It is one of FDA’s five major initiatives. USDA has an agency devoted to it for agricultural producers. CDC includes it among its top project management tools. As the food industry works to transform its initiatives from reactive response to proactive prevention, the concept of risk management is gaining ground.
As defined by FDA, “the risk management initiative encompasses a search for new and better ways to reduce risks to public health. It pledges that FDA will continue to effectively manage product risks throughout their life cycle — from research and development through use/consumption.”
While it is important that such initiatives are conducted at the federal level, it is even more critical that proactive risk management practices be applied at the plant level itself. One area that lends itself quite readily to the practice is that of plant sanitation. While plants must, by law, conduct certain sanitary practices, taking these practices to the inspection level enables a plant to manage associated risks.
“We are always reviewing our work. Always,” said Bruce Ferree, quality manager/organic coordinator at California Natural Products (CNP), an aseptic packaging and ingredients company in Lathrop, Calif. “We are always looking at it because you can’t sit still.” Rather, he said, plants need to undergo regular audits and inspections, and regularly review practices, documentation and preventive maintenance programs to validate and verify plant sanitation. It’s not just a matter of validating that you have processes in place, he explained, you also need to verify that through the practices, you are achieving a sanitary environment. “Can you run every day without problems?”
“I think (sanitation) is a moving target,” said Sherman McDonald, president of Sanitation Strategies. “You have to start with a program well founded in sanitation practices and continually monitor it for continuous improvement. You’re never ‘there.’” While each processing plant is different, there are basic sanitation and inspection practices that apply to all, such as identifying CCPs that require particular practices to address; conducting regular reviews of procedures to verify the level of sanitation being achieved; and proactively assessing GMPs and sanitation practices to identify needed improvements.
THE SANITATION INSPECTION. Jim Whitehead, general manager of Superior Contract Cleaners, compares the sanitation inspection to a naturalist’s focused examination of a forested environment: He starts with a perusal of the forest to gain an overview and understanding of the big picture; then he looks at specific trees, examining each on its own merits; and finally he inspects individual leaves on all sides for a full, 3-D inspection.
To apply this to the plant, he said, first look at the “forest,” that is, the entire room, from a distance; then approach each “tree,” or piece of equipment, as its own environment; then minutely inspect each “leaf,” or product zone, of the equipment. And, just as you would route a path through a forest, create an organized pathway around your own environment. “As you approach each piece of equipment, have some organization to it,” Whitehead said. “Have a pathway that you move along from one piece to the next so you have complete coverage.”
In most sanitation inspections, he said, “The biggest problem is the failure to think in three dimensions. Most people think two dimensionally.” It’s easy to look at the areas which are readily visible and directly in front of your eyes, that is, between the forehead and knees, he explained, but it is critical to inspect the more difficult areas as well. As such, a three-dimensional inspection should include:
1. Everything within the product zone, including the food contact surfaces themselves.
2. Everything above the product zone, such as condensation build-up on overhanging pipes or the undersides of framework.
3. All areas outside the product zone, where incidental contamination could result.
Daily 3-D, top-to-bottom inspections — along with surface bacteria testing to document and verify results — will enable a plant to track repeated failures, and implement corrective action, training and repetitive measurements.
“You can pick up and correct a problem early on, before it becomes a systemic issue,” Whitehead said.
MUNCHICIZE THE ELEPHANT. Invoking his own metaphor, Ferree recommends that plants “munchicize” the steps of their sanitation processes. “The world is a big elephant,” he said. “You can’t eat it all in one bite, you have to munchicize it.”
By doing so, Ferree said, “We’ve found some things that would surprise you.” And when something is found, corrective action is put in place for continuous improvement. This might mean changing the cleaning regimen for a piece of equipment requiring further disassembly or reorganizing the routine for an area in which a line was being missed. By munchicizing one step, line or area at a time, you are able to conduct a more detailed inspection — looking at individual “leaves” — and asking in-depth questions.
“You learn to ask ‘Why?’ five times,” Ferree said.
Why is that tank not at the proper temperature? (Oh, it is. It’s at 120°.)
Then why is its thermometer showing 110°? (We don’t look at that one, we use this portable one.)
Why? (Because that one isn’t calibrated.)
Why? (It stopped working.)
Why don’t we get it fixed?
“Eventually you get to the answer,” he said. “And that’s why you do these inspections, audits and risk analyses — to make sure things are being done.”
DEVELOPING A PROGRAM. Because every plant is different, it is important to assess risk areas in your individual plant. “There’s no silver bullet answer that applies to everyone,” Whitehead said. The first thing is to determine the degree of equipment disassembly, sensory inspection, cleaning and testing necessary to manage or eliminate risk.
In a thorough inspection, Whitehead said, “You really have to use a lot of your senses.” Besides vision, he cites smell and touch as two of the key senses critical to inspection. Touching equipment surfaces and undersides of framework can reveal problems such as grease build up that may not be visible to the naked eye. In the same way, he said, if you are inspecting a drain, you may not see any indication of contamination, but if you smell a bad odor, the area most likely needs further cleaning. “Smell is a way to pick up what we may not normally see,” he said.
“It really boils down to setting it up properly,” Ferree said. “Design your program so it works for you.” To munchicize its sanitation elephant, CNP uses the task and reminder functions of Microsoft Outlook. Personnel who are in lead or supervisory positions all have computers, so food safety, food defense and operational tasks are assigned through the software with dates specified for each.
When a task is due, a reminder pops up on the computer of the person charged with completing it. The tasks can also be set with priority (low, normal, high), and tracked according to status (not started, in progress, completed, waiting on someone else, deferred) and percent completed. As a task is worked, the owner updates its record and the revised documentation is sent back to both the operations’ group office manager and Ferree. If no response comes back, Ferree knows that another reminder needs to be sent. “They’re used to me sending out messages if I haven’t gotten a response back,” he said. And with his own reminder to check on tasks set to recur every Wednesday, he tends to get a lot of responses back on Tuesdays, Ferree said.
USING TECHNOLOGY. Using electronic systems to document inspections and sanitation practices increases the ability to track the processes and enhances the ability to make improvements, McDonald said. In fact, software designed specifically for sanitation data management is now available. Sanitation chemicals and equipment can be bar-coded, then the application captured with the use of a hand-held scanner.
When uploaded, the sanitation data can then be viewed and built into reports to identify and track trends relative to a plant’s sanitation program. “By using more of a digital approach to capture data, then analyze the data, you can identify potential risks and those things which are potentially contributing to negative outcomes,” McDonald said.
THE MORE THINGS CHANGE. While technology continues to improve and change business practices as a whole, some things about sanitation inspections never change, Whitehead said. “I’ve seen a lot of inspection programs where they are not using flashlights,” he said. “It’s impossible to effectively inspect a piece of equipment without a flashlight.”
Whether you are integrating the latest technologies, or following the tried and true, it is the consistent, through inspection process that will enable a plant to continuously improve its risk management process to maintain a food-safe environment. “We are all human and are subject to failure,” Whitehead said. “So you need to have enough inspection and verification built in so that no one mistake can lead to contamination of the food being produced.” QA
The author is Staff Editor of QA magazine.
Unsealed Soap Systems Can Carry Bacteria
Handwashing is a critical control point in the food processing industry. Washing hands with soap and water is supposed to rid hands of contaminants, but University of Arizona studies on soap dispensed from open refillable bulk dispensers show that you may actually be washing your hands with germs.
The studies showed 23 percent to 25 percent of samples taken from open refillable bulk soap reservoir dispensers to be contaminated with unsafe levels of bacteria, with Coliforms found in between 16 and 22 percent of the samples. In contrast, no bacterial contamination was found in soap dispensed from sealed systems.
The studies, conducted under the direction of Charles Gerba, professor of environmental microbiology at the University of Arizona, and funded in part by GOJO Industries of Akron, Ohio, concluded that open refillable bulk soap reservoir dispensers may become a breeding ground for germs and result in a public health risk.
The bacteria found in greatest numbers, said Gerba, were opportunistic pathogens; that is, pathogens capable of causing serious infections in the young and immunocompromised.
Any open refillable dispenser could be subject to contamination, including stainless steel dispensers, Gerba said. “Stainless steel will not control microbial growth. They are very easy surfaces to clean. But, they won’t control microbial growth.”
Gerba said he is unaware of any established protocol for effective cleaning and sanitizing of the open refillable dispensers, and suggests that data on product efficacy and use frequency be reviewed for any such recommendation. In addition, because the studies showed that no pathogens were found in soap collected from sealed systems, he believes that the only safe solution is to use sealed systems. This is, in part, because plant employees who refill the bulk soaps may dilute them with water, adding contaminants or may put their fingers in the soap.
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