Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMB Meeting 4-11-2019 Pre-read Materials

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AOAC  Reviewed and Recognized P rogram   Policies and Procedures 

requested from the AOAC RI Manager or obtained online at  http://www.aoac.org/testkits/testkits.html . 

Reviewed and Recognized application packages for Application Note evaluations must  contain the following:  Completed AOAC Reviewed and Recognized Review Application Form (Appendix 5) [to be added later] Signed AOAC Reviewed and Recognized Review Agreement (Appendix 6) [to be added later] Manufacturing Quality Assurance program description or copy of International Organization for Standardization‐ ISO 17025 certificate. Technology providers are encouraged to recommend potential Expert Reviewers.   However, the AOAC RI is not obligated to accept the recommendations of the  Technology Provider.  The Expert Reviewers cannot relate to the Technology Provider or  related entities in any way, other than as a customer.    1) 2) 3) 4) Application Note(s)

Electronic applications are preferred. Send electronic applications to aoacri@aoac.org .   

5.2.1 AOAC Reviewed and Recognized Application Review: 

The AOAC Reviewed and Recognized Application package will be reviewed for  completeness by AOAC RI staff.  An acknowledgement letter, checklist review,  and an invoice will be sent to the Technology Provider within two business days  of receiving an application. 

5.2.2 Check List:   The Check List contained in the AOAC Reviewed and Recognized Application  package is intended for use by the Technology Provider and the AOAC RI staff to  determine if the basic submission requirements have been satisfied.  (Appendix  7) [to be added later] 5.2.2 Certification of QA Program and QC Practices:   Technology providers must submit a description of the quality assurance  program and quality control practices used in the manufacturing, production,  storage, and delivery of the Application Note components.   

5.2.3 Project Manager: 

A Project Manager is assigned by the AOAC RI Manager when an AOAC  Reviewed and Recognized application is submitted.  Typically, the Technical  Consultant who provided the Consulting Service is assigned as the Project 

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04/05/2019