Helping companies across the supply chain address FSMA 204
The TagOne Compliance Wheel is a unique framework for executing traceability compliance projects. For nearly two decades, we've been helping companies identify and overcome supply chain traceability compliance challenges across industries.
Our 5-Step Project
Execution Framework
We believe a comprehensive FSMA 204 compliance solution needs to address 5 key things that we define as part of our compliance wheel. This includes a complete understanding and coverage of:
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All roles across the supply chain
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Identification of the appropriate data types
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Flexible data capture options catering to different business user types
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Seamless data share capabilities
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Secure data repository for one-click reporting
TagOne Compliance Link for FSMA 204 checks all the boxes. In fact, we can confidently say that in addition to helping you address the immediate FSMA 204 requirement, it will also help you use this investment as building blocks for the future, to drive competitive advantage.
1. SUPPLY CHAIN ROLES
Identify your FSMA 204 role in the supply chain
Supply chain partners dealing in FTL foods be it Harvesters, Coolers, Packers, Wholesalers, Processors, Distributors, Retailers, Restaurants or others, will now need to capture, store and share additional information about these food items.
What this means is that for specific pre-defined events performed across different roles in the supply chain (called CTEs), companies now need to capture and share specific pre-defined data elements (KDEs) defining that event. These CTEs include events like Harvesting, Cooling (if applicable), Packing, Shipping, Receiving and Transformation and supporting KDEs include data elements like Commodity (Food Item) name, Lot Number, transaction location, transaction dates, quantity, unit of measure, etc.
Although this might sound like a lot of different KDEs defining multiple CTEs, the FSMA 204 data can be broken down into three main data types:
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Product Data
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Location Data
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Transaction Data
2. DATA IDENTIFICATION
Classify KDEs that need to be captured for your role
These three data types fully describe a food item's movement as it progresses through the supply chain via tracking events and ensure the comprehensive traceability the FDA seeks to drive.
Product Data
In its simplest form, product data is information that helps identify the food item in more detail to avoid confusion about the commodity being tracked. This includes the product's name, brand, variety, packaging size, style, etc. This information is part of what the industry calls a Master Data element (Product/Item Master). I.e., the information has to be captured once and can be referenced repeatedly regarding the food product in question.
Location Data
Location data is meant to identify all the locations the food item has traveled over its life cycle, from the time of harvest (as in the case of a Raw Ag. Commodity) all the way to where the Retail Food Establishment (RFE) makes it available to consumers for final consumption. Typical location data includes physical location address or coordinates and key contact information like business name and phone number for all locations where the food product was handled. Like product data, location data is also part of a company's Master Data (Location Master).
Transaction Data
The transaction data is what ties the food item’s (product data) journey across the supply chain locations(location data), together. Each critical event (Harvesting, Cooling, Packing, Receiving, Transformation, Shipping) is uniquely defined by a set of KDEs assigned to them, as the food item moves through the supply chain. Examples of typical transaction data include KDEs like event date, event location, quantity & unit of measure (for the food Product) and Lot Number.
3. DATA CAPTURE
Capture traceability data your own way
The TagOne solution is set up to make data capture a breeze for our customers. Our solution provides 8 easy ways to help them easily capture Key Data Elements to support relevant Critical Tracking Events, as a food item moves between different supply chain partners across the supply chain. This is a vital first step to ensure a company’s compliance with FSMA 204, and an area TagOne has greatly focused on over the past few years.
WEB UI
Simple to use UI that can be accessed and viewed via a web browser and used across different mediums like a desktop, laptop, or tablet.
4. DATA SHARE
Ensure seamless data exchange with your business partners
Once the relevant KDEs have been captured and stored for the different CTEs specific to a company's supply chain role, the next vital step is to share shipping KDEs with customers as efficiently as possible. This is a core requirement of the FSMA 204 ruling, and this is where TagOne's Integration Engine and Supplier Link solutions come in to make life super easy for our customers.
The TagOne Integration Engine has been built to help customers address direct system-to-system data exchange requirements with TagOne. This could be linking their internal systems to TagOne or integrating with their business partners (external systems) to ensure the easy capture, storing, validation, and sharing of KDEs covered under the FDA’s Food Traceability Final Rule. TagOne’s Integration Engine supports leading data exchange protocols like SOAP, SFTP and AS2, data exchange formats like XML, JSON and is fully compliant with GS1 standards. EDI transactions between partners are fully supported.
The TagOne Partner Link has been custom-built to address the FSMA 204 compliance requirements of smaller and medium-sized companies that do not have IT systems to enable automated system-to-system data exchanges. For these scenarios, the TagOne Partner Link provides companies with an easy-to-use web-based application that gives them multiple options to collect, store, and share FSMA 204 relevant KDEs applicable to CTEs their company is responsible for. For example, for distributors, this could be capturing KDEs for Receiving and Shipping, while for food processors, it would be Receiving, Transformation, and Shipping.
5. DATA REPOSITORY
Advanced FSMA 204 reporting
The success of regulatory compliance programs often boils down to the quick and easy availability of compliance data. This can be a significant challenge, particularly when meeting the requirements of a complex regulation like FSMA-204 which demands detailed traceability data for a food item, identified at the lot level, within 24 hours.
With our extensive experience in the traceability compliance space spanning nearly two decades, we have not only been there and done that, but we have also gained a deep understanding of what it takes to simplify compliance reporting. This knowledge has led us to develop our Compliance Cockpit, a solution that not only facilitates 1-click FDA reporting but also equips our clients with multiple exception management and error handling reports, ensuring they are always in control of their compliance requirements.
