• posted by: Lee Smith
• posted on: October 11, 2016

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.....

• posted by: Lee Smith
• posted on: September 26, 2016

During one development meeting early in my industrial career, a process development group member asked me whether the value my group had reported in one result was okay to use. I confidently replied “Yes, it’s fine. It’s about 40, somewhere between 38 and 42. The other person raised his eyebrows - an answer not met with full understanding, but rather concern.