Essential Components for a Comprehensive Foreign Material Control Program

A foreign material control program is a procedure established to prevent, detect, and investigate instances of physical contamination in any facility that processes or manufactures food. Insufficient elimination of foreign contaminants can raise concerns regarding consumer safety and quality or necessitate product recalls. Thus, a foreign material control program is designed to resolve the risk of physical contaminants on consumers, production processes, and brand image.

Foreign substances may originate from fields, producers, processing facilities, or even during the transportation or storage of goods. A systems strategy for a well-rounded foreign material control program should integrate the elements capable of interpreting the probable risks up and down the supply chain and put in place suitable preventive and remediation protocols against foreign contamination. These include:

Risk Assessment & Management in Farming

Food manufacturers and ingredient producers, such as farmers or agronomists, must have a thorough comprehension and clarity of the origins and handling procedures of their ingredients. Risk assessment within the agricultural sector involves a systematic evaluation and analysis of hazards and vulnerabilities that could lead to the introduction or contamination of foreign materials in the farming process, from planting and cultivation to harvesting and post-harvest handling.

Examples of related hazards include the use of contaminated irrigation water or soil leading to the presence of harmful chemicals or pathogens in crops, improper handling and storage of pesticides or fertilizers causing cross-contamination, inadequate pest control measures facilitating the intrusion of foreign matter, and deficient sanitation practices during harvesting and post-harvest handling resulting in the inclusion of physical contaminants like debris or pests.

Risk Management

All the factors that come under farming operations are scrutinized to identify and eliminate points of foreign material entry. Good Agricultural Practices (GAP) can play a critical role in these efforts. GAP is grouped into eleven segments for controlling food safety hazards in the respective area, primarily site history and management, planting material (propagation material), fertilizers and soil additives, irrigation/fertigation, agro and non-agrochemicals, harvesting and handling produce, equipment maintenance, cleaning and sanitation, animal and pest control, and storage and transport. Complying with GAP brings robust foreign material control into agricultural practices by providing guidelines and standards that minimize the risk of contamination throughout the production process.

Risk Assessment & Management in Receiving, Storage & Transportation

When materials are delivered to a food or ingredient processing facility, the responsibility then falls on the receiving and storage procedures to ensure the safety and wholesomeness of the items. Risk assessment involves locating sources of foreign material contamination in receiving, storage, and transportation stages, evaluating their chances of occurrence, and assessing the potential impact on product quality and safety. This process encompasses packaging integrity, handling procedures, storage conditions, and transportation methods.

One of the most significant challenges encountered during the receiving phase is related to bulk shipments, whether they are in liquid or solid form. For instance, processors often receive dry commodities like grain, seed, flour, and sugar in large quantities, which are typically transferred using delivery vehicles and pneumatic devices and conveyed into storage bins, which might contain foreign materials like rusted metals.

Risk Management

Supplier verification through in-depth assessment, monitoring, and validation is integral to efficient foreign material control in a supply chain as it allows companies to ascertain that their suppliers adhere to stringent quality standards and practices. This not only helps establish trust and transparency with suppliers but promotes the early detection and prevention of foreign material issues.

Processors should incorporate one or more intervention strategies during the receiving, storage, and transportation to ensure the cleanliness of products received in bulk. The installation of an in-line grate magnet or sieve between the bulk delivery vessel and the storage bin can effectively remove metal particles from dry goods. In the case of bulk liquids, an alternative approach involves using stainless-steel baskets, bag filters, or a combination of both placed between the delivery vessel and the storage container to remove contaminants.

Should foreign materials be detected during inspections, it is crucial to promptly notify the supplier, providing clear information about the discovery and timing and even including visual documentation like photographs. This proactive communication allows the supplier to grasp the situation comprehensively and take appropriate actions to rectify the issue.

Good Manufacturing Practices (GMP)

According to World Health Organization (WHO), Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification. GMP defines general measures to guarantee that processes necessary for production and testing to minimize foreign material contamination are clearly defined, validated, reviewed, and documented and that the personnel, premises, and materials are suitable for the production of the concerned products. These initiatives comprise the following parts.

Personnel

Food manufacturers should institute policies concerning attire, hair restraints, and jewelry. Employee uniforms, typically provided by companies, should be manufactured from breathable, non-shedding materials and should not feature pockets above the waist. Uniform closures should involve snaps, zippers, or hook and loop fasteners, while buttons are best avoided due to the risk of detachment into products. They should often supply metal-detectable earplugs and brightly colored and metal-detectable bandages to employees. Verification programs should ensure the detectability of earplugs and bandages using metal detectors for each batch.

Premises

Implementing effective premise control measures is a non-negotiable aspect of the food industry to prevent foreign material contamination. It includes conducting regular maintenance of machinery and equipment to prevent any degradation that might lead to contamination, creating designated areas for different processes, reducing the risk of cross-contamination, installing screens and filters on openings to prevent pests from entering the premises and an operational waste management system to eliminate potential breeding grounds for contaminants. By adhering to these steps, food businesses can retain a safe and uncontaminated premise, safeguarding the integrity of their products.

Equipment Designing and Utensils

When designing equipment and utensils for the food industry, attention must be paid to preventing foreign material contamination. They should be crafted from materials that resist shattering or splintering. Wooden utensils, especially those with wooden handles, should be excluded from the process. Opt for smooth and non-porous surfaces that are easy to clean, reducing the likelihood of residue buildup. Select materials that are corrosion-resistant and food-grade, minimizing the risk of particles breaking off into the product. Metal utensils are the most suitable choice. In cases where plastic utensils are employed, regular inspection is essential, and any signs of chipping or splintering should lead to removal from service. Incorporate seamless welds and joints to prevent crevices where contaminants can accumulate. Additionally, design equipment with accessibility in mind, allowing for thorough cleaning and inspection. Regular maintenance protocols should be established to monitor equipment integrity.

Preventive Maintenance

A well-designed and managed preventive maintenance program that is developed, documented, and implemented based on the type of production operation is of great consequence in foreign material control efforts. Various equipment in a production setup requires different schedules for maintenance. This can range from daily tasks like lubrication or bolt tightening to weekly, monthly, and even quarterly maintenance checks.

Food processors should assess their operational processes to determine the appropriate timing and frequency for maintenance tasks. This is especially important for components with defined usage lifespans, such as gaskets, fittings, and drive belts. The goal is to replace such parts before they malfunction and pose an occasion for foreign material contamination. Preventive maintenance programs should be designed with this principle in mind. Documenting preventive maintenance programs through good maintenance records serves as a valuable resource when requesting new equipment purchases from management.

Wood Control

Pallet Management: An integrated pallet management program incorporating several key facets, as given below, goes a long way in eradicating foreign material contaminants that can originate from pallets.

• Defining pallet specifications
• Managing pallet storage
• Conducting pallet inspections
• Overseeing pallet usage both within and outside the facility
• Ensuring pallet upkeep
• Meeting shipping criteria
• Maintaining pallet cleanliness

Glass and Brittle Plastic

Food manufacturers must own a dedicated glass and brittle plastic program as part of their GMP. The initial step involves setting a policy prohibiting the presence or usage of glass or ceramic items in the food processing area or warehouse. Production or warehouse windows should either be shatterproof or covered with plastic to contain potential breakage. An extensive inventory of all glass and brittle plastic items present in food and ingredient storage or handling areas, with their item locations, item types, and any protective features, is required. The inventory must be consolidated into a master list or register, forming the basis for risk assessment, along with documenting the corresponding corrective actions.

Sanitation and Validation

One of the components within the FSMA regulatory framework for preventive controls pertains to the implementation of measures to prevent unsanitary conditions. When a company is engaged in the processing of products that could be susceptible to compromise due to inadequate sanitation, the establishment of preventive controls for sanitation becomes mandatory. Food items such as ready-to-eat (RTE) meats, cheeses, seafood, pasta, and various others are examples of products that might be compromised by subpar sanitation practices.

Sanitation involves thorough cleaning and disinfection of equipment, facilities, and production areas. Validation, on the other hand, entails rigorous testing and verification to confirm that cleaning procedures and equipment are capable of consistently eliminating foreign materials. Manufacturers ought to contemplate broadening the scope of their cleaning validation activities involving an inclusive examination of the production line.

Detection and Removal with Ongoing Surveillance

Food manufacturers need to consider characteristics such as the type of product, production speed, sensitivity to contamination, and regulatory requirements when selecting and implementing detection and removal methods. The main kinds of equipment used to detect and remove foreign materials are concluded as:

• Sieves and Filters – Sieves and filters are basic methods employed in the food industry to detect and remove foreign material contamination. By passing food products through these meshed or porous structures, they effectively separate and capture undesirable particles, debris, and foreign objects. Sieves and filters are particularly adept at removing larger foreign materials such as stones, sticks, and larger particles from raw ingredients or processed products.
• Electronic Sorting – The adoption of electronic sorting systems within the industry is on the rise, largely driven by advancements such as lasers, vision-based technologies, or other methodologies. These sorting systems are precisely programmed to identify specific faulty attributes within the processed products and subsequently extract items exhibiting these imperfections.
• Centrifugation – Centrifugation is a separation technique widely used for foreign material detection and removal in the beverage industry and capitalizes on the varying densities of components within a liquid mixture. By subjecting the liquid to high-speed rotation within a centrifuge, the heavier contaminants are forced outward, accumulating along the walls of the centrifuge container. This separation process effectively isolates foreign materials such as sediment, particles, and impurities from the beverage product. Centrifugation not only enhances the quality and clarity of beverages by eliminating undesirable materials but also contributes to product safety and consumer satisfaction.
• Magnets – Magnets are engineered to eliminate either ferrous or nonferrous metals, fulfilling two primary roles: bolstering product quality and safety while safeguarding equipment integrity. A diverse array of magnet types has been devised to accommodate various processing systems, such as grate, tube, plate, liquid in-line systems, pneumatic, chute, pipe, and drum magnets. In the realm of beverage production, magnets (or screens) are frequently placed just upstream of the fillers to attract metallic debris that could harm the filler machinery and trigger production shutdown. Food processing utilizes two distinct magnet types: ferrous magnets and rare earth magnets. To uphold performance standards, regular magnet testing is imperative, employing a pull test methodology. The frequency of testing hinges on the risk assessment undertaken by the company’s HACCP or food safety team.
• Metal Detectors – Metal detectors are engineered to detect metal objects exceeding a specific size threshold within food products. Ideally, the optimal placement for a metal detector is post-packaging, which substantiates the widespread preference for gate systems. The detectable size of the metal object is contingent upon both the nature of the product and its packaging. To ensure effective performance, it’s advisable for processors to collaborate with the equipment manufacturer to ascertain the ideal configurations and metal detection thresholds tailored to their particular products. Processors should secure a documented declaration from the equipment manufacturer outlining the minimal detection thresholds applicable to the metal detector for each product undergoing inspection.
• X-ray Machines – The appeal of X-ray machines lies in their capacity to identify a broader range of contaminants, not only metal but also glass, stones, calcified bone, and select plastics. Depending on the specific product and material, X-ray machines might even extend their detection capabilities to include other substances. The advantages of X-ray machines include swifter processing, heightened versatility, and the ability to spot more than just metal contaminants. Meticulous testing to validate the system’s accuracy, particularly if the X-ray system is designated as a critical control point, is mandatory. Processors should also collaborate with suppliers to calibrate the machine according to the requirements of each product slated for processing on the production line.

These tools should not be solely relied upon as independent mechanisms, and their utilization must be augmented through internal quality and safety programs, supplier qualification, and proper employee training. Continuous surveillance through inspections, routine checks, and regular audits aid in verifying the adequacy of existing production operations, food safety protocols, and prerequisite programs. Moreover, data-driven analysis through real-time monitoring systems can provide intuitive insights into trends and patterns related to the presence of foreign materials.