Managing both FSMA and GFSI requirements is an extensive undertaking for any food facility. Fortunately, the way in which these requirements have been established allows for virtually seamless alignment, enabling many facilities to establish programs that satisfy both the regulatory and non-regulatory aspects of food safety.
As you consider how to align your FSMA and GFSI efforts, here are some key points to remember:
- Although they share many similarities, FSMA compliance is mandatory while GFSI participation is voluntary. While both can result in better food safety outcomes and increased business opportunities, failure to comply with FDA regulations carries more severe consequences, including potential criminal charges.
- There are a number of FSMA rules which must be satisfied to ensure compliance, including supply chain management and FSVP, preventive controls, sanitary transportation of human and animal foods, intentional adulteration, and record-keeping.
- FSMA and GSFI share many similarities, including the appointment of a food safety qualified individual, supplier verifications, and hazard analyses to address preventive controls.
- GFSI PRPs align with FSMA cGMPs.
- Appointing one or more PCQIs is a pillar of FSMA that closely aligns with the team leaders seen in the GFSI program.
- FSMA’s FSVP requirements are largely covered by GFSI’s supplier verification programs. In fact, GFSI requires the satisfaction of applicable regulatory requirements, such as FSMA, so the requirements for supplier qualifications within GFSI and FSMA can be met within one joint program.
- GFSI version 7.1 reflects many of FSMA’s latest developments, including food defense assessment and controls, intentional adulteration, and environmental monitoring. Version 7.1 also has a greater focus on food fraud, incorporates unannounced audits, and addresses the auditor’s competence.
- The results from GFSI audits and FDA FSMA inspections reveal many similarities. For instance, both show that lack of effective pest control and sanitation monitoring continue to be challenges seen across the industry. There are minimum reporting requirements for FSMA inspections, along with requirements that must be met for successful GFSI audits.
- Non-conformances, either with regulatory requirements or otherwise, can impact the outcome of GFSI audits. FSMA non-compliances may result in more severe consequences, depending on the nature of the inspection findings.
Although aligning FSMA and GFSI compliance efforts requires some careful planning, it can create substantial efficiencies by preventing redundant efforts. Moreover, taking a closer look at both sets of requirements will help to ensure compliance from both a regulatory and non-regulatory perspective and create a comprehensive approach to food safety across your facility.