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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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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
What is it? • Aka FMEA • Actions • Prevention / reduction of failures • Tool for risk reduction
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
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
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
FMEA Types • Concept • Design/Product • Process • Equipment • System • Service • Software
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
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
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
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
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.
FMEA Cycle Source 1
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