Sep 8, 2007


The powers that be have recently started discussing moving the company down the street to a slightly bigger, nicer, cheaper place. If this happens I may have to be restrained from stabbing myself in the eye. While there are certainly good reasons to move a medical device company, the people working on validations never ever want to hear the words "We're moving." To them, this translates into "Everything you've done in the last year is now worthless." Softening the blow with a raise at that point is just good form, if anything a company moves because they're doing well, right?

Moving a medical device manufacturing facility basically means a revalidation of almost everything. Every piece of manufacturing equipment must undergo an installation, operation and performance (or process) qualification (IQ/OQ/PQ- terminology can vary from company to company) when you start to use it. These can range from simple to complex, with most taking less than a day to complete and document. Move a piece of equipment across the room and you are supposed to perform at least the IQ again (which can be very simple) - usually we do all just to be on the safe side. It can become tedious depending on how it is set up, a lefty moving a balance to the other side of the table can give you fits. (Although I don't think I've yet met a QA who kept track of exactly where a piece of equipment was placed, they've relied on Manufacturing to tell them of moves- sounds like something that should be added on the IQ form.) A move to a new building invalidates everything and on top of that you have to show that you can produce product of the same or better quality that you previously produced.

My company and I assume most other companies perform and document these qualifications in house. Engineers generally write them, a tech or engineer will perform them, and then QA will sign off on them and keep them in an equipment log. At my company its a relatively informal process and QA runs the entire show without management involvement.

The silver lining to moving the company is that you don't have revalidate sterility, biocompatibility and maybe some performance testing, but everything else I can think of now is fair game. And of course that raise.

PS: Really nice companies have downloadable sample IQ/OQ/PQs available.

1 comment:

Kenneth said...

I would be interested in your contact info -- it would be great to have you talk to our bioengineering students if you are in the Phila area

I am also looking for interesting cases for use in my ethics course for biomedical engineers, and your blog has a lot of interesting leads.

regards,Ken Foster

Kenneth R Foster, Ph.D., P.E.
Professor, Department of Bioengineering
University of Pennsylvania
240 Skirkanich Hall, 210 S. 33rd Street
Philadelphia PA 19104-6392
215-898-8534 (office) fax/voicemail (reflects to my email) 1-610-896-0620
Editor in Chief -- BioMedical Engineering Online
Technology and Democracy course this summer