Module-10

Failure Modes and Effects Analysis (FMEA)

Failure Mode and Effects Analysis Learning Objectives

• At the end of this section delegates will be able to:

• Understand the role of Failure Mode and Effects
Analysis, FMEA within the DMAIC Improvement
Process
• Conduct a Process FMEA on an existing, new or
modified transactional process
• Use the Process FMEA to prioritise areas for
attention
• Use the Process FMEA to support the generation of
Control Plans
 Failure Mode and Effects Analysis - Agenda

• Introduction to Failure Mode and Effects Analysis

• FMEA Within DMAIC
• FMEA Roadmap
• FMEA Form and Control Plans
• Implementing FMEA
• Summary
 “Classic” Failures

• City trader buys 15,000,000 shares instead of 15,000

• Leap day shuts down bank cash machines
• NASA probe lost due to Metric/Imperial units
confusion
• Worldwide Perrier stocks withdrawn due to filter
failure
• Pilot shuts down wrong aircraft engine
• Company emails confidential account information to
analysts and has to suspend trading
 Introduction to FMEA

• Failure Mode and Effects Analysis, FMEA is:

• A systematic method of identifying and investigating potential
design or process weaknesses.
• A means to evaluate and manage product risks.
• A means of evolving organizational knowledge.
• Developed in the aerospace industry in the mid 1960’s
• Also sometimes referred to as Failure Mode Effect and
Criticality Analysis, FMECA
 FMEA Purpose

• Purpose:

• Recognise and evaluate the potential failure

modes and causes associated with the design
and manufacture of a product or design and
operation of any process.
• Identify actions which could eliminate or
reduce the chance of the potential failure
occurring.
• Document the analysis and changes made.
 Application of FMEA in Six Sigma

• In Design for Six Sigma - (Design FMEA) :

• to identify potential failure modes
• to identify potential causes of failure
• to eliminate/minimise the potential failure modes within
the Design process
• In Transactional/Operational Six Sigma (Process
FMEA) :
• to analyse the existing processes (identify possible x’s)
• to improve the process (elimination/reduction of failure
modes)
• to select new process alternatives
• to develop control plans
 Six Sigma Transactional Improvement Process
Define Measure Analyse Improve Control

Select Project
Define Measures (y’s)
Develop Detailed
Brainstorm Potential
Control Critical x’s

Define Project Process Maps Improvement Strategies
10.2 Upper Control Limit
START
Select Improvement
Objective
PROCESS Strategy 10.0

Form the Team
Check Data Integrity STEPS

9.8 Lower Control Limit

DECISION Criteria A B C D 9.6

1 5 10 15 20
Time + s - +
STOP
Cost + - + s
Monitor y’s
Service - + - +

Identify Critical Etc s s - +
Process Steps (x’s)

Determine Process by looking for:

Map the Process Stability
Plan and Implement
– Process Bottlenecks y

Identify Customer
Determine Process
Pilot
Requirements Capability – Rework / Repetition
Verify Improvement
Validate Control
– Non-value Added Plan
Steps LSL USL
LSL USL
– Sources of Error /
Mistake

Map the Ideal 15 20 25 30 35
15 20 25 30 35 Process
Identify further

Identify Priorities
Implement opportunities
Set Targets for
Identify gaps

Countermeasures
Close Project

Update Project File between current and
Measures
ideal

Phase Review Phase Review Phase Review Phase Review Phase Review
 Application of PFMEA in DMAIC

• Analyse:
• To analyse the existing processes and identify
possible x’s (causes of failure)
• Improve:
• To improve the process (elimination/reduction of
failure modes)
• To select new process alternatives
• Control:
• To develop control plans
• It is only necessary to conduct PFMEA on the
modified/changed areas of the process
 1.Describe
9.Assess Process 2.Define
Results Functions

8.Take
Process FMEA 3.Identify Potential
Action Failure Modes
Roadmap

7.Calculate 4.Describe Effects

Risk of Failure
6.Current 5.Determine
Controls Causes

Greenall
Barnard
Associates 6σ
σ Force Field Analysis
 Step 1: Describe Process

1.Describe
Process

• Process Flow Diagrams

• Error & Correction Data Process
• Internal Problem Data Knowledge
• Customer Feedback
 Step 1: Describe Process- Order Fulfilment
Receive order
1.Describe
Process Check stock Order stock

All No
available? Notify Sales

Suppliers: Yes Outputs:

Sales Pull product and check Packaged Product
Stores Shipping requisition
Package product Order fulfilment note

Inputs: Weigh product

Order
Product Correct No Customers:
Packaging weight? Sales
Yes Shipping
Transfer to Goods Out End customer
 Step 2: Define Function

2.Define
Functions

List of Functions
(Purposes)

Process
Flow
Diagram
 Examples of Functions

2.Define
Functions

Action Action
Verb Noun Verb Noun
Process Information Publish Report

Check Address Approve Credit

Contact Customer Release Product

Receive Stock Gather Data

Project Sales
Deliver Order

Calculate Price Test Part

 Step 2: Define Function

2.Define
Functions

Functions
Receive order
• Receive order
Check stock Order stock
• Check sufficient stock
All No • Notify sales
available? Notify Sales
• Order stock
Yes
• Pull product
Pull product and check
• Check product
• Etc.
 Step 3: Identify Potential Failure Modes

3.Identify Potential
Failure Modes

List of Potential
Failures
Does not/Cannot
Too much
Too little
Does Not Too early
Function Too late Function
Function? Degraded
Intermittent
Incorrect
Unwanted
 Step 3: Identify Potential Failure Modes

Process Function Potential Failure Modes

• Receive Order Does not receive order
Receives incorrect order
Receives too many orders
• Check sufficient stock Does not check sufficient stock
Incorrect check (wrong conclusion)
-Insufficient stock when sufficient
-Sufficient stock when insufficient
• Notify Sales Does not notify sales
Notifies sales too late
Notifies sales with incorrect information
 Step 4: Describe Effects of Failure
Assume the failure could occur
4.Describe Effects
of Failure - what would be the effect ?
Consider :
• How it affects the process (processor):
• next operation
• subsequent downstream operations
• How it affects the end user (customer).
• Immediate & delayed impact.
• Be realistic.
Note: There may be several potential effects for each failure, but
these are listed together as one overall effect.
 Step 4: Describe Effects of Failure
Assume the failure could occur
4.Describe Effects
of Failure - what would be the effect?

Potential Failure Modes Potential Effects

• Does not Receive Order • Order not fulfilled, customer has to

• Incorrect stock check
(Concludes insufficient when
sufficient available)
• Incorrect stock check
(Concludes sufficient stock
when insufficient available)
• Notify Sales too late
re-submit order
• Delay in fulfilling order, excess
stock, possible loss of order
• Incomplete order, delay, customer
dissatisfaction
• Customer not aware of delay, sales
takes further orders
 Step 5: Determine Causes
What could cause the potential failure mode
5.Determine to occur ?
Causes

• Process / processor errors that could lead to the failure

• Be specific, “processor error” or “equipment failure”
are too vague
• Consider the working environment of the process,
condition of equipment, IT systems
• There will typically be several causes for each failure
mode
• Identify root causes for severe failures
 Step 5: Determine Causes
What could cause the potential failure mode to
5.Determine
Causes occur ?

Potential Failure Modes Potential Causes

• Does not receive order • Incorrectly addressed

• Delivered to wrong department
• Lost in post
• Incorrect stock check • Error in inventory levels
• Entered wrong part code
• Entered wrong quantity
• Multiple orders in process
 1.Describe
9.Assess Process 2.Define
Results Functions

8.Take
Process FMEA 3.Identify Potential
Action Failure Modes
Roadmap

7.Calculate 4.Describe Effects

Risk of Failure
6.Current 5.Determine
Controls Causes
Greenall
Barnard
Associates 6σ
σ Force Field Analysis
 Workshop 1:Identify Potential Failures Modes
1. For the given example, describe the process using a process flowchart. Describe
each process step in terms of its function using a verb noun combination e.g.
check stock, calculate profit , complete invoice, check form etc. (N.B. depending
on the detail of the flowchart there may be more than one function at each
step).
2. Working from the process flowchart, identify potential failure modes by adding
the key words: does not/cannot/incorrect function, too much/too little function,
too early/late function etc. Each function should have at least one failure mode.
3. For each of the failure modes identify the potential effects of the failure on the
process, processor and/or the customer. If there are several effects then group
these together as the overall effect for the failure mode. Each failure mode
should have one effect.
4. For each failure mode, identify the possible causes of the failure. Be specific,
“processor error" is too vague. There will typically be more than one cause per
failure mode.
5. Prepare a short presentation on your team's findings.
Workshop 1

Time:
 1.Describe
9.Assess Process 2.Define
Results Functions

8.Take
Process FMEA 3.Identify Potential
Action Failure Modes
Roadmap

7.Calculate 4.Describe Effects

Risk of Failure
6.Current 5.Determine
Controls Causes
Greenall
Barnard
Associates 6σ
σ Force Field Analysis
 Step 6: Current Controls

6.Current Identify the current controls to prevent / detect the

Controls
failure before it reaches the customer

In order of preference there are three types of current

controls :
1. Prevent the cause
2. Detect the cause, leading to corrective action
3. Detect the failure (defect)

These might include:

• Control Charts
• Check Sheets
• Mistake Proofing
• Training
• Information Technology
 Step 6: Current Controls
Identify the current controls to prevent / detect
6.Current
Controls the failure before it reaches the customer

Potential Potential
Failure Modes Causes Current Controls
• Incorrect stock check • Error in inventory • Stock take (annual),
levels Stock control system
• Entered wrong part • Double entry required
code
• Entered wrong quantity • Double entry required
• Multiple orders in • No controls
process
 Step 7: Calculate Risk

7.Calculate
Risk

Probability Detection Risk

Severity of X of X (Capability of = Priority
the Effect Occurrence Current Controls) Number
 Process FMEA Severity Rating
How serious is the effect ?
Sev Effect Customer Effect Processor Effect

5 Hazardous Safety compromised or non- May endanger processor or

compliance with legal issue
4 High Loss of service
3 Moderate Very dissatisfied, service
provided but much degraded
2 Low Inconvenient, service provided Some process disruption, some
but not up to expectations
1 Very Not noticed by most
minor/none customers
process equipment
Process stops, 100%
transactions incorrect
Significant process disruption,
many transactions require
correcting
transactions require reworking
Minor disruption to process
or no effect

Note : Many organisations choose to modify the descriptions to best describe their industry.
 Process FMEA Occurrence Rating
How likely is the cause ?
Occ Probability Likely failure rates

5 Very high, persistent failures ≥1 in 10 transactions (opportunities)

4 High, frequent failures 1 in 100 transactions (opportunities)

3 Moderate, occasional failures 1 in 1,000 transactions (opportunities)

2 Low, relatively few failures 1 in 10,000 transactions (opportunities)

1 Remote, failure is unlikely ≤1 in 100,000 transactions (opportunities)

Note : Many organisations choose to modify the descriptions to best describe their industry.
 Process FMEA Detection Rating

How effective are the Current Controls?

Det Criteria Typical Detection/Control Method Type

5 No Controls Cannot detect or is not checked ?

4 Controls detect failure Inspection, checking 3

3 Controls detect cause Control charts (focused on outputs) 3/2

2 Controls prevent failure Control charts (focused on inputs) 2/1

1 Controls prevent cause Mistake Proofing, training 1

 Step 7: Calculate Risk

7.Calculate
Risk
Failure Mode
Incorrect Stock Check
Effect
• Incomplete order, delay, customer Severity = 3
dissatisfaction
Cause
• Multiple orders in process Occurrence = 3

Current Controls
• No Controls Detection = 5

RPN = 3 x 3 x 5 = 45
 Step 8: Take Action

8.Take
Action Corrective Action Effects On RPN Rating

Corrective Action Severity Occurrence Detection

1. Process change Maybe Yes Yes
2. Improve Current Control No Maybe Yes
3. Improve Employee training No Yes Yes
4. Mistake proofing No Yes Yes
5. Increased inspection No No Maybe

Note : Do not modify RPN until corrective action is completed (Step 9)

 Step 8: Take Action

8.Take
Action
Failure Mode
Incorrect Stock Check
Effect
• Incomplete order, delay, customer Severity = 3
dissatisfaction
Cause
• Multiple orders in process Occurrence = 3

Current Controls
• No Controls Detection = 5
RPN = 3 x 3 x 5 = 45 Stock is temporarily reserved
against enquiry
 Step 9: Assess Results

9.Assess Review corrective actions and modify

Results
RPN figure based on results.
Before Improvement

Reduced
Risk
RPN

After Improvement
 Step 9: Assess Results

8.Take
Action
Failure Mode
Incorrect Stock Check
Effect
• Incomplete order, delay, customer Severity = 3
dissatisfaction
Cause
• Multiple orders in process Occurrence = 3

Current Controls
No Controls Detection = x
52
RPN = 3 x 3 x 2 = 18 Stock is temporarily reserved
against enquiry
 1.Describe
9.Assess Process 2.Define
Results Functions

8.Take
Process FMEA 3.Identify Potential
Action Failure Modes
Roadmap

7.Calculate 4.Describe Effects

Risk of Failure
6.Current 5.Determine
Controls Causes

Greenall
Barnard
Associates 6σ
σ Force Field Analysis
 FMEA Purpose

• Purpose:
• Recognise and evaluate the potential failure
modes and causes associated with the design and
manufacture of a product or any process.
• Identify actions which could eliminate or reduce
the chance of the potential failure occurring.
• Document the analysis and changes made.
 FMEA Form
FAILURE MODE & EFFECTS ANALYSIS – PROCESS FMEA

Product: PROCESS FMEA No. Page : of

Application: Issue No. Originators:
Customer: Date:

ITEM PROCESS POTENTIAL POTENTIAL POTENTIAL CURRENT RECOMMENDED RESP. ACTION RESULTS
FUNCTION FAILURE MODE EFFECTS OF SEV CAUSE(S) OF FAILURE OCC CONTROLS DET RPN ACTIONS FOR ACTIONS SEV OCC DET RPN
FAILURE ACTION TAKEN
3 Checks Incorrect Incomplete 3 Multiple orders in process 3 No controls 5 45 Stock reserved SCB 18.08.03 3 3 2 18
sufficient stock Stock Check order, against enquiry
(Concludes delay,
sufficient customer
stock when dissatisfacti
insufficient on
available)
 FMEA Form

ITEM PROCESS POTENTIAL POTENTIAL POTENTIAL

FUNCTION FAILURE MODE EFFECTS OF SEV CAUSE(S) OF FAILURE OCC
FAILURE
3 Checks Incorrect Incomplete 3 Multiple orders in process 3
sufficient stock Stock Check order,
(Concludes delay,
sufficient customer
stock when dissatisfacti
insufficient on
available)
Expand detail in
Control Plan

CURRENT RECOMMENDED RESP. ACTION RESULTS

CONTROLS DET RPN ACTIONS FOR ACTIONS SEV OCC DET RPN
ACTION TAKEN
No controls 5 45 Stock reserved SCB 18.08.03 3 3 2 18
against enquiry
 Control Plan

• Detail of the Current Controls are held in an

additional form – the Control Plan
• Control Plan (and Current Controls) may need to
change based on recommended actions
• The effectiveness of the Control Plan is tested during
the Control phase of DMAIC
• All Critical x’s should be included in the Control
Plan
 Workshop 2: Risk Assessment
1. Transfer the failure modes, effects and causes identified in workshop 1 to the large
FMEA form.
2. Using the Severity rating scale, rate each of the failure mode effects and record the
number in the appropriate column. Where there are several possible effects for a
failure mode, take the worst case for the rating. There should be only one severity
rating for each failure mode.
3. Using the Occurrence rating scale and your team's expertise, rate each of the
potential causes of failure and record the numbers in the appropriate column.
4. For the purpose of the exercise, assume there are no Current Controls (Detection
rating = 5), calculate the Risk Priority Numbers (RPN) and record on the chart.
There should be one RPN score for each cause listed on the FMEA form.
5. For the top five RPN's, identify possible actions to reduce the RPN scores. Identify
which of the categories (Severity, Occurrence, and Detection) would be reduced
once the action has been completed.
Workshop 2
6. Prepare a short presentation to summarise your team's findings.
Time
Implementing FMEA
 Who Should Do FMEA ?

• Team – not an individual

• Cross functional – opportunity to improve
communication and understanding
• Include the processors (people who work in the process)
• Consider including the customer where appropriate
 10 Keys To FMEA Success

• Support by top & middle management

• Motivated team members
• Cross functional representation on the team
• Treat as “before the event” not “after the fact”
• Generate company specific rating scales
• Treat as a living document-reflect latest revisions
• Execute recommended actions
• Integration into your development process
• Generate & use a library of generic FMEA’s
• Follow the spirit, not the form
 Common Mistakes

• Applied too late

• Poor team working, wrong team members or no
team
• Over dependence upon the numbers
• Inconsistency in numbers
• Solving all problems in meetings
 When Do You Start PFMEA ?

• Within Six Sigma DMAIC:

• If there is a Process FMEA available this should be
reviewed during the Measure/Analyse phases. If there is
no FMEA then consider completing one for the part of the
process of interest.
• During the Improve/Control phases a PFMEA should be
updated/completed for the areas of the process that have
changed.
Improving Organisational Capability

Specific Specific
FMEA FMEA

General
FMEA

Knowledge
Base

Design
Check-list
Failure Mode and Effects Analysis Summary
Failure Mode and Effects Analysis Summary

• Process Failure Mode and Effects Analysis,

PFMEA, can be applied within the DMAIC
Improvement Process
• A Process FMEA can be conducted on an existing,
new or modified process
• The Process FMEA prioritises areas for attention
• The Process FMEA can be used to support the
generation of Control Plans
 Application of PFMEA in DMAIC
•Analyse:
• To analyse the existing processes and identify possible x’s
(causes of failure)
•Improve:
• To improve the process (elimination/reduction of failure
modes)
• To select new process alternatives
•Control
• To develop control plans
•It is only necessary to conduct PFMEA on the
modified/changed areas of the process
 Six Sigma Transactional Improvement Process
Define Measure Analyse Improve Control

Select Project
Define Measures (y’s)
Develop Detailed
Brainstorm Potential
Control Critical x’s

Define Project Process Maps Improvement Strategies
10.2 Upper Control Limit
START
Select Improvement
Objective
PROCESS Strategy 10.0

Form the Team
Check Data Integrity STEPS

9.8 Lower Control Limit

DECISION Criteria A B C D 9.6

1 5 10 15 20
Time + s - +
STOP
Cost + - + s
Monitor y’s
Service - + - +

Identify Critical Etc s s - +
Process Steps (x’s)

Determine Process by looking for:

Map the Process Stability
Plan and Implement
– Process Bottlenecks y

Identify Customer
Determine Process
Pilot
Requirements Capability – Rework / Repetition
Verify Improvement
Validate Control
– Non-value Added Plan
Steps LSL USL
LSL USL
– Sources of Error /
Mistake

Map the Ideal 15 20 25 30 35
15 20 25 30 35 Process
Identify further

Identify Priorities
Implement opportunities
Set Targets for
Identify gaps

Countermeasures
Close Project

Update Project File between current and
Measures
ideal

Phase Review Phase Review Phase Review Phase Review Phase Review
 FMEA References

• References:
• AIAG QS9000 - Potential Failure Mode and Effects Analysis
• 3rd Edition July 2001 , Automotive Industry
• SAE J 1739: Potential Failure Mode and Effects Analysis in
Design and Potential Failure Mode and Effects Analysis in
Manufacturing and Assembly Processes Reference Manual
• Mil Standard - 1629 , Military, aerospace applications
• Failure Mode and Effect Analysis, Stamatis, D. H. (2003),
ISBN: 0-87389-598-3, ASQ Quality Press, Milwaukee, WI