🧭 Why this lesson matters #
Your PFMEA is only as strong as the evidence that it works every day. This lesson turns your Step-7 deliverables into a living control system: metrics, audits, and fast checks that keep risk down after launch.
1) “Proof You’re in Control” — Core Metrics & Targets #
Use these on your line dashboard. Tie each metric to PFMEA row IDs and Control Plan characteristics.
| Metric | What It Proves | Target (Safety/CTQ → bold) |
|---|---|---|
| FPY (First Pass Yield) | Overall process health | ≥ 98% |
| DPMO / Defect Pareto (Top-N) | Where risk is leaking | Trending ↓; Top-3 with actions |
| Cpk/Ppk on SCs (depth, torque, leak, flow) | Capability vs. spec | Cpk ≥ 1.67 (SCs), ≥1.33 (others) |
| %GRR (key gages) & ndc | Measurement system reliability | ≤10%, ndc ≥ 10 |
| SPC rule violations (per week) | Stability of key steps | 0–1; auto-hold on 2+ |
| Master checks (leak/flow benches) | False-accept protection | Pass 100% daily; 2-point |
| Gate overrides (“no scan → no progress”) | Escape pathway closed | 0 |
| ESD incidents / audit pass rate | Latent electronics risk | Incidents 0; audits ≥98% |
| PM & Calibration compliance | Tool readiness | ≥ 95% on time |
| Rework & Scrap rate | Cost of poor quality | Trending ↓; ≤ plan |
| LPA completion rate | Discipline at the point of work | ≥ 95% on time |
Post these in a single-page cell dashboard at the line. Green/Amber/Red with direct links to evidence.
2) Daily/Weekly/Monthly Cadence (who looks at what) #
| Cadence | Owner(s) | Focus | Outputs |
|---|---|---|---|
| Shift-Start (10 min) | Supervisor, Operator Lead | FPY last shift, SPC alerts, master results, tool audits, ESD status | Containment if any red; assign 8D owner |
| Daily Quality Walk (15 min) | QE, Mfg Eng | Review SC checks (OP05/06/09/12), gate overrides, open AP-H/M | Sign off reactions; update tracker |
| Weekly Risk Review (30 min) | CFT | Trends (FPY, DPMO, SPC, ESD), AP-H/M closure, LL | Close actions; escalate blockers |
| Monthly Management Review | Plant Mgmt | Capability (Cpk), audit scores, PPAP commitments | Reallocate resources; policy changes |
3) Layered Process Audits (LPA) — schedule & sample checks #
Schedule matrix
| Layer | Role | Frequency | Scope highlights |
|---|---|---|---|
| L1 | Line Lead / Supervisor | Each shift | OP05 depth/force signatures; OP06 vision; OP09 torque curve; OP12 master run; MES gates |
| L2 | QE / Mfg Eng / Test Eng | Weekly | MSA logs, SPC reactions, recipe locks, 2-point masters |
| L3 | Plant/Quality Manager | Monthly | SC capability, residual risks, override audit trail |
Sample LPA questions (yes/no with evidence)
- OP05: LVDT sticker valid? Last GR&R ≤10%? Depth SPC in control? Reaction plan posted?
- OP06: Vision system shows current rev? Lip/face features enabled? Cleanliness audit in last 2h?
- OP09: Socket ID interlock active? Tool audit done today? Random curve matches strategy?
- OP12: Daily two-point master logged? Dual-check (flow vs ΔP/RPM) enabled?
- MES: Any gate override in last 7 days? Two-person rule verified?
4) Gemba Walk Script — 10-minute “at the line” verification #
- Start OP05: Spot-check last subgroup chart, open the last NOK press curve, confirm hard-stop shim kit present.
- OP06: Trigger the vision “bad part” and verify the station stops; check particle counter log.
- OP07: Read ESD monitor (live), open potting mass log from last hour.
- OP09: Scan a unit and display torque+angle curve; confirm socket ID captured.
- OP12: Run master leak check; open last 3 flow curves; verify recipe hash rev.
- MES terminal: Show today’s override report (should be zero).
- Control Plan binder: Match one PFMEA row ID to a Control Plan reaction; operator explains it.
If any item fails → immediate containment + add to the action tracker.
5) Self-Audit (Mock Customer) — 12 tough questions #
- Show me one PFMEA row and trace to the Control Plan and evidence.
- Why is D=3 for OP05? Prove it (100% detection + MSA + interlock).
- What happens when SPC breaks a rule? Show the auto-hold log.
- How do you prevent test bypass? Show override logs & two-person rule.
- Prove your flow meter can’t drift unnoticed (masters, dual-check).
- Show Cpk for press depth and torque in the last 30 days.
- Where are the Lessons Learned deployed on other lines?
- What’s your gate for incoming Ra on shafts? Evidence?
- If the vision camera mis-classifies, how would you know?
- What’s your ESD plan during dry weather spikes? Logs?
- How many rework loops occurred last week and why?
- Which AP-Medium is still open—and what’s the containment?
6) Audit Readiness Pack — index & cross-refs (print or digital) #
This complements Lesson 5.7’s pack with quick-grab exhibits.
- Cover & Summary (PFMEA status, KPIs, sign-offs)
- Control Plan (final) with PFMEA Row IDs
- PFD (Rev) with rework/quarantine & SC checkpoints
- Evidence Tabs
- SPC: last 30 days (OP05/09/12) + reactions
- MSA: GR&R summaries (LVDT, torque, leak, flow), master routines
- Capability: Cpk/Ppk for SCs + trend
- MES: gate override report, recipe rev hash, heartbeat logs
- PM/Cal: due/past-due list, completion trend
- ESD: continuous monitor logs + weekly audits
- Action Tracker: before/after O/D/AP snapshots
- Residual Risk Register: signatures + monitoring plan
- Lessons Learned: deployments & owners
Add QR codes on the cover to open live MES/SPC/MSA dashboards.
7) Readiness Rubric — quick self-score (0–5) #
| Area | 0–1 | 2–3 | 4–5 (Ready) |
|—|—|—|
| PFMEA–CP coherence | Gaps | Mostly aligned | Row IDs match; reactions visible at station |
| Metrics & evidence | Ad hoc | Partial | All SCs green; evidence current |
| MSA & capability | Missing | Mixed | %GRR ≤10%; Cpk ≥1.67 on SCs |
| Escapes & gates | Weak | Some | No bypass; overrides=0; daily masters |
| LPA & gemba | Sporadic | Regular | On-time ≥95%; issues closed |
| LL & sustainment | Local | Draft | Deployed plant-wide with owners |
Mark reds → convert to actions (Step 6 playbook).
8) Triggers, Escalation & Containment #
Triggers (any = immediate action):
- SPC rule break on SC, master fail, gate override, Cpk < 1.33 on SC, %GRR > 10%, FPY < 98%
Containment flow (2 hours max):
- Stop & tag; quarantine last known good lot
- Verify gage/bench → fixture/tool → material → method
- Temporary reaction + comms to CFT
- Raise 8D; update PFMEA, CP, WI, MES as needed
9) Sustainment & Continuous Improvement #
- Quarterly PFMEA refresh with field returns/scrap Pareto
- Annual MSA re-qualification (key gages)
- LL rollout plan with audit of adoption across lines/suppliers
- KPI drift watch: if two consecutive amber months → management review
10) Downloadables / Templates (for the course) #
- Line Dashboard (FPY/DPMO/Cpk/%GRR/SPC/gates/masters)
- LPA Checklists (L1/L2/L3) + schedule sheet
- Gemba Walk Script (10-min card)
- Mock-Audit Q&A sheet
- Audit Readiness Pack Index (fillable)
- Readiness Rubric (0–5 score)
- Trigger & Containment SOP (swimlane)
🧠 Pro Tip #
For every metric on your dashboard, keep one click to the underlying proof. That’s how you turn audits from interrogations into tours.
🎓 Module 5 Wrap-Up #
You now have an end-to-end PFMEA: from planning through optimization to a living control system that proves risk stays low.
