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INTRODUCTION
HISTORY
When FMEA?
Why FMEA? 
 Advantages of FMEA 
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INTRODUCTION 
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
FMEA (Failure Mode & effect Analysis) is a specific methodology to evaluate
(https://www.instagram.com/quality_engi
a system, design and process or services for possible ways in which failures 
can occur, so it will help identify actions which could eliminate or reduce (https://www.linkedin.com/qualityenineer
the chance of failure occurring. in addition, for each of the failure’s identify 
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an estimate is made of its effect on total system / design, its causes and its

control method. (https://www.youtube.com/channel/UCN6

So FMEA is an analytical methodology used to ensure that potential

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

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05 Quality Core Tools to ensure quality
(2022)
FMEA follows the principle of preventing failure instead of a after treating (https://qualityengineerstuff.com/5-
quality-core-tools/)
failure recognition and –correction (failure handling) through in time
Product Development: Here are Incredible
identification of potential failure causes at the development phase. The ways to Reduce Cost In Your Startups
(https://qualityengineerstuff.com/product
costs for a change in design in an early phase of development are much
-development-here-are-incredible-ways-
lower than before the launch of the product, because the design is not fix to-reduce-cost-in-your-startups/)

yet. What is the Role of supplier management

in Development?
It is the prevention-base methodology, so most effective for defect (https://qualityengineerstuff.com/what-is-
the-role-of-supplier-management-in-
prevention. The cost of defect rectified during product/ process launch is development/)

far greater than same defect identified and rectified during design/ drawing 5 Importance of Electrical Testing and

stage itself. Therefore, It will help to reduce the number of complaints and Inspection
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failures after product launch and dispatch. FMEA is a structured mean for nce-of-electrical-testing-and-inspection/)

evaluating the problem that are likely to be encountered and the

consequences of such problem. This is also useful for evaluating the effects Join Community

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The failure mode and effect analysis (FMEA) has been developed at the
mid-sixties in the USA for the Apollo Project by the NASA. After applying
that method in aeronautics and the aerospace industry, as well as in the
nuclear technology, its usage had been introduced soon in the automobile
industry. The FMEA finds now globally a widespread application. The FMEA
nowadays a methodical component of quality management systems for
many automobile manufacturers and their suppliers.

When FMEA?
There are three basic cases for which FMEA process is to be applied, each
with a different scope or focus:

Case 1: New designs, new technology, or new process. The scope of the
FMEA is the complete design, technology, or process.

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Case 2: Modifications to existing design or process. The scope of the FMEA

should focus on the modification to design or process, possible interactions
due to the modification, and field history. This can include changes in
regulatory requirements.

Case 3: Use of an existing design or process in a new environment, location,

application, or usage profile (including duty cycle, regulatory requirements,
etc.). The scope of the FMEA should focus on the impact of the new
environment, location, or application usage on the existing design or
process.

Why FMEA?
FMEA is a systematic and reliable method for ensuring demanded
product characteristics (https://qualityengineerstuff.com/sc-and-cc/).
Early recognition and evaluation of possible failures already during the
design- or process planning phase
Prioritized problem handling
Definition of appropriate Countermeasures (preventing or verifying)
FMEA documents the generated knowledge (Prevention of Repetitive
Errors; Knowledge Management)
Increase of functional safety and reliability of products and processes.

Decrease of Warranty, through extension of the legal warranty period
 Shorter Development periods
Adherence of Schedules
More efficient Manufacturing and Assembling
Buildup of a knowledge base within the company
Failure prevention instead of failure correction (early use)

FMEA is of two type

1. Design FMEA
2. Process FMEA

Advantages of FMEA
Aiding in the objective evaluation of design requirements and design
alternatives.
Aiding in the initial design for manufacturing and assembly requirements.
Providing additional information to aid in the planning of thorough and
efficient design test and development programs.
Developing a list of potential failure modes ranked according to their
effect on “customers”.
Providing an open issue format for recommending and tracking risk
reducing actions.
Providing future reference to aid in analyzing field concerns.

Lets Elaborate the FMEA (Failure Mode & effect Analysis) template, we have
both Design & Process FMEA (Failure Mode & Effect Analysis).

Design FMEA

Process FMEA

1. FMEA NUMBER :

Enter the FMEA document number, which may be used for tracking. And a
unique identification number for FMEA.


2. System & Sub System :

Indicate the appropriate level of analysis and enter the name and number
of the system, subsystem or component being analyzed.

2. Part No., Part Name :

Indicate the appropriate level of analysis and enter the name and number
of the system, subsystem or component being analyzed.

3. Model :

Enter the intended model and vehicle

line that will utilize and/or affected by
the design / process.

4. Core Team :

List the names of the responsible individuals and Departments which have
the authority.


5. Drawing No. / Revision No.:

It is the cell for the latest drawing release no. and the revision status of the
part drawing for which the FMEA is made.

6. Design / Process Responsibility :

For Design enter the OEM, Department and group. Also include the
supplier name if known, and for Process enter the name of manufacturer /
Process owner.

7. FMEA Date :

Key date is the initial FMEA due date before which the FMEA should be
completed. Therefore in case of Design FMEA the key date should be
before release date for production and in Process FMEA it should be before
the PPAP submission or SOP date.

The next FMEA date is the date where the original FMEA completed and
release.

8. Prepared By : 
Enter the name of facilitator / the
group / person who prepare the
FMEA.

9. Operation no., Description & Requirement:

For Process FMEA we have to enter the operation number as per the
sequence in process flow. Write the operation name / process name /
Description in respective column. Then enter the process/ operation
requirement in 3rd column.

Item/Function :

For Design FMEA, enter the name and item being analyzed and show the
design level as indicated on drawing. Enter the function of the item to meet
design intent. Include environment issues (e.g. Temp., pressure, humidity
etc.) If the item has more than one function with different potential
modes of failure, list all the functions separately.

10. Potential Failure Mode :

Identify and list the each failure that could potentially fail to meet the
design intent. A recommended starting point is a review of past things gone
wrong, concern reports and group brainstorming.


11. Potential Effect of Failure Mode :

Identify the effect of the failure mode on the function as perceived by the
customer. It is stated in terms of the specific system, subsystem or
component being analyzed.

12. Severity (S) :

It is an assessment of the seriousness of the effect of the potential failure

mode to the next component, system, subsystem or customer. Severity
applies to the effect only. A reduction in severity ranking index can be
affected only through a design change. It could be estimated on a “1” to
“10” scale.

Severity is the value associated with the most serious effect for a given
failure mode.


13. Classification :

Classify any special product characteristics (e.g. Critical, key major,

significant (https://qualityengineerstuff.com/sc-and-cc/)) for components,
subsystem, system that may require additional process controls. Each item
identified here in Design FMEA should have the special process controls
identified in the Process FMEA.

14. Potential causes of failure :

It is an indication of a design weakness, the consequences of which is the

failure mode. The cause should be listed so that remedial efforts can be
aimed at pertinent causes.


15. Current Design / Process Control (Prevention):

List the prevention, design validation/verification (which will assure the

design adequacy for the failure and cause under consideration. There are 3
types of design controls : 1) Prevent the cause or failure mode effect from
occurring or reduce 2) Detect the cause and lead to corrective action and 3)
Detect the failure mode.

Avoid failure cause if possible, otherwise avoid failure

Actions apply to design and not to hardware
Actions assure observation of specifications

16. Current Design / Process control (Detection)

Detection of failure cause

Tests apply to assembly or parts (Hardware)
Tests according to fulfillment of function and not to fulfillment of
specification

17. Occurrence :

The value for occurrence evaluates the likeliness with which the cause can
occur and generate a failure mode and is defined by the number of
warranty cases. If the evaluated product is a new

development and there are no warranty cases the value for “Occurrence”
will have to be rated
according to experiences from former projects.

A value of 10 means that the likeliness of

occurrence of failure cause is high, like if it is a new technology.

Occurrence ranking table as per AIAG is as below

18. Detection :

Detection column is for the rank associated

with the best detection control list in the
Current Design / Process Control detection
column.

This detection ranking table as per AIAG as below,


19. RPN:

The RPN is evidence as the risk of a failure / a failure cause.

Severity x Occurrence x Detection = Risk Priority Number

If the RPN is higher than a threshold-value (specified by customer or

internal specification) there must follow an optimization, including one or
multiple actions, to lower the risk and with that the RPN. so If the
revaluation is not successful, the team will have to arrange a new action if
the value of RPN is above the defined threshold-value.
Occurrence and detection are independent from each other.
A FMEA report summarizes the knowledge of a development team of the
product, system or process and the risk assessment of the design.
It is important to know that FMEA reports are not being issue to
customer as it contains expertise of the company.
19. Recommended Action(s) : 
The recommended action is the action taken on highest RPN’s, to reduce
the respective occurrence & severity ranking.

20. Responsibility :

Enter the organization and individual responsibility for the recommended

action and the target completion date.

21. Action Taken :

After the recommended actions has been implement, enter a brief

description of the actual action and effective date.

22. New RPN :

After the corrective action identified, estimate and record the resulting
severity, occurrence and detection rankings to calculate resulting RPN.

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