
Tell the Story of Build Control to FDA Investigators
The other thing that I call “build control” can do is rationalize and connect other concepts, and it tells the story of control. Again, I keep returning to this story because it’s critically important.
We need to understand the story of how we control the manufacturing process of these regulated products. But more importantly, or as important, we need to be able to represent that to the investigators that walk in the door... and they often don’t have a clue about our operations.
When an investigator walks in the door, many companies don’t tell them anything. They just let them go. Are you kidding me? That’s crazy! We want to tell our story.
We want to show that we’ve done our job. We want to tell them precisely what’s essential, and by the way, this is how great a job we’ve done on controlling it!
...because they will find a story if you don’t tell it. Because in every plant, there is something that goes wrong. And they’re going to pull that thread like a loose sweater. And they will unravel it until a mess of lines are on the ground. We want to tell our story!
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