Your Most Important Procedure

I taught a course on Quality Systems at the University of Michigan, Ann Arbor.  Because I’m lazy I decided that I’d ask my friends to come in and guest lecture.  That didn’t work to well, probably because most of my friends just like to drink beer and watch football.  So I ran out of guest lecturers in a hurry.

My backup plan was a moonshot.  I called up the Detroit office of FDA and asked if they had anyone who would like to give a seminar at UoM.  Amazingly they did.  And who should show up but the Director of the Office of Compliance.

He was wearing a suit and a badge.  He looked like a cop.  He pounded the lectern as he reeled off all the procedures that a pharmaceutical or medical device company needs.  The students were scared.  I was scared.  When he was done, he demanded to know if there were any questions.

I silently pleaded with anyone to ask a question.  For if no one did, I would have to ask one.  Finally one brave soul raised her hand.  “Of all the procedures that we have to write, is there any one of them that’s more important than the others?”

“YOU GOT TO HAVE ‘EM ALL,” he retorted, with another fist pound.

Then, he relented and said, “But if I had to pick one procedure, it would be CAPA.”

Why do you think that CAPA (Corrective And Preventive Action) would be the most important procedure in the mind of FDA?

Please take a minute before you read on to formulate your answer.

FDA knows that perfection is not possible in this real world that we inhabit.  Errors are going to happen.  Our WORKERS ARE HUMAN.  Yes, we have redundant checks in place. But there are so many things going on with even the simplest operation that the occasional error will creep in to even the best organizations.

FDA also knows that inspectors can only spend limited time at your location.  They have to rely on you to find your own problems and correct them BEFORE they can escape into the marketplace and endanger consumers.

Therefore, it’s imperative that you have a mechanism in place that:

• detects errors as early in the process as possible,
• finds the root cause,
• corrects any bad product,
• eliminates the cause so that particular problem cannot re-occur and,
• prevents similar situations from occurring in the future

That mechanism is your Corrective And Preventive Action procedure.  The theory behind it is that most errors have relatively benign outcomes because of your redundant quality systems.  But, if caught early enough, and investigated properly, serious problems can be kept from the marketplace.

What does FDA look for when they inspect your CAPA file?

One item that will surely be examined is the percentage of CAPAs that have root causes assigned to ‘operator error’.  If it’s more than one or two percent, expect deeper scrutiny.  FDA knows that:

• blaming the error on the operator does NOT correct the root cause,
• retraining the operator by running them through the same training system that allowed the error in the first place, and expecting a different outcome, is insane,
• blaming employees only INSTILLS FEAR in the workplace and inhibits workers from reporting errors when they occur.

You can get a head start on FDA by checking yourself.  What is your % operator error?  If it’s too high, think about your company’s Quality Culture.

One way that FDA checks whether your workers are reporting most of your errors is by classifying your CAPAs and Nonconformance reports.  If they see a range of types of problems, from serious to minor, no alarm bells here.

If, on the other hand, they see only serious problems, they will know that your workers are NOT REPORTING minor issues, and the most probable cause for that is that they have seen what happens to the messenger who reports problems in your company.  Expect FDA to file a wicked 483.

How about you?  Do you have a similar story?  What has worked best for you?  Comment below.