Statistics Meeting Book (May 23, 2018)

AOAC International Committee on Statistics Draft Minutes Present: Sidney Sudberg, Chair, Alkemist Labs Qian F. Graves, FDA Paul Wehling, Medallion Labs Robert A. LaBudde, Least Cost Solutions Jim Yuk, Waters (?) Hilde Skaar Norli, Norwegian Veterinary Institute (Minutes-taker) AOAC Staff: Deborah McKenzie - Delia A. Boyd - Scott Coates Item # Discussion /Action Item

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Welcome and Introduction We thought we had no quorum, but we had. Please introduce yourself when joining the meeting.

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Minutes from 04/18/2018 – No quorum

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Current Method Conformity Assessment Projects

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Changes to Annex J Qualitative Methods & Quantitative Methods

Paul has worked on recommendations for changes to Annex J to OMB. Paul was requested to compile the suggestions and to forward it to Sidney/Delia for distribution to the statistical committee members. The stat members should comment on the suggestions and discuss the recommendations at the next meeting. When agreed upon, the recommendations are forwarded OMB. ISPAM – Acceptance Criteria for Quantitative Methods There is a need for acceptance criteria for quantitative methods (AL 0.5 log cfu – often used), and the stat committee in ISPAM under the lead of Paul will be brought to life again. Sidney, Robert, Hilde and possible others are interested in contributing. Paul forwards draft suggestion to interested party. Statistic Committee’s Terms of Reference (ToR) Update The committee members and the OMB have agreed upon the ToR. The OMB had some minor editorial changes. The ToR will be forwarded for the BOD for voting in June. Bimonthly statistical articles in ILM – “Random Thoughts” Robert will publish the first article: “Providing the statistical equivalency of a Candidate method to a Reference method using a collaborative study” For input to articles in ILS, write Sidney or Delia

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