DFSS BB210 Dfmea

Design for Six Sigma
Design Failure Modes & Effects Analysis

(DFMEA)
DFSS BB210 DFMEA.ppt
210-1 Revised 31-Aug-09 NS

Objectives
Provide insight to the uses of FMEA

Identification of risk sources
Define the different types of FMEA
To learn the steps in developing a Design FMEA
Practice creating an FMEA
210-2
© 2003 by Sigma Breakthrough Technologies,
DFSS Roadmap
DEFINE
DEFINE Rally
Rally Points
Points 0-1
0-1
Establish Business Needs & Priority Analyze/Minimize Product &

Process Risks
Develop Project Charter & Plan
Model & Analyze Tolerances &
Identify Target Markets & Segments
Sensitivities
Identify Customer Needs/Wants Develop/Evaluate Measurement
Establish Critical to Quality Systems
Characteristics (CTQC’s)
Initial Robust Product Design
Establish Technical Features
OPTIMIZE
OPTIMIZE Rally
Rally Points
Points 4-6
4-6
CONCEPT
CONCEPT Rally
Rally Points
Points 1-2
1-2
Minimize Product Complexity
Identify CTQC Metrics/Measures
Maximize Product Velocity
Identify Key Measurement Systems
Optimize Critical Inputs - Final
Develop Optimal Design Concept Robust Design
Develop Business Case & Schedule Optimize, Simulate Processes
Final Robust Product Design

DESIGN
DESIGN Rally
Rally Points
Points 3-4
3-4
Design System, Subsystems &

VERIFY
VERIFY Rally
Rally Points
Points 5-8
5-8
Components
Set Initial Control Systems/Plans
Design Processes
Verify Product Performance
Model & Assess Critical Parameters
Verify Process Performance
Test Plans & Reports

210-3
DFSS Linkage
Concept
Definition
Feasibility
Concept Design
Critical Parameters
Design Options
Mock-up Model
Usability Models DFMEA
Voice Of The Customer
Design Selection
Function Tree
Cost Model
QFD Concept Selection
Pugh Concept Selection
Value Proposition
210-4
DFSS Linkage
Concept
Process
DFMEA Development
Process FMEA
Key issues from DFMEA Control Plan
Critical Parameter Management Process Design
Product Permanent
Record
Development
Analysis & Simulation
Prototype Test Plan
Design Verification & Validation
Reliability Testing
210-5
Definition - FMEA
A structured approach to:

 Identifying the ways in which a product can fail
 Estimating the risk associated with each failure mode
 Rank ordering the failure modes to prioritize the design
teams efforts
 Track corrective actions and provide a permanent record for
subsequent design and process FMEAs
Primary Directive: Identify ways that a product can fail and

take action to remove the failure modes before they occur
210-6
Where do Risks Come From?
Insufficient Knowledge of
Potential Safety Environmental
Unclear Customer Hazards Requirements
Expectations
Poor Design
Cumulative Risk
Raw Material
Variation
Poor Process
Control
Poorly developed
Machine Specification Limits
Reliability Measurement
Variation (Online
and QC) D. H. Stamatis, FMEA:FMEA from Theory
to Practice, Quality Press, 1995
210-7
History
First used in the 1960’s in the Aerospace industry during

the Apollo missions
In 1974 the US Navy developed MIL-STD-1629 regarding
the use of FMEA
In the late 1970’s, automotive applications driven by liability
costs
In the 1980’s, automotive industry used FMEA’s to improve
quality and product reliability
210-8
Types of FMEA’s
System - Used to analyze failures of the end product in a customers
system
 Focuses on potential failure modes associated with the functions of
the end product
Functional - used to analyze systems and sub-systems of the product

in the early concept and design stages
 Focuses on potential failure modes associated with the functions of
each system and sub-system
Component / Material - used to analyze systems and sub-systems

down to the fundamental components and materials used in the design
 Focuses on Components and Material
Process - used to analyze manufacturing and assembly processes

 Focuses on Process Inputs
210-9
When is an FMEA Started?
Recommended DFMEA PFMEA
Timing
Concept Selection Initiate Systems and Initiate

Upper Level
Functional DFMEAs
Prototype Testing Update and extend Update
down to Component
and Material Level
Design Verification Complete Update
/Validation
Commercialization Feedback Ongoing

BB’s, GB’s, and High
Perf. Work Teams
update
210-10
How is a Design FMEA different
from a Process FMEA?
The Design FMEA assumes that the process is in control and capable of
meeting the process spreads used in the design.
 It also assumes that material, and components are performing as specified
in the design documentation.
 Failures can be caused by:
 Unclear specifications
 Inadequate knowledge of environmental conditions
 Insufficient Analysis, Modeling and Simulation
 Poor Design
 Insufficient Testing
 Not designing for process requirements
 Controls are related to the design process:
 Prevention - Analysis, Simulation and Modeling
 Detection - Prototype Testing, Design Verification Testing, Reliability Testing
The Process FMEA assumes that the design is capable and focuses on
process capability and control.
210-11
Role of Design FMEA
Key tool of the design team to improve the product in a

preemptive manner (before failures occur)
Used to prioritize resources to insure product development
efforts are beneficial to customer
Used to document completion of projects
Should be a dynamic document, continually reviewed,
amended, updated
Should serve as starting-point for future DFMEA’s of
similar products.
Is the catalyst of Process FMEA’s.
210-12
Purposes of Design FMEA
Analyzes new product designs

Identifies deficiencies in the product validation methods
Establishes the priority of actions
Evaluates the risk of product changes
Identifies potential variables to consider in DOE studies
Guides the development of new products and product
feature changes
Helps set the stage for breakthrough
210-13
FMEA Inputs and Outputs
Inputs
 Product concept design
 QFD
 Experience with related products
 Benchmarking
 Product performance requirements
Outputs
 Prioritized list of actions to prevent / minimize causes or to
detect failure modes
 History of actions taken
210-14
FMEA Team
Team approach is necessary
Responsible design engineer leads the team
Recommended representatives:
 Design Engineering
 Manufacturing Engineering
 Quality
 Reliability
 Materials
 Testing
 Key Suppliers
 Customers / Marketing
210-15
FMEA - Step by Step
1. Develop a block diagram of the Design Item / Function being
analyzed. This can be a product, system, sub-system, and or
component
2. For each Design Item / Function, determine the ways in which it can
fail (Failure Modes)
3. For each Failure Mode associated with the item, determine Effects of
the failure on the customer
 Remember the internal customers!
4. Identify potential Causes of each Failure Mode
5. List the Current Design Controls for each Cause or Failure Mode
6. Create Severity, Occurrence, and Detection rating scales
7. Assign Severity, Occurrence and Detection ratings to each Cause
8. Calculate RPN’s for each Cause
9. Determine Recommended Actions to reduce high RPN’s
10. Take appropriate actions and recalculate RPN’s
210-16
DFMEA Worksheet
Before we move to the example let’s take a closer look at the DFMEA worksheet
The information on this sheet is transferred directly to the DFMEA form
The purpose of this worksheet is to focus the team on the DFMEA inputs and not
on scoring
Note: The scoring should be done after the basic inputs have been made
Failure Mode and Effects Analysis
(Design FMEA)
S ys t e m / C o m p o n e n t : D e s ig n R e s p o n s ib ilit y:
C o re T e a m :
O D
Item /
S Potential Cause(s)/ c Current Design e R.
Process Potential Failure Potential Effect(s) Current Design
e Mechanism (s) of c Controls t P.
Mode of Failure Controls Detection
v Failure u Prevention e N.
Function
r c
DFSS BB210a DFMEA Template.xls
210-17
Item / Product Function
Should be a clear and concise description of what is

required to meet design intent
 Often associated with product test requirements
 Include any pertinent description of operating environment
 Include nomenclature as indicated on engineering drawing
 Functions should not be combined
210-18
Definition of Terms - Failure Mode
Failure Mode
 The way in which a specific product feature fails to meet the designed
intent
 If it is not detected and either corrected or removed, it will cause the Effect
to occur
 The failure mode can also be the cause of a potential failure mode in a
higher level assembly
Examples
 Surface contamination
 Wear
 Loose
 Current leakage
 Fractured joint
Methods to Brainstorm Potential Failure Modes
 Review past problem reports associated with similar products
210-19
1. Block Diagram of the system, sub-system
and/or component being analyzed
Block Diagram Examples

 A relational diagram showing all the components and their
relationships
 The flow of information, energy, force, fluid, etc.
 (Recall Function Structure from week 1)
Purpose
 To understand the deliverables (input) to the block, the process
(function) performed in the block, and the deliverables (output) from
the block.
 It also establishes the relationship of each item/function to the
overall system
210-20
2. For each Design Item / function, determine the
ways in which it can fail (Failure Modes)
List all possible failure modes. (We show one example)
Failure Modes - Effects on

Characteristic or What can go Customer
Part Function wrong? Requirements Causes Design Controls
Coil resistance Too high
210-21
Brainstorm Potential Failures - C&E Diagram
Cause & Effect Diagram for Bright Light
Measurement Materials People
Power On
Light Meter
Instructor
Low Bulb
Brightness
Room Instructions Computer Settings

Brightness
Bulb
Environment Methods Machine
210-22
Definition of Terms - Effect
Effect - impact on the item’s functionality and performance
to designed intent (as perceived by customer)
Examples
 Surface contamination: Poor adhesion
 Wear: Early corrosion
 Loosened: Intermittent rattle
 Current leakage: Premature battery failure
 Fractured joint: Mechanical failure of system
210-23
Linking Failure Modes to Effects
Failure
FailureMode
Mode11
OR Effect
Effect11
Failure
FailureMode
Mode22
Effect
Effect11
Failure
FailureMode
Mode11
Effect
Effect22
Failure
FailureMode
Mode11
AND Effect
Effect11
Failure
FailureMode
Mode22
Note
Notethat
thatthe
therelationship
relationshipbetween
betweenthe
theFailure
FailureMode
Modeand
andthe
theEffect
Effect
is
isnot
notalways
always1-to-1
1-to-1
210-24
3. For each Failure Mode associated with the item,
determine Effects of the failure on the customer
Remember the effects on higher level sub-assemblies as well
Light emitted too low at
specified current
A customer is not only the end user. Customers may include:

 Manufacturing
 Higher level assembly design groups
 Suppliers
 Field Service
210-25
Definition of Terms - Cause
Cause
 Sources of design process errors or a design weakness that
causes the Failure Mode to occur
 List every possible cause associated with each failure mode
Examples
 Surface contamination: Incompatible raw materials
 Wear: Inadequate lubrication
 Loosened: Inadequate material specified
 Current leakage: Low resistance short
 Fractured joint: Low strength welding material
210-26
4. Identify potential Causes of each Failure Mode
List all possible causes

Leave no stone unturned !!!

Coil resistance Too high Incorrect material
specified current
Incorrect number of
windings
Wrong material
composition
210-27
Definition of Terms - Current Design Controls
Current Design Controls
 Systematized methods in place to prevent or detect failure
modes or Causes (before causing effects)
 Prevention of design defect (failure mode) or reducing the
rate of occurrence
 Examples include mathematical modeling, reliability modeling,
etc.
 Detection of either cause or failure mode:
 Performance testing, lab analysis, prototyping, Alpha site
testing, etc.
Which is more important to product development,
prevention or detection?
210-28
5. List the Current Design Controls
for each Cause or Failure Mode
Remember, these are controls you CURRENTLY have in your design

process for this product

Light emitted too low at Material properties
Coil resistance Too high Incorrect material
specified current DOE
Incorrect number of Mechanical design
windings simulation
Wrong material
Material specs
composition
210-29
FMEA Model
Cause
Cause
Failure
FailureMode
Mode
(Defect)
(Defect)
Design Activity
Effect
Effect
Design Item
External customer
Controls
Controls
210-30
Prevention = Analyses, Modeling, Simulation
FMEA Model
Detection = Prototype Testing, Design Verification/
Cause
Cause Validation Testing, Reliability Testing
Detection = Production
Inspection and Test
Failure
FailureMode
Mode Detection
(Defect)
(Defect)
Design Activity = External
Effect
Effect Customer
Design Item
External customer
Controls
Controls Which is best case?
Which is worst case?
210-31
Risk Priority Number (RPN)
The output of an FMEA is the Risk Priority Number

The RPN is a calculated number based on information you provide
regarding
 the potential failure modes,
 the effects, and
 the current ability of the design process to detect the design
failures before reaching the customer
It is calculated as the product of three quantitative ratings, each one
related to the effects, causes, and controls:
RPN = Severity X Occurrence X Detection
Effects
Effects Causes
Causes Controls
Controls
210-32
Risk Priority Number
Act upon highest RPN first

The Risk Priority Number is not sacred
Scaling for Severity, Occurrence and Detection can be
locally developed
 Best Practice: establish a set of standard scales (AIAG)
Other categories can be added
 For example, one engineer added an Impact score to the RPN
calculation to estimate the overall impact of the Failure Mode on
the process
210-33
Definition of RPN Terms
Severity (of Effect)- importance of effect on customer
requirements - could also be concerned with safety and
other risks if failure occurs
 1=Not Severe, 10=Very Severe
Occurrence (of Cause)- frequency with which a given
Cause occurs and creates the Failure Mode
 1=Not Likely, 10=Very Likely
Detection (capability of Current Design Controls) - ability of
current design control scheme to detect the causes or the
effect of the failure modes (do not rate prevent, as this
would be rated under occurrence)
 1=Likely to Detect, 10=Not Likely at all to Detect
210-34
6. Create Severity, Occurrence &
Detection rating scales
We will use the AIAG FMEA scale summarized on the next

page. Each of you have been given copies of the
reference.
210-35
Example Rating Scale
Rating Severity of Effect Likelihood of Occurrence Ability to Detect
10 Hazardous without warning Can not detect

Very high:
Failure is almost inevitable
9 Hazardous with warning Very remote chance of detection
8 Loss of primary function Remote chance of detection

High:
Reduced primary function Repeated failures
7 Very low chance of detection
performance
6 Loss of secondary function Low chance of detection

Moderate:
Reduced secondary function Occasional failures
5 Moderate chance of detection
performance
Minor defect noticed by most
4 Moderately high chance of detection
customers
Minor defect noticed by some
3 High chance of detection
customers Low:
Minor defect noticed by Relatively few failures
2 Very high chance of detection
discriminating customers
1 No effect Remote: Failure is unlikely Almost certain detection
210-36
FMEA Scoring
There are a wide variety of scoring “anchors”, both

quantitative or qualitative
Two types of scales are 1-5 or 1-10
The 1-5 scale make it easier for the teams to decide on
scores quickly
The 1-10 scale allows for better precision in estimates and
a wide variation in scores
The
The1-10
1-10scale
scaleis
isgenerally
generallyconsidered
considered
to
tobe
bethe
thebest
bestoption
option
210-37
FMEA Form - Initial Assessment
S O D R
Characteristic or Characteristic or Current Design Evaluation or
Potential Failure Mode Potential Failure Effects E Potential Causes C E P
Part Part Function Control
V C T N
What is the What is the In what ways does this What is the impact to the What causes the loss of What are the tests, methods or
How often does cause
How well can you

detect cause or FM?
How Severe is the
or FM occur?
cusotmer?
effect to the
Characteristic or purpose of the characteristic lose its Customer (Internal or function? techniques to discover the cause
Part under characteristic or functionality? External)? before design release?
evaluation? part?
210-38
7. Assign Severity, Occurrence and Detection
ratings to each Cause
Use the AIAG rating system however you should attempt to make the
rating system match your business needs
Calculate the RPNs
S O D R
Characteristic or Current Design Evaluation or
Part Control
V C T N
What is the In what ways does this What is the impact to the What causes the loss of What are the tests, methods or
cusotmer?
effect to the
or FM occur?
How well can you

How Severe is the
detect cause or FM?

Characteristic or characteristic lose its Customer (Internal or function? techniques to discover the cause
Part under functionality? External)? before design release?
evaluation?

specified current
8 Incorrect material 3 Material properties DOE 5 120
8 Incorrect number of windings 2 Mechanical design simulation 2 32
8 Wrong material composition 2 Material specs 10 160
210-39
FMEA Form - Long Term History
D R S O D R
Current Design Evaluation or Actions
E P Resp. Actions Taken E C E P
Control Recommended
T N V C T N
What are the tests, methods or What are the actions Who is What are the completed
How well can you

detect cause or FM?
techniques to discover the cause for reducing the Responsible actions taken with the
before design release? occurrence of the for the recalculated RPN? Be
Cause, or improving recommended sure to include
detection? Should action? completion
have actions only on month/year
high RPN's or easy
fixes.
0 0
0 0
0 0
210-40
9. Determine Actions to reduce high RPN’s
10. Take appropriate actions & recalculate RPN’s
Assign actions to each of the RPNs which need attention.
Estimate effect on the RPN.
O D R S O D R
Current Design Evaluation or Actions
Potential Causes C E P Resp. Actions Taken E C E P
Control Recommended
C T N V C T N
What causes the loss of What are the tests, methods What are the Who is What are the
or FM occur?
How well can you

detect cause or FM?
function? or techniques to discover the actions for Responsibl completed actions

cause before design reducing the e for the taken with the
release? occurrence of the recommend recalculated RPN?
Cause, or ed action? Be sure to include
improving completion
detection? Should month/year
have actions only
on high RPN's or
Incorrect material 3 Material properties DOE 5 120 0
Incorrect number of
2 Mechanical design simulation 2 32 0
windings
Review specs and JR Fudd
Wrong material receiving
2 Material specs 10 160 0
composition procedures
210-41
Philosophical Approach
Focus on Safety Issues

Focus on high priority Design Requirements from QFD
Assume materials are perfect and design is not good
Assume design is perfect and materials are not good
210-42
Overview
S O D R
Characteristic or Characteristic or Current Design Evaluation or
Part Part Function Control
V C T N
What is the What is the In what ways does this What is the impact to the What causes the loss of What are the tests, methods or
How well can you

detect cause or FM?
How Severe is the
cusotmer?

or FM occur?
effect to the
Characteristic or purpose of the characteristic lose its Customer (Internal or function? techniques to discover the cause
Part under characteristic or functionality? External)? before design release?
evaluation? part?
What is How How How

the Bad? Often? well?0
Function?
What can 0
go wrong What is the

What are How can 0
with the Effect on

the these be
Function? the
Causes? found or
Outputs?
prevented?
210-43
End of Module
Discussion
(Exercise on following slide)
210-44
Exercise
• In teams, create a DFMEA for the
catapult launching process that you
created earlier
• How could a projectile fail to hit
the target?
Time Allotment:
30 minutes, 15 minute debrief
Save this exercise for later in the course

210-45

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Design for Six Sigma

Design Failure Modes & Effects Analysis

210-1 Revised 31-Aug-09 NS

Provide insight to the uses of FMEA

Establish Business Needs & Priority Analyze/Minimize Product &

Develop Business Case & Schedule Optimize, Simulate Processes

Final Robust Product Design

Design System, Subsystems &

Test Plans & Reports

A structured approach to:

Primary Directive: Identify ways that a product can fail and

First used in the 1960’s in the Aerospace industry during

Functional - used to analyze systems and sub-systems of the product

Component / Material - used to analyze systems and sub-systems

Process - used to analyze manufacturing and assembly processes

Concept Selection Initiate Systems and Initiate

Commercialization Feedback Ongoing

Key tool of the design team to improve the product in a

Analyzes new product designs

DFSS BB210a DFMEA Template.xls

Should be a clear and concise description of what is

Block Diagram Examples

List all possible failure modes. (We show one example)

Failure Modes - Effects on

Measurement Materials People

Room Instructions Computer Settings

Environment Methods Machine

A customer is not only the end user. Customers may include:

List all possible causes

Failure Modes - Effects on

Remember, these are controls you CURRENTLY have in your design

Failure Modes - Effects on

The output of an FMEA is the Risk Priority Number

Act upon highest RPN first

We will use the AIAG FMEA scale summarized on the next

10 Hazardous without warning Can not detect

8 Loss of primary function Remote chance of detection

6 Loss of secondary function Low chance of detection

1 No effect Remote: Failure is unlikely Almost certain detection

There are a wide variety of scoring “anchors”, both

How often does cause

How well can you

How well can you

detect cause or FM?

Light emitted too low at

8 Incorrect number of windings 2 Mechanical design simulation 2 32

8 Wrong material composition 2 Material specs 10 160

How well can you

How well can you

function? or techniques to discover the actions for Responsibl completed actions

Focus on Safety Issues

How well can you

How often does cause

What is How How How

go wrong What is the

with the Effect on

(Exercise on following slide)

Save this exercise for later in the course