Biomanufacturing Quality Management Systems – A holistic approach

In this podcast, we interviewed Katie Keller, Director of Quality and Safety at Asahi Kasei Bioprocess America, about the importance of quality management and how to achieve the best possible results. Topics included the most critical elements of quality management, how to ensure the purchase of high-quality equipment, and future trends.

I started the conversation by asking Katie what she thought were the most critical elements of quality management. Katie replied by saying that a holistic approach to quality is best for any organization. It used to be that the quality unit was considered responsible for product quality, making all the decisions, and driving all the improvements and that’s not really the case today. She feels the most successful approach is that since quality is so important, everyone should be responsible for it. She went on to say that when all employees understand how they contribute to product and service quality and therefore customer satisfaction, there is more buy in throughout the organization. People are empowered to take responsibility for the improvement of the processes they manage, and this total quality management is achieved by clearly defining the interaction of each process to another, ensuring employees understand that, and then setting the expectation that quality is achieved from every level of the organization with everyone playing a part.

I then asked Katie what should bioprocess equipment customers be looking for to ensure that they are purchasing high quality equipment? She told me that across industries, it’s common for customers to search for suppliers with robust quality management systems. As a supplier, Asahi Kasei Bioprocess America (AKBA) can minimally prove this by achieving and advertising certification to ISO 9001. This shows that Asahi Kasei meets the minimum expectations for a manufacturing company to provide those quality products and services, but it really doesn’t stop there. If they can show their customers that they have well designed, thorough processes that are continually improving, this naturally leads to better quality products and customers gain confidence in their ability to meet ongoing needs.

I continued the discussion by asking if she could talk a bit about ISO certification and why it’s an important part of their quality management system. Katie explained that ISO 9001 really is the minimum. Their customers in the pharmaceutical industry might stop and look when they see the ISO certification, but what really brings them confidence and satisfaction are the ways Asahi Kasei goes above and beyond this. For AKBA, ISO certification is not just words on a page, there is a reason why every requirement in that standard exists. Katie shared that she believes it is her job to interpret this in a way that means something to her organization, so they can not only live it but improve upon it and take the next step. She elaborated on her point by saying that it is how you build upon those minimum criteria that truly shows a customer who you are and what is important to you as an organization. This is how a company can start to build that quality culture where the employees believe in the message that customer satisfaction, both internal and external, comes first.

I asked her about how these quality management systems affect the design and build of their equipment and how they have an impact beyond the quality management systems. Katie said that having ISO as a guideline is helpful for this, especially if they need to create or revamp a process. Asahi Kasei Bioprocess starts by asking what ISO requires to get a baseline and then looks at what their customers’ expectations for safety, quality, and productivity are. She explained that by keeping both these things in mind, they can create robust processes with controls or checkpoints to ensure they are satisfying all the requirements.

However, that example is at the front end of creating a new process, a robust quality system also ensures you have a mechanism to continue to learn. AKBA uses the data collected from previous equipment builds or customer facing activities to apply lessons learned to future projects. These lessons can come in the form of data compiled from nonconforming product customer feedback at reflection meetings, which are all incredibly important pieces of their quality system. Lessons provide inputs for future process and product improvements. In this way they are always learning, growing, and therefore continually improving their equipment design as well as the customers’ experience with it.

Next, I asked her what trends she sees in quality management going forward in the industry and what it might look like in five to ten years. Katie responded by saying that right now she can see a digital transformation, because even less than ten years ago, many companies were working on transitioning from paper-based quality management systems to electronic systems and now everything is in the cloud. Moving forward, she feels we can expect full digitization throughout all different kinds of organizations’ quality systems, both large and small companies, and the new norm could be interacting digitally through cloud-based portals instead of emails. Another example could be that communication will be digitally scanned and accepted rather than receiving paper-based packing lists attached to shipments.

Additionally, she thinks the implementation of AI is growing at a rapid pace in manufacturing and this will result in the automation of more quality judgments. She went on to say that there has been lots of talk in the quality sphere about quality 4.0 and whether quality professionals will be out of a job soon, but she strongly believes there will still be a need for quality professionals to advise on ways to grow a business using quality tools and concepts. She said that we must make sure we can evolve with the times, but skills like problem solving and process improvement are still innately human skills that will always be needed. By continuing to keep people connected to each other and engaged in the quality system through the total quality management approach, we can continue to build a culture where everyone is responsible and accountable and motivated to keep improving. To sum up her answer she said, “I believe that when you have everyone in an organization living and breathing a unified message for quality, you can really do some great things, and I can’t wait to see how far we’ll have come in 10 years”.

I closed the interview by asking her if she had anything else to add for listeners. She added that with the rapid pace that everything is changing right now, especially in these certain industries like manufacturing and pharmaceuticals, it’s an exciting time. She thinks the more that we can embrace the change, the greater things we can do. At Asahi Kasei Bioprocess, they are always innovating and trying to meet customers’ needs for tomorrow. She thinks really getting behind that idea with an open mind and  supporting employees internally so they have the empowerment and the mechanisms to be successful will be critical moving forward.

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