The “Transformation” event is one of the seven traceability Critical Tracking Event (CTE) types American businesses will be required to record under Section 204 of the Food Safety Modernization Act (FSMA). Here are the relevant record keeping requirements specified by the FDA:
The Transformation event is a little different from the other CTEs. A CTE like “Shipping” is simple to represent as a line on a spreadsheet because one event refers to one Traceability Lot Code. But a transformation event can refer to several traceability lot codes: during processing or manufacturing, multiple inputs are combined or processed to produce a new batch/lot of output food.
Consider the example below: Acme Foodworks, a fictitious food processor, has produced a lot of 200 units of packed salads with the code “S101”. To do this, they have used 100 pounds of lettuce from lot “L101”, and 50 pounds of the same type of lettuce from a different lot (“L201”), and 40 pounds of tomato from lot “T801”.
Three different lots were processed (“Transformed”) to produce one lot of Packed Salads. What is a good way of representing this “many to one” relationship in a row-based spreadsheet?
Our objective is to ensure that we can sort and filter to quickly look for specific Transformation Events that contain specific Lot Codes. In our FSMA 204 Sortable Spreadsheet Example (download it here), we recommend a method where the single traceability event is split over several rows:
The “Event ID” field indicates that all three rows are part of the same logical Transformation event. Some KDEs, such as the Event Date/Time (“Date transformation was completed”) and Event Location (“Location description for where you transformed the food”) are repeated over the three rows.
Each row has a unique reference to an input traceability lot code and quantity - one row for each lot that was used to produce the output food:
The details of the output Lot that was produced (the packed salads) is kept in separate columns, with the values repeated, since each of the three unique inputs are related to the one output.
This technique is useful because it allows the FDA to quickly filter your spreadsheet to find specific Traceability Lot Codes that they are looking for.
For example, you could filter to find all the input ingredient Lots that were used to produce the output salad lot “S101”:
Similarly, you could filter for the input ingredient lot “L501” to find all instances where this lot was used as an ingredient in a manufacturing process:
We hope you found these recommendations for the FSMA 204 sortable spreadsheet useful - for more guidance download our full sortable spreadsheet example 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!