Professional Documents
Culture Documents
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
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??