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FORD PINTO AFFAIR

FAILURE MODES AND
EFFECTS ANALYSIS - FMEA
PRESENTATION BY
SESHAGIRI. V ( BCM
SS’09 )

SUBMITTED TO PROF.
MATTHIES (MANAGING
CONSULTING
COMPANIES )
FAILURE MODE AND
EFFECTS
AGENDA
ANALYSIS (FMEA)
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
1 Hr unsafe 2 Unsafe landings / Computers shipped
drinking day at any Airport in every Year
water/day the world

22,000 Checks deducted Your heart skips
300,000 Defective from the wrong account/ beating 32844
tires Shipped every year times every year
year
HISTORICAL OVERVIEW OF
1.Late 1940’s for Military Usage 2.Aerospace/Rocket Industry
By US Armed forces to avoid errors in Costly
Rocket Development
Technology

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
CAUSE
An example: -Inadequate
Electrical
Connection
FAILURE
MODE
( MOTOR
STOPS)

CAUSE -
Inadequate
Locking FAILURE MODE
Feature ( 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 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
FRAGEN??