Analyze

Opportunity Part 1

Failure Modes Effect Analysis

(FMEA)
 Learning Objectives
To understand the use of Failure Modes
Effect Analysis (FMEA)
To learn the steps to developing FMEAs
To summarize the different types of FMEAs
To learn how to link the FMEA to other
Black Belt tools
To perform an exercise to actually perform
an FMEA

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 Whats In It for Me?
Allows us to identify areas of our process
that most impact our customers
Helps us identify how our process is most
likely to fail
Points to process failures that are most
difficult to detect

3
 Application Examples
Manufacturing: A manager is responsible for
moving a manufacturing operation to a new
facility. He wants to be sure the move goes as
smoothly as possible and that there are no
surprises.
Design: A design engineer wants to think of all the
possible ways a product he is designing could fail
so that he can build robustness into the product.
General: A Black Belt wants to use FMEA so that
he can focus on the key improvement
opportunities for a process.

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 What Can Go
Wrong?

What Is A Failure Mode?

A Failure Mode is:
The way in which the component,
subassembly, product, input, or process could
fail to perform its intended function
Failure modes may be the result of upstream
operations or may cause downstream operations to
fail
Things that could go wrong

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 Evaluate
Failure Modes
and Effects

FMEA
Failure Specific Cause Effect of Failure Likeliness Detectability Severity of Risk
Mode of Failure of Failure Failure Priority
Gas will not Spring broke Explosion resulting in 3 5 10 150
shut off preventing valve property damage
from closing and/or serious injury

Likeliness of Failure: 1-10 with 10 representing most likely

Detectability of Failure: 1-10 with 10 representing most difficult
Severity of Failure: 1-10 with 10 representing most severe
Risk Priority = (Likeliness of Failure) X (Detectability of Failure) X
(Severity of Failure)

What
Failure Modes & Effects Analysis is a methodology to
evaluate failure modes and their effects in designs and
in processes.

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 FMEA
Why
Methodology that facilitates process
improvement
Identifies and eliminates concerns early in
the development of a process or design
Improve internal and external customer
satisfaction
Focuses on prevention
FMEA may be a customer requirement
FMEA may be required by an applicable
Quality System Standard

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 Implementing
FMEA

FMEA
How
Team identifies potential failure modes for
design functions or process requirements
They assign severity to the effect of this failure
mode
They assign frequency of occurrence to the
potential cause of failure and likelihood of detection
Team calculates a Risk Priority Number by
multiplying severity times frequency of
occurrence times likelihood of detection
Team uses ranking to focus process
improvement efforts

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 Exercise

FMEA Form

9 Blank FMEA form in Virtual Coach

Exercises Chapter 3.4 - FMEA Form.xls
 FMEA
A structured approach to:
Identifying the ways in which a product or
process can fail
Estimating risk associated with specific
causes
Prioritizing the actions that should be taken
to reduce risk
Evaluating design validation plan (product) or
current control plan (process)

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 When to Conduct an FMEA

Early in the process improvement investigation

When new systems, products, and processes

are being designed
When existing designs or processes are being
changed
When carry-over designs are used in new
applications
After system, product, or process functions are
defined, but before specific hardware is
selected or released to manufacturing
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 Examples

History of FMEA
First used in the 1960s in the Aerospace
industry during the Apollo missions
In 1974, the Navy developed MIL-STD-
1629 regarding the use of FMEA
In the late 1970s, the automotive
industry was driven by liability costs to
use FMEA
Later, the automotive industry saw the
advantages of using this tool to reduce
risks related to poor quality

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 Exercises

Exercises
Discuss some potential failure modes
for delivering a pizza.
Brainstorm with your group pizza delivery
failure modes.
Discuss some potential failure modes
for preparing breakfast.
Brainstorm with your group breakfast
preparation failure modes.

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 A Closer Look

The FMEA Form

Identify failure modes Identify causes of the Prioritize Determine and

and their effects failure modes assess actions
14 and controls
 Specialized
Uses

Types of FMEAs

Design
Analyzes product design before release
to production, with a focus on product
function
Analyzes systems and subsystems in
early concept and design stages
Process
Used to analyze manufacturing and
assembly processes

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 Team Input
Required

FMEA: A Team Tool

A team approach is necessary.
Team should be led by the Black Belt, a
responsible manufacturing engineer or
technical person, or other similar individual
familiar with FMEA.
The following should be considered for team
members:
Design Manufacturing
Quality Reliability
Materials Suppliers
Customers

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 Process Steps

FMEA Procedure
1. For each process input (start with high value
inputs), determine the ways in which the input
can go wrong (failure mode)
2. For each failure mode, determine effects
Select a severity level for each effect

3. Identify potential causes of each failure mode

Select an occurrence level for each cause

4. List current controls for each cause

Select a detection level for each cause

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 Process Steps

FMEA Procedure (Cont.)

5. Calculate the Risk Priority Number (RPN)
6. Develop recommended actions, assign
responsible persons, and take actions
Give priority to high RPNs
MUST look at severities rated a 10

7. Assign the predicted severity, occurrence, and

detection levels and compare RPNs

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 Information
Flow

FMEA Inputs and Outputs

Inputs Outputs
Brainstorming List of actions to
C&E Matrix prevent causes or
Process Map detect failure
Process History FMEA modes
Procedures
Knowledge History of actions
Experience taken

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 Failure Effects
Relationship

Failure Modes and Effects

The relationship between failure modes and
effects
is not always 1 to 1.

Failure Mode 1 Effect 1

Failure Mode 2 Effect 2

Failure Mode 1
Effect 1
Failure Mode 2

Effect 1
Failure Mode 1
20 Effect 2
 Analyzing

Severity, Occurrence,
Failure &
Effects

and Detection
Severity
Importance of the effect on customer
requirements
Often cant do anything about this

Occurrence
Frequency with which a given cause occurs and
creates failure modes
Detection
The ability of the current control scheme to
detect
or prevent a given cause

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 Assigning
Rating
Weights

Rating Scales
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 makes 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 (most common)

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 Assigning
Rating
Weights

Rating Scales
Severity
1 = Not Severe, 10 = Very Severe
Occurrence
1 = Not Likely, 10 = Very Likely
Detection
1 = Likely to Detect, 10 = Not Likely to
Detect

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 Calculating a
Composite
Score

Risk Priority Number (RPN)

RPN is the product of the severity,

occurrence, and detection scores.

Severity X Occurrence X Detection = RPN

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 Lets Try
Using FMEA

FMEA Example

We will conduct an FMEA on the truck stop example

we used to create a C&E Matrix
A Black Belt wants to improve customer
satisfaction with the coffee served at the truck stop
The process map and completed C&E matrix follow

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 Process Map

Truck Stop Coffee Process Map

Inputs Outputs Inputs Outputs
Hot Water Cleaned Carafe Customer Complete Order
Clean Carafe Receive
Soap Dirty Water Order Coffee
Scrubber Wet Scrubber Size Specification Order

Clean Carafe Fill Carafe Full Carafe Complete Order Pour Coffee Filled Cup
Cold Water w/Water Hot Coffee into Cup
Measuring Mark Cup
Full Carafe Filled Maker Customer Reply
Pour Water Filled Cup Offer
into Maker Empty Carafe Amount Specified
Customer Cream &
Cream Sugar Complete Order
Filter Maker w/Filter
Place Filter in Maker Sugar
Amount Desired
Maker w/Filter Maker w/Filter &
Put Coffee
Fresh Coffee Coffee Complete Order Make Change
in Filter Complete
Dosing Scoop Money Transaction Temperature
Taste
Maker w/Filter & Operating Maker
Turn Maker On Strength
Coffee Heat
Brewed Coffee Say Thank You Smile
Coffee Delivery
Happy Customer
Brewing Coffee Hot Coffee
Select Temperature
26 Setting
 C&E Matrix

Truck Stop Coffee C&E Matrix

Temp of
Coffee Taste
8 10
Process Step ----- Process input ----- --------- Correlation of Input to Output ---------
Clean Carafe 0 3
Fill Carafe with Water 0 9
Pour Water into Maker 0 1
Place Filter in Maker 0 3
Put Coffee in Filter 0 9
Turn Maker On 3 1
Select Temperature Setting 9 3
Receive Coffee Order 0 0
Pour Coffee into Cup 3 1
Offer Cream & Sugar 3 9
Complete Transaction 1 1
Say Thank You 0 0
Strength Process Outputs
6 Importance
--------- Total ---------
0
1 36
9 144
1 16
1 36
9 144
0 34
3 120
1 6
3 52
3 132
1 24
0 0
0

We will focus on one of the two

0
0
0

steps with the highest scores 0

0
0
0
0
0
0

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 Determine
Failure Modes

Step 1: For Each Input, Determine the

Potential Failure Modes

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 Identify Effects
and Severity

Step 2: For Each Failure Mode, Identify

Effects and Assign Severity

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 Identify Failure
Causes and Score

Step 3: Identify Potential Causes of Each

Failure Mode and Assign Score

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 Identify Controls
and Score

Step 4: List Current Controls for Each

Cause and Assign Score

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 RPNs

Step 5: Calculate RPNs

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 Identify Actions and
Responsibilities

Step 6: Develop Recommended Actions, Assign

Responsible Persons, and Take Actions

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 Compare
RPNs

Step 7: Assign the Predicted Severity, Occurrence, and

Detection Levels and Compare RPNs

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 Team Exercise

Exercise

Meet together in the same teams as you did

during the Process Mapping and C&E Matrix
exercises
Create an FMEA for a process (project subject)

Limit the FMEA to the top 3 inputs or steps

(for the sake of time)
Return and report results to the group

Be sure to discuss lessons learned as part of

the presentation
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 Key Points

Summary
An FMEA:
Identifies the ways in which a product or process can
fail
Estimates the risk associated with specific causes
Prioritizes the actions that should be taken to reduce
risk
FMEA is a team tool
There are two different types of FMEAs:
Design
Process
Inputs to the FMEA include several other Black
Belt tools

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