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Introduction to FMEA

5
  • What is Risk in FMEA? Why Prevention Important?
  • Introduction to FMEA | Purpose & Key Benefits
  • History of FMEA – NASA to AIAG to AIAG-VDA
  • Types of FMEA – DFMEA, PFMEA, and FMEA-MSR
  • FMEA in APQP & IATF 16949 Context

Foundations of FMEA

7
  • Function Requirement Failure in FMEA
  • Severity in FMEA (AIAG-VDA) | Explained with Examples
  • Occurrence in FMEA (AIAG-VDA) | Explained with Examples
  • Detection in FMEA (AIAG-VDA) | Explained with Examples
  • RPN vs Action Priority (AP) – Why RPN is Outdated
  • FMEA Linkages – ISO 9001, IATF 16949, APQP, PPAP.
  • Why AIAG-VDA 7-Step Approach?

Step-1: Planning & Preparation in FMEA

4
  • Step 1 – Planning & Preparation in FMEA (AIAG-VDA Standard)
  • The Five Ts in FMEA – Intent, Timing, Team, Task, Tools
  • Defining Scope, Boundaries & Assumptions in FMEA
  • Cross-Functional Team Formation in FMEA

Step 2: Structure Analysis in FMEA

4
  • Step 2 – Structure Analysis in FMEA
  • System, Subsystem, and Component Breakdown in FMEA
  • Process Flow – Structure Tree & Block Diagram in FMEA
  • Motor Stator Winding – Structure Analysis in FMEA Example

Step 3: Function Analysis in FMEA

3
  • Step 3 – Function Analysis in FMEA
  • Defining Functions & Requirements in FMEA
  • How to Write Measurable Requirements in FMEA

Step 4: Failure Analysis in FMEA

6
  • Step 4 – Failure Analysis in FMEA (Failure Modes, Effects, Causes)
  • Function Net in FMEA | Chain of Functions
  • Failure at Mode Level – Failure Modes
  • Effects of Failure in FMEA
  • Causes of Failure in FMEA (Design vs Process)
  • Cascading Failures – Failure Cause Mode Effect Relationship in FMEA

Step 5: Risk Analysis in FMEA

9
  • Current Detection Controls in FMEA
  • Current Prevention Controls in FMEA (AIAG-VDA Standard)
  • Risk Evaluation in FMEA
  • Action Priority (AP) vs RPN in FMEA
  • Action Priority in FMEA (AIAG-VDA Standard)
  • Step 5 – Risk Analysis in FMEA
  • Severity in FMEA (AIAG-VDA) | Explained with Examples
  • Occurrence in FMEA (AIAG-VDA) | Explained with Examples
  • Detection in FMEA (AIAG-VDA) | Explained with Examples

Step 6: Optimization in FMEA

2
  • Tracking & Closing Actions in FMEA
  • Step 6 – Optimization in FMEA

Step 7: Results Documentation in FMEA

3
  • Customer Communication & Lessons Learned in FMEA
  • FMEA Report (Summary Table)
  • Step 7 – Results Documentation in FMEA

DFMEA in Practice

8
  • DFMEA in Practice – Step‑by‑Step
  • DFMEA Audit Readiness
  • DFMEA Optimization Step
  • DFMEA Risk Analysis
  • DFMEA Failure Analysis
  • DFMEA Function Analysis
  • DFMEA Structure Analysis
  • Product Snapshot – DFMEA in Practice (Step-by-Step)

PFMEA in Practice

10
  • PFMEA Audit Readiness
  • PFMEA Results Documentation
  • PFMEA Optimization step
  • PFMEA Risk Analysis
  • PFMEA Failure Analysis
  • PFMEA Function Analysis
  • PFMEA Structure Analysis
  • PFMEA Planning and Preparation
  • PFMEA Process Snapshot
  • PFMEA in Practice – Step‑by‑Step

FMEA Linkages

5
  • 📘 Case Study: How DFMEA Links to PFMEA and Control Plan — A Practical Guide
  • How FMEA Links to PPAP Deliverables
  • Prevention and Detection Controls in PFMEA to Control Plan | How to Link Them
  • How FMEA Drives Control Plans in Manufacturing Quality
  • FMEA and Control Plan Linkage

FMEA Tools & Templates

3
  • Excel vs Professional FMEA Software: Explain
  • FMEA in APIS IQ, PLATO SCIO, and Knowlence TDC: Overview of Top FMEA Software Tools
  • Excel-Based AIAG-VDA FMEA Template (Walkthrough)

FMEA Best Practices

2
  • FMEA Moderation: Common Mistakes & Best Practices
  • Common Mistakes & Best Practices in FMEA Creation

FMEA Advanced Applications

12
  • Future of FMEA – AI, Automation & Digital Technology
  • FMEA Use Cases in EVs, Welding, Electronics & Embedded Systems
  • Internal & Customer FMEA Audit Preparation
  • FMEA Moderation Techniques for Cross-Functional Teams
  • Advanced Failure Cause Modeling in FMEA
  • Family FMEA – Save Time Across Product Lines
  • FMEA in APQP Phases and Project Milestones
  • Using FMEA in Functional Safety (ISO 26262)
  • What is System FMEA? Scope, Structure & Interface Analysis
  • Which FMEA Software Should You Choose?
  • Software for FMEA
  • How FMEA Links with Control Plan, PPAP & Special Characteristics
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PFMEA Process Snapshot

FMEA Expert
Updated on September 6, 2025

4 min read

Start your PFMEA right: this Process Snapshot maps the Electric Water Pump (EWP) final assembly and end-of-line testing flow, transfers critical risks from DFMEA, defines stations, characteristics, gages/MSA, traceability, and constraints—ready for AIAG-VDA PFMEA 7-Step execution.


🧭 Why a Process Snapshot? #

Before PFMEA Step 1 (Planning & Preparation), you need a single, shared picture of what process you’re analyzing: flow, scope, constraints, risk handoffs, characteristics, and how quality is verified. This prevents scope creep, missed interfaces, and orphan risks.


🔁 Handoff: DFMEA ➜ PFMEA (What we inherit) #

Carry over special characteristics and high-AP risks so the process can control them.

DFMEA Risk / FunctionSC TagWhat Process Must ControlWhere (Process Station)
Deliver coolant flow (no/low flow)🔺 Safety / 🎯 CTQImpeller press-fit depth, rotor/impeller torque retention, leak & flow verificationOp06 Press-fit, Op14 Flow Test
Prevent leakage (seal integrity)🔧 RegulatorySeal installation method, surface finish cleanliness, early leak screeningOp09 Seal Install, Op13 Pre-Leak, Op14 Final Leak
EMC robustness of PCB🎯 CTQESD controls, handling, potting/curing disciplineOp08 PCB Handling & Potting

Tip: Create a “Handover Matrix” tab in the PFMEA workbook and reference these row IDs in your Control Plan.


🗺️ High-Level Line Map (12–18 steps) #

(Example; rename/merge steps to match your plant)

  1. Incoming & Kitting — Verified parts kit (impeller, shaft, bearings, seal, PCB, housing, screws, O-rings)
  2. Bearing Press — Bearings to housing/shaft (depth & alignment)
  3. Shaft Sub-Assembly — Shaft prep, lubrication/cleaning checks
  4. Stator Into Housing — Seating depth, orientation
  5. Rotor/Impeller Press-Fit — Interference fit to spec with depth/force control
  6. Mechanical Seal Install — Orientation, lip protection, cleanliness class
  7. PCB Handling & Potting — ESD controls, potting volume/time, cure profile
  8. Connector Fit & Solder/Crimp Verify — Pull test/vision check (if applicable)
  9. Housing Closure & Screw Torque — DC tool strategy & traceability
  10. Pre-Leak Screening — Early air decay or pressure hold test
  11. Electrical Spin Test — Basic run-up sanity, current draw
  12. Final Leak & Flow/RPM Test (EoL) — At defined ΔP, duty, temp; results to MES
  13. Final Inspection — Labeling, visual, packaging checks
  14. Pack & Ship — Traceability closure

📦 Process Scope & Boundaries #

  • In scope: Final assembly from kitting to pack-out, including EoL testing and in-line inspections.
  • Out of scope: Supplier manufacturing of components (unless flagged “special supplier process”), vehicle integration, logistics post-shipment.
  • Lifecycle considered: Normal production, changeover, maintenance restart, environmental extremes (humidity/temperature in cell), and run@rate.

⏱️ Constraints & Targets (fill with your plant’s numbers) #

  • Takt time: 36–48 s (target), station balancing within ±10%
  • Capacity: 2 shifts × 8 h, OEE ≥ 85%
  • Cleanliness: ISO 16232 class X at seal station; particle monitor at cell entry
  • ESD: ANSI/ESD S20.20 compliant; <100 V HBM equivalent at PCB station
  • Traceability: Full serialization; torque & test curves tied to unit ID in MES
  • PPM/FPY: FPY ≥ 98% at EoL; line PPM < 500

⚙️ Special Processes (need extra control/validation) #

  • Press-fits (bearing, rotor/impeller): depth/force windows, fixture hard-stops, LVDT
  • Seal installation: guided tooling, chamfers, lubricants, cleanliness
  • Potting/curing: time-temperature recipe lock, mass/volume verification
  • Screw tightening: DC tool with strategy, angle control, socket ID sensing
  • Leak/flow testing: recipe lock, daily master part, GR&R on benches

🧪 Key Process Characteristics & Targets (starter grid) #

Replace X/Y with your nominal/limits; mark SCs with 🔺/🔧/🎯

OpCharacteristic (What)Target / ToleranceSCVerification (How/When)
05Impeller press-fit depth12.00 ± 0.05 mm🎯In-station LVDT 100% + SPC (X̄-R) every 30 pcs
05Press peak forceX–Y kN window🎯Force–distance curve 100% (signature match)
06Seal orientationCorrect key/face🔧Vision 100% + poke-yoke nest
06Shaft surface finish (Ra)≤ 0.30 µm🔧Incoming cert + random audit daily
09Screw torque4.0 ± 0.3 N·m🎯DC tool trace 100% with OK/NOK interlock
10Pre-leak (air decay)≤ X ml/min @ 1.0 bar🔧100% test; daily master part check
12Final leak≤ 0.5 ml/min @ 1.5 bar🔧100% test; auto-lock in MES
12Flow @ ΔP 20 kPa≥ 35 L/min @ 80% duty🔺100% test; store curves & limits
07ESD point-to-point< 100 V🎯Wrist strap & mat tester: start-of-shift

🧰 Gage & MSA Plan (excerpt) #

Gage / TesterForTypeMSA PlanStatus
LVDT depth probePress depthVariableGR&R ≥ 10 parts × 3 appraisers × 3 trials (target ndc ≥ 10)Planned
Press force signatureForce windowAttribute/CurveDiscrete decision + periodic correlation studyActive
DC torque toolTorque/angleVariableBuilt-in audit + annual GR&RActive
Leak benchLeak rateVariableGR&R with masters at 3 pointsScheduled
Flow benchFlow/ΔPVariableGR&R quarterly; temp compensation checkActive
ESD testerESD pathAttributeDaily verification logActive

🧮 SPC & Reaction Plan (starter) #

  • SPC on: press-fit depth (X̄-R), leak rate (I-MR), torque (X̄-R)
  • Rules: Nelson/Western Electric; auto-hold after 2 consecutive rule breaks
  • Reaction: stop-ship for SC excursion; quarantine last OK lot; initiate 8D; verify fixture/tooling; retrain if method cause; calibration check for measurement cause

🧲 Poka-Yoke & Interlocks (examples) #

  • Vision orientation for seal & connector
  • RFID socket sensing for torque tool; recipe lockout in MES
  • Fixture hard-stop for press depth; no-go gauge for sub-components
  • Two-hand start & door interlock on moving tooling
  • Barcode/serial scan at each critical station; no pass → no progress

🌡️ 6M Baseline (environment & interfaces included) #

  • Man: certified operators; job instruction sheets; refresh every 6 months
  • Machine: PM schedule; MTBF/MTTR tracking; spare kit on site
  • Method: WI rev-controlled; photo standards; changeover checklist
  • Material: FIFO; lot control; incoming COA for seals/bearings/lube
  • Measurement: MSA plan approved; calibration matrix synced to MES
  • Mother Nature (Environment): humidity 40–60% at PCB/Seal ops; temp 20–26 °C; particle counter check per shift

🔐 Traceability & Data Strategy #

  • Unit serialization from Op01; scan at each gate
  • Store torque curves, press signatures, leak/flow curves per unit in MES
  • Recipe control: only approved parameter sets downloadable; passworded roles
  • Analytics hooks: FPY, top-N defect codes, trend SPC alerts, PFMEA row ID tags in MES

🧾 Draft PFD (you’ll finalize in Lesson 5.2) #

  • Symbols: Operation ▢, Inspection ◯, Transport ➝, Storage ▤
  • Show part flow + data flow (MES), rework loops, quarantine points, and SC checkpoints.

📋 What to Prepare for PFMEA Step 1 (next lesson) #

  • Current PFD (rev A) and layout
  • Latest DFMEA Summary with SC list
  • Characteristics Matrix (this lesson’s table → spreadsheet)
  • Gage List + MSA status
  • Work Instructions (draft) and Control Plan shell
  • Lessons Learned from prior lines/products

🔗 Internal Linking Suggestions #

  • Lesson 5.1: Step 1 — Planning & Preparation (+ 5T)
  • Lesson 5.2: Step 2 — Structure Analysis (PFD & Process Tree)
  • Template Hub: PFD, Characteristics Matrix, MSA Plan, SPC Pack, Traceability Map

🧠 Pro Tip #

Make the Process Snapshot a living artifact in your MES/PLM. When anything here changes (tooling, limits, WI), it should trigger PFMEA/Control Plan review—that’s how you keep process risk controlled.

Updated on September 6, 2025

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PFMEA Planning and PreparationPFMEA in Practice – Step‑by‑Step
Table of Contents
  • 🧭 Why a Process Snapshot?
  • 🔁 Handoff: DFMEA ➜ PFMEA (What we inherit)
  • 🗺️ High-Level Line Map (12–18 steps)
  • 📦 Process Scope & Boundaries
  • ⏱️ Constraints & Targets (fill with your plant’s numbers)
  • ⚙️ Special Processes (need extra control/validation)
  • 🧪 Key Process Characteristics & Targets (starter grid)
  • 🧰 Gage & MSA Plan (excerpt)
  • 🧮 SPC & Reaction Plan (starter)
  • 🧲 Poka-Yoke & Interlocks (examples)
  • 🌡️ 6M Baseline (environment & interfaces included)
  • 🔐 Traceability & Data Strategy
  • 🧾 Draft PFD (you’ll finalize in Lesson 5.2)
  • 📋 What to Prepare for PFMEA Step 1 (next lesson)
  • 🔗 Internal Linking Suggestions
  • 🧠 Pro Tip
  • Free FMEA Course
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