|Salmonella. Photo by National Institutes of Health|
“At the highest level, the prevention vision embodied in FSMA [Food Safety Modernization Act] is simple: we will make food safer by setting and gaining high rates of compliance with standards that set the bar for industry efforts to prevent hazards from entering the food supply. FSMA provides FDA with a strong mandate to set such standards, as well as important new inspection and enforcement tools to achieve compliance.
… Historically, FDA’s inspectors have inspected food processing facilities for basic sanitation and to detect visible problems with the facility or the product being produced. Under FSMA’s new norm, FDA inspectors will still be looking for what’s gone wrong, but they will also be looking to verify that firms are implementing the systems needed to do things right.”
– Michael Taylor, FDA Deputy Commissioner for Foods, May 19, 2011
In the past, it was enough for a food or beverage manufacturer to pass the sanitation portion of an inspection through a primarily visual assessment. But now, with FSMA, plants must not only pass sanitary checks, they must verify that preventive measures have been put in place to ensure that sanitation.
Because such verification of prevention is applicable to all hazards, it is similar to HACCP (Hazard Analysis Critical Control Plan) programs that have long been required for certain USDA-inspected plants. Thus, plants that are facing such prevention verification regulations for the first time can take a page from HACCP as guidance. “HACCP, obviously, is a key when you are talking about prevention and verification,” said Norman Marriott, Professor Emeritus at Virginia Tech and author of Principles of Food Sanitation Science.
Through HACCP, one takes steps to analyze a hazard—determining whether and where it is likely to occur, then sets critical control points at these locations to prevent the hazard from occurring. Additionally, HACCP requires that the plant establish procedures for verifying that the system is working properly.
While HACCP has been in place since the 1960s, FSMA marks the first time that FDA has required the creation, implementation, verification, and written documentation of prevention plans for all food and beverage processors, said Melanie Neumann, advisor for PwC Governance, Risk, and Compliance. Many plants do have such programs in place but most don’t have them in writing, she said, adding, “Even when we see sanitation and allergen management programs in writing, most need to take a step further as to why and how they got there.”
|Listeria on broccoli sprout. Photo by USDA-ARS-Lisa Gorski|
The message that FDA is imparting through FSMA in relation to increased requirements for programs such as sanitation management, she said is: “We want to understand how you arrived; how you got there.” Plants need to show risk-based and science-based strategies.
Increased Importance. “Sanitation is becoming a larger issue that can precipitate and trigger recalls,” Neumann said. Additionally, a sanitation assessment can be very subjective; and, she said, “It only takes one regulatory official to take a subjective view of what’s sanitary or not.” For both these reasons, as well as general food safety, it is important to set a critical eye toward preventive sanitation programs.
“The reason that sanitation has become more and more critical is that we have more food processing being done outside the home today, and mistakes made in food plants affect more people,” Marriott said. In addition, with the aging population, longer lifespans of those with diseases such as cancer and AIDS, and increases in the food-allergic population, there are more people who are immuno-compromised with lowered resistance to contaminants.
At the same time, the more sanitation we implement, the more we need to implement. “In this country, we have improved our sanitation enough that there are fewer microorganisms there to compete with pathogens, so pathogens have more opportunity to grow,” Marriott said. Marriott cited Listeria monocytogenes as an example, noting that it tends to be the cleaner plants in which this pathogen is most often found. In fact, he said, Listeria monocytogenes is sometimes called “the clean-plant pathogen.”
This isn’t to say that a plant should be dirty. Rather, he said, it shows that plants have to be even more careful with sanitation. For example, he said, equipment can have cracks and crevices or absorbent materials in which pathogens can harbor, and these areas are difficult to clean. But, as part of a prevention-based sanitation program, it is critical that equipment construction be analyzed for such issues, and the equipment be capable of being broken down for cleaning or be replaced if it cannot be cleaned effectively.
Audit for Prevention. Such sanitation analysis should take place throughout your plant and programs. The first step in doing so is analyzing your company’s current program through an internal self-audit with a focus toward existing documentation. Ask yourself, Neumann said, “Does it convey the message that I used a science- or risk-based approach?” Then, she said, “Walk through, and see if it is really being utilized in the plant.”
You may have it in writing, but find that it is not actively being used; or you may find that preventive measures are being implemented that haven’t been documented.
If you do find that something is not being done correctly, Neumann cautioned that you not call out the employee on the spot, but rather, take the opportunity to train and further integrate prevention as a culture in your environment.
“Employees can be a major contamination source,” Marriott said. Workers can bring contaminants into the plant through lack of personal hygiene or sloppy handling, he said; and, in the plant, some will follow standards to a T, while others will take shortcuts wherever possible. “It’s a people world,” Marriott said. “It’s just the difference between workers who will do it and those who don’t.”
For prevention, plants should implement a rigid employee hygiene program that goes beyond the washing and sanitizing of hands, he said. Depending on the risk level of the product being produced, some plants require a change of footwear and/or clothing in production areas. Others, such as meat plants, will place strict limits on travel within the plant, allowing employees to be only in areas to which they are authorized and sanitizing equipment if it must cross between raw and ready-to-eat areas.
A contamination potential that is not always considered is that of maintenance and sanitation workers. Because they are in all parts of a plant, they can carry contaminants with them, Marriott said. Thus, this should also be considered in a prevention program.
Taking a preventive approach toward supplier selection is also not only critical, it is required by FSMA that supplier verification programs be implemented for foreign suppliers. This, with the increased certification and accreditation required of third-party auditing of foreign suppliers, “sends a powerful message to the industry,” Neumann said. Additionally, she said, “even if a supplier causes a food safety incident, it is your recall, it’s your brand, it’s your name in the press.”
Because of this, combining third-party audits with your own internal audits, as well as unannounced external audits, can greatly increase your ability to identify risk in your own and your suppliers’ environments—and to take corrective action.
And with that, Neumann said, should be a strong focus on meaningful documentation. “A lot of companies are doing the right things, they are just not documenting them.” When you follow up action with documentation of verification and validation, you will be taking proactive steps toward greater prevention—and fulfillment of the new law.
As Taylor noted in his address:
The new law shifts our food safety focus from reaction and response to prevention of the problems that can make people sick—from catching food safety problems after the fact to systematically building in prudent preventive measures across the food system, from the farm to the table.
The author is Editor of QA magazine. She can be reached at firstname.lastname@example.org.