KDE Definition and Regulatory Basis
A Key Data Element (KDE) is a specific piece of information that FDA requires you to capture and retain at each Critical Tracking Event (CTE) in your food supply chain. The term comes directly from 21 CFR Part 1, Subpart S — the FSMA Food Traceability Final Rule — and it represents the minimum data standard for traceability records under the rule.
KDEs are not optional fields. They are regulatory requirements. A batch record or receiving log that is missing any required KDE is a FSMA 204 violation, regardless of how detailed the rest of the record is. FDA's position is that traceability records are only useful if they can answer a specific set of questions — and KDEs are the answers to those questions.
The practical purpose of KDEs is to enable what FDA calls "one step back, one step forward" traceability: the ability to identify, at any point in the supply chain, where a specific lot of food came from and where it went. KDEs are the data structure that makes that traceability mathematically possible.
The 5 Universal KDEs Required at Every CTE
FDA requires five KDEs at every CTE — receiving, transforming, creating, shipping, and all others. These are the baseline, and they apply regardless of the food type or the specific CTE:
- Traceability lot code (TLC). The unique identifier assigned to this specific lot of food. This is the key that links all other records. A TLC must be assigned at the point of creation and must remain with the food through every subsequent CTE.
- Quantity and unit of measure. How much of the food is involved in this CTE — in a specific, unambiguous unit. "A pallet" is not sufficient. "840 lbs, net weight" is.
- Location description. The specific location where the CTE occurred — typically a registered facility address. For receiving, this is your facility. For shipping, this is the destination. FDA needs to be able to place the food in a physical location at a specific time.
- Date of the CTE. The specific date (not week or month) on which the CTE occurred — when the food was received, when production occurred, when the shipment departed.
- Reference document type and number. The specific document that can be used to verify this CTE — an invoice number, purchase order number, bill of lading number. This is the cross-reference that links your records to your trading partners' records.
Every single traceability record your facility maintains under FSMA 204 must contain all five of these elements, linked to the specific traceability lot code. A receiving log without a reference document number fails. A shipping record without a quantity and unit of measure fails.
CTE-Specific KDEs
In addition to the five universal KDEs, FDA requires additional data points at specific CTEs:
Growing CTE (farms primarily): the commodity type, the location where the food was harvested, the harvest date or date range, and the name of the grower. Most manufacturers receive food that has already passed through the growing CTE — but you must ensure your suppliers are capturing and passing these records forward.
Receiving CTE: in addition to the five universal KDEs, you must capture the name of the traceability lot code source — the supplier from whom you received the food. This is the link that allows FDA to trace backward from your receiving event to the previous CTE in the supply chain.
Transforming CTE: this is where most manufacturers have the most gaps. In addition to the universal KDEs for the new (output) lot, you must capture the traceability lot codes of all input foods used in the transformation. This is the production-level link — connecting your ingredient lots to your finished product lots — that enables forward and backward traceability through your operation.
Creating CTE: similar to transforming, you must capture the input lot codes for all covered food ingredients used in creating the new food. If you blend multiple ingredients from the FTL into a finished product, every input lot code must be linked to the output lot code.
Shipping CTE: in addition to the universal KDEs, you must capture the name and location of the immediate subsequent recipient — the specific customer, distributor, or retailer that received the shipment.
A Real Example: KDEs for a Frozen Vegetable Receiving Event
Here's what a FSMA 204-compliant receiving record looks like for a frozen spinach receiving event at a mid-market food manufacturer:
- Traceability lot code: LOT-SPINACH-2025-0847 (assigned by supplier, verified on receipt)
- Quantity and unit of measure: 2,400 lbs, net weight, IQF bulk
- Location: Provarx Foods Inc., 1200 Industrial Blvd, Facility C, Columbus OH 43215
- Date received: 2025-03-14
- Reference document: Invoice #INV-2025-03847 from Green Valley Farms Inc.
- Traceability lot code source: Green Valley Farms Inc., 4400 Agricultural Route 7, Salinas CA 93908
Every field is required. If your receiving logs look like this, your receiving CTE is compliant. If they're missing the TLC, the reference document number, or the TLC source location, you have a violation.
How Your Records System Must Store and Retrieve KDEs
FDA's records requirements go beyond just capturing KDEs — they specify how those records must be maintained and retrieved. Your records system must:
- Be able to retrieve all records associated with a specific traceability lot code within 24 hours of an FDA request
- Produce records in a format FDA can read without proprietary software (exportable to CSV, PDF, or structured data)
- Retain records for a minimum of two years from the date of the CTE
- Be available to FDA during a facility inspection or upon written request
This is why paper-based KDE capture almost always fails in practice. Paper records can capture the data — but retrieving all records for a specific lot code within 24 hours, across multiple CTEs, is operationally impossible without a lot-linked digital system.
Common KDE Mistakes to Avoid
The most frequent KDE compliance failures in mid-market facilities follow predictable patterns:
Using internal item codes instead of supplier lot codes. Many facilities relabel incoming lots with their own internal codes at receiving — and never record the supplier's traceability lot code. This breaks the backward traceability chain. You must capture both your internal code and the supplier's TLC.
Vague quantity records. "One truckload" or "full pallet" are not compliant quantity records. FDA requires a specific numeric quantity in a specific unit of measure. Net weight in pounds, or case count with a per-case weight, are acceptable. Vague descriptions are not.
Missing reference document numbers at shipping. Many facilities record customer names and shipping dates but omit the bill of lading or invoice number — the document that links your shipping record to the customer's receiving record. That reference document is required.
No documented link between input and output lots at production. This is the most common manufacturing-specific gap. If your production records don't explicitly capture which ingredient lots went into which finished product lot, your Transforming CTE is non-compliant — regardless of how detailed the rest of your records are.
For a full breakdown of the FSMA 204 framework — CTEs, the 24-hour records requirement, and how to run your own recall drill — see The Complete Guide to FSMA 204 Compliance. To test whether your facility's records can actually support a 24-hour trace, use the FSMA 204 Gap Assessment.