AOAC® Official MethodsSM Program
The Official Methods of AnalysisSM (OMA) program is AOAC INTERNATIONAL's premier methods program. The program evaluates chemistry, microbiology, and molecular biology methods. It also evaluates traditional benchtop methods, instrumental methods, and proprietary, commercial, and/or alternative methods. In 2011, AOAC augmented the Official MethodsSM program by including an approach to First Action Official MethodsSM status that relies on gathering the experts to develop voluntary consensus standards, followed by collective expert judgment of methods using the adopted standards.
The OMA program has undergone a series of transitions in support of AOAC's collaborations, evolving technology, and evolving technical requirements. Methods approved in this program have undergone rigorous scientific and systematic scrutiny such that analytical results by methods in the Official Methods of Analysis of AOAC INTERNATIONAL are deemed to be highly credible and defensible.
OMA program elements include method submission, expert review, and approval and publication of methods.
AOAC offers three modes of entry for methods to be evaluated in the Official MethodsSM program:
(1) Methods may be submitted to AOAC INTERNATIONAL in response to an AOAC-issued call for methods or in response to an existing standard method performance requirement (SMPR). Details on this process are located in Appendix F.
(2) Methods certified as Performance TestedSM may be submitted into the program in the AOAC Research Institute.
(3) Methods from a single source may be submitted into the program in the AOAC Research Institute.
Expert Review of Methods
(1) Expert review panels (ERPs) will be convened to review methods submitted.
(2) ERPs will convene during the AOAC Annual Meeting and during the AOAC Mid-Year Meeting to review methods for First Action status, to review methods with feedback or new information, and to review methods regarding Final Action status. The AOAC policy on voting by the ERP is in Appendix G.
(3) ERPs review First Action status methods for a maximum of 2 years, followed by a recommendation to the Official Methods Board (OMB) for promotion to Final Action status or to repeal the method.
(4) OMB reviews recommendations from the ERPs regarding Final Action status of a method.
Approval and Publication of Methods
(1) All method submitters will receive notification of the approval status.
(2) AOAC staff coordinates the drafting of both the method and manuscript into AOAC format (see Appendix G) for those methods which an ERP adopts as First Action OMA using SMPRs and were submitted in response to an issued call for methods or to existing SMPRs.
(3) Methods submitted to the AOAC Research Institute will be in AOAC format for submission.
(4) All approved methods will be issued an OMA number and published in the Official Methods of Analysis of AOAC INTERNATIONAL and in the Journal of AOAC INTERNATIONAL.
An audit of documented technical resources provided through the volunteer efforts of Association membership represents changing times. The OMA program has a number of technical requirements depending on the type of method, the community represented by developers, and users of the method. Method manuscripts submitted to the AOAC Research Institute for Official MethodsSM consideration require demonstrated and characterized performance data (e.g., single-laboratory validation) and demonstrated reproducibility data. All methods and manuscripts must be written in AOAC format.
As such, the Official Methods of Analysis of AOAC INTERNATIONAL has a collection of appendices that serves as a resource to method developers and users alike. The appendices include a style guide and guidance documents to develop, optimize, and evaluate methods. Appendix D provides the general requirements for chemistry quantitative methods. Appendix J provides the general requirements for microbiology methods. The AOAC Research Institute has a protocol development service known as the "Consulting Service" wherein validation outlines that include acceptable AOAC testing protocols are developed. Review the appendices for specific guidance information.
Method manuscripts submitted to AOAC INTERNATIONAL in response to an AOAC-issued call for methods or in response to an existing SMPR should adhere to the requirements detailed in the call for methods or in the SMPRs. Since standards are in development, refer to the AOAC website for the latest information.
There is a section in the OMA that consists of the voluntary consensus SMPRs developed since 2009. This information provides specific criteria for method developers for methods with specific intended use for specific communities. Review this section to determine if any of the standards may be relevant to your specific method.
All of AOAC INTERNATIONAL's standards development activities and methods work is done by dedicated volunteers. An overview of these volunteer roles is below; however, additional information is located on the AOAC website.
(1) Stakeholder panel chair and members review and adopt voluntary consensus standards.
(2) Working group chair and members develop and recommend draft standards to the stakeholder panel for deliberation and adoption.
(3) ERP chair and members review and adopt AOAC First Action Official Methods of AnalysisSM. The ERP tracks and reviews feedback on Official MethodsSM between First Action and Final Action status. ERPs make recommendations to the OMB on Final Action or Repeal status of First Action methods.
(4) Committee on Safety chair and members serve as technical advisors on method safety.
(5) Committee on Statistics chair and members serve as technical advisors on statistical analysis of data.
(6) OMB chair and members are engaged throughout the standards development and methods approval process. The OMB is responsible for vetting and approving stakeholder panel representative voting members, ERPs, and members for the Committees on Safety and Statistics; reviewing and approving recommendations for Final Action or Repeal status for Official MethodsSM; and recommending and implementing AOAC policies.
METHOD DESIGNATION-FIRST ACTION AND FINAL ACTION
Official MethodsSM remain as First Action for a period of about 2 years. During the First Action period, the method will be used in laboratories, and method users will be asked to provide feedback on the performance of the method.
After a method has been adopted as First Action, ERPs are responsible for tracking the use of and experience with the First Action Official MethodSM. The presiding ERP will monitor the performance of the method, and, at the completion of the 2-year First Action evaluation period, determine whether the method should be recommended to the OMB for adoption as an AOAC Final Action Official MethodSM.
It is also possible that First Action Official MethodsSM are not recommended for Final Action. There are two possibilities for an ERP to decide not to proceed with a First Action method. The first reason is that the feedback from method users indicates that a First Action method is not performing as well in the field as was expected. The second possibility is that another method with better performance characteristics has been developed and reviewed. In either case, the ERP may choose to repeal the First Action status of a method.
All changes in method status and changes in status of standards are announced in the AOAC Inside Laboratory Management magazine. Changes in method status are also recorded in the Official Methods of Analysis of AOAC INTERNATIONAL.
HOW TO GET STARTED
If you are embarking on your initial experience to the AOAC INTERNATIONAL standards development and methods approval process or if you have questions, contact an AOAC INTERNATIONAL executive for scientific and business development:
2275 Research Boulevard, Suite 300
Rockville, MD 20850, USA
Tel: +1-301-924-7077 (Worldwide)
E-mail: [email protected]
Web site: http://www.aoac.org