PQR Trend analysis OOS

Hi everyone,

I’m new to the Process Statistics world and I have a question I can’t seem to find the answer to.

In our processes we get OOS sporadically but in our procedures it is written that when it happens, analysis should be repeated 2 times, and if it is both times correct, batch is still released. Should we include the OOS produced when measuring process capability considering an investigation is carried out every time it happens?

This is a pharmaceutical process, specifically I’m talking about PQR Trend analysis.

thank you very much in advanced

Greetings,