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When a process, product or service is being designed or redesigned, after quality function deployment.
When improvement goals are planned for an existing process, product or service.
FMEA Procedure
(Again, this is a general procedure. Specific details may vary with standards of your organization or industry.)
1.
Assemble a cross-functional team of people with diverse knowledge about the process, product or service
and customer needs. Functions often included are: design, manufacturing, quality, testing, reliability,
maintenance, purchasing (and suppliers), sales, marketing (and customers) and customer service.
2.
Identify the scope of the FMEA. Is it for concept, system, design, process or service? What are the
boundaries? How detailed should we be? Use flowcharts to identify the scope and to make sure every
team member understands it in detail. (From here on, well use the word scope to mean the system,
design, process or service that is the subject of your FMEA.)
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Fill in the identifying information at the top of your FMEA form. Figure 1 shows a typical format. The
remaining steps ask for information that will go into the columns of the form.
Identify the functions of your scope. Ask, What is the purpose of this system, design, process or service?
What do our customers expect it to do? Name it with a verb followed by a noun. Usually you will break the
scope into separate subsystems, items, parts, assemblies or process steps and identify the function of
each.
5.
For each function, identify all the ways failure could happen. These are potential failure modes. If
necessary, go back and rewrite the function with more detail to be sure the failure modes show a loss of
that function.
6.
For each failure mode, identify all the consequences on the system, related systems, process, related
processes, product, service, customer or regulations. These are potential effects of failure. Ask, What
does the customer experience because of this failure? What happens when this failure occurs?
7.
Determine how serious each effect is. This is the severity rating, or S. Severity is usually rated on a scale
from 1 to 10, where 1 is insignificant and 10 is catastrophic. If a failure mode has more than one effect,
write on the FMEA table only the highest severity rating for that failure mode.
8.
For each failure mode, determine all the potential root causes. Use tools classified as cause analysis tool,
as well as the best knowledge and experience of the team. List all possible causes for each failure mode
on the FMEA form.
9.
For each cause, determine the occurrence rating, or O. This rating estimates the probability of failure
occurring for that reason during the lifetime of your scope. Occurrence is usually rated on a scale from 1 to
10, where 1 is extremely unlikely and 10 is inevitable. On the FMEA table, list the occurrence rating for
each cause.
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FMEA Example
A bank performed a process FMEA on their ATM system. Figure 1 shows part of itthe function dispense cash and
a few of the failure modes for that function. The optional Classification column was not used. Only the headings are
shown for the rightmost (action) columns.
Notice that RPN and criticality prioritize causes differently. According to the RPN, machine jams and heavy
computer network traffic are the first and second highest risks.
One high value for severity or occurrence times a detection rating of 10 generates a high RPN. Criticality does not
include the detection rating, so it rates highest the only cause with medium to high values for both severity and
occurrence: out of cash. The team should use their experience and judgment to determine appropriate priorities for
action.
Excerpted from Nancy R. Tagues The Quality Toolbox, Second Edition, ASQ Quality Press, 2004, pages 236240
asq.org/learn-about-quality/process-analysis-tools/overview/fmea.html
http://www.google.com.sa/url?
sa=t&rct=j&q=&esrc=s&source=web&cd=7&cad=rja&uact=8&ved=0ahUKEwiF8qS7iNXPAhVE7hoKHRymBN8QFgg3
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%2F0873898567.pdf&usg=AFQjCNHQ6kY77Ec0qO3kRDwhy5Pxc6RnxA
cardenas.pe/carlos/sixsigma/0873898567.pdf
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Functi
on or Failur Potential
Proces e Type Impact
s Step
SEV
Potent
ial
OCC
Causes
Detecti
on
DET
Mode
Briefly
outline
functio
n, step
or item
being
How
severe is
the
effect to
the
custome
What
causes
the key
input to
go
wrong?
What are
the
existing
controls
that
either
Descri
be
what
has
gone
wrong
What is the
impact on
the key
output
variables or
internal
How
frequent
ly is this
likely to
occur?
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How
easy
is it to
detect
?
RPN
Risk
priorit
y
numb
er
analyze
d
Tire
functio
n:
support
Flat
weight
tire
of car,
traction
,
comfort
requirement
r?
s?
prevent
the
failure
from
occurrin
g or
detect it
should it
occur?
Stops car
journey,
driver and
10
passengers
stranded
Tire
checks
before
journey.
While
driving, 3
steering
pulls to
one side,
excess
noise
Punctur
2
e
Recommen
Responsib Target
ded
ility
Date
Actions
Action
Taken
SE OC DE RP
V C T N
What were
What are the
the actions
actions for
implemente
Who is
What is the
reducing the
d? Now
responsible target date
occurrence
recalculate
for the
for the
of the cause
the RPN to
recommend recommend
or improving
see if the
ed action? ed action?
the
action has
detection?
reduced the
risk.
Carry spare Car owner
tire and
appropriate
tools to
change tire
From
immediate
effect
Spare tire
4
and
appropriate
tools
permanentl
y carried in
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24
60
Low
High
Number Number
Description
High
impact
Not likely
Inevitable
to occur
Very
Not likely
likely to
to be
be
detected
detected
After ranking the severity, occurrence and detection levels for each failure mode, the team will be able to calculate a risk priority
number (RPN). The formula for the RPN is:
RPN = severity x occurrence x detection
In the FMEA in Figure 1, for example, a flat tire severely affects the customer driving the car (rating of 10), but has a low level of
occurrence (2) and can be detected fairly easily (3). Therefore, the RPN for this failure mode is 10 x 2 x 3 = 60.
Setting Priorities
Once all the failure modes have been assessed, the team should adjust the FMEA to list failures in descending RPN order. This
highlights the areas where corrective actions can be focused. If resources are limited, practitioners must set priorities on the
biggest problems first.
There is no definitive RPN threshold to decide which areas should receive the most attention; this depends on many factors,
including industry standards, legal or safety requirements, and quality control. However, a starting point for prioritization is to
Saudi Aramco: Company General Use
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What Is FMEA?
FMEA is a system for analyzing the design of a product or service system to identify potential failures, then taking steps to
counteract or at least minimize the risks from those failures.
The FMEA process begins by identifying failure modes, the ways in which a product, service or process could fail. A project
team examines every element of a service, starting from the inputs and working through to the output delivered to the customer.
At each step, the team asks what could go wrong here?
Here are a few simple examples of failure modes related to the process of providing hot coffee at a truck stop:
One of the inputs to that process is a clean coffee pot. What could go
wrong? Perhaps the water in the dishwasher is not hot enough, so the coffee
pot is not really clean.
The first step in the process is to fill the brewing machine with water. What
could go wrong? Perhaps the water is not the right temperature or the staff
puts in too much or too little.
An output from the process is a hot cup of coffee delivered to the customer.
What could go wrong? The coffee could get too cool before it is delivered.
Of course, all failures are not the same. Being served a cup of coffee that is just hot water is much worse than being served a cup
that is just a bit too cool. A key element of FMEA is analyzing three characteristics of failures:
Saudi Aramco: Company General Use
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Severity score: 8
Frequency score: 4
Likelihood of detecting: 4
RPN = 8 x 4 x 4 = 128
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At the beginning of a project, FMEA can help a team better scope the
opportunity by defining the types of failures and narrowing the focus to a
specific type of problem.
In the Improve phase, FMEA can help uncover potential problems (especially
unintended consequences) with suggested solutions, thereby allowing timely
adjustments.
In the Control phase, FMEA helps identify what measures need to be in place
to make sure that failures will not happen in the future.
Project teams trying FMEA for the first time are advised to keep it simple. Think of it as structured brainstorming a technique
to get teams thinking about potential failures it has not thought of before. Bring together people from different work areas and
disciplines. FMEA works best in a team environment with cross-functional representation. Subject matter expertise is critical.
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Item(s)
Function(s)
Failure(s)
Effect(s) of Failure
Cause(s) of Failure
Current Control(s)
Recommended Action(s)
Most analyses of this type also include some method to assess the risk associated with the issues identified during the analysis
and to prioritize corrective actions. Two common methods include:
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Figure 1
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Rate the likelihood of prior detection for each cause of failure (i.e. the likelihood of
detecting the problem before it reaches the end user or customer).
The RPN can then be used to compare issues within the analysis and to prioritize problems for corrective action.
Criticality Analysis
The MIL-STD-1629A document describes two types of criticality analysis: qualitative and quantitative.
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Note: The quantitative criticality analysis in ReliaSoft's software tools (Xfmea and RCM++) is patterned after the concepts in
MIL-STD-1629A but modified to use a more general approach that overcomes several inherent limitations and simplifications
present in MIL-STD-1629A (including the assumption of a constant failure rate). For specific details on this approach, see
http://www.ReliaWiki.org/index.php/Criticality_Analysis.
References
The following resources provide additional information on FMEA / FMECA.
Web Resources
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SAE International: The Society for Automotive Engineers provides the ability to
purchase the J1739 and ARP5580 standards, as well as the AIR4845 document.
AIAG: The Automotive Industry Action Group provides the ability to purchase the
AIAG FMEA Fourth Edition (FMEA-4) guidelines.
Effective FMEAs - Reader's Website: This website is dedicated to the readers of the
Effective FMEAs book by Carl S. Carlson. It contains checklists, links and articles related
to performing FMEAs.
NASA STI Special Bibliography for FMEA: NASA's Scientific and Technical Information
(STI) program provides a "sampler bibliography" that contains abstracts for documents
related to Failure Mode and Effects Analysis (FMEA) and Failure Modes, Effects and
Criticality Analysis (FMECA) in the NASA STI Database.
Printed Resources
Automotive Industry Action Group (AIAG), Potential Failure Mode and Effects
Analysis (FMEA Third Edition or Fourth Edition). July, 2001 or June, 2008.
Automotive Industry Action Group (AIAG), Advanced Product Quality Planning and
Control Plan (APQP First Edition or Second Edition). June, 1994 or July 2008.
Carlson, Carl S., Effective FMEAs: Achieving Safe, Reliable, and Economical Products
and Processes using Failure Mode and Effects Analysis. John Wiley & Sons, Hoboken,
New Jersey, 2012.
Crowe, Dana and Alec Feinberg, Design for Reliability. Ch. 12 "Failure Modes and
Effects Analysis." CRC Press, Boca Raton, Florida, 2001.
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Dhillon, B.S., Design Reliability: Fundamentals and Applications, Ch. 6 "Failure Modes
and Effects Analysis." CRC Press, Boca Raton, Florida, 1999.
McDermott, Robin E., Raymond J. Mikulak and Michael R. Beauregard, The Basics of
FMEA. Productivity Inc., United States, 2008.
Stamatis, D.H., Failure Mode and Effect Analysis: FMEA from Theory to Execution.
American Society for Quality (ASQ), Milwaukee, Wisconsin, 1995.
Hyperlinks to third-party websites are provided by ReliaSoft Corporation as a convenience to the user. ReliaSoft does not control these sites and is not
responsible for the content, update or accuracy of these sites. ReliaSoft does not endorse or make any representations about the companies, products, or
materials accessible through these hyperlinks. If you opt to hyperlink to sites accessible through this site, you do so entirely at your own risk.
http://www.weibull.com/basics/fmea.htm
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Xfmea
[Editor's Note: This article has been updated since its original publication to reflect a more recent version of the software
interface.]
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.
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 5 or 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, Figure 1 shows a generic five point scale
for Severity [Stamatis, 445].
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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.
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.
Occurrence/Severity
Matrix
Because the RPN is the product of three ratings, different circumstances can produce similar or identical RPNs. For example, an
RPN of 100 can occur when S = 10, O = 2 and D = 5; when S = 1, O = 10 and D = 10; when S = 4, O = 5 and D = 5, etc. In
addition, it may not be appropriate to give equal weight to the three ratings that comprise the RPN. For example, an organization
may consider issues with high severity and/or high occurrence ratings to represent a higher risk than issues with high detection
ratings. Therefore, basing decisions solely on the RPN (considered in isolation) may result in inefficiency and/or increased risk.
The Occurrence/Severity matrix provides an additional or alternative way to use the rating scales to prioritize potential problems.
This matrix displays the Occurrence scale vertically and the Severity scale horizontally. The points represent potential causes of
failure and they are marked at the location where the Severity and Occurrence ratings intersect. The analysis team can then
establish boundaries on the matrix to identify high, medium and low priorities. Figure 2 displays a matrix chart generated with
ReliaSoft's Xfmea software. In this example, the Occurrence and Detection ratings were set based on a ten point scale, the high
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# = Corrective action needed if the Detection rating is equal to or greater than the
given number.
For example, according to the risk ranking table in Figure 4, if Severity = 6 and Occurrence = 5, then corrective action is required
if Detection = 4 or higher. If Severity = 9 or 10, then corrective action is always required. If Occurrence = 1 and Severity = 8 or
lower, then corrective action is never required, and so on.
Other variations of this decision-making table are possible and the appropriate table will be determined by the organization or
analysis team based on the characteristics of the product or process being analyzed and other organizational factors, such as
budget, customer requirements, applicable legal regulations, etc.
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 and/or risk ranking tables. 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.
ReliaSoft's Xfmea software facilitates analysis, data management and reporting for all types of FMEA, with features to support
most of the RPN techniques described here. On the web at http://www.ReliaSoft.com/xfmea.
References
The following references relate directly to the examples presented in this article. Numerous other resources are available on
FMEA techniques and styles.
Crowe, Dana and Alec Feinberg, Design for Reliability, Chapter 12 "Failure Modes and Effects Analysis." CRC Press, Boca
Raton, FL, 2001.
McCollin, Chris, "Working Around Failure." Manufacturing Engineer, February 1999. Pages 37-40.
Stamatis, D.H., Failure Mode and Effect Analysis: FMEA from Theory to Execution.
American Society for Quality (ASQ), Milwaukee, Wisconsin, 1995.
http://www.reliasoft.com/newsletter/2q2003/rpns.htm?
_ga=1.138643697.310119673.1476524044
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www.stat.purdue.edu/~kuczek/stat513/IT%20381_Chap_7.ppt
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