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
[email protected]
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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
Plot # : 14, Door # 18, Second Floor,
Salmas Amar Enclave,
East Main Road,
Cell : 094428 92185
th
Lakshmi Nagar 4 Stage,
Nanganallur,
Website : www.sripadhmam.com
Chennai 600 061
E-mail : [email protected]
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