A Certificate of Analysis (COA) provides a level of confidence in the quality and purity of its product. Companies should take this document a step further and assess what the results mean. Using Failure Modes and Effects Analysis (FMEA) can help a company identify, quantify and assess risks associated with pathogen detection methods, giving them the background information they need to trust the results. FMEA can help companies understand the differences between testing methods by individually identifying the risks associated with each method on its own. Maureen Harte, President and CEO at HartePro Consulting, and Lean Six Sigma Master Black Belt, talks about the challenges a company faces when assessing results on a Certificate of Analysis and the role of FMEA.