With the Food Safety Modernization Act (FSMA) looming, the food and beverage industry faces some of the most sweeping safety regulations since Congress passed the Federal Food, Drug, and Cosmetic Act of 1938, which authorized factory inspections and established standards of identity, quality, and fill-of-container for foods.
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For many food and beverage production companies, compliance with FSMA’s stringent new requirements can seem daunting—even as operating in a world where the threat of contamination, allergen exposure, or package mislabeling seems to be an inevitable part of doing business. Based on the “Food Quality & Safety Survey 2016” conducted by Sparta Systems, only 54 percent of respondents say their organizations are compliant with the finalized FSMA regulations.
Regulations Across the Board
The food and beverage industry is increasingly experiencing tighter controls similar to regulations that have been in place in the life science industry for years, including pharmaceuticals and medical devices. These life science companies have established many similar programs that ensure compliance to federal safety regulations—in particular, the need to partner preventive controls with supply chain traceability in identifying and managing the risks of a product recall.
Recall response planning is a critical element for any business, but food is especially vulnerable. A browse through the FDA’s recall database shows a preponderance of recent food-related problems—from a massive recall due to traces of Listeria in private-label organic frozen vegetables, to undeclared peanut allergens in private label grocery cakes and cookies. Many of the root causes of these issues could have been caught early in the supply chain process through improved preventive controls, including timely supplier audits.
In the past, most food and beverage companies and their suppliers relied on a certificate of analysis, documenting the understood agreement that the supplier had proper controls in place and was delivering a safe product. Now, under FSMA, food and beverage companies are accountable for the quality of their supply chain and must adhere to strict supplier process verification guidelines, including the requirement to share product data, conduct supplier audits, and conduct quality assurance testing. While this process may seem intimidating to food and beverage companies, supply chain traceability and QA are long-standing practices in life sciences. To ensure the highest standard of quality and preserve patient safety, pharmaceutical companies have processes in place to ensure adherence to current Good Manufacturing Practices. This vendor oversight extends to the increasing number of contracted manufacturers who do everything from supplying active pharmaceutical ingredients to commercializing and distributing products.
Conducting both internal and partner audits is also standard practice for pharmaceutical companies to gauge the robustness of their quality system. These audits effectively evaluate the company’s and suppliers’ alignment with the principles in the quality system, ensure consistent, high-quality production, and embrace a state of continuous improvement—the foundational aspects of a culture of product safety. All of these aspects are elements of FSMA.
More Defined Label Layout?
Another similarity between current life science practices and new FSMA regulations is the requirement to maintain supply chain traceability—something that pharmaceutical and medical device manufacturers have been practicing for years.
When the FDA passed the standardized labeling guidelines known as Unique Device Identification (UDI) and National Drug Code (NDC) for medical devices, the intention was to increase public insight into the item’s production history, while providing a more efficient way to identify and manage product recalls.
The key to identifying a product and its manufacturing lineage is the standardized barcode, such as the international GS1 Standard. The Global Trade Item Number in the GS1 standard means that the identification information on every product’s label has the same look and feel, printed in clearly identified human readable text.
This information is also encoded in a printed barcode on the product label, similar to the UPC barcode on all consumer packaged food and beverage goods, which allows the manufacturer, distributor, or wholesaler to easily scan and track the product from supply to manufacturing and all the way to the consumer. This “track and trace” concept is crucial in managing the product through the supply chain. The barcodes can also include product serialization, depending on the need to track individual products or whole lots or batches.
The efforts to track and trace products in the life sciences arena suggest a similar evolutionary path for food and beverage labeling. Under the NDC and UDI, the FDA and pharmaceutical industry had a clearly defined layout upfront for what information should be included in the new label markings, and what industry or international standards should be followed. A similar goal and definition has not yet been established for the food and beverage industry. The Global Food Safety Initiative (GFSI) is aware of the topic and has begun some discussions, and the GS1 consortium is now in the early stages of examining this issue relative to applying the GS1 standard to the food and beverage industry. But clear goals and guidelines must be established before the food and beverage industry can begin to address this next step.
Get Started on the Basics
While some food and beverage companies are confident in their efforts to comply with FSMA, others may benefit from following a few basic steps to get started on their compliance journey.
- Centralize the audit function. Food and beverage companies can combine different types of audits from their suppliers and co-manufacturers into a centralized audit format. Combining the audit agenda into core elements can help reduce the redundancy of asking for the same topic in each audit. For example, a manufacturing, QA, and environmental safety audit could share core elements to be merged into a single agenda, enabling a team of two auditors to visit the co-manufacturer or supplier during their prescribed visit time and eliminate the need for at least one additional audit.
- Optimize audit readiness. This year, the Safe Quality Food (SQF) organization, which provides a safety certification framework around a company’s food safety practices, instituted unannounced audits in their certification process which consequently will more closely mirror the FDA’s use of unannounced inspections. Normally within SQF, organizations will undergo a scheduled audit every three certification cycles (possibly four to five years between each audit). This gives the company time to plan and prepare for the audit. Unscheduled audits, however, can be intimidating as companies have much less time to prepare. Typically, a company must scramble to complete activities and hope that it is acceptable to the auditor. A new approach focuses on a constant state of audit readiness to ensure that the company is always prepared for an audit and can be assessed at any given time through on-demand access to real-time metrics, with the areas of focus assessed for risk and impact. A common practice in the life science industry is to perform mock audits to enable this state of readiness.
- Get certified. By becoming certified under GFSI, a food or beverage company signals to the world that they are operating under the highest industry standards. Although mandatory audits are still required, becoming certified may reduce the probability for a company to be hit with random audits. The certification process itself helps improve overall process management by instilling processes that proactively identify and manage risks. It also gives the FDA and local authorities confidence that the food or beverage provider is serious about a food safety culture.
- Develop a roadmap for recalls and corrective action. Having systems to verify and document that your suppliers are meeting your expectations with respect to food safety, and having a well-documented, exercised recall plan in case things go wrong are necessary steps to be able to respond to possible FDA inspection findings. It is also essential to be proactive and have a well thought-out corrective action process and plan of attack. Corrective action plans involve the development of a process and procedure to describe who, what, when, where, and how the company will address any identified problems. Training and rehearsing these response plans before an actual event helps ensure proper readiness, reduces overall response-time, and lessens the overall level of panic that often accompanies these events.
Grzesiak is managing director at Integrated Project Management Co., Inc. (IPM). Reach him at email@example.com. Manno is a senior project management consultant at IPM. Reach him at firstname.lastname@example.org.
Case Studies: Three examples of food traceability tracking
As part of expanding the GS1 standards for food and beverage companies in the U.S. and abroad, the Product Traceability Initiative (PTI) is designed to help maximize the effectiveness of existing trace-back procedures while standardizing the improved speed and efficiency of future traceability systems.
Three recent examples of improving this process involve food and beverage businesses integrating PTI best practices into their existing systems and experiencing improved results.
- Global produce supplier Oppenheimer Group, Safeway, and iTradeNetwork collaborated on a pilot for implementing produce traceability via the Advance Ship Notice system. This is conducted over the Internet in an electronic data information or extensible markup language format, providing information about when an order will be shipped and other information, including mode of transportation and carrier. Benefits include reduced costs for both suppliers and receivers due to not using Hybrid Pallet Labels; improved inventory and warehouse management for receivers due to advanced visibility of shipment; and elimination of “missing data” errors and the avoidance of labor of having to scan barcodes on each individual case.
- In response to repeated disease outbreaks at the burrito chain’s stores, Chipotle Mexican Grill is working with leading food experts—including a former FDA official—to find ways to prevent future health problems. A spokesperson from the chain said the restaurant has cut some smaller suppliers and is focusing on food traceability as a way to minimize contamination. Chipotle has partnered with traceability solution provider Food LogiQ to implement a traceability program based on GS1 standards for sharing standardized product information at each step along the supply chain. The collaboration resulted in improved QA and logistics efficiencies; real-time visibility of food at each point in the supply chain; improved stock recovery process; the ability to capture and share quality attributes throughout the supply chain and enhance reporting at the restaurant level; and more direct access to supplier-provided information about sustainability efforts.
- Leading Polish food retailer JMP (Jeronimo Martins Poland), through its Biedronka stores, implemented Global Trade Item Number on its variable measure fresh products such as meats, poultry, fresh salads, bread, dairy, and fish with GS1 barcodes. The switch enabled the chain to manage the expiration date of products in an automated way at the point of sale, ensuring that the products meet freshness quality standards, and are traceable in the event of a recall.—S.G. and C.M.