Do you feel overwhelmed with the food traceability rule and feel perplexed about how to prepare for FSMA 204 FDA inspections? Do you even need to worry about compliance?
FSMA 204 compliance date is in less than a year, and more food manufacturers are trying to answer these questions.
I want to guide you through the 204 rule implementation process and answer any questions you may have. In this blog, I’ll describe the main FSMA implementation steps, who needs to comply, and more. So, here it is, a step-by-step guide to food traceability 204 rule implementation.
1. Study the Food Traceability Rule
You should be well aware of what you are dealing with and gain a total understanding of FDA food traceability rule requirements, dates, challenges, etc. By reading this article, you can get a general idea of what you should do. Let’s see some common questions about the rule.
What Is FSMA 204?
The food traceability final rule requires food manufacturers, processors, packers, or holders to maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs).
Based on this, you must identify the CTEs and KDEs relevant to your operations.
You must ensure you are aware of the documents you need to keep. See our detailed guide on FSMA 204 to learn the details.
What Is FSMA 204 Compliance Date?
The FSMA 204 deadline is January 2026. Knowing this will help you understand how much time you have to prepare and how to allocate it.
Who Needs To Comply With the Food Traceability Rule?
Food manufacturers must follow the rule requirements if they are on the Food Traceability List (FTL). The FTL identifies the foods for which additional traceability records are needed. The list includes some cheeses, shell eggs, nut butters, fresh cucumbers, fresh leafy greens, sprouts, and more.
2. Gap Assessment and Risk Assessment
A significant step to FSMA 204 compliance is identifying your current state and conducting a gap assessment.
Evaluate your existing processes, systems, and supply chain workflows to identify where your efforts fall short and find improvement areas. It involves analyzing traceability workflows, data collection methods, and overall compliance readiness.
Conducting a risk assessment can also reveal potential vulnerabilities in your food traceability system. These insights will help you determine the technologies, tools, and resources needed to meet FSMA 204 requirements effectively.
3. Analyze Your Supply Chain
The supply chain is one of the main heroes in your food traceability compliance journey. You should map out your supply chain, identifying each stage and every moment where the product changes hands.
This is how you identify responsible workers, avoid blind spots, and ensure supply chain transparency. Collaboration with supply chain partners is also essential, as this is how you can ensure your suppliers, distributors, or retailers adhere to the procedures.
By fostering open communication and aligning processes, expectations, and data-sharing protocols, you create a unified approach to traceability.
4. Identify Critical Tracking Events
You’ve already heard about Critical Tracking Events in the FSMA 204 requirement, and they play a critical role in the rule.
What are Critical Tracking Events?
CTEs are activities or actions in the food supply chain that must be recorded for traceability and transparency. Harvesting, cooling, transformation, receiving, and shipping are great examples of CTEs.
Your task is identifying the main CTEs and ensuring your traceability system can record and link these events with the appropriate Key Data Elements.
5. Collect and Manage Key Data Elements
Another familiar term from the traceability rule is key Data Elements (KDEs). You must maintain records that include key data elements describing CTEs. Examples of KDEs could be product identification (lot or batch number), dates, quantities, etc.
Make sure you maintain proper records and can provide them any time they are needed.
6. Train a Team
Proper team training is necessary for a smooth transition and efficient traceability systems. Your employees must follow new procedures to ensure compliance by using technology and maintaining records, so you should provide their confidence in their day-to-day responsibilities.
You can start with the basics and move on to practical tasks like managing traceability lot codes and recordkeeping.
Don’t hesitate to invest in professional training or a FSMA 204 consultant to guide you and your workers through implementing a traceability rule.
7. Standardize Your Processes With SOPs
Standard Operating Procedures are vital for guaranteeing consistency in FSMA 204 rule implementation. You will be sure that your workers follow established procedures, minimizing errors or miscommunication.
For instance, you can make written guidelines on managing critical tracking events (CTEs) and recording key data elements (KDEs), Traceability Lot Code (TLC) creation, handling recalls, etc.
8. Work on Your Traceability Lot Code (TLC) System
What Is a Traceability Lot Code (TLC)?
A traceability lot code is a unique identifier for a specific batch of products in a company’s records. It works as the product’s ID, which consists of numbers and letters. It ensures traceability throughout the supply chain and is similar to what is commonly known as a ‘lot’ or ‘lot code.’”
How To Create a Traceability Lot Code System?
Your company does not have to assign a TLC in a specific way. It can be any kind within your Food Traceability Plan, such as a randomly generated number.
To develop a strong TLC system, you need to:
- Create a consistent and unique format
- Automate code generation with software
- Link TLCs to Key Data Elements (KDEs)
- Integrate with supply chain partners
- Audit your system for compliance and efficiency.
9. Work on a Food Traceability Program
Of course, creating a food traceability plan is the cornerstone of the FSMA 204 compliance process. The plan safeguards food safety, quality, and consumer trust by enabling efficient monitoring and tracing of foods in the supply chain.
The document describes the processes, tools, and responsibilities necessary for monitoring and documenting the product journey in the supply chain.
Wondering what to start with? Read our blog about how to write a food traceability plan that complies with the New Traceability Rule.
10. Mock Recalls
Mock recalls are simulated recall exercises that help you test the effectiveness of your food traceability system and compliance efforts. The rule does not mandate them, but mock recalls are strongly recommended as a best practice.
This approach will allow you to evaluate how well you can trace products through the supply chain, identify potential issues, and address process gaps. You will also be able to validate that CTEs and KDEs are well-recorded and accessible.
Mock recalls will reveal the quality of communication between internal teams and supply chain partners. Moreover, they are a great way to reassure yourself that you are well prepared for supply chain discrepancies and can protect customers and your brand reputation in case of an issue.
11. Implement Food Traceability Technologies
Food traceability technologies are essential to meeting food traceability goals. Consider food traceability software you can use to participate in the process.
The solution will bring many benefits, such as improved food safety, regulatory compliance, better operational efficiency, etc. In addition, you can use barcode technology or IoT devices. These will help you track products faster and better and contribute to a food traceability system.
FoodReady food traceability software handles traceability procedures and will help you get FSMA 204-ready. With FoodReady, you will follow the FSMA 204 readiness roadmap, a structured approach for FSMA compliance by January 2026.
We help food companies identify gaps and areas for improvement, plan implementations, assign tasks, and track progress using customizable systems. However overwhelming FSMA compliance can be, we strive to minimize the hustle and increase your chances of success.
12. Continuous Improvement: Maintaining FSMA 204 Compliance
Compliance with the FSMA 204 rule is not a one-time task. You must continuously monitor and update your food production to meet regulatory requirements.
Regular process reviews will help you identify gaps in data collection, inefficiencies, or significant supply chain changes. For instance, you should audit your CTEs and KDEs’ performance to ensure they are correctly recorded and easily accessible.
Continuous improvement is crucial when your business scales, regulations change, or technologies emerge. Consistent updates also build a more resilient and interoperable food safety system.
The Role of GS1 in FSMA 204 Compliance
GS1 standards help make food traceability systems interoperable and scalable by providing a universal framework for data exchange and traceability. This helps food manufacturers achieve FSMA 204 compliance.
GS1 standards will allow companies to capture and share Key Data Elements (KDEs) at Critical Tracking Events (CTEs), which is vital for efficient traceability rule implementation.
GS1 makes using barcodes and RFID tags easier, streamlining data collection and improving traceability efficiency. Adhering to these standards and technologies enhances supply chain transparency.
This means you will respond to recalls faster and demonstrate a proactive approach to food safety.
What Are the Challenges of FSMA 204 Implementation?
The food traceability rule is demanding and can be challenging. The first challenge is understanding the rule requirements, CTEs, and KDEs.
In addition, companies that use outdated data management systems need to transition to a modern record-keeping framework, which can involve time, training, and extra cost.
Regarding expenses, FSMA 204 implementation costs can be high and become an obstacle for smaller companies with tight budgets.
It’s also challenging to ensure interoperability across the supply chain and coordinate supply chain partners so everyone is aligned. Global supply chains are complex, making it more difficult to manage traceability.
Another hidden obstacle is resistance to change when working on FSMA compliance—employees may see it as a burden.
It’s not only a food manufacturer who finds inconveniences when trying to implement the rule. Indeed, the requirements can be hard to follow, and they are widely discussed in the food industry.
Last spring, the Reagan-Udall Foundation conducted a series of roundtable discussions, based on which they resealed a report.
They mentioned concerns about the final rule, such as a low awareness level, lack of traceability lot codes and labeling standardization, lack of warehouse management capabilities, implementation schedule, etc.
FSMA compliance challenges are recognized, and leading organizations strive to help businesses grow awareness and improve compliance. Eight leading organizations, including GS1 US, the Food Industry Association (FMI), the Association of Food & Drug Officials (AFDO), the Institute of Food Technologists (IFT), and others, formed a collaboration to tackle the food Industry’s FSMA rule 204 challenges.
To avoid issues and overcome the implementation obstacles, you can address professionals who will guide you through the process and alleviate the hustle.
Get FSMA 204-Compliant With Our Expert Guidance and Software.
If you are searching for a digital solution to manage your food traceability records and FSMA compliance, we are here to help. FoodReady food traceability software is a universal tool that will help you implement the final rule in your business.
The software enables food manufacturers to comply with regulatory requirements efficiently by automating the capture and management of KDEs and CTEs. You can feel safe regarding your records as they will be stored on a secure cloud platform and easily accessible when needed.
Our technology helps eliminate human error and minimize time-consuming processes associated with manual tracking methods. Moreover, it offers real-time visibility into the product movement in the supply chain.
The software has advanced features, including lot tracking, monitoring, supplier management, and GS1 barcode scanning, that help high-risk food manufacturers comply with FSMA 204.
Moreover, we offer comprehensive consulting services. Our experts will guide you through the most intricate and challenging aspects.
They will help you find areas for improvement, prepare documentation, conduct a mock recall, and prepare for a food safety audit.
Many reputable companies, including Leelanau Coffee Roasting and Eurobake, are our clients with whom we have helped comply with the FDA and FSMA regulations. Become our client and benefit from a modern and convenient food traceability platform—book a demo to learn more!
Key Takeaways
FSMA 204 compliance is a complex process that requires you, as a food business, to build a solid implementation strategy.
The strategy will include building awareness, training, managing a food traceability program, supplier coordination, mock recalls, software adoption, and other crucial steps.
Adhering to food traceability rule requirements is a hurdle. Costly implementation, lack of knowledge, and complex requirements can test your patience and resilience, but it’s worth it in the long run.
At FoodReady, we are here to help you overcome obstacles and build a successful FSMA 204 implementation plan. Our features and services will give you more opportunities to thrive and efficiently manage your food traceability. Contact us to find out more!
FAQs
Compliance with the Food Traceability Rule ensures regulatory adherence, proves dedication to food safety, builds consumer trust, and minimizes recall risks.
The FDA plans to update the FTL every five years.
Noncompliance with FSMA 204 can lead to adverse outcomes, including fines, suspended registration, product seizure, import or export restrictions, recalls, or, in extreme cases, legal punishment.
Communicate with your suppliers and try to align with them. In a worst-case scenario, if your suppliers violate the food traceability rule, consider finding new suppliers to avoid regulatory penalties. However, this can be an extra challenge, as it may not be practical or cost-effective.
Yes, the food traceability rule covers restaurants, and they must keep traceability of certain food items.
However, there are some exemptions. For instance, the rule does not regulate small restaurants whose average annual monetary value of food sold or provided during the previous 3-year period is less than $250,000.
