The Ultimate Guide to FSMA Compliance Checklist

Complete Guide to Writing Maintenance Report

On January 4, 2011, the Food Safety Modernization Act (FSMA) was signed into law by then US President Barack Obama. The goal of FSMA was to modernize food safety, and one of the ways it did this was by creating a compliance checklist for food producers. 

Fast forward to today, and the FSMA compliance checklist is now an essential part of exporting food to the United States. But what exactly is an FSMA checklist, and how can you make one for your food exporting business?

If you are looking to export your food products to the United States, then you must comply with FSMA standards. This article will talk about what FSMA is and how to create an FSMA compliance checklist for your business.


What is FSMA?

The Food Safety Monitoring Act (FSMA) is a United States federal law that was enacted in 2011. The FSMA is overseen by the Food and Drug Administration (FDA) and sets forth regulations for food safety. It has two main goals: to prevent foodborne illnesses and ensure that the United States’ food supply is safe. The FSMA currently provides seven major rules for food companies to follow compliance with food exporting standards.


What is an FSMA Compliance Checklist?

An FSMA compliance checklist is a type of monitoring tool used by food producers to ensure compliance with FSMA regulations. The checklist helps food producers track their progress in meeting FSMA standards and identify areas where they need to improve.

An FSMA checklist usually specifies the scope and personnel (e.g., designating a competent sanitation manager and auditor) and includes food hazard analysis, validation, and verification of the preventive controls and reanalysis of the established comprehensive food safety program.


7 Major Rules of FSMA Compliance

As mentioned earlier, the FSMA currently provides seven major rules for food companies to follow compliance with food exporting standards. Therefore, all food companies need to implement a food safety program that complies with these rules. Failure to comply with FSMA regulations will result in serious consequences such as fines, lawsuits, product recalls, or a complete shutdown. 


Below is a breakdown of the seven major rules of FSMA compliance to make sure your food safety program is up to par:

Produce Safety Rule

The produce safety rule presents a mandatory federal standard for growing, harvesting, storing, and packing fresh produce. This rule states that it is the farm’s responsibility to protect their crops from contamination by creating requirements for the following areas:

  • Water quality testing
  • Raw manure application
  • Examining grazing areas
  • Employee health and hygiene training


Preventive Controls for Human Food Rule

The Preventative Control for Human Food Rule is a regulation that requires food companies to have a written food safety plan. This rule also establishes new standards for hazard analysis and risk-based preventive controls. 

To comply with this rule, food companies must:

  • Identify food safety hazards
  • Implement and monitor preventive controls
  • Verify that the controls are effective
  • Establish a system to maintain records of the preventive controls


Preventive Controls for Animal Food Rule

The Preventative Controls for Animal Food Rule is similar to the Preventative Controls for Human Food Rule, but it applies to animal food instead. This rule requires companies that manufacture, process, pack, or hold animal food to have a written food safety plan. 

Foreign Supplier Verification Programs (FSVP) Rule

The FSVP Rule is for importers of food products. This rule requires importers to verify that their foreign suppliers produce food that meets US food safety standards. 

To comply with this rule, importers must:

  • Evaluate the risks associated with the food
  • Develop and implement a plan to address the risks
  • Conduct supplier audits
  • Monitor supplier performance
  • Maintain records of the supplier verification activities


Sanitary Transportation of Human and Animal Food

The Sanitary Transportation of Human and Animal Food is a rule that protects food from becoming contaminated during transportation. This rule applies to businesses that transport food by motor or rail vehicle, whether the food is raw, cooked, or processed. 

To comply with this rule, businesses must:

  • Use clean and properly maintained vehicles.
  • Keep food at proper temperature levels during transport
  • Prevent contamination from contact with non-food items
  • Prohibit transportation of food by vehicles that have been used to transport hazardous materials
  • Maintain records of the sanitary transportation activities


Accreditation of Third-party Auditors/Certification Bodies

This rule presents a voluntary program for the accreditation of third-party certification bodies to certify foreign food facilities. The certification bodies will also conduct food safety audits. 

To comply with this rule, certifying bodies must:

  • Be accredited by an accrediting body that FDA recognizes
  • Have a food safety audit and certification program that meets FDA requirements
  • Maintain records of the accreditation activities


Prevention of Intentional Adulteration of Food

The Prevention of Intentional Adulteration rule applies to food facilities required to register with the FDA. This rule establishes risk-based preventive controls to protect against the intentional adulteration of food. 

To comply with this rule, food facilities must:

  • Conduct a vulnerability assessment
  • Develop and implement a food defense plan
  • Monitor the effectiveness of the food defense plan
  • Maintain records of the food defense activities


Tips When Creating an FSMA Compliance Checklist

Now that you know the rules you need to comply with, here are some tips to help you create an effective FSMA compliance checklist:

  • Make sure you understand the requirements of each rule.
  • Identify the hazards associated with your food products.
  • Determine which preventive controls are necessary to address the hazards.
  • Implement the preventive controls and monitor their effectiveness.
  • Maintain records of your FSMA compliance activities.


Create FSMA Compliance Checklist with DATAMYTE

DATAMYTE is the perfect tool for creating FSMA compliance checklists. In addition, our Digital Clipboard is a powerful workflow automation software that can help you create comprehensive workflows that help you stay compliant with the seven major rules of FSMA compliance. 

With the DataMyte Digital Clipboard, you can:

  • Create a comprehensive FSMA compliance checklist
  • Streamline your workflow to ensure compliance
  • Monitor your process to identify areas of improvement
  • Maintain records of your compliance activities
  • Automate data collection
  • Reduce paper usage
  • Improve data accuracy
  • Access real-time reports and dashboards
  • and More!


To learn more about how DATAMYTE can help you with FSMA compliance, contact us today! We’ll be happy to discuss your specific needs and show you how our Digital Clipboard software can streamline your workflow and improve compliance.



By following these tips, you can create an FSMA compliance checklist that will help you ensure a safe and high-quality food supply. Make sure you study and familiarize the seven rules of FSMA compliance to create an effective checklist. Then, stay compliant to avoid penalties and easily export your products to the US. Good luck!



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