In this article, we demonstrate a full, filled-in example of a “sortable spreadsheet” that the FDA might request from food producers under Section 204 of the Food Safety Modernization Act (FSMA) legislation. To grab a copy of the template discussed in this article, head here.
FSMA 204 legislation defines seven “Critical Tracking Events” (CTEs), each with their own “Key Data Elements” (KDEs), that must be recorded (and sometimes shared downstream) by businesses that handle any food on the Food Traceability List. Growers, packers, manufacturers, distributors, retailers and restaurants may be subject to FSMA 204 requirements.
For our FSMA example spreadsheet, we have created a simple example supply chain with mock businesses from each category that have to handle a subset of CTEs. The spreadsheet contains tabs with worked examples specific for each business.
Let's open the spreadsheet example and take a look around. Start at the tab marked “START-HERE”. Here you will see links to field definitions as well as examples for each business type in the scenario. Simply find the business closest to yours, and go to the example tab.
Let’s explore the CTEs recorded by “Acme Foodworks”, a fictitious processor that manufactures ready-to-eat salads from tomato and lettuce. Navigating to the “Sample-Processor” tab, we see an example of each CTE such a business may capture: Receiving, Transformation, and Shipping.
There are many columns to capture all the KDEs specified by the FDA in the legislation. A lot of the columns are only used for certain CTEs, and otherwise are left blank.
Let’s have a look at the Receiving event in detail. The key data element requirements for Receiving are as follows:
Let's step through the Receiving event in the spreadsheet. Each row identifies the event type, and the event date/time (in Receiving, this is “Date you received the food”). Each event has a primary location where it occurred - in the context of Receiving, this is the “Location description for when the food was received”:
High level terms such as “Location description” which are used repeatedly in different contexts have further definitions from the FDA:
Each mention of a location in the spreadsheet is made up of a set of GS1 standards-aligned, best practice columns that fit the above requirements.
For the receiving event, we also must record “Location Description of the Immediate Previous Source”:
Each row also of course has a reference to the subject of the event - the Traceability Lot Code itself. Following interoperability best practices and open standards, we recommend defining a Traceability Lot Code as a combination of a GS1 Global Trade Item Number (GTIN) - which is a reference code for the type of Product, and a Lot Code. We also need to record “Product Description of the Food” and the “Quantity and unit of measure of the food”. It looks like this in the spreadsheet:
And we can’t forget the “Traceability Lot Code Source” - which is the location where the Traceability Lot Code was first assigned. This is not necessarily the same as “Immediate Previous Location” if the food has be resold via distributors.
We also have places in the spreadsheet for reference documents.
We hope you found this quick tour of our FSMA 204 sortable spreadsheet example useful - download the full spreadsheet here.
We are offering free consultations to help businesses navigate FSMA 204.
During this in-depth 1 hour personalized session, we will:
- Provide an overview of the FSMA Section 204 Food Traceability Rule
- Review the FDA requirements for your business, identifying the Critical Tracking Events (CTEs) and Key Data Elements (KDEs) you’ll need to gather, record and share with your business partners
- Demonstrate how to use the Sortable Spreadsheet for your business
- Discuss how to deal with common challenges you might face as you scale, including:
- How to receive and share data electronically with business partners
- How to use barcode scanning to reduce labor
- How to automatically generate sortable spreadsheets for any set of data the FDA requests
Book a timeslot that suits you using the calendar below.