FMEA

1
FMEA

• Intelligent use of FMEA

Presented by Quality Associates
International Visit us at www.quality-one.com
2
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
Potential Cause(s)/ Mechanism(s) Of Failure
Current Design Controls Prevention
Current Design Controls Detection
Item
Action Results
Responsibility Target Completion Date
O C C U R
D E T E C
C L A S S
Potential Failure Mode
Potential Effect(s) of Failure
S E V
R. P. N.
Recommended Action(s)
R. P. N.
S E V
O C C
D E T
Actions Taken
Function
3
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
• Coordinated/Documented team effort
• To determine what can go wrong
• A method to determine the need and priority of
  actions
• It is not designed to record previously designed
  elements

4
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.

5
FMEA Strategy

• Strategic Deployment of FMEA to support DFSS
  (Design for Six Sigma)
• The requirements cascade to achieve success

6
CPPDM Overview
Life Cycle Plan Approved Project Started
Phase 0
Phase 4
Phase 3
Phase 2
Phase 1
PPAP/IPPAP, Equipment, Tooling and Processes
Ready, FPE Vehicles Built, Approved to Launch
Project Close Out and Make Good
Definition Complete Design Feasibility
Demonstrated
Design, Development, Vehicle Integration and
Parts Authorized
Concept Developed / Business Rationale
Business
Business Rationale Developed
Business Case Confirmation
After Action Reviews
Business Case Developed
Project Plan Complete
Business Case Confirmation
Resources Assigned
Initial Service Life Cycle Costs
Motorcycle Support Information
Systems, Sub-systems, and Components are Qualified
Make vs. Buy decisions sources selected
Make Good Reports
Regulatory Reqs Complete Documented
Base E.O. Assigned
Design Risk Assessment (FMEAs)
Product Validation
System, Sub-System, Vehicle Specs. Developed
Research of existing knowledge
Design
PPAP/IPPAP
Make Good Reports
Full Vehicle Requirements Defined
Process Risk Assessment (PFMEA)
Plant Training
Styling Inputs
After Action Reviews
Operation Instructions
Visual or Physical Rep. of Concept
Process Control Plan
Manufacturing Process Definition
FPE Vehicles Built
Training Plans
Containers, Crating, Material Handling Reqmnts.
Production System Validation
Prelim. Mfg Assessment
Process Verification
Process
Project Records / Documentation Collected
Project Reviews / Technical Reviews Ongoing
7
CPPDM Summary (Verification vs. Validation)
Phase 0
Phase 4
Phase 3
Phase 2
Phase 1
PPAP/IPPAP, Equipment, Tooling and Processes
Ready, FPE Vehicles Built, Approved to Launch
Project Close Out and Make Good
Definition Complete Design Feasibility
Demonstrated
Design, Development, Vehicle Integration and
Parts Authorized
Concept Developed / Business Rationale
Business
Product
Concept
Verification
Validation
Design
Process
Concept
Verification
Validation
Process
8
(No Transcript)
9
Requirements Cascade

• How Fmea fits into Product and Process Development

10
Phase I QFD
Product Specifications
Phase Progression
Systems / Sub-Systems / Components
Phase II QFD
Customer Wants (Marketing Information)
DFMEA Failure Modes
Product Specifications
System DFMEA
Sub-System DFMEA
Component DFMEA
QFD Phase Progression
11
The Completed Characteristics Matrix
Characteristics Ranked in order of Importance
Process Operation from Process Flow
Potential Significant and Critical
Characteristics from DFMEA
High/Medium Interactions are causes/failure modes
in PFMEA
Prioritized ranking of process steps relative to
risk
12
Phase III QFD
Process Operations
System DFMEA
Sub-System DFMEA
Phase IV QFD
Component DFMEA
Process Parameters / Variables
High Priority Process Operations
SCs CCs
Classification of Characteristics
Causes from DFMEAs
SCs CCs
Process Related SCs CCs From all DFMEAs
Causes on PFMEA
Failure Modes on PFMEA
Key Control Characteristics
Process FMEA
Control Plan
QFD Phase Progression
13
Potential Key Characteristic Development

• Requirements Documents
• Regulatory
• Dimensional
• Cosmetic
• Req. Spec. Document
• Drawings
• Warranty History

Robustness Tools Boundary Diagram P-Diagram Inter
face Matrix
Cascade Technical Requirements Into Special
Product Characteristics
14
Characteristics Matrix Development
Process Flow

• Special Characteristics Sources
• DFMEA (Potential KPCs Significant and Critical
  Characteristics)
• Drawings
• Regulations

15
Characteristics Matrix
Characteristics Ranked in order of Importance
Potential Significant and Critical
Characteristics from DFMEA Other Sources
Process Operation from Process Flow
High/Medium Interactions are causes/failure modes
in PFMEA
Prioritized ranking of process steps relative to
risk
16
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

17
System/Subsystem/ Design FMEA

• Failure Mode Pure anti-function

18
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

19
Severity Column
Severity Column
20
SEVERITY EVALUATION CRITERIA
EFFECT
CRITERIA Severity of Effect
RNK.
Very high severity ranking when a potential
failure mode affects safe vehicle operation
and/or involves noncompliance with government
regulation without warning
Hazardous- 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
21
FMEA General

• For High Severity 9/10

22
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
23
Causes

• Causes from P-Diagram
• Noise factors
• Continue through all failure modes.
• Note that many causes are recurring.

24
Occurrence Column
Occurrence Column
25
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
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
26
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
27
Example of Significant/ Critical Threshold
Used by permission of Ford Motor Company
28
Classification And Definition Column
C l a s s
O c c u r
D e t e c
Action Results
Item
Potential Cause(s) / Mechanism(s) of Failure
Response Target Complete Date
S e v
R. P. N.
Potential Failure Mode
Potential Effect(s) of Failure
Current Design Controls
Recommended Actions
Actions Taken
O c c
S e v
D e t
R. P. N.
Function
Classification and Definition Column
29
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

30
Detection Rating
SUGGESTED DETECTION EVALATION CRITERIA
CRITERIA
RNK.
DETECTION
Design Control will not and/or cannot detect a
potential cause/ mechanism and subsequent failure
mode or there is no Design Control.
Absolute Uncertainty
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
31
Analysis Of Risk

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

32
RPN / Risk Priority Number
33
Evaluation by RPN Only

• Case 1
• S5 O5 D2 RPN 50
• Case 2
• S3 O3 D6 RPN 54
• Case 3
• S2 O10, D10 200
• Case 4
• S9 O2 D3 54

WHICH ONE IS WORSE?
34
Example

• Extreme Safety/Regulatory Risk
• 9 10 Severity
• High Risk to Customer Satisfaction
• Sev. gt or to 5 and Occ gt or 4
  
• Consider Detection only as a measure of Test
  Capability.

35
Example of Significant/ Critical Threshold
Used by permission of Ford Motor Company
36
Actions
Potential Failure Mode and Effects
Analysis (Design FMEA)
Your Company Name Here
FMEA Number Page of Prepared
by FMEA Date (Orig.) (Rev.)
System Subsystem Component
Design Responsibility Key Date
Model Year/Vehicle (s) Core Team
Item
A c t i o n R e s u l t s
c l a s s
Potential Cause (s)/ Mechanism (s) Failure
Responsibility Target Completion Date
Potential Failure Mode
Potential Effect (s) of Failure
o c c u r
Current Design Controls
s e v
D e t e c
R. P. N.
Recommended Action(s)
Actions Taken
s e v
o c c
D e t
R. P. N.
Function
37
Actions
38
Re-rating RPN After Actions Have Occurred
39
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

40
FMEA Requirement/Specification Cascades for
CPPDM
41
V Model
42
V Model

• The V Model shows the path a product follows from
  concept to completion specific to FMEA
  integration
• It follows the path of the CPPDM
• It provides a natural way to cascade critical
  items through the entire design FMEA process from
• Concept
• System
• Sub-System
• Component

43
Voice of the Customer/Market

• The true customers wants, needs, desires, and
  delights must be represented to assure Excitement
  Quality, i.e. Customer Satisfaction
• This is typically captured from surveys, market
  research, customer feedback, etc.
• Added to Vehicle Requirements if cost and value
  are demonstrated

44
Vehicle Requirements

• Vehicle performance and features with measures
  are listed
• Developed directly from Voice of the
  Customer/Market
• Legacy
• Engineering and styling inputs

45
Concept FMEA

• The various vehicle concepts are compared by risk
  of not meeting vehicle or system requirements
• The Concepts come directly from the Vehicle
  requirements phase

46
System Specifications

• All specifications are determined for each of the
  high level vehicle systems cascaded from the
  vehicle requirements
• The system specifications will be generated
  directly from the vehicle requirements

47
System FMEA

• To create effective Design FMEAs, the design
  must have between 50-75 design content
• The System FMEA will highlight sub-system and
  components that have the most risk, based on
  safety, regulatory, etc.
• The system specifications will provide the
  necessary functions for the System FMEA
• Part of the FMEA process is the creation of the
  boundary diagram, the p-diagram, and the
  interface matrix these ensure that robustness
  is achieved

48
Example Boundary Diagram
Engine Mounting System
Engine Lubrication System -breather
Electrical System
Evaporative Emissions System
Clearance
Grounding
Carburetor
External Shift Linkage
Calibration
Vehicle Frame System
Primary Drive System
Exhaust System Mounts (All Subsystems)
Crank Case (Big Twin)
Secondary Drive System (All Subsystems)
Starter System
Instrumentation (Speedometer Sensor)
Clearance
Rear Brake Line

• Lubrication System
• Dyna/FLT physical interface
• Buell material exchange

Engine Management System (ECM)
Ergonomics
Rider Interface (Foot Pegs)
DFMEA Boundary
Interfaces
Physical Energy Data Materials
49
Example P-Diagram
Potential Causes
Design Function (Detail)
Design Function
Design Controls
Failure Modes
50
Example Interface Matrix
51
System Verification Testing (DVPR)

• The outputs from the System FMEA will drive the
  DVPR, which are noise factors which must be
  considered in the testing strategy

52
Risk Strategy

• The Risk Strategy is generated from the System
  FMEA
• It highlights critical characteristics with
  severities of 9s and 10s and significant
  characteristics with severities from 5 to 8 with
  probabilities high enough to warrant
  consideration
• These characteristics are nominated for KPCs

53
Sub-System FMEA

• The Sub-System FMEA is similar to the System FMEA
• It may not be necessary in all instances, as the
  System FMEA may be cascaded directly to the
  Component FMEA
• Example
• System Styled surfaces
• Sub-System
• Fenders
• Tour Pack

54
Sub-System Verification Testing (DVPR)

• The outputs from the Sub-System FMEA will drive
  the DVPR and reliability studies
• Noise factors which must be considered in the
  testing strategy are potential causes of failure

55
Component Specifications

• All component specifications are cascaded from
  the System Specifications, the System FMEA, and
  the Sub-System FMEA
• The component specifications will be used to
  determine, in conjunction with the risk strategy
  from the Sub-System FMEA, which component FMEAs
  need to be completed.

56
Risk Strategy

• The Risk Strategy is generated from the
  Sub-System FMEA
• It highlights critical characteristics with
  severities of 9s and 10s and significant
  characteristics with severities from 5 to 8 with
  probabilities high enough to warrant consideration

57
Component FMEA

• The Component FMEA will highlight characteristics
  that have the most risk, based on safety,
  regulatory, etc.
• Component FMEAs are only necessary for
  components that contribute to higher level
  failure system/sub-system
• New technology
• Changed product
• Past failures
• New environment for use
• The boundary diagram, the p-diagram, and the
  interface matrix are also created for components
  similar to system/sub-systems
• The Risk Strategy, Sub-System FMEA, and Component
  Specifications dictate which components need to
  be addressed

58
Component Bench Testing (DVPR)

• The outputs from the Component FMEA will drive
  the component DVPR
• Bench tests

59
Risk Strategy

• The Risk Strategy used in the Component FMEA
  determines which characteristics need to be
  addressed
• It highlights critical characteristics with
  severities of 9s and 10s and significant
  characteristics with severities from 5 to 8 with
  probabilities high enough to warrant
  consideration
• These become KPC/KCC at manufacturing

60
Prototype Control Plan

• The characteristics that are required to be
  correct for appropriate design verification are
  listed on the prototype control plan
• The prototype control plans are used by those
  producing the prototypes

61
Design Review

• There are vehicle level design reviews which
  focus on vehicle level indicators, such as cost,
  timing, weight, etc.
• There are system level design reviews which focus
  on timing and systems level issues
• There are technical design reviews which are
  related to specifications and performance
• Action reviews from FMEAs/test results are
  addressed in design review

62
Phase I QFD
Product Specifications
Phase Progression
Systems / Sub-Systems / Components
Phase II QFD
Customer Wants (Marketing Information)
DFMEA Failure Modes
Product Specifications
System DFMEA
Sub-System DFMEA
Component DFMEA
QFD Phase Progression
63
The Completed Characteristics Matrix
Characteristics Ranked in order of Importance
Process Operation from Process Flow
Potential Significant and Critical
Characteristics from DFMEA
High/Medium Interactions are causes/failure modes
in PFMEA
Prioritized ranking of process steps relative to
risk
64
Phase III QFD
Process Operations
System DFMEA
Sub-System DFMEA
Phase IV QFD
Component DFMEA
Process Parameters / Variables
High Priority Process Operations
SCs CCs
Classification of Characteristics
Causes from DFMEAs
SCs CCs
Process Related SCs CCs From all DFMEAs
Causes on PFMEA
Failure Modes on PFMEA
Key Control Characteristics
Process FMEA
Control Plan
QFD Phase Progression
65
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

66
Training and Facilitation

• Fmea benefits certainly outweigh the obvious
  difficulty in developing them.
• To maintain efficiency, FMEA must be deployed
  with several methods of varying degrees of
  intensity.
• Methods to consider
• Computer based training
• Pin point Facilitation for Family groups.
• Database approach to legacy