A little bit of background might help. I instituted a SPC program complete with flowcharts and questionnaires in response to out of control/trend signals. I thought this was going to be the best thing since sliced bread. Shortly thereafter, I saw the problem which hit me like a brick. The OOT signals were easy enough to document (GMP environment…[Read more]
Thanks for the reply @Cseider and @Brunehilde. Unfortunately, and this is where the rub is, we receive the samples after production. Our batch size is large enough and they are quantitative measurements but to try and fix the process is not in the cards since the product is manufactured offsite. Perhaps I could appease them with some sort of…[Read more]
I was wondering if the powers that be might have any insight into situations where it does not make sense to perform SPC. In the pharmaceutical industry, for example, it can be common to have a minimal amount of batches produced per year for certain products (1-2). Does it even make sense to trend?
Reading up on some of the other…[Read more]