OMB Meeting Book (June 25-26, 2015)

Members of the Committee on Statistics did participate as observers during the discussions on 1 developing general SLV protocol guidance.

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REPRODUCIBILITY/UNCERTAINTY: 4 A. For quantitative methods, data demonstrating Reproducibility & Uncertainty must be present. 5 Experimental designs to collect this data may vary with the method protocol, available laboratories, 6 and the intended use of the method (i.e., collaborative studies, proficiency testing, etc…) 7 8 The ERP reviewed data statistical sheets 12 with multi-laboratory testing data for AOAC 2012.16. The data 9 was collected using a general multi-laboratory protocol has been established by the method authors, 10 ERP chair and OMB liaison to SPIFAN ERP. Method authors drafted their own testing protocols and 11 these were forwarded to the ERP chair and the OMB liaison for their input and comments. The multi- 12 laboratory study results were submitted for the ERP’s consideration during their March 2015 meeting. 13 B. Guidance and support can be obtained from the AOAC Committee on Statistics. 14 15 The OMB liaison served as facilitator by working with both members of the AOAC Committee on 16 Statistics and the method author to ensure a sound study design for the multi-laboratory testing and to 17 ensure the appropriate statistical tools were available to analyze the data. Since this method will be 18 reviewed within ISO and IDF, members of the AOAC Committee on Statistics also reviewed the statistical 19 tool with respect to ISO standards for methods. 22 A. Document method performance versus SMPR criteria. Note which SMPR criteria are met. For SMPR 23 criteria not met, the ERP documents the reasoning why the method is still acceptable. 24 25 The draft SMPR 13 was presented and approved in 2012 by AOAC SPIFAN. The ERP found that the 26 method did meet the SMPR method performance criteria satisfactorily in their collective judgment. The 27 two parameters of AOAC SMPR 2012.009 that were not met by the method at the time it was adopted 28 for First Action OMA status included reproducibility and use of the stated reference material, NIST SRM 29 1849a. The ERP were satisfied that these would be addressed in the multi-laboratory testing for AOAC 30 12 AOAC 2012.16 multi-laboratory testing data summary reports 13 Pan, Shang-Jing, Approval of SMPR for Pantothenic Acid (2012) AOAC SPIFAN Meeting – AOAC Annual Meeting, September 29, 2012. 20 21 COMPARISON TO SMPR:

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