Investigating Unforeseen Outcomes in a Culture of Quality
A willingness to investigate unwelcome results is integral to building and maintaining a culture of quality.
My first two Quality Quarterly issues focused on bioassays and total analytical error. I chose these topics because the resolving power of assays is inextricably linked to defining a drug’s therapeutic window, establishing appropriate lot-release specifications and demonstrating that manufacturing processes are operating in a state of control.
Consistent safety and efficacy outcomes for patients can only be achieved by knowing which process parameters need to be controlled and why. Such deep understanding can only come from meaningful data gathered throughout the research and development process.
However, critical information about making and testing a product is often gained from investigating unexpected assay results at all phases of development. Unless mistakes or deviations are discovered that can readily justify invalidating aberrant test data, a deeper dig or “failure investigation” is usually warranted.
A seeming paradox between outcomes and expectations is sometimes resolved by revisiting assumptions that turn out to have been wrong. Even well-supported conclusions may need to be modified with the emergence of new data that was unknowable under prior conditions.
Unexpected findings usually create anxiety for the bearers of “bad news” and a rising panic in those who must deal with the business and regulatory consequences of unsettling data. Those natural responses can interfere with the thorough investigations needed to identify causes of failure and, ultimately, the appropriate corrective and preventive actions.
Problems arising from complex biological circumstances such as rare or novel interactions, require a team of people with varied experience and knowledge who are comfortable speaking “truth to power” to identify root causes and develop practical approaches in response. Unfortunately, these learning opportunities are not always seized.
Dr. Amy Edmondson, Novartis Professor of Leadership and Management at Harvard business school and author of “The Fearless Organization”, posits why failure analysis often gets shortchanged in organizations:
“…examining our failures in depth is emotionally unpleasant and can chip away at our self-esteem. Left to our own devices, most of us will speed through or avoid failure analysis altogether. Another reason is that analyzing organizational failures requires inquiry and openness, patience, and a tolerance for causal ambiguity. Yet managers typically admire and are rewarded for decisiveness, efficiency, and action—not thoughtful reflection. That is why the right culture is so important.”
-2011 Harvard Business Review article
By pointing to issues of self-esteem, Edmonson suggests that our vulnerability as social beings can affect our willingness to participate fully in the investigative process. In the Principles of Psychology, 19th century Harvard psychology professor, William James, coined the term self-esteem and expressed it as a concept algebraically as:
Using his “ratio of our actualities to our supposed potentialities,” failed results can reduce self-esteem, and the only available counterbalance to preserve it, is to lower our “pretensions”.
In my experience, effective leaders do not consider unexpected results as personal failures. In general, they are humble in their assessment of their status as a subject matter expert.
However, some scientists grow up prized and praised for their educational achievements (often ending up at prestigious institutions.) For them, there is an understandable resistance to accepting the inevitable lessons that a complex biologic teaches. The lowering of long held pretensions about what they know and should control can be a challenge.
However, a culture of quality makes the investigative process a safe and natural one across the organization. What Edmondson calls the “right culture,” is one that supports quality in experimental medicine as I have defined it for myself:
“Quality comes from making patient safety a priority that all employees apply in doing their job and from making it a core value that informs the behavior of leaders and employees toward each other.”
Organizations interested in building and maintaining a culture of quality are committed to bringing together a diverse group of people to achieve critical complementarity across all functions. By allocating resources appropriately and encouraging people to flag anything unusual, people are rewarded for routinely engaging in efficient information gathering and sharing.
The silencing of individuals or turning teams into silos is not tolerated, nor is any action that would negatively impact failure investigations. And while everyone can expect to be humbled by the challenges faced during drug development, no one should be humiliated or held accountable for outcomes beyond their control.
When leadership fosters a model of collective responsibility for continuous improvement across the organization, failures tend to become less frequent. When they do occur, they are viewed as novel opportunities for ongoing learning, professional growth and, most importantly, reducing risks to patients.
A culture of quality manifests when individuals at all levels understand that valid data and a willingness to pay attention to it are critical to understanding products and processes. It manifests in leaders who understand, model and convey that how people treat each other at work, is the ultimate underpinning of all quality outcomes.
“High quality organizations respond to unsettling or surprising results by creating both calm and synergy in the service of continuous improvement for the sake of patients.”
