Purpose: Develop an extension tool (audit checklist) for human food manufacturing facilities to determine if they comply with the FSMA Preventive Controls for Human Food Rule.
Methods: The audit checklist was developed by analyzing 21 CFR 117 for the requirements of the Human Food Rule, Subpart B (Current Good Manufacturing Practices) and Subpart C (Hazard Analysis and Risk-Based Preventive Controls), as well as the British Retail Consortium (BRC), and Safe Quality Foods (SQF) auditing schemes. It will be piloted by several companies before its public release to ensure all points are properly addressed and understandable.
Results: The 38-page finalized tool contains two checklists and is featured on the ncrfsma.org website. The first checklist is dedicated to Hazard Analysis and Risk-Based Preventive Controls (Subpart C), which includes 13 sections that walk through major aspects of Subpart C, whereas the second checklist contains 9 sections explaining features of Current Good Manufacturing Practices (Subpart B) such as sanitation, equipment, and personnel. Each section is split into several questions that describe how the plant should normally run as defined by 21 CFR 117. Hints were provided as further explanation for each point in the checklists while comments and definitions were added at the end of each section to emphasize important points and government definitions for cohesion and clarity.
Significance: FSMA implementation has been source of concern and confusion for many fruit and vegetable processors. These checklists will aid those processors in their compliance with the Human Food Rule.