What Does the Draft Guidance Say?
FSMA & Sanitary Design: What Does It Mean to You?

Quality Assurance & Food Safety Magazine | October 24, 2016 | by Editor of QA magazine.


QA magazine takes a detailed look at guidance provisions specifically related to sanitary design in the FDA released draft (August 23, 2016) of the first five chapters of what is to be a multi-chapter guidance on FSMA’s Preventive Controls for Human Food Rule.

To determine what the sanitary design provisions of FSMA’s Preventive Controls draft guidance really mean on the plant floor, QA Magazine asked two industry experts to provide their thoughts. Following are seven recommendations from Commercial Food Sanitation Founder Joe Stout and Precision Iceblast VP of Business Development Joel Williams. 


  1. If you can’t see it, reach it, clean it, or sample it, it could be a concern. One of the most important characteristics of a cleanable piece of equipment is that during cleaning, it is easily opened and accessible for cleaning, inspection, and sampling. Historically, issues have arisen from areas that are not cleanable which may be considered a niche, such as a hollow roller, tubular framework, or sandwich joint (e.g., two surfaces that abut each other but are not hermetically sealed). These enable liquid collection and can become harborage points for bacterial growth. These are the areas that concern me when thinking about sanitary design of equipment. (Stout)
  2. The materials the equipment is made of need to be sanitizable over the expected life of the  equipment, which should also be compatible with the food products being produced in them. Equipment should be  designed in such a way that it is easily maintained, cleaned, inspected, and sanitized; it should have no little nooks and  crannies that could collect food particles or other matter. (Williams)
  3. The less robust a product or the formulation, the more robust sanitary design needs to be. When food processors select a piece of equipment, it should be based on their specific product characteristics, robustness, and sensitivities. For example, if you’re making a cheese product subject to spoilage, the equipment needs to be well-designed and fully cleanable and sanitized for quality and food safety reasons. If you’re making a product, such as a sugar-based powdered beverage mix or coffee, the designs do not have to be as robust because these products are less likely to support microbial activity. The best way to determine suitability is to use an equipment design checklist which will help the supplier and the processor work together to determine the best, most suitable design. These are available online from various companies and associations for meat, dairy, produce, and low-moisture foods and should be used as a starting point. (Stout)
  4. While equipment redesign might not always be possible, better sanitation practices by staff can help produce safer foods.  It would be beneficial for all personnel who are involved in the maintenance or running of the machine to be fully trained on the best sanitation processes in the food industry. Working with equipment manufacturing companies to remanufacture specific problem areas of the equipment might also  assist in equipment sanitation and safety. (Williams)
  5. Often the thought is that sanitary design is for new equipment, but, in fact, it is just as important for existing equipment and infrastructure. Processors can certainly help themselves with existing/legacy equipment and facility designs. For equipment and facilities, processors must consider the need for periodic equipment cleaning (PEC) and periodic infrastructure cleaning (PIC),  which is a teardown of equipment and infrastructure components and a thorough deep cleaning. This should be completed based on a risk assessment which should look at microbiological, chemical, and foreign material potential contamination. Once the appropriate teardown frequency is determined for both PIC and PEC, the teardowns should be identified and managed through the Master Sanitation Schedule (MSS). I call this a sanitary design workaround, but it is a very important component of a sanitation program that will protect food safety and quality. (Stout)
  6. FSMA puts the responsibility of supplier-related items on the processor, whether ingredients or equipment. As such, I could see that it would be viewed that the processor is fully responsible for its supply chain which would include ingredients, infrastructure, and equipment. (Stout)
  7. Food manufacturing companies need to continue keeping up on new breakthroughs in sanitation and  equipment changes  that may be  pertinent to their businesses.  (Williams)

This is an excerpt, read the full article in QA magazine here. The author is Editor of QA magazine. She can be reached at llupo@gie.net.