AOAC ISPAM Quant. Micro Acceptance Criteria 6-28-18

AOAC ISPAM – Working Group on Microbiological Quantitative Statistics

Overview

Current Issues ƒ No acceptance criteria set for valid data for • Difference of Means

• 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 a statistical workbook that can provide all statistical analysis data ƒ Need further guidance for method developers/contract labs/industry on what is required, what the results mean, and are they acceptable