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It’s our belief that culture poses a direct risk to life science companies. And by understanding your culture and having a predictive diagnostic model that you can then do an assessment, see where your needed improvements are, target your remediation on that culture, you can then inherently reduce your risk and tangibly reduce your risk, for those organizations.

So let’s look first of all at a healthy quality culture. This is what you would want to have if your company was doing this assessment and you described it as a healthy culture. It orients you to have these diagrams. This is a radar plot. At the top is the expressed value score. Underlying assumptions on the right hand lower, and systems and structures is on the left hand lower. And the higher the score, the longer these arms extend, and the healthier your culture will be. It’s a quick way to get a look at your culture in aggregate across the whole of the organization. We’re not going to talk about sub-populations at this level. But this is a healthy score. And here are the reasons why we view this as a healthy score. These scores are relatively high. They’re represented on a one to 10 scale, so these scores are eights, nines and 10s. And what’s particularly important is that the scores are balanced between all three and they are strong between all three. It means that you have favorable outcomes on all the scored items. It’s well distributed across the organization. And this indicates an organization where there is a high degree of clarity in the organizational mission, vision and values. What’s said is what is done. You reward people on doing those things, and it’s very clear that your rewards and recognition align with what you want to accomplish with respect to quality and your ways of operating help you to achieve those goals instead of hindering them. You have a great deal of clarity in that. This type of culture goes a great distance in reducing and mitigating risk, because everyone is pulling on the same rope in your very strong quality systems, and there’s alignment in decision making.

Now let’s look at an example where you have one of these is weak. And this is probably one that you’re most familiar with because it’s the most tangible. And it’s also, if you were to exclude expressed value and underlying assumptions from your daily assessment, it would appear as an audit. Because an audit is only going to look at this systems and structure piece. They’re not going to look at your cultural pieces from these other two culture vectors. So this is one where you may have a company that has very strong expressed values and the belief systems may align very well with it. Everyone wants to do those things and you have leadership support to do them. But you have procedures and policies and structures and systems, including your rewards and recognition systems, that don’t really help you do that. It takes heroic efforts often by a select few incumbents who have a great deal of experience operating in this, and have that knowledge base to operate within this, to achieve everyday results. Because you have these weak structures and systems, you rely on that individual effort rather than the structures and systems.

This is something you see very often in startups. You’ve got a very small group of people who are very tightly aligned. Many of the decisions are made around the cafeteria lunch table, and that intuitive exchange that occurs almost unconsciously over time begins to be your system rather than being your procedure. It can also happen in a mature company during a gap period and you don’t spend the time to update your procedures because you’re focusing on cost cutting measures. If you’ve got products that are going off patent and you don’t have something to fill that gap period, so you’re distracted by that gap period. Or it may be a contract organization, where the margins in a contract organization are so small and so tight that you have to be laser-focused on that margin basis and your budget, that sometimes it becomes a distraction from doing the right thing in difficult times. You can’t make those investments in improving your systems. You’re too busy getting things out the door.

 

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

Filed Under: Achieving Compliance

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      • Audits & Assessments
      • FDA Enforcement Response/Remediation
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      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
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