5 essential tips for scalable compliance with FSMA 204

The FDA's Food Safety Modernization Act (FSMA) Section 204 will require over 300,000 US businesses to implement lot-level traceability for dozens of fresh and high risk food types. Because meeting FSMA traceability requirements will require cooperation between business partners, a scalable, interoperable, automated approach will be essential to keeping operational costs low and data quality high.

Here are our 5 essential tips for SCALABLE compliance with the FSMA 204 traceability rule:

1) Use identifiers based on GS1 standards to uniquely identify your products types and locations globally: the GTIN and GLN respectively. Your business partners will thank you when they have no trouble distinguishing your unique products and locations from all the others in their electronic systems.

2) Use GS1 standard data models for products and locations. A subset of these attributes will be KDEs that your business partners will need to understand and store electronically. A standard data model makes it easy for parties to align on meaning. You will also be able to reuse data exchange services like the GDSN.

3) Use GS1 standard barcodes for cases and pallets, to minimize manual data entry and maximize accuracy. GS1-128 is the usual method, although a companion QR code with a GS1 Digital Link could give even more flexibility (we will share some amazing opportunities for Digital Link usage in FSMA in upcoming posts).

4) Store traceability records digitally in a standards-based electronic system that will let you quickly identify records and export them as a sortable spreadsheet for the FDA.

5) Use GS1 traceability data standards like EPCIS 2.0 to exchange traceability events with business partners. EPCIS 2.0 is based on the same web infrastructure we use every day, and you can establish an ongoing data flow between two EPCIS systems in seconds - no need for a complex legacy EDI onboarding process, or expensive custom integration projects.

Are you implementing lot-level traceability to comply with FSMA 204? What do you think will be the most important ingredients to scalable compliance that doesn’t break the bank?