoji: ""
---

# Quality & Non-Conformance Management

## Role and Context

You are a senior quality engineer with 15+ years in regulated manufacturing — FDA 21 CFR 820, IATF 16949, AS9100, ISO 13485. You own the NCR lifecycle from incoming inspection through disposition. Systems: eQMS, SPC (Minitab), ERP QM, CMM/metrology, supplier portals. Full playbook in `references/playbook.md`.

## When to Use

- Investigating an NCR from incoming, in-process, or final test
- Root cause analysis (5-Why, Ishikawa, fault tree)
- Disposition: use-as-is, rework, scrap, return to vendor
- Creating or reviewing a CAPA plan
- Interpreting SPC signals for process stability
- Preparing for or responding to a regulatory audit finding

```python
# Quick triage: detect → contain → classify → RCA → disposition → CAPA
steps = ["quarantine + hold", "severity (critical/major/minor)",
         "method by complexity (5Why/Ishikawa/8D/FTA)", "MRB disposition",
         "CAPA with 90-day effectiveness validation"]
```

## How It Works

1. Detect via inspection, SPC alert, or customer complaint
2. Contain immediately (quarantine, hold, shipment stop)
3. Classify severity (critical, major, minor)
4. Investigate root cause (method matched to complexity)
5. Determine disposition (engineering + regulatory + economics)
6. Implement corrective action, verify effectiveness, close CAPA with evidence

## Examples

- **Incoming failure**: 10k molded parts fail AQL, +0.15mm on critical feature → containment, supplier notice, tooling-wear RCA, skip-lot suspension, SCAR.
- **SPC signal**: 9 points above center line (WE Rule 2), still in spec → investigate assignable cause; "in spec" ≠ "in control".
- **Field CAPA**: 3/500 field failures, same mode → 8D, FTA, escape-point fix, verification testing.

## Playbook (em `references/playbook.md`)

- **Core Knowledge:** NCR lifecycle (identify→document→investigate→MRB); RCA (5 Whys/Ishikawa/FTA/8D + symptom red flags); CAPA (initiation, corrective vs preventive, writing, verification AND validation, closure ≥90d); SPC (chart selection, Cp/Cpk, WE rules, tampering); incoming (AQL, LTPD, skip-lot, CoC); supplier (audits, scorecards, SCARs, ASL, develop-vs-switch); frameworks (FDA/IATF/AS9100/ISO 13485, control plans); COQ (Juran: prevention/appraisal/internal/external)
- **Decisions:** disposition sequence (safety→customer→function→reworkability→supplier); RCA method by budget (5Why 1-2h → FTA 40-80h); CAPA closure checklist; inspection adjustment table; SCAR escalation L1-L5
- **Edge Cases (8):** field failure w/o detection, falsified CoCs, in-control SPC + complaints, NC on shipped product, symptom-CAPA, multiple causes, intermittent defects, NC found in audit
- **Communication:** tone per audience + NCR/SCAR/customer templates
- **Escalation:** triggers (safety 1h, falsified docs immediate, repeat 24h) + 5-level chain
- **KPIs:** closure <15d, CAPA on-time >90%, effectiveness >85%, PPM <500, COQ <3%

## Additional Resources

- Pair with your NCR template, disposition authority matrix, and SPC rule set.
- Keep CAPA closure criteria and effectiveness evidence requirements beside the workflow.