FMEA – Failure Mode and Effect

Analysis
Analyze

Risk Analysis:
Where Does Risk Come From?

Potential Poor Control

Unclear Customer Safety Plans and SOPs
Expectations Hazards
Poor Process
Capability
Cumulative
Vague Risk
Raw Material
Workmanship
Variation
Standards
Poorly Developed
Machine Measurement Specification
Reliability Variation Limits
(On-line and QC)

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

2
Risk Analysis Tools
• Risks/Benefits Analysis
• Force Field Analysis
• Brainstorm/Affinity Diagram
• Cause & Effect/Fishbone Diagram
• Failure Modes and Effects Analysis (FMEA)

Industrial Chemicals | L6S 3

FMEA: the purpose of an FMEA

Failure Modes and Effect Analysis (FMEA) is particularly useful for:
Looking into the future and brainstorming what can go wrong, what the
mode of failure will be and how it will effect the customer. Three criteria
are used:
• Severity, how serious the problem will be.
• Occurrence, how likely it is to occur.
• Detection, how easily the controls will detect or prevent the failure.
By using this approach we can identify problems and then:
• Design problems out of the product or process.
• Reduce the likelihood of their occurrence.
• Improve our ability to detect and prevent problems reaching our customers.

Lean Six Sigma | Brown Belt Training 4

FMEA: the purpose of an FMEA
Objective: Find out which sub-process pose the most threat to customer
requirements. This is an important process for the project.

Severity of failure

RPN
Risk Priority
Number
Likelihood Likelihood
of detection of occurrence

Lean Six Sigma | Brown Belt Training 5

FMEA: the purpose of an FMEA

FMEA’s can be used:
• For evaluating new designs/processes or improving old ones.
• For both transactional and manufacturing projects/processes.
• Where little or no data exists.
• For eliminating errors made by people (Error Mode Effects Analysis).
• In situations where problems are sporadic.
• In situations where our goal is zero defects.

Lean Six Sigma | Brown Belt Training 6

FMEA: keys to successful FMEA‘s
• Ensure your team contains a cross section of people with process knowledge
(the process experts).
• Ensure the team understand the purpose of the exercise and why they are
there.
• Conduct some basic training for the group prior to carrying out the exercise.
• Ensure detailed fishbone diagrams, process maps and CSM’s have been
generated prior to its use.
• Keep the FMEA up to date along with fishbone diagrams, process maps and
CSM’s.
• Where possible use data to help you make your decisions.

Lean Six Sigma | Brown Belt Training 7

FMEA: the FMEA steps

Who with Process Steps
Customer 1. Identify the Defect, CTx , process steps, inputs, improvement items or
or Possible Causes etc.. (FMEA can be used in many different situations)
Process 2. Identify team members to perform FMEA (you might want to first do a first pass
Sponsor version)
3. Identify:
• Demands on the product/process
Total Failure – Does Not ……
• Potential failure mode Partial Failure – Sometimes does not….
• Potential effect(s) of failure Degraded - Works but has flaws (eg
• Potential cause(s) of failure squeeky)
4. Determine the risk for every possible cause:
Process
• Severity of effect
Experts
• Likelihood of detection
• Probability of occurrence
5. Calculate the Risk Priority Number,
RPN = Severity x Detection x Occurrence
6. The highest RPN determines the area for improvement
7. The project is the reduction of the probability of failure

Lean Six Sigma | Brown Belt Training 8

 FMEA: the FMEA worksheet
Process/Product
Failure Modes and Effects Analysis
(FMEA)
Process or Product
Prepared by: Page ____ of ____
Name:
Responsible: Blackbelt/Greenbelt FMEA Date (Orig) _______ (Rev) _____

S O D R Actions S O D R
Process Potential Potential Potential Current
E C E P Recommende Resp. Actions Taken E C E P
Step/Input Failure Mode Failure Effects Causes Controls
V C T N d V C T N
What is the process In what ways does What is the impact What causes the What are the What are the What are the

Can you detect the

How Severe is the
effect to customer

cause or Failure ?
step and Input the Key Input go on the Key Output Key Input to go existing controls actions for reducing completed actions

How often does it

under wrong? Variables wrong? and procedures the occurrence of taken with the
investigation? (Customer (inspection and the Cause, or recalculated RPN?
Requirements)? test) that prevent improving

occur?
either the cause or detection?
the Failure Mode?

0 0

0 0

0 0

0 0

0 0

0 0

Lean Six Sigma | Brown Belt Training 9

FMEA: how to complete an FMEA

• Use a large white board or piece of paper with an FMEA chart drawn on it.
Alternatively use a computer projector and fill in the Excel spreadsheet live.
• Agree the specific area of study with your team (product or process).
• If a specific process or process step, have your process map available. Ideally
conduct the FMEA in the area the process takes place.
• If looking at a product, have the component parts and subassemblies available
as this will help during the FMEA generation.

Lean Six Sigma | Brown Belt Training 10

 FMEA: how to complete an FMEA
Process/Product
Failure Modes and Effects Analysis
1) FMEA Information
(FMEA) Important that this is
Process or Product
Name:
Prepared by: Page ____ of ____ kept up-to-date.
Responsible: Blackbelt/Greenbelt FMEA Date (Orig) _______ (Rev) _____

S O D R Actions S O D R
Process Potential Potential Potential Current
Step/Input Failure Mode Failure Effects
E
Causes
C
Controls
5) SEVResp. Actions Taken E C
E P Recommende E P
V C T N d V C T N
Severity Weighting of the
What is the process In what ways does What is the impact What causes the What are the What are the What are the
impact on the process

Can you detect the

How Severe is the
effect to customer

cause or Failure ?
step and Input the Key Input go on the Key Output Key Input to go existing controls actions for reducing completed actions

How often does it

under
investigation?
wrong? Variables
(Customer
wrong? and procedures
(inspection and
output ( taken
the occurrence of
the Cause, or
KPOV with the ) on a 1-10
recalculated RPN?
Requirements)? test) that prevent improving scale.

occur?
either the cause or detection?
the Failure Mode?
4)0 Effects of each failure mode. 0

0
The effect on customer (usually 0
2) Process Steps 3) Failure Modes external). Note: One failure
0 0

Listed in order of Potential ways that mode may have several effects)
0 0
occurrence. the process step
0 0
could theoretically
0 0
fail.
If you are looking for probable cause you might want to use 0,1,3,9 scale
Lean Six Sigma | Brown Belt Training 11

FMEA: Link to “Cause & Effect“ Fishbone

Process/Product
Failure Modes and Effects Analysis
(FMEA)
Process or Product
Prepared by: Page ____ of ____
Name:
Responsible: Blackbelt/Greenbelt FMEA Date (Orig) _______ (Rev) _____

S O D R Actions S O D R
Process Potential Potential Potential Current
E C E P Recommende Resp. Actions Taken E C E P
Step/Input Failure Mode Failure Effects Causes Controls
V C T N d V C T N
What is the process In what ways does What is the impact What causes the What are the What are the What are the
Can you detect the
How Severe is the
effect to customer

cause or Failure ?

step and Input the Key Input go on the Key Output Key Input to go existing controls actions for reducing completed actions
How often does it

under wrong? Variables wrong? and procedures the occurrence of taken with the
investigation? (Customer (inspection and the Cause, or recalculated RPN?
Requirements)? test) that prevent improving
occur?

either the cause or detection?

the Failure Mode?

Causes Effects

Lean Six Sigma | Brown Belt Training 12

 FMEA: how to complete an FMEA
Process/Product
Failure Modes and Effects Analysis
(FMEA)
Process or Product
Prepared by: Page ____ of ____
Name:
Responsible: Blackbelt/Greenbelt FMEA Date (Orig) _______ (Rev) _____

S O D R Actions S O D R
Process Potential Potential Potential Current
E C E P Recommende Resp. Actions Taken E C E P
Step/Input Failure Mode Failure Effects Causes Controls
V C T N d V C T N
What is the process In what ways does What is the impact What causes the What are the What are the What are the

Can you detect the

How Severe is the
effect to customer

cause or Failure ?
step and Input the Key Input go on the Key Output Key Input to go existing controls actions for reducing completed actions

How often does it

6) Potential causes
under
investigation?
wrong? Variables
(Customer
wrong? and procedures
(inspection and
the occurrence of
the Cause, or
taken with the
10) Risk Priority No.
recalculated RPN?
For each Failure Requirements)? test) that prevent improving

occur?
either the cause or detection?
Effect (one Effect the Failure Mode? RPN=SEV x OCC x
may have several 0 DET 0

Causes) 0 0

0 0
7) OCC 8) Current controls 9) DET
Rates how often a In-place for each 0
Rates how well the 0

particular cause- cause-effect in the 0 cause or failure can 0

effect occurs process. 0 be detected 0

(Weighting on a 1- (Weighting on a 1-
10 scale) 10 scale)
If you are looking for Probable Cause you might want to use 0,1,3,9 scale
Lean Six Sigma | Brown Belt Training 13

FMEA Occurrence (OCC) scores

• Using the table below as a guide, agree on the probability of each
potential cause occurring.
• Add the (OCC) score to the FMEA in the column provided.
Potential failure
Occ Severity
rates
1 Remote. Failure is unlikely. 1 in 1,500,000

2 Very low. Isolated incidents from similar processes. 1 in 150,000

3 Low. Isolated incidents from processes under evaluation. 1 in 15,000

Note: These tables are
4 Moderate. Occasional failures. 1 in 2,000 based on those generated
5 Moderate. Occasional failures from similar processes. 1 in 400
by the AIAG (Automotive
Industry Action Group).
6 Moderate. Occasional failures from process under evaluation. 1 in 80 The FMEA standards for
7 High. Failure is almost certain. 1 in 20
the USA car industry.

8 High. Failure is almost certain. 1 in 8

9 Very High. Assured of failure. 1 in 3

10 Very High. Assured of failure. 1 in 2

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FMEA Detection (DET) scores
• Using the table provided, score the ability of each of these controls in
detecting or preventing the failure mode if it occurred.
• Add the (DET) score to the FMEA in the column provided.

Det Detection Criteria

1 Almost Certain Current controls are almost certain to detect/prevent the failure mode
Very high likelihood that current controls will detect/prevent the failure
2 Very High
mode
High likelihood that current controls will detect/prevent the failure
3 High
mode
4 Moderately High
Moderately high likelihood that current controls will detect/prevent the Note: These tables are based on
failure mode those generated by the AIAG
Moderate likelihood that current controls will detect/prevent the failure
5 Moderate
mode (Automotive Industry Action
6 Low
Low likelihood that current controls will detect/prevent the failure Group). The FMEA standards for
mode the USA car industry.
Very low likelihood that current controls will detect/prevent the failure
7 Very low
mode
Remote likelihood that current controls will detect/prevent the failure
8 Remote
mode
Very remote likelihood that current controls will detect/prevent the
9 Very Remote
failure mode
10 Absolute Uncertainty Current controls will NOT detect/prevent the failure mode

15

Other rating example

Rating Severity of Effect Likelihood of Occurrence Ability to Detect

10 Hazardous without warning Cannot 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 Moderately high chance
4 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

If you are looking for Probable Cause you might want to use 0,1,3,9
scale
Industrial Chemicals | L6S 16
 FMEA: how to complete an FMEA
Process/Product
Failure Modes and Effects Analysis
(FMEA)
Process or Product
Prepared by: Page ____ of ____
Name:
Responsible: Blackbelt/Greenbelt FMEA Date (Orig) _______ (Rev) _____

S O D R Actions S O D R
Process Potential Potential Potential Current
E C E P Recommende Resp. Actions Taken E C E P
Step/Input Failure Mode Failure Effects Causes Controls
V C T N d V C T N
What is the process In what ways does What is the impact What causes the What are the What are the What are the

Can you detect the

How Severe is the
effect to custom er

cause or Failure ?
step and Input the Key Input go on the Key Output Key Input to go existing controls actions for reducing completed actions

How often does it

under wrong? Variables wrong? and procedures the occurrence of taken with the
investigation? (Customer (inspection and the Cause, or recalculated RPN?
Requirements)? test) that prevent improving
11) Map-out each

occur?
either the cause or detection?
the Failure Mode?
process-step and
xxx xxx xxx xxx xxx 0
failure mode 0

xxx 0
1-at-a-time, so that 0

xxx xxx 0 you can list the 0

xxx xxx xxx 0 causes and Current 0

xxx xxx 0 Controls in-place. 0

xxx 0 0

Lean Six Sigma | Brown Belt Training 17

Risk Priority Number (RPN)

An product of
• Seriousness of a group of effects (Severity)
• Likelihood that cause will create failure associated with effects (Occurrence)
• Ability to detect failure before it reaches customer (external, internal partner,
Dow) (Detection)
• Other criteria, as needed

In equation form, RPN = S*O*D

• This number helps identify the most serious risks, leading to corrective action

Lean Six Sigma | Brown Belt Training 18

 Dynamics of RPN

Sev. Occ. Det. Result Actions

1 1 1 Ideal situation No action
1 1 10 Assured mastery No action
10 1 1 Failure does not reach user No action
10 1 10 Failure reaches user Yes
1 10 1 Freq. fails, detectable, costly Yes
1 10 10 Freq. fails, reaches user Yes
10 10 1 Freq. fails w/major impact Yes
10 10 10 Big trouble! Yes!

Action YES means lower your RPN number by decreasing one or

more elements (Sev, Occ and/or Det)

19

FMEA: how to complete an FMEA

Process/Product
Failure Modes and Effects Analysis
(FMEA)
Process or Product
Prepared by: Page ____ of ____
Name:
Responsible: Blackbelt/Greenbelt FMEA Date (Orig) _______ (Rev) _____

S O D R Actions S O D R
Process Potential Potential Potential Current
E C E P Recommende Resp. Actions Taken E C E P
Step/Input Failure Mode Failure Effects Causes Controls
V C T N d V C T N
What is the process In what ways does What is the impact What causes the What are the What are the What are the
Can you detect the
How Severe is the
effect to custom er

cause or Failure ?

step and Input the Key Input go on the Key Output Key Input to go existing controls actions for reducing completed actions
How often does it

under wrong? Variables wrong? and procedures the occurrence of taken with the
investigation? (Customer (inspection and the Cause, or recalculated RPN?
12) Actions Recommended Requirements)? test) that prevent improving
occur?

either the cause or detection?

Based on SAFETY and the RPN the Failure Mode?
scores the team agrees the priority of 0 0

actions to reduce the either the SEV, 0 0

OCC, or DET. 14) Actions Taken
0 0
These actions MUST be
0 0
proved to have
13) Responsibility 0
successfully reduced the0

For completion of 0 either the SEV, OCC, 0

each action and or DET.
target completion
dates. Applicable in the Improve phase
Lean Six Sigma | Brown Belt Training 20
 FMEA: how to complete an FMEA
Process/Product
Failure Modes and Effects Analysis
(FMEA)
Process or Product
Prepared by: Page ____ of ____
Name:
Responsible: Blackbelt/Greenbelt FMEA Date (Orig) _______ (Rev) _____

S O D R Actions S O D R
Process Potential Potential Potential Current
E C E P Recommende Resp. Actions Taken E C E P
Step/Input Failure Mode Failure Effects Causes Controls
V C T N d V C T N
15. New ImprovedWhat RPN
What is the process In what ways does
is the impact What causes the What are the What are the What are the
» RPN numbers on

Can you detect the

How Severe is the
effect to custom er

cause or Failure ?
step and Input
should
the Key Input go
be
the Key Output
re-calculated
Key Input to go
when corrective
existing controls
actions have
actions for reducing completed actions

How often does it

under wrong?
Variables wrong? and procedures the occurrence of taken with the
been completed
investigation? and proven over time. (inspection and
(Customer the Cause, or recalculated RPN?
Requirements)? test) that prevent improving
» Never recalculate an RPN without implementing an improvement!

occur?
either the cause or detection?
the Failure Mode?
Guessing is not allowed!
0 0
» Usually, it is difficult to reduce the severity of a failure mode. However,
0 0
sometimes a failure mode can be eliminated.
» The most effective RPN reduction is reducing the likelihood 0
of 0

occurrence. 0 0

» The least effective RPN reduction is increasing inspection 0 (reducing the 0

detection ranking). Although, Poka-Yoke can reduce the 0 detection 0

ranking and reduce cost!

Applicable in the Improve phase
Lean Six Sigma | Brown Belt Training 21

FMEA
Possible Filtering Process

» Fishbone
diagrams
30 - 50 Inputs (X).
» Characteristic
selection Matrices
10 - 15 inputs (X).

» FMEA
8 - 10 Critical X’s
(KPIV’s).

Validate !!
Industrial Chemicals | L6S 22
FMEA: example FMEA for our coffee process
Below is the result of the coffee FMEA to minimise the risk of process errors
causing complaints about coffee : strength, colour or taste.

Lean Six Sigma | Brown Belt Training 23

FMEA: example FMEA for our coffee process

Below is the result of the Coffee FMEA to minimize order-errors.
This is the Poke-Yoke order-form, to ensure that staff ask a set series of
questions and mark them down accordingly = Accurate orders taken.

Coffee order form

Please put crosses in the appropriate boxes
Instant Filter
Type of coffee Decaffeinated Douwe Egberts
Standard X Kenco
Black or white Black White X
If white Cream Milk X

X
Coffee colour once made if white

Lean Six Sigma | Brown Belt Training 24

FMEA: example FMEA for our coffee process

14) Actions Taken

These actions MUST be
proved to have
successfully reduced the
either the SEV, OCC or
DET.
15) New RPN Scores
The RPN’s highlighted in
green are now the next-
highest priority to be
actioned.
Still too high ?
Lean Six Sigma | Brown Belt Training 25

Practice activity
• Objective: practice constructing an FMEA
• Activity deliverables: FMEA for booking a meeting
• Take one potential cause from the fishbone
• Work in table groups

• Reconvene in 15 minutes and present results

Lean Six Sigma | Brown Belt Training 26