Great, great discussion. When you think about all of the different applications and use cases that you both articulated so nicely, maybe one of the questions I started thinking about is, what makes this different in terms of quality culture as opposed to just a culture-based assessment? I mean, I think there’s a lot of things that are out there in the in the market space around cultural assessment tools. Quality Pulse® really does focus on quality culture specifically. Can we talk a little bit about that in terms what makes that unique?
Sure. I’ll take that one, Jerry. There’s a great number, as you mentioned, of culture assessments. Some are developed within the company. Some are provided by 3rd parties. Those deal with a generalized business context and are applicable to a wide variety of industries whether it be sales, development, manufacturing, etc. What’s unique about Quality Pulse® is we’ve taken that body of research, and a lot of that understanding of behavioral context in an organization, and then adapted into what we all know is a structured regulatory framework for life sciences. The regulations for both pharmaceuticals, biopharmaceuticals, devices, combination products, those regulations are diverse, they are specific in some cases, and they put operating constraints around how things are done. You have to have certain systems in place in order to meet the regulation and do your business. Those constraints have to be accounted for in the culture model because they constrain behavior and drive uptake of beliefs of what’s important. Quality Pulse® has built that into it so we understand that operating context that’s unique to life sciences. So, that’s how it differentiates change from those general, what are often HR, and leadership-type, culture assessments.
What I like about the tool that has been developed, beyond what Ken has said, is the fact that we focus on behaviors. We ask a lot of very pointed questions against scenarios to ask people what they observe in their environment. What are the messages in their environment? What’s being said versus what do they see? What do they hear? Think about being a new employee in the company when you come in…there’s everything you read in the procedures, and the policies, and all the things that you’re trained on when you’re in a regulated-type environment. And then you get to budget season, or performance review season, or other periods of time and you ask your peers, what’s really important here? What’s the real scoop? Right? What’s the real skinny? What does the boss really want?
And you know, I find that interesting because, as this tool has been developed, what differentiates our tool from some of the other quality culture surveys out there, frankly, is many of those are talking about the suitability, and the applicability, and how well the quality system as it’s designed is executed. Right, Ken? And what ours does is not focus on how well your quality system is designed, or how well people are executing CAPA, it asks things like, so when you need a CAPA in your company does your boss put the best people or the worst people against the CAPA? And how high on the priority list is the execution in the completion of that CAPA? And what’s the expectation about the robustness and thoroughness of the root cause investigation?
So, based on the experience Ken, and I, and others have had that have been involved in the development of tool, what we know about quality culture is – it’s all about what people do, and what you see, and what the boss says and does, and how that’s different from the slogans on the wall, the official messages and memos that come out, and all of that sort of thing. Right, Ken?
Absolutely! You touched on one point that I recall from our many discussions in the development of the tool. How we had to pivot and become acutely aware that this is not an audit. This is not trying to assess the health of your quality system. We’ve all done audits, we all see what those are, and there’s plenty of great audits. Most companies have their own internal audits, and there are people who do those audits. It’s a context, but it’s not what we’re getting at. We’re looking at what’s driving behavior, and belief drives behavior, and systems provide context. That’s a unique perspective that I think Quality Pulse® brings that no one else does. It’s not benchmarking, it’s not seeing how well are we doing against our peers… that’s interesting, but it’s not driving improvement and action.