For food manufacturers, the Food Safety Modernization Act (FSMA) and other regulations have created an environment of constant and critical change. The operational effectiveness of production plants determines financial outcomes, company image, and sustainability, yet organizations may ignore key prevention measure to ensure these facilities operate in a food safe manner.
Preventive measures and controls are more important than ever, and with that in mind, Chestnut Labs has compiled a list of 20 indicators that your food safety program needs help! We’ve also included some first steps to take in each case.
1. The FDA has visited and issued a Form 483.
An FDA Form 483 is issued to firms at the conclusion of an inspection when investigators have observed any condition(s) that may constitute violations of the Food Drug and Cosmetic Act (FD&C) and related Acts.
Observations are made when conditions or practices observed would indicate that any food has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
In theevent of a Form 483, ensure that a true root cause is identified and the chance of reoccurance is minimalized.
2. You’ve had ongoing positive environments for Salmonella, Listeria or other pathogens.
Pathogen Environmental Monitoring (PEM) is among the most important components to a robust food safety program. If pathogens are re-occurring in your production facility, your entire operation is compromised from a safety standpoint.
You’ll want to confirm that you do not have resident micro-organisms in your facility. Plot all positive results on maps and review historic trends and your CAPA for root cause. Control foot traffic and know where people and wheels move. Make sure your infrastructure is in good condition as you continue to isolate environmental causes.
3. You have rust on your production equipment.
Rusted equipment (pumps/pipes/motors, etc.) cannot be cleaned, and rust acts as a harborage for Salmonella and other microorganisms.
Remove rust and work with a sanitation provider to determine what chemicals to use to avoid corrosion, yet provide an effective microorganism kill.
4. You do not have a pre-, during and post-construction planning process.
Production facilities are often expanded or reformatted, requiring construction in a portion of the facility while production continues. If environmental monitoring is not increased during construction activities, checkpoints are missing as your risks climb for contamination.
Debris and trash from the construction area must also be accounted for and a plan for removal mapped.
Organizations in this situation must prepare construction planning operating procedures and ensure all team members know the plan for foot traffic of employees and contract workers, controlling risks in the process. Contractors’ tools and machinery must also be managed.
5. You are failing internal audits.
Internal self-inspection audits vary by organization, but if you aren’t living up to internal standards, your chances of complying with the FDA and other regulating bodies are dramatically reduced.
You can get ahead of this issue by keeping accurate and timely records for all noncompliance events. Categorize all issues by type and assign a responsible person and known timeline for resolution.
6. You regularly have CAPA open more than 90 days.
When auditors visit food facilities, they want to see your Corrective and Preventative Action (CAPA) plan. The actions outlined in such plans should be able to take effect within short order after an issue occurs.
Taking longer than 90 days reduces the effectiveness of the CAPA. Ensure your corrective actions are timely. If capital is required and causing delay, identify the items and make sure any documentation is submitted to request them. Keep records that show corrective actions are in progress.
7. Foreign materials complaints are occuring in your product line.
Foreign materials complaints are the single largest cause of customer complaints received by many food manufacturers, retailers, and enforcement authorities.
Employ a sign-out, sign-in process for sampling tools such as scoops and spoons, and use metal detection tools. Enhance preventive monitoring of gaskets, and inspect motors, pumps, and in-line magnets and screens frequently.
8. You have no traffic control plans for people and wheels.
According to the FDA, you should have linear product flow and traffic control to minimize cross-contamination from raw to ready-to-eat (RTE) materials. This extends to people and moving equipment, which can be significant sources of contamination.
You can address this by having current color-coded traffic maps available to employees. Use varied colors for bump caps and footwear covers.
9. There is no formal hygiene zone mapping of the manufacturing facility.
Hygiene zone mapping helps identify high hygiene areas from regular GMP areas. High hygiene zones typically are areas or rooms where product may be exposed (bag rooms, packaging areas, and filling equipment are typical examples).
There must be a “stop point” for increased mitigation before entering high hygiene zones. Again, ensure a current color-coded map that clearly outlines “high hygiene” areas is made available to employees.
10. You have no foot mitigation for staff including maintenance and QA personnel.
Captive shoe policies are ideal. Shoes should also be sampled as part of the PEM program. A combination of shoe covers, dry sanitizers and wet sanitizers in wet production areas can be effective in mitigating pathogens on feet.
Make sure employees know where and how to travel through the production facility and ensure shoe tread depth is minimized as much as possible.
11. Non-stainless floor and deck grating is used.
Plastic grating (often colored green or yellow) becomes brittle and allows for bacteria to harbor.
Additionally it cannot be effectively cleaned and sanitized. Use swabbing data for APC, EB, and pathogens to prove cleaning effectiveness. As feasible, replace plastic deck grating with cleanable materials.
12. Glass and/or wood is present in manufacturing areas.
Glass and wood are two of the largest contributors to foreign material complaints in food products.
Remove all glass in production areas associated with infrastructure. Ensure exposed wood is not present, as it can retain moisture and harbor microorganisms.
13. Conveyors are made of non-cleanable, braided or fabric materials.
Conveyor belts must be regularly cleaned and disinfected. A smooth and non-porous surface can be easily cleaned, but many braided and fabric materials still present in facilities today cannot be cleaned at the microbiological level. As feasible, eliminate these outdated conveyors.
14. Equipment has niche points, hollow rollers, hollow legs or exposed threaded legs.
Food equipment must be constructed to ensure effective and efficient cleaning over the life of its usage. Since any hollow portion of equipment can allow for the harborage of bacteria, addressing these trouble areas is paramount for food production safety.
Cross-functional teams should inspect equipment legs, ladders, tables, etc. to identify and work to eliminate these areas.
15. Your organization is neglecting or behind in GMP Training.
A Good Manufacturing Practice (GMP) system helps ensure that products are produced and controlled according to quality standards.
An effective GMP plan will help minimize risks that cannot be eliminated through testing a finished product. Create interactive GMP training programs and reward employees for correct acts.
Train, train, and re-train employees, explaining why basic aseptic techniques for hand-washing and sanitizing are important.
16. High pressure hoses are used in drain cleaning.
Utilizing high pressure hoses in drains causes aerosols to spread bacteria in small water droplets.
Use only low pressure hoses and eliminate water where possible. Microorganisms need water to grow and multiple
17. Condensation from dripping pipes, air units, or similar are present in manufacturing areas.
Food Safety News has called condensation “the liquid enemy.” It’s an ominous term, but condensation is a serious food safety concern.
Excessive moisture from condensation helps bacteria thrive and can even attract mold and insects.
Act quickly when overhead pipes, air units, or other sources are producing condensation. Inspect elements frequently and use condensation-resistant materials to wrap pipes.
18. Roof leaks have not or are not resulting in a cease production.
Roof leaks have contributed to several high-profile outbreaks of foodborne illness. The same issues apply here as with condensation: water allows bacterial growth.
In the case of roof damage, a leak can bring in rainwater contaminated with bird droppings and various other microbial hazards. Placing a bucket under a roof leak in a production area and continuing to operate is not acceptable.
Roof leaks must be contained at the source and environmental sampling must be used to ensure the production area has been qualified and is “fit for use” prior to resuming production.
19. You have no valve and gasket preventive inspection program.
Cracked or pitted gaskets allow for microbial harborage and, ultimately, foreign material risks.
Include all valves and gaskets on regular pathogen environmental monitoring (PEM) programs and document their age and condition.
20. You do not have a robust preventive pathogen environmental monitoring (PEM) program.
PEM programs aimed at monitoring preventative controls are essential when evaluating a current program or starting a new one from scratch.
Sampling should occur weekly in production area. Sample sites must be chosen based on inherent risk. See our PEM article for additional information.
Call or email us for any additional questions and to discuss any needed assistance with risk assessment and prevention in your food production facility.