Famous Software and FSMA 204

FSMA 204 Overview

Section 204(d) of the Food Safety Modernization Act mandates enhanced traceability records for foods on the Food Traceability List (FTL) to expedite identifying and removing contaminated food from the market and reducing foodborne illnesses. The rule requires maintaining Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs) and reporting to the FDA within 24 hours or an agreed reasonable time. Applicable to both domestic and foreign firms in the food supply chain, compliance for recordkeeping is set for January 20, 2026.

Get FSMA 204 Ready with Famous Software!

Traceability has long been a cornerstone of the Famous Software platform. Since the publication of the final rule, Famous has been working hard to make sure you are FSMA 204 Ready. We created a steering committee to help understand the rules more fully and make updates to our software to ensure you have the tools you need to be in compliance. Below are some best practices and recommendations you can start now to help smooth the transition.

1. BE PROACTIVE - LEARN ABOUT THE RULE

Do your homework on FSMA 204. Research the FTL and understand which foods you produce that are on the list and will require more data capture. Gain an understanding of the CTEs to learn which areas affect your company. Study the KDEs and gain an understanding of what data you will need to capture and transmit. Start working on your Traceability Plan so that you are ready when the rule will be enforced.

Famous Software has resources to help as do several other industry partners such as GS1 and IFPA.

GS1 - https://www.gs1us.org/supply-chain/standards-and-regulations/food-safety-modernization-act

IFPA - https://www.freshproduce.com/resources/supply-chain-management/fsma-204-resources

2. TAKE IT STEP BY STEP

Once you have learned about the rule, do an internal assessment of which CTEs apply to your company, then look at the KDEs you will need to capture. Understand what data you are capturing today and which data elements you will need to start capturing. Many of these data fields already exist within Famous, and we are making updates throughout the next year to ensure you will be able to capture the data you need. More details about our approach and what Famous is doing now can be found at the bottom of this article.

Once you have completed your assessment, create a plan to capture the additional data you will need. Make this plan simple, concise, and straight to the point. Keep your internal stakeholders in the loop on what your plans are. Some key internal stakeholders might be Sales, IT, Receiving, Production, Harvesting, and more. With careful planning and a comprehensive plan, you can be FSMA 204 ready, and we are here to help you along the way!

3. CONNECT WITH YOUR CUSTOMERS

Your customers likely already have thought about FSMA 204 and want to partner with you to be successful in implementing the rule. Start a dialogue with those core customers to understand what their requirements will be and when they want you to be in compliance. You might consider sending a survey to multiple customers, so you can capture all the information in one place. Get an understanding of how they are planning to be in compliance and what data they will be requiring. Talk to a variety of different customers as they may require different information. Also get an understanding of how they want to receive the data from you, and how they will be storing the data. This will not only help foster effective communication but will help them have a level of comfort with your plan and that you want to partner with them!

4. DON’T LOSE SIGHT OF THE GOAL

Although this rule requires additional work on everyone’s part in the fresh produce industry, the goal is to have a safer supply chain for consumers, which is a good thing for everyone! With concerns about food safety in the public consciousness, regulations like FSMA 204 can help consumers feel confident that the fresh produce they purchase is safe and healthy for them to consume.

Famous Software's Approach

Customers using Famous Software already satisfy a majority of the FSMA 204 requirements such as:

• Unique Pallet Tags
• Case Tags
• Logistics Labels
• Palletized ASN
• Unique Transaction Identifiers
• Sourcing Traceability with Full Audit
• Document Management Solution to Store and Access Critical Documentation
• Traceability data captured will be formatted to comply with the FSMA 204 requirements.

The following screenshots show the various fields within Famous that will help you to be FSMA 204 ready.

Receiving Requirements – Grower Product

Receiving is one of the Critical Tracking Events that requires Key Data Elements.

Receiving Entry with Block or Packing Entry with Block

Within Grower Block Maintenance, Famous has several fields which will help with FSMA 204 compliance including Block ID, Location, Commodity, Variety, Latitude, and Longitude.

Grower Block Maintenance

Additionally, at Receiving Entry, there are several fields that are critical for FSMA 204 compliance (highlighted in yellow).

Receiving Entry – Delivery Tab with Harvester and Crew

At the Delivery tab, you can add harvester and crew information.

Receiving Entry - Delivery Tab

Receiving Requirements – Purchased Product

If you are receiving purchased product (a Critical Tracking Event), Key Data Elements are required.

Receiving – Purchased Product

Similarly with grower product, you can include vendor identification and location at Receiving Entry.

Receiving Entry

Transformation Requirements

Transformation is another Critical Tracking Event that requires additional Key Data Elements.

Transformation – Repacking

At Repacking, several fields like Run Number, Run Date, Warehouse Location, and Input details help provide the Key Data Elements for the Transformation CTE.

Repacking

Shipping Requirements

Shipping is a Critical Tracking Event with Key Data Elements.

Shipping

At Shipping Entry there are several fields that satisfy the requirements of the KDEs for the shipping CTE.

Shipping Entry

Vendor/Carrier Requirements

Vendor/Grower Certification Document Tracking with Expiration Dates/Vendor and Carrier Maintenance

Vendor Maintenance allows the inclusion of grower and vendor certifications with relevant dates.

Vendor Maintenance

Traceability Plan

As part of FSMA 204, a plan detailing your procedures for traceability is required to be created, maintained, and updated on a regular basis.

Elements required in the Traceability Plan:

• Description of procedures you use to maintain records.
• Description of the procedures you use to identify foods.
• Description of how traceability lot codes are assigned.
• Statement identifying point of contact for questions regarding your traceability plan.
• If you grow food, a farm map showing the areas in which you grow such foods.

Record Availability and Format

As part of our initiative with PTI many years ago, we created a Traceability Report within Famous. This report prints with key columns, but the report can be downloaded as an Excel spreadsheet with dozens of columns that can be used as your electronic, sortable spreadsheet.

Famous Traceability Report

Example of Required, Electronic, Sortable Spreadsheet That the FDA May Request

What’s Coming in Famous ERP

As always, we are working to make Famous Software as user friendly and compliant as possible. We have several initiatives in process that will further enhance your ability to be in compliance with FSMA 204.

• Harvester Tracking at Receiving Entry – Complete in ERP Update 2023​
• Vendor/Grower Certification Document Tracking with Expiration Dates – Complete in ERP Update 2023
• Updated Traceability Report to Support Additional Columns Required by FSMA – Slated for ERP Update 2024
• Cross Reference of Shipper Pallet Tag for Purchased Product – Slated for ERP Update 2024

To learn more about how Famous Software can help you be in compliance with FSMA 204, contact us today!

Check out our support site for more resources: https://support.famoussoftware.com

Contact our support team: 559-438-3600 or [email protected]