We’re developing requirements for our product, including setting reliability requirements. Or we’re setting acceptance criteria for our test plans.

What confidence levels do we choose? We don’t have to blindly set them - we can base it off the risks of failure, using our FMEA (failure mode effects analysis). FMEA is a great tool for us to refer to, to help us choose a relevant confidence level by basing our decision on one or more metrics that the FMEA can provide. 

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ABOUT DIANNA
 Dianna Deeney is a product development process strategist with over 25 years of experience in regulated industries. She is president of Deeney Enterprises, LLC, where she helps product development teams make better decisions upstream — before costly design mistakes get built in.