An Emphasis on Collaboration: Each Employee Plays a Role in Ensuring Quality.
Interview with Amandine Simon, Site Production Manager
What is bioMérieux’s philosophy on quality?
Quality is a key aspect of bioMérieux’s commitment. We believe the shared goal and responsibility of all bioMérieux employees is to understand customers’ needs and provide high medical value products and services that enhance public health worldwide. Every bioMérieux team member plays a role in guaranteeing the full execution of our quality standards.
We strive to create and maintain a sustainable quality culture to continuously empower employees and improve our processes. This culture helps us both meet and anticipate customers’ expectations in an evolving regulatory environment.
For example, the Manufacturing team that I lead, is responsible for guaranteeing a high level of quality at each step of our process and ensuring reproducibility between every batch.
Which quality standards and criteria do you follow?
We have obtained many quality certifications over the years: ISO 9001 for quality management; ISO 13485 for medical devices; ISO 17025 for the competence, impartiality and consistent operation of laboratories; AFNOR certification; and more.
This means that on a daily basis, we are needing to meet several criteria, ranging from the product’s weight to printing to the color of the product. We also test the sterility and microbiological performance of our media to ensure constant quality. Of course, the quality of a product is linked to its traceability, which we ensure through batch recording. We follow data integrity principles with the utmost accuracy, as any event could impact the quality of the product.
What are bioMérieux’s strengths in regards to quality management?
We lean on a robust quality system and highly skilled teams that support our production work. The collaboration between our team members is very strong and takes many forms. Every employee receives regular training and precise instructions. We also conduct several internal audits in collaboration with quality teams, as well as external audits to renew our certifications. Last but not least, we conduct around twenty customer audits per year, about one every two weeks.
Indeed, our customers’ feedback is always key to ensuring continuous improvement, and we have to be ready to adapt to the evolutions of their regulatory environment. They also need to adapt to new markets —such as the boom in biologics —which can lead to new manufacturing challenges such as digitalization and automation of the entire production workflow. So, we make sure that our solutions evolve with their needs: this is the case for the 3P® SMART PLATES we produce at the Craponne site. 3P® SMART PLATES utilize GS1 barcodes and LOCKSURE® lids that decrease the risk of manual errors or accidents, and a new ultra-clear design, making identifying and counting colonies easier.
Whenever it is necessary, we make the required human and technical investments to help keep our customers compliant and audit ready.
How is quality management evolving?
We are currently implementing many new digital solutions. For instance, we are adopting a Computerized Maintenance Management System (CMMS) to track the maintenance operations on our equipments. We are also investing in a Laboratory Information Management System (LIMS) to improve data management.
These tools help us accelerate the collection of data, improving the analysis of our processes and our overall efficiency. They are necessary to keep offering our customers the agility and reactivity they need. However — people remain parmount. Nothing will ever replace the human brain. Although powerful, digitalization can only support of the human work.
When it comes to quality, what is the advantage of being a global company?
bioMérieux has several production sites that can back each other up. For instance, the production sites of Craponne, in France, and Tres Cantos, in Spain manufacture many of the same products, which is critical to help secure and manage production in case of a high demand. Another example — tornados hit the US in March 2023, which forced us to shut down our Lombard, Illinois site for about ten weeks. Due to a close collaboration with the Lombard teams and an incredible commitment of everyone involved, our Craponne site took over production and delivered key American customers with the quality standards they expected. It surely is a great illustration of our agility.
