Comprehensive Guide to Failure Mode and Effect Analysis (FMEA)
Failure Mode and Effect Analysis (FMEA) is a crucial process that identifies potential failures in products or processes, evaluates their impact, and proposes actions to prevent or mitigate these failures. FMEA aims to prevent problems, improve product development, ensure regulatory compliance, and enhance team collaboration. By conducting FMEA, organizations can reduce customer complaints, warranty costs, safety failures, and product liability claims, ultimately leading to better products and customer satisfaction.
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Failure Mode and Effect Analysis Jackie Harris, Josh Agusti, and Natasha Sommer
Objectives What is FMEA? Why is an FMEA important? History of FMEA Benefits of FMEA Limitations of FMEA How to conduct an FMEA?
Who is in Attendance? Anyone conducted an FMEA before? Anyone completed a Risk Analysis Procedure?
What is FMEA? Failure Mode and Effect Analysis A systemized group of activities designed to: recognize and evaluate the potential failure of a product/process and its effects identify actions which could eliminate or reduce the chance of potential failure document the process
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 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 Indentifies 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
History An offshoot of Military Procedure MIL-P-1629, titled Procedures for Performing a Failure Mode, Effects and Criticality Analysis, dated November 9, 1949. Used as a reliability evaluation technique to determine the effect of system and equipment failures. Failures were classified according to their impact on mission success and personnel/equipment safety. Formally developed and applied by NASA in the 1960 s to improve and verify reliability of space program hardware.
Concept FMEA Used to analyze concepts in the early stages before hardware is defined (most often at system and subsystem) Focuses on potential failure modes associated with the proposed functions of a concept proposal Includes the interaction of multiple systems and interaction between the elements of a system at the concept stages.
Design FMEA Aid in the objective evaluation of design requirements and design alternatives Aid in the initial design for manufacturing and assembly Increase the probability that potential failure modes have been considered Provide additional information to aid in the planning of efficient design testing
Process FMEA Indentify potential product related process failure modes Assess the potential customer effects of the failures Indentify the potential manufacturing causes on which to focus on Develop a ranked list of potential failure modes Document the results of the manufacturing
Resources Needed Commitment of top management Knowledgeable individuals Individuals attentive to FMEA timelines People resources may be internal or external to the business or a combination of both
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
Advantages Enhance design and manufacturing efficiencies Alleviate late change crises Minimize exposure to product failures Augment business records Improve bottom line results Add to customer satisfaction
Limitations Employee training requirements Initial impact on product and manufacturing schedules Financial impact required to upgrade design, manufacturing, and process equipment and tools These limitations should be recognized and treated as short term and minimal interruptions to a business.
Risk Assessment Factors Severity (S): A number from 1 to 5, depending on the severity of the potential failure mode s effect 1 = no effect 5 = maximum severity Probability of occurrence (O): A number from 1 to 5, depending on the likelihood of the failure mode s occurrence 1 = very unlikely to occur 5 = almost certain to occur
Risk Assessment Factors Probability of detection (D): A number from 1 to 5, 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 detention 5 = 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 125 (extreme risk).
Risk Priority Number File:FMEA.png
Procedures for FMEA Necessity Problem Effects How bad is it? Causes How Likely? Score Steps to Prevent Process Function Failure Mode Occurrence Severity
Procedures for FMEA Necessity Problem Effects How bad is it? Causes How Likely? Score Steps to Prevent Process Function Failure Mode Occurrence Severity Put PB on bread
Procedures for FMEA Necessity Problem Effects How bad is it? Causes How Likely? Score Steps to Prevent Process Function Failure Mode Occurrence Severity Put PB on bread No PB
Procedures for FMEA Necessity Problem Effects How bad is it? Causes How Likely? Score Steps to Prevent Process Function Failure Mode Occurrence Severity Put PB on bread No PB Jelly Sandwich
Procedures for FMEA Necessity Problem Effects How bad is it? Causes How Likely? Score Steps to Prevent Process Function Failure Mode Occurrence Severity Put PB on bread No PB Jelly Sandwich 5/5
Procedures for FMEA Necessity Problem Effects How bad is it? Causes How Likely? Score Steps to Prevent Process Function Failure Mode Occurrence Severity Put PB on bread No PB Jelly Sandwich 5/5 Out of Stock Past Expiration
Procedures for FMEA Necessity Problem Effects How bad is it? Causes How Likely? Score Steps to Prevent Process Function Failure Mode Occurrence Severity Put PB on bread No PB Jelly Sandwich 5/5 Out of Stock 2/5 Past Expiration
Procedures for FMEA Necessity Problem Effects How bad is it? Causes How Likely? Score Steps to Prevent Process Function Failure Mode Occurrence Severity Put PB on bread No PB Jelly Sandwich 5/5 Out of Stock 2/5 10 Past Expiration
Procedures for FMEA Necessity Problem Effects How bad is it? Causes How Likely? Score Steps to Prevent Process Function Failure Mode Occurrence Severity Put PB on bread No PB Jelly Sandwich 5/5 Out of Stock 2/5 10 Check Pantry Past Expiration Check Expiration Date
Conduct an FMEA Conduct a process FMEA on a paper airplane Build a paper airplane Conduct a design FMEA on your paper airplane Paper Airplane Competition
Conclusion What is FMEA? Why is an FMEA important? History of FMEA Benefits of FMEA Limitations of FMEA How to conduct an FMEA?
References Lean Six Sigma - http://www.leansixsigma.com/ Stunell Technology - http://www.stunell.com/images/fmea.j pg
