Wednesday, July 09, 2008

Work

Work has been very different these last two weeks. We have had a regulatory agency audit from the agency which regulates our industry (okay, fine, it's the FDA). Due to my boss being out on vacation, I was the one called upon to lead the audit - something which I have never done before.

In my industry, leading an FDA audit is a bit of a big deal. It has ramifications, as any observations or violations of law can carry legal penalties. On a bright note, the regulatory auditors I have dealt with (and it has been nine or ten in the last three years) have without exception been individuals who were tough but fair, and to a person, friendly. They're there to do a job, you're there to do a job. As long as everyone follows the ground rules, and a tense situation is not created by treating as an "Us-Them" relationship, things go along pretty well.

The different thing has been in my schedule and my life. As a result of the audit, I have sleeping 7+ hours a night, getting up with about 1.5 to 2 hours in the morning before I leave and seeing my family in the morning. I've gotten home a little later (that has been the major change there, although that has been due to holiday traffic as much as anything).

Certainly from a stress point of view, it's been much less: working on the audit, you tend to focus on the audit. The real change in this has been being removed from the day to day chaos back at the home office. I monitor it via e-mail and phone, but it is different than someone plopping in your office with "I have a problem you need to solve right now!".

The audit has also made me more intransigent concerning the work I do and what I am associated with. As I have often pointed out to others, it's not what you think, it's what the law means, and how it is applied - so why not do it right the first time. And in terms of association, frankly there's no excuse for sloppy or less than excellent work - we spend so much time correcting problems that could be fixed easily by doing it right the first time, why not just do it right?

It should be interesting when I get back...

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