United States

13 FSMA responsibilities you cannot fail to meet


The Food Safety Modernization Act (FSMA) emphasizes proactive procedures rather than a reactive response. It enables the FDA to initiate preemptive measures to safeguard public health. The FSMA includes five mandates, including: prevention, inspections and compliance, response, imports and enhanced partnerships. In addition to specifying the five broad mandates and their subsections, the FSMA provides detailed guidelines for organizations to follow when developing food safety documentation. The following is a summation of 13 FSMA key responsibilities that organizations must consider as they work to comply with the law

  1. The FSMA requires that a written plan be prepared to detail the company’s procedures for the safe management of food products. The plan must follow basic food safety protocols including: evaluating hazards, implementing and monitoring preventative controls, performing corrective actions, responding to various hazards and other steps as required.
  2. Companies must ensure management involvement in the food safety plan. The involvement may be from an authorized individual or a team, depending on the size of the company.
  3. The written plan should be in an easily accessible location, preferably in both hard copy and soft copy. The hard copy should be protected in a waterproof container.
  4. Plan documentation should include both building and facility maps, as well as process flow maps for food processing.
  5. Companies must maintain accurate documentation on how ingredients enter the facility and the location of all finished goods.
  6. Companies must have a detailed written recall action plan for tracing products after distribution.
  7. A checklist must be developed for vendor approval requirements and to ensure the list is maintained, and vendors are checked.
  8. Companies must perform documented tests on finished food goods to ensure against chemical and biological hazards. The tests should be measurable.
  9. Written procedures should be developed for cleaning out containers and storage bins to ensure against cross-contamination. All bulk materials must be stored in a manner that prevents contamination. Ensure all container labels are waterproof and environment-proof.
  10. Safety documentation should include written policies on employee conduct and dress code, as well as procedures to follow concerning restrictions on employee work (i.e., regulations against eating, drinking or smoking while around food products or after contamination with infectious disease). Ensure all employees participate in training programs covering the approved safety plan.
  11. Companies must document cleaning procedures to follow concerning both equipment and facilities. Sanitation processes may include scheduled clean-ups, a spill-handling policy, hand-washing practices, and sewage or septic system inspection.
  12. All food processing facilities must develop an established pest control program to include periodic inspections, building adjustments to ensure pests do not enter the facility, and written records provided by pest control personnel.
  13. Finally, a company must have a written plan with the procedures to guard against intentional contamination of food products. Such procedures may include measures to control employee-building access after-hours, passwords and locks on computer systems, employee background checks, and vehicle and transportation control.

The FSMA was developed following a number of incidents of food-borne illnesses between 2000 and 2010. These incidents underscored the need for greater emphasis on prevention and constant vigilance in protecting our food supply.


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Cristin Singer 
National Food and Beverage Sector Leader