2014 ERP New Member Book

FIRSTACTIONTOFINALACTIONMETHODS

GUIDANCEFORAOACEXPERTREVIEWPANELS

Expert ReviewPanelsworkingwithin theAOAC alternate pathway processmay recommend a First Action statusmethod be elevated toFinal Action status. Such a recommendation leverages theERP’s high level of expertise supported by data from the initial evaluation, and results from the subsequent two yearmethod performance evaluation period. TheOfficialMethodsBoard receives the recommendationwith supporting documentation, and determines if Final Action status iswarranted. OMB’s review verifies themethod processwas conducted in compliancewith the guidelines and protocols of theAssociation. For transparency and to expedite the review process, themain areasOMBwill reviewwhen evaluating ERP recommendations topromotemethods toFinal Action are listed below. Documentation of the areas listed belowwill also increase confidence inmethodperformance and assist users to properly and safely perform themethods at their locations. A. MethodApplicability a. Amethod’s applicability to the identifiedStakeholder needs is best assessed by the Stakeholder Panel and should be a part of the process from the onset. OMB liaisonswill remindStakeholder Panels tomaintain this focus point. b. OMBmay askERPs andStakeholder Panels for feedback to improve the applicability of themethod such as potentialmethod scope expansions and potential points of concern. B. SafetyConcerns a. A safety reviewmust be performed for amethod to be recognized as First Action. b. All safety concerns identified during the 2year evaluation periodmust be addressed. c. Guidance and support canbe obtained from theAOACSafetyCommittee. C. ReferenceMaterials a. Document efforts undertaken to locate referencematerials. Methodsmay still progress to Final Action even if referencematerials are not available. b. Guidance and support canbe obtained from theAOACTechnical Division onReference Materials. D. SingleLaboratoryValidation a. Data demonstratingResponseLinearity, Accuracy, Repeatability, LOD/LOQ, andMatrix Scopemust be present. Experimental designs to collect this datamay varywith the method protocol and the intended use of themethod.

Effectiveas of February 1, 2012