A practical approach to FSMA compliance

Is your food business preparing to be FSMA compliant?

This is the second article in a series about how FSMA rules affect food-industry businesses.

The Food Safety Modernization Act (FSMA) affects all sectors and the operations of companies throughout the food supply chain, from farm to fork. Yet, the act will affect companies of different sizes to varying degrees. Large food companies, with deeper pockets and bigger staffs, are generally better prepared. Small companies have longer to comply and are exempt from certain rules based on their size. It is midsize companies that seem to feel the most anxiety over FSMA compliance. They lack big budgets. And with a limited workforce and skill sets to address such a broad new mandate, prioritizing and implementing actions can be daunting. What’s more, many of their customers are larger food companies, which expect them to be FSMA-compliant as soon as possible.

FSMA’s seven rules go into effect in phases beginning as early as September through 2018. In this article, we look at practical steps that all food companies can take now — especially midsize firms — to address the rules’ scope and detail.

1.  Lead from the top with a multi-disciplinary team

Leadership from the C-suite is imperative for a successful transition to FSMA compliance. The C-suite must understand the magnitude of FSMA and the ramifications for non-compliance. Leadership should set the tone, establish a company’s FSMA strategy and provide the resources necessary for an ongoing compliance process, according to one of many articles about FSMA in Food Safety magazine. Once high-level support is established, the formation of a multi-disciplinary team is key. While a quality control or regulatory compliance person or department will be heavily involved, it takes a team of experts from across a company — from food safety, legal and IT (Information Technology), to supply chain, engineering, production, logistics and marketing — to make necessary changes by mandated deadlines. The best team members are those who are respected by their peers, have the support of their immediate supervisors and are good at delegating tasks. 

2.  Reach out to partners and customers

Communication with partners is one of the best ways to create a supply chain that supports FSMA compliance. Ask suppliers, transportation companies and logistics providers about their processes and operations as they pertain to sources for products, how they handle them in their facilities, and where they are sent further down the supply chain. Do suppliers use up-to-date qualification and audit methods? Do their product- or ingredient-testing methods meet certification requirements?

Companies should also reach out to their customers. A pattern of complaints from customers, for instance, can indicate a problem, according to Food Safety. A customer’s heads-up can help identify where the problem is occurring within production or distribution as well as its cause — such as an issue with packaging, refrigeration or handling. With as many details gathered from customers as possible, it will be easier to correct problems or prevent similar ones from occurring in the future.

3.  Create and execute a plan

An effective FSMA plan will evaluate the following elements, according to Kelley and Drye, a law firm that advises food companies about FSMA compliance.

  • Current hazard-analysis plans for hazards, critical control points, auditing and documentation. The written plan should include updated guidelines for production and material-handling processes, equipment and facility sanitation, allergen cross-contamination and the entire supply chain.
  • Records and capabilities for tracing every product movement forward and backward. Suppliers should be able to produce proof of forward and backward lot traceability.
  • A protocol for product recalls that enables a company to respond quickly to minimize any impact on customers.  In fact, many mid-sized firms have already put protocols in place for recalls and product tracing. FSMA rules accelerate the need for effective processes in these areas.
  • Whether facility records are ready for inspection by FSMA authorities. Understanding records guidelines as they are part of FSMA rules will help the team bring records up to date.

4.  Train employees

Preparing for FSMA does not end with process changes or upgraded equipment. Involvement extends from the c-suite and FSMA team to employees throughout the company. Be sure they understand all FSMA regulations that affect the firm and put measures in place to encourage their participation. Successful compliance requires long-term learning and ongoing awareness, so it is important for managers to regularly set aside time to review FSMA updates with workers. In addition, employees should have easy access to the Food and Drug Administration (FDA) website to stay current on guidance documents, FSMA-sponsored trainings and rule changes.

FSMA is a work in progress

The FDA has stated that FSMA will continue to evolve to support the continuous process of providing safe food for consumers, as reported in Food Engineering. Consequently, food companies should anticipate the need to be flexible and adapt to changes as needed. Establishing a FSMA protocol and then letting it sit idle could make a company vulnerable once again. By maintaining a cross-functional FSMA team that encourages regular communication, training and financial support, a company can maintain a sustainable and consistent approach to FSMA compliance from rollout to long into the future.