Kurt Wrase, principal professional services consultant for Produce Pro Software, offers some best practices to help growers, packers and shippers get ready for FSMA 204.
“Preparing for compliance with FSMA 204 involves detailed planning and implementation of robust traceability systems,” he said.
Here are Wrase’s Top 10 best practices in preparation for FSMA 204:
- Develop a comprehensive traceability plan — “Developing a written plan detailing your traceability procedures is a key part of FSMA 204,” he says. “The [Food and Drug Administration] has a detailed list of what is required in your plan. It includes describing how you maintain your records, how you assign traceability lot codes and how you identify foods on the [food traceability list].”
- Create and update farm maps — “If you grow or raise food, you are required to have a farm map detailing those areas. This needs to be a part of your traceability plan,” he says. “Having detailed maps of fields and growing areas, including geographic coordinates, is essential for pinpointing locations where specific foods are produced. This will aid in rapid traceability and containment efforts.”
- Assign traceability lot codes — “Lot codes are crucial for tracking products throughout the supply chain,” he said. “Being a grower/packer/shipper, you will be the traceability-lot-code source for most of your product, so getting the TLC assigned and tracking it properly is vital.”
- Invest in technology — “Technologies such as RF scanning, RFID and internal barcode labeling can enhance real-time tracking and boost your organization’s traceability,” Wrase says. “Your improved tracking will ensure that accurate data is passed along the supply chain to your customers.”
- Implement electronic record-keeping systems — “Electronic systems streamline record-keeping and retrieval, making it easier to provide sortable spreadsheets to the FDA within 24 hours,” he says. “This will also facilitate communicating the required KDE information to your customers.”
- Communicate with supply chain partners — “FSMA 204 requires that the TLC and TLC source (among other information) is passed down the supply chain,” he says. “Talk to your customers to verify how you can effectively pass this data to them. The method of communication could vary from customer to customer.”
- Train staff on traceability requirements — “Regular training ensures all employees understand their role in maintaining traceability and can effectively implement the procedures outlined in the traceability plan,” he says.
- Regular audits and testing — “Perform regular internal audits and mock traceability tests to ensure your systems are functioning correctly and can quickly provide the required information in case of an FDA request,” he says.
- Prepare for rapid response to FDA requests — “Being able to provide traceability information to the FDA within 24 hours is the key to FSMA 204,” he says. “Quick responses help contain potential food safety issues and protect public health.”
- Stay informed and work together — “Keep up to date with any changes or updates to FSMA 204 regulations,” he says. “Talk with your suppliers and customers to make sure that everyone is on the same page and your traceability systems are compatible. Your customers cannot be compliant if you are not compliant, so everyone needs to play their part.”


