Culture.  With regards to the FDA, this word typically refers to growing microorganisms or other living materials in a medium.  You will also find the word “culture” in The FDA’s Draft Guidance for the “Request for Quality Metrics.”  The word is used 10 times in fact.  In an effort to promote risk based inspections and reduce drug shortages, the FDA has plans to ask the industry to gather product related metrics and information on a quarterly basis.  The term culture is discussed in this metric request, but it has a completely different meaning, and an insight into the FDA’s evolving mindset for product quality.


The proposed Optional Metrics section discusses Quality Culture. “The FDA acknowledges the importance of quality culture to the overall state of quality of the product, process, and commitment to quality.” Several questions seek to gain information about the relationship between quality assurance and operations groups. Could teamwork and collaboration between the groups yield a higher quality and more reliable supply of product? Personally, I believe so. I believe the FDA will be able to prove this in the future by collecting these metrics.

So how do you improve Quality Culture when the QA group is all too often viewed as an overbearing impedance, showing up just to point out every little problem and leave operations with a list of issues to figure out how to remediate? The answer is to invite them in. In my experience (in both operations and quality), the more time the QA group spends with the operations group, the more productive the relationship is. In turn, this results in the betterment of both the product and process.

Here are a few reasons why I think this works:

  • Quality can be incorporated into all stages of the manufacturing process. Having the ability to be a part of casual discussions about frustrations or issues can allow the QA group to provide input on regulatory and quality implications before issues ever occur. Greater access between the manufacturing personnel and their QA team eases these conversations. It is also much more constructive to modify a process when it is in development, rather than waiting until it is fully approved and is being executed in uncompliant ways.
  • QA can have a deeper understanding of the process if they are involved in it every day. With a deeper knowledge of the process, they have the opportunity to understand why things may be difficult or done a certain way. They can make suggestions on improvements, rather than just observe a deviation when performing an internal audit or reviewing a completed document. Having this knowledge reduces the “picky” findings that are sometimes generated due to lack of process familiarity and allows the manufacturing group to focus on meaningful observations.
  • Fosters good communication and more effective problem solving. The more you communicate with someone, the easier the conversations become. Even just a friendly “hello” can break down walls that exist between the groups. If the two groups tend to not have regular interaction, it makes building a working relationship a lot more difficult. Conversations turn from “Shh, don’t let QA find out about this” to “Hey, let’s ask QA the right way to handle this.”

At Blue Mountain Quality Resources, the entire team embraces the Quality Culture through collaboration. Senior Management is a strong advocate for this. All department heads work together to foster a culture that allows us to provide the best quality products and services possible, just as the FDA is looking for.