Official MethodsSM: Conformity Assessment and Standards Development
Valuable opportunities exist for AOAC members and customers to submit urgently needed methods for consideration as First Action Official Methods of AnalysisSM (OMA). The process of methods entering AOAC through stakeholder activity has proven to be highly successful. Since its implementation in 2011, the stakeholder process has resulted in over 20 new and modern methods now available to the infant formula, food, and veterinary drug residues communities—a number not seen since the early 1990s.
In addition to the stakeholder process, methods can enter the Official MethodsSM system through the AOAC Research Institute as part of the harmonized Performance Tested MethodsSM (PTM)/OMA Program or as single-source methods.
"AOAC is responding to members' varying needs and offering pathways to OMA status for virtually all methods submitted to AOAC for consideration," said Stan Bacler, Health Canada and president of AOAC. “This process addresses the diverse interests of our stakeholders who need to have methods with Official MethodsSM status."
AOAC is a leader in standards development, best known for its Official MethodsSM. As such, AOAC focuses exclusively on development of voluntary consensus standards and the adoption of Official MethodsSM by properly vetted expert review panels (ERPs). ERPs judge methods against consensus-developed standard method performance requirements (SMPRs) as approved by AOAC stakeholder panels. This process, adopted by the Board of Directors in March 2011, has formerly been referred to as the "alternative pathway."
AOAC encourages methods to be submitted through the stakeholder process. These methods address an urgent need of a significant number of stakeholders. Perhaps the most important benefit of this approach is that it opens up many new—and higher level--opportunities for members and volunteers to do what they are truly passionate about--propose methods, identify priorities and issues, and find the best science. Serve as a working group member or on an ERP to evaluate methods for possible First Action adoption. AOAC encourages members to participate and find out for themselves that the process is relevant and complete.
Harmonized PTM/OMA Program (Proprietary Methods)
The harmonized PTM/OMA Program is well-defined for proprietary methods. PTM validation studies are harmonized with the AOAC OMA Program, thereby satisfying the requirements for the OMA single-laboratory validation (SLV) study. Methods are evaluated against manufacturers’ claims.
Single-Source Methods (Nonproprietary Methods)
Effective September 7, 2012, and in line with the Association’s focus on standards development activities and AOAC’s future, the Board of Directors consolidated all conformity assessment activities through the AOAC Research Institute, including single-source methods. Although it is highly encouraged that method authors submit through the stakeholder process whereby methods are judged against consensus-developed SMPRs, the Board of Directors determined that a single-source pathway still meets the needs of some members.
Single-source methods (for example, those from an individual method author/developer) in process, or any new single-source methods, will now proceed through the AOAC Research Institute for Official MethodsSM status. The AOAC Research Institute will continue to facilitate the PTM Program. Nonproprietary methods will be judged against their scope and applicability statements.
Method authors will have access to ERPs for guidance at any stage in the process to help ensure that methods provide the best science. In addition, the AOAC Research Institute offers consulting services designed to provide complete individualized validation outlines, for example, testing protocols, acceptance criteria, etc.
To further ensure a successful study, AOAC encourages method submitters to make full use of the various validation guidelines available as appendices in the Official Methods of Analysis (19th Edition print and online products). These guidelines include validation of microbiological methods for foods and environmental surfaces, validation of dietary supplements and botanicals, SLV of infant formula and adult nutritionals, and community guidance on validation of food allergens.
To help meet members’ and customers’ different needs, AOAC offers various approaches to submit methods to achieve Official MethodsSM status. Resources are available to provide method developers with the information and processes needed to submit a promising method for AOAC consideration. Whether the outcome is a standard, PTM, or OMA, the process is transparent and impartial.
Figure 1. Process flowchart
For a fee schedule, visit the AOAC website at http://www.aoac.org/testkits/FEESCHEDv2_(2).pdf