FMEA
• Intelligent use of FMEA
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.
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
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
ValidationTestingPlan
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
Requirements Cascade
• How Fmea fits into Product and Process Development
Potential KPC Development
6
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
Characteristics Matrix Development
Sev
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Assessment
Direction of Improvement
Po
ten
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Cri
tica
l an
d S
ign
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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
Characteristics Matrix
8
Sev
erit
y
Process Steps
Re
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e M
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Mat
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l han
dlin
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Co
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CustomerAssessment
Direction of Improvement
Po
ten
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Cri
tic
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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
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
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
P-Diagram
11
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
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 development12
System/Subsystem/ Design FMEA
– Failure Mode: Pure anti-function
13
FUNCTION
(ANTI)
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
15
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
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
FMEA General
• For High Severity 9/10
Failure Mode/Cause Relationship
In Different FMEA LevelsInadequateElectrical
Connection
InadequateElectrical Connection
MotorStops
Causes
Cause
FailureMode
FailureMode
InadequateLockingFeature
HarnessToo Short
Causes
– Causes from P-Diagram• Noise factors
– Continue through all failure modes.– Note that many causes are recurring.
19
Occurrence Column
20
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
Occurrence Evaluation Criteria
21
*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
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.
22DATA HARD FACTS
Example of Significant/ Critical Threshold
23
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
Classification And Definition Column
24
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.
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
26
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.
Analysis Of Risk
– RPN / RISK PRIORITY NUMBER– What Is Risk?– Probability of danger– Severity/Occurrence/Cause
27
RPN / Risk Priority NumberTop 20% of Failure
Modes by RPN
RPN
Failure Modes
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
29
WHICH ONE IS WORSE?
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
31
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
Actions
32
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
Actions
33
EXAMPLE:
Project: Date OfMeeting:
IssueNumber
Issue Status/Open Date
IssueChampion
ActionNumber
ActionDate
Action Person Resp.Team
CompletionDate
143
Re-rating RPN After Actions Have Occurred
34
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
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
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
The Completed Characteristics Matrix
39
Sev
erit
y
Process StepsR
ece
ive
Ma
teria
l
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
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
QFDProcess
Parameters / Variables
High 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
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