Failure Mode and Effects Analysis (FMEA)

By:S.K.Sethiya, Dy. CME, West Central Railway at Jabalpur

Abstract

Failure Mode and Effects Analysis (FMEA) is a systematic process for looking at how a design or process
could fail and the possible results of a failure. The purpose of FMEA is to examine possible failure modes
and determine the impact of these failures on the product (Design FMEA - DFMEA), process (Process
FMEA -PFMEA) or service (Service FMEA - SFMEA). From there, FMEA team members identify the
steps necessary to eliminate or minimize the potential causes of each potential failure, before they occur. A
Design or Product FMEA focuses on specific systems or components such as raw materials, sub-assemblies
and finished goods, while a Process FMEA focuses on a process and its individual steps. The early and
consistent use of FMEAs in the design process allows the engineer to design out failures and produce
reliable, safe, and customer pleasing products. FMEAs also capture historical information for use in future
product improvement. The aim of this paper is to give introduction of FMEA technique, FMEA Procedure,
understanding of Risk Priority Number ( RPN), Benefits ,Limitations & Abuses of FMEA.RPN the most
important item from the risk values point of view, characterized by high RPN, and should be separated
from those characterized by a significantly lower RPN value. Efforts should undertake to reduce the
calculated risk through corrective actions.

Introduction

In present scenario of growing global marketing customers are demanding high quality,
reliable products. The increasing capabilities and functionality of many products are
making it more difficult for manufacturers to maintain the quality and reliability in
competitive environment. There is virtually no margin for error, so when a company is
introducing a new product, reengineering a process - or undertaking any project –
company want to ensure success and minimize the risk of failure. But success doesn't
happen by chance. This is a challenge to manufacturers to design a quality and reliable
product early in the developmental stage. The way to ensure it is through the use of
Failure Mode and Effects Analysis (FMEA) - a proven method for minimizing failure in
products and processes

Failure Mode Effect Analysis (FMEA) is one of the well known risk-assessment
methodology for analyzing potential reliability problems, early in the development cycle
where it is easier to take actions to overcome these issues, thereby enhancing reliability
through design. FMEA was first used in 1960’s in the aerospace industry and helping to
make safe, effective commercial air travel possible. It is now recognized as a
fundamental tool in the Reliability Engineering field. In the 1970's FMEA helped the
auto industry improve its track record by minimizing risks and improving safety and
performance. Today, the specialists at Competitive Edge Resources bring the same
benefits of FMEA to companies in a wide range of industries - enabling them to bring
new products to market faster and at a lower cost.

FMEA goes beyond the pre-conceived notions or limitations of a single department and
gets cross-functional teams working on effective solutions. FMEA sessions typically
bring together staff from quality assurance, manufacturing, manufacturing engineering,
design engineering, marketing/sales, and the shop floor, at a minimum. FMEA is
actionable providing all the information needed to begin reducing the risks in a particular
design or process.

There are several types of FMEAs, some are used much more often than others. FMEAs
should always be done whenever failures would mean potential harm or injury to the user
of the end item being designed. The types of FMEA are:

System FMEA - Sy.FEMA: focuses on global system functions design, is used to

analyze system designs before they are released to function . System FMEA focuses on
potential failure modes associated with the functions of systems and caused by the design
deficiencies.
Design FMEA - DFMEA: focuses on components and subsystems, is used to analyze
product designs before they are released to production. DFMEA focuses on potential
failure modes associated with the functions of product and caused by the design
deficiencies.

Process FMEA -PFMEA: focuses on manufacturing and assembly processes, is used to

analyze the already developed or existing processes. PFMEA focuses on potential failure
modes associated with both the process safety/effectiveness/efficiency, and the functions
of a product caused by the process problems.
Service FMEA – SFMEA: focuses on service functions SFMEA is used to analyze the
product serviceability, i.e. it is focused on the potential problems associated with both
maintenance issues and field failures of the manufactured products.
Software FEMA- Soft. FEMA: focuses on software functions design, is used to analyze
software designs before they are released to function. Software FMEA focuses on
potential failure modes associated with the functions of developed software and caused
by the design deficiencies in programme.
Timing
1. Initially, the FMEA should be performed while in the design stage, but it also may be
used throughout the life cycle of a product to identify possible failures as the system
ages.
2. Failure mode and effect analyses
may vary in the level of detail
reported, depending
upon the detail needed and the
availability of information. As a
development matures, assessment of
criticality is added in what become a
Failure Mode, Effects, and Criticality
Analysis (FMECA).
A failure mode, effects, and criticality
analysis can be a starting point for
many other types of analyses,
including:
1. System Safety Analysis
2. Production Planning
3. Test Planning and Validation
4. Repair Level Analysis
5. Logistics Support Analysis
6. Maintenance Planning Analysis.
These additional analyses may also be used to update and improve the FMECA as new
information evolves.

Basic approaches
There are two basic approaches for conducting an FMECA: a bottom-up (Hardware) approach
and a top-down (Functional) approach. Either method can be successfully used in an RCM
analysis, but each has its strengths and weaknesses. The key attribute of both approaches is that
they are inductive analysis techniques that guide the RCM analysis team in establishing the
cause-and-effect relationship needed to define maintenance requirements and discover other
improvements. The following table describes each approach.

Bottom-up (Hardware) FMECA Approach Top-down (Functional) FMECA Approach

This type of approach investigates smaller This type of approach assumes a failure,
portions of the system, such as and then identifies how that failure could
subassemblies and individual components. occur.

Performed by explicitly analyzing each
equipment item of interest.
Focuses on determining what effects different
equipment failure modes have on the operation
of the system.
Determines whether the equipment
failure mode results in a local effect that causes
a functional failure that causes an end effect
of interest.
This type of approach ensures that all
equipment items are analyzed and all plausible
equipment failure modes are considered. In
addition, a standard list of failure modes can be
developed for common equipment items, the
following guide phrases may be used to help
develop a list of failure modes to be
considered:
i) Premature operation
ii) Failure to operate at a prescribed time
iii) Intermittent operation
iv) Failure to cease operation at a prescribed
time
v) Loss of output or failure during operation
vi) Degraded output or operational capability
Performed by analyzing each function and its
associated functional failures.
Focuses on determining what effects different
functional failures have on the operation of the
system and then what equipment failures (e.g.,
failure mode) can result in the functional
failure.
Determines whether the functional failure
results in an end effect of interest and then
determines which equipment failures can cause
the functional failure.
This type of approach is typically used
when individual items cannot be identified
or a complex system exists.
The functional approach generally involves
a top-down analysis in which a specific
failure mode for the entire system is traced
back to the initiating subsystem failure
mode(s).
vii) Other unique failure conditions
thus making the analysis somewhat easier to
perform and helping to ensure consistency
between RCM teams
Following are the steps for performing a Following are the steps for performing a top-
bottom-up FMECA: down FMECA:
i) Select an equipment item for analysis i) Select a function for analysis
Identify the potential failure modes for the
equipment item
ii) Select a failure mode for evaluation ii) Select a functional failure for evaluation

v) Determine the local, next higher level and
end effects for the postulated failure mode
If the end effect results in a consequence of
interest, determine the causes of the
failure mode
iii) Determine the local and end effects for the
postulated functional failure If the end effect
results in a consequence of interest, determine
the equipment failures that can result in the
functional failure

iv) Determine the failure characteristic (e.g., v) Determine the failure characteristic (e.g.,
wear-in, random, wear-out) for the failure wear-in, random, wear-out) for the failure
mode mode

vii) Determine the criticality of the failure vi) Determine the criticality of the failure mode
mode using the risk decision tool using the risk decision tool

viii) Repeat steps as necessary until all vii) Repeat steps until all functions and
equipment items and associated failure modes functional failures are evaluated
have been evaluated

FMEA Procedure

The process for conducting an FMEA is straightforward. The basic steps are as under :

1. Describe the product/process /system and its function. An understanding of the

product or process/ system under consideration is important to have clearly
articulated. This understanding simplifies the process of analysis by helping the
engineer identify those product/process uses that fall within the intended function
and which ones fall outside. It is important to consider both intentional and
unintentional uses since product failure often ends in litigation, which can be
costly and time consuming.

2. Create a Block Diagram of the product or process/system. A block diagram of the

product/process /system should be developed. A block diagram is used to show
how the different parts of the system interact with one another to verify the
critical path. The recommended way to analyze the system is to break it down to
different levels (i.e., system, subsystem, subassemblies, field replaceable units).
Review schematics and other engineering drawings of the system being analyzed
to show how different subsystems, assemblies or parts interface with one another
by their critical support systems such as power, plumbing, actuation signals, data
 flow, etc. to understand the normal functional flow requirements. A list of all
functions of the equipment is prepared before examining the potential failure
modes of each of those functions. Operating conditions (such as; temperature,
loads, and pressure), and environmental conditions may be included in the
components list.
The diagram shows the logical relationships of components and establishes a
structure around which the FMEA can be developed. Establish a Coding System
to identify system elements. The block diagram should always be included with
the FMEA form.

SYSTEM BREAKDOWN CONCEPT

SYSTEM… a
composite of
subsystems whose
functions are integrated
to achieve a mission /
function (includes
materials, tools,
personnel, facilities,
software, equipment)
SUBSYSTEM… a
composite of
assemblies whose
functions are integrated
to achieve a specific
activity necessary for
achieving a mission
ASSEMBLY… a composite of subassemblies

SUBASSEMBLY… a composite of components

COMPONENT… a composite of piece parts

PIECE PART… least fabricated item, not further reducible

INTERFACE… the interaction point(s) necessary to produce the desired /

essential effects between system elements (interfaces transfer
energy / information, maintain mechanical integrity, etc.
A example of pressure cooker given below is
illustrates System description and block diagram
:

• Electric coil heats cooker.

• Thermostat controls temperature
— Switch opens >250° F.

• Spring-loaded Safety Valve

opens on overpressure.

• Pressure Gage red zone

indicates overpressure.

• High temperature/pressure
cooks/sterilizes food — tenderizes
and protects against
botulin toxin.

3. Complete the header on the FMEA Form worksheet: Product/System,

Subsys./Assy., Component, Design Lead, Prepared By, Date, Revision (letter or
number), and Revision Date. Modify these headings as needed.
 4. Use the diagram prepared above to begin listing items or functions. If items are
components, list them in a logical manner under their subsystem/assembly based on
the block diagram.

5. Identify Failure Modes. A failure mode is defined as the manner in which a

component, subsystem, system, process, etc. could potentially fail to meet the
design intent. Or the manner in which a fault occurs, i.e. the way in which the
element faults. Some example of failure mode are shown in table below;

Element Failure Mode Examples

Switch open, partially open, closed, partially closed, chatter

Relay contacts closed, contacts open, coil burnout, coil short

Cable stretch, break, kink, fray

Valve open, partially open, closed, partially closed, wobble

Spring stretch, compress/collapse, fracture

Operator wrong operation to proper item, wrong operation to wrong item
proper operation to wrong item, perform too early
 Failure causes, such as normal wear and tear, corrosion, abrasion, erosion, fatigue,
etc., should be recorded in sufficient detail to enable an appropriate failure
management strategy to be identified. Failures caused by human error should be
included if firm evidence exists to support such failures, or if operator error can
induce significant consequences. It is important to ensure that the causes are
sufficiently identified so that the subsequent maintenance recommendations address
the cause of failure rather than its symptoms.
6. A failure mode in one component can serve as the cause of a failure mode in another
component. Each failure should be listed in technical terms. Failure modes should be
listed for function of each component or process step. At this point the failure mode
should be identified whether or not the failure is likely to occur. Looking at similar
products or processes and the failures that have been documented for them is an
excellent starting point.

7. Describe the effects of those failure modes. For each failure mode identified the
engineer should determine what the ultimate effect will be. A failure effect is
defined as the result of a failure mode on the function of the product/process as
perceived by the customer. They should be described in terms of what the customer
might see or experience should the identified failure mode occur. Keep in mind the
internal as well as the external customer. Examples of failure effects include:
a. Injury to the user
b. Inoperability of the product or process
c. Improper appearance of the product or process
d. Odors
e. Degraded performance
f. Noise

Establish a numerical ranking for the severity of the effect. A common

industry standard scale uses 1 to represent no effect and 10 to indicate very
severe with failure affecting system operation and safety without warning.
The intent of the ranking is to help the analyst determine whether a failure
would be a minor nuisance or a catastrophic occurrence to the customer. This
enables the engineer to prioritize the failures and address the real big issues
first. Severity is classified
 as:

8. Identify the causes for each failure mode. A failure cause is defined as a design
weakness that may result in a failure. The potential causes for each failure mode
should be identified and documented. The causes should be listed in technical terms
and not in terms of symptoms. Examples of potential causes include:
a. Improper torque applied
b. Improper operating conditions
c. Contamination
d. Erroneous algorithms
e. Improper alignment
f. Excessive loading
g. Excessive voltage
9. Enter the Probability factor. A numerical weight should be assigned to each cause
that indicates how likely that cause is (probability of the failure occurence). A
common industry standard scale uses 1 to represent not likely and 10 to indicate
inevitable. )
Probability of Failure Occurrence: Failure modes identified in the failure mode and
effect analyses are assessed in terms of probability of occurrence when specific
parts configuration or failure rates are not available. Individual failure mode
probabilities of occurrence should be grouped into distinct, logically defined levels.
They are:
10. Identify Current Controls (design or process). Current Controls (design or process)
are the mechanisms that prevent the cause of the failure mode from occurring or
which detect the failure before it reaches the Customer. The engineer should now
identify testing, analysis, monitoring, and other techniques that can or have been
used on the same or similar products/processes to detect failures. Each of these
controls should be assessed to determine how well it is expected to identify or
detect failure modes. After a new product or process has been in use previously
undetected or unidentified failure modes may appear. The FMEA should then be
updated and plans made to address those failures to eliminate them from the
product/process.

11. Determine the likelihood of Detection. Detection is an assessment of the likelihood

that the Current Controls (design and process) will detect the Cause of the Failure
Mode or the Failure Mode itself, thus preventing it from reaching the Customer.
Based on the Current Controls, consider the likelihood of Detection* using the
following table for guidance.

Rating Description Definition

10 Absolute uncertainty
9 Very remote
8 Remote
7 Very low
The product is not inspected or the defect caused by failure is not detectable
Product is sampled, inspected and released based on Acceptable Quality Level
(AQL) sampling plans
Product is accepted based on no defectives in a sample.
Product is 100% manually inspected in the process
 6 Low Product is 100% manually inspected using go/no-go or other Mistake-
proofing gauges.
5 Moderate Some Statistical Process Control (SPC) is used in process and product is final
inspected off-line.
4 Moderately high SPC is used and there is immediate reaction to out-of control conditions
3 High An effective SPC program is in place with process capabilities (Cpk) greater
than 1.33.
2 Very high All products is 100% automatically inspected.
1 Almost certain The defect is obvious or there is 100% automatic inspection with regular
calibration and preventive maintenance of the inspection equipment.

*Should be modified to fit the specific product or process.

12. Review Risk Priority Numbers (RPN). The Risk Priority Number is a mathematical
product of the numerical Severity, Probability, and Detection ratings:
RPN = (Severity) x (Probability) x (Detection)
The RPN is used to prioritize items than require additional quality planning or
action.

RPN prioritization
From the risk values point of view the most important items, characterized by high RPN,
should be separated from those characterized by a significantly lower RPN value.
Selected ‘High Priority’ items represent issues for corrective action plan development.
The question is ‘How such separation can be performed?’ Common recommendations of
the conventional FMEA concerning calculated RPN values are usually very general. For
example, ‘For higher RPN’s the team must undertake efforts to reduce the calculated risk
through corrective action(s)’
• ‘Focus attention on the high RPN’s’
• ‘Expend team effort on top 20 to 30% of problems as defined by RPN values’
• The common practice of an FMEA team analyzing RPN values in Pareto fashion
is to limit the list of recommended corrective actions to ‘Top ‘X’ Issues’. Chosen
X-value could be 3 or 5 or 10, etc. In any case, the ‘X’ will be an absolutely
random choice.
Obviously, this kind of decision-making is very problematic. How it can be decided
which RPN values characterize critical issues that should be immediately treated?
There are some rather sophisticated statistical techniques supporting distribution
analysis, but application of a very simple and quite effective graphical tool "Scree
Plot "can be used for RPN value analysis. This tool actually represents graph of
ordered RPN values and is used in principal component analysis. Scree Plot settings
require preliminary ordering of the RPN values by size, from smallest to largest.
These values are then plotted, by size, across the graph. Normally, when observing
from the right, Scree Plot appears like a cliff, descending to base level of ground
The calculated RPN usually form a right-skewed distribution, with a short tail on the
left (negligible risk values) and a long tail on the right (due to critical risk values
representing ‘outliers’ from the distribution analysis point of view). Therefore, the
shape of the points forms a nonsymmetrical upward curve on a Scree Plot. The lower
long part of the plot is characterized by a gradual increase of the RPN values that can,
usually, fit a straight line with a rather slight slope (showed by 1st dotted line on
plot). The RPN values scattered around this line should be considered as a kind of
‘Information Noise’. The issues characterized by these RPN do not require immediate
attention. The short uppermost part of Scree Plot is characterized by a very steep
increase of the RPN values (RPN jumps). A straight line with a very strong slope
(showed by 2nd dotted line on plot) could fit it. The RPN values scattered around this
line are related to the most critical issues of FMEA that need to be dealt with
promptly.
 12. Determine Recommended Action(s) to address potential failures that have a high
RPN. These actions could include specific inspection, testing or quality procedures;
selection of different components or materials; de-rating; limiting environmental
stresses or operating range; redesign of the item to avoid the failure mode;
monitoring mechanisms; performing preventative maintenance; and inclusion of
back-up systems or redundancy.

Choice of preferable corrective action

There are, usually, several possible competitive corrective actions that, theoretically, are
capable of reducing the RPN for any given failure mode. Although there are actions that
aim at failure mode severity reduction (usually by redesign), the bulk of the actions,
deemed appropriate, aim at either occurrence ranking reduction or detectability ranking
reduction. Actions aimed at occurrence ranking reduction seek to prevent the occurrence
of the cause of failure mode, or to reduce the rate at which the cause and/or the failure
mode occur. Actions aimed at detectability ranking reduction adopt a course of action
focused on improvement or on the detection of the cause and/or the failure mode prior to
its occurrence and to issue a warning. Since conventional FMEA does not provide any
guidelines for the optimal choice between competitive corrective actions, the FMEA team
faces a difficult task. Priority of the alternatives under comparison usually is subjectively
established based on intuition, experience and/or feelings of FMEA team members. The
final solution recommended by the FMEA team is, often, far from being the optimal one,
such as an action preferable from the department manager’s point of view or the one
suggested by the loudest member of the team. The FMEA procedure provides the basis
for the optimal corrective action choice. This procedure implies evaluation of both the
feasibility of a corrective action implementation and the expected RPN value after
implementing this action. Since feasibility estimation is a multidimensional problem, its
evaluation should be performed by posing the question: ‘How feasible is it to implement
a given corrective action under the existing constraints of safety, cost, resources, time,
quality & reliability requirements, organizational structure, personnel resistance, etc.?’
Moreover, EFMEA takes into consideration both chance of success (i.e. the RPN
reduction) and the probability of an undesirable impact (on people, system, product,
process or environment) as a result of a corrective action implementation.
Similar to the conventional FMEA’s procedure, the feasibility rank (F) is estimated on a
‘1’ (Best Case) to ‘10’ (Worst Case) scale using the criteria proposed by the authors and
presented in Table 1. The EFMEA procedure results in prioritization of the analyzed
alternatives. The final decision, i.e. the choice of the optimal corrective action, is based
on the results of the comparative analysis of the differences between the RPN values
before and after the implementation of given corrective actions divided by the
corresponding feasibility ranking factors Where: RPNi Before and RPNi After are RPN
values for a given item before and after implementation of the i-th corrective action,
∆RPN is the difference between these values; Fi is the feasibility rank of i-th corrective
action. The calculated ratio belongs to the family LTB (‘The Larger-the Better’), i.e. the
most preferable corrective action is characterized by the largest ratio. A table below
showing a example of corrective action prioritization.

There is an alternative approach for feasibility evaluation based on a known procedure of

Pareto Priority Index calculation. The feasibility estimate can be calculated as the
geometrical mean of values of all feasibility related dimensions (such as cost, time
consumption, chance of success, etc.). Obviously, the same dimensions, measured on the
same scales, should characterize all competitive corrective actions.

13. Assign Responsibility and a Target Completion Date for these actions. This makes
responsibility clear-cut and facilitates tracking.

14. Indicate Actions Taken. After these actions have been taken, re-assess the severity,
probability and detection and review the revised RPN's. Are any further actions
required?

15. Update the FMEA as the design or process changes, the assessment changes or new
information becomes known.
Benefits of FMEA

The use of FMEA can contribute significantly to the bottom line, by helping the
organization to

• Increase customer satisfaction

• Early identification and elimination of potential product/process failure modes
• Prioritize product/process deficiencies
• Capture engineering/organization knowledge
• Emphasizes problem prevention
• Documents risk and actions taken to reduce risk
• Provide focus for improved testing and development
• Minimizes late changes and associated cost
• Catalyst for teamwork and idea exchange between functions
• Improve product performance

• Focus design and manufacturing resources where they're needed most

• Reduce warranty and product failure costs
• Reduce product development costs
• Condense the product development and launch cycle
• Document the history of potential failures
• Analyze products systematically, not haphazardly

Uses of FMEA

. Develop product or process requirements that minimize the likelihood of those

failures.

• Evaluate the requirements obtained from the customer or other participants in the
design process to ensure that those requirements do not introduce potential
failures.
• Identify design characteristics that contribute to failures and design them out of
the system or at least minimize the resulting effects.
• Develop methods and procedures to develop and test the product/process to
ensure that the failures have been successfully eliminated.
• Track and manage potential risks in the design. Tracking the risks contributes to
the development of corporate memory and the success of future products as well.
• Ensure that any failures that could occur will not injure or seriously impact the
customer of the product/process.

Other possible uses of FMEA

a. FMEA can be used in the preparation of diagnostic procedures.

b. FMEA can be used to set appropriate maintenance procedures and intervals.

c. In legal proceedings, FMEA may be used as documentation of the safety
considerations that were involved in the design.
d. As per MIL-STD-1629A, additional applications for FMEA include
“maintainability, safety analysis, survivability and vulnerability, logistics support
analysis, maintenance plan analysis, and for failure detection and isolation subsystem
design.” Failure mode and effect analyses can be used for many applications in
which reliability and safety are a concern.

PRINCIPAL LIMITATIONS & ABUSES OF FMEA

• Frequently, human errors and hostile environments are overlooked.
• Because the technique examines individual faults of system elements taken singly, the
combined effects of coexisting failures are not considered.
• If the system is at all complex and if the analysis extends to the assembly level or lower,
the process can be extraordinarily tedious and time consuming.
• Failure probabilities can be hard to obtain; obtaining, interpreting, and applying those
data to unique or high-stress systems introduces uncertainty which itself may be hard to
evaluate.
• Sometimes FMEA is done only to satisfy the altruistic urge or need to “do safety.”
Remember that the FMEA will find and summarize system vulnerability to SPFs, and it
will require lots of time, money, and effort. How does the recipient intend to use the
results? Why does he need the analysis?

References:
• Articles available on Internet " FMEA process for quality problem solving
(FAILURE MODE & EFFECT ANALYSIS)" SEQ80.Doc
• "Reliability centered maintenance" by -Alan Pride available on Internet
• MIL-STD-1629A, Procedures for Performing a Failure Mode, Effects and
Criticality Analysis. available on Internet
• Guides notes 2004 -RCM-by ABS, Hunston, USA. available on Internet
• Failure Mode and Effects Analysis.-by R.R.Mohr available on Internet
• Articles available on Internet" Expanded FMEA (EFMEA)"
by-Zigmund Bluvband, ALD Ltd., Beit-Dagan., Pavel Grabov, ALD Ltd., Beit-
Dagan,Oren Nakar, MOTOROLA Israel Ltd.,Tel-Aviv.

Feed back may be sent on email-----dmed_nkj@yahoo.com