Preventive Controls Implementation Expansion in North Carolina.

预防控制措施在北卡罗来纳州的实施扩展。

• 批准号: 10173996
• 负责人: Daniel Gaines
• 金额: $ 15万
• 依托单位: NC STATE DEPT OF AGRI AND CONSUMER SERV
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10173996
• 关键词: Preventive; Controls; Implementation; Expansion; North

Project Summary/Abstract – Preventive Controls Implementation Expansion in North Carolina The Preventive Controls Implementation Expansion Supplement is intended to augment the current processes and procedures in place for training, auditing, program improvement, infrastructure development, PC inspection, compliance implementation strategies, legislative research, rulemaking, policy analysis, outreach, joint work planning, and enforcement. The goal for training is to continue developing a fully trained staff to conduct preventive control (PC) inspections. This will be accomplished by hiring a training/outreach coordinator to provide risk based inspection methodology training to the field inspection staff. The goal for the auditing is to maintain consistency and proficiency in conducting PC inspections. This will be accomplished by incorporating PC audits into existing Manufactured Food Regulatory Program Standard (MFRPS) Standard 4 – Inspection Audit Program. Program Improvement and Infrastructure development will be evaluated during the 3 year grant period to determine if enhancements are needed to equipment and/or IT processes. The goals for PC inspection and compliance implementation strategies are to incrementally increase contract and initiate non-contract PC inspections. This will be accomplished by utilizing the training/outreach coordinator to teach the field staff risk based preventive controls methodology for conducting PC inspections. The compliance specialist would serve as an internal compliance specialist for PC inspections and external resource for industry. A workgroup will be developed to evaluate the feasibility and resources needed to adopt the Intentional Adulteration and Sanitary Transportation rules within the 3 year grant period to address legislative research, rulemaking, and policy analysis section. The goals for outreach are to educate the small and medium firms regarding the PC rule and inspection compliance with firms under inspection. The training/outreach coordinator will provide training on the PC rule to small and medium industry firms. The compliance specialist will provide guidance information for industry regarding critical and chronic violations documented on observation sheets during PC inspections. Joint workplanning and enforcement activities between NCDA&CS FDPD and FDA are collaborative efforts and will be realized through formal and informal communications. These communications will address contract expectations, joint inspection planning, joint complaint follow up and other PC related situations regarding the interest of public health safety.

项目概要/摘要-北部预防控制实施扩展 卡罗莱纳 预防控制实施扩展补充旨在增强 培训、审计、项目改进的现行流程和程序， 基础设施开发、PC检查、合规实施策略、立法 研究、规则制定、政策分析、外联、联合工作规划和执行。目标 培训的目的是继续培养一支训练有素的人员进行预防控制（PC） 巡视为此，将雇用一名培训/外联协调员， 对实地检查人员进行基于检查方法的培训。审计的目标是 在进行PC检查时保持一致性和熟练性。这将是完成 通过将PC审核纳入现有的制造食品监管计划标准 （MFRPS）标准4 -检查审核计划。项目改进和基础设施 开发将在3年的赠款期内进行评估，以确定是否增强 设备和/或IT流程所需。PC检查和合规性的目标 实施战略是逐步增加合同和启动非合同PC 巡视这将通过利用培训/外联协调员教授 外地工作人员基于风险的预防性控制方法进行PC检查。的 合规专家将担任PC检查的内部合规专家， 工业的外部资源。将制定一项战略，以评估可行性， 采取故意掺假和卫生运输规则所需的资源， 3年的赠款期，以解决立法研究，规则制定和政策分析部分。 外联的目标是教育中小公司有关PC规则， 检查受检查公司的遵守情况。培训/外联协调员将提供 向中小型工业公司提供关于PC规则的培训。合规专员将 就记录的严重和长期违规行为为行业提供指导信息 在PC检查期间的观察表上。联合工作规划和执法活动 NCDA和CS之间的FDPD和FDA是合作的努力，将通过正式的 非正式沟通。这些沟通将解决合同期望、联合 检查计划，联合投诉跟进和其他PC相关情况， 公共卫生安全利益。