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Archive for August, 2015

Thoughts on Verification: Doing Our Work in Regulated Industries

Tuesday, August 18th, 2015 by Alex Melikian

In this edition of “Thoughts on Verification”, Verilab consultant Jeff Montesano interviews fellow consultant Jeff Vance on verification in regulated industries. Jeff Vance has extensive verification experience in the regulated nuclear equipment industry. The discussion explains the role of regulators and how it can affect verification processes as well as interactions within the team. They also discuss the challenges and how innovation manifests in such an industry.

Jeff Montesano: Hi, everyone. Welcome to another edition of Thoughts on Verification. I’m pleased to have my colleague, Jeff Vance here with me to discuss his experience in working in regulated industries and how it would impact verification. Jeff, thanks for joining me.

Jeff Vance: Thanks. Happy to be here.

JM: So let’s talk a little bit about what would you think are the primary differences between working in regulated industries, such as nuclear and military, versus unregulated industries, where you’re making commercial products that might be going into cell phones and things like that.

JV: Yes. My experience is mostly in the nuclear industry, working on safety critical systems for the automation of nuclear power plants. There are a lot of differences working in that domain compared to most non-regulated industries. The biggest difference is you have a regulator such as the Nuclear Regulatory Commission (NRC) who has to approve the work you’re doing. So there’s a huge change to priorities. There’s a change to the daily work that you do, the mindset of the people and how the work is done. Ultimately, it’s not enough just to design your product and catch all your bugs. You have to prove to a regulator that you designed the correct thing, that it does what it’s supposed to do, and that you followed the correct process.

JM: I see, I believe we’ve covered something like this before with the aerospace industry. So you said there’s a difference in priorities, can you give me an example of what types of priorities would be different?

JV: I think the biggest difference is that you must define a process and prove that you followed it. That’s how you prove that the design has no defects. So even if you designed the perfect product and the verification team found all the bugs; there will still be an audit. They’re going to challenge you, and you’re going to have to prove that everything you did is correct. The primary way to do this is to define a process that the regulator agrees is good and create a lot of documentation that demonstrates you followed it. If you can prove that you followed that process throughout the entire life cycle of the product, that demonstrates to an auditor that your design is correct and can be used.


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