During the past few months, CQ has been working with a number of small medical device companies. While the products these companies produce are vastly different, they all have similarities in their culture and day-to-day business practices. And of these commonalities, the one that is most glaring to me pertains to the Quality System.
First, I should qualify that I prefer a descriptive meaningful picture instead of pages and pages of words.
Apparently, though–at least from my recent experiences, small medical device companies prefer lots of wordy procedures. In my opinion, my small medical device clients are overburdening themselves because of their QS. Yes, I know they need to address the FDA / ISO QS requirements. However, I’m kind of confused why they chose to waste so many words on paper to do so.
I suspect the reason is pretty simple. Many of the procedures I’ve been reviewing are more or less a regurgitation of FDA and ISO terminology. The company puts their “unique” spin on things, adding their lexicon and specific terminology. And while their procedures may in fact be in compliance with the regulations, I know there is a huge disconnect. I know they are NOT in compliance because they don’t always follow the words written in their procedures.
I know there is a better way to document QS procedures–especially for the small medical device company. My simple advice is this: map the processes and create a pretty, easy to follow flow chart.