School's out for summer!

Too bad work ain't!

June has and will be an interesting month. The main reason is that the FDA will be here next week to do a site inspection and going through our records. Now, most of us are pretty seasoned vets at audits since there were a slew of them this year, especially Big Pharma in March. However, they don't have the power to shut your doors like the Feds do. For those of you who haven't been through an audit, I'll give you a brief overview.
1. The Audit team arrives and holds a brief meeting, w/ a schedule for their visit.
2. They take a tour of the facility--show and tell--and ask questions, usually wrapping up by lunch.
3. After lunch they dig into paperwork for the bulk of the remainder of their visit.
4. An audit boils down to two things:
A) Do you have procedures for what you're doing?, and
B) Are you following your procedures?
5. They'll do a wrap-up with the managers and send a formal report a couple of weeks later, which, if there are recommendations or deficiencies, we'll have a couple of weeks to respond with how we've fixed things or plan to fix them.

I feel fairly confident that we are on the right path to being FDA-compliant, but you never know. Our client sent an independent auditor to see how we're doing with things. He was able to bring up some things that we haven't thought of that we can put in place before next week.

But since our QA (Quality Assurance) department is scurrying around making sure all our ducks are in a row, our throughput has been scuttled. The thing is, we're exceedingly busy with several new products that we haven't tested before. And QC (Quality Control) is also R&D. It's been hard to keep up with all the work. Actually, I personally have hope our QA department won't be wound as tight as a Major League baseball. This week they were at what I like to call 'Def Con 5'. They had their doors shut and kept calling people in to make corrections. I didn't even try to make them laugh. They might've bit my head clean off. I shudder to think what next week will be like. Is there a Def Con 10? I think it might be invented.

Stay cool...if you can.