ApprovedbyOfficialMethods Board, November 13, 2008
ApprovedbyAOACBoardof Directors, December 9, 2008
AppealsProcessAppended–September 2009
RevisedbyAOACBoardof Directors,May 25, 2011
Page 4 of 6
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):
