Failure Mode and

Effect Analysis
Objective:
• The Breakthrough Strategy
• Warm-up exercise
• Description & definitions
• FMEA basics
• The form
• The method
• Step-by-step example
• Next steps
• Exercise
• Approaches to FMEAs
The Breakthrough Strategy
Step I: Process Measurement

Plan project and identify key

Step III: Process Improvement
process input / output variables

Perform gage studies essential

measurement systems Verify critical inputs using DOE

Perform short-term capability Determine the optimum operating

studies and evaluate control plan window

Update the control plan

Step II: Process Analysis
Step IV: Process Control
Complete FMEA and evaluate
control plan
Finalize the process control plan
Complete Multi-vari studies and
identify potential key inputs Ongoing verification of the
Review data and stability and capability of the
prioritize key input variables process
Measurement Phase
• Project Definition:
– Problem Description (Authorize.ppt)
– Project Metrics (Metrics.xls)
• Process Exploration:
– Process Flow Diagram
– C&E Matrix, PFMEA, Fishbones
– Data collection system
• Measurement System(s) Analysis (MSA):
– Attribute / Variable Gage Studies
• Capability Assessment (on each Y)
– Capability (Cpk, Ppk, s Level, DPU, RTY)
• Graphical & Statistical Tools
• Project Summary
– Conclusion(s)
– Issues and barriers
– Next steps
• Completed “Local Project Review”
Where Does Risk Come From?
Potential
Poor control
Safety
Unclear Customer plans & SOP’s
Hazards
Expectations Poor Process
Capability

Cumulative Risk
Raw Material
Vague Variation
Workmanship
Standards
Poorly developed
Machine Specification
Reliability Measurement
Limits
Variation (Online
and QC)

D. H. Stamatis, FMEA:FMEA from Theory to Practice, Quality Press, 1995

History of FMEA

• First used in the 1960’s in the Aerospace

industry during the Apollo missions
• In 1974 the Navy developed MIL-STD-1629
regarding the use of FMEA
• In the early to mid 1970’s, automotive
applications driven by liability costs
Definition - FMEA

• A structured approach to:

– identifying the ways in which a product or process can fail
– estimating the risk associated with specific causes
– prioritizing the actions that should be taken to reduce the risk
– evaluating the design validation plan (Product) or the current
control plan (Process)
• Primary Directive: Identify ways the product or process
can fail and eliminate or reduce the risk of failure
• In short… a process FMEA will:
– ultimately capture the entire process
– identify ways the product or process failed because of these X's
– and facilitates the documentation of a plan to prevent those
failures
Role of Process FMEA
• Key tool for the process team to improve the process in a
preemptive manner (before failures occur)
• Used to prioritize resources to insure process improvement
efforts are beneficial to customer
• Used to document completion of projects
• Should be a dynamic document, continually reviewed,
amended, updated
• Used to analyzes new manufacturing processes
• Used to identifies deficiencies in the Process Control Plan
• Can establish and prioritize actions
• Evaluates the risk of process changes
• Identifies potential variables to consider in Multi-vari and DOE
studies
• Guides the development of new manufacturing processes
• Helps set the stage for breakthrough
Type of FMEA’s
• System
– used to analyze systems and sub-systems in the early concept
and design stages. Focuses on potential failure modes
associated with the functions of a system caused by the design.
• Design
– used to analyze product designs before they are released to
production. A DFMEA should always be completed well in
advance of a prototype build. Focuses on product function.
• Process
– used to analyze manufacturing, assembly, or any other
processes. Focuses on process inputs.
• Project:
– documents and addresses failures that could happen during a
major program.
• Software:
– documents and addresses failure modes associated with
software functions.
FMEA Inputs and Outputs

• Inputs
– Process map
– C&E matrix
– Process history
– Process technical procedures
• Outputs
– List of actions to prevent causes or to detect
failure modes
– History of actions taken and future activity
Terminology
• Failure Mode :
– a description of a “non-conformance” at a particular process step (also know as a
shop floor defect).
• Failure Effect :
– the effect a particular failure mode will have on the customer (attempt to quantified
with respect to Y's).
• Severity (of failure effect, scale of 1 to 10) :
– an assessment of the seriousness of the failure effect on the customer. The
customer can be the end customer and / or the next process operation.
• Failure Cause :
– something which can be corrected or controlled (X) that describes “how the failure
mode could have occurred”.
• Occurrence (of failure cause, scale of 1 - 10) :
– an assessment of the frequency with which the failure cause occurs. “How often
does this X fail in a specific way”?
• Detection (of failure cause or failure mode, scale of 1 - 10) :
– an assessment of the likelihood (or probability) that your current controls will
detect 1) when the X fails or 2) when the failure mode occurs.
• Risk Priority Number :
– = Severity X Occurrence X Detection.
– used to prioritize recommended actions. Special consideration should be given to
high Severity ratings even if Occurrence and Detection are low.
Definition of Terms - Failure Mode
• Failure Mode
– the way in which a specific process input fails - if not detected and
either corrected or removed, will cause Effect to occur.
• Can be associated with a defect (in discrete manufacturing) or a process
input variable that goes outside of specification.
– Anything that an operator can see that’s wrong is considered a
Failure Mode.
• Continuous Process Examples
– Processing time too long
– Customer waiting time too long
– Temperature too high
• Discrete
– Pits
– Internal Contamination
Definition of Terms - Effect

• Effect
– impact on customer requirements. Generally external customer
focus, but can also include downstream processes.
• Continuous Process Failure Mode/Effect Examples:
– Temperature too high: Melt Viscosity Variable
– Customer waiting time too long: Reduce customer satisfaction
– Application processing time too long: Reduce future customer
• Discrete Process Failure Mode/Effect
– Pits: Internal opens on printed circuit
– Internal Contamination: Short between layers in a multi-layer printed
circuit board
Definition of Terms - Cause
• Cause
– Sources of process variation that causes the Failure
Mode to occur. Identification of Causes should start with
Failure Modes associated with the highest severity
ratings.
• Continuous Process Failure Mode/Cause Examples:
– Temperature Too High: Thermocouple out of calibration
– Customer waiting too long : Less counter being opened
– Application processing time too long: Too many
approval needed
• Discrete Process Failure Mode/Cause Examples
– Pits: High particle count in clean room
– Internal Contamination: Flaking paint
Definition of Terms - Current
Controls
• Current Controls
– systematized methods/devices in place to prevent or detect failure modes
or Causes (before causing effects).
– Prevention consists of fool proofing, automated control and set-up
verifications
– Controls consists of audits, checklists, Inspection, laboratory testing,
training, SOP’s, preventive maintenance, etc.
• Which is more important to process improvement, prevention or detection?
• Continuous Process Cause/Current Controls Examples
– Thermocouple out of calibration: Calibration schedule
– Dowtherm temp too high: Computer Control of primary Dowtherm supply
– Faulty inverter: Inverter infra-red inspection schedule and sign-off
• Discrete Process Cause/Current Controls
– High particle count in clean room: Spc on particle count
– Flaking paint: Evaluation of paint samples to determine source of flakes.
 Overview

What is How
S O How can How
D R
Process
Potential Failure Mode
the Effect
Potential Failure Effects E Bad?Potential Causes C Current Controls E P
Actions
Step/Input
What What V C this be well?
T N
Recommended

on the found?
is the can go Outputs?
Input wrong 0 What are 0 0 0 What can
with the the How be done?
Input? 0
Causes?
0
Often? 0 0

0 0 0 0

0 0 0 0

0 0 0 0
FMEA Model
Cause
Cause

Failure
FailureMode
Mode
(Defect)
(Defect)
Material or process
input Effect
Effect

Process Step

External customer
Controls
Controls or downstream
process step
FMEA Model
Prevention
Detection
Cause
Cause Which is best case?
Which is worst case?

Detection
Failure
FailureMode
Mode
(Defect) Detection
(Defect)
Material or process
input Effect
Effect

Process Step

External customer
or downstream
Controls
Controls process step
Linking Failure Modes to Effects
Failure Mode 1 Effect 1
Failure Mode 2 Effect 2

Effect 1
Failure Mode 1
Effect 2

Failure Mode 1
Effect 1
Failure Mode 2

Note that the relationship between the Failure Mode and the Effect is not
always 1-to-1
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 process to detect the 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
Risk Priority Number
• Risk Priority Number is not sacred
• Scaling for Severity, Occurrence and Detection can be locally developed.
• Other categories can be added. For example, one Black Belt added an Impact
score to the RPN calculation to estimate the overall impact of the Failure
Mode on the process.
• 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 Failure Mode.
Can sometimes refer to the frequency of a Failure Mode (1=Not Likely,
10=Very Likely)
• Detection (capability of Current Controls)
– ability of current control scheme to detect or prevent:
– the causes before creating failure mode
– the failure modes before causing effect
– 1=Likely to Detect, 10=Not Likely at all to Detect
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

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
• The 1-10 scale allows for better precision in
estimates and a wide variation in scores.
• The 1-10 scale is generally considered to be the
best option.
FMEA Model
Because the Detection score is a little difficult to understand, we will do
a quick exercise. Give a Detection score for each of the boxes below:

Prevention
Cause
Detection
Cause

Detection
Failure
FailureMode
Mode
(Defect) Detection
(Defect)
Material or process
input Effect
Effect

Process Step

External customer
or downstream
Controls
Controls process step
Answer
Det = 1
Det = 3
Prevention
Detection
Cause
Cause
Det = 7
Detection
Det = 10
Failure Mode
Failure Mode
(Defect)
Detection
Material or process (Defect)
input Effect
Effect

Process Step

Controls External customer or

Controls downstream process
step
Quiz!
Take 5 minutes to fill in the results (internal and external) and
what action should be taken. Take another 10 minutes with your
group to discuss. Be prepared to present results.

Occ Sev Det Result Actions

1 1 1
1 1 10
1 10 1
1 10 10
10 1 1
10 1 10
10 10 1
10 10 10
Dynamics of the RPN
Occ Sev Det Result Actions
1 1 1 Ideal Situation No Action
1 1 10 Assured Mastery No Action
1 10 1 Failure does not reach user No Action
1 10 10 Failure reaches user Yes
10 1 1 Freq. fails, detectable, costly Yes
10 1 10 Freq. fails, reaches user Yes
10 10 1 Freq. fails w/major impact Yes
10 10 10 Big Trouble! Yes!

Which ratings are most affected by design? By manufacturing?

 FMEA Form - Initial Assessment

S O D R
Process Actions
Potential Failure Mode Potential Failure Effects E Potential Causes C Current Controls E P
Step/Input Recommended
V C T N

What is the In what ways does the Key What is the impact on the Key What causes the Key Input to What are the existing controls and What are the actions

or FM occur?
cusotmer?
effect to the

detect cause or FM?

How Severe is the

How well can you

How often does cause
process step/ Input go wrong? Output Variables (Customer go wrong? procedures (inspection and test) for reducing the
Input under Requirements) or internal that prevent eith the cause or the occurrance of the
investigation? requirements? Failure Mode? Should include an Cause, or improving
SOP number. detection? Should
have actions only on
high RPN's or easy
fixes.

0
FMEA Form - Long Term History

D R S O D R
Actions
Current Controls E P Resp. Actions Taken E C E P
Recommended
T N V C T N

How well can you

What are the existing controls and What are the actions Whose What are the completed

detect cause or FM?

procedures (inspection and test) for reducing the Responsible actions taken with the
that prevent eith the cause or the occurrance of the for the recalculated RPN? Be
Failure Mode? Should include an Cause, or improving recommended sure to include
SOP number. detection? Should action? completion month/year
have actions only on
high RPN's or easy
fixes.

0 0

0 0

0 0

0 0
Methodology

• Make sure to address safety issues.

• Assume incoming material is perfect and process is not.
• Assume process is perfect and incoming material is not.
• Two major approaches:
– Starting with the Cause & Effect Matrix
– Starting with FMEA directly from the Process Map
• We will explain the approach using the C&E matrix, though
both approaches are very similar
• Spreadsheet tools have been prepared to assist you in the
preparation of the FMEA
Starting with C&E Matrix

• Advantage
– The Cause & Effect Matrix assists the team in defining the important
issues that the FMEA should address by helping to prioritize
• Important customer requirements
– Process inputs that could potentially impact these requirements
– Prioritizing the Key Process Inputs according to their impact on the
Output variables (We want to focus on Inputs that highly impact a
large number of Outputs first)
– The C&E Matrix also provides quantitative output that can be used in
the determination of the specific severity ratings for the next stage of
the FMEA process.
FMEA - Step by Step

• 1. For each Process Input, determine the ways in which the input can go
wrong (These are Failure Modes)
• 2. For each Failure Mode associated with the inputs, determine Effects:
• 3. Identify potential Causes of each Failure Mode
• 4. List the Current Controls for each Cause
• 5. Assign Severity, Occurrence and Detection ratings to each Cause
• 6. Calculate RPN
• 7. Determine Recommended Actions to reduce High RPN’s
• 8. Take appropriate Actions and Document
• 9. Recalculate RPN’s
C&E Matrix Example

Consider a project: Reduce telecommunication bills

Measure phase
Process mapping - Initials
Work Flow of making a Phone Call

STD
rate that
third
party not
User making out able to Malaysia Telecom
going call PABX system (X) provide service (X)
(C)

Yes
Is that internal No Third party service
No Cos Local calls?
Yes Call? device (X & C)

No
(X) - Critical
IP zone
(N) - Noise
Special
(C) - Controllable rate
provided
by thrid
party
Process mapping
KIPV Process step KPOV
User attitude Telephone bills
User access policy
Phone type
Call procedures
Caller location
User eligibity User making calls
Time of call
Call type
Personal handphone claim
Call method

Time of call Provider type

Line rates
System configuration PABX system

Line rates Telephone bills

Network coverage Rebate rate
Network configuration Customer support
Time of call
IP Zone
Network speed
Customer service

Tariff specification Telephone bills

Time of call Rebate rate
Network speed Customer support
Line coverage TELEKOM
Contract
Customer service
Cause and Effect Diagram

Cause and Effect Diagran

Measurements Materials Personnel

Caller attitude
Line rates
User eligibility
Phone type
Personal handphone c
Tariff specification
Customer service

High cost of telephone bills

Contract Network speed

Call type
Network configuratio
Time of call Call procedures
Network coverage
User access policy

Call method System configuration

Environment Methods Machines

 Cause and Effect Matrix
Cause and Effect
Matrix
Rating of Importance to
10 8 10 10
Customer

Telephone bills

Provider type
1 2 3 4 5 6 7 8

Rebate rate

Customer

support
Total

Process Step Process Input

1 User making calls User eligibity 9 9 9 9 342

2 User making calls Call procedures 9 9 9 7 322
3 User making calls User access policy 9 7 9 7 306
4 User making calls Time of call 7 7 9 9 306
5 User making calls User attitude 9 9 9 5 302
6 User making calls Phone type 9 9 7 7 302
20 IP Zone Line rates 9 9 9 5 302
8 User making callsPersonal handphone claim 9 5 9 7 290
9 IP Zone Customer service 9 5 7 9 290
7 IP Zone Network speed 9 5 5 9 270
10 User making calls Call type 9 5 5 9 270
11 PABX system Time of call 9 5 9 5 270
12 IP Zone Time of call 9 5 9 5 270
13 TELEKOM Tariff specification 9 5 5 9 270
14 TELEKOM Time of call 9 5 9 5 270
15 TELEKOM Network speed 9 5 5 9 270
16 TELEKOM Line coverage 9 5 5 9 270
17 IP Zone Network configuration 9 9 5 5 262
18 User making calls Call method 9 5 5 5 230

KPIV`s with score > 290 points is being carried forward to FMEA analysis next…
19
21
PABX system
IP Zone
Line rates
Network coverage
9
9
5
5
5
5
5
5
230
230
22 PABX system System configuration 7 7 5 5 226
23 TELEKOM Contract 5 9 5 5 222
24 User making calls Caller location 7 5 5 5 210
25 TELEKOM Customer service 5 5 5 5 190
FMEA Worksheet
Before we move to the example let’s look at an FMEA worksheet.
The information on this sheet is transferred directly to the FMEA form.
The purpose of this worksheet is to focus the team on the FMEA inputs
and not on scoring. The scoring should be done after the basic inputs
have been made.

Failure Modes -
Process What can go
Step Key Process Input wrong? Effects Causes Current Controls
Step 1)
1. For each critical (high value) Process Input,
determine the ways in which the input can go wrong
(These are Failure Modes)
S O D R
Potential Failure
Key Process Input Potential Failure Mode E Potential Causes C Current Controls E P
Effects
V C T N

Abuse of making calls (un-

User access policy
authorized user making calls)

Time of call Making calls at peak hours

User attitude User making unnecessary calls

Step 2)
2. For each Failure Mode associated with the
inputs, determine Effects
These effects are internal requirements for the
next process as well as customer effects.
S O D R
Potential Failure
Key Process Input Potential Failure Mode E Potential Causes C Current Controls E P
Effects
V C T N

Abuse of making calls (un- High cost of

User access policy
authorized user making calls) telephone bills

High cost of
Time of call Making calls at peak hours
telephone bills

High cost of
User attitude User making unnecessary calls
telephone bills
Step 3)
3. Identify potential Causes of each Failure Mode
In most cases, there will be more than one Cause for a
Failure Mode. We’ll keep it simple for this exercise.
S O D R
Potential Failure
Key Process Input Potential Failure Mode E Potential Causes C Current Controls E P
Effects
V C T N

Abuse of making calls (un- High cost of FSA does not have proper
User access policy 10
authorized user making calls) telephone bills policy for phone calls

High cost of Less awareness on calling

Time of call Making calls at peak hours 10
telephone bills procedures

High cost of
User attitude User making unnecessary calls 10 User attitude problem
telephone bills
Step 4)
4. List the Current Controls for each Cause
For each Cause we list how we are either preventing or detecting it. We
would like to place a procedure number wherever we have an SOP.
S O D R
Potential Failure
Key Process Input Potential Failure Mode E Potential Causes C Current Controls E P
Effects
V C T N

Abuse of making calls (un- High cost of FSA does not have proper
User access policy None
authorized user making calls) telephone bills policy for phone calls

High cost of Less awareness on calling

Time of call Making calls at peak hours None
telephone bills procedures

High cost of
User attitude User making unnecessary calls User attitude problem None
telephone bills

This is how the FMEA identifies initial holes in the Current Control
Plan. Process teams can start working on these holes right away.
Step 5)
5. Assign Severity, Occurrence and Detection ratings to
each Cause
We are now ready to assign appropriate criteria. The team
then starts scoring each cause to compute an RPN number.
S O D R
Potential Failure
Key Process Input Potential Failure Mode E Potential Causes C Current Controls E P
Effects
V C T N

Abuse of making calls (un- High cost of FSA does not have proper
User access policy 10 8 None 10 800
authorized user making calls) telephone bills policy for phone calls

High cost of Less awareness on calling

Time of call Making calls at peak hours 10 8 None 10 800
telephone bills procedures

High cost of
User attitude User making unnecessary calls 10 User attitude problem 8 None 10 800
telephone bills
 Approaches to FMEA’s
• Approach One (C&E Matrix Focus)
– Start with Key Inputs with the highest scores from the C&E Matrix analysis
– Fill out the FMEA worksheet for those Inputs
– Calculate RPN’s and develop recommended actions for the highest RPN’s
– Complete the Process FMEA for other Inputs over time
• Approach Two (Customer Focused):
– Fill out the Failure Mode and Effects columns of the worksheet. Copy to FMEA form
and rate Severity.
– For High Severity Ratings, List Causes and rate Occurrence for each Cause
– For the highest Severity * Occurrence Ratings, evaluate Current Controls
– For Highest RPN’s develop recommended actions
• Approach Three (Comprehensive)
– Good approach for small processes
– Fill out the FMEA worksheet beginning with the first process step and ending with the
last
– Score SEV, OCC and DET for all causes
– Develop recommended actions for highest RPN’s
• Approach Four (Super Focused)
– Pick the top Pareto defect item (Fiber Breakouts) or Failure Mode (Variability in
Temperature)
– Focus the FMEA process on only that defect or Failure Mode
– Purpose: To “Kill” that Failure Mode
The End

Next Topic…

MSA Variable