Our consultants meet with key stakeholders in your organization to familiarize ourselves with your business operations and existing traceability systems. Then we meet with your executive team onsite to brief them on the FDA’s FSMA 204 Final Food Traceability Rule. This gives your executive leadership – including operations, food safety, IT departments, and legal, regulatory, and compliance specialists – the opportunity to better understand and plan for the rule. Briefing materials are tailored to each group based on roles and responsibilities.

New Era Partners will educate your traceability stakeholders on FDA’s FSMA 204 Final Food Traceability Rule in an interactive, hands-on workshop. We help key personnel understand options for implementing the requirements in your organization. During the workshop, we will conduct hands-on exercises with stakeholders at a client or supplier warehouse or production facility to cement learnings. This also provides a clear understanding of the supply chain data needed to create an electronic sortable spreadsheet as required by FSMA 204.

Our consultants perform remote readiness evaluations of enterprise and supplier operations to assess your preparedness for FDA’s Food Traceability Rule. This includes extraction of existing supply chain data sets to identify key data element (KDE) and critical tracking event (CTE) collection and recording gaps. For complex organizations, additional data collection may be required, including inventory evaluation and sample testing of receiving, shipping, initial packing, and transformation data. Our consultants deliver a visual scorecard that will help you understand how well your internal systems and processes are meeting the FSMA 204 requirements and whether your suppliers are sharing key data. We also provide a roadmap for addressing any gaps.

We assist enterprises on their path to compliance with FSMA 204 by providing personalized guidance on a retainer basis. Consulting areas may include the following and will be based on the individual client’s needs and priorities: