FMEA ANALYSIS : To Enhance
Quality and Performance
Done by:
S Vishnu vardhan
. 192110147
CSE
Introduction
What is fmea
Objectives of
Types of fmea
Benefits of fmea
Why fmea
Advantages
Disadvantages
INTRODUCTION
FMEA is a formal design methodology in the 1960s by the aerospace industry,
with their obvious reliability and safety requirements.
They also used it to improve production and design.
FMEA is used during the design stage with an aim to avoid future failures.
Most current FMEA methods use the risk priority number (RPN) value to
evaluate the risk of failure.
FMEA determines the risk priorities of failure modes through the risk priority
number (RPN), which is the product of the occurrence (O), severity (S) and
detection (D) of a failure. (RPN = O * S * D)
What is FMEA
Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for
evaluating a process to identify where and how it might fail and to assess the relative
impact of different failures, in order to identify the parts of the process that are most in
need of change.
Teams use FMEA to evaluate processes for possible failures and to prevent them by
correcting the processes proactively rather than reacting to adverse events after failures
have occurred. This emphasis on prevention may reduce risk of harm to both patients and
staff.
FMEA is particularly useful in evaluating a new process prior to implementation and in
assessing the impact of a proposed change to an existing process.
OBJECTIVES OF FMEA
OBJECTIVES
1.DESIGN IMPROVEMENTS The FMEA drives product design or process
Improvements as the primary objective.
2. HIGH RISK FAILURE MODES The FMEA addresses all high-risk failure modes With
effective and executable action plans.
3. DVP&R/CONTROL PLAN The Design Verification Plan & Report (DVP&R) or The
Process Control Plan (PCP) considers the failure modes from the FMEA.
4. INTERFACES The FMEA scope includes integration and interface failure Modes in
both block diagram and analysis.
5. LESSONS LEARNED The FMEA considers all major “lessons learned” (such as High
warranty, campaigns, etc.) as input to failure mode identification.
Types
Concept FMEA (CFMEA): The concept FMEA is used to analyze concept in the early
stages before hardware is defined (most often at system and subsystem level). It focuses on
potential failure modes associated with the proposed functions of a concept proposal.
Design FMEA (DFMEA): This type of FMEA has the purpose of identification and
prevention of failure modes of products, which are related to their design
Process FMEA (PFMEA): This type of FMEA focuses on potential failure modes of the
process that are caused by manufacturing or assembly process deficiencies.
Ten Steps for an FMEA
Review the Process or Product
Brainstorm potential failure modes
List Potential effects of each failure mode Assign a Severity Ranking for each failure
mode.
Assign Occurrence Ranking for each failure mode.
Assign detection ranking for each failure mode or effect Calculate the RPN for each effect
Prioritize the Failure Modes for Action
Take action to eliminate or reduce high risk failure modes
Calculate the RPN again as the failure modes are reduced or eliminated.
When to Perform FMEA
There are times or phases when performing FMEA makes sense, and they are:
When you design a new process/product/service
When you think of improving an existing process or performing in a different way
Whenever you put up a quality improvement goal for a process/product
When you need to understand the underlying failure of the process
Benefits of FMEA
The FMEA consists of many tools to help companies detect failure as early as possible in
the process/product design stage. Using FMEA, companies benefit from:
Multiple options for eliminating the risk.
Verification and Validation of changes increase with FMEA
Product and process collaborate to create a hassle-free experience
Helps in enhancing manufacturing and assembly
Helps lower the entire project costs
Criteria for FMEA Analysis
A General FMEA methodology uses three basic criteria to assess an issue, and they are:
Severity:
The severity of the effect on the end customer. This criterion incorporates all standards that are
important to the specific industry. These could be safety standards, production continuity, loss of
business, damaged reputation, environment, etc.
Frequency:
Frequency of the problem. This criterion ranks the probability of each failure mode during the expected
product’s/process’s lifetime.
Detection:
Detection level of the problem (how easy it’s to detect). Many issues pop up, which can be ranked
accordingly based on how easy it is to detect problems and take constructive action to prevent failure.
Limitations of fmea
FMEA is a big job. The team must balance between too big a scope and too small. Many
failure modes can be overlooked if you don’t pay enough attention to these details.
Another limitation is the FMEA’s method of prioritizing failure modes based on their risk.
These will not eliminate failure modes and may require additional actions beyond the
FMEA or the team that is carrying it out.
The last problem many organizations face is failing to recognize the FMEA isn’t a static
model. The FMEA must be updated regularly to identify new failure modes and develop
control plans. This will ensure that risk management is successful.
FMEA Scope
The scope of the FEMA must be well defined
Specific and a clear definition of the process and product should be written and understood
Team member should have scope to clarify doubts
Specific and clear definition is more important for a process FEMA
Start UP FEMA Worksheet will always help See next slides for sample worksheets
FMEA Corrective Actions
sThe final stage is for everyone to agree on what the priorities are. Then, moving on to
taking corrective actions to reduce or eliminate failure modes or help detect them easily.
The leader among the participants will assign these actions and set target completion dates.
Once the corrective actions have been done, the team must meet again to determine and
reassess the failure modes and rescore on the different criteria.
It improves the effectiveness of the corrective actions taken.
Conclusion
FMEA cannot substitute good engineering; rather, it optimizes good engineering by
applying apt knowledge and experience in reviewing the design progress of a
product/process by assessing its risk of failure.
It’s a valuable tool for businesses to improve their customer experience and leverage it to
improve their market acquisitions and retention.
FMEA provides an easy tool to determine which risk has the greatest concern and therefore
an action is needed to prevent a problem before it arises.
The development of these specifications will ensure the product will meet the defined
requirement
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