The Food and Drug Administration (FDA) has announced sweeping new regulations that mean big changes to record-keeping rules for food manufacturing, processing, packing, and storage. The new regulations are outlined in Rule 204, which the FDA published in November 2022, and are in effect as of January 2023. Additional food traceability is now required for hundreds of thousands of food items. The requirements make manual tracing impractical. Therefore, many companies are relying on food traceability software to help implement appropriate tracking.
If you have MobileConductor, you already have the last-mile tools you need to manage additional Rule 204 record-keeping.
Rule 204 & Subsequent Record Keeping Rules
Section 204 rules are a result of the Food Safety Modernization Act (FSMA), signed into law by President Obama in January 2011. The law allowed the FDA additional oversight to create new rules governing food production, handling, and import into the United States. In Section 204, the FDA has detailed the Food Traceability Final Rule, which establishes additional recordkeeping requirements for entities that manufacture, process, pack, or hold foods on the Food Traceability List.
The FDA added the items on the list after going through a risk-ranking model to identify which foods U.S. consumers typically consume that most easily can develop hazardous contaminants like E. coli and other bacteria.
Record Keeping
To meet the demanding new requirements, many businesses are turning to a food traceability software solution to help track the additional required records. The FDA has outlined the metrics they require to be tracked and has named them Key Data Elements (KDEs). These KDEs correspond to different events in the supply chain called Critical Tracking Events (CTEs), including:
- Harvesting, Cooling, and Initial Packing are the first events in the series of CTEs. Information such as the exact location on the farm where an item was harvested, dates for all three steps, and temperatures must be recorded. This applies to raw agricultural commodities not obtained from a fishing vessel.
- First Land-Based Receiver is a CTE for seafood that requires recording information such as the date the food was harvested, the date it was landed, and locations for both harvesting and landing.
- Shipping includes the obvious data points such as location received and shipped from, product description and quantity, and dates for each step.
- Receiving requires similar information to shipping only for the entity receiving the shipment.
- Transformation is made up of two parts: food used as ingredients and new food produced.
Every supply chain change where KDE is referenced is an indication of where digitization and data capture is now required.
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You Need a Powerful Food Traceability Software Solution
Some delivery organizations and supply chain companies are working hard to enact additional record-keeping solutions to comply with Section 204 requirements. However, DecisionPoint clients that have access to MobileConductor software already have the tools they need to track and trace every KDE and CTE the FDA can require.
MobileConductor uses an efficient, paperless workflow to help businesses streamline record keeping. Last mile proof of delivery help clients capture extensive data on the handling, shipping, and receiving of goods across the supply chain.
MobileConductor helps businesses overcome a variety of record-keeping challenges, including:
- Manual processes that carry an inherent potential for human error
- Paper-reliant methods, are prone to error and loss and are more challenging to access than electronic records
- Legacy systems with a delay in how quickly transaction data and records are updated
- Visibility into paper records is limited by the physical space where those records are stored
- Accountability, is difficult, mainly if paper records are not filled out correctly
The benefits of using MobileConductor as your food traceability software solution include:
- Eliminating administrative overhead by automating repetitive tasks
- Electronic Invoicing for faster payments and easier tracking
- Delivery Confirmations transmitted to the customer and all internal stakeholders and automatically update back-end accounting systems
- Proof of Delivery, which captures customer signatures and reason codes for returns or credits.
- MobileConductor’s ease of use for teams on the move
Adopt a Food Traceability Solution for Success
Reporting requirements are increasing and successful businesses must keep up with FDA mandates and other regulations. Harnessing technology to help streamline your operations, especially if you’re using a paper route-planning system, will improve efficiency and your bottom line.
Don’t be overwhelmed by the thousands of pages of new regulations and requirements. MobileConductor can help your business handle recordkeeping with ease. Let us show you the features and use cases today.