FSMA Rule 204 Enhanced Traceability Compliance

This company manufactures and distributes a number of soft cheeses covered by FSMA Rule 204. Faced with the rapidly approaching deadline, leadership needed a supply chain traceability expert to effectively assess the impacts to their way of doing business and develop potential solutions. They also needed to solve for customer requirements that go beyond Rule 204, e.g., product labeling. Faced with these challenges the company needed traceability and FSMA Rule 204 expertise in order to augment their knowledge and accelerate their program for compliance and traceability investment.

Adapting and tailoring our four phase methodology we applied the Discovery phase. Discovery includes education on traceability and provides clarity on FSMA Rule 204 so managers can make informed decisions. A major activity of Discovery is conducting a comprehensive review of the clients product portfolio, supply chain, overall flow of materials and finished goods, business processes and electronic systems. Discovery uncovers current state capabilities and highlights gaps for future state capabilities. Discovery enables management to confidently move to the Design phase where workable solutions are developed.

The results of the Discovery phase highlighted both compliance needs as well as opportunities for improvements in inventory management. A thorough review of business processes and electronic systems revealed only minor gaps in receiving, storing and sharing traceability data - the system could be modified without major disruption to operations. Opportunities were also identified that would result in improvements in warehouse inventory management and overall efficiency. With our help the client was able to move quickly into the Design phase. We provided the client with a program management structure enabling them to establish the necessary project management, sponsorship and governance to sustain their efforts and de-risk their investment.