Fmea

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? 1 Hr unsafe drinking water/day

300,000 Defective tires Shipped every year

2 Unsafe landings / day at any Airport in the world

22,000 Checks deducted from the wrong account/ year

14,208 Defective Computers shipped every Year

Your heart skips beating 32844 times every year

HISTORICAL OVERVIEW OF 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.

2.Aerospace/Rocket Industry to avoid errors in Costly Rocket Development Technology

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 Locking Feature

CAUSE Harness too short

CAUSE -Inadequate Electrical Connection

FAILURE MODE ( MOTOR STOPS)

FAILURE MODE ( INADEQUATE ELECTRICAL CONNECTION)

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 from Theory to execution, Second Edition, D.H Stamatis 3. http://healthcare.isixsigma.com/library/content/c04031 Dr. Deborah Smith 4. http://www.quality-one.com/services/fmea.php 5. http://www.embeddedtechmag.com/content/view/181/1 6. http://www.asq.org/learn-about-quality/process-analysis

FRAGEN??