I want to begin before I turn it over to Ken and talk a little bit about FDA’s thoughts on quality culture. I think this is one of the areas that I’ve seen FDA become more and more interested in over the last decade or more. I’ve seen more and more warning letters issued over the last 10 to 15 years where FDA actually cites and references the lack of quality leadership, and indirectly discusses the issues and challenges around the culture in the organization with respect to quality. And I think what’s important, and you’ll see in the upper right hand corner of this slide, is the linkage between leadership and the corporate quality culture.

There are decisions that are made every single day in an organization. As a senior quality leader, as an executive, one of the things that I used to coach my team on, on a regular basis was, every decision we make every day impacts our quality compliance profile. Whether we’re at a plant, a corporate function, an operating unit, a marketing company, a distribution center, research and development, clinical operations, that quality compliance and the profile that a company maintains around quality compliance is a little bit like the old printers we had that printed pixel by pixel. And every single day we made decisions, and those decisions every single day creates that picture. And that picture can either end up with a strong quality culture that produces consistency in our manufacturing processes, consistency in our supply processes through our distribution channels. It provides consistency and quality outputs in design and in product development; allows for smooth transfer from research and development into the manufacturing environment in our clinical operations; run robust, reliable clinical studies with few protocol deviations; and results that are easy to understand and interpret.

We also can make choices on a daily basis that can lead us to unreliable systems, chronic manufacturing problems, many deviations and issues during clinical trial studies. And all of those issues net us out with defects, regulatory actions and business failures. We have firms that struggle to meet financial commitments on a monthly or quarterly basis. We don’t meet case fill rate metrics in our plants. We struggle with the number of deviations and deviations at a given clinical investigator site because we have challenges with the quality system and the appropriate oversight and understanding. We need to have appropriate oversight of our clinical studies. We end up with product shortages in some cases that can have a significant impact on a patient. We have products today that if we interrupt treatment, those products become ineffective. If we have shortages of needles, if we have shortages of syringes, if we have shortages of gauze, if we have shortages of certain other types of materials, catheters and things that are commonly used as devices to assist in the delivery of our drugs, in devices that are normally used in emergency or regular situations, we end up with shortages, unreliability, recalls, rejected product. And all of those things impact our business. We also, if we’re in product development, we end up with submissions that are reviewed by FDA that lead us to sometimes complete response letters, and sometimes to very challenging outcomes and discussions with the FDA or other global health authorities.

I think it’s interesting, because in 2011, Rick Friedman did a presentation on 21st century quality. That was adapted from something that Richard Davis actually presented as far back as 2004. And some of the points that Rick made at that time were, a good quality culture, what they see as FDA when they interact with firms that have a good culture, is you see support for the quality organization. You see actions more than words and slogans and long elaborate quality policies. You see an investment in quality in the people, in the processes, in the IT tools. You see quality involved in the relevant business decisions. You see quality at the table discussing recommendations in the budget for things that will improve quality and reliability in production. The quality of the work that you accept becomes the organizational standard.

I can remember interacting with FDA investigators at some of the sites I was a quality director for throughout my career. And one of the things the FDA said to some of the folks in the inspection front room was, in a firm, you always have the opportunity to gravitate to the lowest common denominator. And that means that the quality level that I would expect, and that the people in my organization would expect, as they’re reviewing batch records and deviations and change controls, validation protocols and reports, etc., that the quality of the work we were willing to accept would become the organization standard. And that, indeed, affects the outcomes, both from an FDA inspection perspective as well as in terms of the performance and the quality and the safety of the products emerging from that plant. And then last but not least, the organizational structure. That structure has to assure that QA is independent and not subordinate to R&D, or to supply chain, or to production or to any other organization. That quality really needs to stand separate and independent, and have the independence and the authority and the ascribed roles and responsibilities that allow them to function independently.

 

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