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Failure Mode Effect Analysis

FMEA is a systematic method to identify and prevent potential product and process problems. It focuses on finding failures before they occur to enhance safety and customer satisfaction. Ideally, FMEAs are conducted during design or development, but can also benefit existing products or processes. The objectives of FMEA are to uncover safety hazards, malfunctions or shortened product life that could result from failures. Benefits include reducing costs and improving reliability, quality, and customer satisfaction.

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Charanjeet Singh
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165 views36 pages

Failure Mode Effect Analysis

FMEA is a systematic method to identify and prevent potential product and process problems. It focuses on finding failures before they occur to enhance safety and customer satisfaction. Ideally, FMEAs are conducted during design or development, but can also benefit existing products or processes. The objectives of FMEA are to uncover safety hazards, malfunctions or shortened product life that could result from failures. Benefits include reducing costs and improving reliability, quality, and customer satisfaction.

Uploaded by

Charanjeet Singh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPTX, PDF, TXT or read online on Scribd
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FMEA

Failure Mode Effect Analysis


Objectives
• What is FMEA?
• Why is an FMEA important?
• Benefits of FMEA
• Limitations of FMEA
• Types of FMEA
Failure Mode & Effects Analysis
(FMEA)
• FMEA is a systematic method of identifying and
preventing system, product and process problems
before they occur
• FMEA is focused on preventing problems,
enhancing safety, and increasing customer
satisfaction
• Ideally, FMEA’s are conducted in the product
design or process development stages, although
conducting an FMEA on existing products or
processes may also yield benefits
Failure Mode and Effect Analysis
• Simply put FMEA is:
A process that identifies all the possible types of failures that could
happen to a product and potential consequences of those failures.

FMEA & Failure Analysis


• Failure analysis is a postmortem after the failure has occurred.
• Where as FMEA is proactive tool for avoidance of failure mode to
occur.
FMEA Terms
• Failure mode - the way in which something might fail
• Effects analysis – studying the consequences of the various failure modes to
determine their severity to the customer.

Why do an FMEA?

• Preventing problems is cheaper and easier than cleaning them up.


• Some things are too risky or costly to incur mistakes.
The Reasons for FMEA

• Get it right the first time


• Identifies any inadequacies in the development of the
product
• Tests and trials may be limited to a few products
• Regulatory reasons
• Continuous improvement
• Preventive approach
• Team building
• Required procedures
FMEA Provides the Potential to:

• Reduce the likelihood of customer complaints


• Reduce the likelihood of campaign changes
• Reduce maintenance and warranty costs
• Reduce the possibility of safety failures
• Reduce the possibility of extended life or reliability failures
• Reduce the likelihood of product liability claims
Benefits
• Identify potential and known failures
• Reduce the number of engineering changes
• Reduce product development time
• Lower start-up costs
• Greater customer satisfaction
• Increased cooperation and teamwork
between various functions
• Continuous improvement
Advantages of FMEA
• Contributes to improved designs for products and processes.
– Higher reliability
– Better quality
– Increased safety
– Enhanced customer satisfaction
• Contributes to cost savings.
– Decreases development time and re-design costs
– Decreases warranty costs
– Decreases waste, non-value added operations
• Contributes to continuous improvement
Process FMEA

• Identify potential product related process failure modes


• Assess the potential customer effects of the failures
• Identify the potential manufacturing causes on which
to focus on
• Develop a ranked list of potential failure modes
• Document the results of the manufacturing
What is the objective of FMEA?

• Uncover problems with the product that


will result in safety hazards, product malfunctions, or
shortened product life, etc.
• Ask ourselves “how the product will fail”?
• How can we achieve our objective?
– Respectful communication
– Make the best of our time, it’s limited; Agree for ties to
rank on side of caution as appropriate
FMEA Timing

• FMEA should be updated:


▪ at the conceptual stage
▪ when changes are made to the design
▪ when new regulations are instituted
▪ when customer feedback indicates a problem
FMEA – Excuses!
Excuses given for not doing the FMEA

• No Training
• It’s the Quality teams job
• Still fire fighting previous problems
• They are a waste of time & we learn nothing
• It’s a carry over part/system
• Still designing the part/system
• No time , Project time line has crossed.
• No resource
Risk Assessment Factors
Severity (S): A number from 1 to 10, depending on the severity of the potential failure
mode’s effect
1 = no effect
10 = maximum severity
Probability of occurrence (O): A number from 1 to 10, depending on the likelihood of
the failure mode’s occurrence
1 = very unlikely to occur
10 = almost certain to occur
Probability of detection (D): A number from 1 to 10, depending on how unlikely it is
that the fault will be detected by the system responsible (design control process, quality
testing, etc.)
1 = nearly certain detection
10 = impossible to detect
Risk Priority Number (RPN): The failure mode’s risk is found by the formula RPN = S x
O x D.
RPN = Severity x Probability of Occurrence x Probability of Detection.

RPN will be a number between 1 (virtually no risk) and 1000 (extreme risk).
Process Failure Mode
and
Effects Analysis
( based on FMEA 4 Edition)
th
Considerations for PMEA

• Cost of Defects
• Risk of Defects
• Mfg. Strategies
• Protecting On-Time Delivery
• Cost of Stopping Production
• Cost of Recall Campaigns
• Benefits of Traceability
Team Members for a PFMEA
• Process engineer
• Manufacturing supervisor
• Operators
• Quality
• Safety
• Product engineer
• Customers
• Suppliers
PFMEA Assumptions
• The design is valid
• All incoming product is to design specifications
• Failures can but will not necessarily occur
• Design failures are not covered in a PFMEA, they
should have been part of the design FMEA
Process Controls
• Preventative • Detection
– SPC – Functional test
– Work instructions – Visual inspection
– Maintenance – Touch for quality
– Error proof by design – Gauging
– Method sheets – Final test
– Operator training – Set up verification
– DOE – First piece approval
Risk Priority Number (RPN)
• RPN provides a method for a prioritizing process
concerns
• High RPN’s warrant corrective actions
• Despite of RPN, special consideration should be
given when severity is high especially in regards to
safety
Recommend Actions

• The intent with recommended actions is to


reduce risk.
• Recommended actions will be focused to:
– Reduce Severity
– Reduce Frequency of Occurrence
– Improve Detection
10 steps to conduct a FMEA

1. Review the design or process


2. Brainstorm potential failure modes & causes
3. List potential failure effects
4. Assign Severity ratings
5. Assign Occurrence ratings
6. Assign detection rating
7. Calculate RPN
8. Develop an action plan to address high RPN’s/Severity
9. Take appropriate action
10. Reevaluate the RPN after the actions are completed
Key Points to Remember
Upon successful completion of this course, you should know:

1. Potential FMEA Reference Manual is the authoritative reference.


2. Severity scores of 9 or 10 must be used for safety related risks.
3. Occurrence ranks how often each cause is likely to result in failure.
4. It is appropriate to focus on high severity items first.
5. Credit for preventive actions shows up in the frequency of
occurrence.
6. Risk Priority Numbers provides a rank order to risks and action
items.
7. An effective approach is to continually focus on the top five
concerns.
8. Process FMEA should result in tangible improvement to process
performance.
Hints for a successful FMEA

• Take your time in defining functions


• Ask a lot of questions:
– Can this happen…..
– What would happen if the user….
• Make sure everyone is clear on Function
• Be careful when modifying FMEAs
Reasons – Why FMEA’s fail
1. One person is assigned to complete the FMEA.
2. Not customizing the rating scales with company specific data, so they
are meaningful to your company
3. The design or process expert is not included in the FMEA or is allowed
to dominate the FMEA team
4. Members of the FMEA team are not trained in the use of FMEA, and
become frustrated with the process
5. FMEA team becomes bogged down with minute details of design or
process, losing sight of the overall objective
6. Rushing through identifying the failure modes to move onto the next
step of the FMEA
7. Listing the same potential effect for every failure i.e. customer
dissatisfied.
8. Stopping the FMEA process when the RPN’s are calculated and not
continuing with the recommended actions.
9. Not reevaluating the high RPN’s after the corrective actions have been
completed.
10. Becoming only a paper exercise just a formality
THANK YOU

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