A New Quality Culture Paradigm

Ken Ray |

These two slides date back almost 20 years, and the FDA intuitively saw that culture is tremendously impactful on the outcomes of life science companies, just as Teresa described.

And they intuitively described, and empirically described, what they saw as driving what creates culture. Those daily decisions are somehow linked to creating a strong culture or creating a weak culture. And some of the attributes of that quality culture when it’s healthy, and the direct risks that are associated with it.

What we wanted to do, in looking at how to really engage a culture paradigm, is how can we take those intuitive observations, or empirical observations of, here’s good culture when we see it, here’s not so good culture when we see it, and create a quality culture model? Or a new way of looking at culture that we can then apply in the field to actual clients in actual operations that can assess culture, diagnose what the issue is, and then predictably and reliably, take action that will improve culture.

That took a little bit of work and a lot of digging into understanding where these daily decisions derived from. If you’re a worker at a life science company, particularly in the quality or the manufacturing or any of the regulated areas, particularly in GMP or even in the filings area, there are individual daily decisions that are driven by your individual beliefs, behaviors and actions. That’s what is going to inform your decision-making. What have I been trained in? What do I believe is true? What’s going to affect my job performance, my goals and objectives, the company’s stated goals and objectives? Those are driven by very key things that are developed over time, which are the individual’s beliefs and values within that operating context. If you’re operating in a company or an organization, that organization is going to influence your beliefs and your values over time.fda quality culture

What is driving that beliefs and values creation? It’s what the individual observes in that environment. So if I’m operating, and this is true in our own careers, if you’re working in an organization and you observe things around you, how your manager is behaving, how your peers re behaving, and how your leadership behaves, particularly under times of ambiguity and stress, are they making a decision or taking an action which is aligned with your stated, observed objectives and values? Or are they doing something else? Or how are they reconciling that? What an individual observes in that is going to inform their beliefs and values. Those beliefs and values are then going to drive how that individual makes their daily decisions, just as Rick Friedman described, and which path you take, whether it’s strong corporate culture or weak corporate culture. It’s going to be driven by that and as the result of the organizational culture.

Now perhaps the most important piece here is this is not a linear diagram. This is, in fact, a dynamic system. And in researching this, among the literature, this is perhaps the biggest leverage point in understanding quality culture. What individuals observe over time creates their belief systems, and what’s important and what they’re going to be rewarded for, and what they should do. That’s going to drive their behaviors and actions, and over time, that reinforces the quality culture because other people are going to observe what they’ve done. This is the new paradigm that was the basis for developing Quality Pulse.

Transcript taken from June 15th Webinar – “Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”

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