Compliance Insight, Inc.
Building a Sustainable Quality Culture

Building a sustainable, effective and balanced compliance process offers many benefits to pharmaceutical, medical device, and cell/gene therapy companies. It helps better manage risk, reduces capital spent correcting mistakes and improves companies' product consistency and organizational success. But to build and maintain such a quality culture, it takes consistent effort, and most firms focus on the symptoms—built-up poor processes, workload, compliance issues, etc.—which according to Troy Fugate, the Vice President at Compliance Insight, Inc., are not the real issues. "After several years doing these projects, we found that the real issues were, many times, 'thinking problems,'" he mentions.

What Fugate means by this is that the people were not thinking of the solution the right way. “For them, quality is a necessary evil or a roadblock to progress. We work to align everyone on a shared vision and mission and to understand the real value of quality, which we equate to control,” he states. That’s where Compliance Insight can help by approaching quality differently. The company views quality as not only a compliance aspect but also a business function. “We’ve established ourselves as quality leaders in the industry in that we approach compliance with a clear understanding of vision and mission,” says Fugate.

Compliance Insight offers a partnership with client rather than just delivering a service by focusing on a three-step program for developing GMP habits. Step one is the most important—and one that most people miss—is to understand the “why” of GMPs. To develop an understanding of the purpose and personal meaning of GMPs or quality is essential. After that, we then pick up on next two steps: the how and what of GMPs. “We strive to be extraordinary and to be to that level, we must have colleagues that work with us who are aligned with that vision,” says Fugate. Compliance Insight has developed a series of “Codes” for the over 100 people that currently work for the company —code of conduct, code of commitment, and code of ethics. "We interview to these factors and hold people accountable. Some examples include: ethics, owning the solution, and being flexible to problem resolution.

We’ve established ourselves as Quality leaders in the respect that we approach compliance with a clear understanding of vision and mission.

What drives Compliance Insight is its commitment to help their partners (clients) be successful by making safe, effective, and pure products. To this end, the company has developed a PEPPER concept—Promote, Educate, Prepare, Practice, Examine and Remediate. It has been built off the approach of Plan Do Study Act but with an emphasis on "infusing those concepts of GMPs into the clients' DNA”. In an example, Compliance Insight engaged and helped one of its partners with investigations, validations, establishing systems of control, etc. but soon realized that the people were struggling to change – the systems were there but the people were not. Implementing PEPPER, it took constant messaging, training, coaching, mentoring, oversight and reinforcement, and finally, the people were able to modify their habits. “The “quick fix” of implementing a Quality Management System by only changing the procedures typically does not work”, Fugate states.

Being a premier compliance service provider, Compliance Insight offers innovative, effective and simplistic tools. "Our 3 Sins concept gets people to think on the nature of the errors at their firms," states Fugate. Also offered is the 10 GMP Work Commandments for the 21st century, where they break down the concepts of workforce, work system, and workplace. "These processes are not conceptual ideas formed in a boardroom but are real world tools that have been tested and honed for success," concludes Fugate. “If you have read this article and want to know more, go to our website and request samples of our tools,” offered Fugate.