Apr 16 2021
As Jay Bitsack pointed out in his comments on LinkedIn about my previous post, the portability of a method from epidemiology to manufacturing quality is not a foregone conclusion. Formally, the logic of validating a vaccine seems applicable to the solution of a quality problem. They look similar when you consider only outcomes in terms of infection rates or the proportion of defectives.
There are differences between data sets from a clinical trial and tests run before and after a process change in production that may affect the applicability of a method. We examine the conditions for the approach developed by Carlo Graziani for vaccine efficacy to cross over to quality control. Then we work out the math of Graziani’s method and the means to apply it.