FDA has developed a free application through which food facilities can build a Food Safety Plan that complies with FSMA requirements. The Food Safety Plan Builder was modeled after the Food Defense Plan Builder, which was similarly created to assist food facilities build a plan specific to their facility. It is important to note that while the Food Safety Plan Builder (FSPB) was designed for use by small manufacturers to assist those with limited resources, it can be used by anyone – but use is not required for anyone. That said, FDA states, “Although manufacturers are not required to use the program, the FDA designed this program to help companies organize their food safety information and minimize the burden of creating their food safety plan.” Which, to us, means that you should at least review the tool and ensure that your Food Safety Plan has everything that this tool includes. FDA also cautions that, while it has developed the content of the tool to be consistent with existing guidance and regulations, its use does not mean (this is bolded by FDA) that your food safety plan, preventive controls, GMPs, or other food safety procedures are approved by FDA or compliant with FDA requirements. So, what exactly is the FSPB and how well does it work? To review the new application, we asked our Science Writer, Lisa Lupo, to download the application and walk through the steps. Following is her assessment: If I were a food facility that has been expected to have my food safety plan in place for more than a year now, my first thought in looking at the application would be: “Wow. I wish I’d had this a couple years ago!” Whether you use the app to build your plan or simply as reference to ensure you have everything that FDA expects in your existing plan, the app will provide you with a very thorough package – taking you step-by-step from facility information and preliminary stages through a full document, with an electronic or manual signature page, all of which can be saved to your computer and/or printed. But before you can start working in the app, you need to download it. When you do so, be sure to follow FDA’s download instructions to the letter. They are fairly simple, and I thought I had followed them, but the app would not open. So, I started over, downloaded, unzipped, and installed exactly as specified. In less than a minute, the app opened on my computer. The key is to be absolutely sure that you are opening the downloaded file from your Windows File Explorer; do not click the one that shows at the bottom of the Internet page as having been downloaded. Also, if you work on an Apple computer, you won’t be able to use the app, it is not Mac compatible. Once the app is downloaded, you do not need Internet access to work on it. The app has 15 tabs/sections with pop-up Introduction pages (which you can opt to not show again by checking the box). The Introductions generally reference the applicable provision of the rule and provide basic guidelines. Be sure to also read any Notes that FDA includes in the top margin of certain tabs – for example, in the Supporting Documents section, you need to know that these will be saved in a separate folder from the Food Safety Plan itself, so you have to print or access them separately for FDA. Additionally, while you can save the FSP that you built as a pdf, which can be viewed or printed from any computer that has access, the supporting document files (and any information in the app not saved as a pdf) can only be viewed or printed from a computer on which the app has been installed. It will be helpful to click through the tabs first, reviewing FDA’s pop-ups and notes and compiling the information that you will need to complete the forms. If you have an existing, or partial, Food Safety Plan but would like to recreate it in the app, you will likely have a good portion of the information you will need. If you don’t have everything there, then it is a good bet that you missed something when you developed your plan. The tabs are set up to be followed in order, left to right. This is because the information for some sections is automatically, or can be, imported to later sections, so that you are not having to duplicate information. For this reason, as well, if you need to make changes to a processing step, you may need to return to a previous tab to do so. For example, if you need to change a processing step identified as requiring a food allergen preventive control, you need to return to the HARPC tab to do so; the data will then import to the allergen section. Additionally, some sections, such as that for GMPs and Recordkeeping, are checklists which you can designate as applicable or not, include comments, etc. The checklists are primarily to guide the user in compliance and ensure the plan is complete; they do not need to be included in the FSP. The tool also includes a section in which important contacts can be listed, with the information then included in the FSP or not, as you prefer. In addition to the information and guidelines in the FSPB, FDA has provided a number of ways for users to get help. Videos posted on FDA’s Food Safety Plant Builder YouTube page provide an overview of the application and individual videos for each tab. Or users can opt to check out the written User Guide in pdf format. If you still have questions, FDA has set up a specific email, [email protected], through which users can get additional assistance. Because I am not actually a food facility, my review is simply a cursory overview of the tool and its application. If you have used the app, we welcome any feedback, comments, or advice you’d have for others using the contact form at the bottom of our homepage or e-mail us at [email protected]. So, as you can see, we think that this new tool can be very helpful if you are starting from scratch or wanting to check that you have all your bases covered per the FDA requirements. But, we need to emphasize the continued important role of the PCQI and the need to really understand where your risk are (supply chain, in-plant processing, environmental monitoring, etc.) and to control those that need a preventive control. As a further thought, many of the companies we work with are already GFSI certified. As we have said before, being GFSI certified has put you in an excellent place for FSMA Preventive Control Rule compliance. But, we strongly recommend that you also develop the right story to respond to FDA inspectors when they ask to “see your Food Safety Plan.” Pointing to a pile of files labeled “GFSI audit” is not going to work! 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
