Key Data Elements (KDEs) for FDA Traceability Compliance

What Are Key Data Elements?

Key Data Elements (KDEs) are the specific pieces of information that must be collected and maintained at each Critical Tracking Event (CTE) in your supply chain. They provide the essential data points needed to trace food products from their source to their destination.

Under the FDA’s Food Traceability Rule, businesses handling foods on the Food Traceability List must record these KDEs to create a complete traceability record that can be shared within 24 hours if requested by the FDA.

Essential Key Data Elements for Traceability

While specific KDEs vary by Critical Tracking Event, several core data elements appear consistently across the traceability continuum:

1. Traceability Lot Code

A unique identifier assigned to a product lot or batch
Must follow a consistent format that your company establishes
Should be maintained throughout the supply chain

2. Location Identifiers

Physical address of the location where the CTE occurs
May include FDA registration numbers, DUNS numbers, or GLNs
Both origin and destination locations for transfer events

3. Date and Time Information

Date when the CTE occurred
May include time stamps for high-risk products
Date format should be consistent (e.g., YYYY-MM-DD)

4. Product Description

Clear identification of the food item
May include variety, brand name, or commodity
Should match commercial documentation

5. Quantity and Unit of Measure

Amount of product involved in the CTE
Consistent units (e.g., cases, pounds, kilograms)
Should reconcile across shipping and receiving records

6. Reference Records

Links to related business documents
May include purchase orders, BOLs, invoices
Creates connections between traceability data points

KDEs Required for Each Critical Tracking Event

Each type of Critical Tracking Event requires specific Key Data Elements:

Growing KDEs

Location description (field or growing area)
Traceability lot code
Location identifier (coordinates or address)
Commodity and variety
Date of harvest
Quantity harvested and unit of measure

Initial Packing KDEs

Location where packing occurred
Traceability lot code assignment
Date of packing
Commodity and variety
Quantity packed and unit of measure
Reference to growing information

Processing/Manufacturing KDEs

Location where processing occurred
Traceability lot code assignment
Date of processing/manufacturing
Description of the food produced
Quantity produced and unit of measure
References to incoming ingredients and their lot codes
Processing steps applied (optional but recommended)

Shipping KDEs

Location shipping from
Location shipping to
Date of shipping
Traceability lot code(s) being shipped
Description of food being shipped
Quantity shipped and unit of measure
Reference to transporter information
Expected arrival date (optional but recommended)

Receiving KDEs

Location receiving at
Location received from
Date of receipt
Traceability lot code(s) received
Description of food received
Quantity received and unit of measure
Receipt status (accepted/rejected)

Best Practices for KDE Collection and Management

To ensure your KDE records meet FDA requirements and support effective traceability:

1. Standardize Data Formats

Use consistent date formats (YYYY-MM-DD recommended)
Standardize product descriptions across your organization
Develop a uniform lot coding system

2. Implement Data Validation

Create systems that verify data completeness
Use dropdown menus instead of free text when possible
Implement automatic checks for required fields

3. Minimize Manual Entry

Use barcode scanning or automated data capture
Implement electronic record systems
Reduce opportunities for human error

4. Establish Data Hierarchies

Create clear relationships between products, lots, and shipments
Maintain parent-child relationships for ingredients and finished goods
Document transformation ratios for processing events

5. Ensure Data Accessibility

Store KDEs in sortable, searchable formats
Maintain records that can be provided within 24 hours
Create systems for rapid data retrieval during investigations

Common KDE Challenges and Solutions

Challenge: Inconsistent Lot Code Formats

Solution: Develop a standardized lot coding system that includes date, production line, and batch information in a consistent format.

Challenge: Missing Data from Suppliers

Solution: Create supplier agreements that require all necessary KDEs and provide templates for data submission.

Challenge: Managing Data Volume

Solution: Implement a dedicated traceability or ERP system that can handle large volumes of data while maintaining accessibility.

Challenge: Connecting KDEs Across Events

Solution: Use reference numbers or identifiers that link related events, such as connecting a receiving event to its corresponding shipping event.

Challenge: Maintaining Historical Records

Solution: Implement a data retention policy that preserves traceability records for at least 2 years while ensuring they remain accessible.

Technology Solutions for KDE Management

The right technology approach is critical for effective KDE management. Here’s what you need to know:

1. No-Code Traceability Platforms

Ready out-of-the-box with FDA compliance built in
Configurable without coding to match your specific processes
Regular updates to stay current with regulatory changes
Rapid implementation compared to custom development

2. The Dangers of Custom-Coded Solutions

Development delays often jeopardize compliance deadlines
Maintenance burden grows with each regulatory update
Knowledge dependency on specific developers or vendors
Integration challenges with existing systems
Testing requirements increase with each code change

3. Enterprise Resource Planning (ERP) Systems

Integrates traceability with other business functions
Can automate KDE collection during normal operations
Provides reporting capabilities for compliance
Consider ERP add-ons rather than custom development

4. Blockchain Solutions

Creates immutable records of traceability data
Enables secure sharing across supply chain partners
Provides transparency and verification
Look for no-code blockchain platforms with FDA templates

5. Cloud-Based Data Management

Allows access from multiple locations
Simplifies data sharing during investigations
Provides backup and redundancy for critical records
Eliminates on-premise infrastructure management

6. Mobile Data Collection

Smartphone apps for capturing KDEs at the point of action
Offline capabilities for areas with poor connectivity
Built-in validation to prevent incomplete records
Photo documentation capabilities for visual verification

Need Help Managing Your KDEs?

Properly collecting and maintaining Key Data Elements is essential for FDA compliance and effective traceability. Our team can help you develop systems and procedures tailored to your specific operations.

👉 Contact us today for a consultation or system assessment.