Caution. This will not be the typical article about technical details of hygienic design. I would characterize it more as a historical perspective of hygienic design since my engagement with the food industry (40 years—ouch!). I have had significant experience with both highs and lows of hygienic designs associated with food safety recalls and problems with sanitation efficiency and effectiveness, and while progress has been made, it has been an uphill battle to improve hygienic design. The food industry needs to update its approach to change the culture of how we think of hygienic design. In the absence of such an updated process, we will repeat the struggle with the technical and functional challenges as we have in the past. We need to think and act smarter using science and collaboration.

This story follows my career learnings while providing guidance and thoughts on continuous improvement in hygienic design for safer food and more effective and efficient production, operations, and sanitation. To advance beyond the current state, we need a shift in the culture of hygiene, starting with design.

The 30,000-Foot View

My view of hygienic design in the food industry is grounded in plant floor engagement and the impact of hard-to-clean facilities and equipment that result in food safety issues. Effective and efficient sanitation ensures clean equipment in a simple, straightforward way to protect employees’ personal safety and ultimately protects customers and consumers. The goal of enhanced hygienic design is to eliminate, or at worst minimize, cross-contaminants of any type, essentially unlabeled ingredients, unwanted microbes, and foreign material, from food products. None of these items appear on the label. We want yeast in beer but not Listeria in cheese. This is accomplished by the design of the process and preventive controls along the supply chain from field to fork. Hygienic designs ensure the absence of harborage areas that could allow cross-contamination of products with allergens or unwanted microbes. A benefit of the positions I've held over the years was to visit food plants during cleaning. I took every chance to observe cleaning in action to see hard work and struggles and feel the pain of our sanitors and sanitation supervisors as they attempted to clean a manufacturing facility (infrastructure and equipment).

During my career, I have been involved in many food safety situations related to failed cleaning, many of which were a result of hard-to-clean areas due to poor hygienic design. Some of these situations required a hygienic restoration to eliminate the root cause and establish preventive controls to avoid repeats. Some examples were: Listeria in ice cream, waffles, chicken strips, lunch meat, hot dogs, and fruit and vegetables, Salmonella in chocolate and peanut butter, Escherichia coli in produce, metal in finished product, pest infestation in pasta products, allergens in ice cream, and the list goes on. In most of these cases, the common thread was the difficulty in cleaning to remove cross-contaminants due to poor hygienic design. It’s not that the equipment couldn’t be cleaned. It was cleanable but not in the time allotted. If time had been taken to recognize the harborage areas and clean at the appropriate frequency, food safety events could have been avoided. In the case of foreign-material contamination, avoidance could have been achieved through a higher level of scrutiny to observe the equipment and infrastructure during pre-op inspections and preventive maintenance work. These situations could have been prevented with the right culture.  

“My view of hygienic design in the food industry is grounded in plant floor engagement and the impact of hard-to-clean facilities and equipment that result in food safety issues.”

The View from the Plant Floor

If you're interested in hygienic design of equipment and infrastructure and the cleaning challenges, I encourage you to visit a cleaning shift at a plant to observe sanitors’ activities from start to finish. They work in less-than-comfortable conditions with extreme temperatures and at physical risk due to wet floors, hot water, and climbing ladders to access equipment and infrastructure. I visit cleaning shifts often, as they are a constant reminder of the cleaning challenges we face in hygienic design. In some cases, equipment and facilities are just not cleanable to the expectations of 2021. Cleaning challenges are not new—they have been with us for generations. However, what is new is the high visibility of failures and consumers who appropriately alert processors or regulatory agencies when discovering an issue and raising it for correction.

I recently visited a plant in which there was a dated picture proudly displayed in the lobby. It showed two employees working on a production line probably 60 years ago. The line was not mechanized in terms of conveyance or product handling. It showed a filler that filled one glass jar at a time and was operated by a person who also applied a closure. This was for packaging a powdered ingredient. The conveyors were made of wood, which looked splintered and abused. There were loose nails and other debris on the floor. These were the bad old days when things were very unsafe. No one thought about cleaning, sanitation, or swabbing for Salmonella and the implications for creating foodborne illnesses with consumers.

The industry has come a long way in 60 years, but we still need a culture revolution in hygiene. Honestly, as we learn more about food safety and complete root-cause analysis following failures, it becomes obvious that we have a way to go to be perfect. Risk and exposure have changed dramatically. Due to advances in productivity, processors fill about 60,000 jars in the time it took to produce 1,000 at the time of the picture, reaching many more consumers.

The View from Another Industry

I often compare the progress of the design of food processing equipment or infrastructure to automobile design and manufacturing. I purchased a Ford Pinto in 1979 for $4,200, which included an AM radio, crank windows, heat, front window defroster, no AC, manual transmission, rear-wheel drive, and a spare tire. I’ve also purchased a 2018 Honda Accord with a base price of $23,000 that included front-wheel drive, AC, power windows and door locks, five air bags, power driver seat, cruise control, an AM/FM radio with a CD player, power steering, and USB ports. Does it get much better than this compared with my 1979 Pinto? I am amazed at the technology and design for safety, efficiency, quality, and vehicle life expectancy. Extras are included in automobile pricing at a limited and incremental cost compared with inflation. Our expectations as consumers have changed. One of my college physics professors purchased personal vehicles with manual steering, crank windows, and no AC. His only extra was an AM radio. He wanted fewer opportunities for failure. Why do companies design and build cars at nearly the same relative cost today? It's to satisfy their consumers who are willing to pay extra for convenience, fuel efficiency, and durability. In the food industry, we need to shift our culture to one of continuous improvement in hygienic design, just like the auto industry. One of my college friends had a head-on collision in a 1973 Oldsmobile. I saw the vehicle following the accident, and it was totaled. I was amazed he survived. This happened to be a test-fleet vehicle that was designed with one air bag. He was a believer in the benefits that air bags provided, as was I. Now most cars have multiple air bags, which are considered standard equipment. Innovation with electric vehicles is another new approach that is revolutionizing the auto industry.

“During my career, I have been involved in many food safety situations related to failed cleaning, many of which were a result of hard-to-clean areas due to poor hygienic design.”

The View from the Outside

Food companies need to embrace a change in their culture to one of collaboration with their internal colleagues and their equipment and infrastructure supply chain. The focus should be on the cost of ownership versus the cost to purchase. Individuals who clean facilities and equipment must vocalize their needs and be heard. Choose designs that deliver effective, efficient cleaning, consistent with preventive controls. If a sanitor or a food product consumer made the decision about which equipment to purchase, I feel confident they would buy easy-to-clean equipment and design infrastructures. Consumers prove this all the time. How many households choose to wash dishes, pots, and silverware by hand instead of using a dishwasher? Proof: Dishwashers are in almost every residence. Consumers make the decision to buy a dishwasher versus washing dishes by hand. Yes, they cost more but save labor and water and clean better and more efficiently and effectively than washing by hand. Our industry needs to follow the lead of consumers and choose against the washing-by-hand approach and shift to alternative, automated cleaning methods. We are smarter today and shouldn’t expect the sanitors to “tough it out” and to routinely and successfully clean equipment with poor design.

One comment heard over the years is that original equipment manufacturers (OEMs) don’t or can't build the type of equipment needed today. I'm happy to tell you that they can build what you want! It may cost more, but they can and are willing to do it. The industry must be willing and be ready to pay a little more for it up front while considering the return they will have on their investment.

Just as the auto industry transitioned from crank windows and our consumers choose dishwashers versus hand washing, OEMs have the capability, passion, and knowledge to create hygienically designed equipment and infrastructures. All we need to do is ask and collaborate to share design challenges, and they will develop solutions. They will respond just as auto companies did. I would say there is a willingness to join the hygiene culture under the umbrella of smarter food safety.

I continually use the terminology “effectiveness and efficiency.” That's because hygienic design is being food safe and driving effectiveness and efficiency in the cleaning process. This delivers higher-quality and safer food. If the hygienic design is better, it makes cleaning less complicated and more effective. The less time needed for cleaning, the more time available for production (which equals more money for the company). That's why the sanitation and food safety community encourage hygienic design: It’s good for everyone involved.

The View from the Food Industry

There has always been a high level of interest in creating hygienic design standards. If I've heard once, I've heard 100 times that we need a new standard to follow. For many years, I've said, “I don't care what standard. Just pick one applicable to your industry and use it.” I have supported new or updates to design standards because it was the right thing from a technical perspective, and it was a comfort zone that passionate sanitarians can control. Here's the challenge with that thinking: Hygienic design is not just about the technical details, it's also about the culture in a company or industry that embraces it. It needs industry and nontechnical leadership, plus cross-functional support. If we follow existing principles and guidelines when supported by senior management who understands hygienic design, we could do so much better as an industry. That’s hygiene culture.

To be honest, I am a slow learner but diligent in what I do. Let me explain: I’ve always believed the right path was working hard technically to be successful in my role as a sanitarian and food safety professional. I was wrong. The best approach is to work collaboratively within your individual company toward a culture of hygiene. It takes a great coach and a talented team to win a world championship, and it takes a company with a hygiene culture to raise the standard to adopt and integrate hygienic design.

The U.S. Food and Drug Administration (FDA) has socialized the phrase “smarter food safety.” Hygienic design is applicable for Core Principles 2 (Prevention) and 4 (Food Safety Culture) of the agency’s New Era for Smarter Food Safety Blueprint initiative, meaning both industry and regulatory professionals should partner in a preventive fashion to minimize risk for consumers and customers through different, better, and smarter ways, One smarter way is a collaborative approach throughout an organization to help sanitation do better at what they do: Work smarter, not harder. In most cases, sanitarians and sanitors work very hard silently in the middle of the night. Most people in companies say they respect the work sanitors do and that they’re the most important employees, but very few visit them as they struggle to get a plant and equipment clean, especially those with poor designs. We need to have solidarity with sanitors and provide them with equipment, infrastructure, cleaning tools, and methods for success. That’s hygiene culture!

“The industry has come a long way in 60 years, but we still need a culture revolution in hygiene.”

The View from Operations

Hygienic design established correctly enables a facility to operate at optimal levels. Reduced cleaning time is operationally better and more efficient. It offers more uptime for production, which, if capacity is constrained, means less capital investment for a new building or another line. Hygienically designed equipment is safer for maintenance and sanitation employees to work with. It's less restrictive in terms of time needed for preventive maintenance and periodic equipment cleaning (PEC). PEC requires maintenance to disassemble and reassemble equipment while the sanitation department does the cleaning. Less disassembly and reassembly reduces foreign-material potential (fewer bolts or nuts to lose). There are fewer areas for allergens, spoilage organisms, and pathogens to contaminate and then resurface later or, for microbes, when there is logarithmic growth. When redesigning lines or building a new facility and lines, these items must be discussed as part of a culture change. With better equipment and infrastructure, we will have repetitive cleaning events that are successful—they will pass pre-op inspection, lead to a reduction in foreign material, improve and/or maintain quality, and lead to fewer or zero food safety issues. These all link together under the umbrella of hygienic design: safer products, happier consumers, happier customers, and repeat sales. It's a win-win situation.

Companies often invest money to increase the speed of production lines to make product faster and with fewer people. Likewise, we need to invest in hygienic design to reduce labor in sanitation and clean faster. There can be incremental costs associated with better-designed equipment. We need to accept this. Let’s use better technology and programs to design equipment that can optimize the cleaning process. Technology is available today to enable this.

A Visionary View?

Let's go back to the automobile example. Automobiles today run for 200,000 or 300,000 miles with fewer routine repairs. There is no distributor cap or points as these were replaced by an electronic ignition. There is no need for oil changes every 3,000 miles according to manufacturers’ recommendations. Cars are designed better and are mechanically superior to past models. Why can't we make processing equipment in a comparable way that is sophisticated, smarter, faster, and more easily cleaned? Investing money in hygienic design will yield better results in productivity, personnel, and food safety. For the most part, cleaning today is as mechanical and as demanding as it was when I graduated from college. To illustrate, I took a two-credit course called Sanitation Techniques, which was held on Saturday mornings. It was a lecture with a 3-hour lab on cleaning techniques. I learned techniques that we still use today. The industry needs to break out and be smarter about sanitation and hygienic design. This is not a criticism of sanitation staffing; it’s a recommendation. They clean plants faster and better with many of the same tools and methods. A different approach can be included under FDA’s New Era of Smarter Food Safety Blueprint. A culture of enhanced design with automated cleaning will increase preventive controls, reduce cleaning time, reduce labor staffing, reduce personnel safety risk, and increase productivity. We can do a better job and have food products delivered at an affordable price for consumers.

In the Smarter Food Safety approach, Core Principle 2 references prevention, while Principle 4 is focused on food safety culture. The vision to develop a facility hygiene culture across the food industry starts with cross-functional partnerships (procurement, OEMs, operations, engineering, food safety, sanitation) at each company and shares the approach between companies. It's brilliant to strive for a culture of hygiene under the umbrella of Smarter Food Safety and see how we can enhance both. We need to think more broadly and experimentally to develop different approaches for design with cleaning in mind. We need to use science and be smarter about opportunities in the industry with engineering and OEMs.

OEMs and food companies compete but with other industries that deliver better, faster, and safer products and services than the food industry does. Some see the food industry’s poor hygienic design and criticize the lack of innovation. There are innovative designs, but they are still hard to clean. This isn't a high-tech industry, it's not sexy, and we can't match the innovation of the Internet or the cell phone. It’s low tech but has high importance: Health can  be maintained only with safe food, and a hygiene culture helps deliver it in a responsible way. Let’s all do our part to bring about a revolution in hygienic design.