From the Editors: Psychological Safety in the Manufacturing Lab: A New Set of “GMP” Standards

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Ashley Krull, Ph.D.
Associate Director, Cell Therapy Manufacturing and Engineering
The James Comprehensive Cancer Center Cellular Therapy Laboratory
Assistant Professor, Hematology
The Ohio State University
Columbus, Ohio, United States

When I starting exploring the idea of psychological safety specifically in the context of a cell and gene therapy (CGT) manufacturing laboratory environment, I found exactly zero articles on applying psychological safety in a clinical or research lab. Thankfully, original research around psychological safety conducted by Dr. Amy Edmondson, Ph.D., and others around the turn of the last century (yes, writing that makes me feel psychologically unsafe in an existential way, too) involved medical care teams and still rings true for workplaces today. Subsequent work by Edmondson and others has only reinforced her original findings and made the insights even more applicable to clinical lab manufacturing teams. As such, I delved into this work to provide a brief introduction to psychological safety and spark a discussion around its profound importance in the laboratory environment.

To start, what is psychological safety? The term is defined generally as the “shared belief held by members of a team that it’s OK to take risks, to express their ideas and concerns, to speak up with questions, and to admit mistakes — all without fear of negative consequences.” As Dr. Edmondson states, “it’s felt permission for candor.”1

Allow me to acquaint those unfamiliar with the take-home finding of the original research. In short, hospital care teams with greater psychological safety had more reported errors than teams with lower psychological safety2. How could this be? Greater communication should mean fewer errors, right? The answer to this puzzle was that the teams with more openness were likely voicing more errors rather than hiding them for fear of retribution, punishment, or shame.

I think that finding should resonate with anyone who has ever performed a quality audit in a manufacturing lab setting. I never would believe a lab that reported zero mistakes. If you report zero mistakes, that means people aren’t telling you about them, not that there are none to report. Lack of evidence is not evidence of lack.

So what? Apart from reporting more of our mistakes, why does psychological safety matter? I found three big reasons to highlight. First, it fosters in team members a sense of ownership in the work, so they tend to be more engaged and driven. Second, when people feel confident and safe to voice thoughts and diverse perspectives, this leads to improved decision-making. Third, such a culture promotes continuous learning and improvement, which is vital to a manufacturing lab. Winston Churchill said, “Never waste a crisis.” Applied to the lab environment, have a culture where any mistake is viewed as an opportunity to learn and improve a process to prevent the mistake’s recurrence and get better as a unit.

What are the potential consequences of working in a team lacking psychological safety? The consequences are the horrible buzzwords we hear everywhere nowadays: poor employee well-being, stress, burnout, turnover. I don’t think any of us need another reminder of the high level of turnover already experienced by manufacturing labs. But perhaps examining our lab’s culture of psychological safety could be one way of improving retention…worth a shot, right?

Still not convinced this principle applies to labs? Edmondson has stated that the most recent evolution of her work has shown that “The relationship between psychological safety and performance is stronger in situations where the results or work aren’t prescribed, when you’re doing something creative, novel, or truly collaborative.”1 The work of Torralba et al., 2020, also references the intriguing notion of a “hidden curriculum” for medical learners or trainees, made up of norms, values, and behaviors exhibited by instructors3. The authors state, “These norms, values, and behaviors become part of the culture of the clinical learning environment. The vulnerability of learners in this environment is magnified by the hierarchal nature of medicine, and the complexity, uncertainty, and the ambiguity inherent to medical conditions.”

Picture a highly hierarchical structure in which workers are asked to perform novel, creative, collaborative work at a high level with patient outcomes at stake. Sounds like a clinical manufacturing lab to me. We demand much from those who work in cell and gene therapy, many of whom have never had formal training until joining a CGT lab. I strongly maintain that those who choose to join such an environment – particularly as freshly certified technicians – possess a unique hunger for continuing education and a drive to perform work at the cutting edge of medicine, crafting therapies that are being used in patients for the first time. The products they create may be the patient’s last best hope for treatment, and mistakes have far-reaching consequences. Those consequences only get worse if consequential mistakes go unreported. Therefore, fostering psychological safety within the laboratory is vital to long-term success of any GMP manufacturing group. Technicians need to adhere to a standard of excellence while knowing that mistakes will happen and learning is part of the job. These are expectations that start from the highest levels of leadership and form the foundation of the culture of the lab.

How can we all – but particularly leaders – start fostering psychological safety in the lab? This where the good ole’ GMP acronym comes in – in this case, good management practices: clearly communicate norms and expectations, invite feedback, practice active listening, praise open communication, model humility and gratitude when employees voice opinions. Readers are encouraged to refer to the helpful figures in Grailey et al., 2021, for excellent visual schematics summarizing the barriers and facilitators of psychological safety as well as the specific influence of situational context on psychological safety in a healthcare setting4.

Taken together, the research around psychological safety has shifted this principle from a “nice to have” to a “must have” aspect of lab culture. The stakes are too high to have team members afraid of voicing mistakes. Promotion of a culture where people not only can speak up but are actively encouraged to do so will enhance product quality, personnel engagement, and organizational success. Let us know if you have such a culture at your institution and/or if you have taken specific steps to enhance psychological safety and the outcomes thereof. Let’s keep this conversation going.