Oct 29, 2007

Getting people to do what they say they're doing

Things are pretty busy in our happy medical device company lately, I'm waiting for some issues we've run up against to get resolved one way or another before I post on them. Until then I'll post on one that I doubt we'll ever completely beat. We've learned that some of the manufacturing personnel say whatever they thing people want to hear concerning their work when in fact the complete opposite may be true. As part of the failed product sterility test review we decided first to concentrate on things we can control, i.e. what happens in our cleanrooms. Although all the bioburdens are good, we did a thorough cleaning and general improvement of some cleanroom things that we let slide for too long, change room trash piling up and gloves remaining in the cardboard box they came in for a couple of examples.

When doing the general review and also working towards the next lots of product we discovered the general attitude of saying what ever makes people happy while it might not be true. Two items of note, the cleaning log was signed off by people who who never went in the clean room that day or weren't even there and product was also being moved depending on who was asking what it was for, one answer for QC and another for manufacturing management. We're not making product for clinical use, but that line control violation is a huge problem.

The company I work for is very laid back, mistakes are forgiven easily and quickly as long as progress is made in fixing them. We're not so interested in blame as in resolving, then moving forward. However, this philosophy might be the reason we get the above behavior, it may be interpreted as not taking the project seriously enough if there is no yelling. We generally haven't been under the gun as far as the production schedule so I can't figure out the reason for some of things that happened.

While I'm picking on manufacturing, and they will feel the most pain, the quality department shares some of the blame, as this has been going on for a while and wasn't caught or fixed.

Anyway, QA is going to spend a couple days hammering the point home that when you sign off on something you're going to be held responsible and hopefully that will fix the problem. Being a yes-man won't get you far in the medical device field, there are too many people and agencies checking up on you.

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