The document provides an overview of Failure Mode and Effects Analysis (FMEA) including: 1) FMEA is a systematic approach to identify potential failures in a process or product and their causes and effects. It is performed before a change to understand risks. 2) A cross-functional team prepares the FMEA, which is a living document maintained throughout the product or process lifecycle. 3) The FMEA worksheet involves assessing each step of a process to identify potential failure modes, causes, current controls, occurrence, detection, severity, and recommended actions. This helps prioritize the highest

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Trainer: Sachin Agrawal
Sachin@simplexiti.com
Lean Six Sigma
Green Belt Training
Improve

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Tools For Improve Phase
2
Pugh Metrics
Work Standardisation
Improve Workflow
5 S
FMEA
Mistake Proofing
Kaizen
Evaluating Solutions

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• A systematic approach used to identify potential product
or process failures and their effects
• Drill down to root cause and identify actions that
eliminate or reduce the failure from occurring
• Performed before a process, product, or service is
changed or designed
• Prepared by a team representing all effected areas
• A living document that is to be maintained and reviewed
throughout the life of the product, process, or service
3
FMEA Summary

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• Measure
– To identify process outputs (y) that cause dissatisfaction
• Analyse
– To identify process inputs (x) and prioritize them
• Improve
– To determine root cause and to assign and implement
recommended actions
• Control
– To be maintained as a living document as part of the ongoing
control plan
4
When do I use it?

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Approach
Who is involved?
• Team approach is essential
• Members represent all groups affected by the process
• BB or GB leads the team
• Process owner owns the document and is responsible for
maintaining it
Preparation
• Scope and boundary definition
• Process map, SOP’s, C&E matrix, etc.
5

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FMEA – Each component asks a question
6
Process
Function
Potential Failure Mode Potential Failure Effects
S
E
V
Potential Causes
O
C
C
Current Controls
D
E
T
R
P
N
Actions
Recommended
0 0 0 0
0 0 0 0
0 0 0 0
0 0 0 0
0 0 0 0
What is
the
Process
Step or
Function
?
What is
the Effect
on the
Outputs/
Customer
?
What are
the
Causes
of the
Failure?
How
Bad is
the
effect?
How
Often
does the
Failure
Occur?
What
controls
exist to
prevent or
detect the
failure?
How
well?
What
can be
done?
What can go
wrong (create
dissatisfaction)?
How weak
is the
process?

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A ctio n R esults
Item /
Function
Potential
Failure
Mode(s)
Potential
Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s
) of Failure
P
r
o
b
Current
Design
Controls
D
e
t
R
P
N
Recommende
d
Action(s)
Responsibilit
y & Target
Completion
Date
Actions
Taken
NewSev
NewOcc
NewDet
NewRPN
Car Tyre
Function:
support weight
of car, traction,
comfort
Flat tire Stops car
journey, driver
and passengers
stranded
10 Puncture 2 Tire checks
before journey.
While driving,
steering pulls to
one side, excess
noise
6 120 Carry spare tire
and appropriate
tools to change
tire
Car owner,
immideate
Spare tire and
appropriate
tools
permanently
carried in trunk
4 2 6 48
Phone
Answer Phone Answer on or
after 5th ring
Customer
Hangs up,
become
unhappy, loss
of potential
sales
6 Can't hear the
phone
3 Ringer set to
loud
5 90 Remove music
from order area
Duty Manager,
1st July 2014
As
Recommended
5 3 2 30
6 Phone too far
to reach on
time
8 Fix spot for
phone handset
7 336 Buy Wireless
phone headset
Restaurant
Owner, 1st July
2014
Too expensive
deffered to next
quarter
5 8 7 280
6 Staf tied up in
work that
cannot be
interrupted
4 One staff
always asign to
phone duty
3 72 None None None 5 4 3 60
FMEA – Example
Recommended actions can come through mistake proofing

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Activity – FMEA
8
• Do an FMEA for withdrawing cash from ATM
machine in night
•Work together : 10 min
•Discuss the results: 5 min