I’m in charge of ice cream, an important element of my household and as a result there are agreed upon criteria for success. I have internal inspectors (me) and external (my teenagers). I can thus produce a fairly simple graph of internal and external inspections and see the areas where there is a difference.
From this I can tell which categories of findings are pain points and can look for systematic ways to fix them.
In my case, it’s clear the kids do not appreciate only having vanilla, strawberry and chocolate ice cream.
You can apply the same process to your internal vs. regulatory agencies (or certifying body or similar) audit findings.
You can quickly find two major patterns:
- Places you are gapping
- Places you are tougher than regulatory agencies
For those areas where you are gapping, evaluate your systems and determine what process improvements are necessary. A good area to include in this evaluation is the skill set of your internal auditors. For example, do you need more intensive data integrity training?
For those areas where you are tougher than regulatory agencies, do a quick check to ensure internal expectations are appropriately aligned. And then congratulate yourself.
You might have some areas where you have internal findings but absolutely no external. This might be a good indication that this might be a cutting edge area and you are doing a great job keeping ahead of the curve.
Take an additional step. Go to a source of inspection findings, such as the FDA’s 483 collection, and add them to your graph. This can help you identify additional areas of potential improvement. This can be especially helpful if you are a smaller company that does not have a wealth of data to draw.
We should all be doing what we can to anticipate trends and benchmark ourselves. This sort of data review and go a long way to finding some potential pain points before they get worse.