FMEA and Design Reviews
We submit that a Failure Mode and Effects Analysis (FMEA) review is a form of design review. After all, one of the purposes of a design review is to try and remove defects before they appear in the product and that is the entire rationale for the FMEA in the first place. Yet, most of the time, the design reviews we have attended did not even attempt to review the product or module FMEAs, thus limiting the value gained from the design review.
We must ask ourselves, what is the purpose of a design review? Do we sit there like zombies and rubber stamp approve the spiffy slide show we just attended or do we put some teeth in the review and start asking the hard questions nobody wants to deal with.
Of course, a design review can also include schedule and cost considerations in addition to the quality issues. The FMEA review doesn’t eliminate that and we should add these considerations to the agenda while realizing we have now added enough power to the FMEA portion to eliminate the vast majority of the stupid mistakes and, if we are diligent, the more subtle and costly mistakes as well.