More and more I'm learning one of the keys to making good devices that meet quality and regulatory standards is finding people who will take ownership. Lately I've been working in the packaging area a lot and almost every time I'm in there I find discarded labels without lines drawn through them. Of course these are always discarded by the other shift. Everyone already knows the labels need lined out when questioned, so the basic training is there.
If you're an owner, you walk into your area and you own it top to bottom. You don't not fix things because you weren't around. You correct the issue and take it up with the supervisor on shift change. These are the types of people you want, and why many large medical device companies pay way over what they could for manufacturing labor. Pointing out the same non conformance over and over to the same people is ridiculous.
I've been involved with contract manufacturing in China and they were excellent at following instructions. They picked up GDP about 3 times faster than anyone else and have maintained it. This is not to say everything is perfect, but the basics were taken care of. Some of the more complicated situations that came up with the contract manufacturer were really botched up before we were notified, but at least I know the easy stuff is covered.
I'm not sure that me telling the 19 year old putting labels on boxes that this is the era of global competition and she has to work smarter and harder than they are really sinks in. Hopefully, we have a chance to develop the skills necessary because you only get so many chances.
Your blog has been one I've watched for the last two years. This post is exactly one of the reasons why.
ReplyDeleteYou hit the nail right on the head: ownership is key. Every cause and non-conformance has to attributable to someone, somewhere, in case something goes wrong. It is an empowerment of responsibility that every line-out has the date and intials of the person changing it. Every employee in medical devices should feel this ownership. Embracing consquences is a hard thing to impart on those who are merely "working at a job" versus dedicating their career to a medical product, but you boil down the buy-in pretty succintly.
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