42
This guideline is for training purposes only; Not ISO co FMEA Intelligent use of FMEA

This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

Embed Size (px)

Citation preview

Page 1: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

This guideline is for training purposes only; Not ISO controlled

FMEA

Intelligent use of FMEA

Page 2: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

2

PotentialFailure Mode and Effects Analysis

(Design FMEA)__ System__ Subsystem__ Component

Model Year/Vehicle(s):Core Team:

Design ResponsibilityKey Date:

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

Item

Function

PotentialFailureMode

PotentialEffect(s) of

Failure

Potential Cause(s)/

Mechanism(s)Of Failure

CurrentDesign

ControlsPrevention

CurrentDesign

ControlsDetection

RecommendedAction(s)

Responsibility& Target

CompletionDate

ActionsTaken

Action ResultsSEV

CLASS

OCCUR

DETEC

R.P.N.

SEV

OCC

DET

R.P.N.

Page 3: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

3

What Is An FMEA?

Opportunity to Defeat Murphy’s Law Focus on Prevention Failure Mode And Effects Analysis is

An assessment of Risk Safety Regulatory Customer Satisfaction Program

Coordinated/Documented team effort To determine what can go wrong

A method to determine the need and priority of actions

MURPHY’SLAW

Page 4: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

DFMEA

Design & Development - Section II

GD & T- Drawings- Math Data

DFMEA

Design ActionsTest Plans- Design Verification

Design Change

IFDesign

OK

Special Characteristics

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

Kick Off Tools / Equipment Gages

No

Yes

Prototype ControlPlan

Plan & Define Section 1IDEA

OpportunityDefined

Form Team- Timing- Resources

CollectMarket Research

CustomerWants/ Needs/Desires- QFD

PrioritiesWants/ Needs/

Desires

Develop ProductSpecifications

- Linked to Customers

Develop Concepts- Product- Process

InputFrom

5

- Failure Mode Analysis- History- Past Performance- Lessons Learned

IFFeasible

No

Yes

Initial Process

Feasibility- Team

Process Design & Development - Section III

Process FlowFinalized

CharacteristicMatrix

PFMEA- Manufacturing- Assembly

Process Validation Plan- Gage Plan- Capability Plan

PackagingDesigns

IF

Process Risk Assessment

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

- Equipment Installation- Tooling Progress- Gage Design & Progress

SpecialControls

Instructions- Initial

YES

NO

Pre - Launch Control Plan- Risk/ Action- Special Characteristics- Current Controls Process Validation - Section IV

Process TrialRun

Min 300 pcs/Hits/ shots

GR & R- Gage Plan Repeatability

Reproducibility

Statistics- Via Control Plans- Capability Plan

ValidationTesting

Plan

Sample The Process

- Source Warrants- Supporting Documentation- Level of PPAP

DesignChange

Back to II

YES

NO

- Reduced (n)- Reduced (f)- Optimizing Characteristics

IF

IF

Can we changeprocess to contain?

IFYES

STABLE?

CAPABLE?

IF

OK?

YES

NO

NO

Revisit IIIPFMEA

For AdditionalPotentialFailures

NO

YES

Create ProductionControl Plan

PLANNING

ConceptInitiation/Approval

ProgramApproval Prototype Pilot Launch

PLANNING

CONTROL PLANS

PRODUCT DESIGN AND DEV.

PROCESS DESIGN AND DEVELOPMENT.

PRODUCT AND PROCESS VALIDATION.

FEEDBACK ASSESSMENT AND CORRECTIVE ACTION

PRODUCTION

Open Issues / Time Line

RELIABILITY BY DESIGNAPQP Tool Linkage

Process Development

Page 5: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

This guideline is for training purposes only; Not ISO controlled

Requirements Cascade

How Fmea fits into Product and Process Development

Page 6: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

6

Potential KPC Development

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken

Action ResultsResponse &

TargetComplete

Date

RecommendedActions

RPN

Detec

Current

Controls

Occur

PotentialCause(s)/

Mechanism(s)Of Failure

Class

Sev

PotentialEffect(s) of

Failure

Potential FailureMode

Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken

Action ResultsResponse &

TargetComplete

Date

RecommendedActions

RPN

Detec

CurrentDesign

Controls

Occur

PotentialCause(s)/

Mechanism(s)Of Failure

Class

Sev

PotentialEffect(s) of

Failure

Potential FailureMode

Item / Process Step

Function

DFMEA

Requirements Documents

•Regulatory•Dimensional•Cosmetic

Req. Spec. DocumentDrawingsWarranty History

Robustness Tools

Boundary DiagramP-DiagramInterface Matrix

10

9

8

7

6

5

4

3

2

1

1 2 3 4 5 6 7 8 9 10

S

E

V

E

R

I

T

Y

O C C U R R E N C E

POTENTIAL CRITICAL CHARACTERISTICS

Safety/Regulatory

POTENTIALSIGNIFICANT

CHARACTERISTICSCustomer Dissatisfaction

Special Characteristics Matrix

ANOYANCEZONE

ALL OTHER CHARACTERISTICS

Appropriate actions /controls already in place

Cascade Technical Requirements Into Special Product Characteristics

Page 7: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

7

Characteristics Matrix Development

Sev

erit

y

Process Steps

Rec

eive

Mat

eria

l

Mat

eria

l han

dlin

g

Shi

ppin

g D

amag

e

Com

pone

nt M

anuf

actu

re

Veh

icle

Ass

embl

y

Primary Drive Manufacturing Process Steps

Op

100

Ste

p 1

PR

E-L

OA

D D

OW

EL

PIN

S T

O

FIX

TU

RE

Op

100

Ste

p 2

PR

E-L

OA

D J

AC

K S

HA

FT

SE

AL

TO

FIX

TU

RE

Op

100

Ste

p 3

PR

E-L

OA

D P

RIM

AR

Y

HO

US

ING

BU

SH

ING

TO

FIX

TU

RE

Op

110

Pre

-loa

d be

arin

g to

fix

ture

#2

Op

120

Pre

-loa

d m

ain

shaf

t oi

l sea

l to

man

drel

Op

200

Hou

sing

to

fixtu

re #

1

Op

210

Ope

rate

pre

ss

Op

220

Ret

aini

ng r

ing

to t

op g

roov

e

Op

230

Rel

oad

fixtu

re #

1

Op

300

Hou

sing

to

fixtu

re #

2

Op

310

Ope

rate

pre

ss

Op

320

Ret

aini

ng r

ing

to t

op g

roov

e

Op

330

Man

drel

to

mai

n sh

aft

bore

I.D

.

OP

340

Ope

rate

pre

ss

Op

350

Re-

load

fix

ture

#2

and

man

drel

Op

400

Hou

sing

to

tabl

e

Op

410

Res

erve

d

Op

420

Cha

in a

dj s

ub a

ssy

to h

ousi

ng

Op

430

Lubr

icat

e bu

shin

g &

sea

l

Op

445

Mov

e or

sta

ge f

or f

inal

ass

y

Op

10

O-r

ing

to s

hift

er t

ube

Op

500

Shi

fter

tub

e to

hou

sing

Op

510

Cla

mp

to s

hift

er t

ube

Op

20

Ass

embl

e sh

ifter

leve

r

Op

520

Wav

e w

ashe

r to

shi

fter

leve

r

Op

530

Shi

fter

leve

r to

shi

fter

tub

e

Op

535

Que

for

fin

al a

ssy

line

Customer

Assessment

Direction of Improvement

Po

ten

tial

Cri

tica

l an

d S

ign

ific

ant

1.090 TO 1.110 " FACE OF PRIMARY HOUSING

BUSHING TO FACE OF JACK SHAFT

SEAL

DOWEL PINS 0.260 TO 0.270 " TO

FACE

JACK SHAFT SEAL AGAINST

SHOULDER

BEARING FLUSH TO SNAP RING FACE

SEAL COMPRESSION HEIGHT

PRIMARY GASKET SEAL SURFACE FINISH

SERATION DAMAGE

Weighted Importance

Relative Importance

G F

H F

H F

G F G

H G H H F H H

F F Y H H H H H G G

F

5

3

9

3

9

9

5

0 81 81 72 0 9 41 0 0 27 54 261

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

Special Characteristics

Matrix

START

OPERATION

OPERATION

IF

END

YES

NO

Process Flow

Special Characteristics Sources

•DFMEA (Potential KPCs: Significant and Critical Characteristics)

•Drawings

•Regulations

Page 8: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

8

Characteristics Matrix

Sev

erit

y

Process Steps

Re

ceiv

e M

ate

rial

Mat

eria

l han

dlin

g

Shi

ppin

g D

am

age

Co

mpo

nent

Man

ufac

ture

Veh

icle

Ass

emb

ly

Primary Drive Manufacturing Process Steps

Op

100

Ste

p 1

PR

E-L

OA

D D

OW

EL

PIN

S T

OF

IXT

UR

EO

p 10

0 S

tep

2P

RE

-LO

AD

JA

CK

SH

AF

TS

EA

L T

O F

IXT

UR

EO

p 10

0 S

tep

3P

RE

-LO

AD

PR

IMA

RY

HO

US

ING

BU

SH

ING

TO

FIX

TU

RE

Op

110

Pre

-load

bea

ring

to f

ixtu

re #

2

Op

120

Pre

-load

mai

n sh

aft

oil s

eal t

om

andr

el

Op

200

Hou

sing

to

fixtu

re #

1O

p 21

0O

pera

te p

ress

Op

220

Ret

aini

ng r

ing

to t

op g

roov

e

Op

230

Rel

oad

fixtu

re #

1O

p 30

0H

ousi

ng t

o fix

ture

#2

Op

310

Ope

rate

pre

ss

Op

320

Ret

aini

ng r

ing

to t

op g

roov

e

Op

330

Man

drel

to

mai

n sh

aft

bore

I.D

.O

P 3

40O

pera

te p

ress

Op

350

Re-

load

fix

ture

#2

and

man

drel

Op

400

Hou

sing

to

tabl

e

Op

410

Res

erve

d

Op

420

Cha

in a

dj s

ub a

ssy

to h

ousi

ng

Op

430

Lubr

icat

e bu

shin

g &

sea

lO

p 44

5M

ove

or s

tage

for

fin

al a

ssy

Op

10O

-rin

g to

shi

fter

tub

eO

p 50

0S

hift

er t

ube

to h

ousi

ngO

p 51

0C

lam

p to

shi

fter

tub

eO

p 20

Ass

embl

e sh

ifter

leve

rO

p 52

0W

ave

was

her

to s

hift

er le

ver

Op

530

Shi

fter

leve

r to

shi

fter

tub

eO

p 53

5Q

ue f

or f

inal

ass

y lin

e

CustomerAssessment

Direction of Improvement

Po

ten

tial

Cri

tic

al a

nd

Sig

nif

ican

t

1.090 TO 1.110 " FACE OF PRIMARY HOUSINGBUSHING TO FACE OF JACK SHAFT

SEAL

DOWEL PINS 0.260 TO 0.270 " TOFACE

JACK SHAFT SEAL AGAINSTSHOULDER

BEARING FLUSH TO SNAP RING FACE

SEAL COMPRESSION HEIGHT

PRIMARY GASKET SEAL SURFACE FINISH

SERATION DAMAGE

Weighted Importance

Relative Importance

G F

H F

H F

G F G

H G H H F H H

F F Y H H H H H G G

F

5

3

9

3

9

9

5

0 81

81

72

0 9 41

0 0 27

54

261

3 0 54

81

3 0 0 0 27

0 45

9 9 0 0 0 0 0 0 0

Special CharacteristicsMatrix

Process Operation from Process Flow

Potential Significant and Critical Characteristics from DFMEA & Other

Sources

High/Medium Interactions are causes/failure modes in

PFMEA

Characteristics Ranked in order of

Importance

Prioritized ranking of process steps relative to risk

Page 9: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

9

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.

Page 10: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

System Boundary Diagram

Lifter Assembly•Body•Insert•Roller•Pin•Clip•wire

CAM Shaft

Pushrod•Rod•Cup•Ball

Intake Rocker AssemblyExhaust Rocker Assembly•Body•Insert•Roller•Pin•Clip

Arm Group Assembly•Intake rocker assembly•Exhaust rocker assembly•Stand(s) W & W/o oil supply•Shaft Assembly•Mounting Bolt•Spring/Spacer

Bridge

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

CAM Bearings

Thrust Plate

Cylinder Block

Oscillating Lifter

•Pressure Lube

OR

Bore in Block

•Pressure Lube

Lube Oil

Cylinder Head

Vibration

Valve CoverClearance

Shaft Assembly•Shaft •Cup•Pin

Valve

•Injector oil

Floating

Cylinder Head Load

Valve Stem SealClear at full stroke

Lube Oil

Cylinder Head

Cylinder Head

Seat Insert

Valve Seat

Additional Clearances

•Injector & Spring

•Injector & Spring Base

•Injector & retainer

•Injector & Bridge

•Injector & injector clamp

Compression Brake

Vibration

Page 11: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

11

P-Diagram

1. Piece to piece variation 2. Other systems 3. Customer usage/duty cycleHeat shields Foot peg location After market changesPipe maufacturing variation Engine mount -mufflers, foot pegs, decorative coversFrame variation Change calibrations, runs hotter, componet discoloring, over drive

system, excesive lean angleSupension changes, lowers bikeImproper storage practices

4. Deterioration/degredagtion over time 4. EnvironmentGasket wear Ocean sea side (salt)Motor mount wear Sand, dustCorrosion GravelLoss of torque on fasteners Parade duty (low speed)

Input Ideal function

Exhaust gases from engine Exhaust Pipes, Front & RearEngine vibrationRoad vibration Meet Styling Requirements

Transfer of exhaust gas Adequate clearance to other components

Control factors Meet Durability Requirements

Regulatory Error statesLean Angle (SAE)

Difficult to serviceDurability Requirements (GES) Does not meet styling review

Difficult to assembleHigh warrantyPoor lean angle

Noise Factors

Page 12: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

12

FMEA Preparation Vertical Approach

Key Elements of Efficient Development Identify all functions/process steps

Boundary DiagramP 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

Page 13: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

13

System/Subsystem/ Design FMEA

Failure Mode: Pure anti-function

FUNCTION

(ANTI)

Page 14: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

14

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

Page 15: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

15

Severity Column

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken

Action ResultsResponse &

TragetComplete

Date

RecommendedActions

RPN

Detec

CurrentProcessControls

Occur

PotentialCause(s)/

Mechanism(s)Of Failure

Class

Sev

PotentialEffect(s) of

Failure

Potential FailureMode

Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken

Action ResultsResponse &

TragetComplete

Date

RecommendedActions

RPN

Detec

CurrentProcessControls

Occur

PotentialCause(s)/

Mechanism(s)Of Failure

Class

Sev

PotentialEffect(s) of

Failure

Potential FailureMode

Item / Process Step

Function

Severity ColumnSeverity Column

Page 16: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

16

AUTOMOTIVE EXAMPLE SEVERITY EVALUATION CRITERIA

Hazardous-withwarning

Very High

High

Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning

Low

Very Low

Minor

Very Minor

None

Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning

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.

10

8

7

6

3

2

1

Hazardous-withoutwarning

Moderate

4

5

EFFECT CRITERIA: Severity of Effect RNK.

SEVERITY EVALUATION CRITERIA

9

Page 17: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

17

FMEA General

For High Severity 9/10

Page 18: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

18

InadequateElectrical

Connection

InadequateElectrical Connection

MotorStops

Causes

Cause

Failure Mode/Cause Relationship

In Different FMEA Levels

FailureMode

FailureMode

InadequateLockingFeature

HarnessToo Short

Page 19: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

19

Causes

Causes from P-Diagram Noise factors

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

Page 20: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

20

Occurrence Column

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken

Action ResultsResponse &

TragetComplete

Date

RecommendedActions

RPN

Detec

CurrentProcessControls

Occur

PotentialCause(s)/

Mechanism(s)Of Failure

Class

Sev

PotentialEffect(s) of

Failure

Potential FailureMode

Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken

Action ResultsResponse &

TragetComplete

Date

RecommendedActions

RPN

Detec

CurrentProcessControls

Occur

PotentialCause(s)/

Mechanism(s)Of Failure

Class

Sev

PotentialEffect(s) of

Failure

Potential FailureMode

Item / Process Step

Function

Occurrence Column

Occurrence Column

Page 21: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

21

Occurrence Evaluation Criteria

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

Probability of Likely Failure Rates Over Design Life Ranking Failure

SUGGESTED OCCURRENCE EVALUATION CRITERIA

Very High: Persistent failures

High: Frequent failures

Moderate: Occasional failures

Low: Relatively few failures

Remote: Failure is unlikely

100 per thousand vehicles/items

50 per thousand vehicles/items

20 per thousand vehicles/items

10 per thousand vehicles/items

5 per thousand vehicles/items

2 per thousand vehicles/items

1 per thousand vehicles/items

0.5 per thousand vehicles/items

0.1 per thousand vehicles/items

0.01 per thousand vehicles/items

10

9

8

7

6

5

4

3

2

1

Page 22: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

22

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

Page 23: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

23

Example of Significant/ Critical Threshold

*Used by permission of Ford Motor Company

10987654321

1 2 3 4 5 6 7 8 9 10

SEVERITY

O C C U R R E N C E

POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory

POTENTIALSIGNIFICANT

CHARACTERISTICSCustomer Dissatisfaction

ALL OTHER CHARACTERISTICS

Appropriate actions /controls already in place

Special Characteristics Matrix

ANOYANCEZONE

Page 24: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

24

Classification And Definition Column

Sev

R.P.N.

Item

Function

PotentialFailure Mode

PotentialEffect(s) of

Failure

Class

PotentialCause(s) /

Mechanism(s)of Failure

Occur

CurrentDesign

Controls

Detec

RecommendedActions

Response &Target

Complete Date

ActionsTaken

Classification and Definition Column

Action Results

Occ

Sev

Det

R.P.N.

Page 25: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

25

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

Page 26: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

26

Detection Rating

AbsoluteUncertainty

Very Remote

Remote

Very Low

Low

Moderate

ModeratelyHigh

High

Very High

AlmostCertain

10

9

8

7

6

5

4

3

2

1

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.

Very 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.

Design Controls will almost certainly detect a potential cause/ mechanism and subsequent failure mode.

DETECTION

SUGGESTED DETECTION EVALATION CRITERIACRITERIA RNK.

Page 27: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

27

Analysis Of Risk

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

Page 28: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

28

RPN / Risk Priority Number

Top 20% of FailureModes by RPN

RPN

Failure Modes

Page 29: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

29

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

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

WHICH ONE IS WORSE?

Page 30: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

30

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.

Page 31: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

31

Example of Significant/ Critical Threshold

*Used by permission of Ford Motor Company

10987654321

1 2 3 4 5 6 7 8 9 10

SEVERITY

O C C U R R E N C E

POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory

POTENTIALSIGNIFICANT

CHARACTERISTICSCustomer Dissatisfaction

ALL OTHER CHARACTERISTICS

Appropriate actions /controls already in place

Special Characteristics Matrix

ANOYANCEZONE

Page 32: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

32

Actions

Item

Function

System Subsystem Component:

Model Year/Vehicle (s):

Core Team:

Your Company Name Here PotentialFailure Mode and Effects Analysis

(Design FMEA)

Design Responsibility:Key Date:

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

PotentialFailureMode

PotentialEffect (s) of

Failure

sev

class

PotentialCause (s)/

Mechanism (s)Failure

occur

CurrentDesign

Controls

Detec

R.P.N.

RecommendedAction(s)

Responsibility& Target

CompletionDate

ActionsTaken

sev

occ

Det

R.P.N.

A c t i o n R e s u l t s

Page 33: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

33

Actions

EXAMPLE:

Project: Date OfMeeting:

IssueNumber

Issue Status/Open Date

IssueChampion

ActionNumber

ActionDate

Action Person Resp.Team

CompletionDate

143

Page 34: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

34

Re-rating RPN After Actions Have Occurred

Item

Function

System Subsystem Component:

Model Year/Vehicle (s):

Core Team:

Your Company Name Here PotentialFailure Mode and Effects Analysis

(Design FMEA)

Design Responsibility:Key Date:

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

PotentialFailureMode

PotentialEffect (s) of

Failure

Sev

Class

PotentialCause (s)/

Mechanism (s)Failure

Occur

CurrentDesign

Controls

Detec

R.P.N.

RecommendedAction(s)

Responsibility& Target

CompletionDate

ActionsTaken

Sev

Occ

Det

R.P.N.

A c t i o n R e s u l t s

Page 35: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

35

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

Page 36: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

36

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.

Page 37: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

37

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.

Page 38: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

38

Phase I QFD

Phase II QFD

Product Specifications

Customer Wants

(Marketing Information)

ProductSpecifications

Systems / Sub-Systems / Components

Phase Progression

System DFMEASub-System DFMEA

Component DFMEA

DFMEA Failure Modes

QFD Phase Progression

Inputs

•Boundary Diagram

•P-Diagram

•Interface Matrix

•Drawings

•Warranty

•FMA

Page 39: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

39

The Completed Characteristics Matrix

Sev

erit

yProcess Steps

Re

ceiv

e M

ate

rial

Mat

eria

l han

dlin

g

Shi

ppin

g D

am

age

Co

mpo

nent

Man

ufac

ture

Veh

icle

Ass

emb

ly

Primary Drive Manufacturing Process Steps

Op

100

Ste

p 1

PR

E-L

OA

D D

OW

EL

PIN

S T

OF

IXT

UR

EO

p 10

0 S

tep

2P

RE

-LO

AD

JA

CK

SH

AF

TS

EA

L T

O F

IXT

UR

EO

p 10

0 S

tep

3P

RE

-LO

AD

PR

IMA

RY

HO

US

ING

BU

SH

ING

TO

FIX

TU

RE

Op

110

Pre

-load

bea

ring

to f

ixtu

re #

2

Op

120

Pre

-load

mai

n sh

aft

oil s

eal t

om

andr

el

Op

200

Hou

sing

to

fixtu

re #

1O

p 21

0O

pera

te p

ress

Op

220

Ret

aini

ng r

ing

to t

op g

roov

e

Op

230

Rel

oad

fixtu

re #

1O

p 30

0H

ousi

ng t

o fix

ture

#2

Op

310

Ope

rate

pre

ss

Op

320

Ret

aini

ng r

ing

to t

op g

roov

e

Op

330

Man

drel

to

mai

n sh

aft

bore

I.D

.O

P 3

40O

pera

te p

ress

Op

350

Re-

load

fix

ture

#2

and

man

drel

Op

400

Hou

sing

to

tabl

e

Op

410

Res

erve

d

Op

420

Cha

in a

dj s

ub a

ssy

to h

ousi

ng

Op

430

Lubr

icat

e bu

shin

g &

sea

lO

p 44

5M

ove

or s

tage

for

fin

al a

ssy

Op

10O

-rin

g to

shi

fter

tub

eO

p 50

0S

hift

er t

ube

to h

ousi

ngO

p 51

0C

lam

p to

shi

fter

tub

eO

p 20

Ass

embl

e sh

ifter

leve

rO

p 52

0W

ave

was

her

to s

hift

er le

ver

Op

530

Shi

fter

leve

r to

shi

fter

tub

eO

p 53

5Q

ue f

or f

inal

ass

y lin

e

CustomerAssessment

Direction of Improvement

Po

ten

tial

Cri

tic

al a

nd

Sig

nif

ican

t

1.090 TO 1.110 " FACE OF PRIMARY HOUSINGBUSHING TO FACE OF JACK SHAFT

SEAL

DOWEL PINS 0.260 TO 0.270 " TOFACE

JACK SHAFT SEAL AGAINSTSHOULDER

BEARING FLUSH TO SNAP RING FACE

SEAL COMPRESSION HEIGHT

PRIMARY GASKET SEAL SURFACE FINISH

SERATION DAMAGE

Weighted Importance

Relative Importance

G F

H F

H F

G F G

H G H H F H H

F F Y H H H H H G G

F

5

3

9

3

9

9

5

0 81

81

72

0 9 41

0 0 27

54

261

3 0 54

81

3 0 0 0 27

0 45

9 9 0 0 0 0 0 0 0

Special CharacteristicsMatrix

Process Operation from Process Flow

Potential Significant and Critical

Characteristics from DFMEA

High/Medium Interactions are causes/failure modes in

PFMEA

Characteristics Ranked in order of

Importance

Prioritized ranking of process steps relative to risk

Page 40: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

40

System DFMEASub-System DFMEA

Component DFMEA

Classification

of Characteristi

cs

SC’s & CC’s

Process Operations

Process Related SC’s & CC’s

From all DFMEA’s

Process FMEA

SC’s & CC’s

Phase III QFD

Phase IV QFD

Process Parameters /

VariablesHigh Priority

Process Operations

Causes on PFMEA

Failure Modes on

PFMEA

Causes from

DFMEA’s

Control Plan

Key Control Characteristi

cs

QFD Phase Progression

Inputs

•Process Flow

•Line Layout

•MFMEA

•Failure Data

•Process Capability

10987654321

1 2 3 4 5 6 7 8 9 10

SEVERITY

O C C U R R E N C E

CRITICAL CHARACTERISTICS

Safety/Regulatory

SIGNIFICANT CHARACTERISTICS

Customer Dissatisfaction

ALL OTHER CHARACTERISTICSAppropriate actions /

controls already in place

Special Characteristics Matrix

ANNOYANCEZONE

Page 41: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

41

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

Page 42: This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA

This guideline is for training purposes only; Not ISO controlled

Q&A