FMEA

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 ANALYSIS (FMEA)AGENDAINTRODUCTIONNEED FOR FMEAHISTORICAL OVERVIEW AND

APPLICATIONSFMEA PROCEDURE- HAZARD

IDENTIFICATION, HAZARD ANALYSIS AND REDUCTION MEASURES

IMPLEMENTATION AND BENEFITSCONCLUSION

INTRODUCTION TO FMEAFMEA is an acronym that stands for

Failure Modes and Effects AnalysisToday’s World - Demand for High Quality ,

Reliable ProductsFMEA - Focus on Product Design,

developmentFocus on Process Focus on Service functions

Identify Potential failure modesDetermine effect on Operation of productIdentify actions to mitigate failure

NEED FOR FMEAWHAT IS 99.9% QUALITY?

1 Hr unsafe drinking water/day

2 Unsafe landings / day at any Airport in the world

14,208 Defective Computers shipped every Year

300,000 Defective tires Shipped every year

22,000 Checks deducted from the wrong account/ year

Your heart skips beating 32844 times every year

HISTORICAL OVERVIEW OF FMEA1.Late 1940’s for Military Usage By US Armed forces

2.Aerospace/Rocket Industry 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 FMEAINDUSTRIES 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 redesignedWhen analyzing Failures of an existing process,

product or serviceWhen setting improvement goals for a product

or processPeriodically throughout the life of a process,

product or service

FMEA PROCEDURE

HAZARD IDENTIFICATION Most time consuming partIdentify possible failures, their

consequences and causes of failure6-8 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:

FAILURE MODE( MOTOR STOPS)

CAUSE -Inadequate Electrical Connection

FAILURE MODE( INADEQUATE ELECTRICAL CONNECTION)

CAUSE - Inadequate Locking Feature

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 INVOLVEDCalculation 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 MEASURESTechnical measures - E.g. Change the facility

( if the facility is the cause of the failurePersonnel Measures – E.g. Staff TrainingOrganizational measures – E.g. Introduction

of Organizational Regulations ( Standard Operating procedures )

Document corrective actionsRecalculation of RPN

DEFINITION OF REDUCTION MEASURES

10 30 50 80 120

210

0

20

40

60

80

100

120

140

Risk Priority Number RPN – O.S.D

Nu

mb

er

of

fail

ure

mod

es

FREQUENCY AFTER IMPLE-MENTATION OF REDUCTION MEASURES

0

10

20

30

40

50

60

Risk Priority Number RPN – O.S.D

Nu

mb

er

of

fail

ure

mod

es

FREQUENCY WITHOUT REDUCTION MEASURES

IMPLEMENTATION AND BENEFITSSummary of results for Top managementDocumentation of the performed processFollow up and implementation of Measures

needs meticulous planningBENEFITS:

Semi Quantitative Evaluation of risks Evaluation guide for Subsequent process,

product and system ChangesAlso suitable for non GMP risks (GMP- Goods

Manufacturing Products )

CONCLUSIONFMEA helps improve customer

satisfaction and thus Brand image and competitiveness

Offers continuous improvementGeneral 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

REFERENCES1. 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 Stamatis3. http://

healthcare.isixsigma.com/library/content/c040317a.aspDr. Deborah Smith4. http://www.quality-one.com/services/fmea.php5. 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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