Navigating the Roadblocks: Overcoming Common Challenges in FSMA Compliance 

 March 28, 2024

By  Rachel Montgomery

The Food Safety Modernization Act (FSMA) represents a crucial leap forward in regulation to ensure the safety of our food supply. However, with innovation comes challenges, and businesses striving for FSMA compliance often encounter roadblocks along the way. In this article, we’ll explore some of the common challenges in FSMA compliance and provide insights on overcoming them to steer your business towards success with regulatory compliance.

Challenge 1: Understanding Complex Regulations

Overcoming the Challenge:

Navigating the intricacies of FSMA regulations can be daunting. Invest in comprehensive training programs for your team, ensuring they gain a solid understanding of the regulatory requirements. Consider workshops and seminars facilitated by experts to break down complex concepts into digestible insights.

Challenge 2: Resource Constraints

Overcoming the Challenge:

Resource limitations, both in terms of manpower and finances, are common obstacles. With knowledge from taking training courses, identify and prioritize tasks and assign internal resources to the tasks.  Integrate your existing procedures and programs for maximum efficiency and also effectiveness.   Virtual courses which don’t require travel save both valuable time as well as money.  Live and interactive virtual training can enable you and your key team members to learn best practices within the industry that other participants may have discovered and implemented.

Challenge 3: Keeping Pace with Regulatory Changes

Overcoming the Challenge:

FSMA is a dynamic framework, subject to updates and amendments. Establish a system for staying informed about regulatory changes. Subscribe to industry newsletters, participate in forums, and regularly review updates from regulatory authorities to ensure your compliance measures are always up-to-date.

Challenge 3: Implementing Preventive Controls

Overcoming the Challenge:

Identifying hazard sand those needing preventive controls is the core aspect of FSMA compliance. Knowing how to efficiently and effectively conduct a thorough hazard analysis, identify critical control points, and establish robust monitoring and verification procedures. Y       our investment in training will ensure your team understands the significance of identifying preventive controls and implementing them effectively.

Challenge 4: Keeping Pace with Regulatory Changes

Overcoming the Challenge:

FSMA is a dynamic framework, subject to sometimes frequent and comprehensive updates to FDA guidance documents.  First, stay informed about regulatory changes by signing up and having your key team members sign up for updates announced by FDA,  and changes featured on the FDA website, including the FSMA page.

Determine a target frequency, such as very three years for you and your team members to repeat courses as an opportunity to interact with the trainer and other participants and keep abreast of updates to guidance and learn about hazards that may emerge.  Some trainers may provide significant discounts for your team members to repeat courses as a refresher. Having employees participte in these refreshers can be set on a rotating basis to ensure changes are captured.  Having those employees reporting back to the whole team is an opportunity for regular discussion, empowerment through, and thereby improving food safety culture. 

Challenge 5: Building a Food Safety Culture

Overcoming the Challenge:

Cultivating a food safety culture requires a mindset shift within the organization, which underscores the criticality of involving cross functional team members. Including employees from different disciplines can lead to open communication about the importance of food safety, from top management to frontline employees. Encourage discussion of potential hazards and celebrate milestones in achievements and maintaining a safe food environment.

Challenge 6: Supplier Verification Challenges

Overcoming the Challenge:

Verifying the safety practices of suppliers, especially for imported goods, can be challenging. Establish a robust supplier verification program and leverage technology for traceability. Develop strong relationships with suppliers, ensuring their understand of the FSMA regulations and criticality of adherence to the details of those regulations for manufacturing food for consumption in the United States.  Consider providing FSMA courses to suppliers, especially for niche products you have discovered, which may not have widespread importation into the U.S.

Challenge 7: Documentation Burden

Overcoming the Challenge:

The documentation requirements of FSMA can be extensive. Implement efficient record-keeping systems, digitize documentation processes where possible, and conduct regular internal audits to ensure all necessary records are up-to-date and readily accessible.  Training courses can provide a benefit to documentation as well, with collaboration with other participants and sharing of their best practices that may benefit your organization in efficiency and effectiveness of recordkeeping.

Challenge 8: Staff Turnover

Overcoming the Challenge:

High turnover rates can disrupt the continuity of FSMA compliance efforts. Prioritize ongoing training to ensure new staff members quickly grasp the importance of compliance. Establish comprehensive onboarding processes that include an overview of FSMA requirements. Schedule for those new employees to take official courses on FDA FSMA requirement during or soon after their orientation period.

Challenge 9: Addressing Allergen Controls

Overcoming the Challenge:

Keep in mind that allergen controls are a critical component of FSMA compliance and employees that have not worked in companies handling allergens may have very little awareness of the risks of allergens.   If you handle allergens, undoubtedly you have implemented stringent procedures for allergen identification, segregation, and labeling, but to ensure allergen controls have considered the risks from planning changes to products, through every step of production, a thorough risk analysis is becoming more and more of an expectation by customers.   An experienced consultant can work with you on a thorough allergen risk analysis.

Challenge 10: Balancing FSMA with Other Regulations

Overcoming the Challenge:

Businesses often need to comply with multiple regulations simultaneously. Develop an integrated compliance strategy that considers all relevant regulations. As recommended,  creating cross-functional teams and utilizing commonalities of compliance can streamline compliance efforts.

Conclusion: Embracing Success in FSMA Compliance

In conclusion, while FSMA compliance poses its challenges, overcoming them is not only possible but essential for the success of your food business. By addressing these challenges head-on, implementing proactive solutions, and fostering a culture of continuous improvement, you can navigate the complexities of FSMA and ensure the safety and quality of your food products.

Remember, the journey to FSMA compliance is ongoing. Regularly reassess your processes, stay informed about industry best practices, and prepare to proactively address emerging challenges. In doing so, your business will not only meet regulatory requirements but also thrive in an environment where food safety is a priority

About the author

Mrs. Montgomery is an FSPCA Lead Instructor for PCQI Human Food, PCQI Animal Food and Foreign Supplier Verification Programs (FSVP) courses with over 30 years experience as a food safety executive in large-scale manufacturing. Montgomery offers virtual training spread over multiple shorter days to fulfill the hours required yet allow team members more time to absorb the training and also stay in touch with their work teams. Montgomery is the Principal of Simple Compliance Solutions, LLC and a Registered Microbiologist (National Registry of Certified Microbiologists).

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