Just over a decade ago, a beloved ice cream company was at the center of the type of food safety crisis that keeps industry professionals up at night. A Listeria outbreak linked to a Blue Bell Creameries manufacturing plant left three people dead and ten more hospitalized. The company was ordered to pay $17.24 million in penalties related to the Listeria contamination. This sum pales in comparison to the damage caused to the company’s revenue and hard-earned reputation.
Inspection forms produced by the FDA cited a failure to clean food-contact surfaces frequently enough to prevent contamination, a failure to wear beard covers effectively, and insufficient hand washing and sanitation by employees.
But what the Blue Bell case also indicates is a critical truth in food manufacturing: ironclad hygienic zoning guidelines are not optional.
Hygienic zoning is a food safety hazard management method designed to prevent the spread of pathogens, allergens, and physical contaminants in food and beverage manufacturing environments. It involves dividing the manufacturing facility into distinct areas based on risk levels to create protective “bubbles” that prevent the transfer of microbial, chemical, and physical risks from one area to another.
It also involves strict oversight of employee movement within the facility and the protocols they follow when moving from one area to another.
Hygienic zoning is critical for:
Under the FDA’s Food Safety Modernization Act (FSMA), food companies must maintain a written food safety plan that includes a series of risk-based preventive controls. These include process controls that ensure control parameters are met, procedures to prevent allergen cross-contact, and sanitation controls “to ensure that the facility is maintained in a sanitary condition to minimize or prevent hazards such as environmental pathogens, hazards from employees handling food, and food allergen hazards.”
Hygienic zoning is one of the most central ways to pull that off and is highly manageable with a committed food safety team.
Step 1: Conduct a Thorough Risk Assessment
You can’t manage a threat you haven’t identified. To begin planning out a hygienic zoning scheme for a facility, the food safety team must walk through the facility and locate all potential threats to the production environment.
This is essential for determining the specific threats and how to mitigate the risks posed by the two types of dangerous microorganisms in the production environment:
Facility walk-throughs entail seeing where different materials enter the facility, where the processing takes place, where and how employees enter and exit the workplace, and where products are stored, among others. Successful walk-throughs help identify high-risk areas where products are exposed and vulnerable, and the low-risk areas that are of lower concern.
Step 2: Map the Facility and Use Visual Cues
There are five specific zones in a manufacturing facility, each with its own level of hygiene requirements to mitigate the risk of contamination.
These include:
Once your team has identified and mapped the different areas in a facility, color code them and all tools, uniforms, and equipment to correspond to the zones in question.
Step 3: Control the Flow of Traffic
Mapping your facility is essential for managing the traffic flow, which entails controlling the movement of people, equipment, materials, and products through a facility. Controlling the traffic flow prevents raw ingredients from contaminating finished goods, and proper mapping makes the process safer and easier.
To prevent contamination from hitching a ride on staff members, there should be a linear flow in which personnel move from higher to lower hygiene areas and not vice versa, unless proper sanitation measures have been taken. Equipment should be separated by zone and should be cleaned and sanitized if moved from one zone to another.
You must also establish strict transition areas that make it clear that team members are moving from one zone to another. There should be clear protocols for moving through these areas, as well as hand-washing stations and hygiene measures such as boot scrubbers and gowning posts. In addition, required hygiene protocols should be clearly posted for employees to review.
Step 4: Define Sanitation for Each Zone
Once the zones are mapped out and color-coded along with the requisite equipment, it's important to determine the specific sanitation SOPs for each zone.
High-pathogen control zones require more stringent and frequent cleaning than non-manufacturing areas where the risk is lower. Defining these requirements entails not only the frequency but also which chemicals and which cleaning methods are most suited for each zone.
Risk management and hygienic zoning also require frequent environmental monitoring procedures to regularly test surfaces for contamination threats. This helps ensure these threats are under control and helps confirm the level of risk in specific zones.
Step 5: Focus on Training and Proper Equipment
Even the best hygienic zoning scheme will fall short if employees don’t “understand the why” or how to manage it.
Food safety supervisors must hold frequent, trackable training to ensure employees understand the importance of the sanitation and zoning guidelines they must uphold and how to carry them out effectively. Effective training empowers employees to navigate the various zones safely and efficiently without increasing risk or slowing down the workflow - and without needing the guidance of a supervisor.
Food safety supervisors should develop strong sanitation and zoning SOPs that are updated when needed, due to new ingredients and formulations or emerging workplace risks.
In addition, facilities must focus on sanitary design in the construction and renovation of facilities, as well as the equipment used in those facilities, to ensure that bacteria don’t have any nooks or crannies to hide in.
Study Hygienic Zoning with Rootwurks
Food safety is a marathon, not a sprint. It requires a daily, concerted effort and the development of a safety culture that integrates with the workflow.
To help companies learn how to create and manage separate protective “bubbles,” we have deployed our hygienic zoning awareness course in the Rootwurks platform and have made it available on our online store.
Enroll today and help reduce the risk of cross-contamination and food safety recalls.