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FMEA Corner 
This Month's Theme is Application Tips - Begin with Concerns
Next month's theme will be "discussing the controversial issue of FMEA pre-population"

Every month in FMEA Corner, join Carl Carlson, a noted expert in the field of FMEAs and facilitation, as he addresses a different FMEA theme (based on his book Effective FMEAs) and also answers your questions.

Questions and answers are a great way to learn about FMEAs, for both experienced and less experienced FMEA practitioners. Please feel free to ask any question about any aspect of FMEAs. Send your questions to Carl.Carlson@EffectiveFMEAs.com, and your contact information will be kept anonymous. All questions will be answered, even if they are not featured in the FMEA Corner.



con·cern [kuhn-sern, noun]
The Oxford English Dictionary defines "concern" as "a worry or issue raised by an individual or group in connection with a particular matter."

How do concerns relate to FMEAs?

Properly done, FMEAs will identify areas of higher risk and develop effective actions to reduce the identified risk to an acceptable level.

The following is an optional technique to front-load areas of concern at the beginning of the FMEA process. It is one way to harness the creative energy of the FMEA team and save valuable time spent in meetings. The FMEA facilitator begins the analysis by asking the subject matter experts for areas of concern. What keeps them up at night? What do we want to be sure does not happen?

These areas of concern can be solicited before the first team meeting, or they can be requested at the first meeting.

Sticky notes are a good way to document the concerns. For each item’s function, ask the FMEA team to write sticky notes for the primary concerns they have, not emphasizing if the concern is worded as a failure mode, effect or cause. The writing of sticky notes is done concurrently; in other words, all the FMEA team members are writing sticky notes at the same time until they have noted all of their primary concerns. The sticky notes are placed on a wall or table easily visible to the FMEA team and organized into similar groupings. The FMEA team reviews the information and determines what goes into the FMEA. This technique encourages contribution by all team members, fosters creativity and saves meeting time.

Best of all, identifying the major concerns of key stakeholders early in the FMEA process will help to ensure that no major issues are missed within the scope of the FMEA analysis.

How to follow up on concerns in the FMEA worksheet
The soul cannot think without a picture. – Aristotle

Some companies make the list of concerns visible in the FMEA worksheet, by adding a temporary column next to the corresponding function. Once the concerns have been solicited either before or during the first meeting, they can be mapped to the corresponding function and entered into a temporary column called "Concerns." The FMEA team conducts the analysis according to FMEA procedure, and before finalizing the FMEA, ensures that each of the concerns has been adequately addressed.

How to add a temporary Concerns column in Xfmea

If the FMEA team decides to add a temporary column to document the concerns, this can be done in the following manner.  

Choose Project > Management > Configurable Settings > Interface Style. In the navigation panel, under FMEA, click Functions. For one of the Function User Text fields, click inside the Enabled column to toggle it to Yes and type Concerns in the Display Name column. Click OK to add the Concerns column to the FMEA. If you use the worksheet view, you can drag the Concerns column to the location next to Functions. If you use the hierarchy view, the Concerns field is shown in the Function Properties window.

FMEA Worksheet View
FMEA worksheet view

FMEA Hierarchy View
FMEA hierarchy view

!FMEA Tip of the Month

It is a good practice to limit failure modes to those of concern to at least one member of a properly constituted FMEA team. It is not an academic listing of every conceivable failure mode (such as the unlikely event of a meteor striking the item) but rather a list of potential failure modes of concern to at least one of the FMEA team members (assuming a properly constituted FMEA team).

?Something I’ve always wanted to know about FMEAs
The important thing is not to stop questioning. - Albert Einstein

A reader submitted the following question to Carl Carlson. To submit your own question about any aspect of FMEA theory or application, e-mail Carl at Carl.Carlson@EffectiveFMEAs.com.

It was nice to read your book about effective FMEA implementation.

Recently we received in the plant, a visit of one of our largest customers and after seeing our improvement facilities and quality controls, he mentioned that we are missing to reflect those improvements in the FMEAs.

If a customer requests such improvements into the FMEA, such as investments for a clean room, where in the FMEA can we place this information and how will the ranking will be given?

One of my thoughts is to check the location for particle control and then use the same Severity rank, Occurrence rank will be taken from the times that we suffered a particle failure on the manufacturing line, and Detection will be guided by the ranking of how well we can detect particles.

Main question is how we can place into the FMEA the investment of a clean room to prevent or control particle contamination in the manufacturing line as well as the RPNs.

Carl: Thanks for getting in touch with me with your question about customer-suggested improvements for your Process FMEA.

Let me begin with FMEA definitions for controls and specifically prevention-type process controls.

As you note, you are investing in a clean room to prevent or control particle contamination in the manufacturing line. I suggest that you look at your clean room methods and see how they relate to the definitions above, and enter them as appropriate in the process controls for the PFMEA. If you have clean room methods to prevent particle contamination in the manufacturing line, these are candidates for prevention-type process controls. If you have methods to detect particle contamination, these are candidates for detection-type process controls.

Best of luck to you, and let me know if you have any further questions.


About the Author

Carl S. CarlsonCarl S. Carlson is a consultant and instructor in the areas of FMEA, reliability program planning and other reliability engineering disciplines. He has 35 years of experience in reliability testing, engineering and management positions, and is currently supporting clients from a wide variety of industries, including clients of HBM Prenscia. Previously, he worked at General Motors, most recently senior manager for the Advanced Reliability Group. His responsibilities included FMEAs for North American operations, developing and implementing advanced reliability methods and managing teams of reliability engineers. Previous to General Motors, he worked as a Research and Development Engineer for Litton Systems, Inertial Navigation Division. Mr. Carlson co-chaired the cross-industry team that developed the commercial FMEA standard (SAE J1739, 2002 version), participated in the development of SAE JA 1000/1 Reliability Program Standard Implementation Guide, served for five years as Vice Chair for the SAE's G-11 Reliability Division and was a four-year member of the Reliability and Maintainability Symposium (RAMS) Advisory Board. He holds a B.S. in Mechanical Engineering from the University of Michigan and completed the 2-course Reliability Engineering sequence from the University of Maryland's Masters in Reliability Engineering program. He is a Senior Member of ASQ and a Certified Reliability Engineer.

Effective FMEAsSelected material for FMEA Corner articles is excerpted from the book Effective FMEAs, published by John Wiley & Sons, ©2012. Information about the book Effective FMEAs, along with useful FMEA aids, links and checklists can be found on www.effectivefmeas.com. Carl Carlson can be reached at carl.carlson@effectivefmeas.com.