Failure Mode and Effect Analysis

Failure Mode and Effect AnalysisJackie Harris, Josh Agusti, and Natasha Sommer

ObjectivesWhat is FMEA?Why is an FMEA important?History of FMEABenefits of FMEALimitations of FMEAHow to conduct an FMEA?

Who is in Attendance?Anyone conducted an FMEA before?Anyone completed a Risk Analysis Procedure?

What is FMEA?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 processFailure Mode and Effect Analysis

Failure Mode and Effect AnalysisSimply 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 TermsFailure 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 FMEAGet it right the first timeIndentifies any inadequacies in the development of the productTests and trials may be limited to a few productsRegulatory reasonsContinuous improvementPreventive approachTeam buildingRequired procedures

FMEA Provides the Potential to: Reduce the likelihood of customer complaintsReduce the likelihood of campaign changesReduce maintenance and warranty costsReduce the possibility of safety failuresReduce the possibility of extended life or reliability failuresReduce the likelihood of product liability claims

BenefitsIdentify potential and known failuresReduce the number of engineering changesReduce product development timeLower start-up costsGreater customer satisfactionIncreased cooperation and teamwork between various functionsContinuous improvement

HistoryAn 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 FMEAUsed 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 proposalIncludes the interaction of multiple systems and interaction between the elements of a system at the concept stages.

Design FMEAAid in the objective evaluation of design requirements and design alternativesAid in the initial design for manufacturing and assemblyIncrease the probability that potential failure modes have been consideredProvide additional information to aid in the planning of efficient design testing

Process FMEAIndentify potential product related process failure modesAssess the potential customer effects of the failuresIndentify the potential manufacturing causes on which to focus onDevelop a ranked list of potential failure modesDocument the results of the manufacturing

Types of FMEA

Resources NeededCommitment of top managementKnowledgeable individualsIndividuals attentive to FMEA timelinesPeople resources may be internal or external to the business or a combination of both

FMEA TimingFMEA should be updated:at the conceptual stagewhen changes are made to the designwhen new regulations are institutedwhen customer feedback indicates a problem

AdvantagesEnhance design and manufacturing efficienciesAlleviate late change crisesMinimize exposure to product failuresAugment business recordsImprove bottom line resultsAdd to customer satisfaction

LimitationsEmployee training requirementsInitial impact on product and manufacturing schedulesFinancial 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 FactorsSeverity (S): A number from 1 to 5, depending on the severity of the potential failure modes effect 1 = no effect5 = maximum severity

Probability of occurrence (O): A number from 1 to 5, depending on the likelihood of the failure modes occurrence1 = very unlikely to occur5 = almost certain to occur

Risk Assessment FactorsProbability 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 detention5 = 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 FunctionProblem

Failure ModeEffectsHow bad is it?

SeverityCausesHow Likely?

OccurrenceScoreSteps to Prevent

Procedures for FMEA

Necessity




OccurrenceScoreSteps to PreventPut PB on bread

Procedures for FMEA

Necessity




OccurrenceScoreSteps to PreventPut PB on breadNo PB

Procedures for FMEA

Necessity




OccurrenceScoreSteps to PreventPut PB on breadNo PBJelly Sandwich

Procedures for FMEA

Necessity




OccurrenceScoreSteps to PreventPut PB on breadNo PBJelly Sandwich5/5

Procedures for FMEA

Necessity




OccurrenceScoreSteps to PreventPut PB on breadNo PBJelly Sandwich5/5Out of Stock

Past Expiration

Procedures for FMEA

Necessity





Past Expiration2/5

Procedures for FMEA

Necessity





Past Expiration2/510

Procedures for FMEA

Necessity





Past Expiration2/510Check Pantry

Check Expiration Date

Conduct an FMEAConduct a process FMEA on a paper airplaneBuild a paper airplaneConduct a design FMEA on your paper airplanePaper Airplane Competition

ConclusionWhat is FMEA?Why is an FMEA important?History of FMEABenefits of FMEALimitations of FMEAHow to conduct an FMEA?

ReferencesLean Six Sigma - http://www.leansixsigma.com/Stunell Technology - http://www.stunell.com/images/fmea.jpg

Our objectives for this class is for each person to be knowledgeable of the following things:

What is FMEA?Why is an FMEA important?History of FMEABenefits of FMEALimitations of FMEAHow to conduct an FMEA?

*Has anyone here ever conducted an FMEA before?

Has anyone ever completed a Risk Analysis Procedure before?*FMEA is an acronym for Failure Mode and Effect Analysis.An FMEA is a rigorous, step by step process, to figure out everything that could go wrong and what can be done to keep those things from happening. It is not something we dont do everyday. There are risky things that people do. For example when we get into a car we know that we could have a car accident so we put on a seatbelt. Its a way of thinking what could go wrong ahead of time and preventing that from happening.*Simply put an FMEA is:a process that identifies all the possible types of failures that could happen to a product and potential consequences of those failures.

The Failure Mode is what could go wrong and The Effect Analysis is how it would happen; how likely is it to go wrong; how bad would it be

*Failure mode - the way in which something might fail. For example, a cars tire might fail by puncture from a sharp object. It might also fail from a blowout resulting from wear. Puncture and blowout are two of the many tire failure modes.

Effects analysis studying the consequences of the various failure modes to determine their severity to the customer. Of the two tie failure modes we just talked about, the blowout is likely to have the most serious consequence, since when a tire suddenly explodes the speeding car usually goes out of control, often with dire consequences. On the other hand, a puncture problem usually allows the tire pressure to decrease gradually, allowing the driver time to sense the problem before he looses control. Neither failure mode is something the driver wants but of the two the puncture is preferred.

*It is important to know why we would do an FMEA. Its for procedures or inventions that would be very risky or very expensive. Healthcare is a good example of this because we have very costly and risky procedures. An FMEA is critical for healthcare procedures because preventative medicine is less costly than curative medicine. We want to prevent problems before they happen and that is exactly what an FMEA does. My favorite example is the space shuttle where we are putting fragile human lives in a tin can and sending them to space and getting them home safely. There is a lot that can go wrong. Lives are at steak. And space shuttles are expensive. Doing an FMEA is imperative to making sure things run smoothly.*There are many reason to do an FMEA, several of the reason were already mentioned and this is a list of other reasons that one would want top conduct an FMEA. The main reason to do an FMEA is to identify any inadequacies in the product and to get it right the first time so that there are no costly mistakes later.*There are many benefits to doing an FMEA. Some of them are to:Identify potential and known failuresReduce the number of engineering changesReduce product development timeLower start-up costsGreater customer satisfactionIncreased cooperation and teamwork between various functionsContinuous improvement

*FMEA was invented by the military about 60 years ago. It was used as a reliability evaluation technique to determine the effect of failures.*A concept FMEA is used to analyze concepts in the early stages. It focuses on potential failures to the overall concept.*A design FMEA is used to evaluate design requirements and design alternatives. It aids in the initial design and provides additional information to aid in the planning process

*A process FMEA is used to identify potential process failures and it assess the potential customer effects.

*These are the two types of FMEAs. We have the design FMEA and the process FMEA.

The main difference between the two is that:A Design FMEA is done during the design phase of a product to ensure failure modes have been addressed andA Process FMEA is done to a process (like a factory) to ensure failure modes have been addressed.

*An FMEA needs the following resources:

Commitment from top management

Knowledgeable individuals with expertise in: Design Manufacturing, Assembly, Service, Quality, Reliability

Individuals attentive to FMEA timelines because you want to achieve the greatest value. These individuals want to identify failure modes before a design or process failure mode has been unknowingly designed into the product

And lastly you needPeople resources. They may be internal or external to the business or a combination of both

*FMEA should be updated:at the conceptual stagewhen changes are made to the designwhen new regulations are institutedwhen customer feedback indicates a problem

*There are many advantages to doing an FMEA

They:Enhance design and manufacturing efficienciesAlleviate late change crisesMinimize exposure to product failuresAugment business recordsImprove bottom line resultsAdd to customer satisfaction

*There are limitations to doing an FMEA.

There are employee training requirements.There may be an impact on product and manufacturing schedulesAnd there is a financial impact due to upgrading a design, adjusting manufacturing, or needing new equipment and tools.*These are the risk assessment factors used in an FMEA. Severity is a rating of how severe the failure would be.Probability of Occurrence is a rating of how likely it is to happen.*The probability of detection is a rating on how likely it is to detect the failure

And the risk priority number is found by multiplying the severity rating by the probability of occurrence by the probability of detection.

The auto industry says that a risk priority number of 75 is acceptable. Anything more than that is unacceptable.*These flow charts are a visual on how to obtain the risk priority number.

The risk priority number is found by multiplying the severity rating by the probability of occurrence by the probability of detection.

*It is important to know what an FMEA looks like. You want to gather all your smart people together. The process is tedious, time consuming and exhausting. The FMEA process can be summed up in a special worksheet. Weve created one to show the example of creating a peanut butter and jelly sandwich.This is an example of a process FMEA. CLICK Our necessity of process function is to put peanut butter on the bread. Another function would be to put jelly on the bread. CLICK Next up is the problem or failure mode. My problem is that I have no peanut butter in my house. Peanut butter is essential to getting peanut butter on the bread. Other problems could be I dont have a knife or I dont have bread or my hands are not working or I cant open the jar. CLICK The effect of having no peanut butter is that I end up with a jelly sandwich rather than a peanut butter and jelly sandwich. CLICK The next column is how bad that is or the severity of the effect. Here I will use a 0 to 5 scale with 5 being the worst thing that could happen. In healthcare if a patient could die then that is obviously a rating of 5. I am giving this a high rating because if I have no PB then I have no PB and jelly sandwich. CLICK The next column is all the reasons why this happened. All the reasons why I dont have peanut butter. It could be that I dont have any in the pantry or that what I do have is expired. CLICK The next column is another rating on how likely this is to occur. At my house since I have kids that really like to eat PB I would rate this a 2 out of 5. CLICK Next we multiply the score of how likely something is to happen with the how bad it is or severity rating. And this creates a Hazards Score CLICK The next column is the steps to prevent this. *********So now we are going to split into three groups. Each group will conduct an process FMEA on a paper airplane.

Next each group will construct a paper airplane. When a group is done they can begin testing it out. After several flying attempts we will ask them to conduct a design FMEA with the new knowledge they obtained from the design process and flying attempts.

After all groups are done with the second FMEA we will have them compete for the following:

Which design flies the furthest?Which design flies the most accurate?Which design stays in the air the longest?

*So who knows :What is FMEA?-to figure out everything that could go wrong and what can be done to keep those things from happeningWhy is an FMEA important?-Its for procedures or inventions that would be very risky or very expensive to correctHistory of FMEA-designed by the military 60 years agoBenefits of FMEA-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 improvementLimitations of FMEA-There are employee training requirements.-There may be an impact on product and manufacturing schedules-And there is a financial impact due to upgrading a design, adjusting manufacturing, or needing new equipment and toolsHow to conduct an FMEA?-find severity rating-find probability of occurrence-find probability of detection-find the risk priority number is found by multiplying the severity rating by the probability of occurrence by the probability of detection.

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Failure Mode and Effect Analysis