With the ongoing implementation of the Food Safety Modernization Act (FSMA), prevention is becoming a key buzzword across the processes and practices of the industry, and sanitation is no exception. With that in mind, we wanted to focus on a basic fundamental of sanitation management, that is, the design of equipment to facilitate cleaning.
To give an expert viewpoint to the topic, we asked two industry experts – Joe Stout, CEO and founder, Commercial Food Sanitation, and Ben Trustem, applications engineering manager, Arrowhead Systems – to weigh in on some common questions in sanitary design for equipment. Following are their answers:
Q. What exactly is sanitary design as it relates to equipment?
Stout: Sanitary design is so critical to food safety. The best way to describe it is: equipment and facilities easily accessible and cleanable to a high level of effectiveness and efficiency. Not only do you need to clean it, but you also need to access it for sampling and inspection. If you can’t see it, you can’t clean it or sample it.
Trustem: Two of the most important aspects of sanitary design of equipment are visibility and clean-ability. Equipment needs to be designed so as to allow visibility and allow the sanitation crew to easily clean it and verify its cleanliness. This means that the design allows visibility of the framework and product-contact surfaces during production without disassembly; then, when not in production, it can be easily disassembled for cleaning, inspection, and reassembly without excessive downtime.
Q. When purchasing new equipment or redesigning current equipment, what should a plant seek in sanitary design?
Stout: As a plant starts to think about a redesign, the most important thing is the linked engagement with quality, operations, sanitation, and procurement. The best sanitary design development processes I have seen were generated by cross-functional teams who all had skin in the game and a level of earned ownership. Sanitation must clean it, quality needs to monitor it, operations must run it, and procurement must buy it. To get the best design for food safety, productivity, quality, clean-ability, and price, all must agree on what is most important and work together strategically to get it.
Trustem: For ease of cleaning, always check the surface finish of the equipment, as this will play a major role in removal of solids and residues. Surfaces such as polished and bead-blasted stainless steel and extruded plastics, will generally be more cleanable. Also ask the equipment manufacturer about any certifications they have attained, such as that of the USDA, NSF, or BISSC. Although these certifications may not be required for many installations, the certification provides an assurance that the manufacturer conforms to specific standards. Attaining these certifications also provides the manufacturer with advanced sanitary-design education.
Also important is the ease of breakdown of equipment, particularly the ability to break it down without the use of tools. Anytime an operator has to use a tool, it is more difficult to do and takes additional time. Tool use also introduces more opportunity for contamination and cross contamination of equipment. Any components that are bolted on are less likely to be removed and properly sanitized.
Q. How does sanitary design relate to the new prevention provisions in FSMA?
Stout: The FSMA linkages between sanitary design and food safety are not well delineated. However, with regulatory access to review food safety records and environmental monitoring results, one could be certain that if problems are continually evident in a food plant or an industry, it will lead one to the root cause—which may be poorly designed equipment or facilities.
Trustem: FSMA hasn’t completely translated to a significant increase in sanitary-designed equipment being purchased, in part, because much of the processor’s time and effort toward compliance is being focused on documentation and traceability. While this is important, it is not getting to the root of the problem—which is contamination. I do see this, though, as eventually coming full circle once companies start recognizing the true risks and indirect costs associated with equipment which is not designed with sanitation in mind.
Q. What else do processors need to know?
Stout: A signature, even by the President of the United States, does not cause an industry to change quickly. Most companies are working on documentation and their food safety plans, which are core to meeting the expectations of FSMA. Although documentation is important, it is also critical to focus on changing the culture in plants and companies to engage the hearts and minds of all employees. All of the documents on HACCP, sanitation, allergens, pest control or environmental monitoring will be worthless unless employees are engaged and passionate about their job requirements to make safe food. Without the right culture, FSMA will be a paperwork exercise that will increase regulatory actions against the industry without improving food safety statistics.
Trustem: An additional benefit of sanitary design that companies don’t always realize is its contribution to a reduction in changeover time and the associated cost benefits of that. If you have to dedicate what could be a full production shift to cleaning and sanitation rather than producing food, it carries a tremendous expense. Some of the savings of sanitary design gets clouded by the upfront cost of the equipment, but over time, the hours that are saved in proper cleaning and sanitization will add up quickly to more than make up for the initial cost difference.
Eight Years Later, Sanitary Design Food Safety Recommendations Remain Applicable
In 2004, FDA contracted with Eastern Research Group (ERG) for a study designed to improve understanding of the current state of food safety hazards at food processing facilities. The objectives were to identify the main problems that pose microbiological, chemical, and/or physical hazards and to determine the preventive controls and/or corrective actions that food manufacturers should implement to address each of the problems identified.
Including extensive literature review and expert elicitation, the study identified the major areas of concern including the most significant food safety problems and foods at high risk for these problems, followed by recommendations from the experts on preventive controls to address them. While the original study differentiated between small and large facilities, the expert recommendations did not differentiate the preventive control recommendations by facility size, despite the higher risk rankings of smaller facilities.
While the industry has continued to improve on its food safety practices in the eight years since that study, there is benefit in reassessing one’s practices and programs, and the study provides a good starting point. Among the top 10 food safety problems were poor plant and equipment sanitation, poor plant design and construction, no preventive maintenance and difficult-to-clean equipment—all of which had recommendations related to equipment sanitation or sanitary design. These included:
- Implement a formal, written plant and equipment sanitation program with a dedicated crew, assigned accountabilities, and validated and pre-operational verified procedures.
- Conduct cross-department inspections, and have a tech group trained in auditing and evaluating sanitation effectiveness. Include internal and third-party audits.
- Develop SSOPs for all equipment, including input or instruction from suppliers, and have personnel sign off when completed.
- Measure efficacy of sanitation processes by quantitative pre-op and operational micro counts and organoleptic evaluations through bioluminescence, swabs, or ATP.
- Implement keypad controls.
- Ensure there is sufficient time, proper tools, and supplies for complete sanitation.
- Make sanitation a core corporate value.
- Implement training programs for management, supervision, and cleaning personnel with a focus on cleaning techniques, cleaning and sanitation compounds, and how to evaluate performance. Improve all worker training.
- Conduct daily visual inspections and weekly sanitation tests.
- Develop a sanitary-design control program based on process-flow concepts and prevention of cross contamination.
- Ensure internal maintenance and sanitation personnel, as well as equipment companies and engineers, understand and implement sanitary-design criteria.
- Develop a priority list and plan for redesign or repurchase of equipment not meeting sanitary design criteria.
- When necessary, implement programs to compensate for design flaws, e.g., more frequent cleanup, more people on the line, focus on areas prone to niches, etc. Add a kill step at end of processing, if any doubt remains.
- Ensure all equipment is easily accessible for cleaning; weld gaps where possible; limit condensation and splash. If necessary to ensure sanitation and accessibility for cleaning, purchase new equipment.
- Hold monthly meetings to discuss problems and how to make corrections, involving all personnel.
- Develop a maintenance request system, with emergency maintenance logs, a parts reconciliation system, production sign off of repaired equipment acceptance prior to putting back into service, and records maintenance.
The author is Editor of QA magazine. She can be reached at firstname.lastname@example.org.