This Month's Theme is Legal Guidelines for FMEAs
Next month's theme will be "how to get better results with FMEAs, in less time"
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.
"Wisdom consists of the anticipation of consequences." - Norman Cousins
le·gal [le-gal, adjective]
The Oxford English Dictionary defines "legal" as "relating to the law." The word "law" is defined as "the system of rules which a particular country or community recognizes as regulating the actions of its members and which it may enforce by the imposition of penalties."
guide·line [gid-lin, noun]
The Oxford English Dictionary defines "guideline" as "a general rule, principle, or piece of advice."
What legal guidelines should be followed when doing FMEAs?
The following is an excerpt from chapter 5 of Effective FMEAs:
It is important for the FMEA team to understand that FMEAs are legal documents that support the demonstration of due care in product development. As legal documents, they are subject to subpoena for legal proceedings. The FMEA team members should familiarize themselves with and adhere to any relevant company guidelines regarding legal documentation, and closely follow advice from company legal representatives. They should also follow common sense principles, such as:
- All FMEA database entries should be factual and absent of emotional words or exhortations.
- All FMEA database entries that state an action will be taken to address a problem should be closed out with a corresponding entry saying what specifically was done, leaving no "open loops."
- All FMEA database entries should be detailed and specific enough so that anyone who is not part of the FMEA team can read the entry and understand the meaning and context.
- The FMEA team should never omit raising an issue or addressing a problem because it does not have an immediate solution or out of concern for legal ramifications. If there are important concerns that are legal in nature, the team should discuss these issues with management and company legal representatives.
- FMEA teams should continue the FMEA project until an acceptable level of risk is reached.
- Safety issues are always the highest priority, regardless of likelihood of occurrence. No FMEA is complete unless the FMEA team is satisfied that there are no unaddressed safety related issues within the scope of the FMEA project.
- When entering information into the FMEA database, care should be taken to characterize concerns as "potential" or "possible" when appropriate, unless the team is certain the issue will occur. One example is entering an effect that has a possibility of injury. Here it is appropriate to say "with the possibility of injury" rather than saying "will result in injury."
Can you anticipate everything?
In the words of Niels Bohr, "Prediction is very difficult, especially if it's about the future."
Consider this question: In an FMEA, is it possible to think of everything that might happen in the future?
FMEAs are intended to anticipate potential risk and develop actions that will reduce risk to acceptable levels. However, as pointed out in an article written by Daniel Simons entitled "You Can’t Anticipate Everything,"  there is a danger in over confidence.
A standard approach to safety engineering is to try to define all of the potential risks in advance and to design protocols that, if followed precisely, will avoid all of the known hazards. Such safety-by-protocol is great in principle, but it has a critical failing: the illusion of knowledge. The approach assumes that we can know and anticipate all of the potential risks.
In theory, a properly constituted FMEA team using proper FMEA procedure should be able to anticipate problems and recommend design or test improvements to reduce risk to an acceptable level. However, it is not impossible for something to be missed. This is why it is a good practice for FMEA to be performed as part of a comprehensive reliability program.
This subject is further discussed in FMEA Corner Issue 185 "Can You Anticipate Everything?"
Scenarios involving FMEAs, including potential legal consequences
The following is excerpted from a paper presented by Carl Carlson and Jeffrey Patterson to the American Bar Association in Phoenix, Arizona in April 2016, titled "FMEA: How to do it right and the litigation consequences of doing it wrong." 
By FMEA definition, the cause of a failure mode is a design or manufacturing deficiency. FMEAs can identify design or manufacturing deficiencies and recommend actions to correct the deficiencies.
An FMEA is done properly and no significant design deficiencies are identified. No legal consequences should result from the FMEA.
An FMEA is done properly and design deficiencies are identified, with risk fully addressed. There should be no legal consequences resulting from the FMEA.
An FMEA is done improperly and no design deficiencies are identified. A claim can be made that design deficiencies were possibly missed due to incorrect FMEA procedure.
An FMEA is completed and design deficiencies are identified. However, the risk from the design deficiencies is not fully addressed. A claim can be made that the company knew of deficiencies in design or manufacturing process and did not take adequate action to address the associated risk.
Consider using the FMEA quality objectives when asking the question, "Was the FMEA done properly?" The FMEA Corner article in HotWire issue 180 "Common FMEA Mistakes" discusses the most common FMEA mistakes and the corresponding quality objectives.
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.
I would like to enquire about failure mode libraries.
The company I work for deals with companies in many industries, and I would like to be able to compare failure modes, and perhaps failure rates between pumps across multiple industries, as an example.
Thank you in advance for taking the time to read this email.
Carl: Thanks for the question.
I'll begin my reply with a quote from chapter 5 of my book.
FMEA practitioners should be aware of the benefits and limitations of using generic listings of failure modes, effects, causes, etc. Generic lists of failure information can be good thought-starters for FMEA teams, provide standardized descriptions, and ensure completeness of analysis. Controlling the description of individual failure modes enables analysis and dissemination of failure information between project teams and the entire organization.
The limitations of using generic failure information include the suitability of generic descriptions to the current project, potential for inclusion of information in current FMEA that is not of concern to FMEA team, and the possibility of stifling the creativity of the FMEA team to "think outside the box" and identify issues not previously seen. This last issue can be addressed by the proper use of brainstorming before exposing the FMEA team to generic failure information. In addition, generic failure data may come from significantly different operating environments and usages than current application.
There are publications with selected generic failure modes. In addition to the one you mentioned, I'm aware of these: 1. The book Failure of Materials in Mechanical Design: Analysis, Prediction, Prevention, by Jack Collins, lists typical failure mechanisms; and 2. Alion System Reliability Center offers a publication "Failure Mode/Mechanism Distributions" which is a compendium of failure mode and mechanism data, including relative probabilities of occurrence.
As you can see from the excerpt from my book, I advise caution when using generic failure modes. They can be helpful, under limited circumstances.
Good luck in your application.
1. "You Can't Anticipate Everything", The Invisible Gorilla, 2010. [Online] Available: http://theinvisiblegorilla.com/blog/2010/08/11/you-cant-anticipate-everything/.
2. C. Carlson and J. Patterson, "FMEA: How to do it right and the litigation consequences of doing it wrong." in the American Bar Association Annual Conference on Motor Vehicle Litigation, 2016.
About the Author
Carl 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.
Selected 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 firstname.lastname@example.org.