Category: Uncategorized

ASQ Audit Conference – Speaking

I’ll be a Session Speaker at the 2019 ASQ Audit Conference in Orlando, Florida on 17-18 October. My sessions “Lessons on Change Management from a Consent Decree Site” and “ Auditing the Quality System for Data integrity”, two topics I hope folks known I am passionate about.

The Food, Drug and Cosmetic Division is sponsoring a track of speakers and I volunteered to participate. I look forward to meeting anyone who is at the conference.

Top 5 Posts by Views in 2019 (first half)

With June almost over a look at the five top views for 2019. Not all of these were written in 2019, but I find it interesting what folks keep ending up at my blog to read.

  1. FDA signals – no such thing as a planned deviation: Since I wrote this has been a constant source of hits, mostly driven by search engines. I always feel like I should do a follow-up, but not sure what to say beyond – don’t do planned deviations, temporary changes belong in the change control system.
  2. Empathy and Feedback as part of Quality Culture: The continued popularity of this post since I wrote it in March has driven a lot of the things I am writing lately.
  3. Effective Change Management: Change management and change control are part of my core skill set and I’m gratified that this post gets a lot of hits. I wonder if I should build it into some sort of expanded master class, but I keep feeling I already have.
  4. Review of Audit Trails: Data Integrity is so critical these days. I should write more on the subject.
  5. Risk Management is about reducing uncertainty: This post really captures a lot of the stuff I am thinking about and driving action on at work.

Thinking back to my SWOT, and the ACORN test I did at the end of 2018, I feel fairly good about the first six months. I certainly wish I found time to blog more often, but that seems doable. And like most bloggers, I still am looking for ways to increase engagement with my posts and to spark conversations.

Thoughts on day 1 of ASQ WCQI

Thoughts from the pre-day at ASQ World Conference of Quality Improvement. May become a more meaty post.

Food, Drug and Cosmetic Division (FDC)

  • What separates this division for the biomedical division? The commonalities between food, drug, cosmetics and medical devices are more pronounced in the US with the common regulatory responsibilities. But I have trouble seeing the cosmetics industry more closely aligned to me than a medical device.
    • I think there is more commonality between cosmetics and type 1 and drugs and type 3 than there is often between drug and cosmetics. Though the drug to cosmetic or drug to food is a slippery slope.
  • The type of conferences the FDC division attends tend to be more focused on nutrients and OTC then cutting edge bio it feels like.
  • I’d love to see a SWOT, force-field analysis and definitely an X-matrix as they discuss strategic plan.
  • Yep, ASQ is not getting technology. Oh dear, I feel what they really want is a stack exchange (ASQ should totally have licensed stack exchange instead of whatever is powering my.ASQ)
  • Love to understand the decrease in CPGP. I think there is a a value statement the ASQ has failed to make.
  • Would like to learn more about the new CHA BoK. Will it recognize the greater value of the tool outside of food industry? Can it do that without weakening the BoK’s value for the food industry?
  • Still no training for the CPGP. Still volunteering and hoping to get called on. Part of forming that value statement will need to be good training.
  • Maybe I should be glad my attempts to volunteer this year never went anywhere. Lots of talk on expense reports and I am super bad at expense reports.
  • Pins. Between badges and ribbons and pins I feel like I am back in the boy scouts.

Business Meeting

  • Still not feeling the commitment to transparency that should be at the heart of a quality organization
  • Change is hard
  • Technology is super hard. But really we mean to get it this year (how about a smart phone app, pretty please)
  • I think I like the new membership structure but still not sure how technical organizations will work

Warren bill would get feds into generic drug manufacturing – POLITICO

Warren is one of several senators eyeing White House runs who have introduced bills targeting the pharmaceutical industry. Just last week, Sens. Jeff Merkley (D-Ore.), Kamala Harris (D-Calif.) and Amy Klobuchar (D.-Minn.) introduced the CURE High Drug Prices Act, which would allow the federal government to block price increases on certain drugs. Merkley put forward separate legislation, the Low Drug Prices Act, weeks earlier. And Sen. Bernie Sanders (I-Vt.) introduced his own bill, the Prescription Drug Price Relief Act, in November.

The flurry of bills suggests that the powerful pharmaceutical industry will be a major populist target during the Democratic presidential primary and possibly the general election, as millions of Americans struggle with rising health care costs.
— Read on www.politico.com/story/2018/12/17/elizabeth-warren-bill-drug-manufacturing-prices-1067916

An Office of Drug Manufacturing. That could be interesting.

ASQ Lean and Six Sigma Conference – Speaker

I will be presenting at the ASQ Lean and Six Sigma Conference on March 5, 2019 on the topic “Training as Part of Lean Change Management.”

If you plan on being at the conference, let me know. I always enjoy sitting down with colleagues and chatting.

This topic unites three of my passions: change management, knowledge management and continuous improvements. 

One of the key parts of any change stemming from a project is preparing people to actually do the work effectively. Every change needs to train and building valid and reliable training at the right level for the change is critical.

Training is valid when it is tied to the requirements of the job – the objectives; and when it includes evaluations that are linked to the skills and knowledge started in the objectives. Reliability means that the training clearly differentiates between those who can perform the task and those who cannot.

In this session we will take a risk based training approach to the best outcome for training. The following criteria will be examined and a tool provided for decision making:

  • Is a change in knowledge or skills needed to execute the changed process?
  • Is the process or change complex? Are there multiple changes?
  • Criticality of Process and risk of performance error? What is the difficulty in detecting errors?
  • What is the identified audience (e.g., location,size, department, single site vs. multiple sites)?
  • Is the goal to change workers conditioned behavior?

Armed with these criteria, participants will then be exposed to specific training tools to enable quick adoption of the training:reader-doer, pre-job briefings, and structured discussions. Advantages of each method, as well as common mistakes will be evaluated.

Knowledge management as a key enabler to lean improvements will be examined. Participants will gain an understanding of how to draw from their organizations formal and informal knowledge management systems, and gain an understanding a tool to ensure results of a lean project feedback into the knowledge management system.

Participants will leave this training with the ability to execute decision making around providing successful training for their lean projects and ensuring that this deepens their organization’s knowledge and the ability to apply that knowledge in the future.