August 3, 2022

From Listeria in ice cream to E. coli in lettuce, there’s one central question in any foodborne illness outbreak: where did the contamination happen? It’s a simple question with often complex answers, requiring detailed supply chain traceability into food manufacturing processes, suppliers and distribution networks. Traceability is the foundation of this visibility and the centerpiece of the FDA’s New Era of Smarter Food Safety initiative.

Focused on creating a safer, more resilient food system, this initiative builds on the Food Safety Modernization Act (FSMA). The goal, according to the FDA, is to create a “more digital, traceable food system.”

In this article, we look at the critical role of traceability in food manufacturing and how the FDA is addressing it. In addition, we’ll explore quality management system (QMS) tools that improve traceability, limit the risk of recalls, and protect consumers.

Why Supply Chain Traceability is Key to Food Safety  

Responding quickly and effectively to food safety incidents demands traceability throughout the food supply chain. As food systems become more complex, tools for detecting and acting on food safety risks must advance to keep pace.

Food-borne illness, contamination, adulteration, and undeclared ingredients all require an ability to identify the root cause and isolate affected products. The problem is that food manufacturers have relied for decades on outdated methods like spreadsheets to manage processes and record keeping.

When a food safety failure does occur, many are left scrambling to determine where it originated, how much product was affected, and where it is in the supply chain. Having this data locked away on paper or spreadsheets makes it take much longer to identify and contain problems. Furthermore, paper can be lost or data may be illegible.  The result is larger, more expensive recalls affecting more products, as well as a greater risk to consumers.

To effectively respond to a food safety failure, you first need to know the location of files to search. In that respect, a big advantage QMS software provides is the ability to capture critical quality data in a central repository.  The result is a reduction in the scope, impact, and cost of quality events, and an acceleration of supply chain traceability.

The FDA’s Blueprint for Smarter Food Safety

The FDA released a Blueprint for Smarter Food Safety outlining how the agency plans to achieve its vision for a new era of food safety. This approach focuses on using emerging technology to improve predictive capabilities and accelerate prevention and outbreak response.

The four core elements of this blueprint are:

  1. Tech-enabled supply chain traceability
  2. Smarter tools and approaches for prevention and outbreak response
  3. New business models and retail modernization
  4. Food safety culture

Furthermore, the FDA has zeroed in on several priorities, including:

  • Standardization of critical tracking events including growing, receiving, transformation, creation, and shipping
  • Standardization of key data elements such as locations, lot codes, quantities, product identifiers, and reference record types and numbers
  • Promoting industry adoption of tech tools such as a digital QMS to enhance food safety
  • Receiving information from companies in digital form to speed up tracebacks and traceforwards
  • Recognizing adoption of strong traceability systems when determining oversight activities such as risk-based planning for agency inspections

Supply Chain Traceability and the QMS

Within the QMS, several tools are critical to helping food manufacturers ensure traceability and fast response to potential issues.

Traceability means that an organization must be able to identify what went into the affected product and at what point in the supply chain. Therefore, two vital processes to have in place are supplier quality management and inbound controls for tracking all lot numbers for components and raw materials. As a result, a traceable system will allow you to drill-down to determine which lots to investigate further.

Tracking supply chain traceability in a digital QMS can help you get to the root cause and contain the problem faster. An automated process helps guide the proper product testing, supplier tracing, and the implementation of corrective actions.

In addition, sanitization processes are another key area where the FDA looks during its investigations. For example, food-borne illness from bacterial growth is hot on the radar. In this case, the FDA will require documentation of sanitization procedures and training records as evidence of quality controls. Again, a digital QMS is key to a timely response. In the event of an FDA 483 observation or warning letter, one thing you don’t have is time to waste.

Companies have just 15 days to respond, highlighting the need for a document control system to access records quickly. Moreover, companies that can’t confirm they know where a problem is coming from can be shut down by the FDA, a move that can potentially put them out of business. The earlier Listeria and E. coli examples above are prime examples of businesses put at risk due to poor visibility.

The International Organization for Standardization (ISO) has standards for food safety as well (ISO 22000).

The Future of Supply Chain Traceability

For now, getting a reliable, scalable quality management platform established is the right place to start. The best enterprise quality management system (EQMS) can provide the technology needed to integrate with future systems if and when the need presents itself.

As technology continues to advance, there are opportunities to advance food safety. Companies that keep pace with technological change have a competitive advantage, compared with those that rely on manual methods.

For instance, blockchain is likely to become a key tool in the fight for a safer food system, providing a permanent digital archive that traces the movement of food from seed to fork. In the future, scanning food from the grocery store will reveal its precise origin.

Products will be traceable back to the grower, manufacturer, batch, and lot number, allowing for faster response to outbreaks and reduced risk to consumers. For instance, Walmart has implemented a blockchain traceability system that has reduced the time it takes to track mangoes from seven days to just 2.2 seconds. Since 2019, the retail giant has required all suppliers of leafy greens to use the blockchain system to help reduce the risk of Listeria outbreaks.

In addition, artificial intelligence (AI) will also likely play a role as the FDA looks to improve its predictive capabilities. For example, the agency hopes to use this technology when screening imported foods at ports of entry. Today, trending tools in a QMS can provide invaluable data for improving quality controls.


In conclusion, food companies can no longer fly under the radar given the FDA’s focus on moving the industry forward technologically. Traceability is everything, with headlines from a single quality escape able to erase stock value and market share. Consequently, these failures can sink a business entirely, and cause changes to industries and supply chains.

The next era of food safety demands that manufacturers use digital tools for tracing products back to raw materials. Just as important, they must be able to trace food forward to any point in the distribution system. In the future, blockchain and AI are likely to become more prominent. For now, companies need to get a handle on more fundamental technology. This includes a digital QMS that fosters traceability and fast response to any identified issues.


About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.

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