It’s 2017: Are you ready for FSMA?

by | Jul 11, 2017

Food Safety Modernization

The Food Safety Modernization Act (FSMA) marks a sweeping change for the FDA, and this new, final rule covering preventive controls for the safety of human foods has been enforced since September 2016, with some parts of the rule being fully enforced for large businesses beginning in April of 2017.

If you aren’t ready yet, you are already behind.

How does your company prepare for this landscape of new requirements? How do you ensure that the plan you have in place is clear for your employees and your suppliers? What tools can you use to plan effectively and logically for the coming increased scrutiny of supply chain regulations?

The answers to these questions lie in education, communication, and automation.

FSMA Education

A quick internet search will reveal mounds of information written about each new requirement of the Food Safety Modernization Act. Consuming and comprehending all of this new information is time-consuming but critical.

Having a thorough understanding of the new regulations will assist in shaping your long-term strategic approach to compliance. Your knowledge of the requirements, and how the FDA will be interpreting these requirements, is key to your success.

The FDA website provides an overview of the four key areas boasting the new FSMA requirements:

  • Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for a written food safety plan.
  • The definition of a “farm” is clarified to address the difference between “primary production farms” and “secondary activities farms” and the regulations around each.
  • New supply-chain requirements around risk-based programs, approved suppliers, preventative controls, and supplier verifications.
  • Updates to the Current Good Manufacturing Practices

It’s important to treat FSMA like a college course and stay current on any updates or discussions around the new act and watch for opportunities to interact with regulators through industry forums and events.

FSMA Communication

The overarching goal of the Food Safety Modernization Act is to keep our food supply safe by acting proactively, rather than reactively. Companies that fall under this regulation should now seek to prevent contamination, rather than just respond to it. As a result, there should be increased confidence in the food that consumers eat, as well as the companies that supply it–in addition to fewer occurrences of foodborne illness.

It is critical that you communicate effectively with your internal and external partners around FSMA compliance plans.

Internal Partners

Full compliance with the new act will require involvement from many different teams at your organization, including, but not limited to:

  • Quality Control
  • Shipping
  • Legal
  • IT
  • Procurement

Each of these departments will be involved in the development, implementation, execution, and measurement of your ongoing FSMA compliance.

In addition to working with leaders from each of these teams to ensure you create a holistic approach to complying with the FDA’s new regulations, you must also ensure that compliance and food safety become a standard part of your company culture, communicated by managers to all contributors. Ongoing training across relevant teams will help develop an internal expertise around your products and the processes of your company food safety plan.

External Partners

Because external partners are a critical link in the chain of FSMA compliance, your communications with them must be strategic and tactical. When considering your relationship with suppliers, you must not only weigh costs and quality of their products but their ability and willingness to comply with regulations. Under the new Act, the FDA will expect you to validate that you have approved your suppliers and continually monitor them for ongoing compliance with your food safety plan.

FSMA Automation

Clearly, a number of the new requirements outlined in the Food Safety Modernization Act can be tracked with software and technology solutions designed to help with process auditing, reporting, and alerts when items need corrective action. All facilities–including those that transport, hold or receive food–must keep records of their internal risk audits and food safety plans; plus, these records must be accessible on-demand.

In a recent interview, Joann Givens, co-chair for the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, answered questions about the forthcoming act enforcement by saying:

Facilities should set up a thorough system for documenting what they do. The better the records, the more a company can demonstrate that it is meeting the legal standard. Put processes in place to prevent problems in the first place, and consider having some redundancy in the system so that if one measure fails, another can take its place… If there is a problem, state or federal investigators will ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for the problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees?

Technology solutions that make compliance auditing automated and easy are the best way to meet the FSMA requirements and protect your brand. An end-to-end software solution, like RizePoint, can help ensure that your food safety plan and compliance is well documented and accessible as it is used to guide your adoption of the FSMA.

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