AOAC ISPAM Stakeholder Panel Meeting Book 3-13-18

AOAC ISPAMWorking Group on Quantitative Microbiology Methods Acceptance Criteria The working group/stakeholder panel developed the fitness-for-purpose statement: The Working Group Co-Chairs, Patrick Bird and Patrice Arbault provided an overview of the current challenges with the Quantitative Statistics in AOAC Appendix J Guidelines. Several examples were presented for discussion. To develop statistical tools and acceptance criteria of quantitative microbiological methods that will balance the goals of: 1. Minimizing the chance of accepting a method that is not fit for purpose 2. While maximizing the chance of accepting a method that is fit for purpose 3. Providing guidance on relevance of deviations Current Issues ƒ Guidelines indicated only Valid data should be included! What does valid mean? ƒ No acceptance criteria set for valid data for • Difference of Means · Determined through CI’s or set value? • Number of Acceptable Deviations per Validation · i.e. # of out of range levels per assay (1 per every 2-3 matrix?) • Determine Limits for # of acceptable “0” data points for low contamination levels ƒ Need for approval of updated statistical workbook and further guidance that covers all statistical analysis in Appendix J Motion: Michael Farrow moved and Virendra Gohil second to endorse the fitness for purpose statement with the changes: Motion passed.