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With the implementation of the Food Safety Modernization Act (FSMA) and media coverage of food safety issues and recalls, ensuring a facility is maintained in a condition that allows safe production of food has become a paramount issue on the minds of food manufacturers.

Conditions can change daily in a food manufacturing environment. To verify that these changes are not negatively impacting food safety, a robust food plant inspection program is needed. This program will help ensure that the processes you put in place are working as designed to control issues that could impact product safety. In this case, verification is the on-the-floor physical review of conditions in the facility when the site is in production — and when it is not.

PREPARATION. Appropriate preparation is key to ensuring a successful inspection program. This means setting aside uninterrupted time to accomplish the physical inspection; determining the needed tools and access (lifts, ladders, flashlight, screw drivers, wrenches, spatulas, cabinet/receiving area keys, etc.); and dressing appropriately. The inspection should include time while the plant is down to gain access to equipment and provide a thorough evaluation of the conditions.

In most cases, it is not practical to inspect an entire site in a day. Instead, facilities will often break down their self-inspection programs so that one-fourth of the facility is inspected each week with the entire site inspected monthly.

Why should this be completed on a monthly basis? Because the life cycle of most stored product pests is approximately a month, so inspecting monthly helps identify pest issues before they become full-blown infestations.

Data that is gathered through other programs such as tailings logs, environmental monitoring, or IPM trend reports and sighting logs also may be used to help identify areas of risk that require a more in-depth evaluation. For example, has there been an increase of rodent pressure as evidenced by the catch log or pest-sighting log? Did microbiological trend data increase in an area that could indicate an issue with a floor, drain, or piece of equipment that could provide harborage? Do tailings logs show that stored product insects or larvae are identified whenever flour is pulled from a specific bin? Such monitoring data can be used to provide focus on potential problems in the facility.

Who is on your food safety inspection team? Is it one person or is it comprised of a multi-disciplinary team with different talents and expertise that they can lend to the inspection process?

One way to organize an inspection is to start at the beginning. Follow the process flow from receiving to shipping if that makes the best sense for your site.
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A bearing that is ready to fail may be considered simply an annoying noise to one team member, while an experienced maintenance team member may recognize the sound as a bearing that is failing. The more eyes you have on the facility, the greater the opportunity to identify issues that could impact the safety of the food being produced.

WHERE DO YOU START? When in doubt, start at the beginning. Follow the process flow from receiving to shipping if that makes the best sense for your site. However, this may not make the best sense if you handle raw and cooked products or pasteurized and unpasteurized products. In those cases, to protect finished product, a better plan of action would be to start in the finished product areas and work backward through the process. This will reduce the risk of pathogenic bacteria being transferred from the raw- to the cooked-product side of the facility.

RECEIVING. Typically, there are two types of receiving activities that you will see at a food manufacturing plant: bulk receiving and receipt of ingredients via tractor trailer. Additionally, bulk receiving can be broken down into two types: liquid and dry. When evaluating receiving practices, consider FDA’s new sanitary transport guidelines as they pertain to your program. Is a current wash certificate or prior-load verification evaluated as part of the receiving program? Are hatch seals inspected and verified against the receiving documentation? Is a filter placed on top of any hatches that are opened to vent the trailer as part of the inspection process? Are hoses, caps, and gaskets on unloading lines being inspected? Were the receiving lines locked to prevent tampering prior to unloading? Is there an opportunity to look inside the trailer before loading or after unloading to see if the interior of the trailer is sound, clean, and free of foreign material? Are there clean filters on blowers, and is the unloading equipment clean and free of insects for foreign material? Do you have adequate protection or procedures defined for unloading activities occurring in inclement weather? Are hoses being maintained off the ground or floor during unloading? Are they capped to protect the interior product-contact surface when not in use?

Foreign material control devices also are associated with the receiving process. When observing receiving, evaluate in-line magnets, strainers or sifters, and tailings, if possible, to determine if the devices are clean and in good condition. While strainers, magnets, and tailings should be readily accessible for review, inspection of the sifter may need to be scheduled during down time to allow disassembly and inspection.

The vessels into which the materials are received also should be included in this evaluation. If there is a tank or silo, you will need to be able to climb to the top to inspect the interior. On top of bulk flour and sugar silos, there will be hatches for access and inspection and, possibly, bag or filter houses that contain the breather bags or filters for the silos.

If silos are outside, there could be significant changes in the temperature from morning to evening, especially during seasonal transitions, that may allow moisture from the flour to condense on the sides and in the headspace of the bin. If this is not addressed, flour accumulations will build up and potentially mold in these areas, providing direct contamination of the flour. In addition, stored product insects, such as flat grain beetles, develop in off-grade materials, such as mold in the headspace, which would provide a secondary source of contamination to this raw material. If airline dryers are used to help mitigate this, they, too, must be inspected to ensure they are properly set up, cleaned and maintained.

Depending on the type of facility and the products produced, inspection techniques will vary to aid in identification of the unique risks of each.
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Filters and baghouses also will need to be inspected to verify that they are clean and in good condition. Just like the silo, if filters are not inspected and changed, flour accumulations in these areas can mold if they get wet, or can provide an area for stored product insect development in the product zone.

The baghouse and silo structures should be inspected when the bins are empty to ensure there are no issues with the interior coating, cracks, seams, or evidence of leaks that could allow for product contamination or provide an area for stored product insect development or growth. UV lights and filters are provided on bulk-liquid sugar tanks to sterilize the air to prevent mold growth in the headspace. Are the UV lights functioning, and is there a clean filter in place? Is the UV light shatterproof? Is it part of the glass and brittle plastics program?

Another area of receiving to be inspected is that where packaged goods, whether dry, refrigerated or frozen, are received typically via tractor trailer. Small quantity items also may be received through a delivery service, such as FedEx or UPS. Again, sanitary transport rules need to be considered when evaluating this area. Are there any materials being received for which temperature control would be required for food safety? How do you verify that the load was maintained at an appropriate temperature throughout shipment? What devices are used to verify temperature upon receipt; are they calibrated and functioning properly? Are receivers taking and recording temperatures based on procedures; do they know the expectations of when to accept or reject product? How is this recorded?

Take the opportunity to inspect the trailers and evaluate the product-receiving procedures and how they are being executed. Is the condition of the trailer such that it provides a food-safe environment? The trailer is basically a “warehouse on wheels,” so the integrity of the floors, walls, ceilings, and doors is essential to protect the product.

Are the trailers sealed, and does the seal correspond to what is listed on the bill of lading? If less-than-load (LTL) or one-off shipments from FedEx or UPS are received, how are they secured in transit, and what requirements are in place to ensure that product has not been tampered with? When there are issues, are they appropriately documented and escalated? Are refusals documented, including the reason? Do receivers inspect the product upon receipt? Are they looking for evidence of contamination, infestation, or rodent activity? Do they have sufficient training and tools to identify insect or rodent issues? Are tools such as black lights and flashlights operable, readily available, and used? Does your site receive allergens? How are these products identified as from an approved vendor and for appropriate storage? Do any products require a COA that must be verified before product can be received?

STORAGE. The integrity of the warehouse includes, but is not limited to, doors, floors, walls, ceilings, racks, shelves, trash receptacles, light fixtures, and refrigeration units that must be evaluated as part of the inspection. Doors should be sealed to prevent pest entry into the facility.

The standard rule for pest proofing to prevent rodent entry is to eliminate any gaps greater than one-fourth inch. However, you also need to consider other pests such as insects that can enter the facility and do not need the same clearance. While gaps are typically observed at doors, do not forget that these also can be noted in areas where utilities come into the building, in addition to holes or other barrier breaches created by damage to structures. Holes in hollow walls or structures can provide excellent harborage for pests. This includes areas above drop ceilings, which need to be inspected.

The integrity of drains and floor and wall surfaces will need to be examined during the inspection. In many cases, drains in cooler or dry-storage areas may be overlooked when product is stored above them. A map with drain locations may be useful to identify these. Just because a drain is in a dry-storage area does not mean there will be no issues. Product residue can accumulate in drains through damage or spillage, and if left, may allow development of fruit flies or stored product insects that then can be introduced into materials stored in the warehouse.

Maintenance of inspection perimeters in warehouses is essential to allow access for cleaning, inspection, and pest control.

Perimeter inspections can yield vital information as part of the process. Droppings or evidence of dead insects on the inspection perimeters or glue boards, or evidence of rodent activity in traps, can provide data on issues in the facility. The inspector can take the opportunity to verify stock rotation by determining the receiving or expiration dates of product at the back of slots and comparing these to the front of slots which would be selected for use. If computerized systems are used for product selection, this program also may be challenged as part of the inspection. Cleaning can be assessed from this vantage in addition to blockage of the perimeters that could prevent inspection of pest-control devices and provide harborage for pests.

Other devices, such as insect light traps and pheromone traps, also may be present in the warehouse. Review of these monitoring devices will enable the evaluator to see the types and quantities of insects being captured. The clues provided by examination of these devices should trigger a more in-depth inspection of materials stored in areas adjacent to these devices for evidence of infestation.

Even if the devices do not yield any findings, evaluation of insect-susceptible materials is a critical part of any evaluation to determine if materials are showing signs of infestation. This exercise should also identify the age of the material being inspected to verify that it is evaluated monthly for evidence of pest activity.

Storage practices are a key part of the food safety system evaluation. Does the site have allergens? Are allergens identified and stored in segregated areas according to the allergen-control policy? Is spill cleanup part of this policy? Are there other products that should be considered for segregation in storage where there may be cross-contamination risk from a microbial standpoint if damage or leaks occurred? Items such as raw meat and poultry may need to be segregated in addition to liquid eggs, shell eggs, and milk so that leaks or damage do not contaminate non-like products stored below.

Other activities to be challenged as part of the warehouse inspection include cleaning of the storage racks and shelving. Rack leg footings are often overlooked in spill cleanup and can provide an excellent area for product to accumulate. If left, this can provide an area for insect development or infestation.

Some wire-rack shelving has U-shaped cross supports that will collect and hold product spillage if not cleaned. Cleaning spillage in storage areas is particularly critical where allergen or microbiological cross-contact and -contamination could be a risk. Think of a cooler where liquid eggs could be stored over produce. Not only is this a poor storage practice, it provides a two-fold risk in that the produce could be consumed raw, and contamination from any damaged eggs could cause a microbiological risk and allergen cross-contact.

Inadequately maintained coolers or freezers could allow condensate or frost buildup from vapor leaks in these storage areas. Hot air entering the cold environment will cause condensate or frost to form in the area where the leak is noted and may create a warm spot in this area of the cooler or freezer making it challenging to maintain appropriate temperatures. Chiller units that are frozen over may not function properly. Clogged drains in pans under chiller units may allow stagnation of condensate water, which can allow mold development or spill over onto product stored below. Roof leaks may cause product contamination if not identified or addressed.

Food-contact packaging in storage needs to be treated the same as raw materials. Any contamination of food-contact packaging can be transferred to the finished product if it is not protected.

When evaluating receiving practices, consider FDA’s new sanitary transport guidelines as they pertain to your program.
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PRODUCTION. Depending on the type of facility and the products produced, inspection techniques will vary to aid in identification of the unique risks of each. Production facilities vary from flour mills processing raw agricultural commodities into products used as a raw material of another product, to sites that take raw materials and turn them into ready-to-eat finished products. Depending on the type of product produced, risk of microbial contamination or allergen cross-contact may be significant, but there are universal elements that should be considered as part of any good self-inspection process.

With FSMA’s preventive controls requirements, the condition of the facility and infrastructure is even more important in ensuring that a suitable environment is provided to produce a safe and wholesome food product. All sites have floors, walls, and ceilings to evaluate. The level of importance of maintenance and the risk of potential product contamination escalates in areas where raw materials and products are exposed.

Walls and Ceilings. Are walls and ceilings smooth and easily cleanable? Are they constructed of materials suitable for the type of process? Are there cracks, holes, gaps, or damage that could provide an area for product accumulation or pest harborage that need to be addressed or eliminated? Are painted walls or ceilings peeling, and is it a threat to product? Are walls and ceilings clean? Is there evidence of condensate, mold, mildew, or other material that could contaminate product?

Look at your environmental monitoring program zoning. Although mold may not be located directly in the product zone, could this be aerosolized during cleaning or could mold spores be transferred to product zones via air currents? Is this a risk that is likely to occur that would indicate a program failure? Are wall or ceiling structural supports (such as I-beams) and ledges clean and free of rust or other foreign material? Are wall penetrations in good condition where conveyors or pipelines move product through the wall? Is the area on the wall above the product zone maintained to prevent condensate formation, mold development, and foreign material contamination of product (e.g., from peeling paint or other substances)?

Access to lifts and ladders to allow inspection of ledges or wall penetrations may be needed to fully evaluate these areas. If drop ceilings are present, the area above the drop ceiling will need to be evaluated to ensure that there is no product build up or pest harborage. Light fixtures in production areas or product zones must be intact and provide protection against breakage.

Floors and Drains. Floors and drains incur the heaviest use at most facilities. They must withstand process demands and heavy traffic, and be resistant to deterioration from chemicals, steam, or discharge from processes, product overflows, and cleaning chemicals. Floor structures also can include piers that elevate equipment off the floor to prevent deterioration or allow cleaning access. When drains, floor surfaces, tile, or grout fail, pockets or areas under these can allow for standing water or product accumulations that cannot be cleaned or sanitized. Such accumulation then can provide microbial harborage and insect harborage and development.

Sometimes drains are located in areas under equipment that are not easily accessed for cleaning and inspection, so inspection beneath equipment is necessary to determine if there are drains and to evaluate the condition of floor surfaces, tile, and grout. Inspection of drains should include removal and inspection of the undersides of drain covers and baskets to check for improper cleaning or accumulations, which could provide areas for mold development or pest harborage. Think again about your environmental program and zoning and how these areas are cleaned. Would aerosolizing potentially impact the product, or would issues found beneath the product zone and equipment, such as mold or insect development, cause product risk?

Equipment. The concerns and techniques for equipment inspection can vary tremendously depending on the products manufactured, however there are common themes for evaluation when tackling a facility’s production and packaging areas. It is always important to schedule at least some of your self-inspection time while the line or equipment is not running to be able to open panels, tanks, pumps, and areas within the equipment that are not accessible while the line is in operation.

This provides an opportunity to evaluate the effectiveness of cleaning in these areas, and to see if there are issues with design and access that challenge the ability to clean and maintain the equipment. It also enables evaluation of the effectiveness of the cleaning processes whether they be wet cleaning to remove calcium or other deposits in tanks or dry cleaning to ensure removal of materials, such as flour, to prevent infestation of equipment.

Another area to address is ease of opening equipment for cleaning. If it is not practical to access an area, then the likelihood that cleaning will be effectively completed may be compromised. Additionally, are appropriate tools and equipment provided to adequately clean the equipment? Are the processes for cleaning in the production area being followed? Are overheads being cleaned first? Is allergen-containing material being removed during allergen cleaning? How do you verify that allergen cleaning procedures are effective?

Equipment review not only enables you to assess how well the equipment is being cleaned, it also enables identification of potential issues that could lead to foreign material or other contamination potential in the product zone. Examine belt conditions to determine if wear or damage is presenting the potential for belt string or pieces to be added to the product as foreign material.

For overlapping metal parts, is there sufficient clearance to prevent metal-on-metal wear in the product zone? When dismantling displacement pumps, are the impellors in good condition? If foreign material is forced through a pump, then metal wear can occur on metal impellors or, in the case of rubber impellors, cracks can develop that could allow ineffective cleaning and potential for microbial growth. Is there any plastic on equipment that is cracked that could potentially add brittle plastic to product? What about missing bolts? Were they left off the equipment when it was reassembled, or did they get dropped or vibrate off in the product zone as foreign material?

Examination of auxiliary equipment that is not directly related to the process should also be included. Are the spray balls used in clean-in-place tanks full of foreign material? If spray balls are clogged, they will not effectively clean the interior tank surfaces. The foreign material in the spray ball may be forced through the holes and into the product as foreign material.

What is the condition of the equipment used for cleaning? Is it clean and in good condition prior to use; is it cleaned afterwards? Is there a color-code system for cleaning tools; is it being followed? This is especially critical when completing allergen cleaning to ensure that cross-contact does not occur. Are floor scrubbers and sweepers cleaned so they do not enable mold or fly development? What about the forklifts and pallet jacks used to transport raw materials and finished products throughout the facility? Are containers, scoops, bins, trash cans, and other vessels and utensils used in processing and storage areas clean and in good condition? Are they properly stored?

FINISHED PRODUCT/SHIPPING. Evaluation of finished-product or shipping areas would include many of the same elements as in the inspection of a raw-material warehouse. Inspection and evaluation of finished-product stock rotation, suitability and maintenance of outbound trailers or transports, and storage area integrity should be evaluated using the same principles as for raw-material storage areas. Many sites will use the same or similar procedures to verify the cleanliness, condition, and temperatures of outbound transports as they do for receipt of materials.

SUPPORT AREAS. Consider support areas as part of your inspection. Employee welfare areas, boiler rooms, and maintenance shops also must be clean, well-organized, and free of pest activity to ensure that issues in these areas do not impact production and storage areas. Inspection should include opening cabinets, lockers, and toolboxes, especially if they are used in production areas. Flour accumulations left in toolboxes can provide excellent areas for stored product insect development or infestation. Think about how tools may be used. Would the same tools be used to make a repair in the restroom and then potentially be used in a product zone?

OUTSIDE GROUNDS AND ROOF. The outside grounds and roof need to be included in a robust self-inspection program. Areas, such as compactors, should be reviewed to ensure that they are closed and do not leak and attract pests to the building. Dock leveler pits should be clean and free of pest activity. Trees, canopies, or exterior fixtures should be evaluated for evidence of bird roosting or nesting. Roof inlets, air intakes, and exhaust fans should be functional and appropriately filtered to prevent entry of foreign material or insects. Product spillage on the roof may attract pests and will need to be addressed in addition to holes or any other potential entry points that may be identified. Could neighborhood activities negatively impact your facility? What can you do to mitigate those risks?

SUMMARY. There is no list that can adequately capture all the potential issues or scenarios that can be identified as part of the self-inspection program. The age and size of the facility in addition to the age, size, number, and type of equipment all vary to create unique circumstances that are facility dependent. The goal of a healthy self-inspection program is to ensure that you are identifying issues that can impact the food safety of the product that is produced at your site and to verify the effectiveness of the programs that help control these risks. Food safety programs are dynamic and not static. Review, evaluation, and updating of the programs to meet the demands, pressures, and changing environment are key in identifying and mitigating risks to the product produced at your facility.

The author is Regional Manager, Food Safety Services, AIB International.