The Final FSMA Rules are Here: It’s Time to Comply

The U.S. Food and Drug Administrations’ Food Safety Modernization Act (FSMA) is among the most significant legislative changes impacting the global food supply chain and represents the most sweeping change to food safety laws in more than 70 years. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. In short, FSMA requires greater transparency from the entire supply chain and fundamentally changes the way food is regulated in the U.S. and abroad, from farm-to-fork.

Now that the FSMA deadlines have arrived, there is much anticipation and uncertainty about compliance. Food facilities will have only 1 to 3 years to comply, depending on the size of the business. To date, the implementation of the new FSMA rules and regulations has been slow. Because the set date for noncompliance penalties is still flexible, some food manufacturers are crawling to participate. While no one doubts the eventuality of FSMA’s impact, many companies are waiting for the rules—and corresponding enforcement and penalties—to become clearer.

Smart food retailers and manufactures need to start taking steps to comply now—compliance isn’t something that can be done overnight. It is time to get educated on the FSMA requirements, talk to partners and customers, assemble internal compliance teams, understand what programs are in place, identify gaps that exist, and prioritize issues based on available resources. With that in mind, here are five tips to jump start your FSMA compliance efforts now:

Get Educated on Requirements
There are seven key regulations under FSMA that have been proposed. Your requirements differ if you are a food retailer, supplier or manufacturer and if the products you sell are domestically produced or internationally sourced. Do not limit efforts to advance food safety to just upgrading equipment and process changes. More importantly, you also must train your employees.

Ensure team members understand all regulations that affect your company and have measures in place to encourage active participation by all employees. Compliance training should not be thought of as “just training” because it’s about long-term learning and awareness. It is important that managers set aside time on a regular basis to review relevant FSMA compliance information with their employees. Employees should have access to the FDA’s website so they can stay current on future guidance documents, proposed rules and final rules concerning FSMA.

Talk with Your Partners and Listen to Your Customers
The heightened transparency into supply chain operations means companies need to provide additional documentation in order to meet FSMA standards. One of the best ways to collect information to prepare for FSMA is to ask questions of your organization’s carriers, third-party logistics providers and suppliers. Ask your partners:

“Where did you get product?”
“What did you do with it in your facility?”
“Where did you send it?”

They should be able to provide proof of forward and backward lot traceability. Food regulations can even change state to state, so it is important to also consider where your partners are located and their insight into local compliance regulations.

Beyond talking to food manufacturing partners, companies need to lend an ear to their customers. For instance, if there is a pattern of complaints coming from your customers, take notice. Make sure to identify where the problem is occurring within the production and distribution cycle, as well as the context of the problem. Is it packaging integrity? Temperature or time sensitivity? The more details you glean from your customers, the easier it is to direct corrective and preventative action.

Create a FSMA Compliance Team
Now that your organization has done the FSMA background research, you need to create a team that is focused on meeting regulations. Regardless of the size of a company, implementing a FSMA compliance team requires a company’s leadership to sets the tone for the organization’s culture and strategy, and provides the discipline and resources needed to implement a sustainable process. A multifunctional team should include members from the C-Suite down, including top management, and members with experience across multiple disciplines including food safety, legal, IT, supply chain, engineering and marketing.

The best-performing food manufacturing companies are reexamining which compliance and risk management activities they perform and how—not just within the risk and compliance departments, but across the entire organization. These organizations encourage active participation with a commitment for change and compliance improvement at all levels.

Review Your Current Systems and Processes
The FDA’s expanded access to company records will be one of the biggest regulatory changes under the FSMA. Requirements to improve record-keeping are sprinkled throughout the act, including the preventive controls provision and the foreign supplier verification program. Companies will also have to make their hazard analyses accessible to the FDA, in addition to keeping records of their monitoring processes and any corrective measures they took in response to potential problems. Finally, organizations will have to maintain documentation to show their sanitation and bacteria-elimination procedures are effective.

A company’s review of its current compliance measures usually starts with an audit. Most organizations become anxious about audits because they fear the unknown; however, the audit process is not designed to be a “surprise attack” and is meant to help improve operations. Some questions to consider preparing for an audit include:

“Are compliance measures followed?”
“Is monitoring and documentation accurate?”
“Are we able to evaluate trends and document corrective actions?”
“Do we have adequate record keeping policies in place?”

The audit process will help identify possible gaps before they become an issue.

Invest in Technology
A main component of these new FSMA regulations will encompass data tracking, management and control mechanisms. Investing in manufacturing and quality software that sufficiently monitors products throughout the entire production process, and provides accurate records for the FDA and state government officials, is imperative for future compliance with FSMA.

The good news is that cloud-based technology now exists to help food manufacturers meet FSMA requirements while working to prevent foodborne outbreaks and quickly limit outbreaks when they do occur. This technology goes beyond just storing digital copies of documents—it helps to manage compliance with exception-based alerts for expired, missing or inaccurate records. Real-time predictive analytics are also vital to help food manufacturers understand what could happen based on trends or if there are parameter changes, providing critical support to foresee issues and make decisions before an event occurs.

Organizations need to take a step back and ask themselves, what kind of functionality does our food supply chain management system have? Is it enough? A wealth of solutions are available—from lot and bar-code tracking to radio-frequency identification—that can facilitate information sharing among multiple supply chain partners. In addition, advanced software technology with predictive analytics may leverage robust modeling engines and multivariate analysis to preempt alarm and failure events based on historical models. If your current operations do not have these real-time data analytic capabilities in place—get them!

Waiting for the government to force your company to update its technology could mean lost customers and lost revenue. Complying with FSMA does not have to represent a significant one-time investment in technology. Proactively implementing cloud-based technology will streamline current processes, reduce overhead, and support new customer or regulatory requirements—naturally putting your organization in a position to sell more and grow its market share.

Why Wait? Act Now!
There is no need to wait for the FDA to demand that your organization takes action. In fact, your company shouldn’t wait to take action since many of the requirements of the FSMA are already in place. Implement a compliance program now and establish, monitor and maintain protocols for identifying food product hazards or defects in a timely manner. Improve system capabilities to track food production from source materials all the way through to the finished product in order to provide the best insight into how the food product was manufactured.

Although the FSMA will impact every aspect of a food manufacturer and will require additional resources up front, the long-term benefits of happy and loyal customers are immeasurable. Building a food supply chain that protects your brand’s reputation from risk is more important now than ever before. Having a well-documented food production plan and utilizing real-time predictive analytics is crucial for the continued success and vitality of your business. Remember, the FSMA regulations are bound to naturally evolve over time so organizations need to be flexible and adapt to these changes as needed. The biggest mistake food manufacturers can make now with FSMA compliance is to sit idle until they are forced to take action.