F M E A 4th Edition, June 2008

( Design & Process FMEA )

Chrysler

Ford

General Motors

Initiator
A V Manivannan
Principal Consultant & Trainer

Sri Padhmam Consultancy & Training

Chennai & Pondicherry

94428 92185
avm@sripadhmam.com
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Website : www.sripadhmam.com

Introduction to the

POTENTIAL FAILURE MODE

AND EFFECTS ANALYSIS

FMEA - FOURTH EDITION

June-2008
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INDICATIVE LIST OF CHANGES IN THE

FOURTH EDITION
Improvements to the Severity,Occurrence,Detection tables
Format options ( Flexible in nature )
RPN not to be used as the primary means of assessing risk
Formatting used for easier reading
- An index included
- Icons used for key paragraphs and visual cues are used

INDICATIVE LIST OF CHANGES IN THE

FOURTH EDITION

Need for management support, interest and review of

the FMEA process

Linkage between DFMEA and PFMEA and linkage to

other tools

Additional examples and verbiage provided

RPN methodology : Alternate methods suggested

Estimated RPN : Revision of RPN only after the actions

are implemented by the APQP team members.

KEY DEFINITIONS
FAILURE :

NON PERFORMANCE
NON CONFORMANCE
NON FULFILMENT OF A REQUIREMENT

FAILURE MODE :
MANNER OR WAY IN WHICH FAILURE HAS
HAPPENED OR WILL HAPPEN
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FAILURE MODE

The manner by which a failure is observed

For a DESIGN,
It is how a part may fail to meet its design intent, functional
requirement, and / or the expectations of a customer.

For a PROCESS,
It is what the part is rejected for ( Say diameter over-size )
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FMEA PROCESS
FMEA is an analytical methodology.

Used to ensure that potential problems have been

considered and addressed throughout the product
and process development process
(APQP- Advanced Product Quality Planning)
Its most visible result is the documentation of the
collective knowledge of cross functional teams.

DESIGN FMEA
Design FMEA is used to analyze product

designs before they are released to

production tooling.

Focuses on potential failure modes of

products caused by design deficiencies.

PROCESS FMEA
PROCESS FMEA is used to analyze

manufacturing and assembly processes,

before tooling actions are carried-out.

Focuses on potential product failure

modes caused by Manufacturing or
Assembly process deficiencies

FMEA PURPOSE
To identify potential failure modes and rate

the severity of their risks.

To identify critical characteristics and

significant characteristics ( CC & SC ).
To rank order potential design and process
failure modes
To help engineers focus on eliminating
process concerns and help prevent problems
from occurring

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FMEA BENEFITS
Establishes disciplined approach for prevention of problems.
Improves the Quality, Reliability and Safety of products.
Helps to increase customer satisfaction.
Reduces product development timing and cost.
Documents and tracks actions taken to reduce risk.

Avoids post mortems and associated cost penalty.

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FMEA FEW POSSIBLE PIT FALLS

Formal meetings drift into informal discussions

Meetings miss the schedules for want of forum.

Egoism over rides the group opinions at times.

Assessments needs same group members existence

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FMEA - DISADVENTAGES

Formal documentation is laborious & time consuming.

Measure of performance not easy and clear.

Effectiveness cant claim a 100% result

Assessment is subjective and not comparable.

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TIMELINESS
- the Crux during FMEA process

It is meant to be a Before the the event action.

Not an After the fact exercise.

To achieve the greatest value, FMEA must be done before the

implementation of a product / a process in which the failure mode exists.

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WHEN FMEA IS INITIATED ?

DESIGN FMEA
In the early stages of the Product design.

PROCESS FMEA
Before tooling or manufacturing
developed and purchased

equipment

is

or after preparation of process flow diagram.

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FMEA PROCESS

The FMEA evolves throughout each stage of the

design and manufacturing development process
and may also be used in problem solving.

FMEA can also be used in non-manufacturing

areas.

Eg. Risk in a Admin process or a safety initiative

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FMEA in which situations

Scope

New design
Situation # 1 New technology
New processes

Complete design, technology or process

Modified design
Situation # 2 Modified technology
Modified processes

Modified design, technology or process

and the possible interactions with other
systems.

Existing design
Situation # 3 Existing technology
Existing processes

For a new application, Environment or

Location

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FMEA : Management support

Can take considerable time.

Commitment of the required resources.

Process owner

Multi-disciplinary approach.

Suitability of APQP members

Appropriate actions on time.

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FMEA : Training program

A comprehensive training programme including:

Management Overview

Training for users

Supplier training

Facilitator training

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FMEA : Management responsibility

Ultimately, management has the responsibility

and ownership for -

development of FMEAs on time and

maintenance of the FMEAs

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Approach 1

Approach 2

X
Filling out the format

Understanding the
FMEA approach

No effective actions

Collective wisdom

No improvements

Identify high risk areas

Status Quo

Initiate timely actions

Blaming the system

Status improves
Customer satisfaction
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FMEA
FOLLOW UP
Decide effective preventive / corrective actions.
Appropriate follow up on those actions
FMEA will be of limited use without positive & effective
preventive / Corrective action.

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FMEA
The FMEA is a living document and should always reflect the latest design
level, as well as the latest relevant actions in production.

FMEA should be reviewed periodically and also when customer complaints

are received.

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F M EA
T

IS A TOOL

Helps to Prevent Potential

Failures.

IS A PROCEDURE

Structured / Systematic approach

on Design & Process.

IS A DAIRY

Record of things happened.

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Responsibility for Constructing

F M E A.

Representatives from Engineering ( R&D ).

Quality.
Manufacturing.
Methods Engineering.
Maintenance.
Purchase.

Logistics management

Suppliers &
Customers.
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Basic Questions to be raised - while making FMEA.

How can the present / proposed
design / process
FAIL to deliver the
expected results. ( Failure mode )?

What should be the Preventive action plan ?

Proposed Measure ?
Who has to do ?
When to Complete ?
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Severity ( S )
( 1 to 10 Ranking )

Occurrence ( O )
( 1 to 10 Ranking )

Detection ( D )
( 1 to 10 Ranking )

Risk Priority Number ( Product of S - O - D )

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Other Similar Tools

Hazard Analysis
Fault Analysis
Critical Analysis

Failure Mode & Criticality Analysis

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Sri Padhmam Consultancy & Training

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th
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Chennai 600 061

E-mail : avm@sripadhmam.com

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