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The Ugly Truth About Managing Design Controls on Spreadsheets

It’s not the job that’s the problem. It’s the tools you have to do it with.

Photo by orbtal media on Unsplash
Etienne Nichols
Wed, 12/06/2023 - 12:02
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At one point in my career, after managing design controls and risk management documentation, I decided to move on.

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When the day came to put in my two-week notice, I walked over to another engineer’s cubicle with the news. “From now on,” I said, “design controls are yours.”

I’ll never forget the way their smile faded when they heard that. Managing and updating the design controls documentation for this product line was done in an Excel spreadsheet, and that spreadsheet was turning into a full-time job.

It’s unfortunate, but managing design controls (and the general documentation load) that way is one of the reasons talented engineers leave the medtech industry. But it doesn’t have to stay that way.

What are design controls for, anyway?

Before I get into why Excel causes engineer attrition in medtech, I want to talk a little about why we have design controls in the first place. Because design controls are, at the most basic level, what good engineers do naturally.

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