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2
What Is An FMEA?
3
Plan & D efine Section 1 RELIABILITY BY DESIGN
ID E A APQP Tool Linkage
D esign & D evelopment - Section I I
O pportunity Process D esign & D evelopment - Section I I I
D efined GD & T
- D rawings Process F low
- M ath D ata F inalized
F orm T eam
- T iming
Prototype C ontrol C haracteristic
- Resources DFME A Special Characteristics
?
of
DFME A Plan
Pro
M atrix Pre - L aunch
ke
C ontrol Plan
Process Validation - Sectio
sta
Mi
C ustomer - R isk/ Action
C ollect PF M E A YES
Wants/ N eeds/ D esires - Special C haracteristics
M arket R esearch - M anufacturing IF Process T rial
- Q FD - C urrent C ontrols
- Assembly R un
Packaging
NO M in 300
pcs/ H its/ shots V alidation
D esign T est Plans D esigns
D esign A ctions T esting
I nput Priorities D evelopCChange
oncepts - D esign Verification Special
C ontrols Plan
F rom Wants/ N eeds/ - Product Process V alidation Plan
5 D esires - Process - G age P lan GR & R
No IF - G age Plan Repeatability OK?
D esign - C apability Plan
- F ailure M ode Reproducibility
A nalysis OK I nstructions
- H istory D evelop Product Yes - I nitial IF
Feasibility NO
- P ast P erformance Specifications
- T eam
- L essons L earned - L inked to C ustomers Statistics
D esign R isk A ssessment Revisit III YES
- Via C ontrol Plans
Process Development - O pen I ssues
- Spec. A greements
PF M E A
For Additional
- Capability Plan
IF N o - M aterials Potential
Feasible - Budget Failures STA BLE ?
- M anufacturing Process R isk A ssessment IF
Concept Yes NO
- Program R isks - E quipment YES
Initiation/Approval - Gages YES
Can w e chang e
- Controls
Program p ro ce ss to I F
- I nstructions C A PA BL E?
Approval Prototype Pilot Launch - E quipment I nstallation co n t a in ? NO
- Plans IF
- T ooling Progress - Status of O pen I ssues NO
K ick O ff T ools / E quipment G ages
PLANNING - G age D esign & P rogress
I nitial Process PLANNING D esign YES
C hange Sample T he
PRODUCT DESIGN AND DEV.
B ack to II
C reate Production - Source Wa
PROCESS DESIGN AND DEVELOPMENT. C ontrol Plan - Supportin
- L evel of P
PRODUCT AND PROCESS VALIDATION. - R ed u c e d (n )
- R ed u c e d (f)
- O p t im izin g C h ar a c t e ris tic s
PRODUCTION
Requirements Documents
•Regulatory
•Dimensional
•Cosmetic
Robustness Tools
Req. Spec. Document
Drawings Boundary Diagram
Warranty History P-Diagram Item / C O Current D Action Results
Process Potential Response &
Potential Potential S l c Design e R
Interface Matrix
Step Cause(s)/ Recommended Target S O D R
Failure Effect(s) of e a c Controls t P Action
Mechanism(s) Actions Complete
Mode Failure v s
Of Failure
u e N
Date Taken E C E P
s r c V C T N
Function Prevent Detect
DFMEA
S 9 Safety/Regulatory
E 8 POTENTIAL
V 7 SIGNIFICANT
Cascade Technical E
R
6
5
CHARACTERISTICS
Customer Dissatisfaction
1 2 3 4 5 6 7 8 9 10
OCCURRENCE
6
Special
Sources
•Drawings
•Regulations
•DFMEA (Potential
Characteristics
Potential Critical and Significant
SEAL
FACE
KPCs: Significant and
SHOULDER
Critical Characteristics)
SERATION DAMAGE
Matrix
Relative Importance
DOWEL PINS 0.260 TO 0.270 " TO
Weighted Importance
BUSHING TO FACE OF JACK SHAFT
Special Characteristics
Direction of Improvement
5
9
9
3
9
3
5
Severity
0 Receive Material
81 Material handling
F
81 Shipping Damage
F
72 Component Manufacture
Y
0 Vehicle Assembly
Op 100 Step 1
9 PRE-LOAD DOWEL PINS TO
H
FIXTURE
Op 100 Step 2
41 PRE-LOAD JACK SHAFT
G
G
SEAL TO FIXTURE
IF
Op 100 Step 3
END
0 PRE-LOAD PRIMARY
START
HOUSING BUSHING TO
YES
FIXTURE
Op 110
0
OPERATION
OPERATION
Op 120
27 Pre-load main shaft oil seal to
H
mandrel
54 Op 200
Process
H
Housing to fixture #1
261 Op 210
F
F
F
F
H
Operate press
Op 220
3
G
0 Op 230
Reload fixture #1
54 Op 300
H
H
Housing to fixture #2
81 Op 310
F
Operate press
Process Steps
3 Op 320
G
0 Op 330
Mandrel to main shaft bore I.D.
0 OP 340
Operate press
0 Op 350
Re-load fixture #2 and mandrel
27 Op 400
Primary Drive Manufacturing Process Steps
Housing to table
0 Op 410
Reserved
Op 420
45
F
Op 430
9
G
9 Op 445
G
0 Op 10
O-ring to shifter tube
0 Op 500
Shifter tube to housing
0 Op 510
Clamp to shifter tube
0 Op 20
Assemble shifter lever
0 Op 520
Wave washer to shifter lever
0 Op 530
Shifter lever to shifter tube
0 Op 535
Que for final assy line
Customer
Assessment
7
Characteristics Matrix Development
Potential Critical and Significant
SEAL
FACE
SHOULDER
SERATION DAMAGE
Matrix
Sources
Relative Importance
DOWEL PINS 0.260 TO 0.270 " TO
Weighted Importance
BUSHING TO FACE OF JACK SHAFT
Special Characteristics
Direction of Improvement
5
9
9
3
9
3
5
Potential Significant and
Severity
0 Receive Material
81 Material handling
F
81 Shipping Damage
F
72 Component Manufacture
H
Y
0 Vehicle Assembly
Op 100 Step 1
9 PRE-LOAD DOWEL PINS TO
relative to risk
FIXTURE
of process steps
Op 100 Step 2
Prioritized ranking
41 PRE-LOAD JACK SHAFT
G
G
SEAL TO FIXTURE
Op 100 Step 3
PRE-LOAD PRIMARY
0
HOUSING BUSHING TO
FIXTURE
Op 110
0 Pre-load bearing to fixture #2
Op 120
27 Pre-load main shaft oil seal to
H
mandrel
Importance
Op 200
54
Characteristics
H Housing to fixture #1
Op 210
Ranked in order of
F
F
F
F
Housing to fixture #2
Op 310
81
F
H
H
Operate press
Process Steps
Op 320
3
G
Housing to table
Op 410
0 Reserved
Primary Drive Manufacturing Process Steps
Op 420
45
F
Op 510
0
Clamp to shifter tube
Process Operation
Op 20
from Process Flow
8
Characteristics Matrix
FMEA Deployment
9
System Boundary Diagram
Cylinder Head Compression Brake
on
Vi rati
br Vib
at
Additional Clearances ion
Arm Group Assembly Shaft Assembly
•Injector & Spring •Intake rocker assembly •Shaft
Intake Rocker Assembly Clearance Valve Cover
•Exhaust rocker assembly •Cup
•Injector & Spring Base Exhaust Rocker Assembly
•Stand(s) W & W/o oil supply •Pin
•Body
•Injector & retainer •Shaft Assembly
•Insert
•Injector & Bridge •Mounting Bolt
•Roller
•Spring/Spacer
•Injector & injector clamp •Pin
•Clip
Valve Floating Bridge Lube Oil
Pushrod
•Injector oil •Rod
•Cup
Spring Group •Ball
•Inner & Outer Springs
Cylinder Head Load •Spring Base
•Retainer/Rotator
Lifter Assembly
•Valve Keeper
ok e •Body
str
Valve Stem Seal at full
Clear Valve Group •Insert
•Intake Valve •Roller
•Exhaust Valve •Pin
•Intake Seat •Clip
Lube Oil •wire Oscillating Lifter
•Exhaust Seat
•Valve Guide •Pressure Lube
CAM Shaft
Cylinder Head •Valve Guide Seal OR
Bore in Block
Valve Seat CAM Bearings
•Pressure Lube
Seat Insert
Thrust Plate
Cylinder Head
Cylinder Block
P-Diagram
Noise Factors
11
FMEA Preparation Vertical Approach
12
System/Subsystem/ Design FMEA
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
Severity
Column
15
AUTOMOTIVE EXAMPLE SEVERITY EVALUATION CRITERIA
Hazardous- Very high severity ranking when a potential failure mode affects safe vehicle
without operation and/or involves noncompliance with government regulation without
10
warning
warning
Hazardous- Very high severity ranking when a potential failure mode affects safe vehicle
with operation and/or involves noncompliance with government regulation with warning
9
warning
Very High Vehicle/item inoperable (loss of primary function). 8
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most
Very Low customers (greater than 75%). 4
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of
Minor customers. 3
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by
Very Minor discriminating customers (less than 25%). 2
16
FMEA General
17
Failure Mode/Cause Relationship
In Different FMEA Levels
Inadequate
Electrical
Connection
Failure
Cause Mode
Motor
Stops
Failure
Mode Inadequate
Electrical Connection
InadequateCauses Harness
Locking Too Short
Feature
18
Causes
19
Occurrence Column
Occurrence
Column
20
Occurrence Evaluation Criteria
*Note: Zero (0) rankings for Severity, Occurrence or Detection are not allowed
21
Occurrence Rating
10 POTENTIAL CRITICAL
9 CHARACTERISTICS Safety/Regulatory
S
E 8 POTENTIAL
V 7 SIGNIFICANT
E 6 CHARACTERISTICS
Customer Dissatisfaction
R 5
I 4 ANOYANCE
T 3 ZONE
Y 2 ALL OTHER CHARACTERISTICS
Appropriate actions /
1 controls already in place
1 2 3 4 5 6 7 8 9 10
OCCURRENCE
*Used by permission of Ford Motor Company 23
Classification And Definition Column
C O D Action Results
Item Potential Response &
Potential Potential S l c Current e R.Recommended
Cause(s) / Target
Failure Effect(s) of e a c Design t P. Actions Actions S O D R.
Mechanism(s) Complete
Mode Failure v s u Controls e N. Taken e c e P.
of Failure Date
Function s r c v c t N.
Classification and
Definition Column
24
Design Verification (Current Design Controls)
25
Detection Rating
SUGGESTED DETECTION EVALATION CRITERIA
DETECTION CRITERIA RNK.
Design Control will not and/or cannot detect a potential cause/ mechanism and
Absolute
subsequent failure mode; or there is no 10
Uncertainty Design Control.
Very Remote chance the Design Control will detect a potential cause/mechanism and
Very Remote 9
subsequent failure mode.
Remote chance the Design Control will detect a potential cause/ mechanism and
Remote 8
subsequent failure mode.
Very Low chance the Design Control will detect a potential cause/mechanism and
Very Low 7
subsequent failure mode.
Low chance the Design Control will detect a potential cause/mechanism and
Low 6
subsequent failure mode.
Moderate chance the Design Control will detect a potential cause/ mechanism and
Moderate 5
subsequent failure mode.
Moderately Moderately High chance the Design Control will detect a potential cause/mechanism
4
High and subsequent failure mode.
High chance the Design Control will detect a potential cause/ mechanism and
High 3
subsequent failure mode.
Very High chance the Design Control will detect a potential cause/ mechanism and
Very High 2
subsequent failure mode.
Almost Design Controls will almost certainly detect a potential cause/ mechanism and
1
Certain subsequent failure mode.
26
Analysis Of Risk
27
RPN / Risk Priority Number
R
P
N
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
WHICH ONE
Case 3
IS WORSE?
S=2 O=10, D=10 = 200
Case 4
S=9 O=2 D=3 = 54
29
Example
30
Example of Significant/ Critical Threshold
10 POTENTIAL CRITICAL
9 CHARACTERISTICS Safety/Regulatory
S
E 8 POTENTIAL
V 7 SIGNIFICANT
E 6 CHARACTERISTICS
Customer Dissatisfaction
R 5
I 4 ANOYANCE
T 3 ZONE
Y 2 ALL OTHER CHARACTERISTICS
Appropriate actions /
1 controls already in place
1 2 3 4 5 6 7 8 9 10
OCCURRENCE
*Used by permission of Ford Motor Company 31
Actions
32
Actions
EXAMPLE:
Project: Date Of
Meeting:
Issue Issue Status/ Issue Action Action Action Person Resp. Completion
Number Open Date Champion Number Date Team Date
143
33
Re-rating RPN After Actions Have Occurred
34
Re-rating RPN After Actions Have Occurred
35
FMEA in a continuous flow process
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
Progressi
on
Systems / Sub-
Phase II Systems / Components
QFD
Customer
Wants
(Marketing
Information)
Product
Specifications System DFMEA
Sub-System DFMEA
Component DFMEA
Inputs
•Drawings•Boundary
Diagram
•Warranty
•P-Diagram
•FMA
•Interface
Matrix
SEAL
FACE
SHOULDER
SERATION DAMAGE
Matrix
Relative Importance
DOWEL PINS 0.260 TO 0.270 " TO
Weighted Importance
BUSHING TO FACE OF JACK SHAFT
Special Characteristics
Direction of Improvement
5
9
9
3
9
3
5
Severity
DFMEA
and Critical
0 Receive Material
81 Material handling
F
Characteristics from
Potential Significant
81 Shipping Damage
F
72 Component Manufacture
Y
H
0 Vehicle Assembly
Op 100 Step 1
9 PRE-LOAD DOWEL PINS TO
relative to risk
FIXTURE
of process steps
Op 100 Step 2
Prioritized ranking
41 PRE-LOAD JACK SHAFT
G
G
SEAL TO FIXTURE
Op 100 Step 3
PRE-LOAD PRIMARY
0
HOUSING BUSHING TO
FIXTURE
Op 110
0 Pre-load bearing to fixture #2
Op 120
27 Pre-load main shaft oil seal to
H
mandrel
Importance
Op 200
54
Characteristics
H
H
Housing to fixture #1
Op 210
Ranked in order of
F
F
F
F
261
H
Operate press
Op 220
3
G
Housing to fixture #2
Op 310
81
F
H
H
Operate press
Process Steps
Op 320
3
G
Housing to table
Op 410
0 Reserved
Primary Drive Manufacturing Process Steps
Op 420
F
Op 510
0
Clamp to shifter tube
Process Operation
Op 20
from Process Flow
39
The Completed Characteristics Matrix
Phase III Process
System DFMEA
Sub-System DFMEA
QFD Operations
Phase IV
Component DFMEA
QFD
Process
Parameters /
High Priority Variables
Process Operations
S 9 Safety/Regulatory
E 8 SIGNIFICANT
V 7 CHARACTERISTICS
E 6 Customer Dissatisfaction
R 5
I 4 ANNOYANCE
T 3 ZONE
SC’s & CC’s
ALL OTHER CHARACTERISTICS
Y 2 Appropriate actions /
1 controls already in place
1 2 3 4 5 6 7 8 9 10
OCCURRENCE
Process Related
SC’s & CC’s Failure Causes on
From all DFMEA’s Modes on PFMEA Key Control
PFMEA Characteristi
Process FMEA cs
Inputs
•Failure •Process
Data Flow Control Plan
•Process •Line Layout
Capability •MFMEA
41
Q&A