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 《ISO/IEC 17025：2005国家食品检测实验室认可》建议书（U18）RFA-FD-12-008 项目摘要 北卡罗来纳州农业和消费者服务部（NCDA&CS），食品和药物 保护司很高兴有机会提交一份项目提案， 维持及加强本署实验所的ISO/IEC 17025认证。 FDPD实验室是NCDA和CS食品和饲料监管计划的服务实验室。的 实验室认证使食品计划能够满足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 饲料检测认证要求。 FDPD实验室有一个坚实的程序，以维持认证。质量 经理和她的工作人员为所有实验室的质量管理小组会议提供便利，每两周召开一次会议 主管，与质量管理委员会进行季度管理审查，几乎每月一次 内部审计，所有这些都有助于就实验室发生的事情以及 我们需要工作质量经理和工作人员刚刚完成了9个课程， 培训新员工了解我们的质量管理体系和ISO 17025要求。质量 管理人员指导开发了几个数据库，以管理文件控制和跟踪 培训、能力证明、设备、校准、稽查、NCR、汽车和PAR。 在进行初步认可审核后，化验所在第一年的评估审核中扩大了范围 并在两年内更新审计。在已经将我们的大多数测试方法放在范围内之后， 在我们的食物及饲料测试能力范围内，我们只剩下几种测试方法可供增加。 这些都列在项目提案中。我们将与我们的食品和饲料计划客户合作， FDA将确定我们将在范围中添加哪些测试方法。 在我们的项目中提出的主要和最耗时的增强是一个灵活的范围， GCMS和LCMS。灵活的范围将允许实验室为我们的客户提供认可的数据 用于更广泛的基质和分析物。根据我们对A2 LA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 组在本项目中，我们要求一名化学家协助验证研究，沿着 与保持认证一致的其他职责。 实验室将作为另一个国家实验室的导师，继续参与FERN，参加 会议和培训，并根据FDA指南提供项目成果报告。 第1页第1页

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