Four Types of Problems by Art Smalley

Four Problem Solving Types

Four Types of Problems: from reactive troubleshooting to creative innovation by Art Smalley (2018,
 Lean Enterprise Institute, Inc. ) is a fascinating book focusing on dividing problem solving and innovation into four major types:

  1. Troubleshooting: A reactive process of rapidly fixing abnormal conditions by returning things to immediately known standards. While beneficial in the immediate term this approach often fails to solve the problem’s root cause.
  2. Gap-from-standard: A structured problem-solving process that aims more at the root cause through problem definition, goal setting, analysis, countermeasure implementation, checks, standards, and follow-up activities.
  3. Target-state: Continuous improvement that goes beyond existing levels of performance to achieve new and better standards or conditions.
  4. Open-ended and Innovation: Unrestricted pursuit through creativity and synthesis of a vision or ideal condition that entail radical improvements and unexpected products, processes, systems, or value for the customer beyond current levels.

Art Smalley is a well known Lean expert, and this book definitely grows out of the wisdom and is a pretty good read. He shares
the strengths and weakness of each problem solving technique providing many points of introspection, such as the questions at the end of each chapter and excellent illustrations.

This book provides s a framework, a mental model, to effectively approach and assess a situation in order to seek and bring the appropriate kind of thinking to calmly, confidently address the problem at hand.

In many ways this book was my favorite quality book of 2018. I think it could serve as a valuable primer and I’m contemplating how to use it for internal training this year.

Avalanche or Roadblock: FDA Publishes Flurries of Biologic and Biosimilar Materials

The proposed technical correction regulation, the other two guidance documents, and the list deal with the transition of certain biological products from NDAs to BLAs.  Starting with the simplest, the proposed (so-called) technical correction would amend the definition of “biological product” in 21 C.F.R. § 600.3(h) to conform to the definition implemented in the BPCIA and provide an interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.”  FDA calls it a “technical correction” in the proposed rule, but this isn’t really technical, nor is it a correction.  Indeed, it reflects a significant change to the definition of biological product because the rule would replace the phrase  “means any” with the phrase “means a” and would add the phrase “protein (except any chemically synthesized polypeptide)” to the definition of “biological product.”  Consistent with the April 2015 Questions & Answers guidance, the proposed rule would amend 21 C.F.R. § 600.3(h) to further define protein as any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size, and the term chemically synthesized polypeptide as any alpha amino acid polymer that: (1) is made entirely by chemical synthesis and (2) is greater than 40 amino acids but less than 100 amino acids in size.  Given that that FDA has been using this definition since the publication of the April 2015 final version of this Question and Answer guidance,  this proposed regulation is unlikely to catch industry by surprise.  But this is just one of multiple steps FDA is taking to prepare industry for the March 2020 transition of certain biological products approved under NDAs to BLAs.
— Read on www.fdalawblog.net/2019/01/avalanche-or-roadblock-fda-publishes-flurries-of-biologic-and-biosimilar-materials/

Layering metrics

We have these quality systems with lots of levers, with interrelated components. And yet we select one or two metrics and realize that even if we meet them, we aren’t really measuring the right stuff nor are we driving continious improvement.

One solution is to create layered metrics, which basically means drill down your process and identify the metrics at each step.

Lots of ways to do this. An easy way to start is to use the 5-why process, a tool most folks are comfortable with.

So for example, CAPA. It is pretty much agreed upon that CAPAs should be completed in a timely manner. That makes this a top level goal. Unfortunately, in this hypothetical example, we are suffering a less than 100% closure goal (or whatever level is appropriate in your organization based on maturity)

Why 1Why was CAPA closure not 100%
Because CAPA tasks were not closed on time.

Success factor needed for this step: CAPA tasks to be closed by due date.

Metric for this step: CAPA closure task success rate
Why 2Why were CAPA tasks not closed on time?
Because individuals did not have appropriate time to complete CAPA tasks.

Metric for this step: Planned versus Actual time commitment
Why 3Why did individuals not have appropriate time to complete CAPA tasks?
Because CAPA task due dates are guessed at.

Metric for this step: CAPA task adherence to target dates based on activity (e.g. it takes 14 days to revise a document and another 14 days to train, the average document revision task should be 28 days)
Why 4Why are CAPA task due dates guessed at?
Because appropriate project planning is not completed.

Metric for this step: Adherence to Process Confirmation
Why 5Why is appropriate project planning not completed?
Because CAPAs are always determined on the last day the deviation is due.

Metric: Adherence to Root Cause Analysis process

I might on report on the top CAPA closure rate and 1 or 2 of these, and keep the others in my process owner toolkit. Maybe we jump right to the last one as what we report on. Depends on what needs to be influenced in my organization and it will change over time.

It helps to compare this output against the 12 system leverage points.

Donella Meadows 12 System Leverage Points

These metrics go from 3 “goals of the system” with completing CAPA tasks effectively and on time, to 4 “self organize” and 5 “rules of the system.” It also has nice feedback loops based on the process confirmations. I’d view them as potentially pretty successful. Of course, we would test these and tinker and basically experiment until we find the right set of metrics that improves our top-level goal.

Conducting an ACORN test on my mission statement

Here is my first draft at a mission statement developed after reviewing my SWOT and doing a quick brainstorming exercise asking myself some what, why and how questions:

The mission of my blog is to encourage a thoughtful life as a quality professional. I want to ask and explore questions related to building a quality culture and utilizing system thinking to spark a dialogue with my peers. I am to become a leader in quality both internal to my own company and externally to the wider profession.

An acorn

The ACORN test is a check on a mission or project charter goal to determine if it well defined. I am drawing from The Quality Toolbox, but this is a tool you can find all over the internet.

QuestionThoughts
AAccomplishment. Does the goal describe results rather than behaviors? The goal here is to write. Secondary to that I want to spark a dialogue and also be invited to conferences and other speaking opportunities.

The mission statement as is could use some tightening here.
CControl. Does the team’s actions determine whether not the goal is accomplished? If the way the mission is articulated primarily depends on others outside the team, consider rewriting it.
I am a team of one. Everything within my mission statement is in my own power. I can write, and publish and share. Publicizing my posts is within my control.
OOnly Objective. If this and only this was accomplished would it be enough?

O is sometimes also phrased as “Overall Objective” — Make sure that the mission truly captures the organization’s reason for being. Avoid writing a mission that is simply a subgoal of that overall purpose.
My only goal is thinking aloud. I am not trying to sell anything, nor am I concerned about finding a job (I work in pharmaceutical quality in Boston, getting a new job involves going to Kendall square and waving a resume around)
RReconciliation. Will accomplishing this goal prevent another group within the organization from accomplishing its goal? Does anyone else have this goal?
Various units should be working in harmony to achieve the overall organization mission.
As an individual, I do not need to worry about other groups. However it is important for my mission statement for this blog not to interfere or conflict with any of my other goals.

This mission statement is aligned to my personal and professional goals. In fact it helps further several of them.
NNumbers. Can this goal be measured?Blogging has several measurements built in – views, visitors, likes, shares and comments.

I can also measure other things like invitations to speaking opportunities, questions directed to me, and others.

An overall mission statement must pass all give parts of the ACORN test in order to be well defined. In my case I pass but need some tightening in accomplishment.

Conference Speaking

Conference proposals are a different writing beast than articles or columns or papers. Don’t be coy. Don’t give us a promise.  Tell us the problems and what we will learn.

Johanna Rothman “Writing Advice for Conference Proposals”

Good advice from Johanna Rothman on conference proposal writing.

Giving back to the profession, sharing best practices and lessons is an important part of being an ethical practioner, and also a great way to build your career. Preparing and speaking at a conference is also a great way to build connections with the material and to stretch in order to build expertise.

In 2019 I’m speaking at 4 conferences:

In addition, I tend to speak at a variety of internal events and provide a ton of training.

I hope to run into some of you at these events next year.