Republic of Sudan

Ministry of High Education & Scientific Research

Nile Valley University

College of Post Graduate Studies

Failure Mode and Effects Analysis (FMEA)

Reported by/

Abdulhmeed Mohamed Elhassan Mahjoub Ali

Failure Mode and Effects Analysis (FMEA)

Introduction

Failure Mode and Effects Analysis (FMEA) is a method designed to

identify and fully understand potential failure modes and their causes, and the

effects of failure on the system or end users, for a given product or process. It

helps us to assess the risk associated with the identified failure modes, effects and

causes, and prioritize issues for corrective action. Using FMEA we can identify

and carry out corrective actions to address the most serious concerns. An FMEA

is an engineering analysis done by a cross-functional team of subject matter

experts that thoroughly analyzes product designs or manufacturing

processes early in the product development process, so as to find and correct

weaknesses before the product gets into the hands of the customer. An FMEA

should be the guide to the development of a complete set of actions that will reduce

risk associated with the system, subsystem, and component or

manufacturing/assembly process to an acceptable level. If FMEA is effectively

used throughout the product life cycle, it will result in significant improvements

to reliability, safety, quality, delivery, and cost. Just performing an FMEA just to

fill a checkbox in the Product Development Process and then filing it away, never

to be seen again, is a waste of time and adds no value.As a tool in risk evaluation,

FMEA is considered to be a method to identify severity of potential effects of

failure and to provide an input to mitigating measures to reduce risk. In

many applications, FMEA also includes an estimation of the probability of

occurrence of the causes of failure and their resultant failure modes. This broadens

the analysis by providing a measure of the failure mode ‘ s likelihood. To

minimize risk, the likelihood of failure occurrence is reduced which

increases product or process reliability. FMEA is a tool that is instrumental in

reliability improvement. 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.

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

FMEA should focus on the modification to design or process, possible interaction

due to the modification and field history and 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 primary objective of an FMEA is to improve the design.For System FMEAs,

the objective is to improve the design of the system. For Design FMEAs, the

objective is to improve the design of the subsystem or component. For Process

FMEAs, the objective is to improve the design of the manufacturing process.

The other objectives for doing FMEAs are to identify and prevent safety

hazards, minimize loss of product performance or performance

degradation, improve test and verification plans (in the case of System or Design

FMEAs), improve Process Control Plans (in the case of Process

FMEAs), consider changes to the product design or manufacturing

process, identify significant product or process characteristics, develop

Preventive Maintenance plans for in-service machinery and equipment

and develop online diagnostic techniques.

The three most common types of FMEAs are:

System FMEA

Design FMEA

Process FMEA

System FMEA:

It is analysis is highest-level of an entire system, made up of various

subsystems. The focus is on system-related deficiencies, including system safety

and system integration, interfaces between subsystems or with other

systems, interactions between subsystems or with the surrounding environment,

single-point failures (where a single component failure can result in complete

failure of the entire system),The focus of FMEA is also on functions and

relationships that are unique to the system as a whole (i.e., do not exist at lower

levels) and could cause the overall system not to work as intended, human

interactions and service. Some practitioners separate out human interaction and

service into their own respective FMEAs.

Design FMEA:

Analysis is at the subsystem level (made up of various components) or component

level. The Focus is on product design-related deficiencies, with emphasis

on improving the design, ensuring product operation is safe & reliable during the

useful life of the equipment and interfaces between adjacent components. Design

FMEA usually assumes the product will be manufactured according to

specifications.

Process FMEA:

Analysis is at the manufacturing/assembly process level. The Focus is on

manufacturing related deficiencies, with emphasis on improving the

manufacturing process and to ensure that the the product is built to design

requirements in a safe manner, with minimal downtime, scrap and rework.

Process FMEA also emphasis on manufacturing and assembly operations,

shipping, incoming parts, transporting of materials, storage, conveyors, tool

maintenance, and labeling. Process FMEAs most often assume the design is

sound.

The common elements of FMEA are:

1. Identify the team:

The development of FMEA should be the responsibility of cross

functional or multi disciplinary team, whose members should have the

necessary subject matter knowledge which also includes the knowledge of

FMEA process. The team leader should have the necessary facilitation

expertise and should select team member with relevant expertise and necessary

authority. The team approach benefits the FMEA development process and

ensure input & collaboration from all affected function areas.

2. Define the scope:

ScopeestablishestheboundaryofFMEA analysis. Scope is essential

because itsetslimitsonagivenFMEA, that is, it makes it finite. It defines what is

included and excluded, determined based on the type of FMEA being

developed, i.e., system, subsystem, or component. BeforetheFMEA can begin,

a clear understanding of What is to be evaluated must be determined. What to

exclude can be just as important as what to include in the analysis. The scope

needs to be established at the start of the process to assure consistent direction

and focus. Several documents may assist the team in determining the scope of

a Process FMEA such as Function Model, Block (Boundary)

diagrams, Parameter (P) diagrams, Interface diagram, Processflow

diagram, Interrelationship matrices, Bill of Materials(BOM),

System FMEA:

A System is made up of Various subsystems. Examples of systems

include Chassis System, Powertrain System, or Interior System,etc.

The focus of the System FMEA is to address all interfaces and

interactions among systems, subsystems, the environment and the

customers

Subsystem FMEA:

A Subsystem FMEA is a subset of a System FMEA. An example of a

subsystem is the front suspension subsystem, which is a subset of the

chassis system. The focus of the Subsystem FMEA is to address all

interfaces and interactions among the subsystem components and

interactions with other subsystems or systems.

Component FMEA:

A Component FMEA is a subset of a subsystem FMEA.

For example, a brake pad is a component of the brake

assembly, which is a subsystem of the chassis system.

NOTE: Any subsequent adjustments to the scope may require a

modification of the tearn structure and membership.

3. Define the Customer:

Customer knowledge can contribute precise definition of functions,

requirements, and specifications.Knowledge of these customers can help to

define the functions,requirementsandspecifications more robustly as well as

aid in determining effects of related failure modes. For examples OEM will

have four major customerstobeconsideredintheFMEA process,

End Users:

the person or organization that will utilize product. The FMEA

analysis affecting the End User could include, for example,

durability.

OEM ASSEMBLY and MANUFACTURING CENTERS

(PLANTS):

the OEM locations where manufacturing operations (e.g., stamping

and powertrain) and vehicle assembly take place. Addressing the

interfaces between the product and its assembly process is critical to

an effective FMEA analysis.

Supply Chain Manufacturing:

The supplier location where manufacturing, fabricating or

assembling of production materials or parts takes place. This includes

fabricating production and service parts and assemblies and

processes such as heat treating; welding, painting,plating or other

finishing services;‘These.may be any subsequent or downstream

operation or next tier manufacturing process.

Regulators:

Government agencies that define requirements and monitor

compliance to safety and environmental specifications which can

impact the product or process.

4. Identify Functions, Requirements, Specifications:

Identify and understand the functions, requirements and specifications

relevant to the defined scope. The purpose of this activity is to clarify the

item design intent or process purpose. This assists in the determination of

the potential failure mode for each attribute or aspect of the function.

5. Identify Failure Modes:

Failure mode is defined as the way or manner in which a product or process

could fail to meet design intent or process requirements. The assumption is

made that the failure could occur but may not necessarily occur. A concise

and understandable failure definition is important since it properly focuses

the analysis. Failure modes should be described in technical terms and not

as a symptom necessarily noticeable by the customer. A large number of

failure modes identified for a single requirement may indicate that the

defined requirement is not concise.

6. Identify Effects:

Potential effects of failure are defined as the effects of the failure mode as

perceived by the customer. The effects or impact of the failure are described

in terms of what the customer might notice or experience. The customer

may be an internal customer as well as the End User. Determining potential

effects includes the analysis of the consequences of the failures and the

severity or seriousness of those consequences.

7. Identify Potential Causes:

Potential cause of failure is defined as an indication of how the failure could

occur, described in terms of something that can be corrected or can be

controlled. Potential cause of failure may be an indication of a design

Weakness, the consequence of which is the failure mode. There is a direct

relation between a cause and its resultant failure mode (i.e., if the cause

occurs, then the failure mode occurs). Identifying the root cause(s) of the

failure mode, in sufficient detail, enables the identification of appropriate

controls and action plans. A separate potential cause analysis is performed

for each cause if there are multiple causes.

8. Identify Controls:

Controls are those activities that prevent or detect the cause of the failure or

failure mode. In developing controls it is important to identify what is going

wrong, why, and how to prevent or detect it. Controls are applicable to

product design or manufacturing processes. Controls focused on prevention

will provide the greatest return.

9. Identifying and Assessing Risks:

One of the important steps in the FMEA process is the assessment of risk.

This is evaluated in three ways i.e by severity, occurrence, and detection.

Severity is an assessment of the level of impact of a failure on the customer.

Occurrence is how often the cause of a failure may occur. Detection is an

assessment of how well the product or process controls detect the cause of

the failure or the failure mode. Organizations need to understand their

customer requirements for risk assessment.

10. Recommended Actions and Results:

The intent of recommended actions is to reduce overall risk and likelihood

that the failure mode will occur. The recommended actions address

reduction of the severity, occurrence and detection.

The following can be used to assure that the appropriate actions are taken,

including but not limited to:

Ensuring design requirements including reliability are achieved,

Reviewing engineering drawings and specifications,

Confirming incorporation in assembly/manufacturing processes, and,

Reviewing related FMEAS, control plans and operations

instructions.

Responsibility and timing to complete the recommended actions should be

recorded. Once actions are completed and results captured, the updated ratings for

severity, occurrence and detection should also be recorded.

11. Management Responsibility:

Management owns the FMEA process. Management has the ultimate

responsibility of selecting and applying resources and ensuring an effective

risk management process including timing. Management responsibility also

includes providing direct support to the team through on-going reviews,

eliminating roadblocks, and incorporating lessons learned.

FMEA definitions:

1. Item:

An “item” is the focus of the FMEA project. For a System FMEA this is

the system itself. For a Design FMEA, this is the subsystem or component

under analysis. For a Process FMEA, this is usually one of the specific steps

of the manufacturing or assembly process under analysis, as represented by

an operation description.

2. Function:

A “function” is what the item or process is intended to do, usually to a given

standard of performance or requirement.

For Design FMEAs, this is the primary purpose or design intent of the item.

For Process FMEAs, this is the primary purpose of the manufacturing or

assembly operation. Functions are typically described in a verb-noun

format. There can be many functions for each item or operation.

Example: Provides the correct level of friction between brake pad assembly

and wheel rim to safely stop bicycle in the required distance, under all

operating conditions.

3. Failure Mode:

The term “failure mode” combines two words that both have unique

meanings. The Concise Oxford English Dictionary defines the word

“failure” as the act of ceasing to function or the state of not functioning.

“Mode” is defined as a way in which something occurs. A “failure mode”

is the manner in which the item or operation potentially fails to meet or

deliver the intended function and associated requirements. It may include

failure to perform a function within defined limits, inadequate or poor

performance of the function, intermittent performance of a function and/or

performing an unintended or undesired function.

Example: Insufficient friction delivered by hand brake subsystem between

brake pads and wheels during heavy rain conditions.

4. Effect:

An “effect” is the consequence of the failure on the system or end user.This

can be a single description of the effect on the top-level system and/or end

user, or three levels of effects (local, next-higher level, and end effect)For

Process FMEAs, consider the effect at the manuf. or assembly level, as well

as at the system or end user. There can be more than one effect for each

failure mode. However, typically the FMEA team will use the most serious

of the end effects for the analysis.

Example: Bicycle wheel does not slow down when the brake lever is pulled

potentially resulting in accident.

5. Severity:

“Severity” is a ranking number associated with the most serious effect for

a given failure mode. It is based on the criteria from a severity scale. It is a

relative ranking within the scope of the specific FMEA. It is determined

without regard to the likelihood of occurrence or detection.

6. Cause:

A “cause” is the specific reason for the failure, preferably found by asking

“why” until the root cause is determined. For Design FMEAs, the cause is

the design deficiency that results in the failure mode. For Process FMEAs,

the cause is the manufacturing or assembly deficiency that results in the

failure mode. At the component level, cause should be taken to the level of

failure mechanism. If a cause occurs, the corresponding failure mode

occurs. There can be many causes for each failure mode.

7. Occurrence:

“Occurrence” is a ranking number associated with the likelihood that the

failure mode and its associated cause will be present in the item being

analyzed. For System and Design FMEAs, consider the likelihood of

occurrence during the design life of the product. For Process FMEAs

consider the likelihood of occurrence during production. It is based on the

criteria from the corresponding occurrence scale. It has a relative meaning

rather than absolute value, determined without regard to the severity or

likelihood of detection.

8. Controls:

“Controls” are the methods or actions currently planned, or are already in

place, to reduce or eliminate the risk associated with each potential cause.

Controls can be the methods to prevent or detect the cause during product

development, or actions to detect a problem during service before it

becomes catastrophic. There can be many controls for each cause.

Prevention-type Controls:

For System or Design FMEAs, prevention-type design controls describe

how a cause, failure mode, or effect in the product design is prevented

based on current or planned actions. They are intended to reduce the

likelihood that the problem will occur, and are used as input to the

occurrence ranking.

Detection-type Controls:

For System or Design FMEAs, detection-type designs controls describe

how a failure mode or cause in the product design is detected, based on

current or planned actions before the product design is released to

production, and are used as input to the detection ranking. They are

intended to increase the likelihood that the problem will be detected

before it reaches the end user.

9. Detection:

“Detection” is a ranking number associated with the best control from the

list of detection-type controls, based on the criteria from the detection scale.

It considers the likelihood of detection of the failure mode/cause, according

to defined criteria. It is a relative ranking within the scope of the specific

FMEA. It is determined without regard to the severity or likelihood of

occurrence.

Risk Priority Number (RPN):

“RPN” is a numerical ranking of the risk of each potential failure mode/cause,

made up of the arithmetic product of the three elements:

severity of the effect

likelihood of occurrence of the cause

likelihood of detection of the cause.

RPN is not a perfect representation of the risk associated with a failure mode &

associated cause as it is subjective and not continuous. High severity must be

considered regardless of RPN value

10. Recommended Actions:

“Recommended actions” are the tasks recommended by the FMEA team to

reduce or eliminate the risk associated with potential causes of failure. They

should consider the existing controls and the relative importance

(prioritization) of the issue. The cost and effectiveness of the corrective

action. There can be many recommended actions for each cause.

Example: Require cable DFMEA/PFMEA from cable supplier approved by

All-Terrain FMEA team.

11. Actions Taken:

“Action Taken” is the specific action that is implemented to reduce risk to

an acceptable level. It should correlate to the specific recommended action

and is assessed as to effectiveness by a revised severity, occurrence,

detection ranking, and corresponding revised RPN.

Example: Cable supplier completed DFMEA/PFMEA and approved by All-

Terrain team.

Logical relationship between FMEA elements

Bicycle hand brake example

Steps involved in implementing FMEA:

Failure Mode and Effects Analysis (FMEA) is used to identify specific ways in

which a product, process, or service might fail and to then

develop countermeasures targeted at those specific failures. This will improve

performance, quality, reliability, and safety. FMEA is most commonly used in

the Improve step of the DMAIC method to improve the effectiveness of a

proposed solution, but it is also helpful in the Recognize step for identifying

improvement opportunities, and in the Measure step for determining what data to

collect and where to collect it. FMEA follows the steps of the process and

identifies where problems might occur. It scores potential problems based on

their probability of occurrence, severity, and ability to be detected. Based on the

scores mentioned above, helps to determine where countermeasures are

necessary to avoid problems. IT allows re-scoring of the problem after you

have put countermeasures in place.

1. List the process steps in the first column of a FMEA chart .

2. For each process step, brainstorm potential failure modes—ways in which the

product, service, or process might fail (e.g., jams, sputters, freezes or slows up,

is unreadable).

3. Identify the potential consequences or effects of each failure (e.g., defective

product, wrong information, delays) and rate their severity.

4. Identify causes of the effects and rate their likelihood of occurrence.

5. Rate your ability to detect each failure mode (in the Detection column).There

might be multiple failures for each step and multiple effects for each failure.

Score each separately.

6. Multiply the three numbers (severity, occurrence, and detection) together to

determine the risk of each failure mode. This is represented in the chart by a

risk priority number, or RPN.

RPN = severity × occurrence × detection.

7. Identify ways to reduce or eliminate risk associated with high RPNs.

8. Re-score those failures after you put countermeasures in place.

Design Failure Mode Effect Analysis (DFMEA)

The Design Failure Mode Effects Analysis (DFMEA), supports the design process

in reducing the risk of failures by aiding in the objective evaluation of the design,

including functional requirements & design alternatives and by evaluating the

initial design for manufacturing, assembly, service, and recycling requirements. It

increases the probability that potential failure modes and their effects on system

have been considered in the design/development process. It provides additional

information to aid in the planning of thorough and efficient design, development,

and validation programs. It helps in developing a ranked list of potential failure

modes according to their effect on the customer, thus establishing a priority system

for design improvements, development, and validation testing/analysis. It

provides an open issue format for recommending & tracking risk-reducing

actions, and providing future reference, (e.g., lessons learned), to aid in addressing

field concerns, evaluating design changes, and developing advanced designs.

The DFMEA is a living document and should be initiated before design concept

finalization. It should be updated as changes occur or additional information is

obtained throughout the phases of product development and be fundamentally

completed before the production design is released. It should be a source of

lessons learned for future design iterations.

Maintaining Design Failure Mode Effect Analysis (DFMEA)

The DFMEA is a living document and should be reviewed whenever there is a

product design change and updated, as required. Recommended actions updates

should be included into in subsequent DFMEA along with the final results (what

worked and what did not work). Another element of on-going maintenance of

DFMEAs should include in periodic review of the rankings used in the DFMEA.

Specific focus should be given to Occurrence and Detection rankings. This is

particularly important where improvements have been made either through

product changes or improvements in design controls. Additionally, in cases where

field issues have occurred, the rankings should be revised accordingly.

Leveraging Design Failure Mode Effect Analysis (DFMEA)

If a new project or application is functionally similar to the existing product, a

single DFMEA may be used with customer concurrence. Using a fundamentally

sound baseline DFMEA as the starting point provides the greatest opportunity to

leverage past experience and knowledge. If there are slight differences, the team

should identify and focus on the efforts of these differences.

Linkage of Design Failure Mode Effect Analysis (DFMEA)

Linkage to DFMEA to other Documents

The DFMEA is not a “stand-alone” document. For example, the output of the

DFMEA can be used as input for subsequent product development processes. It is

the summary of the team’s discussions and analysis.

Design Verification plan & Report(DVP&R) and Design Failure Mode Effect

Analysis(DFMEA) have an important linkage. The DFMEA identifies and

documents the current design prevention and detection controls which become

input to the test description included within the DVP&R. The DFMEA identifies

“what” the controls are while the DVP&R provides the “how” such as acceptance

criteria, procedure and sample size. Another imponam linkage is between the

DFMEA and PFMEA. For example a Process (PFMEA) failure mode or a Design

(DFMEA) failure mode can result in the same potential product effect. In this case,

the effects of the design failure mode should be reflected in the effects and severity

rankings of the DFMEA and PFMEA.

Process Failure Mode Effect Analysis (PFMEA):

The process Failure Mode Effect Analysis, referred to as PFMEA,

supports manufacturing process development in reducing the risk of failures by

identifying and evaluating the process functions and requirements. It helps in

identifying and evaluating potential product and process- related failure modes,

and the effects of the potential failures on the process and customers. It identifies

the potential manufacturing or assembly process causes, and process variables on

which to focus process controls for occurrence reduction or increased detection of

the failure conditions. It enables the establishment of is priority system

for preventive/corrective action and controls. The PFMEA is a living document

and should be initiated before or at the feasibility stage, prior to tooling for

production. It should take into account all manufacturing operations

from individual components to assemblies, and should include all processes

within the plant that can impact the manufacturing and assembly operations, such

as shipping, receiving, transporting of material, storage, conveyors or labeling.

Early review and analysis of new or revised processes is advised to anticipate,

resolve, or monitor potential process concerns during the manufacturing planning

stages of a new model or component program. The PFMEA assumes the product

as designed will meet the design intent. Potential failure modes that can occur

because of a design weakness may be included in a PFMEA. Their effect

and avoidance is covered by the Design FMEA. The PFMEA does not rely on

product design changes to overcome limitations in the process. However, it does

take into consideration a product’s design characteristics relative to the planned

manufacturing or assembly process to assure that, to the extent possible, the

resultant product meets customer needs and expectations. For example the

PFMEA development generally assumes that the machines and equipment will

meet their design intent and therefore are excluded from the scope.

Control mechanisms for incoming parts and materials may need to be considered

based on historical data.

Maintaining Process Failure Mode Effect Analysis (PFMEA)

The PFMEA is a living document and should be reviewed whenever there is a

product or process design change and updated, as required. Recommended actions

updates should be included into in subsequent PFMEA along with the final

results. Another element of on-going maintenance of PFMEA should include a

periodic review. Specific focus should be given to Occurrence and Detection

rankings. This is particularly important where there have been product or process

changes or improvements in process controls. Additionally, in cases when, either

field issues or production issues, such as disruptions, have occurred. the rankings

should be revised accordingly.

Leveraging Process Failure Mode Effect Analysis (PFMEA)

If a new project or application is functionally similar to the existing product, a

single PFMEA may be used with customer concurrence. Using a fundamentally

sound baseline PFMEA as the starting point provides the greatest opportunity to

leverage past experience and knowledge. If there are slight differences, the team

should identify and focus on the efforts of these differences.

Linkage of Process Failure Mode Effect Analysis (PFMEA)

The DFMEA is not a “stand-alone” document.

Linkage of PFMEA to other documents

In the development of a PFMEA it is important to utilize the information and

knowledge gained in the creation of the DFMEA, However. the link between the

two documents is not always obvious. The difficulty occurs because the focus of

each FMEA is different. The DFMEA focuses on part function whereas the

PFMEA focus on the manufacturing steps or process. Information in the columns

of each form is not directly aligned. For example. Item/Function-Design does not

equal Process Functions/Requirements; design failure mode do not equal process

failure mode; potential design cause of failure does not equal potential process

cause of failure. However, by comparing the overall analysis of design

and process, a connection can be made. One such connection is between the

characteristics identified during the DFMEA and PFMEA analysis. Another

connection is the relationship between potential design cause of failure (DFMEA)

and potential process failure mode (PFMEA). For example. the design of a feature

such as 3 hole can cause a particular failure mode. The corresponding

process failure mode is the inability of the process to manufacture the some

feature as designed. In this example, the potential design cause of failure (hole

diameter designed too large) would appear to be similar to the potential process

failure mode (hole drilled too large). The potential effect of the failure mode for

both design and process may be identical if there were no additional process

related effects. In other words, the and result (effect) of the failure mode is the

same. but there are two distinct causes. While developing the PFMEA, it is the

team’s responsibility to ensure that all process related potential failure modes

which lead to product related effects are consistent between the DFMBA and the

PFMEA.

In addition to the list of Recommended Actions and their subsequent follow-up as

a result of the PFMEA activity, a Control Plan should be developed. Some

organizations may elect not to specifically identify the related product and

process characteristics in the PFMEA. In this situation, the

“Product Characteristics” portion of the Control Plan may be derived from the

“Requirements” portion of the “Process Function/Requirements” column and the

“Process Characteristics” portion may be derived from the “Potential Cause(s) of

Failure Mode” column. When the team develops the Control Plan, they need to

assure that the PFMEA current controls are consistent with the control methods

specified in the Control Plan.

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Enhance Quality and Efficiency of Bearing Manufacturing Industry, Scholars Journal of

Engineering and Technology (SJET), 2015; 3(4B):413-418.

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October 2013.

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Wind Turbines, North American Power Symposium (NAPS), 2011.

8/ Renato Pickler Patricio et al, Model of Risk Management Based in the FMEA Technique,

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