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FSMA compliance: A comprehensive guide for food safety

FSMA compliance: A comprehensive guide for food safety

Author NameBy Ima Ocon
•
December 23rd, 2024
• 9 min read
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Table of contents

  • What is FSMA?
  • 6 rules of FSMA compliance
  • Requirements for FSMA audits
  • Best practices for FSMA compliance
  • A digital solution for your FSMA compliance checklist
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Summary

This guide explains the key rules of FSMA compliance, including preventive controls, audits, and safety practices. Learn actionable steps and strategies to meet regulatory requirements.

The Food Safety Modernization Act (FSMA) has fundamentally changed how food safety is managed in the United States. This groundbreaking law emphasizes prevention over reaction. For companies involved in the U.S. food supply chain, understanding FSMA is a regulatory necessity–as well as a pathway to ensuring safer practices and building consumer trust.

This guide will explain how FSMA compliance works, along with best practices and actionable steps to achieve compliance so you can build a robust food safety system.

What is FSMA?

The Food Safety Modernization Act (FSMA) is a landmark U.S. law that transformed food safety regulations. It came into force under President Obama in 2011 and described food safety modernization, with a focus on proactively preventing contamination issues. Its goal is to ensure a safe and high-quality food supply.

The FSMA preventive controls apply to the 75% of food supplies regulated by the Food and Drug Administration (FDA) . Compliance with the FSMA is essential for companies exporting food products to the U.S.–otherwise they face legal hurdles or even shipment rejections

Under US food regulation, preventive controls such as those conducted by the Food and Drug Administration (FDA) can be applied. There are also regular food safety inspections to ensure that imported products meet applicable USA standards.

6 rules of FSMA compliance

Updating food safety management systems is particularly important for food businesses involved in the US food supply to ensure FSMA compliance. The consumer should be able to rely on the safety of the food they buy. Accordingly, it is essential to implement a food safety program that complies with FSMA requirements.

Here are the most important rules for FSMA compliance:

Preventive control for human and animal food

This requires facilities to identify potential hazards in food production and implement controls for them. Controls range from processing and packing to storage, addressing risks like:

  • Biological pathogens
  • Chemical contaminants
  • Physical hazards

For businesses producing food for both humans and animals, compliance means creating and maintaining a written food safety plan. This plan outlines hazard analyses, preventive controls, and protocols to monitor and confirm that controls are effective.

Produce safety

The produce safety rule sets science-based standards for the safe production of fruits and vegetables. It covers growing, harvesting, packing, and holding produce. Areas of concern include:

  • Water quality
  • Soil amendments (like manure)
  • Worker hygiene
  • Presence of animals in growing areas

By addressing these factors, the rule helps prevent contamination by harmful pathogens such as E. coli and Salmonella. Compliance involves testing agricultural water regularly, implementing safe composting methods, and ensuring proper handwashing facilities for workers. It also mandates training for farm staff on food safety practices and documenting these.

Foreign Supplier Verification Programme (FSVP)

Another requirement is foreign suppliers to US food importers should meet FDA food safety standards. This rule makes importers accountable since they must verify that their suppliers are producing food as safely as domestic producers. Verification methods might be audits, hazard analyses, and regular performance evaluations.

To comply with the FSVP, importers must keep detailed records of their verification activities, including supplier certifications and corrective actions taken when issues arise. With this rule, consumers can be protected no matter where their food comes from.

Certification by accredited third parties

This rule allows independent certification bodies to assess and verify that foreign food facilities are complying with US safety standards. Certification bodies accredited by the FDA conduct audits to ensure compliance with FSMA regulations, then issue certificates as proof. This system helps streamline the import process.

With the certifications, businesses exporting to the US can reduce the risk of their shipments getting delayed or even rejected.

Sanitary transport

The FSMA also sets standards for transporting food safely to prevent contamination during the process. This applies to shippers, loaders, carriers, and receivers who are involved in transporting food within the U.S. The requirements include:

  • Ensuring that vehicles are clean and maintained
  • Maintaining proper temperature controls for perishable items
  • Protecting food from physical and microbial contamination

Clear communication between all parties in the transportation process is necessary. For example, carriers must provide documentation of cleaning procedures and temperature logs when requested. Training employees on sanitary practices during loading and unloading is also crucial.

Deliberate adulteration rule

This rule focuses on protecting the food supply from intentional acts of contamination, including those motivated by terrorism. Food facilities are required to conduct vulnerability assessments and implement ways to reduce risks. They must consider factors like:

  • Accessibility of food processing areas
  • The criticality of certain ingredients
  • How likely intentional harm is

Businesses must develop and maintain a food defense plan outlining actionable steps to minimize vulnerabilities. This might cover measures like securing access to production areas, training staff to recognize suspicious behavior, and setting up monitoring systems.

Requirements for FSMA audits

Food businesses with annual sales of more than $1 million are required under FSMA’s Preventive Controls for Human Food regulation, to conduct a preventive controls analysis. This includes a hazard analysis and identifying preventive controls. With the help of 6 simple steps, possible risks can be prevented and counteractive measures can be taken. The process for ensuring food safety is as follows:

  1. Identification of hazards: These hazards may include biological agents like pathogens, chemical contaminants such as allergens or pesticides, and physical hazards like metal fragments.
  2. Application of risk-based preventive controls: After identifying hazards, you’ll implement preventive controls to mitigate them, like sanitation procedures and allergen control programs.
  3. Monitoring of the effectiveness of controls: This step involves regularly checking critical control points, such as temperature logs for cold storage.
  4. Take corrective action: If a preventive control fails or a hazard is detected, identify the root cause of the failure and take immediate corrective action to resolve it.
  5. Verification of the implementation and effectiveness of controls: Verification ensures that all controls and corrective actions are not only in place but also effective, usually through audits, product testing, or third-party assessments.
  6. Keeping records and documentation: All throughout, it’s necessary to maintain detailed records of hazard analyses, preventive controls, monitoring results, corrective actions, and verification activities.

Best practices for FSMA compliance

By following these best practices, food businesses can boost the safety and reliability of their operations while boosting their FSMA compliance:

Develop a comprehensive food safety plan

This is based on an in-depth hazard analysis of your business, where you identify risks at every stage of production, including raw material sourcing, processing, packaging, storage, and transportation. You can use tools like HACCP (Hazard Analysis and Critical Control Points) frameworks to map out critical control points (CCPs) where interventions can prevent or reduce hazards. The plan should also outline how often monitoring will happen and who will manage it.

Conduct regular training

Regular employee training is crucial for ensuring FSMA compliance and maintaining high food safety standards. Training should focus on:

  • Familiarizing employees with FSMA requirements
  • Their specific roles in the food safety process
  • Methods for handling and processing food

This isn’t a one-time event, either–there should be ongoing training programs that adapt to new regulatory requirements or updates to the company’s food safety plan.

Leverage technology

Using technology goes a long way towards making FSMA compliance easier because you’ll be automating processes and reducing human error. Even a simple tool like a digital checklist can ensure that all steps are completed consistently and accurately. For example, a checklist can guide workers through inspecting equipment, verifying temperature logs, or conducting sanitation procedures. Through Lumiform, you can download this premade FSMA checklist, which is easy to customize and share.

Keeping digital records also allows you to store and retrieve documentation quickly for audits or FDA inspections. You can then access it for analysis in order to identify patterns and continuously improve your food safety processes.

Perform routine internal audits

Routine internal audits are critical for verifying compliance with FSMA requirements. Internal audits should imitate external inspections so your facility is always audit-ready. Use these audits to assess whether procedures are being followed and preventive controls are effective, then prioritize corrective actions for high-risk issues.

A digital solution for your FSMA compliance checklist

Maintaining good records is one of the important aspects of obtaining an FSMA compliance checklist. Proper documentation helps managers and food producers keep track of food production and processing processes. Gaps in your food safety system can be identified through internal audits. As a result, corrective actions can be taken to continuously improve processes in the food industry. Using a digital FSMA audit checklists facilitate compliance with a uniform standard of quality and safety.

Lumiform helps improve tedious workflows by replacing paper forms, scanning and faxing with a digital app and software – online or offline. Mobile technology is used to work more efficiently.

Benefit from the following advantages of a digital tool:

  • Using the flexible FSMA compliance checklist construction kit, internal checks and processes can be constantly optimised and adapted.
  • Each digital FMSA audit checklist is typically completed approximately 30%-50% faster.
  • Teams will be able to perform better monitoring procedures and risk analysis from a smartphone or tablet.
  • Very easy to use with no margin for error for staff. As Lumiform guides the examiner through the audit, there is no need for any training.
  • Extensive analyses help you to uncover inefficient areas in your company more quickly and thus to continuously improve audit processes.

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Frequently asked questions

How do I prepare for an FDA inspection under FSMA?

Review your food safety plan to confirm it aligns with FSMA standards, including a detailed hazard analysis, preventive controls, and documentation of monitoring activities. Conduct a mock inspection using FDA inspection guidelines, and organize records like monitoring logs, training documentation, and corrective action reports for easy access.

What should I include in a food defense plan?

A food defense plan should identify potential vulnerabilities where intentional contamination could occur, such as access points to critical areas. Include strategies like locking storage areas, using surveillance cameras, and implementing visitor access controls. Add actionable steps to mitigate risks, such as tamper-evident packaging.

What are the most overlooked areas in FSMA compliance?

One commonly overlooked area is proper calibration of monitoring equipment, like thermometers and pH meters, which can lead to regulatory issues. Another is keeping supplier documentation updated, especially for imported goods under the Foreign Supplier Verification Program (FSVP). Facilities also often miss routine reviews of their food safety plans.

Author
Ima Ocon
Ima is a writer and editor who specializes in technology, with experience crafting content for companies like Canva and FluentU. She's passionate about startups, remote work, and language learning, as well as the applications of AI in marketing. Currently, she is based in Asia, and she previously studied in Taiwan and Singapore.
Lumiform offers innovative software to streamline frontline workflows. With over 12,000 ready-to-use templates or custom digital forms, organizations can increase efficiency and automate key business processes. The platform is particularly user-friendly, offering advanced reporting capabilities and powerful logic functions that enable automated solutions for standardized workflows. Discover the transformative potential of Lumiform to optimize your frontline workflows. Learn more about the product

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