I agree with the general consensus in the above posts that the quality assurance process and quality control process is very important to ensure a device will be safe and reliable for the end user. However, I also agree with those who view the quality processes to be burdensome as well. Speaking from experience, the quality department seems to think that the more procedures that they have in place, the higher the quality of the product will be. I don’t necessarily agree with that sentiment. There comes a point where the quality documentation becomes so expansive that it is very easy for something to slip between the cracks, making the company more susceptible to an audit finding that they aren’t complying with their own procedures. I think companies need to be very careful about “over-proceduralizing” their quality system. Another thing I have noticed is that with so many procedures, you can lock yourself in a little box, and when a situation arises that may not exactly fit the procedures in place, quality does not know how to react, and they go back and forth about how to handle the situation. I believe that is another reason why the quality department has the tendency to be viewed as burdensome.