This document provides an overview of failure mode and effects analysis (FMEA). It defines FMEA as a method to identify potential failure modes, causes, and effects. The document outlines the history of FMEA, from its origins in 1955 to its widespread use today. It also describes the different types of FMEA (system, design, process) and when each is applied. Key aspects of performing a process FMEA like potential causes, controls, severity, occurrence, detection, and risk priority number are defined.

1. BY
SUNIL G
QA
8105269302

2. Welcome TO All

3. KEEP YOUR
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4. Prepared By : SUNIL G

5. Today’s Agenda
What is FMEA
History of FMEA
Definition
Why FMEA
When FMEA
Types of FMEA
How to do Process FMEA

6. What is FMEA
FMEA is a method designed to: identify
and fully understand potential failure
modes and their causes, and the effects
of failure on the system or end users,
for a given product or process.
F
M
E
A
Failure
Mode
Effect
Analysis
Systematic method for early analysis of failure - “What can go wrong”

7. History of FMEA
 1955 Spread of “ Analysis of Potential Problems(APP)” by
Kepner –Tregoe
 1963 Development and use of FMEA by NASA for Apollo Project
 1965 Use of FMEA for aircraft and aerospace technology
 1975 Use of FMEA in Nuclear technologies
 1977 Use of FMEA in Automotive Industry
 1980 Widespread use of FMEA in USA, JAPAN, Europe
 1990 Additional use of the FMEA in
• Medical Technology
• Communications Technology
• Household appliance technology

8. Types of FMEA
System
Design
Process
FMEA
When it is applied to interaction of
parts
Applied to a product
Applied to a process

9. A Failure is that a Component, Assembly or System
Which does not meet the requirements or Function
in accordance with Design intent
I.e, Not meeting the Specifications
Turned
Component
not OK
Failure ???:

10. A Failure mode is the manner in which a
component,assembly or System failure occurs
I.e., How the Component Could not meet the
Specifications
OD Over
Size / Under
size
Length
Variation
Failure Mode :

11. An Effect is an adverse consequence
that the Customer might experience.
For each failure mode as exactly as
possible, describe all different failure
effects on the end customer.
Cannot Fit
or assemble
Poor
Appearance
Effect:

12. Potential Cause(s) Of Failure:-
list down all the possible causes
for Failure Mode. Use Cause &
Effect Diagram / Why-Why
Analysis.
 A “cause” is the specific reason for
the failure, preferably found by
asking “why” until the root cause
is determined.

13. CONTROLS:-
1)Prevention-type Controls .
2)Detection-type Controls
 Controls” are the methods or actions
currently planned, or are already in place, to
reduce or eliminate the risk associated with
each potential cause.

14.  Is the rank associated with most serious
effect for a given failure mode.
 Requires Customer involvement while
assessing the severity.
 Reduction in Severity ranking requires
change in design.
 (10 high -1 low , Higher Value = Higher
Severity)
Severity(Sev.): -

15. occurrence
the occurrence reflects the probability that the
failure mode, as a result of the failure cause being
considered (probability of failure occurrence
during process)
(10 high -1 low ,Higher Value = Higher
Probability of Occurrence)

16. Is the rank associated with the best detection
control listed in current Design control
column
 10 low- 1 high ,
 Higher Value = Lower Ability to Detect
Detection

17.  Is the Product of Severity(S),
Occurrence(O) & Detection(D)
 RPN = S * O * D.
 Is used to rank order the concerns in the
process.
Risk Priority Number(RPN):-

18.  “Recommended actions” are the tasks recommended
by the FMEA team to reduce or eliminate the risk
associated with potential causes of failure
 Recommend the actions based on High RPN & High
Severity
 Give special attention, if severity ranking is 9 or 10.
 Actions should lead to reduction in RPN.
Recommended Actions:-

19. PFMEA
Process S C Potential
O
D Recommended Responsibilty
Function Potential Potential e l Cause (s) / c Current e R. Action (s) & Target Actions S O D R.
Failure Effect (s) of v a Mechanism (s) c Process t P. Completion Date Taken e c e P.
Requirements Mode Failure s of Failure u Controls e N. v c t N.
s r Detection / Prevention c
Item Key Date: Process Resp: FMEA No.
Model / Year Core team Date of Orig Date of Rev
Prepared By:

20. Why FMEA
• To minimize the Late Changes in
Product /Process
• Legal & qms Requirements
• Increased customer expectations
• Shorter Development time
• Early detection & identification of
potential failure in product & process
• Enhancing safety

21. Why FMEA
Origin of
Failure
Product Development
Concept Product Process Mfg Sample Testing Production Despatch
Design Design
Time
Failure
rate in %
Solving of
Failures
FMEA helps to solve the failures at the
Origin Phase itself !!

22. When FMEA
A new product is under development
A product & process changes significantly
Customer demands
Changes to product or process ,operating conditions
Processing of 8D (Fmea updation after corrective
action )
After Implementing recommended actions.