Performance metrics for processes are an area of much regulatory interest currently. There isn’t always a readily available clear definition of what is needed, however, and guidance from regulators is ...

For a stable and controlled process, “process capability” (PC) refers to the least quality variability that the process can provide. In other words, the PC is the measure of a process’s ability to ...

A quantitative approach for linking baseline sample size to statistics provides a statistically justified basis for ...

The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient ...