One major element missing from current mandates and provisions in the FSMA is electronic records, which are not required but are nonetheless critical for producers to prove traceability. Because the FSMA does provide the FDA with expanded access to facility records and requires those producers to quickly recall their products, food companies should proactively evaluate how they capture, record, and manage information.
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Most of the required traceability elements are covered under enterprise resource planning systems, the rest of the compliance elements under an enterprise quality management system. The typical EQMS currently used by FDA-regulated companies under 21CFR11 or 21CFR820 compliance is easily adapted for FSMA compliance. Such a system, paired with FDA accepted best practices, could also help organizations in the following critical areas:
- Hazards analysis, control plans, and mitigation;
- Corrective and preventive action and remediation management;
- Employee safety and competency training;
- Internal and external audit management; and
- Supplier management.
The FDA’s management of regulations in the life sciences sector is a good indication of how the agency might also approach the new regulations in the FSMA. Beginning with the largest food companies, whose products “touch” the broadest spectrum of people, the FDA will likely work from the top to the bottom of the food supply chain.
Additionally, because major food manufacturers will be responsible for their suppliers, a top-down approach enables larger organizations to cover a swath of smaller suppliers as part of safety tracking and food safety/quality. Organizations should start to prepare for FSMA requirements by proactively evaluating the systems, processes, and technology needed to meet new regulatory standards.
Mohan Ponnudurai is an industry principal at Sparta Systems, addressing the needs of the food and beverage and oil and gas sectors on how automated quality and compliance solution can be used to manage, track, and improve food safety processes globally. Katie Dowling is a senior solutions consultant at Sparta. She tracks trends in the food and beverage and manufacturing industries.