Try FDA’s FSP Builder! In the fall of 2017, FDA released its Food Safety Plan (FSP) Builder. The purpose of the free software program was to assist food facilities develop food safety plans that are specific to their facilities and meet the requirements of the Human Preventive Controls Rule. In the recent FSMA Fridays session, we provided some insights on the program and tips for its use. Enabling a food facility to organize its plan into a single electronic file, the FSP Builder guides the user through plan development by listing questions relevant to each provision of the rule with the “step number” automatically assigned. FDA also provides supplementary information at each step to support the required responses. The software does have a few limitations, in that it can be run on Windows (7 or 10) systems but not on a Mac, and it can only be used on a single dedicated computer of a company. However, users can copy/paste information from other electronic documents into the program to respond to questions, and attachments, links, or notes to where further information is filed (e.g., validation, verification, calibration and daily records) can be inserted at the end. To assist in completion, FDA also provides training videos. It can be very helpful to view these videos before you begin, as they can help ensure you have the needed information at hand and provide explanation for each section. Keep them available as you work through the program, as well, to refer to for further questions. The step-by-step program provides food facilities with a great way to ensure your Food Safety Plan fulfills all the requirements of the Human PC rule – and it’s easy to update when required (e.g., at the annual review, when an ingredient or process change is made, etc.) We also need to emphasize the continued importance of the role of the PCQI, the need to really understand where your risks are (e.g., supply chain, in-plant processing, environmental monitoring, etc.), and the necessity to control those that need a preventive control. The program does have a few weaknesses, however. It can be cumbersome to navigate, and if a mistake is entered early on, all related questions will be impacted and pre-populated with a corresponding question awaiting a response. As an electronic program accessed through the government site, there has been some question and concern as to whether this means that FDA has access to and can track your use or information. Be assured that this is not so. FDA does compile numbers on how many times its program has been downloaded, but not on identifying specifics. So your information does remain confidential – until you need to share it with an FDA official during an inspection. The FDA has the authority to receive a copy upon request, however it is exempt from FOIA requests. Which also answers the question that, yes, you can use the FSP you generate through the builder program as evidence during an FDA inspection – either through the electronic program itself or by downloading/printing a pdf of the resulting plan. In fact, doing so shows your due diligence and efforts to comply. To view the recording of this FSMA Fridays session – click here. TAG is delighted to have just celebrated 5 years of FSMA Fridays! Hosted in conjunction with SafetyChain Software each month, these live 30-minute discussions are a great way to stay-up-to-date with all things FSMA. Interested in learning more about how TAG can help your organization with FSMA? Including FSMA compliance assessments and more? Contact TAG! About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
