Engineering Design: It Takes an Industry
March 01, 2010
by Steve Berne
The days of autonomy for equipment suppliers’ engineering designs are over. Likewise, bakery and snack makers who consider sanitation procedures only as an afterthought when procuring new equipment are making a serious mistake. These were the themes discussed at the recent Equipment & Plant Design Workshop for Allergen/Pathogen Control.
The workshop’s purpose was to create an understanding and open dialogue between processors and equipment suppliers regarding challenges and requirements of proper sanitation that occur in food manufacturing plants. Processors expressed a desire to establish consistent design elements of equipment to help facilitate the sanitation process. Suppliers learned about an area for which they may have little knowledge yet critically impact, and they also presented their challenges of manufacturing design to meet processor demands.
The sold-out 2-day workshop, co-sponsored by nine industry associations, included a 50:50 supplier-to-processor ratio. The initial processor team, under the umbrella of the Grocery Manufacturers Association, included key personnel from Kraft Foods (and Cadbury), Sara Lee, Kellogg Company, Bama Foods, General Mills, Campbell’s, PepsiCo (Quaker, Frito Lay), Heinz, Nestle, ConAgra and Land O’ Lakes.
To introduce the topic, Joe Stout, director of product protection and hygienic design, Kraft Foods, Northfield, IL, outlined 10 guiding principles of sanitary design for equipment. These included:
1. Cleanable 2. Made of compatible materials 3. Accessible for inspection, maintenance, cleaning and sanitation 4. No liquid collection points 5. Hollow areas eliminated or sealed 6. No niches 7. Sanitary operational performance 8. Validation of cleaning and sanitizing protocols 9. Separate processes wherever possible 10. Meet personnel hygiene and sanitation requirements
Subtopics relating to these principles included the types of chemicals used and their impact on construction materials and detailed cost analysis of downtime for cleaning and other factors. Several case studies were presented relating to recent recalls caused either by mislabeling of allergens or industrywide issues such as the peanut butter recall.
Needs for improved sanitation were discussed, and while several suppliers noted their equipment was prethermal or that baking is a lower-risk industry compared with meat or dairy, counterpoints noted allergen control and guilt-by-association effects that impact every segment of the food industry.
Public awareness of food safety is at its highest level, Mr. Stout noted. He presented statistics citing 83% of consumers can name a product that was recalled because of safety concerns; 76% of consumers report they are more concerned today than five years ago about the food they eat; and 57% of consumers have stopped eating a particular product because of a recall. This last statistic does not account for the impact a recall has on the whole category of products indirectly related to the recall.
Both Kellogg’s and ConAgra’s peanut butter production lines were shut down for 90 days, according to Gary Goessel, senior manager of food safety, Kellogg Company, and Randy Porter, director of sanitation, ConAgra. The extent of the recall grew exponentially for these and other companies because each had to establish a “sanitation clean break,” which is defined as a production break that concludes with a documented, verified and validated cleaning process.
To achieve hygienic restoration on their peanut butter lines, Kellogg and ConAgra implemented a strategy involving all building structures (floors, walls and ceilings) and all equipment surfaces in any area where peanut particulates could be present. In many cases, it was the entire facility and all production lines. The companies’ strategies included determining the level of cleaning required; a facility and infrastructure assessment for such tasks; a review and enhancement of existing sanitation standard operating procedures (SSOPs); determining the necessary level of disassembly to attain the targeted level of clean (a step involveing FDA and in many cases required 100% disassembly and cleaning down to nuts and bolts); vendor support for supplies, equipment and contracted services; and establishing sanitation verification and validation with internal departments and regulatory agencies. Costs of restoration (downtime, utility resources, personnel, contracted services and others) for ConAgra surpassed $33 million. This does not include the impact from loss of loyalty and time to restore consumer confidence. Many smaller companies succumbed and were forced out of business.
LIFE CYCLE IMPACT.
Mr. Stout brought his message home when he analyzed the life cycle of a generic piece of equipment in one plant. Assuming the equipment has a useful life of 20 years (which can vary between 10 and more than 50 years), the personnel, downtime and loss of product revenue because of cleaning and sanitation is astounding. “Consider the changes in equipment design in the past 20 years,” he said. “Now imagine the next 20 years. Realizing the speed of technology advancement relating to food safety, we need to be sure equipment design keeps pace.”
An emphasis throughout the workshop was the importance of getting everyone involved in equipment procurement from the outset, including production, engineering, sanitation and other departments, vendors and outside parties to discuss concept and design requirements.
Sanitary standards such as BISSC and NSF were also discussed for their validity, necessity and cost impact. While processors agreed a minimum standard should be met by all suppliers, the vendors noted the wide range of applications and custom engineering required and the challenge of applying a single standard equally to all equipment, considering added costs incurred by suppliers and lack of mandates from all processors for such standards. Attendees also noted that standards for sanitation are continually evolving. By the time the industry settles on a single standard, it is already outdated. The 10 principles were considered more applicable over time and to a wider selection of equipment.
Mr. Stout and the other processors of the working group not only created the 10 guiding principles stated earlier but also provided details for each principle, which generated healthy dialogue and appreciation of the issues among the attendees. “‘Cleanable’ may sound like a basic concept, but processors need equipment to be cleanable to good manufacturing practice (GMP), product hazard (microbial and physical) and quality levels that are validated and verified by various monitoring programs,” Mr. Stout noted. “Suppliers must be aware of the product, environment and proposed cleaning methods (chemical and tools) and use materials of construction compatible with such methods.”
Ease of disassembly without special tools and simple design elements such as sloped flat surfaces, self-draining portals and cross-supports turned 45° to prevent stagnant product buildup or liquid collection are all key needs for processors. Equipment suppliers also must eliminate hollow or sandwiched areas of equipment. “This refers to potential harborage sites for microbes, allergens, rodents or other contaminants,” Mr. Stout said. “Items such as bolts, studs, mounting plates, brackets, junction boxes, nameplates, end caps and sleeves should be continuous-welded to the surface and not attached via drilled and tapped holes or simply spot-welded.”
“Niches” were described as pits, cracks, corrosion, crevices, recesses, open seams, gaps, lap seams, protruding ledges, inside threads, bolt rivets or dead ends. “All welds should be ground and polished smooth,” he continued. “These principles should be part of any good design and pride of workmanship, instead of being considered a premium or upcharge.”
Operational performance relating to sanitation refers to eliminating any unsanitary conditions, which during normal production could create harborage and bacteria growth. This includes maintenance enclosures, wire or conduit runs and supports, eliminating or protecting pushbutton controls, and positioning ancillary systems such as electrical, hydraulic, steam, air or water systems out of direct proximity to equipment where possible. Processors and suppliers must work together from the outset to validate protocols. Procedures for cleaning and sanitation must be clearly written, designed and proven effective and effi cient. Suppliers, processors and even sanitation chemical suppliers should partner on this principle . “The idea is to address sanitation and equipment design issues early on instead of incurring the cost and potential downtime once the equipment is installed,” Mr. Stout said.
Preventing cross contamination through clean breaks and separation or isolation of dissimilar processes or ingredients is also important. As examples, Mr. Stout cited isolating wheat, soy, peanut or other allergens; raw from ready-to-eat processes; and washdown from dry-clean areas.
Finally, personal hygiene procedures and protocols must be clearly defined, written, communicated and enforced. They must apply not only to plant employees but also to management, visitors, contractors and suppliers.
Mr. Stout shared a checklist summary used at Kraft and other companies that quantifies each principle with values that total 1,000 points. Each principle may be subdivided and points awarded in a declining scale depending on a satisfactory, marginal or unsatisfactory grade. “The purpose of the summary sheet is to quantify the level of continuous improvement,” Mr. Stout stated in his presentation. “Kraft does not have a minimum value for acceptance. Rather, acceptance is based on ability, time, resources and cost of implementing and maintaining controls for all noted marginal and unsatisfactory ratings.”
Elements of the checklist can be used prior to equipment procurement, during installation and as an ongoing sanitation monitoring device.
Attention to the facility itself is critical to overall sanitary design of a production plant. Kevin Farnum, director, sanitation center of excellence and engineering sanitation design, quality and regulatory operations, General Mills, Minneapolis, MN, presented his own principles for sanitary design of facilities. “The principles are simple yet critical,” he said. “Overall, there are three basic themes: design facilities to eliminate cross-contamination; to eliminate harborages and growth such as rodents, product and microbial; and for easy sanitation.
“You must establish distinct hygienic zones within a facility and control movement of personnel and materials,” he continued. “Water is a critical factor in preventing microbial growth and should be used only in controlled environments. Never introduce water in a dry processing area. Ambient temperature and humidity also are related to microbial growth as well as ingredient and product integrity and must be controlled.”
He discussed airflow, room air quality and ventilation turns as well as air-handling systems and ducts. “Controlled pressurization and filtration are critical factors affecting condensation and dust,” he added.
He pointed out that you must also address the outside perimeter of the building and the entire property. Poor site design, grading and water management or landscaping for aesthetics can increase the risk of contaminants entering the building.
Other key concepts noted were isolated trash and compactor site(s) to minimize transporting waste within or around the facility, “bone yard” location and pallet inspection, washing and storage. “Pallets, whether wood or plastic, can be a major source of pathogens as well as small rodents and insects,” Mr. Farnum said. “Design and construct building openings (doors, louvers, fans and utility penetrations) to prevent infestation and roofs to be self draining and prevent pooling.” Back inside the facility, pay attention to spatial design and equipment layout. Make sure there is suffi cient space in aisles, around columns and beams, and enough access to clean and maintain all floor-wall interfaces. Further, building components and construction should facilitate sanitary condition. “Use cleanable, durable materials in construction and minimize joints and cavities on walls, ceilings and floors,” Mr. Farnum added. “Utility systems should be isolated and installed outside the processing areas when possible in false ceilings or adjacent rooms. And anticipate employee needs, requirements and movements during sanitation times to maximize access while minimizing needs for dragging hoses, tools or parts to and from storage or designated cleaning areas.” These principles can be implemented on greenfield, brownfield or in existing operations. Both sets of principles were adapted from principles developed by the American Meat Institute in 2004.
PARTNERS IN GRIME.
John Russell, food safety manager, Sara Lee Corp., Downers Grove, IL, brought many of the workshop themes full circle regarding the partnership between processor and supplier. He discussed cleaning procedures and validation. “This is an area where all parties must take part,” he said. “Processors in each industry segment have procedures and schedules for daily cleaning as well as periodic, more thorough, cleaning. Suppliers must understand cleaning needs and protocols and help processors accomplish their goals through design. Going through the sanitary design checklist, critical questions on how to clean, what to clean and level of disassembly can be addressed and answered.”
In the past, suppliers’ main objectives were to design and build equipment to satisfy their customers with process speed, reliability and consistency. In today’s manufacturing environment, that is no longer enough. Details on equipment cleaning and sanitation must also be provided. This is a new area for many suppliers, who do not employ sanitarians as part of their engineering design team.
“Cleaning, inspection and sampling for sanitary verification must be conceptualized, designed, engineered and constructed into equipment by manufacturers and end users,” Mr. Russell concluded. “It will take partnership and education on both sides to understand the challenges and mandates and to develop appropriate details to satisfy all parties, including the ultimate end user.”
This was the first of several planned workshops. The next meeting is scheduled June 23 and 24. Look for details from the supporting associations.