You would think that the corrective and preventive action (CAPA) system would be a business enabler—a disciplined approach to permanently resolving problems once and for all. Unfortunately, the way most CAPA systems are designed and used, it is more of a stumbling block. The system gets so chock full of stuff that backlogs are the norm, and a logarithmic increase in staff is required if you really want to keep current—or at least close as many CAPAs as you open for any given week.

You know the story: We have to get ready for the next inspection. The European Medicines Agency (EMA) said they were coming in, and we are also overdue for an FDA inspection. There is a clutching of the chest because we know we’re not in great shape. Our backlogs are back up again, and we can’t afford another observation about overdue CAPAs. And they are really on to us about liberally doling out extensions to the point that original target dates are meaningless to begin with. But we keep kicking the proverbial can down the road.

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