The FDA 24-hour sortable spreadsheet: how to be ready before anyone asks
Under the FDA Food Traceability Rule, the most stressful requirement is also the shortest one to describe. When FDA asks for traceability records, you have 24 hours to provide them. During an outbreak investigation, a recall or another public health threat, FDA can ask for that information as an electronic sortable spreadsheet.
The rule does not require any particular software. It does require that a person at FDA can open your file and sort and filter it to follow a lot. A stack of scanned invoices does not meet that bar.
What the spreadsheet contains
FDA publishes a template, and it is worth downloading. In practice, each row represents one critical tracking event for one lot, with columns for the key data elements. Typical columns include:
- Traceability lot code
- Product description
- Quantity and unit of measure
- Event type, such as receiving, shipping or transformation
- Date of the event
- Location of the event
- The business you received from or shipped to
- The source of the lot code, meaning who assigned it
- A reference document, such as the invoice or bill of lading number
FDA usually asks for a specific product and date range, and you provide the rows that match.
Why it is hard to produce on short notice
Most small teams have the information somewhere. The problem is that it is spread across places that do not talk to each other:
- Receiving is on paper or in a clipboard photo.
- Invoices and bills of lading arrive by email as PDFs.
- Lot codes are on case labels, not always copied into any system.
- Transformation, such as cutting or mixing, is recorded in production sheets that list ingredients but not their incoming lot codes.
Pulling those together by hand for one lot might take a morning. Doing it for every lot of a product over three weeks, while also answering calls from customers, is how a 24-hour deadline gets missed.
Run a mock trace this month
A mock trace is the fastest way to find out where your records break. Set a timer and try this:
- Pick one incoming lot of a listed food from a few weeks ago.
- Find the receiving record, with the supplier’s lot code, quantity and date.
- If you transformed it, find every production batch it went into and the new lot codes you assigned.
- Find every shipment of those lots, with customer, date and quantity.
- Put the results into FDA’s template.
Write down every place you had to guess, search an inbox or ask a coworker. Each one is a gap to fix. If the whole exercise took more than a couple of hours for one lot, a real request covering many lots will be very hard to meet in 24 hours.
Habits that make the spreadsheet easy
- Record the supplier’s lot code at receiving, every time.
- Print lot codes on your own case labels and put them on invoices and bills of lading.
- Link production batches to the incoming lots they used.
- Keep digital copies of shipping documents in one place, named consistently.
- Repeat the mock trace every quarter.
Where Lotcrumb fits
Lotcrumb is being built to capture key data elements from the documents you already exchange, link lots through transformation, and export the sortable spreadsheet in minutes. Join the waitlist for early access.
This guide is general information, not regulatory advice. Always refer to FDA’s current guidance and template.