Does a 4.5 Sigma score mean your lab is safe? Not necessarily. It’s a question every lab professional should be asking. For years, we’ve aimed for high sigma values, believing they were the ultimate benchmark for quality. But what if that’s only half the story?
The shift to Risk Management, mandated by ISO, CLSI, and CLIA, forces us to look deeper.
It’s not just about process performance—it’s about the real-world likelihood of a patient receiving an incorrect result. Our latest case study shows why: • A process with a 4.5 sigma can be extremely safe at low test volumes. • But when you run 1,000 tests/day, that same process can exceed acceptable risk limits.
The takeaway: Sigma is constant, but risk changes with volume.
This is Lesson #1 in a new series preparing you for our Risk Management Masterclass in late February! What are your thoughts on this? How does your lab account for test volume in your risk assessments? Share your insights below, and join our LabLogic Innovators group https://lnkd.in/gRUv8dFr to dive deeper!