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Reported by/
Abdulhmeed Mohamed Elhassan Mahjoub Ali
thoroughly
analyzes
product
designs
or
manufacturing
associated
with
the
system,
subsystem,
and
component
or
loss
of
product
performance
or
performance
degradation, improve test and verification plans (in the case of System or Design
FMEAs), improve
Process
Control
Plans
FMEAs), consider
changes
to
product
process, identify
significant
the
product
or
(in
the
design
process
case
or
of
Process
manufacturing
characteristics, develop
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
or with other
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
diagrams, Parameter
such
(P)
as Function
Model, Block
diagrams, Interface
(Boundary)
diagram, Processow
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:
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
subsystem
of
the
chassis
system.
End Users:
the person or organization that will utilize product. The FMEA
analysis affecting the End User could include, for example,
durability.
Regulators:
Government agencies that define requirements and monitor
compliance to safety and environmental specifications which can
impact the product or process.
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 dened 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
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
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:
Detection-type Controls:
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 AllTerrain team.
Logical relationship between FMEA elements
Bicycle hand brake example
product,
process, or
service
might
fail
and
to
then
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 nal
results. Another element of on-going maintenance of PFMEA should include a
periodic review. Specic 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
eld 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.
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
teams 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 specically 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
specied in the Control Plan.
References:
1/ Rakesh.R, Bobin Cherian Jos, George Mathew, FMEA Analysis for Reducing Breakdowns
of a Sub System in the Life Care Product Manufacturing Industry, International Journal of
Engineering Science and Innovative Technology (IJESIT) Volume 2, Issue 2, March 2013.
2/ Tejaskumar S. Parsana and Mihir T. Patel, A Case Study: A Process FMEA Tool to Enhance
Quality and Efficiency of Manufacturing Industry, Bonfring International Journal of Industrial
Engineering and Management Science, Vol. 4, No. 3, August 2014.
3/ Henrique C. Mello, and Salomon V., An ISO 9001 based approach for the implementation
of process FMEA in the Brazilian automotive industry, International Journal of Quality &
Reliability Management June 2015.
4/ Carl S. Carlson, Understanding and Applying the Fundamentals of FMEAs, Reliability and
Maintainability Symposium, January, 2014.
5/ Riddhish Thakore , Rajat Dave , Tejas Parsana, A Case Study: A Process FMEA Tool to
Enhance Quality and Efficiency of Bearing Manufacturing Industry, Scholars Journal of
Engineering and Technology (SJET), 2015; 3(4B):413-418.
6/ Shivani Sharma and Ravindra Pratap, a Case Study of Risks Prioritization Using FMEA
Method, International Journal of Scientific and Research Publications, Volume 3, Issue 10,
October 2013.
7/ Salman Kahrobaee and Sohrab Asgarpoor, Risk-Based Failure Mode and Effect Analysis for
Wind Turbines, North American Power Symposium (NAPS), 2011.
8/ Renato Pickler Patricio et al, Model of Risk Management Based in the FMEA Technique,
The Internet Geotechnical Engineering Magazine Vol. 18 [2013].
9/ Namdari M., Rafiee Sh., Jafari A.,
Using the FMEA method to Optimize fuel consumption in Tillage by Moldboard Plow,
International Journal of Applied Engineering Research, Dindigul Volume 1, no 4, 2011.