1. Intelligent use of FMEA
DESIGN FMEA - GENERAL
MODULE 2
Notes:
Design FMEA - Module 2

2. Failure Mode and Effects Analysis
Potential
Failure Mode and Effects Analysis
(Design FMEA)
__ System
__ Subsystem
__ Component
Model Year/Vehicle(s):
Core Team:
FMEA Number:
Page 1 or 1
Prepared by: Lee Dawson
FMEA Date (Orig.):
Design Responsibility
Key Date:
Item
Potential
Cause(s)/
Mechanism(s)
Of Failure
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Potential
Failure
Mode
Potential
Effect(s) of
Failure C L A S O C U R D E T C
Responsibility
& Target
Completion
Date
Action Results S E V R. P. N.
Recommended
Action(s) S E V O C D E T R. P. N.
Actions
Taken
Function
Design FMEA - Module 2

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
Design FMEA - Module 2

4. Open Issues / Time Line RELIABILITY BY DESIGN APQP Tool Linkage
Process Development
Notes:
Design FMEA - Module 2
Design FMEA - Module 2
Rev. 2- 2/2/

5. How Fmea fits into Product and Process Development
Requirements Cascade
How Fmea fits into Product and Process Development
Design FMEA - Module 2

6. Potential KPC Development
Requirements Documents
Regulatory
Dimensional
Cosmetic
Req. Spec. Document
Drawings
Warranty History
Robustness Tools
Boundary Diagram
P-Diagram
Interface Matrix
Detect
Prevent R P N D E T O C S V
Action
Taken
Action Results
Response &
Target
Complete
Date
Recommended
Actions e t c
Current
Controls u r
Potential
Cause(s)/
Mechanism(s)
Of Failure l a s v
Effect(s) of
Failure
Mode
Item /
Process
Step
Design
Function
DFMEA 10 9 8 7 6 5 4 3 2 1 S E V R I T Y
O C C U R R E N C E
POTENTIAL CRITICAL CHARACTERISTICS
Safety/Regulatory
POTENTIAL
SIGNIFICANT
CHARACTERISTICS
Customer Dissatisfaction
Special Characteristics Matrix
ANOYANCE
ZONE
ALL OTHER CHARACTERISTICS
controls already in place
Appropriate actions /
Cascade Technical Requirements Into Special Product Characteristics
Design FMEA - Module 2

7. Characteristics Matrix Development
Process Flow
START
OPERATION IF
END
YES NO
Special Characteristics Sources
DFMEA (Potential KPCs: Significant and Critical Characteristics)
Drawings
Regulations
Severity
Process Steps
Receive Material
Material handling
Shipping Damage
Component Manufacture
Vehicle Assembly
Primary Drive Manufacturing Process Steps
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
Op 110
Pre-load bearing to fixture #2
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
Op 320
Op 330
Mandrel to main shaft bore I.D.
OP 340
Op 350
Re-load fixture #2 and mandrel
Op 400
Housing to table
Op 410
Reserved
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
Customer
Assessment
Direction of Improvement
Potential Critical and Significant
1.090 TO " FACE OF PRIMARY HOUSING
BUSHING TO FACE OF JACK SHAFT
SEAL
DOWEL PINS TO " 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 Y 5 3 9 81 72 41 27 54
261 45
Special Characteristics
Matrix
Design FMEA - Module 2

8. Characteristics Matrix
Potential Significant and Critical Characteristics from DFMEA & Other Sources
Characteristics Ranked in order of Importance
Process Operation from Process Flow
Severity
Process Steps
Receive Material
Material handling
Shipping Damage
Component Manufacture
Vehicle Assembly
Primary Drive Manufacturing Process Steps
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
Op 110
Pre-load bearing to fixture #2
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
Op 320
Op 330
Mandrel to main shaft bore I.D.
OP 340
Op 350
Re-load fixture #2 and mandrel
Op 400
Housing to table
Op 410
Reserved
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
Customer
Assessment
Direction of Improvement
Potential Critical and Significant
1.090 TO " FACE OF PRIMARY HOUSING
BUSHING TO FACE OF JACK SHAFT
SEAL
DOWEL PINS TO " 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 Y 5 3 9 81 72 41 27 54
261 45
Special Characteristics
Matrix
High/Medium Interactions are causes/failure modes in PFMEA
Prioritized ranking of process steps relative to risk
Design FMEA - Module 2

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.
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
Notes:
Design FMEA - Module 2

10. System Boundary Diagram
Cylinder Head
Compression Brake
Vibration
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
Cup
Pin
Additional Clearances
Injector & Spring
Injector & Spring Base
Injector & retainer
Injector & Bridge
Injector & injector clamp
Vibration
Intake Rocker Assembly
Exhaust Rocker Assembly
Body
Insert
Roller
Pin
Clip
Clearance
Valve Cover
Bridge
Floating
Pushrod
Rod
Cup
Ball
Lube Oil
Valve
Injector oil
Spring Group
Inner & Outer Springs
Spring Base
Retainer/Rotator
Valve Keeper
Cylinder Head
Load
Lifter Assembly
Body
Insert
Roller
Pin
Clip
wire
Valve Stem Seal
Clear at full stroke
Valve Group
Intake Valve
Exhaust Valve
Intake Seat
Exhaust Seat
Valve Guide
Valve Guide Seal
Lube Oil
Oscillating Lifter
Pressure Lube OR
Bore in Block
CAM Shaft
Cylinder Head
Valve Seat
CAM Bearings
Seat Insert
Thrust Plate
Cylinder Head
Cylinder Block
Design FMEA - Module 2

11. P-Diagram
Design FMEA - Module 2

12. 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
Key Elements of Efficient Development
Identify all functions/process steps
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
Notes:
Design FMEA - Module 2

13. System/Subsystem/ Design FMEA
Failure Mode: Pure anti-function
FUNCTION
(ANTI)
Design FMEA - Module 2

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
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)
Notes:
Design FMEA - Module 2

15. Severity Column
Severity
Column
Design FMEA - Module 2

16. SEVERITY EVALUATION CRITERIA
EFFECT CRITERIA: Severity of Effect RNK.
Hazardous-
without
warning
Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning 10
Hazardous-
with
warning
Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning 9
Very High
Vehicle/item inoperable (loss of primary function). 8
Vehicle/item operable but at a reduced level of performance. Customer very dissatisfied.
High 7
Vehicle/item operable but Comfort/Convenience item(s) inoperable. Customer dissatisfied.
Moderate 6
Vehicle/item operable but Comfort/Convenience item(s) operable at a reduced level of performance. Customer somewhat dissatisfied.
Low 5
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most customers (greater than 75%).
Very Low 4
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of customers.
Minor 3
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by discriminating customers (less than 25%).
Very Minor 2
None
No discernable effect. 1
Design FMEA - Module 2

17. FMEA General
For High Severity 9/10
Design FMEA - Module 2

18. Failure Mode/Cause Relationship In Different FMEA Levels
Inadequate
Electrical
Connection
Failure
Mode
Cause
Motor
Stops
Failure
Mode
Inadequate
Electrical Connection
Causes
Inadequate
Locking
Feature
Harness
Too Short
Design FMEA - Module 2

19. Causes Causes from P-Diagram Continue through all failure modes.
Noise factors
Continue through all failure modes.
Note that many causes are recurring.
Design FMEA - Module 2

20. Occurrence Column
Occurrence
Column
Design FMEA - Module 2

21. Occurrence Evaluation Criteria
SUGGESTED OCCURRENCE EVALUATION CRITERIA
Probability of Likely Failure Rates Over Design Life Ranking
Failure
 100 per thousand vehicles/items 10
Very High: Persistent failures
50 per thousand vehicles/items 9
20 per thousand vehicles/items 8
High: Frequent failures
10 per thousand vehicles/items 7
5 per thousand vehicles/items 6
Moderate: Occasional failures
2 per thousand vehicles/items 5
1 per thousand vehicles/items 4
Notes:
0.5 per thousand vehicles/items 3
Low: Relatively few failures
0.1 per thousand vehicles/items 2
Remote: Failure is unlikely
 0.01 per thousand vehicles/items 1
*Note: Zero (0) rankings for Severity, Occurrence or Detection are not allowed
Design FMEA - Module 2

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
Design FMEA - Module 2

23. Example of Significant/ Critical Threshold10 9 8 7 6 5 4 3 2 1 S E V R I T Y
O C C U R R E N C E
POTENTIAL CRITICAL
CHARACTERISTICS
Safety/Regulatory
POTENTIAL
SIGNIFICANT
Customer Dissatisfaction
ALL OTHER CHARACTERISTICS
Appropriate actions /
controls already in place
Special Characteristics Matrix
ANOYANCE
ZONE
*Used by permission of Ford Motor Company
Design FMEA - Module 2

24. Classification And Definition Columnr D e t c
Action Results
Item
Potential
Cause(s) /
Mechanism(s)
of Failure
Response &
Target
Complete
Date
Potential
Failure
Mode
Potential
Effect(s) of
Failure S e v
Current
Design
Controls R. P. N.
Recommended
Actions
Actions
Taken S e v O c D e t R. P. N.
Function
Classification and
Definition Column
Design FMEA - Module 2

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
Design FMEA - Module 2

26. SUGGESTED DETECTION EVALATION CRITERIA
Detection Rating
SUGGESTED DETECTION EVALATION CRITERIA
DETECTION
CRITERIA
RNK.
Absolute
Uncertainty
Design Control will not and/or cannot detect a potential cause/ mechanism and subsequent failure mode; or there is no
Design Control. 10
Very Remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.
Very Remote 9
Remote chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode.
Remote 8
Very Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.
Very Low 7
Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.
Low 6
Moderate chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode.
Moderate 5
Moderately
High
Moderately High chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 4
High chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode.
High 3
Very High chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode.
Very High 2
Almost
Certain
Design Controls will almost certainly detect a potential cause/ mechanism and subsequent failure mode. 1
Design FMEA - Module 2

27. Analysis Of Risk RPN / RISK PRIORITY NUMBER What Is Risk?
Probability of danger
Severity/Occurrence/Cause
Design FMEA - Module 2

28. RPN / Risk Priority Number
Design FMEA - Module 2

29. WHICH ONE IS WORSE? Evaluation by RPN Only Case 1 Case 2 Case 3 Case 4
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?
Design FMEA - Module 2

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.
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.
Design FMEA - Module 2

31. Example of Significant/ Critical Threshold10 9 8 7 6 5 4 3 2 1 S E V R I T Y
O C C U R R E N C E
POTENTIAL CRITICAL
CHARACTERISTICS
Safety/Regulatory
POTENTIAL
SIGNIFICANT
Customer Dissatisfaction
ALL OTHER CHARACTERISTICS
Appropriate actions /
controls already in place
Special Characteristics Matrix
ANOYANCE
ZONE
*Used by permission of Ford Motor Company
Design FMEA - Module 2

32. Failure Mode and Effects Analysis
Actions
Your Company Name Here
Potential
Failure Mode and Effects Analysis
(Design FMEA)
System
Subsystem
Component:
FMEA Number:
Page of
Prepared by:
FMEA Date (Orig.): (Rev.):
Design Responsibility:
Key Date:
Model Year/Vehicle (s):
Core Team:
Item
A c t i o n R e s u l t s
Potential
Failure
Mode
Potential
Effect (s) of
Failure c l a s
Potential
Cause (s)/
Mechanism (s)
Failure
Current
Design
Controls
Responsibility
& Target
Completion
Date s e v o c u r D e t c R. P. N.
Recommended
Action(s)
Actions
Taken s e v o c D e t R. P. N.
Function
Design FMEA - Module 2

33. Actions
Design FMEA - Module 2

34. Re-rating RPN After Actions Have Occurred
Item
Function
System
Subsystem
Component:
Model Year/Vehicle (s):
Core Team:
Your Company Name Here
Potential
Failure Mode and Effects Analysis
(Design FMEA)
Design Responsibility:
Key Date:
FMEA Number:
Page of
Prepared by:
FMEA Date (Orig.): (Rev.):
Failure
Mode
Effect (s) of S e v C l a s
Cause (s)/
Mechanism (s) O c u r
Current
Design
Controls D t R. P. N.
Recommended
Action(s)
Responsibility
& Target
Completion
Date
Actions
Taken
A c t i o n R e s u l t s
Design FMEA - Module 2

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
Design FMEA - Module 2

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.
Design FMEA - Module 2

37. Product Grade and requirements documents created.
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.
Design FMEA - Module 2

38. QFD Phase Progression Phase I QFD Phase II QFD System DFMEA
Product Specifications
Phase Progressio n
Systems / Sub-Systems / Components
Phase II QFD
Customer Wants (Marketing Information)
DFMEA Failure Modes
Product
Specifications
System DFMEA
Sub-System DFMEA
Component DFMEA
Inputs
Boundary Diagram
P-Diagram
Interface Matrix
Drawings
Warranty
FMA
QFD Phase Progression
Design FMEA - Module 2

39. The Completed Characteristics Matrix
Characteristics Ranked in order of Importance
Potential Significant and Critical Characteristics from DFMEA
Process Operation from Process Flow
Severity
Process Steps
Receive Material
Material handling
Shipping Damage
Component Manufacture
Vehicle Assembly
Primary Drive Manufacturing Process Steps
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
Op 110
Pre-load bearing to fixture #2
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
Op 320
Op 330
Mandrel to main shaft bore I.D.
OP 340
Op 350
Re-load fixture #2 and mandrel
Op 400
Housing to table
Op 410
Reserved
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
Customer
Assessment
Direction of Improvement
Potential Critical and Significant
1.090 TO " FACE OF PRIMARY HOUSING
BUSHING TO FACE OF JACK SHAFT
SEAL
DOWEL PINS TO " 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 Y 5 3 9 81 72 41 27 54
261 45
Special Characteristics
Matrix
Step 1
Acquire Process Flow Diagram and list operations across the top.
Step 2 - Characteristic List
Review DFMEA for Special Characteristics
Federal Requirements/Regulation
Drawings/Specifications
Past history/feedback
Step 3 - List Characteristics
List Characteristics in column by severity
High to low (YC - YS)
Use FMEA or common sense
High/Medium Interactions are causes/failure modes in PFMEA
Prioritized ranking of process steps relative to risk
Design FMEA - Module 2
Design FMEA - Module 2
Rev. 2- 2/2/

40. High Priority Process Operations
Phase III QFD
Process Operations
System DFMEA
Sub-System DFMEA
Phase IV QFD
Component DFMEA
Process Parameters / Variables
High Priority Process Operations
SC’s & CC’s
Classification
of Characteristics
Causes from DFMEA’s 10 9 8 7 6 5 4 3 2 1 S E V R I T Y
O C C U R R E N C E
CRITICAL CHARACTERISTICS
Safety/Regulatory
SIGNIFICANT
CHARACTERISTICS
Customer Dissatisfaction
ALL OTHER CHARACTERISTICS
Appropriate actions /
controls already in place
Special Characteristics Matrix
ANNOYANCE
ZONE
SC’s & CC’s
Process Related
SC’s & CC’s
From all DFMEA’s
Failure Modes on PFMEA
Causes on PFMEA
Key Control Characteristics
Process FMEA
Inputs
Process Flow
Line Layout
MFMEA
Failure Data
Process Capability
Control Plan
QFD Phase Progression
Design FMEA - Module 2

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
Design FMEA - Module 2

42. Q&A
Design FMEA - Module 2