FAILURE MODES AND EFFECTS ANALYSIS - FMEA PRESENTATION BY SESHAGIRI. V ( BCM SS’09 ) SUBMITTED TO PROF. MATTHIES (MANAGING CONSULTING COMPANIES )

FAILURE MODE AND EFFECTS ANALYSIS (FMEA) AGENDA INTRODUCTION NEED FOR FMEA HISTORICAL OVERVIEW AND APPLICATIONS FMEA PROCEDURE- HAZARD IDENTIFICATION, HAZARD ANALYSIS AND REDUCTION MEASURES IMPLEMENTATION AND BENEFITS CONCLUSION

INTRODUCTION TO FMEA FMEA is an acronym that stands for Failure Modes and Effects Analysis Today’s World - Demand for High Quality , Reliable Products FMEA - Focus on Product Design, development Focus on Process Focus on Service functions Identify Potential failure modes Determine effect on Operation of product Identify actions to mitigate failure

NEED FOR FMEA WHAT IS 99.9% QUALITY? 14,208 Defective Computers shipped every Year 2 Unsafe landings / day at any Airport in the world 1 Hr unsafe drinking water/day 22,000 Checks deducted from the wrong account/ year Your heart skips beating 32844 times every year 300,000 Defective tires Shipped every year

HISTORICAL OVERVIEW OF FMEA 2.Aerospace/Rocket Industry to avoid errors in Costly Rocket Development Technology 1.Late 1940’s for Military Usage By US Armed forces 3. NASA uses FMEA to put man on moon and bring him back safely. 4.FORD introduces FMEA to Automotive Industry after FORD Pinto Affair

APPLICATIONS OF FMEA INDUSTRIES THAT USE FMEA Semiconductor processing, Food service, Plastics,Software, Healthcare, Aerospace & Defense, Machinery Development WHEN TO USE FMEA? When a product, process or service is being Designed or redesigned When analyzing Failures of an existing process, product or service When setting improvement goals for a product or process Periodically throughout the life of a process, product or service

FMEA PROCEDURE

HAZARD IDENTIFICATION Most time consuming part Identify possible failures, their consequences and causes of failure 6-8 members forming an interdisciplinary team ( e.g.. From production , Laboratory, Quality Assurance, Engineering & Information processing ) Suitable methods for recording potential failures – Brainstorming, Fish Bone analysis, Pareto Analysis

FAILURE MODE CAUSE RELATIONSHIP - FISH BONE ANALYSIS An example: CAUSE -Inadequate Electrical Connection FAILURE MODE ( MOTOR STOPS) CAUSE - Inadequate Locking Feature FAILURE MODE ( INADEQUATE ELECTRICAL CONNECTION) CAUSE - Harness too short

HAZARD ANALYSIS HAZARD ANALYSIS -DOCUMENTATION AFTER HAZARD IDENTIFICATION HELPS AID TRACEABILITY INCLUDES ORIGINALLY PLANNED TECHNICAL SYSTEM AND THE IMPROVEMENTS

CALCULATION OF RISK PRIORITY NUMBER (RPN) STEPS INVOLVED Calculation of Severity of the failure consequence ( S) Calculation of the Probability of occurrence of the cause ( O ) Calculation of the probability of detection ( D) Scale of the calculation of Severity (S ), Occurrence ( O) and Detection ( D) = 1 on 10 (or) 1 on 4 RPN = O*S*D ( > 100 = Immediate Action ) ( < 100 = Frequent Monitoring )

DEFINITION OF REDUCTION MEASURES Technical measures - E.g. Change the facility ( if the facility is the cause of the failure Personnel Measures – E.g. Staff Training Organizational measures – E.g. Introduction of Organizational Regulations ( Standard Operating procedures ) Document corrective actions Recalculation of RPN

DEFINITION OF REDUCTION MEASURES

IMPLEMENTATION AND BENEFITS Summary of results for Top management Documentation of the performed process Follow up and implementation of Measures needs meticulous planning BENEFITS: Semi Quantitative Evaluation of risks Evaluation guide for Subsequent process, product and system Changes Also suitable for non GMP risks (GMP- Goods Manufacturing Products )

CONCLUSION FMEA helps improve customer satisfaction and thus Brand image and competitiveness Offers continuous improvement General Requirement of many national and International Standards like ISO and EC 1985 act. LIMITATIONS: Depends on the Expertise of the committee Geometric progression Not Arithmetic

REFERENCES 1. http://www.npd-solutions.com/fmea.html FMEA Kenneth Crow, DRM Associates.2002. 2. http://books.google.com/books?id=T9TxNHWJZmIC&dq=fmea&printsec=frontcover&source=in&hl=en& FMEA from Theory to execution, Second Edition, D.H Stamatis 3. http://healthcare.isixsigma.com/library/content/c040317a.asp Dr. Deborah Smith 4. http://www.quality-one.com/services/fmea.php 5. http://www.embeddedtechmag.com/content/view/181/121/ 6. http://www.asq.org/learn-about-quality/process-analysis-tools/overview/fmea.html

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