Conference Speaking -2020 Lean and Six Sigma

In February I will be presenting at the 2020 ASQ Lean and Six Sigma Conference in Phoenix on Sustaining Change – Executing a Sustainability Plan.

Here’s the presentation summary:

For Lean and Six Sigma projects a central question should always be “how do we sustain this change?” Sustainability is a major part of all the major change models but is often the easiest to neglect. This session will engage the participant in building a Sustainability Plan, a key tool to ensure the change is anchored and embedded in the organization. Through three case study examples of changes at the three major change levels -transactional, organizational and transformational – the participant will gain the knowledge to create and execute an effective change plan.

During this session examples will be given for each component of a sustainability plan:

  • Communication: Mechanisms for persuasive communication and ongoing socialization of the change, rites of parting (saying goodbye to the old ways of doing things), and rites of enhancement (acknowledgment of quick wins and continued adoption)
  • Metrics Tracking: How to identify and execute consistent and effective ongoing measurement and results reporting to track progress and ensure sustained results • Performance Management: Process for observing and objectively measuring desired behaviors and attitudes, including performance appraisal process, promoting, demoting and transferring, and training and development
  • Rewards and Recognition: Program of intrinsic and extrinsic incentives to reinforce desired behaviors and attitudes
  • Sustaining Ownership: Consistent process for ensuring sustained ownership of the change through the ongoing transfer of experience and knowledge
  • Continuous Improvement: Mechanisms for responding to changing requirements and implementing improvements based on feedback, observations, and metrics

The following questions will be explored, and tools for finding answers will be provided:

  • How should organizational achievements reinforcing the change be commemorated
  • What behaviors should be observed and measured on a regular basis?
  • What results should be observed and measured on a regular basis?
  • What metrics should be used for measuring behaviors and results?
  • What mechanisms should be used for reporting results? • What criteria should be used to allocate rewards and promotion?
  • What mechanisms should be used for training, coaching, and role modeling?
  • What processes and procedures should be put in place to ensure sustained ownership of the change?
  • What continuous improvement mechanisms will address low adoption rates and ensure the change becomes part of the organization’s normal functioning?

At the end of the session the user will have a template for creating a sustainability plan and will have been provided tools to successfully execute the sustainability phase of a change.

Learning Objectives 1. Assess the role of sustainability in the major change management methodologies and apply to lean and six sigma projects. 2. Facilitate the sustainability phase of change management. 3. Compose a sustainability plan.

2019 State of the Blog

annex 11 ASQ ASTM E2500 change control change management collaboration communication computer system lifecycle conference contamination control cqv cultural excellence data integrity decision making decision quality Ethics expertise fda ICH knowledge management leadership learning culture metrics Problem solving process psychological safety quality culture quality intelligence quality systems regulatory regulatory inspections regulatory state resilience risk assessment risk management root cause analysis speaking system design system thinking team Team excellence training transparency validation warning letter

I started this blog as an exercise in deliberate practice, as well as reflective. In order to grow it is important to engage in critical reflection, which requires a process of mutual learning, a consciously organised process of deliberative and distributed reflection. Which is what I strive to do in my blog posts.

At the end of last year, I evaluated my blog goals through an ACORN exercise, as well as updating a SWOT. These stand up pretty well, even in a year of changes where I took on member leader responsibilities as the chair of the ASQ’s Team and Workplace Excellence Forum and took a new job.

I met my posting goal, which was 1.5 posts a week, with 81 posts and 33.5k words.

The top 5 posts of 2019 are:

  1. FDA signals – no such thing as a planned deviation: Written in 2018 this post directs a lot of traffic to the blog from search engines, and has the largest geographic spread. Key message here continues to be all temporary changes, all planned departures, need to go through a change control system of appropriate rigor based on the risk involved.
  2. Risk Based Data Integrity Assessment: Data Integrity and Risk Management are two of my favorite topics and in this post I combine the two and provide a fairly usable tool. I wrote this post while at the ASQ’s Audit Conference, where I presented on data integrity.
  3. Lessons Learned as a Developing Leader: I am very gratified that this piece of introspection was viewed as many times as it was. Three months into my current job and this post, and the followup, are a good roadmap.
  4. Decision Quality: How we make decisions, deal with subjectivity and uncertainty and problem-solve are all big concerns for our organizations. This post serves as a good anchor for my thought and practice, as well as the direction of future endeavors.
  5. Driving for Mature Quality Organizations – FDA recent perspective: Building a quality culture, driving maturity in our organizations are critical. The FDA is spot-on, and companies really need to be coming to grips and dealing with this systematically.

Looking ahead to 2020 for the blog, I am going to take a bit of direction from Luigi Sille who set the following goals for himself:

  1. Build up my expertise
  2. Grow my network
  3. Continuously improve every single day

For building expertise, I want to continue to focus on building tools and methods to: deal with subjectivity and uncertainty around decision making and risk management; proactively build a culture of quality and excellence, especially dealing with aspects of data integrity; and, find connections between the larger organizational/leadership/operational bodies of work and adapt them to the quality profession.

This blog is a large part of growing my network and I want to get to 2 blog posts a week consistently. I’ll continue to work with the ASQ as chair of the Team and Workplace Excellence Forum, including holding at least 2 events (including an unconference!). I am also trying to pull together a group of speakers to bring data integrity and quality culture as a stream to ASQ BosCon. I’ll speak at least 2 ASQ Conferences. I’ll also deepen some ties with the PDA, including speaking at one conference.

As I continuously work to improve, I will bring the topics I’m learning and implementing back to this blog.

ASQ TWEF UnConference

I’m organizing a mini UnConference for the ASQ Team and Workplace Excellence Forum.

A survey for logistics and attendance is here.

An UnConference, otherwise known as a OpenSpace or BarCamp, is a tool I’m a huge fan of. They can really serve to generate action and build energy, commitment, and shared leadership with a group by unleashing self-organization. The idea is to make sure that ALL of the issues that are most important to the participants are raised, included in the agenda, and addressed, making it possible for participants to take responsibility for tackling the issues that they care about and for what does or doesn’t happen

Which makes it a great tool for the Team and Workplace Excellence Forum to really generate some activity. If you are interested please respond to the survey above.

Yes…but…and

We have all had the first rule of brainstorming, “defer judgment,” drilled into us for years. The general rule of “When a person proposes an idea, don’t say, ‘Yes, but…’ to point out flaws in the idea; instead, say, ‘Yes, and…’” which is intended to get people to add to the original idea, has become almost a norm in business settings. We have all become improv actors.

That truism is probably not a good one though. It can lend to a fairly superficial approach. Yes we need to be beyond “Yes, but”, but “Yes, and” stifles creativity. The concept of “Yes, and” gives an illusion of moving forward, avoiding conflict, but also prevents truly diving in and exploring issues.

We need to combine the best aspects of criticism and ideation, “Yes…but…and.” I propose idea A, a colleague first addresses what she perceives to be a flaw in it, provides constructive feedback (this is the “but”), and then suggests a possible way to overcome or avoid the flaw, yielding Idea B (this is the “and”). Then you do the same: You acknowledge Idea B, provide a constructive critique, and develop a new, even more improved result. Others can jump in with their critiques and proposals during the process. This kind of constructive interaction encourages a deep cycle of critical dialogues that can lead to a coherent, breakthrough idea.

Here are some things to keep in mind:

  • When you see a weakness in the idea, don’t simply say, “This does not work.” Rather, first explain the problem and then propose an improvement that would make it work.
  • When you do not understand the idea, don’t simply say, “That’s unclear to me.” Instead, first point to the specific spot that is unclear and then propose possible alternative interpretations: “Do you mean X or Y?” This helps all participants to see more detailed options
  • When you like the idea, do not just take it as it is. Instead, search for possible improvements and then push forward to make it even better.
  • When you listen to someone’s critique of your idea,try to learn from it. Listen carefully to the critique, be curious, and wonder, “Why is my colleague suggesting this contrasting view that is not in line with what I see? Perhaps there is an even more powerful idea hidden behind our two perspectives.” The critique becomes a positive force, focusing the team on overcoming its weaknesses and enhancing the original idea.

Good decisions require creativity. But flexing our practices we can drive that in our interactions.

FDA Foreign Drug Establishment Inspections – Congressional Testimony

Subcommittees of the House Committee on Energy and Commerce heard testimony last week from the Government Accountability Office’s Mary Denigan-Macauley and from Janet Woodcock, Director of FDA’s Center of Drug Evaluation and Research, about the state of FDA’s foreign drug establishment inspection program.

Deborah L. Livornese “Testimony About FDA’s Foreign Drug Establishment Inspection Program: GAO and FDA See Things Differently but Both Would Like to See a Fuller Glass.” FDA Law Blog. 16-Dec-2019

Good summary of recent testimony on FDA inspections outside the USA, especially China and India.