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Last updated (December 2012)

 

Steps of Certification


Step 1:
Request Application

The first step in the process is to obtain an Application Package from the AOAC-RI. This package contains information about the program, what types of data are required, application fees, and the agreements (downloadable forms). Our Coordinator will help guide you through what is needed along with the advantages of speaking further with one of our outstanding Consultants. Please call: +301-924-7077 x129.

Step 2: Submit Performance Data
Manufacturers are required to collect and submit data to the AOAC-RI that supports the product performance claims of the test kit. This data should follow the guideline of the Data Submission Requirement documents and be submitted in a method validation report format. In addition, the manufacturer must submit QA/QC information, package insert/user manuals, fee, and application.

Step 3: Review of Submitted Data
Usually two Expert Reviewers are recruited and one General Referee (selected by the AOAC-RI) review the performance data collected and submitted by the mehtod manufacturer. The Expert Reviewers and the General Referee first evaluate the product descriptive inserts to determine the completeness of the inserts and to determine the exact performance claims made for the method. Tthe Expert Reviewers and the General Referee will then evaluate the submitted performance data to determine whether or not the data supports the product.

Step 4: Development of Independent Testing Lab Protocols
After the Expert Reviewers and General Referee have determined the adequacy of the product descriptive inserts, and confirmed that the submitted data supports the product performance claims, the Expert Reviewers and General Referee develop a testing protocol for the Independent Testing Laboratory (selected by the AOAC-RI) to conduct additional performance testing of the method.

Step 5: Independent Testing
Methods, samples and the testing protocol developed by the Expert Reviewers and the General Referee are forwarded to the Independent Testing Laboratory, who then conducts additional performance testing of the method.

Step 6: Review of Independent Testing Lab Data
The data generated by the Independent Testing Lab is sent to the AOAC-RI, and then distributed back to the Expert Reviewers and the General Referee. The Expert Reviewers and the General Referee then review the data generated by the Independent Testing Lab to determine whether or not this data corroborates with the data originally submitted by the manufacturer.

Step 7: Recommendation
If the Expert Reviewers and the General Referee determine that the Independent Testing Lab data corroborates with the manufacturer's submitted data and the product descriptive inserts adequately describe the product performance, then a recommendation is made to grant Performance Tested Methodssm status to the test kit, and the kit manufacturer is licensed to use the certification mark for one year.

APPROVAL

Publication
Successful method certifications will be announced in the AOAC magazine, Inside Laboratory Management (ILM), with selected portions of the performance data of the test kit published. A more complete method validation report describing the method and the evaluation is published in the Journal of the AOAC INTERNATIONAL.

Annual Renewal
Performance Tested Methodssm status must be renewed on an annual basis. AOAC-RI reviews the method's package insert and user manual to ensure that the kit still conforms to the previously granted Performance Tested Methodssm certification. The manufacturer must inform the AOAC-RI immediatley if changes have been made to the method, package insert, manufacturing and/or quality assurance programs since originally receiving Performance Tested Methodssm status. This annual review ensures that no changes have occurred in the method that may adversely affect the performance of the method and ensures that the package inserts and user manual remain accurate, thus providing the end-user with the confidence of maintaning consistency in the method.

Changes in the Test Kit
It is the method manufacturer's contractual obligation to immediately notify the AOAC-RI if and when any changes are made to: (1) the instructions for using the kit or (2) the kit's performance. Failure to promptly notify the AOAC-RI of kit changes may result in cancellation of the Performance Tested Methodssm certificate. If changes are made in the method, the submission of new performance data similar to the original data package must be provided. When the AOAC-RI receives notice of a method change, the managing director, generally in consultation with appropriate experts, will determine if the changes are of sufficient magnitude to warrant a complete re-evaluation of the method. If so, the applicant of record must submit a complete application with the corresponding fee.

Complaints
The manufacturer must maintain a record of complaints and their resolution, which will be made available to the AOAC-RI on request. Failure to adequately address user complaints will result in the AOAC-RI initiating an inquiry and could lead to cancellation of themethod's Performance Tested Methodssm status.





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