FMEA

Intelligent use of FMEA

This guideline is for training purposes only; Not ISO controlled

__ System __ Subsystem __ Component Model Year/Vehicle(s): Core Team:

Potential Failure Mode and Effects Analysis (Design FMEA)

Design Responsibility Key Date:

FMEA Number: Page 1 or 1 Prepared by: Lee Dawson FMEA Date (Orig.):

Item

Potential Failure Mode

Potential Effect(s) of Failure

Function

Potential O C S L C Cause(s)/ E A Mechanism(s) C U V S Of Failure S R

Current Design Controls Prevention

Current Design Controls Detection

D Action Results Responsibility E R. Recommended & Target S O D R. T P. Completion Actions Action(s) E N. E C E P. Date Taken V C T N. C

What Is An FMEA?
Opportunity to Defeat Murphys Law Focus on Prevention Failure Mode And Effects Analysis is
An assessment of Risk
Safety Regulatory Customer Satisfaction Program MURPHYS LAW

Coordinated/Documented team effort

To determine what can go wrong

A method to determine the need and priority of actions

Plan & Define Section 1

IDEA

RELIABILITY BY DESIGN APQP Tool Linkage

Design & Development - Section II
GD & T - Drawings - Math Data

Opportunity Defined

Process Design & Development - Section III

Process Flow Finalized
Pr oo

Form Team - Timing - Resources Customer Wants/Needs/Desires - QFD

Collect Market Research

Input From 5 - Failure Mode Analysis - History - Past Performance - Lessons Learned

Priorities Wants/Needs/ Desires

Develop Concepts - Product - Process

Design Change

Design Actions

Test Plans - Design Verification IF Design OK

Yes

Packaging Designs

PFMEA - Manufacturing - Assembly

Mi sta

ke

DFMEA DFMEA

Special Characteristics

Prototype Control Plan

Characteristic Matrix

Pre - Launch Control Plan - Risk/Action YES - Special Characteristics IF - Current Controls
NO

f?

Process Validation - Section IV

Process Trial Run Min 300 pcs/Hits/shots Validation Testing Plan
OK?

No

Develop Product Specifications - Linked to Customers

Process Validation Plan - Gage Plan - Capability Plan

Special Controls

Feasibility - Team

Instructions - Initial

GR & R - Gage Plan Repeatability Reproducibility

NO

No IF Feasible Yes

Design Risk Assessment - Open Issues - Spec. Agreements - Materials - Budget - Manufacturing - Program Risks

IF
YES

Process Risk Assessment

- Equipment - Gages - Controls - Instructions - Plans - Status of Open Issues

Process Development
Initial Process
Kick Off Tools / Equipment Gages
- Equipment Installation - Tooling Progress - Gage Design & Progress

Revisit III PFMEA For Additional Potential Failures

YES Can we change process to IF contain? NO

Statistics - Via Control Plans - Capability Plan

STABLE? NO

IF
YES

NO

CAPABLE?

IF

Concept Initiation/Approval Program Approval Prototype Pilot Launch

Design Change Back to II

YES

Sample The Process Create Production Control Plan

- Reduced (n) - Reduced (f) - Optimizing Characteristics - Source Warrants - Supporting Documentation - Level of PPAP

PLANNING PRODUCT DESIGN AND DEV. PROCESS DESIGN AND DEVELOPMENT. PRODUCT AND PROCESS VALIDATION.

PLANNING

PRODUCTION FEEDBACK ASSESSMENT AND CORRECTIVE ACTION

CONTROL PLANS

Open Issues / Time Line

Requirements Cascade
How Fmea fits into Product and Process Development

This guideline is for training purposes only; Not ISO controlled

Potential KPC Development

Requirements Documents

Regulatory Dimensional Cosmetic

Req. Spec. Document Drawings Warranty History

Robustness Tools
Boundary Diagram P-Diagram Interface Matrix

Item / Process Step

Function

Potential Failure Mode

Potential Effect(s) of Failure

S e v

C l a s s

O Potential c Cause(s)/ c Mechanism(s) u Of Failure r

Current Design Controls

Prevent Detect

D e t e c

R P N

Action Results Response & Recommended Target S O D R Action Actions Complete E C E P Taken Date V C T N

DFMEA
Special Characteristics Matrix
10
S E
POTENTIAL CRITICAL CHARACTERISTICS

9 8 7 6 5 4 3 2 1

Safety/Regulatory

Cascade Technical Requirements Into Special Product Characteristics

V E R I T Y

POTENTIAL SIGNIFICANT CHARACTERISTICS

Customer Dissatisfaction

ALL OTHER CHARACTERISTICS

Appropriate actions / controls already in place

ANOYANCE ZONE

10

OCCURRENCE

Drawings

Special Characteristics Sources

Regulations

DFMEA (Potential KPCs: Significant and Critical Characteristics)

Potential Critical and Significant

JACK SHAFT SEAL AGAINST SHOULDER

SEAL COMPRESSION HEIGHT

SERATION DAMAGE Matrix

DOWEL PINS 0.260 TO 0.270 " TO FACE

Direction of Improvement

BUSHING TO FACE OF JACK SHAFT SEAL

BEARING FLUSH TO SNAP RING FACE

PRIMARY GASKET SEAL SURFACE FINISH

1.090 TO 1.110 " FACE OF PRIMARY HOUSING

Weighted Importance

Relative Importance Special Characteristics 5 9 9 3 9 3 5 Severity Receive Material Material handling F Shipping Damage F Component Manufacture Vehicle Assembly 0 81 81 72 H Y 0 9 H FIXTURE 41 H G G Op 100 Step 2 PRE-LOAD JACK SHAFT SEAL TO FIXTURE Op 100 Step 3 0 PRE-LOAD PRIMARY HOUSING BUSHING TO FIXTURE 0 Op 110 Pre-load bearing to fixture #2 27 H Op 120 Pre-load main shaft oil seal to mandrel Op 200 Housing to fixture #1 F F F Op 210 Operate press G Op 220 Retaining ring to top groove Op 230 Reload fixture #1 54 81 H H H Op 300 Housing to fixture #2 H F Op 310 Operate press 3 Process Steps Op 100 Step 1 PRE-LOAD DOWEL PINS TO

IF

START

OPERATION

OPERATION

END

YES

NO

54 H H 261 F H

Process Flow

Op 320 Retaining ring to top groove 0 0 0 27 0 Op 330 Mandrel to main shaft bore I.D. OP 340 Operate press Op 350 Re-load fixture #2 and mandrel Op 400 H Housing to table Op 410 Reserved 45 F Op 420 Chain adj sub assy to housing 9 9 0 0 0 0 0 0 0 Op 430 G G Lubricate bushing & seal Op 445 Move or stage for final assy Op 10 O-ring to shifter tube Op 500 Shifter tube to housing Op 510 Clamp to shifter tube Op 20 Assemble shifter lever Op 520 Wave washer to shifter lever Op 530 Shifter lever to shifter tube Op 535 Que for final assy line

Primary Drive Manufacturing Process Steps Assessment

Customer

Characteristics Matrix Development

Potential Critical and Significant

SEAL COMPRESSION HEIGHT SERATION DAMAGE

Direction of Improvement

BEARING FLUSH TO SNAP RING FACE

PRIMARY GASKET SEAL SURFACE FINISH

Potential Significant and Critical Characteristics from DFMEA & Other Sources

1.090 TO 1.110 " FACE OF PRIMARY HOUSING 5 BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS 0.260 TO 0.270 " TO 3 FACE JACK SHAFT SEAL AGAINST 9 SHOULDER

Weighted Importance

Special Characteristics Matrix

Relative Importance 5 Severity Receive Material Material handling Shipping Damage Component Manufacture Vehicle Assembly 9 9 3 0 81

81

72

0 9

Prioritized ranking of process steps relative to risk

41

Op 100 Step 1 PRE-LOAD DOWEL PINS TO FIXTURE Op 100 Step 2 PRE-LOAD JACK SHAFT SEAL TO FIXTURE Op 100 Step 3 PRE-LOAD PRIMARY HOUSING BUSHING TO FIXTURE Op 110 Pre-load bearing to fixture #2

0 27

Characteristics Ranked in order of Importance

54

261

Op 120 Pre-load main shaft oil seal to mandrel Op 200 Housing to fixture #1 Op 210 Operate press

3 0 54 81 3 0 0 0 27 0 45 9 9 0 0 0 0 0 0 0

Op 220 Retaining ring to top groove

Process Steps

Primary Drive Manufacturing Process Steps

H H H F G G

H F G H

Op 230 Reload fixture #1 Op 300 Housing to fixture #2 Op 310 Operate press Op 320 Retaining ring to top groove

Op 330 Mandrel to main shaft bore I.D. OP 340 Operate press Op 350 Re-load fixture #2 and mandrel Op 400 Housing to table Op 410 Reserved

Process Operation from Process Flow

Op 420 Chain adj sub assy to housing Op 430 Lubricate bushing & seal Op 445 Move or stage for final assy Op 10 O-ring to shifter tube Op 500 Shifter tube to housing Op 510 Clamp to shifter tube Op 20 Assemble shifter lever Op 520 Wave washer to shifter lever Op 530 Shifter lever to shifter tube Op 535 Que for final assy line

High/Medium Interactions are causes/failure modes in PFMEA

8

Characteristics Matrix

Customer Assessment

FMEA Deployment
A layered approach is highly recommended as FMEAs can get complex. FMEAs are like ONIONS/LAYERS.
Each layer is closer to the root cause Each layer is more detailed The closer to core the more detail
Core gets to the root cause

Do too many and you will cry.

System Boundary Diagram

Cylinder Head

Compression Brake
Arm Group Assembly Intake rocker assembly Exhaust rocker assembly Stand(s) W & W/o oil supply Shaft Assembly Mounting Bolt Spring/Spacer Shaft Assembly Shaft Intake Rocker Assembly Cup Exhaust Rocker Assembly Pin Body Insert Roller Pin Clip Pushrod Rod Cup Ball

Additional Clearances Injector & Spring Injector & Spring Base Injector & retainer

Valve Cover

Injector & Bridge

Injector & injector clamp Valve Injector oil

Bridge

Lube Oil

Cylinder Head

Spring Group Inner & Outer Springs Spring Base Retainer/Rotator Valve Keeper Valve Group Intake Valve Exhaust Valve Intake Seat Exhaust Seat Valve Guide Valve Guide Seal Valve Seat CAM Bearings Thrust Plate

Valve Stem Seal

Lube Oil

Lifter Assembly Body Insert Roller Pin Clip wire CAM Shaft

Oscillating Lifter Pressure Lube OR Bore in Block Pressure Lube

Cylinder Head

Seat Insert Cylinder Head

Cylinder Block

P-Diagram
Noise Factors 1. Piece to piece variation
Heat shields Pipe maufacturing variation Frame variation

2. Other systems
Foot peg location Engine mount

3. Customer usage/duty cycle

After market changes -mufflers, foot pegs, decorative covers Change calibrations, runs hotter, componet discoloring, over drive system, excesive lean angle Supension changes, lowers bike Improper storage practices

4. Deterioration/degredagtion over time

Gasket wear Motor mount wear Corrosion Loss of torque on fasteners

4. Environment
Ocean sea side (salt) Sand, dust Gravel Parade duty (low speed)

Input
Exhaust gases from engine Engine vibration Road vibration

Ideal function

Exhaust Pipes, Front & Rear

Meet Styling Requirements Transfer of exhaust gas Adequate clearance to other components

Control factors
Regulatory Lean Angle (SAE) Durability Requirements (GES)

Meet Durability Requirements

Error states
Difficult to service Does not meet styling review Difficult to assemble High warranty Poor lean angle

11

FMEA Preparation Vertical Approach

Key Elements of Efficient Development Identify all functions/process steps
Boundary Diagram P Diagram

Identify all failure modes via brainstorming/data/warranty/COQ Identify all effects via brainstorming/data
Customer focus

Develop data pools for

Failure Modes, Effects and Causes for future/ faster FMEA development

12

System/Subsystem/ Design FMEA

Failure Mode: Pure anti-function

FUNCTION
(ANTI)
13

System/Subsystem/ Design FMEA

Effect
Customer view/customers words Regulation violation Level of dissatisfaction

Consider All Customers

End User Engineering Community Manufacturing Community (Operators/Employees) Regulatory Body

14

Severity Column
Item / Process Step C l a s s O c c u r Current Process Controls
Prevent Detect

Potential Failure Mode

Potential Effect(s) of Failure

S e v

Potential Cause(s)/ Mechanism(s) Of Failure

Function

D e t e c

Action Results R P N Response & Recommended Traget Actions Complete Date Action Taken S E V O C C D E T R P N

Severity Column

15

AUTOMOTIVE EXAMPLE SEVERITY EVALUATION CRITERIA

SEVERITY EVALUATION CRITERIA
EFFECT CRITERIA: Severity of Effect Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning RNK.

Hazardouswithout warning Hazardouswith warning Very High High Moderate Low Very Low

10

Vehicle/item inoperable (loss of primary function). Vehicle/item operable but at a reduced level of performance. Customer very dissatisfied. Vehicle/item operable but Comfort/Convenience item(s) inoperable. Customer dissatisfied. Vehicle/item operable but Comfort/Convenience item(s) operable at a reduced level of performance. Customer somewhat dissatisfied. Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most customers (greater than 75%). Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of customers. Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by discriminating customers (less than 25%). No discernable effect.

8 7

Minor
Very Minor None

2
1

16

FMEA General

For High Severity 9/10

17

Failure Mode/Cause Relationship

Inadequate Electrical Connection

In Different FMEA Levels

Failure Mode
Motor Stops

Cause

Failure Mode

Inadequate Electrical Connection

Inadequate Causes Locking Feature

Harness Too Short

18

Causes
Causes from P-Diagram
Noise factors

Continue through all failure modes. Note that many causes are recurring.

19

Occurrence Column
Item / Process Step C l a s s Potential Cause(s)/ Mechanism(s) Of Failure O c c u r Current Process Controls
Prevent Detect

Potential Failure Mode

Potential Effect(s) of Failure

S e v

Function

D e t e c

Action Results R P N Response & Recommended Traget Actions Complete Date Action Taken S E V O C C D E T R P N

Occurrence Column

20

Occurrence Evaluation Criteria

SUGGESTED OCCURRENCE EVALUATION CRITERIA
Probability of Failure Likely Failure Rates Over Design Life Ranking

Very High: Persistent failures

100 per thousand vehicles/items 50 per thousand vehicles/items

10 9 8 7 6 5 4 3 2 1

High: Frequent failures

20 per thousand vehicles/items 10 per thousand vehicles/items 5 per thousand vehicles/items

Moderate: Occasional failures

2 per thousand vehicles/items 1 per thousand vehicles/items 0.5 per thousand vehicles/items

Low: Relatively few failures

0.1 per thousand vehicles/items

Remote: Failure is unlikely 0.01 per thousand vehicles/items

*Note: Zero (0) rankings for Severity, Occurrence or Detection are not allowed

21

Occurrence Rating
If an action would effectively eliminate the possibility of the cause occurring, the action is listed as described earlier.
Occurrence of 1 or 2 require proof using a surrogate product or mistake proofing.

DATA

HARD FACTS
22

Example of Significant/ Critical Threshold

Special Characteristics Matrix

S E V E R I T Y

10 9 8 7 6 5 4 3 2 1

POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory POTENTIAL SIGNIFICANT CHARACTERISTICS

Customer Dissatisfaction

ANOYANCE ZONE
ALL OTHER CHARACTERISTICS
Appropriate actions / controls already in place

3 4 5 6 7 8 9 10 OCCURRENCE
23

*Used by permission of Ford Motor Company

Classification And Definition Column

Item

Potential Failure Mode

Potential Effect(s) of Failure

S e v

Function

C l a s s

Potential Cause(s) / Mechanism(s) of Failure

O c c u r

Current Design Controls

D Response & e R. Recommended Target t P. Actions Complete e N. Date c

Action Results Actions Taken S e v O c c D e t R. P. N.

Classification and Definition Column

24

Design Verification (Current Design Controls)

Think of Design Control in two ways; Prevention and Detection. List them separately. To save time, add any new (untried) prevention/detection ideas to the document under Recommended Actions column.
Prevention is specifically related to reduction or elimination of a cause. Detection is how well the test or series of tests may find the design flaw
Causes Failure Mode

25

Detection Rating
SUGGESTED DETECTION EVALATION CRITERIA
DETECTION CRITERIA Design Control will not and/or cannot detect a potential cause/ mechanism and subsequent failure mode; or there is no Design Control. Very Remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Remote chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. Very Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Moderate chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. Moderately High chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. High chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. Very High chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. Design Controls will almost certainly detect a potential cause/ mechanism and subsequent failure mode. RNK.

Absolute Uncertainty Very Remote Remote

10

Very Low
Low Moderate Moderately High High Very High Almost Certain

26

Analysis Of Risk
RPN / RISK PRIORITY NUMBER What Is Risk? Probability of danger Severity/Occurrence/Cause

27

RPN / Risk Priority Number

Top 20% of Failure Modes by RPN R P N

Failure Modes
28

Evaluation by RPN Only

Case 1
S=5 O=5 D=2 RPN = 50

Case 2
S=3 O=3 D=6 RPN = 54

Case 3
S=2 O=10, D=10 = 200

WHICH ONE IS WORSE?

Case 4
S=9 O=2 D=3 = 54

29

Example
Extreme Safety/Regulatory Risk
=9 & 10 Severity

High Risk to Customer Satisfaction

Sev. > or = to 5 and Occ > or = 4

Consider Detection only as a measure of Test Capability.

30

Example of Significant/ Critical Threshold

Special Characteristics Matrix

S E V E R I T Y

10 9 8 7 6 5 4 3 2 1

POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory POTENTIAL SIGNIFICANT CHARACTERISTICS

Customer Dissatisfaction

ANOYANCE ZONE
ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place

3 4 5 6 7 8 9 10 OCCURRENCE
31

*Used by permission of Ford Motor Company

Actions
Your Company Name Here System Subsystem Component: Model Year/Vehicle (s): Core Team:
Item Potential Failure Mode Function Potential Effect (s) of Failure s e v c l a s s Potential Cause (s)/ Mechanism (s) Failure o c c u r Current Design Controls D e t e c R. P. N. Recommended Action(s) Responsibility & Target Completion Date Action Results Actions Taken
s e v o c c D e t R. P. N.

Potential Failure Mode and Effects Analysis (Design FMEA)

Design Responsibility: Key Date:

FMEA Number: Page of Prepared by: FMEA Date (Orig.):

(Rev.):

32

Actions
EXAMPLE:
Project: Issue Number 143 Issue Status/ Open Date Date Of Meeting: Issue Champion Action Number Action Date Action Person Resp. Team Completion Date

33

Re-rating RPN After Actions Have Occurred

Your Company Name Here System Subsystem Component: Model Year/Vehicle (s): Core Team: Item Potential Failure Mode Function Potential Effect (s) of Failure S C e l v a s s Potential Cause (s)/ Mechanism (s) Failure O c c u r Current Design Controls D R. e P. t N. e c Action Results Recommended Action(s) Responsibility & Target Completion Date Actions Taken S O D R. e c e P. v c t N.

Potential Failure Mode and Effects Analysis (Design FMEA)

Design Responsibility: Key Date:

FMEA Number: Page of Prepared by: FMEA Date (Orig.):

(Rev.):

34

Re-rating RPN After Actions Have Occurred

Severity typically stays the same. Occurrence is the primary item to reduce / focus on. Detection is reduced only as a last resort. Do not plan to REDUCE RPN with detection actions!!!
100% inspection is only 80% effective! Reducing RPN with detection does not eliminate failure mode, or reduce probability of causes Detection of 10 is not bad if occurrence is 1

35

FMEA in a continuous flow process

Steel Making example:
Design FMEA was performed on a Crankshaft to determine the best material for the product being considered. This was a critical application. Key features such as Geometry, Strength, Duty Cycle, were described to the Steel producer.

36

The key product requirements were mapped against the required customer features. E.g. chemistry and microstructure, Internal stress at ingot level, Product Grade and requirements documents created. Key characteristics mapped against processes Process FMEA was performed on processes that affected customer wants based on priority.

37

Phase I QFD

Product Specifications

Phase Progression

Phase II QFD

Systems / Sub-Systems / Components

Customer Wants (Marketing Information) DFMEA Failure Modes

Product Specifications

System DFMEA Sub-System DFMEA Inputs Drawings Boundary Diagram Warranty P-Diagram FMA Interface Matrix Component DFMEA

QFD Phase Progression

38

Potential Critical and Significant

SEAL COMPRESSION HEIGHT SERATION DAMAGE

Direction of Improvement

BEARING FLUSH TO SNAP RING FACE

PRIMARY GASKET SEAL SURFACE FINISH

1.090 TO 1.110 " FACE OF PRIMARY HOUSING 5 BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS 0.260 TO 0.270 " TO 3 FACE JACK SHAFT SEAL AGAINST 9 SHOULDER

Weighted Importance

Special Characteristics Matrix

Relative Importance 5 Severity Receive Material Material handling Shipping Damage Component Manufacture Vehicle Assembly 9 9 3 0 81

Potential Significant and Critical Characteristics from DFMEA

81

72

0 9

Prioritized ranking of process steps relative to risk

41

Op 100 Step 1 PRE-LOAD DOWEL PINS TO FIXTURE Op 100 Step 2 PRE-LOAD JACK SHAFT SEAL TO FIXTURE Op 100 Step 3 PRE-LOAD PRIMARY HOUSING BUSHING TO FIXTURE Op 110 Pre-load bearing to fixture #2

0 27 54 261 3 0 54 81 3 0 0 0 27 0 45 9 9 0 0 0 0 0 0 0

H H H H H H H F G G F G H F G H F F F

Characteristics Ranked in order of Importance

Op 120 Pre-load main shaft oil seal to mandrel Op 200 Housing to fixture #1 Op 210 Operate press Op 220 Retaining ring to top groove Op 230 Reload fixture #1 Op 300 Housing to fixture #2 Op 310 Operate press Op 320 Retaining ring to top groove

Process Steps
Op 330 Mandrel to main shaft bore I.D. OP 340 Operate press Op 350 Re-load fixture #2 and mandrel Op 400 Housing to table Op 410 Reserved

Process Operation from Process Flow

Op 420 Chain adj sub assy to housing Op 430 Lubricate bushing & seal Op 445 Move or stage for final assy Op 10 O-ring to shifter tube Op 500 Shifter tube to housing Op 510 Clamp to shifter tube Op 20 Assemble shifter lever Op 520 Wave washer to shifter lever Op 530 Shifter lever to shifter tube Op 535 Que for final assy line

Primary Drive Manufacturing Process Steps

High/Medium Interactions are causes/failure modes in PFMEA

Customer Assessment

The Completed Characteristics Matrix

39

System DFMEA Sub-System DFMEA Component DFMEA

Phase III QFD

Process Operations

Phase IV QFD
High Priority Process Operations
Process Parameters / Variables

Classification of Characteristics

SCs & CCs

Causes from DFMEAs

Special Characteristics Matrix

S E V E R I T Y 10 9 8 7 6 5 4 3 2 1
CRITICAL CHARACTERISTICS Safety/Regulatory

SIGNIFICANT CHARACTERISTICS
Customer Dissatisfaction

ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place

ANNOYANCE ZONE

SCs & CCs

Process Related SCs & CCs From all DFMEAs

1 2 3 4 5 6 7 8 9 10 OCCURRENCE

Failure Modes on PFMEA Inputs

Causes on PFMEA Process FMEA

Key Control Characteristics

Failure Data Process Capability

Process Flow

Line Layout
MFMEA

Control Plan

QFD Phase Progression

40

Summary
FMEA can be used creatively in continuous processing.

Linking key customer requirements to process outputs instead of standard product grade is valuable.
Future customer requirements will drive new and modified processes to achieve specialty results as a normal practice

41

Q&A

This guideline is for training purposes only; Not ISO controlled