The Food Safety Modernization Act, or FSMA, is unquestionably one of the most significant legal frameworks for the food supply chain. Signed into law in the early 2010s, this U.S. food regulatory framework implemented risk-based preventive controls for certain animal foods and produce to improve safety and mitigate the risks of foodborne illness outbreaks.
While the FSMA has been in effect for several years, it continues to evolve. Moreover, regulatory entities have ramped up verification activities, including FSMA compliance audits, which have raised the stakes for organizations subject to this framework.
Start on the road toward FSMA compliance by checking out this blog. In addition to a comprehensive overview of FSMA requirements, you’ll learn practical tips for adhering to U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) guidelines.
Understanding FSMA Requirements
FSMA rules introduce several key requirements designed to prevent food hazards and ensure the safety of the food supply chain. The specific requirements that apply to your business may vary slightly depending on your position within the supply chain. However, some of the general guidelines are as follows:
- Preventive controls
- Supplier verification
- Hazard analysis and risk-based preventive controls (HARPC)
- Food defense
It’s helpful to unpack each of these stipulations. Regarding preventive controls, food facilities must develop and enforce a food safety plan, which should focus on identifying and addressing hazards that may impact consumer safety. Your strategy should be based on hazard analysis principles.
Additionally, you must establish foreign supplier verification programs to ensure that raw materials and ingredients obtained from importers meet FDA Food Safety Modernization Act requirements. As part of your HARPC efforts, you must conduct hazard analysis and implement risk-based preventive controls to mitigate identified vulnerabilities.
Finally, the FSMA emphasizes the importance of protecting the food supply chain from intentional adulteration and requires your facility to develop defense plans. These strategies should identify and mitigate potential hazards. Compliance with FSMA requirements is critical for your company’s ability to reduce safety risks, protect consumers, and maintain regulatory compliance.
Assessing Your Current Status
Before you can learn how to start FSMA compliance, it’s essential to know where you currently stand. You can do this by conducting an FSMA compliance audit evaluating your sanitation controls, safe food practices, and other procedures. More importantly, an audit will identify areas where your existing processes fall short of FSMA 204 final rule regulations.
Once you have identified gaps in your current processes, you can implement more stringent preventive controls for human food and take other corrective actions to ensure the safety of food products. While assessing your current compliance posture, make sure to account for other food safety laws, such as the Federal Food, Drug, and Cosmetic Act.
Most importantly, remember that meeting food safety regulations is not a one-time process. You must commit to continuous improvement to meet ever-tightening safety standards. Also, it’s crucial to develop stringent record-keeping requirements to demonstrate your adherence to FSMA regulations and food traceability requirements.
Developing a Compliance Plan
After you’ve determined your organization’s position regarding FSMA traceability stipulations, you can implement mitigation strategies to address identified hazards and ensure compliance.
Consider which specific requirements apply to your organization. The rules you are subject to will change based on your position within the food industry.
For instance, distributors, growers, and food manufacturers face a separate set of guidelines from small businesses that engage in direct-to-consumer sales. You can create a custom compliance plan after identifying which aspects of the rule apply to your company.
When crafting your plan, it’s important to set clear objectives for achieving FSMA compliance, including specific goals and milestones. Next, identify what resources you’ll need to achieve your stated aims. These include personnel, time, and budgetary resources, as well as any technologies or tools.
Develop timelines and action plans for implementing necessary changes and achieving compliance milestones. Remember, too, that most compliance dates under the FSMA have already passed, which means the act and its rules are currently in force. Therefore, time is of the essence.
Conducting FSMA Compliance Audits
FSMA compliance audits play a crucial role in verifying your adherence to regulatory requirements and identifying areas for improvement. Your business can conduct internal audits or obtain accredited third-party certifications to ensure that your current good manufacturing practices align with the provisions of the current food safety system.
The audit process involves three key components:
- Preparation: Prepare by reviewing FSMA requirements and gathering relevant documentation
- On-Site Assessment: Auditors will review your documents and observe processes
- Post-Audit Activities: Address findings or non-conformities and implement corrective actions
Selecting experienced auditors and adequately preparing for audits are essential steps for ensuring adherence to FSMA preventive controls and promoting public health.
Utilizing FSMA Compliance Checklists
An FSMA compliance checklist provides a simple means of comparing your current compliance posture with the latest regulatory requirements. These checklists cover multiple aspects of FSMA regulations, including:
- Preventive controls
- Supplier verification
- Food defense
- Allergen mitigation
- Documentation requirements
Check out this free resource if you’d like to incorporate an FSMA compliance checklist into your risk mitigation strategy. There are several other downloadable PDF documents available, many of which are free to use. Take advantage of these tools to streamline your compliance process and improve adherence.
Addressing Common Challenges
Retooling your workflows and business processes can be daunting. However, you can mitigate the complexity of FSMA compliance by familiarizing yourself with the challenges that lie ahead.
One common difficulty that nearly all businesses encounter is resource constraints. Budgetary limitations, a lack of expertise, and time constraints can make it difficult to implement a compliance strategy.
Another common barrier is the complexity of FSMA requirements. The comprehensive act has different rules for each member of the food supply chain. Navigating these rules can be particularly difficult for small and medium-sized businesses with limited bandwidth.
Outdated or inadequate technology represents another challenge that you need to address head-on. Modern tracing tools can help you improve transparency and implement your food defense plan. A real-time tracking tool will also assist with labeling, product validation, and other aspects of FSMA compliance.
Training and Education
A well-trained and informed workforce is your greatest ally in the battle for FSMA compliance. Don’t just tell your staff what they need to do. Make sure they understand the “why” as well. Train them on compliance aspects, including the produce safety rule, recall plans, and general recordkeeping requirements. Also, remember to convey the implications of non-compliance.
There are dozens of great training resources out there. The FDA provides a wealth of information that you can use to educate your staff and empower their compliance efforts. Make sure to take advantage of third-party resources as well. At rfxcel, an Antares Vision Group, we have cultivated an extensive content library with timely, relevant information to help you stay up-to-date on the latest provisions.
Don’t stop with preliminary education on FSMA, though. Ensure that you are also training your staff on how to use new tools and processes to support compliance.
For instance, if you invest in new traceability technology, support the transition to these tools by providing extensive training. If your staff is confident with the tools, they are more likely to embrace change and use the technologies you’ve provided them.
Implementing Continuous Improvement
The regulatory framework is constantly evolving, so you must also evolve. Don’t treat FSMA compliance as a set-it-and-forget-it task. Instead, view it as an ongoing process that requires continuous improvement and innovation to ensure food safety and supply chain security.
You can begin to do so by routinely analyzing your compliance posture and identifying any shortcomings. Once you pinpoint weaknesses, proactively address them by refining your policies, procedures, and technology strategies. Taking a proactive approach will mitigate the risk of fines or other penalties and help you maintain consumer trust.
Case Studies and Success Stories
Examining how one small California farm successfully implemented an FSMA compliance strategy is helpful. The farm, New Native, produces microgreens, which the FDA classifies as a “high-risk” item. Due to its revenue, New Native is subject to full compliance requirements.
Fortunately, New Native and its leadership have been proactive about compliance since day one. As such, they passed their very first FSMA audit, which was conducted in early 2020. Since then, the company has maintained an impeccable record and a strong compliance posture.
Ken Kimes, co-owner and head of compliance for New Native, provided some great tips on preparing for audits. He emphasized the importance of having all documents organized and readily accessible to the auditor. Kimes also recommended making a great first impression, not over-answering any questions, and letting the inspector “drive” the process.
Strengthen Your Compliance Posture With rfxcel
Achieving and maintaining FSMA compliance requires a concerted effort from your entire team and buy-in from key stakeholders. Now that you know how to start FSMA compliance, it’s time to implement your plan by aligning your team, processes, and technologies.
With that in mind, we invite you to explore rfxcel solutions, a modern tracing solution designed for food supply chain members.
