What are guerilla tactics for quality leadership? How do you implement a lean quality management system (QMS) and put requirements in place that are truly required - especially when there is the potential for personnel to resist change?

In this episode of the Global Medical Device Podcast, Etienne Nichols discusses lean QMS implementation with Steve Gompertz, a leader in quality systems management with more than 30 years of experience in the medical device/technology industry.

Some of the highlights of this episode include:

Guerilla tactics for quality leadership that involve thinking outside of the box and trying to get things done without asking for permission from authorities. Sometimes the FDA unintentionally creates fear and creates imaginary boundaries in people’s minds that stifle their creativity.
People will struggle and become frustrated when working with a burdened QMS and restrictive standard operating procedures (SOPs).
The regulations and standards are intentionally vague and open to interpretation because it’s not possible to have a one-size-fits-all. Meet the intent of the requirements and be ready to defend them.
Lean documentation is the best approach. Weed out the things you don’t need. In a regulated or unregulated space, it’s better to have clear, precise, and intentional documentation rather than a pile of papers.
Sometimes regulations and standards create negative opinions because it’s human nature to not want to be told what to do. However, what is their purpose? To produce safe and effective medical devices while also turning a profit.
Approaches to implementing guerilla tactics include burying or sneaking something in without calling it what it is and getting people to do the right thing without them always knowing they are doing it.
Make sure your metrics don’t incentivize the wrong thing. Some companies measure document control in QMS based on time—how fast it takes to make changes? But does that actually make the process more effective and cost less? More likely, it incentivizes cutting corners.
Steve recommends shifting your mindset about document control or value-added changes by first defining the problem correctly. Don’t make assumptions.

Memorable quotes from Steve Gompertz:

“The regs and the standards aren’t actually that specific too often. They are intentionally vague. Sometimes, that is a point of frustration with people. But when you think about it, they have to be.”

“Step back, stop just reading what the words say, and start thinking about why are they there?”

“When you create a quality system, you have to think about the architecture.”

“If it isn’t documented, right, it didn’t happen. If it’s not documented right, things are going to go bad.”

Links:

Quality & Regulatory Consulting - QRx Partners

Ask Me Anything Session with Steve Gompertz

ISO 13485

FDA - Guidance Documents (Medical Devices)

21 CFR Part 820 - Quality System Regulation

The 7 Habits of Highly Effective...

Guerilla Tactics for Quality Leadership

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