When Do I Need a Method Verification?

In this age of the Food Safety Modernization Act (FSMA) it is increasingly important that the methods you (or your third-party lab) are using are validated by a recognized organization. Methods contained in the FDA Bacteriological Analytical Manual (FDA-BAM), the USDA-FSIS Microbiology Laboratory Guidebook, as well as methods approved by independent, non-governmental bodies such as AOAC, ISO, MicroVal, and AFNOR are all acceptable methods to meet regulatory standards.Or are they?Take for example when a rapid pathogen detection method is approved for use by AOAC International. To gain this approval the manufacturer of the instrument, test kit, or media must submit their product for an independent laboratory evaluation (AOAC-RI Performance Tested Method) or the more rigorous Official Methods of Analysis (OMA), which involves a multi-lab evaluation and comparison of the proprietary item against an established methodology.  To prove proficiency, the manufacturer of the item will have the validation study performed on several matrices, such as beef, lettuce, non-fat dry milk, stainless steel environmental surfaces, etc., and then be able to claim the item is able to test a wide range or product types. You become aware of this AOAC-approved method, determine it is in your price range and gives you the turn-around time you need to keep inventory low and allow your product to ship on time.(more…)