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FSMA 204 Compliancy

Compliancy List and how i2i can help.

FSMA

FSMA 204 is part of the broader Food Safety Modernization Act (FSMA), which was signed into law in 2011. FSMA 204 specifically focuses on improving the ability to trace food products throughout the supply chain to quickly identify and address any contamination issues. It establishes requirements for maintaining and reporting key data elements that are crucial for tracing food.

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FSMA 204 primarily applies to facilities that manufacture, process, pack, or hold foods on the Food Traceability List. This includes not only manufacturers but also farms, distributors, and retailers involved in handling these foods. However, small farms and certain other businesses may be eligible for exemptions or modified requirements.

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To comply with FSMA 204, companies need to leverage several tools to effectively track food products, maintain records, and share critical information across the supply chain. Here is a list of tools needed to comply with FSMA 204:

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1. Determine Applicability

  • Identify if your products are on the Food Traceability List (FTL).

  • Determine if your facility is required to comply or qualifies for any exemptions or modified requirements.

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2. Maintain Traceability Records

  • Key Data Elements (KDEs): For each Critical Tracking Event (CTE) (e.g., growing, receiving, transforming, creating, shipping), collect all required KDEs, such as:

    • Lot number, product description, quantity, unit of measure.

    • Location identifiers (origin and destination).

    • Date and time of each CTE.

  • Ensure traceability records are organized and accessible electronically or in paper format.

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3. Record Critical Tracking Events (CTEs)

  • Maintain records for the following CTEs:

    • Growing: Capture information regarding production, including the source.

    • Receiving: Track incoming products, including KDEs related to origin, transportation, and condition upon arrival.

    • Transformation: If the product is transformed (e.g., ingredients combined or packaging changed), track relevant details.

    • Creating: Record new products created, including any new identifiers like lot numbers.

    • Shipping: Track shipments, including details on destination, transport method, and product identifiers.

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4. Develop a Traceability Plan

  • Create a documented traceability plan that includes:

    • Procedures for maintaining traceability records.

    • A description of how traceability works within the facility.

    • A list of all foods on the Food Traceability List that your company handles.

    • Assign a person responsible for traceability compliance.

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5. Technology and Tools for Compliance

  • Use appropriate software solutions such as ERP systems, food traceability platforms, barcode/RFID technologies, and electronic data collection systems to manage and share KDEs.

  • Implement a system for data integration and interoperability to facilitate the exchange of traceability data between supply chain partners.

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6. Training and Staff Responsibilities

  • Train staff on how to maintain traceability records and use software tools.

  • Designate a responsible individual to oversee FSMA 204 compliance, including recordkeeping and traceability practices.

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7. Ensure Record Accessibility

  • Ensure that traceability records can be provided to the FDA within 24 hours upon request.

  • Maintain traceability records for at least 2 years, either electronically or physically, depending on your chosen method.

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8. Review and Update Procedures

  • Regularly review your traceability plan and recordkeeping practices to ensure compliance with FSMA 204.

  • Update the traceability plan and relevant records whenever there are changes in processes or products.

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9. Collaborate with Supply Chain Partners

  • Communicate and coordinate with supply chain partners to ensure traceability information is shared and received seamlessly.

  • Confirm that partners are compliant and that all KDEs are recorded and transmitted accurately.

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10. Verification and Testing

  • Perform internal audits and verification tests of the traceability system to ensure KDEs are complete and records are available.

  • Conduct mock recall exercises to evaluate your ability to trace products quickly and effectively within the supply chain.

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Each of these required systems can be, and has been, covered by i2i Automation for over a decade. Reach out today and find out how we can keep your operation compliant.

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