In today’s column, I will be looking at process validation and the problem of induction. Yesterday, I looked at process validation through another philosophical angle by using the lesson of the Ship of Theseus.

The U.S. Food and Drug Administration (FDA) defines process validation as “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”

My emphases on the FDA’s definition are the two words “capability” and “consistency.” One of the misconceptions about process validation is that once the process is validated, then it achieves almost an immaculate status. One of the horror stories I have heard from my friends in the medical devices field is about a manufacturer that stopped inspecting its product since the process was validated.

 …