“It is what it is”

The most important data is unknown and unknowable. This concept, attributable to W Edwards Deming, was made decades ago, yet still rings true despite the many technological advances we have made as a civilization. Just ask any front line employee tasked with managing day to day deviations!…  No AI/ML model is going to come to the rescue here…. (although they may certainly help).  It’s as universally fundamental as the first law of thermodynamics. “It is what it is” - forevermore, so to speak.

Essentially, the most important data would point us to a perfect process control strategy, which is, as we know from years of best efforts, impossible. It is sometimes managements supposition, however, that zero defects are indeed possible if employees would stick to the procedures and training. Wrong. Front line employees have little influence over Quality. Let that sink in for a moment… 

Don’t let your management fool you on this point, or you will find yourself working in a miserable environment, struggling to meet questionable KPIs and wondering why you are failing. Losing sleep over something in which you have little influence.  If the process could speak, it might say “it’s not you, it’s me”.  As Deming once taught, employees have the right to be happy and find meaning in labor.

So what’s the answer?  Ah!  The regulatory roadmap has already been published = the two enablers found in ICH Q10, or what Dr. Deming once termed a “system of profound knowledge”. That’s the best we can do!  If you find yourself in a company striving to build this system, you are in the right place. I bet you love your job!  That’s a Quality Culture, enjoy it. Life is short.

Pete.