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 1960s 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

Types of FMEA

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 modes effect 1 = no effect 5 = maximum severity

Probability of occurrence (O): A number from 1 to 5, depending on the likelihood of the failure modes 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 modes 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

Procedures for FMEA

Necessity Process Function Problem Failure Mode Effects How bad is it? Severity Causes How Likely? Occurrence Score Steps to Prevent

Procedures for FMEA

Necessity Process Function Put PB on bread Problem Failure Mode Effects How bad is it? Severity Causes How Likely? Occurrence Score Steps to Prevent

Procedures for FMEA

Necessity Process Function Put PB on bread Problem Failure Mode No PB Effects How bad is it? Severity Causes How Likely? Occurrence Score Steps to Prevent

Procedures for FMEA

Necessity Process Function Put PB on bread Problem Failure Mode No PB Jelly Sandwich Effects How bad is it? Severity Causes How Likely? Occurrence Score Steps to Prevent

Procedures for FMEA

Necessity Process Function Put PB on bread Problem Failure Mode No PB Jelly Sandwich Effects How bad is it? Severity 5/5 Causes How Likely? Occurrence Score Steps to Prevent

Procedures for FMEA

Necessity Process Function Put PB on bread Problem Failure Mode No PB Jelly Sandwich Effects How bad is it? Severity 5/5 Out of Stock Past Expiration Causes How Likely? Occurrence Score Steps to Prevent

Procedures for FMEA

Necessity Process Function Put PB on bread Problem Failure Mode No PB Jelly Sandwich Effects How bad is it? Severity 5/5 Out of Stock Past Expiration Causes How Likely? Occurrence Score Steps to Prevent

2/5

Procedures for FMEA

Necessity Process Function Put PB on bread Problem Failure Mode No PB Jelly Sandwich Effects How bad is it? Severity 5/5 Out of Stock Past Expiration Causes How Likely? Occurrence Score Steps to Prevent

2/5

10

Procedures for FMEA

Necessity Process Function Put PB on bread Problem Failure Mode No PB Jelly Sandwich Effects How bad is it? Severity 5/5 Out of Stock Past Expiration Causes How Likely? Occurrence Score Steps to Prevent

2/5

10

Check Pantry 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