1. Failure Mode and Effect Analysis
Jackie Harris, Josh Agusti, and Natasha Sommer

2. Objectives What is FMEA? Why is an FMEA important? History of FMEA
Benefits of FMEA
Limitations of FMEA
How to conduct an FMEA?
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 FMEA
Benefits of FMEA
Limitations of FMEA
How to conduct an FMEA?

3. Who is in Attendance? Anyone conducted an FMEA before?
Anyone completed a Risk Analysis Procedure?
Has anyone here ever conducted an FMEA before?
Has anyone ever completed a Risk Analysis Procedure before?

4. What is FMEA? A systemized group of activities designed to:
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
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 don’t 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. It’s a way of thinking what could go wrong ahead of time and preventing that from happening.

5. 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.
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

6. 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.
Failure mode - the way in which something might fail. For example, a car’s 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.

7. Why do an FMEA?
Preventing problems is cheaper and easier than cleaning them up.
Some things are too risky or costly to incur mistakes.
It is important to know why we would do an FMEA. It’s 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.

8. 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
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.

9. 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

10. 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
There are many benefits to doing an FMEA. Some of them are to:
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

11. 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.
FMEA was invented by the military about 60 years ago. It was used as a reliability evaluation technique to determine the effect of failures.

12. 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.
A concept FMEA is used to analyze concepts in the early stages. It focuses on potential failures to the overall concept.

13. 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
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

14. 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
A process FMEA is used to identify potential process failures and it assess the potential customer effects.

15. Types of FMEA
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 and
A Process FMEA is done to a process (like a factory) to ensure failure modes have been addressed.

16. 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
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 need
People resources. They may be internal or external to the business or a combination of both

17. 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 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

18. 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
There are many advantages to doing an FMEA
They:
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

19. 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.
There are limitations to doing an 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 tools.

20. 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
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.

21. 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).
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.

22. Risk Priority Number
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.

23. Procedures for FMEA Necessity “Process Function” Problem
“Failure Mode”
Effects
How bad is it?
“Severity”
Causes
How Likely?
“Occurrence”
Score
Steps to Prevent
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. We’ve 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 don’t have a knife or I don’t 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 don’t have peanut butter. It could be that I don’t 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.

24. Procedures for FMEA Necessity “Process Function” Problem
“Failure Mode”
Effects
How bad is it?
“Severity”
Causes
How Likely?
“Occurrence”
Score
Steps to Prevent
Put PB on bread

25. Procedures for FMEA Necessity “Process Function” Problem
“Failure Mode”
Effects
How bad is it?
“Severity”
Causes
How Likely?
“Occurrence”
Score
Steps to Prevent
Put PB on bread
No PB

26. Procedures for FMEA Necessity “Process Function” Problem
“Failure Mode”
Effects
How bad is it?
“Severity”
Causes
How Likely?
“Occurrence”
Score
Steps to Prevent
Put PB on bread
No PB
Jelly Sandwich

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

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

29. Procedures for FMEA Necessity “Process Function” Problem
“Failure Mode”
Effects
How bad is it?
“Severity”
Causes
How Likely?
“Occurrence”
Score
Steps to Prevent
Put PB on bread
No PB
Jelly Sandwich
5/5
Out of Stock
Past Expiration
2/5

30. Procedures for FMEA Necessity “Process Function” Problem
“Failure Mode”
Effects
How bad is it?
“Severity”
Causes
How Likely?
“Occurrence”
Score
Steps to Prevent
Put PB on bread
No PB
Jelly Sandwich
5/5
Out of Stock
Past Expiration
2/5 10

31. Procedures for FMEA Necessity “Process Function” Problem
“Failure Mode”
Effects
How bad is it?
“Severity”
Causes
How Likely?
“Occurrence”
Score
Steps to Prevent
Put PB on bread
No PB
Jelly Sandwich
5/5
Out of Stock
Past Expiration
2/5 10
Check Pantry
Check Expiration Date

32. 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
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?

33. Conclusion What is FMEA? Why is an FMEA important? History of FMEA
Benefits of FMEA
Limitations of FMEA
How to conduct an FMEA?
So who knows :
What is FMEA?
-to figure out everything that could go wrong and what can be done to keep those things from happening
Why is an FMEA important?
-It’s for procedures or inventions that would be very risky or very expensive to correct
History of FMEA
-designed by the military 60 years ago
Benefits 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 improvement
Limitations 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 tools
How 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.

34. References Lean Six Sigma - http://www.leansixsigma.com/
Stunell Technology -