FDA Issues Two New Prevention-Focused Food Safety Resources

Root Cause Analyses

FDA’s new RCA webpage defines an RCA as “a structured analytical approach used to identify the underlying cause of a food safety incident” and describes RCAs as helping to “understand why an incident occurred so that targeted interventions can be developed to prevent similar problems in the future.” FDA provides that the following steps are involved in executing an effective RCA:

1. Establish a Qualified Team. To include subject matter experts and relevant cross-functional personnel.
2. Describe the Problem. To include gathering any relevant data (e.g., traceback information, production records, environmental monitoring records, sanitation records, etc.).
3. Analyze the Data. To include the use of appropriate analytical tools (e.g., flow charts, process maps, cause-and-effect diagrams, etc.).
4. Identify the Root Cause or Causes. To include each identified possible cause.
5. Take Action and Verify Effectiveness. To include immediate corrective actions and long-term preventive actions. Verification of the effectiveness of these actions may be required in certain instances.

According to the agency, following these steps and implementing a strong RCA will support broader food safety systems by informing preventive action plans, improving quality and reliability through standardized approaches and increased transparency, and driving continuous improvement. FDA uses the results of RCAs to inform guidance and regulatory actions to improve foods safety more broadly. In this resource, FDA reiterates its commitment to strengthening RCAs through stakeholder collaboration and improved agency procedures and notes that it has completed a global best practices review, performed retrospective pilot testing, engaged with industry, and updated guidance in an effort to fulfill this commitment.

Best Practices

FDA’s best practices resource is a compilation of several sources of industry-created guidance aimed at providing practical approaches to implementing regulatory requirements. According to the agency, the most effective best practices guides are based in science, consider risk, and provide clear and current guidance. FDA can play a role in the development of best practice documents by participating in working groups, providing expertise, or reviewing resources. The current best practices webpage includes eight different resources where FDA provided support in the development of the guidance. Stakeholders interested in discussing the development of a best practices document can submit a request to the agency.

Conclusion

FDA has long pushed for companies to complete robust RCAs when taking enforcement actions, but until now did not provide guidance on what an acceptable RCA looked like. The new RCA resource provides industry with a broad framework for completing RCAs and highlights the expectation that effective preventive actions will be implemented in response to the RCA.

Authored by Elizabeth Fawell, Maile Gradison, and Erin Pannek.