Questions and Carl's responses from the second session of the ASQ Reliability Division 3 part short course on Effective FMEAs.

1. Questions and Answers from Webinar #2
The following questions were answered during the webinar. The webinar, including the answers to
these questions, has been recorded and can be viewed on ASQ RD website, as soon as available.
Q: What is difference between FMEA and FMECA?
Q: What are key factors that you think contribute to FMEA participant satisfaction?
Q: Should we have a different column of root cause besides the cause/mechanism column.
Q: You mentioned Block Diagram. Do you also preach P-Charts?
Q: Is there a relationship between the timing of the FMEA and whether a top-down or bottom-
up approach is used?
Q: Do you want to increase the detection?
Q: What are the most important things to collect from field data?
Q: Is it the Quality rep that is hosting the FMEA meetings and coordinating?
Q: Doesn't this example miss the interface between the brake pad and the rim?
Q: So are we to assume that no PV&V testing was done during the design phase?
All material & answers to questions that were not covered in the webinar presentation can be found
here: http://reliabilitycalendar.org/webinars/
Many positive comments and feedback were provided by the audience, and these are all appreciated.
The following questions were asked, but not answered during the webinar presentation:
Q: Any tricks/techniques that help teams best define intended part function?
A: Yes. First, I ensure the team fully understands the definition of Function:
“Function” is what the item or process is intended to do, usually to a given standard of
performance or requirement. For Design FMEAs, this is the primary purpose or design intent of
the item. For Process FMEAs, this is the primary purpose of the manufacturing or assembly
operation; wording should consider “Do this [operation] to this [the part] with this [the tooling]”
along with any needed requirement. There may be many functions for each item or operation.
It is important to ensure that each of the primary functions is properly worded, including the standard of
performance. I also use a checklist of function types to ensure none are missed. These can be found on
my website at the following link: http://www.effectivefmeas.com/Page_2.html
Q: What is basic distinction between Risk Analysis and FMEA?
A: Risk Analysis is a general body of knowledge that can be applied to engineering or business risk, and
attempts to study and assess the level of safety, cost or other type of risk to a project or program. It is
often done as part of overall risk management. FMEA uses a type of risk analysis that assesses the risk
due to severity, occurrence and/or detection.
Q: How do you ensure linkage from the critical drawing features to the FMEA to the control plan?
A: Critical drawing features can be described as “special characteristics” of the part or process. They can

2. be further categorized as critical, key, or other designations. The Design FMEA can help to identify key
product characteristics, and many FMEA teams use a column called “Classification” to display these key
characteristics. The Process FMEA can help to identify key process characteristics, using a similar
column. The key process characteristics flow to the Process Control Plan to help ensure that the
manufacturing or assembly process controls the key process characteristics and the resulting process is
capable and stable. This is fully described in my book Effective FMEAs, section 6.2.6 “Classification”,
pages 127 to 129 and sections 6.3.2 “Process FMEA Linkage to Process Control Plans and 6.3.3 “Design
FMEA Linkage to Process FMEA”, pages 153 to 157 of Effective FMEAs.
Q: I was not able to access the downloadable information effectivefmeas.com because I hadn't
purchased your book.
A: Please use this link: http://www.effectivefmeas.com/Page_2.html There is no need to purchase the
book to take advantage of the downloadable links.
Q: Should only the final FMEA results be published or how should changes/revisions be
managed/tracked?
A: When working with a client, I prefer to use a relational database, such as ReliaSoft’s Xfmea, for all of
the clients FMEAs. That way all FMEAs are housed in one database, and users can access the full FMEA
information or configurable reports and summaries. Updates should go into the database so they are
accessible to current and future FMEA teams. Changes and revisions and be easily managed and tracked.
Q: Is there ASQ RU Credit available for these webinars? I am not a Reliability div member but am an
automotive div member and they grant credit. If so how do I prove attendance? Thanks!
A: Cheryl says she will double check that and follow up with you.
Q: What sort of "e-tool" have you found useful for documenting and updating FMEAs? MS Excel? Other?
A: As noted above, I prefer to use ReliaSoft’s Xfmea tool. You can find out about it with this link:
http://xfmea.reliasoft.com/
Q: have we already reviewed the block diagram? Or will we be reviewing it?
A: Below is an example of an FMEA Block Diagram for the fictitious bicycle hand brake subsystem.

3. Excerpted from Figure 5.8, page 84, from the book Effective FMEAs, published by John Wiley & Sons, by
Carl S. Carlson, ©2012