North Carolina Department of Agriculture & Consumer Services April 2012 Proposal for ISO/IEC 17025:2005 Accreditation for State Food Testing Laboratories (U18) RFA-FD-12-008 Project Summary The North Carolina Department of Agriculture & Consumer Services (NCDA&CS), Food & Drug Protection Division (FDPD) is pleased to have the opportunity to submit a project proposal for the maintenance and enhancement of our Laboratory accreditation to ISO/IEC 17025. The FDPD Laboratory is the servicing lab for the NCDA&CS Food and Feed Regulatory Programs. The Laboratory accreditation allows the Food Program to meet the MFRPS Standard 10 requirements. For the Feed Program, our Laboratory accreditation enables that Program to be ready for any future requirements for accreditation for feed testing. The FDPD Laboratory has a solid process established for maintenance of accreditation. The Quality Manager and her staff facilitate bi-weekly Quality Management Team meetings for all Laboratory Supervisors, quarterly Management Reviews with the Quality Management Board, and almost monthly internal audits, all of which provide facilitate communication on what is happening in the lab and where we need to work. The Quality Manager and staff have just completed a nine session curriculum for training new employees on our quality management system and ISO 17025 requirements. The Quality Manager has guided development of several databases to manage document control and to track training, demonstrations of competency, equipment, calibrations, audits, NCRs, CARs and PARs. After the initial accreditation audit, the Laboratory enhanced scope during the year one assessment audit and during the year two renewal audit. Having placed the majority of our test methods in scope already, we have only a few remaining test methods within our food and feed testing capability to add to scope. Those are listed in the project proposal. We will work with our Food and Feed Program customers and FDA to determine which of those test methods we will add to scope. The primary and most time consuming enhancement proposed in our project is a flexible scope for GCMS and LCMS. Flexible scope will allow the Laboratory to provide our customers with accredited data for a broader range of matrices and analytes. Per our understanding from A2LA on the required data to support a flexible scope, we have a lot of work to complete to develop validation packages by food groups. In this project we have requested a Chemist who will assist with the validation studies, along with other duties aligned with maintenance of accreditation. The Laboratory will serve as a mentor to another state laboratory, maintain participation in FERN, attend meetings and training, and provide reports on project accomplishments per FDA guidance. Pag 1 o 1
North Carolina Department of Agriculture & Consumer Services April 2012 Proposal for 'ISO/IEC 17025:2005 Accreditation for State Food Testing Laboratories' (U18) RFA-FD-12-008 PROJECT NARRATIVE One of the main goals of the Food Safety Modernization Act is achieving a nationally integrated food safety system. In order to achieve this goal, Microbiological and Chemical food analyses that are performed on behalf of State Manufactured Food Regulatory Programs need to be conducted within the scope of an ISO/IEC 17025:2005 accredited laboratory. To accomplish this goal, the primary food testing laboratories for State manufactured food regulatory programs should achieve and maintain ISO/IEC 17025:2005 laboratory accreditation. North Carolina, which has already achieved accreditation to ISO/IEC 17025:2005, will prepare for accreditation enhancements (flexible scope), expand scope through additional test methods added to scope, and continue to fund elements of accreditation requirements. Increasing our laboratory's accredited scope, as would be accomplished through this cooperative agreement, will in effect serve to increase the analytical capacity for FDA and enhance efforts to protect the food supply. Data generated by our laboratory will be made available for consideration of FDA enforcement actions as well as for surveillance purposes and during response to foodborne outbreaks through eLEXNET. North Carolina's manufactured food regulatory program has already achieved conformance with the Manufactured Food Regulatory Program Standards (MFRPS). As the servicing lab for North Carolina's food regulatory program, our continued accreditation to ISO/IEC 17025:2005 will help the food regulatory program maintain its conformance with MFRPS. Pag 1 o 1
