February, me and the ASQ

February is a busy month for me and the ASQ.

February 11th – Boston Section meeting on “Mixed Reality in Quality 4.0”

Augmented Reality and Virtual Reality are more than just a science fiction dream, with the market expected to exceed $50 billion by 2024.

The technology promises that workers will have more information about the task at hand, which makes them more efficient and productive. In this session we will explore several opportunities the technologies present and provide a glimpse on how Thermo Fisher Scientific is working with key technology providers to implement on the pharmaceutical manufacturing floor.

It will be fun to discuss some of the fun stuff I’m working on at work. Thermo Fisher is hosting the event at the Waltham facility, which I haven’t even visited yet. Should be a fun time.

February 23-25, Lean and Six Sigma Conference in Phoenix

At the conference I will be presenting on “Sustaining Change – Executing a Sustainability Plan.” Sustaining change is one of my core competencies, and I’m excited to continue the conversation on this. If you re coming to the conference I look forward to seeing you there.

February 29, Unconference for the Team and Workplace Excellence Forum

What better day to hold an unconference on leap day, an un-day.

We have a stimulating day planned. We will be discussing team excellence and quality culture and contributing to development of a body of knowledge for the Team and Workplace Excellence Forum. The agenda is here.

The Unconference is free to members of the ASQ. For non-ASQ members there is a charge of $15.00 per person for lunch.

Please RSVP by February 24th, so we can reserve a seat for you. We are looking forward to seeing you there. If there is anything you will need or have any questions, please don’t hesitate to let me know. The RSVP is here.

The my.ASQ.org event page is here: https://my.asq.org/communities/events/item/170/60/1568

It is going to be a great way to end the month and I hope you can join us.

2019 State of the Blog

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.

Lessons Learned as a Developing Leader

My six years at Sanofi were really the transition from manager to leader. It wasn’t always easy, but this is where I started to truly apply self-awareness to my tasks and expanded my perspectives to move beyond the day-to-day and focus on the strategic needs of building a quality organization.

I came into the organization really focused on the immediate needs of building a serious change management and change control. This was a site under a consent decree and I felt pressured to have results fast.

Over time, as the consent decree moved to later stages I shifted focus to being less day-to-day and more about implementing continuous improvements and driving a vision of what quality and excellence really could be.

I made mistakes. I had successes. I’m leaving quite proud of what I’ve done and the relationships I’ve built. Relationships I am confident will continue.

I often joke with folks that I started this blog as a public form of journaling. That remains true, and will continue in the future. As I move into my next position, here are my key things to remember:

  1. Focus on outcomes not deliverables with the long term goal of building a quality culture through innovative digital solutions and thus helping shape not only my organization but others beyond it.
  2. Don’t just instruct but inspire. Strive toinspire, to motivate, and to communicate the overall quality philosophy at every opportunity. If my coworkers are truly inspired by and proud of the ideals and values that I help communicate, then they will drive even more improvements.
  3. Communicate Big Quality Ideas. In addition to setting a digital agenda, utilize the platform to create wider strategies for quality, and defining the tone for quality culture by crafting effective, clear, transparent, and consistent messaging that inspires the best.
  4. Slow down. Be humble. Understand that I do not need to prove myself as the smartest person in every room. Encourage people to speak up, respect differences of opinion and champion the best ideas. Breathe.

Finally, remember the relationships I have and lean into them.

Not sure if these two posts looking forward and back are useful to anyone else, but they certainly position me for starting my new position on Monday.

New Job, What’s the Approach?

On Monday (September 9th) I start as Head of Digital Quality at Brammer Bio, a division of Thermo Fisher Scientific. The symbolism of starting a new job in the fall in the United States, stands out to me.

I’ve been asked “Just what is digital quality?” To which the easy answer was, “What I do, but in the title.” It is important to expand on that definition here, because this is core to the concept of Quality 4.0.

On one level, adding the word digital in front of anything is kind of a buzz term. It is sort of the ‘i’ of decades past. Yep, head of iQuality, that means pretty much nothing.

There has been a ton written about just what digital is, and I am firmly rooted in the idea that digital should be seen less as a thing and more a way of doing things. Being digital requires being open to reexamining the entire way of doing quality, and that is exciting.

It is also not csv. Computer system verification/validation is a tool, but not an ends in itself. While I will always have one foot firmly in this skillset, I consider myself more a customer and an advocate here. Same goes for IT. IT provides services I make sue of. I’m a major stakeholder to IT, and hopefully an influencer, but I don’t do IT –fellow traveller, most definitely.

Nor is it data integrity, which is an objective or requirement to be met.

Being digital means being closely attuned to how quality, and the use of quality processes and tools, is evolving in the broadest sense. That means understanding how behaviors and expectations are developing inside the organization. It means being saavy to regulator and other stakeholder expectations as well as trends outside the pharmaceutical industry.

Yes it is about bringing in new tools. It is also recogning that the pharmaceutical industry has spent the last few decades building IT capability (ERPs and PAT and QMS and so much more) so a big part of the mission is rethinking how to use these and develop new capabilities to design and deliver the best possible quality experience, across all parts of the business. It is about implementing a cyclical dynamic where processes and capabilities are constantly evolving based on inputs from users and stakeholders, fostering ongoing use.

There is an interconnected set of three core capabilities that I think is crucial to this type of role:

Proactive decision making. Relevance is the currency of the digital age. This requires making decisions, based on intelligence, that deliver content and experiences that are personalized and relevant.

Contextual interactivity. Analyzing what is going on, and will go on, and bringing the right tools and decision-making to the job.

Journey-focused innovation. Quality should give permission and encourage the organization to innovate, expanding uses and deepening capabilities.

Being digital is about using data to make better and faster decisions, devolving decision making to smaller teams, and developing much more iterative and rapid ways of doing things. Thinking in this way shouldn’t be limited to just a handful of functions. It should incorporate a broad swath of how companies operate, including creatively partnering with external companies to extend necessary capabilities. A digital mind-set institutionalizes cross-functional collaboration, flattens hierarchies, and builds environments to encourage the generation of new ideas. Incentives and metrics are developed to support such decision-making agility.

So there’s my mini-manifesto of the journey I’m looking to continue on Monday, at Brammer.

Together with my ongoing activities in the Team and Workplace Excellence Forum of the ASQ, this job is really about what is most important to me: bringing great tools to the right teams to make the right decisions to ensure patient quality.