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.

WCQI Day 2 – morning

My day 2 at WCQI is Day 1 of the conference proper. I’m going to try to live blog.

Morning keynote

Today’s morning keynote is the same futurist as at the LSS in Phoenix last month, Patrick Schwerdtfeger, and not only was I dismayed that it was they exact same  I was reminded yet again how much I dislike futurists. I’m all about thinking of the future, but futurists seem to be particularly bad at it. It is all woowoo and bro-slapping and never ever a serious consideration of the impact of technology. Futurists are grifters.

These grifters profit by obscuring facts for personal gain. They are working an angle, all of them: the health gurus and the life hackers peddling easy solutions to difficult problems, the futurists who basically state current trends as revelations.  They are all trying to pull off the ultimate con – persuading people they really matter.

They are selling themselves: their books, their podcasts, their websites, their supplements, their claims to some secret knowledge about how the world works. But I fundamentally doubt that anyone who gave 40 talks in the last year has the bandwidth to do anything that really matters. It is all snake-oil. And as quality professionals, individuals who are dedicated to process and transparency and continuous improvement, we deserve better.

I’m not sure how these keynotes are selected but I think we need to holistically view just what we want to be as a society and the pillars we want for our conferences.

Anyone know a good article that evaluates futurists and life hackers with the prosperity gospel? Seem like they are coming from a similar place in the American psyche.

Ooh, artificial intelligence. Don’t get me wrong there is real potential (maybe not the potential people feel like there is) but most discussions on artificial intelligence is hype and bluster, and this presentation is no different. Autonomous vehicles block chains. Hype and bluster.

There is definitely people thinking this seriously, offering real insights and tools. We’re just not there. The speaker admits he gets 90% of his income from speaking. Pretty sure he isn’t actually doing that much. He might be an aggregator (as most of his slides with real content were attributed) but I keep struggling to see value here.

Gratuitous Steve Jobs picture.

After this there is some white space for vendor stuff.

At least I could multi-task and did some work.

Quality 4.0 Talks

I didn’t attend many of these last year because they were all standing and had a thrown together feeling. This year the ASQ seems to have upped the game. Shorter sessions can be good if the presentation is tight. At 15 minutes that is a hard bar to set.

First up we have Nicole Radziwill on “Mapping Quality Problems to Machine Learning Solutions” Nicole’s very active in the software section, which under the new membership model I’ll start paying a lot more attention to.

In this short presentation Nicole focuses on hitting the points of her 2018 Quality Progress article. Talking about quality 4.0’s path from Taylorism as “discovery & learning.”

She references Jim Duarte’s article Data Disruption.

Hit on big data hubris and the importance of statistics and analysis. The importance of defining models before we use them.

From ” Let’s Get Digital” in Quality Progress

Covers machine learning problem types at a high level.

  1. Prediction
  2. Classification
  3. Pattern Identification (Clustering)
  4. Data Reduction
  5. Anomaly Detection
  6. Pathfinding

High level recommendations were domain expertise, statistical expertise, data quality and human bias.

Next up is Beverly Daniels on “Risk and Industry 4.0”

It is telling that so many of the talkers make Millennial jokes. As a Gen-Xer I am both annoyed because no one ever made Gen-Xer jokes (the boomers never even noticed we were at the conference) AND frustrated because this is something telling about the graying of the ASQ.

Quick review of risk as more than probability. Hit on human beings as eternally optimistic and thus horrible at determining probability. As this was a quick talk it left more questions than answers. Getting rid of probability from risk is something I need to think about more, but her points are aligned to my thoughts on uncertainty.

Focusing on impact and mitigation is interesting. I liked the line “All it does is make your management feel good about not making a decision.”

The FDA and Prescription Drugs: Current Controversies in Context

Harvard is offering a free course though edX on how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing, and testing.
— Check out  www.edx.org/course/the-fda-and-prescription-drugs-current-controversies-in-context

According to the syllabus, the course will be set up with six modules:

Module 1: Overview and history of the FDA
Module 2: Drug development and approval
Module 3: Drug pricing in the United States
Module 4: Marketing strategies
Module 5: Post-approval evaluation
Module 6Emerging medical technologies

An Analysis Of FDA FY2018 Drug GMP Warning Letters

BioProcess Online has a nice summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013.
— Read on www.bioprocessonline.com/doc/an-analysis-of-fda-fy-drug-gmp-warning-letters-0003

Data Integrity definitely continues to be a theme, and I agree that we are seeing a growing trend around process validation. I also think root cause investigations was a theme of 2018 that we are going to be seeing a lot more of.

FDA draft guidance – Continuous Manufacturing

The FDA published today a new draft guidance “Quality Considerations for Continuous Manufacturing Guidance for Industry.” Which, together with ICH plans continues to demonstrate the emphasis on continuous manufacturing.

More a set of questions than anything else, this is a good document for those who are grappling with the challenges of continuous manufacturing.