Let the Excitement Begin!

Today started out quite normal. I slept in a little, forced myself to get up and go to work, then started my day as usual. Jen and I had a quick breakfast then I started into the customer issues that run my life.

Then, the excitement started! I heard an overhead page and actually paid attention. Low and behold it was the “Top Secret” page! Oh my gosh….the FDA just showed up! For those of you who don’t know much about my job, I work for a third party medical device test facility. What does that mean? Well, anything that is going to be used in a hospital, or any product that comes in contact with the human body, must be tested by a third party testing facility, and the results submitted to the FDA. I work in one of those test facilities, and not just “one” of them. I work for one of the largest and most recognized testing facilities in the medical device/nutraceutical/pharmaceutical industries.

Due to the nature of our testing, and the whole purpose of our business, we are open to these special little visits from the FDA at any point in time, with NO warning! Lucky us, today is the first day of our FDA audit. They will be here all week reviewing the testing we have been doing for other customers, and going through all our documentation to make sure we are following all of the rules. Given the testing we do I’m sure you can imagine the number of rules and regulations we have to follow.

This is one of my most favorite times of the year, but please, do NOT tell Dr. Nelson I said that! After the “Top Secret” page was made people started going crazy! One of the most notable is our Accounting Manager, in his typical fashion he went around the building from office to office asking “Did you hear? Do you know the FDA just got here?!” From here he proceeded to call Jeff Nelson (company President) to make sure he knew. Then he called me to make sure I had let my supervisor know. I just have to chuckle.

The madness only increases as you make your way upstairs to the actual “lab” where the testing is done. Here you will see people doing similar rounds making sure everyone is aware of our “special guest”. The frenzy is then on to make sure everything is clean, in order and looking spectacular, just in case the FDA comes into YOUR office! I admit, I had a little house cleaning to do with my people, but we also have the luxury of being right across the hall from the conference room where the auditor will spend the majority of his time. We just had a few minor things to clear up, like proper sample storage at our desks, and making sure we are all caught up on our training.

This kicks off a full week of pins and needles. We should not be surprised that the FDA showed up today, it seems that every time we have a seminar they decide to show up. Right now we are hosting our seminar here in Salt Lake, we are having a great turn out, but this means that all of our “important” people are off-site presenting!

I am hoping that I will not be needed in any of the aspect of the audit, but considering my involvement with the clients and the testing that goes on there is a slight possibility. Hopefully, my training over the last 5 ½ years will kick in and I will remember to:

* Only answer the questions I am asked
* Do not volunteer additional information
* I don’t have to escort the auditor to the bathroom
* If I don’t know the answer to a question don’t try to make something up

Ahhhh…..let the excitement begin!