Top Considerations for FSMA Traceability Rule Compliance Software
The expected rollout of the new Food Safety Modernization Act (FSMA) Traceability Rule underscores the importance of data management. All foods on the FDA Food Traceability List will be subject to FSMA 204, which requires additional traceability records for those who manufacture, process, pack, or hold these listed foods or use them as ingredients in other products. The right FSMA compliance software ensures that food businesses build the digitized foundation they need to move towards a new era of smarter food safety.
A few years ago, we made a list of questions to ask before buying food production software, pointing out some of the common requirements and pitfalls you may not have thought about in advance. When it comes to traceability requirements, finding an adaptable solution that molds to your unique needs is key to ensuring the safety of your products moving forward.
But with all the emphasis from governments on modernization and data management, there are many companies offering traceability technology because everyone can see that manual systems will no longer cut it in the “new era of food safety.” For non-experts, it can be a challenge to know the difference between what is essential, what is necessary, and what is convenient – let alone tell which systems are functional, user-friendly, and effective. We’ve put together another list of questions to ask when considering the right food compliance software for you, with upcoming traceability requirements in mind.
#1: Will the Software Actually Get You FSMA-Compliant Against the new FDA Traceability Rule?
The goal of the new FDA Traceability Rule is to be able to trace any product in the entire food supply chain “one step forward, one step back” anywhere, anytime. That means that food manufacturers have to manage huge amounts of data points (KDEs or Key Data Elements), which have to be tracked in specific ways and be easily retrievable in order to meet compliance requirements. With the upcoming Rule, the scope of traceability widens to track seeds from farm to the product on a fork, and also narrows down to the granular level of batch and lot codes.
Any traceability software not only needs to be able to reliably track this amount of data, but also be able to format and use that data according to FDA standards and methods. Here are some basic functionalities to watch out for:
- Employees should be able to use the software in their day-to-day operations so that the traceability “paper” trail is accurately maintained. Any backlogs of paperwork can multiply exponentially with thousands of KDEs to track. This means that the traceability system should be user-friendly and integrated into employee workflows.
- The system should be cloud-based, able to update automatically and sync records to provide a clear picture of your operations at any time. This also means that it should be accessible from secure, internet-enabled devices to facilitate remote work and use on the production floor.
- Designed with mandated prerequisite programs in mind, it should store information in a way that is correctly formatted and easily retrieved for inspectors, auditors, and customers so you can generate reports and documentation on the spot.
- To ensure data integrity and security, traceability software should be built and maintained by reputable technology experts, with speedy customer support for emergency situations.
The crucial element is that traceability software be designed according to industry best practices, or more particularly, according to Global Food Safety Initiative (GFSI) standards. With globally recognized traceability systems in place, you can easily meet the regulatory requirements of any government or third-party certification bodies in the future. And if new regulatory changes come down the pipeline, you will be ready for them without needing a system overhaul each time.
#2: Does the Software Support GS1 Barcodes for Automated Traceability?
To identify the right traceability system, you also need to ask about the technical details for tracking thousands of KDEs. It is increasingly common and important to use standardized tracking methods; the most internationally used and recognized systems is the GS1 standard, which enables seamless traceability throughout the supply chain with predictable, data-rich barcodes.
With GS1-compliant barcodes, which include regulatory data like shipping information, important dates (such as the manufacturing date), manufacturer ID, and batch and/or lot code numbers, you can close the data loop by drawing accurate records from your suppliers in Receiving and providing customers and distributors with labels that seamlessly feed into their traceability and logistics systems as well.
All this data in handy barcodes means that you can leverage traceability rule requirements to improve logistics and warehouse management, enabling workers to streamline processes with digital scanners and clear workflows. You can even optimize production; for example, with the data in GS1-compliant barcodes, your staff can automatically prioritize production consumption based on efficiency and shelf-life for minimal waste and maximum product quality.
#3: Can It Help You Prevent Recalls by Integrating with Food Safety Software?
A good traceability solution doesn’t just help you conduct an expensive recall – it helps you prevent them in the first place. The right traceability software should provide insights and analytics into production in real-time, helping you stay on track for compliance and stay ahead of problems.
The truly great traceability systems will also be integrated with your food safety program. It is no coincidence that the KDEs you need to track for traceability overlap with the Critical Control Points (CCPs) you need to track for preventative food safety systems. Software that brings these areas of your business together not only gives you a picture of what is going on, but tells you what to do when something goes wrong – and even better, tells you that something is about to go wrong before it becomes a problem in the first place.
Look for systems that provide real-time monitoring, alerts, and automatic tasks according to the practices laid out in your SOPs (including procedures for corrective actions). Laboratory management integration is also a major benefit, as the system will alert you immediately when a test result comes back out of range or indicates an issue. With preventative controls in place along with the ability to respond rapidly to problems, you can avoid potential recalls and compliance penalties.
#4: Does the Software Reduce Your Business’ Overall Cost of Compliance?
Whether you are a small food producer or a large corporation, FSMA Traceability Rule compliance doesn’t have to be costly or time-consuming, although it might seem that way now. The right traceability software has to be at the price point that you can reasonably afford, but be wary of systems that seem too good to be true.
Investing in traceability software – even free software – requires a lot of work. Processes need to be created, implemented, and maintained in every aspect of your operations. It is critical to make good decisions at the outset so that this work is put to good use. Good functionality, decent customer support, and reliable service are all aspects that cannot be compromised without threatening the integrity of the supply chain and your business’ operations.
Given the investment required, you should make sure that the software returns on that investment beyond compliance with government regulations. Look for additional advantages that will benefit your bottom line, like:
- Centralized data and smooth communication: Data collected should be shared effectively to facilitate inter-department communication and productivity, as well as streamline training and workflows.
- Production analytics and insights in the form of dashboards and reporting mechanisms: Generating reports isn’t just for inspectors and auditors. The data required for traceability can also help you identify operational inefficiencies, from optimizing equipment downtime to prioritizing your products according to shelf-life to minimize waste. It can also help you trend data on production and sales, as well as monitor quality control, customer complaints, and more.
- Adaptability and scalability: When choosing traceability software, you should assume that you need a traceability system that can grow with you. That means you need something that is flexible enough to adapt to new regulatory requirements, but also to achieve compliance in new markets and with third-party certifications that can expand your business (for example, allergen-free standards for which stellar traceability is essential).
With the right FSMA software, you can meet the upcoming FSMA Traceability Rule requirements with confidence and transform your business for the new era ahead, taking the benefits beyond traceability and into food safety, vendor management, inventory control, shipping and receiving, sales, accounting, and more – saving time and preventing costly mistakes and waste.
Icicle goes beyond taking your systems paperless. Members of the Icicle Community gain valuable insights to optimize operations, maintain audit-readiness against the latest industry standards, and unlock the agility needed to exceed business goals. Interested in elevating your food production operations with the Icicle Community? Get in touch to discover how Icicle’s unified systems can help you amplify success.