Navigating FSMA 204 Compliance: Manual vs. Automated WMS Workflows

Navigating FSMA 204 Compliance: Manual vs. Automated WMS Workflows

We have dedicated several articles to explore the FSMA 204 FDA compliance and regulation. FSMA 204 is a critical food traceability regulation designed to enhance the speed and transparency of the food supply chain. By 2026, many food distributors and manufacturers will be required to be compliant. While the FDA has a specific list of regulated items, major retailers are already pushing for wider compliance, anticipating that all products with an expiration date will eventually fall under this rule. In this Article, I focus on the differences between manual vs automatic FSMA 204 compliance implementations.

FSMA 204 compliance Worflows

The Manual Compliance Workflow: Challenges and Limitations

For many smaller operations or those just starting to address FSMA 204, manual processes might seem like a straightforward way to comply. This typically involves paper-based or spreadsheet-driven tracking of key data elements (KDEs) at critical tracking events (CTEs), such as receiving, transforming, and shipping products. Here’s a typical manual workflow:

1. Labeling and Lot Code Assignment: Workers manually assign traceability lot codes (TLCs) to products or batches. This includes noting details like product description, quantity, and origin.
2. Recordkeeping: Data is logged in spreadsheets or logs, including CTEs like shipping dates, receiver information, and any transformations (e.g., repackaging).
3. Advance Shipping Notices (ASNs): Before shipment, ASNs are created manually and sent to retailers, incorporating required KDEs such as lot codes and transporter details.
4. Recall Response: In a recall scenario, teams sift through records to trace products, often involving phone calls, emails, and cross-referencing documents.

While this approach can work for low-volume operations, it’s fraught with issues. Manual entry is time-consuming and prone to human error. During high-pressure recalls, delays in locating information could take hours or days, far exceeding the FDA’s 24-hour response expectation. Scalability is another pain point; as volumes grow or the FTL expands, manual systems become unsustainable, diverting resources from core business activities.

The WMS-Automated Workflow: Efficiency and Reliability

In contrast, implementing a Warehouse Management System (WMS) automates FSMA 204 compliance, turning a burdensome requirement into a strategic advantage. A WMS integrates inventory tracking, data capture, and reporting into a single, digital platform, ensuring real-time visibility and accuracy.

Key steps in a WMS-driven workflow include:

1. Automated Labeling and Lot Code Management: Upon receiving goods, the WMS automatically generates and applies TLCs, linking them to KDEs like origin, quantity, and unit of measure. Barcode scanners or RFID tags eliminate manual input errors.
2. Real-Time Recordkeeping: CTEs are captured electronically as they occur. For example, during transformation events (e.g., processing or repackaging), the system logs changes instantly, maintaining a digital audit trail for at least two years as required.
3. Seamless ASN Generation: The WMS compiles all necessary data into electronic ASNs, including lot codes and shipping details, and transmits them to retailers via EDI (Electronic Data Interchange) for faster, error-free communication.
4. Rapid Recall Capabilities: In the event of a safety incident, the system enables one-click tracing, isolating affected lots across the supply chain in just minutes. This meets the FDA’s quick-response mandate and minimizes the scope of the recall, reducing waste and costs.

The benefits are clear: automation reduces errors by up to 90%, provides end-to-end visibility, and scales effortlessly with business growth. As the video demonstrates, a WMS shifts traceability from a “manual burden” to an efficient safety net, allowing teams to focus on profitability rather than paperwork. For high-risk foods, features like temperature monitoring and alerts further enhance compliance.

Companies using WMS report not only regulatory adherence but also operational gains, such as optimized inventory, faster order fulfillment, and stronger supplier relationships. With retailers like Albertsons demanding broader traceability, a WMS positions businesses as reliable partners in a safer supply chain.

Preparing for the FSMA 204 Compliance Deadline: Steps to Take Now

The FSMA 204 compliance deadline is approaching—January 20, 2026, for most operations, though some retailers may enforce earlier requirements (e.g., Albertsons’ potential June 30, 2025, cutoff). Mickey advises starting with a self-assessment: Review your current processes, identify gaps in traceability for FTL items, and evaluate whether manual methods suffice or if automation is needed.

If opting for a WMS, look for systems that support FSMA-specific features like KDE/CTE tracking, EDI integration, and customizable reporting.

Conclusion

Ultimately, FSMA 204 isn’t just about avoiding penalties; it is about building a resilient, transparent supply chain. Whether you are looking to stay compliant or make your operations smarter, this covers what you need to know. LaceUp Solutions offers WMS tailored for food distributors, emphasizing catch weights, inventory management, and profitability tools. Contact us to learn more about our solutions.

I hope this article about FSMA 204 compliance, have been helpful. I will continue to post information related to management, distribution practices and trends, and the economy in general. Our channel has a lot of relevant information. Check out this video on this subject.