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 ...

In a general sense, capability is the ability to do something. Within manufacturing, capability is given a much more specific definition. It is an expression of the accuracy of a process or equip ment ...

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 ...