If you are reviewing a drawing or set of specifications and all the tolerances are set at a blanket value, this should raise your suspicions, for it implies that every tolerance has the same importance as all others. This may be true, yet it is often not possible nor necessary for the design and resulting system to function correctly. Continue reading
I was thinking…if only telepathy were a viable means of communication rather than being told that I had been sent an email, along with several dozen others! Continue reading
Many CRO’s come from compliance, legal, or finance areas. They do not know operations or quality. This person is critical to quality‘s success with ISO 9001:2015 in terms of providing risk approvals, direction, and resources. The quality department should be flexible and work with the CRO, specifically: Continue reading
I participate in several professional social networks and mostly let the questions asked 
pass. One I saw recently (because Howard Weiner, who will do a follow-up post to this article commented) asked about questions to answer when coming to a project review with a steering committee. I want to expand that and talk about the questions that should be asked and answered up front – before substantive work is done on any project. Continue reading