This document contains questions and answers from an FMEA webinar. The questions cover topics like examples of drilling down an FMEA from the system level to component level in books and case studies. Advice is provided for fabless semiconductor companies on how to start FMEAs. Answers indicate FMEAs should be living documents and updated with field experience. Suggestions are made on building a collection of FMEAs across global teams and setting standards. Questions regarding time spent on FMEAs, effectiveness measures, templates and addressing risks when resources are limited are also answered.

1. Questions and answers from FMEA webinar #3
Q: I was wondering if you have a case study in your book that starts from system FMEA and drill
down to the sub-system and component level?
A: Appendix G of SAE J1739 includes three brief Design FMEA excerpts: vehicle steering system,
power steering pump subsystem, and a driveshaft component. These excerpts are also published
as a case study in Figure 8.25, pages 217 to 220 of Effective FMEAs.
Q: Do you have an example of a vehicle level FMEA drilled down to component level detailing
design functional attributes and how each are mitigated or controlled.
A: In addition to the three brief FMEA excerpts mentioned above, the book Effective FMEAs uses
a Bicycle System FMEA, Hand Brake Subsystem Design FMEA and Brake Cable Design FMEA to
show the progression of FMEAs from system, to subsystem to component. The book also has
eight other Design FMEA case studies that provide insight into the mitigations and controls of
design functional attributes through the use of FMEA.
Q: FMEA is a strong requirements for automotive industry specially for semiconductor industry,
any advice how do we start specially for fabless company
A: This was discussed in part during the Webinar. Companies with responsibility for fabless
semiconductors will need to do Design FMEAs to ensure the fabless design is robust and highly
reliable. The company who is doing the manufacturing of the semiconductor should do the
Process FMEA, with results reviewed by the fabless semiconductor company.
Q: Carl, shouldn't a FMEA be a living document and updated with field experience as the product
life goes on?
A: Yes. This was answered during the Webinar.
Q: Any comments on APIS software
A: This was answered during the Webinar.
Q: Do you have information on how to build a collection of FMEAs for a very large global company
with many different teams, how to ensure all global teams have access AND use them, etc.?
A: This was answered during the Webinar.
Q: my question is, what would be a good or standard time to spend on an FMEA?
A: This was answered during the Webinar.
Q: In your first class-The 10 most common FMEA mistakes-the 10th mistake was:Lack of efficient
use of time.
A: For some reason this question arrived incomplete. Please email me at
Carl.Carlson@EffectiveFMEAs.com with any additional information to ensure the question is
complete.
Q: What are good measures of FMEA effectiveness? (RPN Reduction?)
A: This was answered during the Webinar.
Q: Is there a template/ example of an MSAcess FMEA available?

2. A: Xfmea software, by ReliaSoft has a library of many FMEA templates and examples built into the
software. Xfmea uses MS Access as the underlying platform.
Q: What are your suggestions when a company does not have all the requirements for
accomplishing a good FMEA?
A: This was discussed in part during the Webinar. Few companies have all the elements of
effective FMEAs in place before beginning FMEA programs. I would suggest working with
management to decide how to begin implementing needed FMEAs, while at the same time
establishing the strategies and resources that are needed to ensure an effective FMEA program.
Q: Isn't an FMEA a "living document"?
A: This was answered during the Webinar.
Q: quantify a hi risk issue value???
A: There are two different forms of risk in the RPN number: high severity regardless of RPN, and
high RPN by itself. Targeting only RPN misses the potential risk of high severity – low RPN issues,
which can devastate a company. Some companies choose to provide target values or “thresholds”
for RPN, where action is mandated if RPN exceeds the target value. There is no problem with
ensuring that items with high severity or high RPN values get added review. However, mandating
action for RPN above a threshold has the potential of a numbers game. The best practice is to first
ensure that all high-severity items are addressed regardless of RPN; and then to address all high-
RPN items, beginning with the highest and continuing until the FMEA team and management is
satisfied that risk is reduced to an acceptable level. See section 7.1 “Prioritize Issues for
Corrective Action,” pages 163 to 165 in Effective FMEAs."
Q: What are the best ways to obtain management buy in to develop FMEA process?
A: This was answered during the Webinar.
Q: Do you have a case study on FMEA done on software Projects and if available please share?
A: This was answered during the Webinar. Chapter 15 of the book Effective FMEAs covers
Software FMEAs including examples.
Q: What is a typical/average time to complete a FMEA? Hours/Days/Weeks/Months?
A: This was answered during the Webinar.