Meeting FSMA Regulations: Your Facility Zone Checklist
By: Bill Bremer
Principal, Food Safety Compliance, Kestrel Management
All FDA-regulated facilities must ensure compliance with the Food Safety and Modernization Act (FSMA) of 2011. With specific rules of the legislation now going into effect, it’s critical for food and beverage manufacturers to understand and stay current with all relevant standards. This checklist is designed to help you write an effective food safety plan required by FSMA.
Compliance with The Food Safety and Modernization Act (FSMA) requires implementation of a Hazard Analysis and Critical Control Points (HAACP) management system. This system provides tools for food manufacturers to analyze the potential for and to control biological, chemical, and physical hazards that can exist throughout the manufacturing plant. Identifying the 6 primary zones of a food and beverage manufacturing facility is one of the first steps in accomplishing your HAACP and FSMA compliance goals. What follows is a list of these numbered zones, starting from the outside moving inward to where food is produced. Within each zone, specific areas are identified where issues are known to occur.
Zone 6: Facility Exterior and Grounds
From the parking lot to the front entrance, unexpected problems outside a food and beverage facility can have serious consequences.
Area: Parking Lots and Walkways
Issue: Potholes, cracks and settled areas in concrete can create trip hazards, and standing water can attract pests.
Area: Doors and Windows
Issue: Broken windows and gaps around doors can create pest control problems, and inhibit your ability to control indoor temperatures.
Issue: Facility security is essential to keep employees safe and to prevent theft or product contamination. Check for openings in fences and make sure surveillance systems are in working order and all locks are intact.
Area: Exterior Signage
Issue: To ensure regulatory compliance, all parking areas must be properly designated and any rules about pets, smoking or firearms must be posted.
Area: Exterior Lighting
Issue: To ensure safety and security, all facilities must have adequate exterior day and night lighting for sidewalks, the building perimeter and parking lots.
Area: Standing Water
Issue: Standing water is a breeding ground for pests and salmonella, and can also signal drainage problems.
Zone 5: Dock and Warehouse
The dock and warehouse can be vulnerable to everything from pests to chemical contaminants. Controlling this zone is critical to maintaining product integrity and keeping people safe.
Issue: Floors should be properly maintained with all hazardous areas identified and labeled, and all cracks sealed.
Issue: Lighting should be adequate, properly covered and shatterproof. Fixtures must be on a regular cleaning schedule.
Area: Ceilings and Pipes
Issue: Damaged pipes and sealant gaps can lead to combustible dust problems, pest infiltration and contaminants from outside air.
Area: Bug Lights
Issue: Bug lights attract insects and should be for interior use only. They must be regularly cleaned and maintained.
Area: Pallets and Drums
Issue: Wood can be a breeding ground for pests and a leaky drum can lead to contamination.
Area: Non-Food Products
Issue: Non-food products and chemicals near the dock or warehouse can be contamination issue or present fire hazards.
Issue: Pests, dirt and contaminates entering via the dock may migrate into more restrictive zones and cause a food safety issue.
Zone 4: Offices, Employee Areas and Maintenance
Many potential sources of contamination can enter the food safety zones via employees and the items they carry. Evaluate areas where personal belongings are stored.
Issue: Utensils in employee kitchen or break areas should be clean, maintained and color-coded to prevent cross-contamination.
Area: Cleaners and Chemicals
Issue: All cleaners and chemicals should be food safe and properly stored in locked cabinets to prevent food contamination.
Area: Interior Signage
Issue: Zones should be clearly identified, as well as any appropriate access control, PPE requirements, FDA compliance, GMP compliance, company rules and emergency evacuation specific to that zone.
Area: Drains and Sanitation
Issue: Drains, waste management, cleaning and general sanitation programs should be maintained to prevent breeding of bacteria, physical contaminants, and trip hazards.
Area: Walls and Ceilings
Issue: To be in regulatory compliance, walls, ceilings and floors should be free of peeling paint and must be clean, caulked and sealed.
Area: Plumbing and Electrical
Issue: To be in regulation compliance and to prevent physical damage, protection must be provided for protruding pipes and electrical boxes. All palletized products must be 6” away from walls.
Area: First Aid
Issue: First aid must be readily available in all zones to ensure regulatory compliance and employee safety.
Area: Hand Washing Stations
Issue: To prevent contamination between zones, an appropriate number of accessible wash stations must be accessible.
Issue: To ensure employee safety and protection from employee-caused contamination, the right personal protective equipment (PPE) must be available and in use.
Area: Bathrooms and Locker Rooms
Issue: To be in regulation compliance and to ensure employee safety, all bathrooms must be clean, sanitary and equipped with proper amenities. Locker rooms must be clean and well organized.
Zone 3: Unpacking and QC Labs
The handling of ingredients and preparation of food products in this area could result in cross-contamination without proper precautions.
Area: Markings and Labels
Issue: To prevent tampering with product, piping and utilities used for unloading products, such as liquids or powders, should be clearly marked and labeled.
Issue: To ensure food security and safety as well as employee safety, signage should be posted for controlled access and procedural information.
Area: Emergency and First Aid
Issue: To be in regulation compliance and to ensure employee safety, first aid should be readily available and accessible.
Issue: To ensure food safety and regulatory compliance, all food and ingredients should be stored off the floor and away from walls or wood benches.
Area: Vents and Exhausts
Issue: To prevent contamination and ensure air quality, all air vents and exhausts must be cleaned regularly.
Issue: To be in regulation compliance and to ensure food safety and product consistency, quality assurance labs must be clean and well equipped.
Area: Water and Air
Issue: To prevent product contamination, combustible dust, and compressed air leaks, maintain proper utilities and systems for compressed air, water and backflow. Check all water and compressed air lines for leaks, and make sure all drains are working properly and are cleaned on a regular schedule.
Area: Material Handling
Issue: To prevent product contamination, make sure all fork trucks pallet jacks and dollies are completely clean.
Issue: To prevent product contamination, make sure you have a method for regular cleaning of any hoses used for product transfer. Hoses must be stored hanging off the floor.
Issue: To prevent product contamination, all trash cans must have lids that close, and must be emptied daily. All doors inside the facility must be sealed. Parts carts must be clean and in good condition. Shop must be organized and clean.
Zone 2: Staging Areas
Zone 2 is adjacent to where food production occurs. If this zone is contaminated with a pathogen, there is the likelihood that Zone 1 could also become contaminated by the action of an employee or machine.
Area: Physical Plant
Issue: To prevent product contamination, floors, walls and drains cannot be allowed to deteriorate.
Area: Utensil Control Program
Issue: Regulatory inspections require 3 sets of color-coded utensils to prevent product contamination.
Issue: To ensure employee safety and prevent product contamination, proper PPE must be provided and available at all times.
Issue: To prevent product contamination, equipment must be in proper working order. Look for broken glass, plastic and ceramics, and make sure air wands have proper tips.
Area: Allergen Controls
Issue: To prevent cross-contamination, make sure proper controls are in place for specific allergens, including nuts and oils.
Area: Lubrication Control
Issue: All lubricants used must be food-grade and should be stored properly.
Area: Waste and Sanitation
Issue: Make sure all drains are operational and a pump sink is available for mop water. Cleaning chemicals should be food-grade and mixed correctly. Make sure waste management controls are in place and spot cleaning supplies are readily available.
Zone 1: Production/Processing Areas
This zone comprises the entire work area where employees and machinery have direct contact with food and the product is exposed until packaged.
Area: Physical Plant
Issue: Compromised areas around exposed food can lead to contamination.View all floors, walls and ceilings for holes, chips, flaking paint and misaligned ceiling panels.
Issue: To prevent product contamination, review overhead lights for cleanliness and cracking. Verify that fixtures are on a regular cleaning schedule.
Issue: To ensure compliance, as well as employee and food safety, always maintain the highest standard for personal protective equipment.
Area: Spill Control
Issue: To ensure employee safety and protect food from contamination, proper spill control kits must be available and accessible near the production line.
Area: Product Sampling
Issue: To ensure food safety and quality, the proper tools for food sampling off the production line must be available at all times.
Area: Hand Washing
Issue: To prevent food contamination, hand wash sinks and hand sanitizer must be available and accessible to workers.
Issue: To ensure employee safety and regulatory compliance, any hazards such as pinch points or hot surfaces must be identified by the proper signage.
Food and beverage manufacturers are facing increasingly stringent standards for food safety from national, state and local agencies. Many of these standards for food safety have been mandated by the Global Food Safety Initiative(GFSI) and the Food Safety Modernization Act (FSMA). These standards directly impact FDA-regulated facilities, food-contact materials and logistics. The requirements to meet these standards continue to expand. To help keep up with these evolving standards, a checklist like the one above, and photo documentation can help provide the foundation for correcting problems, maintaining FSMA compliance and achieving GFSI certification.
Bill Bremer is a Principal with Kestrel Management’s Chicago area practice and heads Kestrel’s food safety consulting group. In his food compliance roles, he has led compliance and assurance activities to help many food industry companies meet FDA/FSMA, GFSI (i.e., BRC, IFS, FSSC22000, SQF), HACCP, EHS, and overall operations management requirements.
Sources: Food and Agriculture Organization of the United Nations, the American Bar Association.
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