I was blessed enough this weekend to run the Pittsburgh Half-Marathon with my wife, her dad, and her cousin. I had such a blast running in my favorite city in gorgeous weather with 30,000 other crazy people!

To add to the crazy of wanting to run 13.1 miles, I began to think about training in the middle of the race. That might be normal, you might think, based on the fact that we trained since January for this race. But, no, I was thinking about how my training experience for the race seemed to reflect training programs within medical device companies. See? Crazy...

I started thinking about how much more quickly I may have been able to finish the race if I had just been consistent with my training. Of course, in the beginning I was doing so well - short runs during the week on the treadmill, long runs outside on the weekend. I felt great. I felt motivated. And then something went awry - the schedule was thrown off, I didn't fight through it, and my training suffered. That got me thinking of how training systems within medical device quality management systems are often inconsistent and difficult to effectively implement.

As with my running, the training system within a QMS often begins with the best intentions - need to ensure employees are competent and remain competent to complete the responsibilities assigned to each person. But, in the common paper training record format utilized by many manufacturers, it becomes tough and inconsistent. Training is also hard to quantify and qualify. Sure, it's simple to record when I've read an updated QMS procedure, but that won't cover whether the training was effective, whether I understand the impact of my poor performance on the QMS and product quality, or whether I'm continuing to maintain my competency to adequately function in the roles assigned to me.

As with the race, companies still enjoy some level of success as the training systems are functional to maintain compliance. But I want to run a half-marathon faster. I want to run a full marathon. I want to be better. And that's one of the primary goals of a quality management system - continuous improvement. To improve training, investigation might be needed - how was my nutrition, how often did I run, how much cross training did I do, is yoga better cross training than Insanity? The same goes for the training system - how effective are the forms, do they provide a mechanism to evaluate training effectiveness, how are non-production employees informed on how poor performance impacts the QMS or product quality?

Effective change cannot occur overnight - weight-loss, personal habits, and quality management systems prove this to be true. So long as continuous improvement is applied, goals can be obtained no matter how daunting the task.

-RTK

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