.jpg)
QMS & Compliance
- Valid ISO 9001 + internal audit records; SPC in active use.
- CE/ROHS/REACH as needed; raw material traceability.
- NCR quarantine and 8D closure discipline.
Materials & Heat Treatment
- Carbide grades (e.g., YG8C/YG11C) and supplier list; incoming inspection and batch reports.
- Heat‑treat recipes and furnace calibration; braze cross‑section, carburization/decarb control.
- Tip/base matching, solder/braze parameters logged.
Process Capability & Tooling
- Critical dimensions Cpk ≥ 1.33; runout/coaxiality control.
- Tooling registry and TPM schedules.
- Special processes for extra‑long/deep‑hole/large dia (e.g., inner cooling/chip evacuation).
Incoming/In‑Process/Final QA
- Incoming AQL with 100% checks on critical attributes; sampling plans and reject criteria.
- In‑process patrol checks; first/last article confirmations; capability sampling logs.
- Final life sampling and torque/impact tests; retain original test records.
Delivery & Peak‑Season SLA
- Rolling schedules, peak‑season capacity locks and contingency plans.
- On‑time delivery metrics and rework/re‑inspection flows.
- Private label packaging specs and barcode/label verification.
Docs & Retains
- PPAP (if applicable), SDS, COC/COA, batch retains with traceable IDs.
- Change control (ECN) and golden sample library.
- Confidentiality and controlled technical access.
Pre‑Audit Preparation
Document Checklist
- Company profile: license, org chart, line/headcount, key role qualifications
- Quality docs: quality manual, procedures, WIs, SPC/control plan samples
- Supply chain: critical raw list and Tier‑2s; incoming AQL/CTQ standards
- Process capability: heat‑treat curves, braze logs, equipment registry & calibration
- Performance & issues: FPY/RTY, returns/recalls, 8D/5Why samples
Scope & Risk
- Scope by product families and CTQs (e.g., tip grade, braze strength, hardness band)
- Risk score by volume/changeover, outsourcing ratio, historical defect rate
- High‑risk for NPI/special processes (heat‑treat/braze) with higher witnessing
- Cross‑functional team: Quality, Process, Planning, Purchasing
Agenda Template
- 09:00‑09:30 Kick‑off, scope, risk alignment
- 09:30‑11:00 Gemba walk (incoming‑warehouse‑process‑final‑retains)
- 11:00‑12:00 Document checks (traceability, calibration, SPC, CAPA)
- 13:30‑15:00 Witness (heat‑treat/braze/key metrology)
- 15:00‑16:00 Close‑out, CAPA draft, milestones & owners
Audit Day Flow
- Gate Sampling: Randomly pick last 3 batches of FG/WIP; cross‑check traveler vs. actuals
- 5M1E Sweep: Man/Machine/Material/Method/Measurement/Environment; watch outsourcing & rework
- Witness Tests: Re‑measure hardness/runout/coaxiality; delta vs. records ≤ 10%
- Traceability Walk: Order→Batch→Incoming→Process→Final→Retain; draw the closed‑loop map
- 8D Retro: Pull 1 historical 8D; validate corrective and preventive effectiveness
Scoring & CAPA
| Dimension | Weight | Pass Threshold | Trigger CAPA |
|---|---|---|---|
| QMS/Compliance | 20% | ≥ 80/100 | Any mandatory evidence missing |
| Materials/Heat‑Treat | 20% | ≥ 85/100 | No furnace calibration or grade mismatch |
| Process Capability | 25% | Cpk ≥ 1.33 | Any CTQ Cpk < 1.00 |
| QA & Retains | 15% | AQL executed | CTQs not 100% inspected |
| Delivery & SLA | 20% | Peak OTD ≥ 95% | No capacity lock or contingency |
- Red Lines (e.g., falsified records) → Immediate stop‑ship + 100% re‑inspection
- Timeline: D3 draft, D7 corrections, D30 effectiveness check
- Follow‑up: Weekly report + on‑site re‑audit; then move to quarterly maintenance audits
Case Study: Peak Season
Context: Peak months Aug‑Oct, orders +60%, historical OTD dropped to 88%.
Issues
- High outsourcing (> 35%) delaying incoming; schedule favors hot orders, frequent changeovers
- Heat‑treat bottleneck: High night‑shift failure rate; no loop‑closed curve deviations
Actions
- Signed rolling capacity lock (8 weeks): minimum guaranteed capacity + over‑production incentive
- Introduced freeze window (2 weeks): block changes/expedites; minimum lot size for changeovers
- Heat‑treat preventive maintenance + backup recipe; add night‑shift technical support
Results
- OTD up to 97%, changeovers −42%, scrap −0.6pp
Glossary
- AQL: Acceptance Quality Limit; risk‑based sampling intensity
- Cpk: Process capability index; dimensional stability
- PPAP: Production Part Approval Process; for NPI/changes
- CTQ: Critical‑to‑Quality characteristic; impacts function/safety
- CAPA: Corrective and Preventive Actions; includes effectiveness validation
- SLA/OTD: Service Level Agreement / On‑Time Delivery
Need a printable checklist? Contact us for a tailored version and an engineering consult.
