What is covered by the GFSI benchmarked schemes and what isn’t within FSMA.

Global Food Safety Initiative (GFSI) benchmarked schemes, such as the Safe Quality Food (SQF) & the British Retail Consortium (BRC) are gaining International recognition in the food industry, as the highest food safety and quality standards. With the signing of the Food Safety Modernization Act in January 2011; there are new requirements in the Final Preventive Control Rules & current Good Manufacturing Practices (cGMPs) that are covered by the GFSI Benchmarked Schemes, however, there are also some elements that are not addressed in each of the schemes. Each food companies must now incorporate the new Preventive Control Rules & cGMPs into their existing Food Safety and Quality Management Plan to ensure compliance with both GFSI benchmarked schemes and with the Final Preventive Control Rules.

We are going to compare the two main GFSI benchmarked schemes (SQF & BRC) to regulatory requirements in the Food Safety Modernization Act (FSMA) Final Preventive Controls & cGMPs. (21 CFR 117). The BRC and the SQF standards are broad international standards and does not specifically address country specific requirements.

Below is a chart compare the two GFSI benchmarked schemes (SQF & BRC) against to the FDA Preventive Control Rule and cGMPs.

  SQF Standard BRC Standard FDA Preventive Controls & cGMPs
Written Food Safety Plan Yes Yes Yes
Food Safety/Quality Policy Yes Yes No
Pre-requisite Programs Yes Yes Yes
Preventive Control Qualified Individual (PCQI) No No Yes
Raw Material / Incoming Product Assurance Yes Yes No
Allergen Control Yes Yes Yes
Vendor Approval Yes Yes Yes
Sanitation Control Yes Yes Yes
Environmental Monitoring Yes Yes Yes
Corrective Action Yes Yes No
Traceability Yes Yes *No
Recall Plan Yes Yes Yes
Record Retention Yes Yes Yes
Food Defense Yes Yes *No
Food Fraud Yes Yes *No
Internal Audits Yes Yes No
Employee Training Yes Yes Yes
Verification of Controls Yes Yes Yes
Validation of Controls Yes No Yes

*Covered in different sections of the regulation and not in Preventive Controls & cGMPs.

In order to achieve both GFSI Scheme requirements and meet the FDA Preventive Control Rules, it is important to review each specific FDA Preventive Control & cGMPs regulatory requirement. There are certain requirements that are more detailed in the regulation that are not specified in the BRC & SQF Standards. Hence, during a GFSI Scheme audit remember to add a FSMA Compliance Addendum to satisfy all regulatory requirements or conduct a separate FSMA Compliance audit. It is also important to remember that the FDA Preventive Control Rules & cGMPs are the law in the U.S. and regulatory compliance is a must.