If you've ever worked in a company where "quality" was a word spoken with a capital "Q" than this might not seem that foreign to you, but I've been a little amused by the efforts going on at setting up our Quality control systems here at work. Working in the bio-tech field and, hopefully one day, creating systems that will be used to diagnose patients and affect their treatment subject you to the need to worry about certification, primarily by the FDA. In order to meet the requirements your company needs to have tip-top shape documentation about how the Quality of your product has been maintained throughout the development process.
We have a full-time employee whose job it is to define and maintain that documentation and it's only just started to actually affect me. The approach we're taking is using the GMP (Good Management Practice) which is espoused by the FDA. So far, it seems that all of that is just coming in the form of SOPs (or Standard Operation Procedures) which travel around in little blue folders and can only be photocopied once, and blah, blah blah. At the moment, I don't see that it's going to be much of a burden at all in our group. Mostly all of the work is focusing on the lab-based work and the actual engineering group who are responsible for building the device prototypes.
However I did get to sign three documents last week as part of the Quality process, which just made me have to laugh. The first was a "signature list", which was just that ... a list of all the signatures of all the people in the company. Oh, and by the way, atop each of these forms is a Training Form, which each person must sign to say that they have been trained on that particular SOP. So I got to sign the signature list and the training form to say that I signed the signature list. But it gets better!! The next one was the SOP about that Training Form itself. Yes, I signed the Training Form to say that I had been trained on the Training Form! I joked that she just did that for us computer geeks who find that kind of recursion appealing.
As laughable as it is to me, I suppose it's good that someone is looking out for these sorts of things. The last thing you'd want is to get this great technology built and tested only to find out that no one will use it until you can get certified and that you don't have the work done to meet certification. I'm just glad it's not my job!!
I hear (and I don't think they were joking) that SOPs for taking out the trash and refilling the water coolers will be coming soon....
