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.
Curiosity is a superpower that enables us to improve our lives. Empathic curiosity allows people to listen thoughtfully and see problems or decisions from another’s perspective, not to criticize or judge, but to understand. Asking questions promotes more meaningful connections and more creative outcomes. When we carefully listen to the answers we seek, we build better relationships faster, fuel employee engagement, and reduce conflict.
The first dimension, deprivation sensitivity, causes us to recognize a gap in our knowledge. Filling it offers relief. This type of curiosity doesn’t necessarily feel good, but it causes us to feel better once we have a solution to a problem. For instance, a trip to the emergency room will give answers to the question about whether a person has had a heart attack. Both a “yes” or “no” answer will satisfy our curiosity.
The second dimension, joyous exploration, causes us to be consumed with wonder about the fascinating features of the world. This exploration produces pleasure among those curious enough to pursue answers.
The third dimension, social curiosity, encourages us to talk, listen, and observe others to learn what they are thinking and doing. Since we are inherently social animals, we find communication the most effective and efficient way to gain information that will allow us to determine whether someone is friend or foe. Some may even snoop, eavesdrop, or gossip to do so.
The fourth dimension, stress tolerance, relates to our willingness to accept and even harness the anxiety associated with novelty. People who lack stress tolerance see information gaps, experience wonder, and have an interest in others, but they don’t tend to satisfy their curiosity by stepping forward and exploring.
The fifth dimension, thrill seeking, goes beyond tolerating stress to embracing a willingness to take physical, social, and financial risks to acquire varied, complex, and intense experiences. For people with this capacity, the anxiety of confronting novelty is something to be amplified, not reduced.
Curiosity is the catalyst that brings job satisfaction, motivation, innovation, and high performance. It fosters collaboration and fortifies organizational resilience by prompting creative problem- solving in the face of uncertainty and pressure.
Good leaders build and reward curiosity in their organizations by:
Rewarding creative failures. Recognize the value of effort and experimentation, even when it fails.
Understand that curious people learn quickly and bore easily. Encourage continuous growth and learning.
Give ever-challenging work and real authority to make a difference.
Make organizations places where the curious choose to work and become magnets for other top performers.
Give direction in the form of democratic guidance, not an absence of direction. Don’t micromanage. If you try to micromanage a curious person just a little, you will lose that person.
As we build quality culture we need to question our basic assumptions and build new principles of every day interactions. At the heart of this sits a culture where change is viewed as a good thing.
Willingness to change
To what extent are employees willing to continuously review and adapt their own behavior in response to a changing environment? The ideal scenario is for the entire workforce to be willing to change. This willingness to change should not be confined to situations where changes are already being implemented. It means that people should look at environment with open eyes, recognize when there is an opportunity or a need for change and initiate the relevant actions themselves. Willingness to change should be the first principle of culture and is a key enabler of the popular concept often called agility.
To what extent do employees think that their actions should be guided by data- and fact-based knowledge? The term “knowledge” encompasses any knowledge acquired through targeted observation, by chance, through data-based analysis or from practical experience.
Learning cultures attach great importance to mistakes. These organizations have understood that learning and change processes can only be triggered by mistakes. Mistakes provide an opportunity to gain a better understanding of the company’s processes and uncover previously unknown cause-and-effect relationships.
The way an organization deals with mistakes is therefore a key aspect of its culture. Two fundamentally different approaches to mistakes exist.
A negative attitude towards mistakes is reflected in a strategy based on the systematic avoidance of errors, strict penalties for making mistakes and the correction of errors as rapidly and unobtrusively as possible. Employees of companies where this culture prevails are not usually willing to disclose mistakes. This attitude inhibits their willingness to change.
On the other hand, a culture that recognizes the value of mistakes is characterized by open discussion of mistakes when they occur, systematic error documentation and a determination to find both the causes of the mistakes and their solutions. When investigating mistakes, it is critical to focus on understanding the causes rather than on finding out who is to blame.
Openness to Innovation
Openness to innovation and new ways of doing things is an important capability that is required in order to initiate change and adopt the right measures, even if they may sometimes be rather unconventional.
An environment characterized by trust and social relationships provides the basis for open, uninhibited knowledge sharing between employees. Social collaboration, helps to accelerate knowledge sharing within the organization. Good strong social networks build resilience and enable the ability to change.
In order for companies to respond rapidly and to be able to effectively change, employees need to have access to the necessary explicit and implicit knowledge. While explicit knowledge can be provided through the appropriate communication technology, the sharing of implicit knowledge calls for direct communication between the people who possess the knowledge and the people seeking it.
An effective organization needs to abandon the “us and them” mentality. Employees have acquired the capability of open communication if, having taken on board the fact that openly sharing knowledge and working together to achieve a vision increases the total sum of knowledge, they then also act accordingly. Once the organization’s entire workforce is willing to share knowledge with everyone, it becomes possible to significantly accelerate learning processes within the company.
What Does This Look Like?
Social collaboration exists between employees and with customers and partners. Confidence in systems and processes results in high process stability. People are willing to document their acquired knowledge and share it with others. The democratic leadership style values people for the contribution they make and there is a culture of open communication. The workforce is both receptive and willing to change. They learn systematically from the captured data, are open to innovative approaches and participate in shaping change processes. Employees are also conscious of the need to continuously develop their skills and competencies. While mistakes are still made, people recognize that they are valuable because they have the potential to trigger improvements.
Adopting a flexible but consistent approach to decision-making and giving people greater leeway creates the organizational framework for faster decision-making processes. In addition to creating the right framework, however, it is equally important for employees to have confidence in each other so that decisions are not only taken quickly but also implemented swiftly. Rather than merely seeing employees as resources, this requires management to value them as part of the community because of the competencies that they bring to the table. The underlying capability that makes this possible is a democratic leadership style.
Democratic leadership is a style where decision-making is decentralized and shared by all. This style of leadership proposes that decision-making should be shared by the leader and the group where criticisms and praises are objectively given and a feeling of responsibility is developed within the group. Leaders engage in dialogue that offers others the opportunity to use their initiative and make contributions. Once decisions are collectively taken, people are sure of what to do and how to do it with support from leaders to accomplish tasks successfully. It is the “Yes…but…and” style of leadership.
This style requires a high degree of effort in building organizational decision-making capabilities. You need to build a culture that ensures that everyone has an equal interest in an outcome and shared levels of expertise relative to decisions. But nothing provides better motivated employees.
For those keeping track on the leadership style bingo card, this requires mashing democratic and transformational leaders together (with a hefty flavoring of servant leadership). Just the democratic style is not enough, you need a few more aspects of a transformational leader to make it work.
Idealized Influence means being the role model and being seen to be accountable to the culture. Part of this is doing Gemba walks as part of your standard work.
Inspirational Motivation means inspiring confidence, motivation and a sense of purpose. The leader must articulate a clear vision for the future, communicate expectations of the group and demonstrate a commitment to the goals that have been decided upon.
Through Intellectual Stimulation, the leader presents to the organization a number of challenging new ideas that are supposed to stimulate rethinking of new ways of doing things in the organization, thus seeking ideas, opinions and inputs from others to promote creativity, innovation and experimentation of new methods to replace the old ways. The leader articulates True North.
Decentralized decision-making around these new ways of doing are shared by all. Decisions are taken by both the leader and the group where criticisms and praises are objectively given and a feeling of responsibility is developed within the group, thus granting everyone the opportunity to use their initiative and make contributions. Decentralized decision-making ensures everyone empowered to take actions and are responsible for the implementation and effectiveness of these actions. This will drive adaptation and bring accountability.
Arenas, F.J., Connelly, D.A. and Williams, M.D. (2018), Developing Your Full Range of Leadership, Air University Press, Maxwell AFB
Gastil, J. (1994), “A definition and illustration of democratic leadership”, Human Relations, Vol. 47 No. 8,pp. 953-975
Hayes, A.F. (2018), Introduction to Mediation, Moderation and Conditional Process Analysis, 2nd ed.,The Guilford Press, New York, N