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Priyank Patel is a quality expert in the med-tech space, focusing on surgical robots. He's a senior member of ASQ with ASQ certification. He holds the ASQ Pittsburgh Section Program Chair and is the ASQ Supplier Division Education co-chair. He also supports the ASQ Lean Enterprise Division as an expert and is involved with the ASQ Measurement Quality Division.

Michelle: You've written a few articles for Quality and the latest one was called, “What a Quality Signature Really Means.” Can you tell us a little bit about the article and how you decided to write about this topic?

In my decade-long career, I have had the opportunity to work in various different forms at different applications and processes in the medical device industry and even outside of that industry, communicating with fellow experts in the space. One thing that always comes up is “What does quality actually do?”

And to that, a lot of times, it's asked, “What is the value of a quality engineer on a team?” So, I always wanted to answer that question. And this article is one of my attempts at doing so. The checklist in itself is a very valuable tool, but we need to think beyond the checklist.

Like any engineer who is assigned to a project, or a production line, he or she needs to have a really good understanding of the various styles of thinking. Suggest the critical thinking and to not take anything at face value, but rather challenge those assumptions and conform, or whatever is being put out there, or using data as much as possible to make informed decisions, as well as looking at the bigger picture and understanding how all the pieces of the puzzle fit together.

And that's where systems thinking comes into the picture. I just wanted to show that, beyond checklist, I call it a signature, means that a person or a team has gone through all of these thought processes and, as a team, has made an informed decision whether to go with part A versus part B. That's the intent of this article.