North Carolina ISO/IEC 17025:2005 Accreditation for State Food Testing Laboratori

北卡罗来纳州农业和消费者服务部，2012年4月 对《国家食品检测实验室认可标准》(U18)RFA-FD-12-008ISO/IEC2005的建议 项目摘要 北卡罗来纳州农业和消费者服务部(NCDA&CS)，食品和药品 保护司(FDPD)很高兴有机会为 维持和加强我们的实验室认证，使其符合国际标准化组织/国际电工委员会17025标准。 食品和药物管理局实验室是NCDA&CS食品和饲料监管计划的服务实验室。这个 实验室认证使食品计划符合MFRPS标准10的要求。为 饲料计划，我们的实验室认证使该计划能够为任何未来做好准备 饲料检验的认可要求。 FDPD实验室为维持认证建立了一套坚实的程序。质量 经理和她的工作人员协助所有实验室召开每两周一次的质量管理小组会议 主管，与质量管理委员会进行季度管理评审，几乎每月一次 内部审计，所有这些都提供了关于实验室正在发生的事情以及在哪里进行沟通的便利 我们需要工作。质量经理和工作人员刚刚完成了九节课的课程 对新员工进行质量管理体系和国际标准化组织17025要求的培训。质量 经理指导了几个数据库的开发，以管理文档控制和跟踪 培训、能力演示、设备、校准、审计、NCR、CAR和PAR。 在初步认证审计之后，实验室在第一年的评估审计期间扩大了范围 在第二年的续签审计期间。在已经将我们的大多数测试方法放在范围内之后， 在我们的食品和饲料测试能力范围内，我们只有几种剩余的测试方法可以增加。 这些都列在项目建议书中。我们将与我们的食品和饲料计划客户合作 FDA决定我们将增加哪些测试方法到范围内。 在我们的项目中提出的主要和最耗时的增强是灵活的范围，用于 GCMS和LCMS。灵活的范围将允许实验室向我们的客户提供经认可的数据 适用于更广泛的矩阵和分析物。根据我们对A2LA关于所需数据的理解 支持灵活的范围，我们有很多工作要完成，以开发食品验证包 组。在这个项目中，我们要求一位化学家协助验证研究，以及 与保持认证相一致的其他职责。 该实验室将作为另一个州立实验室的导师，保持对FERN的参与，参加 会议和培训，并根据FDA的指导提供项目成果报告。 PAG 1 0 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 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