FSMA Compliance Tips from the Life Sciences Industry

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.

1. 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.
2. 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.
3. 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.
4. 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.