Part two of this article series shows how traditional statistical process control rules can be relaxed or adjusted to allow charting and evaluation of real-life data of pharmaceutical processes with a ...

Regulating manufacturing processes in the medical device industry is challenging. But process signature verification can help manufacturers get a handle on problems before they get out of control.

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant ...