© 2012AOAC INTERNATIONAL
AOACO
FFICIAL
M
ETHODS
OF
A
NALYSIS
(2012)
V
OLUNTARY
C
ONSENSUS
S
TANDARDS
AppendixG, p. 3
FirstAction toFinalActionMethods:
Guidance forAOACExpert ReviewPanels
InDecember2011, theOfficialMethodsBoard (OMB) approved
a guidance document for ERPs to support their work as they
deliberate on methods, adopt methods as Official First Action,
and, subsequently, track method usage and performance between
FirstAction statusandFinalActionconsideration. Theguideline is
basedonparameters of amethod that theOMBwill considerwhen
deliberating on methods recommended for Final Action status.
ERPs are to use this guideline in their deliberations.
ERPs working within the AOAC process may recommend a
FirstAction statusmethod be elevated toFinalAction status. Such
a recommendation leverages the ERP’s high level of expertise
supported by data from the initial evaluation, and results from the
subsequent 2-yearmethod performance evaluation period.
The OMB receives the recommendation with supporting
documentation, and determines if FinalAction status iswarranted.
OMB’s review verifies the method process was conducted in
compliancewith the guidelines and protocols of theAssociation.
For transparency and to expedite the review process, the main
areasOMBwill reviewwhen evaluatingERP recommendations to
promotemethods to FinalAction are listed below. Documentation
of the areas listed belowwill also increase confidence in method
performance and assist users to properly and safely perform the
methods at their locations.
A. MethodApplicability
(
a
) Amethod’s applicability to the identified stakeholder needs
is best assessed by the stakeholder panel and should be a part of
the process from the onset. OMB liaisons will remind stakeholder
panels tomaintain this focus point.
(
b
) OMBmay askERPs and stakeholder panels for feedback to
improve the applicability of themethod, such as potential method
scope expansions and potential points of concern.
B. SafetyConcerns
(
a
) A safety review must be performed for a method to be
recognized as FirstAction.
(
b
) All safety concerns identified during the 2-year evaluation
periodmust be addressed.
(
c
) Guidance and support can be obtained from the AOAC
SafetyCommittee.
C. ReferenceMaterials
(
a
) Document efforts undertaken to locate reference materials.
Methods may still progress to Final Action even if reference
materials are not available.
(
b
) Guidance and support can be obtained from the AOAC
TechnicalDivision onReferenceMaterials.
D. Single-LaboratoryValidation
(
a
) Data demonstrating response linearity, accuracy,
repeatability, LOD/LOQ, and matrix scope must be present.
Experimental designs to collect this datamayvarywith themethod
protocol and the intended use of themethod.
(
b
) Resources can be identified by the AOAC Statistics
Committee.
E. Reproducibility/Uncertainty andProbabilityof Detection
(
a
) Forquantitativemethods,datademonstratingreproducibility
and uncertainty must be present. Experimental designs to collect
thisdatamayvarywith themethodprotocol, available laboratories,
and the intended use of the method (i.e., collaborative studies,
proficiency testing, etc.).
(
b
) Forqualitativemethods, datamust bepresent demonstrating
the probability of detection at specified concentration levels as
defined by the SMPR. Experimental designs to collect this data
may varywith themethod protocol, available laboratories, and the
intended use of themethod.
(
c
) Guidance and support can be obtained from the AOAC
StatisticsCommittee.
F. Comparison toSMPR
(
a
) Documentmethodperformance versus SMPR criteria.Note
whichSMPR criteria aremet. For SMPR criteria notmet, theERP
documents the reasoningwhy themethod is still acceptable.
(
b
) Data is present to assure the matrix and analyte scopes are
covered. This is critical formethods used for dispute resolutions.
G. Feedback fromUsersofMethod
(
a
) Document positive and negative feedback from users of the
method during the trial period.
(
b
) Feedback from users demonstrating method ruggedness
should be documented.
(
c
) Assess the future availability of vital equipment, reference
materials, and supplies.
H. ERPRecommendations toRepeal FirstActionMethods
Recommendations to repeal First Action methods shall be
accompaniedwith detailed reasons for the decision.
TheFirst toFinal Action guidance for ERPswas approved by the
OMB inDecember 2011 and effective as of February 1, 2012.
