2014 ERP New Member Book

The basic requirements for selection ofmethods for further validation studieswill be: fitness for purpose, applicability to the scope needed, clarityofmethod description, satisfactoryperformance characteristics, and single laboratoryvalidation data. To assist thePanel, theAOACwill provide a “Methods SelectionWorksheet,”whichmaybe modified at the discretion of theERP. ERPmemberswill identify the bestmethod(s) for further validation, and identify anymodifications to bemade to themethod. An example of theMethodSelectionWorksheet is attached. Samples: TheERPwill be asked to recommend the specificmaterials (matrices) to be included in the subsequent validation studies, alongwith detailed justifications. SummaryReport: TheChair of theERP prepares aSummaryReport clearly enunciating the recommendations of thePanel, themanner inwhich these conclusionswere reached, anymodifications of themethod(s) chosen, and thematerials (matrices) to be included in the validation studies. The report is to be submitted to theERP in a timely fashion after the concludingERPmeeting. Comments are also due back to theERPChair in a timely fashion. The report is then sent to the stakeholders and a copy is forwarded to theChair of theOMB. Post-ERPActivities: AOAC retains the right to call on the panelists, aswell asmembers of the IndustryGroups, for continued assistance in the subsequent validation studies. Thismay include (1) help in obtaining the required samples for use in the subsequent validation studies, aswell as participating laboratories; (2) help in developing and reviewing the validation studyprotocols; and (3) help in reviewing the data resulting from the validation studies and reviewing themanuscript describing the results. These activitieswill be coordinated by theCSO.

MethodSelectionWorksheet

MethodTitle: MethodNumber: Overall evaluation score (1being lowest, 10 being highest): Additional Factors toConsider:

Recommendation: Signature (date):

ApprovedbyOfficialMethods Board, November 13, 2008 ApprovedbyAOACBoardof Directors, December 9, 2008 AppealsProcessAppended–September 2009 RevisedbyAOACBoardof Directors,May 25, 2011

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