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
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
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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Responsi
CRIT
bility and
Failure (critical Recommended Action
Function Effects S Cause(s) O Current controls S RPN target
mode characteri actions taken
completio
stic
n date
Perform cost analysis
Liquid of adding additional
High level spills on level sensor failed Fill timeout based sensor halfway Jane Doe
sensor customer level sensor on time to fill to low between low and high
Fill tub never trips floor 8 disconnected 2 level sensor 5N 80 level sensors 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
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
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
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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