FDA and the Meaning of Life
Salt Lake City, 15 March 2013 – I’ve written this post three times. I started it on Sunday as I was mentally preparing for an FDA site audit of the company that employs me to manage its device event reporting department. That post was prefaced by the fact that my Garmin decided it was not very happy with the change to Day Light Saving time and shredded my ride data. Things were not looking so good and I didn’t have the wherewithal to push the post button.
On Wednesday, after the auditor finished with what felt like a relatively smooth review of my department’s processes and reporting I went for a self congratulatory ride, had some dinner and went to bed. All of the emotion by then was drained from my head and only exhaustion remained. I had nothing to say. You learn after being a part of such audits that sitting quietly while the auditor is reading and reviewing information that you should not speak. That’s a difficult thing for many people when they are under such pressure. The trait, though difficult to master, is important; it keeps you from sticking your foot in your mouth and giving the auditor some idea of what he should be looking for.
I observed the audit on Thursday, leaving the office thinking we had just been handed our first observation. For those who have never been through such an audit, an observation is not a good thing. It means you’ve got something to clean up that becomes part of the public history of your company’s quality health. After the audit, I biked and promptly repeated my Wednesday night’s activities. Exhaustion overwhelmed me; I went to bed lacking any energy to share my thoughts.
Today is Friday. And although most auditors will tell you that they will be reviewing your practices for at least a week, the government is subject to sequester as much as we mere mortals. The last day is often a wrap-up session filled with requests for documentation, procedures and test reports. As we approached 2:00 the tension in the room was as thick as the processed office air. We sat waiting for the shot to our egos and the findings of the audit. Strangely, after a deep breath we all heard him say there would be no observations, that he had comments but not formal findings. By 2:30 he was gone and there was an emptiness in the building. All that effort to prove our systems were working, when we know we have some spider webs to clear, was effective. Did we win? Or did we lose because most people will go back to their daily grind thinking they’ve accomplished something and that nothing needs to be improved.
If I tried to compare this to riding a bicycle I think it would be comparable to coming in second at a crit and never bothering to try to get to first place. You would just give up, and go home content with mediocrity. Mediocre is just that: meh as they say these days. I don’t see the validation for your effort in that thought process though. Conquer the race, the hill or just your daily loop. Do it because it will help you find the meaning to life.