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

2. 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

3. 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

4. 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 times every year
300,000 Defective tires Shipped every year

5. 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

6. 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

7. FMEA PROCEDURE

8. 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

9. 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

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

11. 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 )

12. 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

13. DEFINITION OF REDUCTION MEASURES

14. 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 )

15. 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

16. REFERENCES
1. FMEA Kenneth Crow, DRM Associates.2002. 2.
FMEA from Theory to execution, Second Edition, D.H Stamatis 3.
Dr. Deborah Smith 4. 5. 6.

17. FRAGEN??