Risk-based Sanitation - Part 1

This is the not the type of letter a food processor wants to receive from FDA:

Your food safety plan for RTE Thai Noodle Salad and Macaroni and Cheese did not identify a preventive control for the food safety hazard of contamination of RTE products with an environmental pathogen, e.g., L. monocytogenes. These RTE products are exposed to the production environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure. Furthermore, WGS (whole genome sequencing) analysis revealed two (2) different strains or clusters of L. monocytogenes that have become persistent in your facility.

Persistent or “resident” bacteria of any kind in a food plant—and especially listeria—typically means a facility and its equipment haven’t been cleaned properly, and while there might be an FDA-based HACCP (hazard analysis and critical control points) and/or HARPC (hazard analysis and risk-based preventive controls) plan in place for regular and thorough cleaning and sanitation, it’s not being diligently followed. In some extreme cases, facilities with resident listeria that couldn’t effectively be removed by repeated cleaning and sanitation have been shut down and/or razed.

How can processors establish an effective risk-based cleaning and sanitation plan that not only ensures proper cleaning of all spaces in a food plant, but also satisfies regulatory requirements as well? What should a risk-based sanitation program look like, and how can it pass muster with FDA, USDA and other regulatory authorities?

“Ecolab recommends a multi-step approach to risk mitigation,” says Rick Stokes, manager, area tech support. The chemical company has worked with thousands of manufacturers to uncover potential risk areas such as inadequate sanitation methods, food safety issues, poor water quality, etc.

“The following steps—risk assessment, risk prioritization and risk mitigation—are where the rubber meets the road,” says Stokes. “We identify the most urgent issues based on our industry expertise and formulate a game plan for mitigating or eliminating risk, which sometimes involves hands-on training or sanitary design consultation. The final step, which is ongoing monitoring and adaptation, is crucial. This is where we can use sophisticated digital tools to drive ongoing, targeted service based on real-time analysis and custom sanitation plans.” Overall, Stokes recommends a proactive stance on risk management.

Architects and engineers are a good source of help in finding and preventing food safety issues arising from microbiological organisms. “Good sanitation and cleaning practices start with integration of thoughtful design practices of the facility,” says Enrico Chua, associate senior architect for Gresham Smith. Sanitation and cleaning operations are an integral part of Gresham Smith’s architectural and engineering design practice, and the firm has leveraged its years of experience by employing a best-practice approach through lessons learned not only with food and beverage companies but from other markets that address similar challenges. These include maintaining optimal cleanliness and managing critical and tight environmental controls—whether designing new facilities or retooling, renovating and adding on to existing facilities.

Gray Solutions, a Control System Integrators Association member, works closely with food manufacturers to understand what their process hazards are, and how to mitigate those hazards through effective cleaning, says Adam Richards, food safety engineer. “Most of the processes we work in will use clean in place (CIP) to assist with their cleaning efforts. Clean-in-place systems help from a labor standpoint, and the turnaround time is typically quicker. We can assist the customer with chemical dosing station recommendations and what cleaning chemicals are best for their process.”

Many Gray Solutions’ employees have completed hygienic design training and understand a processor’s needs regarding what cleaning chemicals and building materials would be best for specific areas, says Justin Basham, commissioning engineer. Gray can also help with choosing equipment best suited for the area, placement of the equipment and elimination of pathogen harborage points—including the correct stainless-steel grade to prevent corrosion.

Tools and Training are Lacking

Problem is, however, many U.S. plants are simply aging, says Ecolab’s Stokes. “They aren’t set up with the equipment and facility designs they would need to invest in modern monitoring tools, and without those tools they lack insights that support better efficiency, food safety, team capabilities, etc.”

One set of tools, the Novolyze platform, aims to increase food safety and quality performance by offering software modules for environmental monitoring, sanitation, smart process control, smart validation and quality forms, says Moussa Ndiaye, product manager. The Novolyze Sanitation Complete module provides digital tools to build a risk-based master sanitation schedule that will take into consideration any risk that might occur in a given factory. The system also supports task force shortage and turnover by facilitating onboarding and training.

“Some facilities aren’t taking advantage of modern training programs, and I think a big part of that is simply not knowing how good training has become,” adds Stokes. “The level of training your team can receive is phenomenal if you know where to look for it, and it can make a measurable difference in your processes.”

Training employees so they can understand what hazards are associated within each department is crucial to a clean facility, says Gray’s Richards. An example of this would be someone working in a raw meat area having to walk through a finished-goods area with open product contact zones. The likelihood of them contaminating the product may be low, but the severity could be detrimental to the product.

Training should be ongoing to be effective. “Along with initial training of employees, annual or bi-annual refresher courses associated with food safety concerns tend to keep it in the forefront of everyone’s minds,” adds Gray’s Basham. The use of practical “quizzes” during the initial and refresher courses gives the employees a way to see how the decisions they make will affect the quality of product they send to customers.

Even if given adequate training, workers will find that some facilities make cleaning inherently difficult. “Often, a facility’s building design is disconnected from its sanitation and cleaning plans due to being developed independently,” says Gresham Smith’s Chua. “A more effective approach integrates both aspects. This becomes very apparent when acknowledging that environmental contamination is a major source of the contamination of processed foods.” End of Part 1