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FSMA 204 is not a QA documentation exercise. It is an operational data project. QA owns the outcome, but receiving, shipping, production, labeling, EDI, and inventory control create the data. Either your ERP captures it during normal operations or your team scrambles for 24 hours when the FDA calls.

How to Implement FSMA The first order of business for any organization is acknowledging the need to implement and comply with the act. Also, taking inventory of how the company stacks up at the present time is paramount to understanding what needs to be improved in order to become FSMA compliant. Often, companies are already in compliance with other food safety programs such as HACCP, with the FSMA being a “catch-all” for all programs under the food safety umbrella. As far as implementation goes