It has come to my attention in webinars I present, mostly through The Tungsten Shield Group, classes I teach at University of California and my consulting work, that many people have lost sight of what their goals should be. When we develop systems, put controls in place, monitor processes, we do it because it makes good business sense. Rather I am sensing a trend for people doing this activity to satisfy regulators. They ask the question
“what do the regulators expect?”
That is instead of developing a robust business process and fine tuning it to meet their needs.
I illustrated this point several months ago related to lot disposition in Designing your QMS post
But in a recent class, I unearthed another example. I was presenting a case for validating components of the cold chain – specifically, the ability of the insulated shipper to keep the product cold for the required time. I iterated that after the validation activity, I would ship certain prodcts with monitoring probes to track the temperature of the shipment for the duration. I indicated I would do it for the first x batches to confirm that the validation was indeed valid. Also it was a measure to assure product integrity if the shipping took longer than planned or the expternal temperature was outside anticipated range. I also indicated that there might be circumstances where I might continue this for a long period.
You might view this as belt and suspenders. But when the integrity of a product in shipment is critical, I think this is small price to pay. When would I do it? For clinical trial materials, where product integrity is critical is one example. I might also do it fr critical product lanuches where success needs to be assured.
The questioner followed up and stated.
If the regulators do not require it I won’t do it?
This in my mind is an example of putting the horse before the cart. and an unwise practice.
We should design processes that meet our business needs. I can assure you that they will meet 95% of regulatory requirements if they are designed well.