“Can I look in your dumpster?”

We laughed. It was refreshing to meet an auditor with a self-aware sense of humor. An audit of splintered pallets, empty bags, and half-eaten club sandwiches is the profession’s logical extreme.

Thirty minutes later, we could see only his legs, because his upper half was rummaging through our dumpster. The joke was no longer funny.

What is he looking for? Did he drop his phone in there? I hope he doesn’t smell bad when he comes out.

He popped up. “The last company I audited got a 483 because they threw non-conforming material in the trash. No problems here.”

Ohhhhhhhhhhh! That makes sense.

What at first appeared insane was actually a review of our material disposition process. Sure, our paperwork was good, but was our scrap in the right place? The dumpster dive was an honesty check.

That audit expanded our minds. The dumpster was no longer a place solely for trash; it was a potential hole in our manufacturing system. It taught us to think creatively to find gaps and errors that had gone unnoticed.

People tense up when I enter a room wearing my (invisible) auditor hat. I hear a lot of canned answers with much pointing to procedures, and I see a lot of very clean work stations when I arrive. This is good! I like that our employees are trained to handle an audit, especially one from the FDA. Nobody wants to accidentally cause problems for the company.

But sometimes I’ll hear a whisper, a comment made off the record. “Hey — we get a lot of errors in Room C; could you check them out?” Those asides are helpful, because they steer me to interesting corners. Sometimes it’s a corner that hasn’t been audited in years. Sometimes production staff is aware of a problem, but management acts with no urgency. Sometimes it’s nothing, and our peace of mind is restored.

These are all good outcomes! It might not sound good if you’re wearing an audit finding around your neck, but these audits are for the sake of improvement. Processes that have worked for years need fine-tuning not because we’re making bad product, but because the industry is held to a higher standard each year. It’s our job as auditors to help keep all of Cook within the forever-moving train of the FDA.

We hope our audits will give you a creative perspective of your department. These findings are indicative of a healthy process and a self-aware organization that pushes itself to be more efficient and more compliant, and that compliance protects both the patient and our business.

So if you see an auditor, help us out. We like interesting problems because they foster ingenious solutions. And keep your dumpsters clean; we might spend an afternoon in there.