Many wineries may have been engaged in the current discussion related to the Food Safety and Modernization Act (or FSMA, pronounced “Fis-mah”) and how it relates to regulatory changes affecting wineries. As a brief background, the enactment of FSMA changed the focus of FDA food regulation from reacting to food contamination or problems, and is instead requiring food processors to prevent food contamination and safety problems.
The FSMA regulation, outlined in 21 CFR 117, is split up into parts, which are highlighted in the CFR as Subparts A through G. A previous “Understanding FSMA” posting from Cornell Cooperative Extension broke this down easily for wineries to understand each section, explaining the purpose of each section of the regulation, and how it pertains to U.S. wineries.
As a general requirement, wineries are now responsible for implementing Subparts A (General Provisions), B (Current Good Manufacturing Practices, or cGMP), and F (Requirements Applying to Records that must be Established and Maintained) into their facilities. This regulation is essentially requiring food companies, including wineries and other alcoholic beverage processing facilities, to document or describe how they are complying with regulations, document what/how they may process their food product (i.e., wine), and maintain records and documentation demonstrating they are actually performing those documented procedures. I actually think this was well explained in this presentation, and particularly found the image on the 3rd-slide-from-the-end of the presentation to drive this point home.
While this may seem like a daunting task, addressing FSMA’s requirements does require some real time dedication, comprehensive knowledge of production sanitation procedures, production gaps in your facility, and an inclusive understanding of regulatory jargon. In the likelihood that a FDA inspector does visit your winery, it is likely that they will want to see your procedures and documentation of those procedures, as opposed to actually viewing the execution of procedures themselves.
While most collegiate institutions offer education and training in understanding FSMA and its components, very few offer services that help wineries develop a Food Quality Manual that FDA inspectors will want to evaluate. Therefore, Denise Gardner Winemaking is here to help wineries build their Food Quality Manual that will address the above regulation by assisting wineries to:
- Develop and write production cGMPs
- Document SOPs and SSOPs for their operation
- Provide training opportunities for employees
- Document employee training to include in their records
This week, I’ve released employee training documentation templates for both individual and group training sessions. These templates, as well as all educational material on the website, are available to all members that have a consulting service package with Denise Gardner Winemaking. For more information on these consulting services, please visit the Consulting Packages page.
Clients are welcome to contact me with how best to implement these documents, and review their overall purpose. As the year goes on, I’ll be adding more content to address these requirements. Additionally, as training resources unfold on the website, your employees will have access to critical training to support your operation.
Obviously, most winery employees are very busy! But having this component as part of your operation will undoubtedly help:
- Improve operational efficiency
- Outline required training and skills for all personnel
- Ensure tasks are fulfilled the same way regardless of who provides the execution
- Enhance product traceability
- Prepare for future regulatory updates
Understanding how this impacts your winery operation can be a challenge. If you think this may be something you’d like to work on and need some assistance, please contact me to discuss the matter at [email protected].