Meet Diane Yamamoto, National Quality Assurance Manager at IDEXX BioAnalytics. Diane gives us an insider’s view of the QA team and explains our unique approach to QA for FDA regulated studies.
Q: Tell us about your role as QA Manager at IDEXX BioAnalytics.
A: A Quality Assurance (QA) unit is required under the FDA GLPs. IDEXX recognizes the importance of an established QA unit to provide regulatory oversight not only for GLP studies, but for GCP (VICH/GL9) studies as well. Our QA team functions independently from operations, and we are responsible for assuring management that regulated studies are processed in accordance with the applicable regulations and/or guidelines. Our QA team assists in general SOP compliance and frequently works together with operations. IDEXX BioAnalytics is unique in that we have permanent QA staff in the West Sacramento and North Grafton labs. I believe this supports IDEXX’s commitment because that means our QA team is on site rather than being called when needed or working remotely. We have been offering GCP services for over a decade and recently reentered the GLP business in July of 2015.
I started with IDEXX in 1986, so my involvement with GLP didn’t just start in 2015 when we began offering GLP histology services again. Our clients appreciate knowing that this IDEXX QA unit collectively has over 20 years of experience in this industry. I encourage our clients to audit us–our lab practices, facility and workflows– not just to assess our level of compliance but to also have the opportunity to share ideas for process improvements which is very important in this business.
Q: What’s unique about your approach to QA?
A: Developing strong relationships -- with both clients and with the laboratory team here at IDEXX BioAnalytics. I welcome client audits because it gives us a chance to meet the client's QA team as well. This also gives the client a sense of who they're working with at IDEXX BioAnalytics from a QA perspective. But even more importantly, it provides an opportunity for our QA staff to develop a strong working relationship with the client’s QA team, which adds a great deal of collaborative confidence in ensuring regulatory compliance.
We’re also unique in that our team has a very strong relationship with the operational side of the business. While the QA unit is completely independent from operations, we have one common goal which is to meet the quality needs of our clients.
Q: Why do you feel so strongly about relationships in QA? What’s the benefit?
A: I encourage a strong working relationship between IDEXX QA and the client’s QA. If I can develop a relationship with their QA, whether it's a company employee or a consultant, it provides both parties with a better line of communication to discuss issues that come up during the course of their study. When I host a client audit, I want the auditor to feel confident with the IDEXX QA team. I have worked for IDEXX for over 20 years in many different positions, and with my experience and background, I have acquired a good understanding of the laboratory business, specifically in regards to operations. Because of this base knowledge, I can confidently address an auditor’s questions directly. When QA can speak from an operational perspective, there is a higher level of confidence with the client that a QA team is knowledgeable in the processes they are auditing. The relationships we form with our clients stems from trust, confidence and expertise.
To learn more about our QA processes and how they make your data reliable and reproducible, contact us today.