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.

Driving for Mature Quality Organizations – FDA recent perspective

Theresa Mullin, FDA’s Associate Director for Strategic Initiatives for the Center for Drug Evaluation and Research recently gave a presentation “Update from FDA CDER” at GMP by the Sea (I need to go to that that some-year).

As in other FDA presentations this presentation summarized the Quality Metrics Research Final Report by the University of St. Gallen as the appropriate steps to ensure quality maturity:

  1. Optimized set-up and cleaning procedures are documented as best practice process and rolled out throughout the whole plant.
  2. A large percentage of equipment on the shop floor is currently under statistical process control.
  3. For root cause analysis, the firm has standardized tools to get a deeper understanding of the influencing factors for problems.
  4. Goals and objectives of the manufacturing unit are closely linked and consistent with corporate objectives and the site has a clear focus.
  5. Manufacturers have joint improvement programs with suppliers to increase performance.
  6. All potential bottleneck machines are identified and supplied with additional spare parts.
  7. For product and process transfers between different units or sites,standardized procedures exist that ensure a fast, stable and compliant knowledge transfer.
  8. Charts showing the current performance status such as current scrap rates and current up times are posted on the shop floor and visible for everyone.
  9. The firm regularly surveys customers’ requirements.
  10. The firm ranks its suppliers and conducts supplier qualifications and audits.

This are some pretty low hanging fruit. They are also the pretty necessary in any organization, not just pharmaceuticals.

There was also a little discussion on the use of Q10 that really makes me wish I had been there to hear exactly what was said. I hope it was “Just freaking implement it already.”

In general, useful slides, I recommend going and checking them out.

Task Analysis

What is Task Analysis?

A task analysis breaks down a complex task into its components – the steps involved and the knowledge required. To do a task analysis, you observe the work and interview a subject matter expert (SME) or key performer.

What do you want to identify in a task analysis?

  • Why someone would learn the skill
  • Prerequisite skills, knowledge and attitudes
  • Special materials or tools required
  • Warnings of dangers, both overall and at specific points in the process
  • The critical steps (no more than five to seven, otherwise you should split it into another task) and their sequence
  • Whether the sequence is critical or flexible
  • Any other steps necessary to complete the task and their sequence
  • How critical any given substep is
  • Conditions that must be satisfied before going on to the next step
  • Reasons for doing steps at a particular point
  • Signs of success for each step (for confirmations)
  • Signs of failure for each step

What is the process for doing a task analysis?

  1. Review any documentation, manuals or process maps
  2. Observe at least one expert and take notes as you observe
  3. Either slow down experts during the task to ask questions or interview afterward
  4. Identify each step
  5. Document what you saw and what the expert told you, then ask for the SME’s reaction, there will almost always be gaps identified
  6. Expect the process to be iterative

What should you ask the SME?

  • What is the SME doing?
  • Why is it important, or what is the rationale?
  • Why is the SME doing it that way?
  • Is there a warning necessary?
  • How does the SME know what to do next (if there is a choice between two or more actions)?
  • How can the SME tell if a step was done right?
  • How can the SME tell if a step was done wrong or incompletely?
  • How is the sequence critical?
  • What does the SME do that isn’t documented?

While often viewed from the training perspective, task analysis is a core quality tool that is utilized in procedure writing, automation, user interface development, problem solving and so much more.

Quality Challenges of Accelerating Investigational Products

Last November, officials from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) met with industry representatives in London to discuss the various quality challenges that arise when the development of investigational products is accelerated .

The report was recently published, and can be found here.

The workshop discussed process validation, control strategies, good manufacturing practice (GMP) compliance, comparability, stability and regulatory tools of early access approaches. Throughout they discussed two elements:

  • Scientific which includes technologies and scientific concepts or principles for development, manufacture and quality risk management, which may or not be present or implied in existing guidelines. Examples include concurrent validation, new modelling methodologies, new analytical techniques, etc.
  • Regulatory/procedural tools are described in the legal, regulatory framework and can be specific to PRIME (or Breakthrough Therapies) (e.g. kick-off meetings) or generally applicable [e.g. Post-approval change management protocols (PACMPs), recommendations, scientific advice (SA)].

I strongly recommend reading the report in it’s entirety.