Total Quality

Management
Naga Vamsi Krishna Jasti
BITS Pilani Asst. Professor
Mechanical Engineering Department
Hyderabad Campus
 BITS Pilani
Hyderabad Campus

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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 FMEA/FMECA History
 The history of FMEA/FMECA goes back to the early
1950s and 1960s.
– U.S. Navy Bureau of Aeronautics, followed by the Bureau of
Naval Weapons:
– National Aeronautics and Space Administration (NASA):
 Department of Defense developed and revised the
MIL-STD-1629A guidelines during the 1970s.
 Ford Motor Company published instruction manuals
in the 1980s and the automotive industry collectively
developed standards in the 1990s.
 Engineers in a variety of industries have adopted and
adapted the tool over the years.
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 Failure Mode & Effects Analysis (FMEA)

 FMEA is a systematic method of identifying and

preventing system, product and process problems
before they occur
 FMEA is focused on preventing problems, enhancing
safety, and increasing customer satisfaction
 Ideally, FMEA’s are conducted in the product design or
process development stages, although conducting an
FMEA on existing products or processes may also yield
benefits

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 FMEA is a Tool
 FMEA is a tool that allows you to:
– Prevent System, Product and Process problems
before they occur
– reduce costs by identifying system, product and
process improvements early in the development
cycle
– Create more robust processes
– Prioritize actions that decrease risk of failure
– Evaluate the system, design and processes from a
new vantage point

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 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 Engineers – Operators
– Process Engineers – Reliability
– Materials Suppliers – Suppliers
– Customers
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 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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 FMEA Evaluate Failure Modes and Effects

Fa ilure Spe cific Ca use Effe ct of Fa ilure Like liness Dete cta bility Se ve rity of Risk
Mode of Fa ilure of Fa ilure Fa ilure 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 Fa ilure: 1-10 with 10 representing most likely

 Detecta bility of Fa ilure: 1-10 with 10 representing most difficult
 Severity of Fa ilure: 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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 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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 How is it useful?
 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

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 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.

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 Quality and Reliability
 Quality is a relative term often based on customer
perception or the degree to which a product meets
customer expectations
 Manufacturers have long recognized that products
can meet specifications and still fail to satisfy
customer expectations due to:
– Errors in design
– Flaws induced by the manufacturing process
– Environment
– Product misuse
– Not understanding customer wants/needs
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 Quality, Reliability and Failure Prevention

 Traditionally quality activities have focused on

detecting manufacturing and material defects that
cause failures early in the life cycle

 Today, activities focus on failures that occur beyond

the infant mortality stage

 Emphasis on Failure Prevention

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 The Bathtub Curve

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 Benefits of FMEA
 Contributes to improved designs for products and
processes.
– Higher reliability
– Better quality
– Increased safety
– Enhanced customer satisfaction
 Contributes to cost savings.
– Decreases development time and re-design costs
– Decreases warranty costs
– Decreases waste, non-value added operations
 Contributes to continuous improvement
Cost benefits are expected to come from the ability to identify
failure modes earlier in the process, when they are less
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expensive to address.
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BITS Pilani, Hyderabad Campus
 What tools are available to meet our
objective?

 Benchmarking
 Customer warranty reports
 Design checklist or guidelines
 Field complaints
 Internal failure analysis
 Internal test standards
 Lessons learned
 Returned material reports
 Expert knowledge
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 What are possible outcomes?

 Actual/potential failure modes

 customer and legal design requirements
 duty cycle requirements
 product functions
 key product characteristics
 Product Verification and Validation

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 FMEA Form

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 Severity evaluation criteria

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 Occurrence evaluation criteria

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 Detection evaluation criteria

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 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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 The FMEA Form

Identify failure modes Identify causes of the Prioritize Determine and

and their effects failure modes assess actions
and controls

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 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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 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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 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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 FMEA Inputs and Outputs

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 Failure Modes and Effects
The relationship between failure modes and effects
is not always 1 to 1.

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 Severity, Occurrence,
and Detection

Severity
– Importance of the effect on customer requirements
• Often can’t 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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 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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 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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 Risk Priority Number (RPN)

 RPN is the product of the severity, occurrence, and

detection scores.

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 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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 Truck Stop Coffee Process Map

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

We will focus on one of the two steps with the highest scores
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 Step 1: For each input, determine the potential
failure modes

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 Step 2: For each failure mode, identify effects
and assign severity

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 Step 3: Identify potential causes of each failure
mode and assign score

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 Step 4: List current controls for each cause
and assign score

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 Step 5: Calculate RPNs

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 Step 6: Develop recommended actions, assign
and take actions

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 Step 7: Assign predicted severity, occurrence & detection
levels compare rpn

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 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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