Preventive Controls Implementation Expansion in North Carolina.

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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.