A Life Science Manufacturing Executive's Role In Establishing A Quality Culture

By Jim Robinson, retired life science executive and serves on the editorial advisory board of Life Science Leader

Creating the appropriate quality culture is arguably the most important element of being a manufacturing leader in the life sciences industry. Yet, reflecting back on my long career, I have not seen a single recipe for doing this, and I don’t profess to have a well-documented approach myself. But, boy, do I have some stories.

IT’S HOW WE WANT PEOPLE TO ACT
Let’s define culture as the behaviors we accept in our company. Expanding this definition, accept can be substituted with tolerate, encourage, demonstrate, and reward. A key corollary of this rule is “who we promote speaks volumes on what we truly value.” The leaders set the tone and manage behaviors that deliver the desired culture.

I remember discussions on what our company’s definition of quality should be. As Lewis Carroll once said, “If you don’t know where you are going, any path will get you there.” The definition of the target condition can vary from “perfect” to “conforms to specifications” to “fit for purpose,” and each of these will lead to potentially different decisions and discussions within your organization.

I recall a meeting with my leadership where we hoped to define how we wanted people to act and what consistent guidance we might provide to every worker touching our product. I remember the rhetoric about how important our products are to the patients who rely on them, but I was frustrated with the lack of specific direction we had developed for the front line. I remember asking, “Can we tell people they can stop the line if they felt the quality was not what it needed to be?” Often the response was something like, “We should be able to, but management wouldn’t like that.” Needless to say, after discussing our own concerns about quality, we did stop all production for a number of months and corrected all critical issues. We set longer-term plans for reaching a higher and sustainable quality state over time. We had the full support of our company’s CEO, and we made a very strong statement to every employee in our division about how serious we were about quality. It was a painful step that led to some product shortages, but it galvanized the team and created a visible example of acceptable behavior as demonstrated by the leadership team.

ARE WE REALLY ALIGNED?
When defining quality for our group, a gap became clear in our leadership team. Operations was focused on efficiency, costs, and managing labor issues — not deliberately at the expense of quality and compliance, but perhaps not in balance with it either. Quality assurance was focused on internal and external inspections, interpreting agency communications to the industry, and how to reduce risk by enhancing systems, in-line checks, and procedures — not intentionally at the expense of cost and efficiency, but also not in balance. The only way to find a balance was to work together, identify the right risk-based compromises, and define our quality and the actions and risks we would all stand behind in executing an aligned target for change. We created a group that met weekly and managed all quality and compliance issues in full transparency while understanding consequences of options and aligned with our target condition. This was another key to getting us all on the same path to the future.

We started as an organization in need of serious remediation. Once stabilized, we recognized that cost and quality can be at odds if we try to reach higher quality in a policing or double-check mode. Instead, if you create and instill the right quality culture where every employee understands what needs to be done and why it needs to be done, and they execute flawlessly (through simplified, controlled and standardized processes), the heavy systems are not necessary, and cost and true quality do not need to be a choice. In my view, it starts with a clear definition, an aligned leadership team, clear direction and full engagement of every person in the organization, and a shared leadership and ownership of every issue along the way.