Quality culture has been something that has been really hard to create tight, and kind of, geometric bounds around. But, in fact, it’s something that’s critically important for industry to understand how to essentially establish a measure of culture…because you really need to know where you are, such that you can achieve where you want to be.
Quality culture has been recognized by the Food and Drug Administration as being critically important…and both on the device and the pharmaceutical side… has been something that the Agency is looking at in their risk based inspection principles as making a cornerstone of how they want to determine what companies’ cultures’ are so they can determine what is it appropriate risk based inspection schedule.
…because they know that companies with good cultures perform better.
Quality Pulse
The Quality Pulse® quality culture diagnostic is a scientific, research-based quality culture assessment model designed specifically for FDA-regulated and life sciences companies. The methodology was developed and adapted from well-established research, including:
- Organizational culture principles of Edgar H. Schein (MIT/Sloan);
- System dynamics principles of Peter Senge (MIT/Sloan);
- Dozens of research articles on corporate culture, quality culture, and organizational behavior, many in the life science context from 2000-present; and
- Decades of direct experience in quality operations across a variety of life science (pharma/device/biotech) organizations (100-100,000 employees).
Developed specifically to help organizations of all sizes understand the drivers of their culture of quality, the methodology and outcome reporting provides actionable intelligence that helps company leadership direct and implement improvement programs that will result in better quality outcomes and improved organizational excellence.
Contact Us
To learn more about why measuring Quality Culture is important for the FDA-regulated industry, contact us using the form below.
