AI/ML-Based SaMD Framework

The US Food and Drug Administration’s proposed regulatory framework for artificial intelligence- (AI) and machine learning- (ML) based software as a medical device (SaMD) is fascinating in what it exposes about the uncertainty around the near-term future of a lot of industry 4.0 initiatives in pharmaceuticals and medical devices.

While focused on medical devices, this proposal is interesting read for folks interested in applying machine learning and artificial intelligence to other regulated areas, such as manufacturing.

We are seeing is the early stages of consensus building around the concept of Good Machine Learning Practices (GMLP), the idea of applying quality system practices to the unique challenges of machine learning.

WCQI Day 4

Last day of the conference and for the first session I present on “Knowledge Enables Change.”

Similar to my BOSCON talk, which was the beta so I think I covered things better in this one.

Expand Your Impact on the Culture of Quality by Kathy Lyall

Solid focus on both external and internal signifiers of quality culture. A little basic but very worth reinforcing.

And then I left, skipping the last keynote to get to the airport.

Good conference this year. Overall I felt that many of my choices for sessions ended up being more basic than I thought, but there is a lot of value in that. I will hopefully make the time to turn my thoughts into better blog posts.

WCQI Day 3 – Afternoon

Afternoon Keynote – Cheryl Cran on NextMapping

Future of work thought leadership….People First, Digital Second

Digital second is an interesting keynote theme (2 out of 4) and I appreciate the discussion on equitable futures and moving companies away from autocracy. Not sure anyone who speaks at large corporations is really all that committed to the concept. And I didn’t feel much more than lip service to the concept in this keynote.

Stressing reverse mentoring is good, something that all of us need to be building the tools to do better. Building it into technology integration is good.

Basic sum-up is that Change Leadership Traits are:

  • Relational vs transactional
  • Focus on ‘people’ first
  • Highly adaptable to people
  • and situations
  • Coach approach
  • Creative solutions
  • Future focused
  • Transparent
  • Empowering

In short, any talk that thinks having a clip from “In Good Company” is a good idea for teaching agile thinking is problematic.

“Storytelling: The Forgotten Change Management Tool ” by Keith Houser

Storytelling is one of the critical jobs of a quality professional, and this was a great presentation. Another flip session with pre-work that a lot of folks didn’t do.

I’m going to let Keith’s template speak for itself: https://www.eventscribe.com/2019/ASQ-World/flipSessions.asp?h=Full%20Schedule&BCFO2=FL

This was marked basic. And unlike a lot of stuff marked intermediate this felt like truly a best practice, pushing the envelope in many ways. Sure I apply these principles, but the discipline here is impressive.

WCQI Day 3 – morning

I didn’t make it to the key note. I had a work conference call so I will never learn the quality secrets of Anheuser-Busch.

“A Fresh Approach to Risk Assessment & FMEA: It’s all about severity” by Beverly Daniels.

After yesterday’s Quality 4.0 session I was not going to miss this as the presenter has a blunt, to the point attitutde, that could be interesting and fun to watch.

Very R&R driven mindset, which is a little far away for me but one I find fascinating. Her approach is to get rid of probability and detection on an FMEA. How does she do that?

  • Create a function diagram and process maps as applicable
  • Create an input:output matrix
  • List functions
  • List failure modes: how a failure presents itself
  • List the effects of the failure modes
  • Determine severity of the failure modes at the local level and system level
  • Develop V&V, mitigation and control plans for all high severity failures.

Which means she’s just not using the risk assessment as a consolidation of decisions (hopefully using some other form of matrix) and always uses  testing data for occurrence.

The speaker made the point about static FMEA’s a lot, I’m a big fan of living risk assessments, and I think that is an approach that needs more attention.

Some interesting ideas on probability and testing here, but buried under some strong rhetoric. Luckily she posted a longer write-up which I’ll need to consider more.

“Using Decision Analysis to Improve, Make or Break Decisions” by Kurt Stuke

Someday I’ll write-up more on why I find long credential porn intros annoying. My favorite intro is “Jeremiah Genest works for Sanofi and has 20 years of experience in quality.” Post my damn CV if you want, but seriously my words, my presentation and my references should speak for themselves.

I like the flip sessions, prepping prior is always good. The conference needs to do a better job letting people know about the prep work. The amount of confusion in this session was telling. The app does not even link to the prep work, only way is an email.

Here are Kurt’s resources: https://www.kurtstuke.com/OER/WCQI/

There is no 100% tool, glad he stresses that at the beginning, as we sometimes forget to do that in the profession.

“Whim leads to advocacy approach which means data looses its voice.”

Used KT as a way for decision analysis. Talking about the “must haves” and “nice-to-haves” Maybe it’s because of the proprietary nature of KT, but I feel their methodology is either someone folks are really familiar with or surprised by.

So this is again basic stuff. I’m not sure if this is what I am deciding to go to or if just where I am in my journey. At my table I was the only one really familiar with these tools.

Good presenter. Love the workshop approach. It was great watching and participating with my table-mates and seeing lightbulbs go off. However, this is a basic workshop and not intermediate.

WCQI Day 2 – afternoon

Leading Teams: Conflict for Innovation and Change” by Carolann Wolfgang, Marilyn Monda and Lukas Cap.

The Human Development and Leadership Division is one of those divisions that I don’t get. Not because I disagree with the content, it’s just I don’t get what makes it different from the Quality Management or Team Excellence Divisions. This presentation by three of the member leaders didn’t make that any easier.

This workshop was an attempt to blend a few concepts, such as powerful questions, human explorers and curiosity types together and build a tool kit for team excellence. As such it wore its source material on it’s sleeves and skipped a few spots. A few specific observations:

  • The powerful questions are good
    • Why does this [point] matter to you?
    • What outcome would make it a success for you?
    • Is the way you think about the conflict useful, realistic or accurate?
    • What events or choices led to this conflict?
    • What other courses of action can you think of?
    • What if this obstacle was removed?
    • What is behind that thought, resistance or idea?
    • What are the priorities right now, in this conflict?
  • Using the Five Dimensions of Curiosity is very interesting. I think it can benefit from more thought on problems and how different curiosities lend themselves to different types of problems.

“System Transformation – Your role as a Lean Leader” by Erin Christiaens and Jaret Moch.

Super high level review of lean transformations and lean leadership. I find these workshops valuable to check-in against and hear what people are saying. Plus the rest of the 3 pm workshops didn’t engage me.

Focused almost exclusively on lean leadership standard work. Gave a few nice templates, and I do like workshops that give templates.

It is fascinating to hear people on different levels of the lean journey, or frankly any quality culture transformation. It is one of my favorite parts of attending conferences.

Provided by Lead2Lean Solutions

Afternoon Keynote – Tricia Wang

Praising statistical analysis at a quality conference is a good crowd pleaser. Way to bond with the audience.