Failure Mode Effects
Analysis
Powerful Prevention Tool and
Knowledge Base
Kathleen Stillings – CPM, CQE, CQA, MBB
Today’s Goals
To understand the role and function of the
FMEA
 To understand the concepts and
techniques of the process FMEA and how
to apply them.
 To complete a Process FMEA
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What is it?
Aka FMEA
 Actions
 Prevention / reduction of failures
 Tool for risk reduction
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What it is not
The FMEA is not a stand-alone tool to be
used to solve problems
 The FMEA presents the opportunities but
does not solve the problems
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Where did it come from?
Introduced in 1940 by US Armed Forces
 Implemented further in 1960 by Apollo
Space program
 Commercially implemented in 1970 by
Ford Motor Company
 Used widely in many industries today
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What can FMEA be used for?
Competing
 Prevention of Litigation
 Identify Weak areas of a process/product
 A bottom-up approach
 To evaluate the effectiveness of the
current control plan
 Prioritize tasks
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FMEA Types
Concept
 Design/Product
 Process
 Equipment
 System
 Service
 Software
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FMEA Challenges
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Continuous Brainstorming
Lengthy consensus-building
Not capturing all possible issues
Team Environment only
Determining and Implementing the action that
drives reduction in risk
Ensuring the high risk failure modes are
addressed
Remember to include interfaces
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FMEA Benefits
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Improve product/process reliability and quality
Increase customer satisfaction
Early identification and elimination of potential
product/process failure modes
Prioritize product/process deficiencies
Capture engineering/organization knowledge
Emphasizes problem prevention
Documents risk and actions taken to reduce risk
Identify CTQs
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Function
Fill tub
Failure
mode
Effects
Liquid
High level spills on
sensor
customer
never trips floor
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Cause(s)
O
Current controls
level sensor failed
Fill timeout based
level sensor
on time to fill to low
8 disconnected
2 level sensor
CRIT
(critical
S
RPN
characteri
stic
5N
Recommended
actions
Perform cost analysis
of adding additional
sensor halfway
between low and high
80 level sensors
Responsi
bility and
target
completio
n date
Action
taken
Jane Doe
10-Oct-10
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FMEA Start-Up Process
Define the FMEA Scope
 Determine the FMEA Boundaries
 Define the Scope of Responsibility
 Define the Provisions
 Assemble the Team
 Define your ratings
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Bring your Data
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Nonconformance reports
Unscheduled outages
Customer complaints
Improvement projects
Equipment failures
Excess shipping charges
Excess returned material charges
Design changes
Process capability studies
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FMEA Procedure
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Identify the function(s), failure(s), effect(s),
cause(s) and control(s) for each item or process
to be analyzed.
Evaluate the risk associated with the issues
identified by the analysis.
Prioritize and assign corrective actions.
Perform corrective actions and re-evaluate risk.
Distribute, review and update the analysis, as
appropriate.
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FMEA Cycle
Source 1
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Sources
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http://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis
http://www.npd-solutions.com/fmea.html
FMEA Minus the Headache – Gavind Ramu – Quality Progress March 2009
AIAG: The Automotive Industry Action Group provides the ability to purchase the
AIAG FMEA Third Edition (FMEA-3) guidelines.
http://elsmar.com/FMEA/sld007.htm
http://lssacademy.com/wp-content/uploads/2007/06/fmea-template.xls
The Quality Toolbox – Nancy R. Tague – ASQ Quality Press Second Edition.
www.QualityWBT.com
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