Frequently when a process development team are putting together the upstream and downstream components of their processes, the last thing on the their minds is the performance of the tests or assays that they'll be measuring it by. Even if they do think about, they may make an unhealthy assumption that they can simply rely on the data. Sometimes they'll be right, often they'll be wrong. When measuring the performance of their process they need to be thinking about the process variability.....
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