"You can't inspect in quality"

The not so happy medical device company I work for has spent the last few weeks in near melt down mode with no one really getting along due to increased attention from the QA department and looming deadlines conveniently coming during the holiday season. We started out with an inexperienced QC who was asleep at the wheel while we did most things in the early phases of product development and manufacturing. Then we went and recently hired two experienced QAs and on top of that management starting getting heavily involved.

Now almost every day is a mini-crisis as quality learns what manufacturing has been doing and frequently hold everything up. All the while engineering is pushing to get things built so we can at least pretend we're trying to meet deadlines. Management is walking the management tightrope of do the right thing but do it right now (Week 2 MBA school). Offhand I'd say about 10% of the concerns mentioned by QA actually matter as far as documentation and product quality are concerned, but they all take a decent amount of time and effort to resolve. I have no idea in a typical company what the average percent of real problems noted would be- I'm guessing that 10% is probably pretty good (I can't decide if I'm serious or not about that). Since time is short, options on fixing problems are limited, what we have is what we have, no time to find another vendor, later maybe, but right now it has to work.

Manufacturing is upset because where was this kind of scrutiny 6 months ago when they were working out the procedures? Plus the quality department has a couple times taken them to task for things that they were following the SOPs to the letter for, as well as doing some stupid things (Hello, you have to wear gloves in the cleanroom) and asking very basic questions that show a lack of knowledge about what manufacturing is doing. We had an unfortunate meeting with management involved where out of 10 or so audit items most of them manufacturing was following the SOP, a couple of the items were due to other quality personnel (ie they removed drawings from the cleanroom for their own use without telling anyone then cited manufacturing for not having the drawings), and a couple other things that should have been fixed months ago. That meeting resulted in a huge amount of lost work, all while I want to things to get finished because I have to answer to the guys on the other end. As the new QAs get broken in hopefully we can reach a better place.

Anyway, not having experienced QA involvement from the start is something we're paying for now as issues that should have been addressed throughout the year leading up to now are compressed into weeks. "You can't inspect in quality" is a phrase I hear from time to time and while technically true, quality can do a lot to ensure the product is improved in the future. Most of the company has a pretty good sense of humor about things and just want to work through them, but I think a couple QAs are going to get some payback for that drawing stunt they pulled.