Proactive Solutions for Risk Mitigation in IVD Manufacturing

The last thing any IVD manufacturer wants to occur is a product recall. This has wide-reaching implications, not only for patient care, but also for the individual manufacturer and their ability to provide relevant and useful IVD testing kits onto the market. Product recalls highlight the importance of rigorous quality control and risk management in the IVD industry ensuring patient safety and preventing adverse events. Global events such as the pandemic and military conflicts have led to supply chain shortages, acutely demonstrating that managing risk is imperative to maintaining a sustainable business. Collaborative proactive risk mitigation with suppliers can better protect a company’s ability to reliably deliver their products and services to their customers with the high quality expected. Risk mitigation is the process of assessing risks and taking one of the following actions: removing the risk, reducing the risk, or accommodating the risk. Critical raw materials require active risk mitigation to ensure: • Manufacturing continuity • Lot-to-lot consistency • Regulatory compliance • Clinical test reliability Manufacturing and testing organisations actively work to avoid disruption to their operations as the impact could be significant. Such disruptions could include: • Delays in manufacturing • Customer backorders • Batch failures • Product recalls • Patient misdiagnosis or harm Dr. Lisa Fitzpatrick, IVD Segment Marketing Manager P