The Great Man Fallacy and Pharmaceutical Quality

Primary Investigator, Study Director, Qualified Person, Responsible Person – the pharmaceutical regulations are rife with a series of positions that are charged with achieving compliance and quality results. I tend to think of them as a giant Achilles heel created by the regulations.

The concept of an individual having all the accountability is nowhere near universal, for example, the term Quality Unit is a nice inclusive we – though I do have some quibbles on how it can end up placing the quality unit within the organization.

This is an application of the great man fallacy – the idea that one person by the brunt of education, experience, and stunning good looks can ensure product safety, efficacy and quality, and all the other aspects of patient and data integrity of trials.

That is, frankly, poppycock.

People only perform successfully when they are in a well-built system. Process drives success and leverages the right people at the right time making the right decisions with the right information. No one person can do that, and frankly thinking someone can is setting them up for failure. Which we see, a lot in the regulatory space.

Sure, the requirement exists, we need to meet it failing the agencies waking up and realizing the regulations are setting us up for failure. But we don’t need to buy into it. We build our processes to leverage the team, to democratize decisions, and to drive for reliable results.

Let’s leave the great man theory in the dustbins where it belongs.

dissolving crown

Building the Risk Team

Good risk assessments are a team effort. If done right this is a key way to reduce subjectivity and it recognizes that none of us know everything.

An effective risk team:

One of the core jobs of a process owner in risk assessment is assembling this team and ensuring they have the space to do their job. They are often called the champion or sponsor for good reason.

It is important to keep in mind that membership of this team will change, gaining and losing members and bringing on people for specific subsections, depending on the scale and scope of the risk assessment.

The more complex the scope and the more involved the assessment tool, the more important it is to have a facilitator to drive the process. This allows someone to focus on the process of the risk assessment, and the reduction of subjectivity.

Quality, Decision Making and Putting the Human First

Quality stands in a position, sometimes uniquely in an organization, of engaging with stakeholders to understand what objectives and unique positions the organization needs to assume, and the choices that are making in order to achieve such objectives and positions.

The effectiveness of the team in making good decisions by picking the right choices depends on their ability of analyzing a problem and generating alternatives. As I discussed in my post “Design Lifecycle within PDCA – Planning” experimentation plays a critical part of the decision making process. When designing the solution we always consider:

  • Always include a “do nothing” option: Not every decision or problem demands an action. Sometimes, the best way is to do nothing.
  • How do you know what you think you know? This should be a question everyone is comfortable asking. It allows people to check assumptions and to question claims that, while convenient, are not based on any kind of data, firsthand knowledge, or research.
  • Ask tough questions Be direct and honest. Push hard to get to the core of what the options look like.
  • Have a dissenting option. It is critical to include unpopular but reasonable options. Make sure to include opinions or choices you personally don’t like, but for which good arguments can be made. This keeps you honest and gives anyone who see the pros/cons list a chance to convince you into making a better decision than the one you might have arrived at on your own.
  • Consider hybrid choices. Sometimes it’s possible to take an attribute of one choice and add it to another. Like exploratory design, there are always interesting combinations in decision making. This can explode the number of choices, which can slow things down and create more complexity than you need. Watch for the zone of indifference (options that are not perceived as making any difference or adding any value) and don’t waste time in it.
  • Include all relevant perspectives. Consider if this decision impacts more than just the area the problem is identified in. How does it impact other processes? Systems?

A struggle every organization has is how to think through problems in a truly innovative way.  Installing new processes into an old bureaucracy will only replace one form of control with another. We need to rethink the very matter of control and what it looks like within an organization. It is not about change management, on it sown change management will just shift the patterns of the past. To truly transform we need a new way of thinking. 

One of my favorite books on just how to do this is Humanocracy: Creating Organizations as Amazing as the People Inside Them by Gary Hamel and Michele Zanini. In this book, the authors advocate that business must become more fundamentally human first.  The idea of human ability and how to cultivate and unleash it is an underlying premise of this book.

Visualized by Rose Fastus

it’s possible to capture the benefits of bureaucracy—control, consistency, and coordination—while avoiding the penalties—inflexibility, mediocrity, and apathy.

Gary Hamel and Michele Zanini, Humanocracy, p. 15

The above quote really encapsulates the heart of this book, and why I think it is such a pivotal read for my peers. This books takes the core question of a bureaurcacy is “How do we get human beings to better serve the organization?”. The issue at the heart of humanocracy becomes: “What sort of organization elicits and merits the best that human beings can give?” Seems a simple swap, but the implications are profound.

Bureaucracy versus Humanocracy. Source: Gary Hamel and Michele Zanini, Humanocracy, p. 48

I would hope you, like me, see the promise of many of the central tenets of Quality Management, not least Deming’s 8th point. The very real tendency of quality to devolve to pointless bureaucracy is something we should always be looking to combat.

Humanocracy’s central point is that by truly putting the employee first in our organizations we drive a human-centered organization that powers and thrives on innovation. Humanocracy is particularly relevant as organizations seek to be more resilient, agile, adaptive, innovative, customer centric etc. Leaders pursuing such goals seek to install systems like agile, devops, flexible teams etc.  They will fail, because people are not processes.  Resiliency, agility, efficiency, are not new programming codes for people.  These goals require more than new rules or a corporate initiative.  Agility, resilience, etc. are behaviors, attitudes, ways of thinking that can only work when you change the deep ‘systems and assumptions’ within an organization.  This book discusses those deeper changes.

Humanocracy lays out seven tips for success in experimentation. I find they align nicely with Kotter’s 8 change accelerators.

Humanocracy’s TipKotter’s Accelerator
Keep it SimpleGenerate (and celebrate) short-term wins
Use VolunteersEnlist a volunteer army
Make it FunSustain Acceleration
Start in your own backyardForm a change vision and strategic initiatives
Run the new parallel with the oldEnable action by removing barriers
Refine and RetestSustain acceleration
Stay loyal to the problemCreate a Sense of Urgency around a
Big Opportunity
Comparison to Kotter’s Eight Accelerators for Change

Teams reason better

Teams collaborate better than individuals on a wide range of problem-solving for two reason:

  • People are exposed to points of view different from their own. If the arguments are good enough, people can change their mind to adopt better beliefs. This requires structure, such as “Yes…but…and
  • The back-and-forth of a conversation allows people to address counterarguments, and thus to refine their arguments, making it more likely that the best argument carries the day.

Both of these work to reduce bias and subjectivity.

Principles of Team Collaboration

There are a few principles to make this team collaboration work.

  • Clear purpose: What is the reason for the collaboration? What’s the business case or business need? Without alignment on the purpose and its underlying importance to the organization, the collaboration will fail. The scope will start to change, or other priorities will take precedence. 
  • Clear process: How will the collaboration take place? What are the steps? What is the timing? Who is responsible for what?
  • Clear expectations: What is the specific goal or outcome we are striving for through this collaboration? 
  • Clear supportProblems will arise that the team cannot handle on their own. In those cases, what is the escalation process, including who and when? 

Ensure these are in your team ground rules, measure success and perform continuous improvement.

Indirect Accountability

The kind of accountability most of us are familiar with is direct accountability: a role is assigned a task and is directly accountable for their result. The role understands the quality, quantity, timeframe, and resource constraints of the deliverable and has the authority to implement plans to achieve it. When completing a RACI this is what we mean by accountability.

Ideally, the individual with direct accountability has the context to understand the limits in which they must work and sufficient knowledge about all of the factors that must be considered to make good decisions. However, that’s not always the case, and for this reason, organizations need to establish lateral roles of indirect accountability to ensure these factors are brought to the attention of the role with direct accountability.

Indirect roles are responsible for initiating action toward directly accountable roles. Indirect roles may be responsible for:

  • Informing: being aware of the factors surrounding the direct and initiating contact to offer advice and recommendations.
  • Persuading: persuading the direct to adjust their actions when there is a risk of undermining process control or when multiple roles fail to work together effectively.
  • Instructing: ordering the direct to stop when working outside of limits and/or take prescribed action to mitigate a catastrophic event.
  • Responding: Provide the direct service and support

Often these indirects are accountable in a supporting process.