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Amity Business School

Failure Modes and Effects Analysis


(FMEA)
• Failure Modes and Effects Analysis (FMEA) is
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 is used to identify
potential failure modes, determine their effect on the
operation of the product, and identify actions to mitigate
the failures. A crucial step is anticipating what might go
wrong with a product. While anticipating every failure
mode is not possible, the development team should
formulate as extensive a list of potential failure modes as
possible.
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Design Failure Modes and Effects


Analysis (DFMEA)
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Types of FMEA's

• 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 - focuses on global system functions
• Design - focuses on components and subsystems
• Process - focuses on manufacturing and assembly
processes
• Service - focuses on service functions
• Software - focuses on software functions
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Benefits of FMEA
• FMEA's provide the engineer with a tool that can assist in providing reliable,
safe, and customer pleasing products and processes. Since FMEA help the
engineer identify potential product or process failures, they can use it to:
• 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.
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Japanese script

Kaize method of continuous incremental improvement


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Five “S” of KAIZEN


• Good housekeeping- This is achieved
through the five Ss:
• Seiri – tidiness. Separate what is necessary
for the work from what is not. This should
help to simplify work.
• Seiton – orderliness. You can increase
efficiency by making deliberate decisions
with regard to the allocation of materials,
equipment, files, etc.
• Seiso – cleanliness. Everyone should help
to keep things clean, organized, looking
neat and attractive.
• Seiketsu – standardized clean-up. The
regularity and
institutionalization of keeping things clean
and organized as part of 'visual
management' is an effective means of
continuous improvement.
• Shitsuke – discipline. Personal
responsibility for living up to the other four
S's can make or break the success of
housekeeping
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Elements of Kaizen
• Kaizen literally means change (kai) to become good (zen). Key
elements of kaizen are: quality, effort, willingness to change and
communication. The kaizen attitude supports a continuous process
of incremental improvements within an organization.
• The foundation of the kaizen model consists of five founding
elements:
• teamwork
• personal discipline
• improved morale
• quality circles
• suggestions for improvement.
• From this foundation, three key aspects of kaizen arise: elimination
of muda (waste, inefficiency, the five-S framework for good
housekeeping and standardization.
• Through its impact on multiple functional parts of the organization,
kaizen can eventually lead to sustainable profit management.
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Kaizen - When to use it

The organization must reduce and eliminate


muda (waste, inefficiency) on the
production floor as a result of
overproduction, excess inventory, rejected
products, movement, production and
assembly, waiting, transportation, etc.
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What is Kaizen all about


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KAIZEN
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KAIZEN
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Supplier Capability Evaluation


• Supplier evaluation is a term used in business
and refers to the process of evaluating and
approving potential suppliers by factual and
measurable assessment.
• The purpose of supplier evaluation is to ensure a
portfolio of best in class suppliers is available for
use.
• Supplier evaluation is also a process applied to
current suppliers in order to measure and
monitor their performance for the purposes of
reducing costs, mitigating risk and driving
continuous improvement
Amity Business School

Process Capability Evaluation


• What is Process capability?
• Process Capability is the strategy to study of capability
or the ability of a process. “Process Capability” study
answers the key questions like , “Is this process capable
enough to meet its objective?” It refers to the capability
of any process to produce a defect free product or
services when the process is in a phase of statistical
control.
• Process capability study is useful to appraise the ability
of any process to meet the needed specifications. We
can judge that how capable is the process in terms of
producing output within the specification limit.
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Process Capability Evaluation


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Phases of Process capability


analysis.
• There are two methodology of calculating
Process Capability:

1. Based on measuring the variability of


the process directly.
(the inherent variation within a sample)
• 2. Based on counting the number of
defects produced by the process.
( DMPO or Six sigma )

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