SPI/ QSP/14/FMEA

QUALITY SYSTEM PROCEDURE Issue: C

Rev. No: 01
Date: 20.01.2020
FAILURE MODE EFFECTIVE ANALYSIS
Page 1 of 7

1.0 Purpose
This procedure provides a systematic analysis of potential failure modes aimed at preventing
failures. It is intended to be a preventive action process carried out before implementing new or
changes in products or processes. An effective FMEA identifies corrective actions required to
prevent failures from reaching the customer; and to assure the highest possible yield, quality,
and reliability
2.0 Application
This procedure applies to FMEAs are conducted in the product design or process development
stages, although conducting it on existing products and processes may also yield benefits

3.0 Responsibility
Roles, Responsibility and Authority for various activities of ‘Failure Mode Effective analysis
Director, Quality Head and New Product Development Team.

4.0 Terms and definitions

FMEA – Failure Mode Effective analysis
RPN –Risk Priority Number
FM- Failure Modes
5.0 Procedure:
Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for evaluating
a process to identify where and how it might fail and to assess the relative impact of
different failures, in order to identify the parts of the process that are most in need of
change. FMEA includes review of the following steps:
1. Review the process
2. Review the process every customer complaint with in 30 days

2. Brainstorm potential failure modes

3. List potential effects of each failure mode

4. Assign a severity rating for each effect

5. Assign an occurrence rating for each FM

6. Assign detection rating for each FM and/or effects

7. Calculate the risk priority # (RPN) for each effect

8. Prioritize the FMs for action

9. Take action to eliminate or reduce the high-risk FMs

10. Calculate the Resulting RPN as the FMs are reduced or eliminated

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 SPI/ QSP/14/FMEA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 01
Date: 20.01.2020
FAILURE MODE EFFECTIVE ANALYSIS
Page 2 of 7

1.0 Select a process to evaluate with FMEA

Evaluation using FMEA works best on processes of doing an FMEA on a large and complex process, such as
Automotive Product, try doing an FMEA on sub processes or variants. Conducting an FMEA of the entire
IATF 16949:2016 management process would be a task. Instead, consider individual FMEA analyses of the
Process
2.0 Recruit a multidisciplinary team
Be sure to include everyone who is involved at any point in the process. Some people may not need to be
part of the team throughout the entire analysis, but they should certainly be included in discussions of
those steps in the process in which they are involved. For example, a New product development team and
quality executive in the line of production quality delivery for all the products

3.0 Have the team meet together to list all of the steps in the process
Number every step of the process, and be as specific as possible. It may take several meetings for
the team to complete this part of the FMEA, depending on the number of steps and the complexity of
the process. Flowcharting can be a helpful tool for outlining the steps. When you are finished, be
sure to obtain consensus from the group. The team should agree that the steps enumerated in the
FMEA accurately describe the process.
4.0 Have the team list failure modes and causes
For each step in the process, list all possible “failure modes”—that is, anything that could go wrong,
including minor and rare problems. Then, for each failure mode listed, identify all possible causes
5.0 For each failure mode, have the team assign a numeric value (known as the Risk
Priority Number, or RPN) for likelihood of occurrence, likelihood of detection, and severity
Assigning RPNs helps the team prioritize areas to focus on and can also help in assessing
opportunities for improvement. For every failure mode identified, the team should answer the
following questions and assign the appropriate score (the team should do this as a group and have
consensus on all values assigned):
The Risk Priority Number (RPN) methodology is a technique for analyzing the risk associated with
potential problems identified during a Failure Mode and Effects Analysis (FMEA). This article presents
a brief overview of the basic RPN method and then examines some additional and alternative ways to
use RPN ratings to evaluate the risk associated with a product or process design and to prioritize
problems for corrective action. Note that this article discusses RPNs calculated at the level of the
potential causes of failure (Severity x Occurrence x Detection). However, there is a great deal of
variation among FMEA practitioners as to the specific analysis procedure and some analyses may
include alternative calculation methods.

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 SPI/ QSP/14/FMEA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 01
Date: 20.01.2020
FAILURE MODE EFFECTIVE ANALYSIS
Page 3 of 7

5.1 Overview of Risk Priority Numbers An FMEA can be performed to identify the potential failure
modes for a product or process. The RPN method then requires the analysis team to use past experience
and engineering judgment to rate each potential problem according to three rating scales:

 Severity, which rates the severity of the potential effect of the failure.
 Occurrence, which rates the likelihood that the failure will occur.
 Detection, which rates the likelihood that the problem will be detected before it reaches the
end-user/customer.

Rating scales usually range from 1 to 10, with the higher number representing the higher seriousness or
risk. For example, on a ten point Occurrence scale, 10 indicates that the failure is very likely to occur and is
worse than 1, which indicates that the failure is very unlikely to occur. The specific rating descriptions and
criteria are defined by the organization or the analysis team to fit the products or processes that are being
analyzed. As an example

Rating Description Criteria

1 No No effect
2 Very slight Customer not annoyed very slight effect on
product or system performance
3 Slight Customer slightly annoyed. Slight effect on product or system
performance
4 Minor Customer experiences minor nuisance. Minor effect on
product or system performance
5 Moderate Customer experiences some dissatisfaction. Moderate effect
on product or system performance
6 Significant Customer experiences discomfort. Product performance
degraded, but operable and safe. Partial failure, but
operable
7 Major Customer dissatisfied. Product performance severely affected
but function able and safe. System impaired.
8 Extreme Customer very dissatisfied. Product inoperable but safe.
System inoperable
9 Serious Potential hazardous effect. Able to stop product without
mishap time dependent failure. Compliance with
government regulation is in jeopardy
10 Hazardous Hazardous effect. Safety related sudden failure. Non-

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 SPI/ QSP/14/FMEA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 01
Date: 20.01.2020
FAILURE MODE EFFECTIVE ANALYSIS
Page 4 of 7

compliance with government regulation

Qualitative scale for the severity index (S)

Rating Description Criteria

1 Almost never Failure unlikely. History shows no failure
2 Remote Rare number of failures likely
3 Very slight Very few failures likely.
4 Slight Few failures likely
5 Low Occasional number of failures likely
6 Medium Medium number of failures likely.
7 Moderately high Moderately high number of failures likely.
8 High High number of failures likely
9 Very high Very high number of failures likely
10 Almost certain Failure almost certain. History of failures e x i s t s
from previous or similar designs.

Qualitative scale for the occurrence index (O)

Rating Description Criteria

1 Almost certain Proven detection methods available in concept stage
2 Very high Proven computer analysis available in early design
stage
3 High Simulation and/ or modeling in early stage.
4 Moderately high Tests on early prototype system elements.
5 Medium Tests on preproduction system components.
6 Low Tests on similar system components.
7 Slight Tests on product with prototypes with system
components installed.
8 Very slight Proving durability tests on products with system
components installed
9 Remote Only unproven or unreliable technique(s) available.
10 Almost impossible No known techniques available

. Qualitative scale for the detection index (D)

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 SPI/ QSP/14/FMEA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 01
Date: 20.01.2020
FAILURE MODE EFFECTIVE ANALYSIS
Page 5 of 7

After the ratings have been assigned, the RPN for each issue is calculated by multiplying Severity x
Occurrence x Detection.

The RPN value for each potential problem can then be used to compare the issues identified within the
analysis. Typically, if the RPN falls within a pre-determined range, corrective action may be
recommended or required to reduce the risk (i.e., to reduce the likelihood of occurrence, increase the
likelihood of prior detection or, if possible, reduce the severity of the failure effect). When using this
risk assessment technique, it is important to remember that RPN ratings are relative to a particular
analysis (performed with a common set of rating scales and an analysis team that strives to make
consistent rating assignments for all issues identified within the analysis). Therefore, an RPN in one
analysis is comparable to other RPNs in the same analysis but it may not be comparable to RPNs in
another analysis.

The rest of this article discusses related techniques that can be used in addition to or instead of the
basic RPN method described here.

6.0 Revised RPNs and Percent Reduction in RPN

In some cases, it may be appropriate to revise the initial risk assessment based on the assumption (or
the fact) that the recommended actions have been completed. This provides an indication of the
effectiveness of corrective actions and can also be used to evaluate the value to the organization of
performing the FMEA. To calculate revised RPNs, the analysis team assigns a second set of Severity,
Occurrence and Detection ratings for each issue (using the same rating scales) and multiplies the revised
ratings to calculate the revised RPNs. If both initial and revised RPNs have been assigned, the percent
reduction in RPN can also be calculated as follows:

For example, if the initial ratings for a potential problem are S = 7, O = 8 and D = 5 and the revised
ratings are S = 7, O = 6 and D = 4, then the percent reduction in RPN from initial to revised is (280-
168)/280, or 40%. This indicates that the organization was able to reduce the risk associated with the
issue by 40% through the performance of the FMEA and the implementation of corrective actions.

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 SPI/ QSP/14/FMEA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 01
Date: 20.01.2020
FAILURE MODE EFFECTIVE ANALYSIS
Page 6 of 7

7.0 Conclusion
As this article demonstrates, the Risk Priority Number (RPN) methodology can be used to assess the risk
associated with potential problems in a product or process design and to prioritize issues for corrective
action. A particular analysis team may choose to supplement or replace the basic RPN methodology with
other related techniques, such as revised RPNs, the Occurrence/Severity matrix, ranking lists, risk
ranking tables and/or higher level RPNs. All of these techniques rely heavily on engineering judgment
and must be customized to fit the product or process that is being analyzed and the particular
needs/priorities of the organization.

Changes

Required changes of this Procedure have to be directed in writing to the team leader of this
Procedure. Such change requests will be discussed within the team and in case of improvement
implemented into the Procedure. The changes have to be described in the revision sheet.
Responsible for documentation and change of the Procedure on the sheet “Revision” is the team
leader.
8.0 Distribution

After release by the QMS Co-Ordinator this Quality System Procedure will be released with
controlled copy to related department as per the distribution list of documents by QMS Co-
Ordinator.

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 SPI/ QSP/14/FMEA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 01
Date: 20.01.2020
FAILURE MODE EFFECTIVE ANALYSIS
Page 7 of 7

9.0 Revisions
Sl:
Revision Date Description of change
No
1 C/00 01.01.2019 New release for IATF16949:2016 Standard

2 C/01 20.01.2020 Every customer complaint review FMEA with 30 days

Revisions authorized by:

Prepared: 20.01.2020 K.M.VIMAL KUMAR

_____________________________ _______________________________________________________________________________________________________________

Date QMS Coordinator

Approved: 20.01.2020 P.GANESH KANDHASAMY

___________________________ _______________________________________________________________________________________________________________

Date MANAGING DIRECTOR

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