Historically, foreign material control within many food production facilities has operated by “looking back” or “getting lucky.” Looking back involves placing a foreign material detection device at the end of a production line. A rejection serves to prohibit a potentially adulterated product from entering commerce and signals the foreign material control process is not working. An absence of rejection validates that the product was produced free of foreign materials detectable by the device but not those not detectable by the device. Sometimes, if you are lucky, the foreign material is visible in the product flow; for example, by observing visible foreign materials while product travels past on a conveyor.
The goal of any foreign material control program must be prevention. There has yet to be a device invented that can detect all possible foreign materials. Dr. W. Edward Deming once said, “Inspection is too late. The quality, good or bad, is already in the product.” This suggests that foreign materials may have already adulterated the product by the time inspection occurs. Prevention is not just a goal; it is also a fundamental requirement for business continuity. For years, it has been recognized that control of Listeria is mandatory for food safety. To control this organism, the North American Meat Institute has hosted a Listeria control workshop for over 20 years that preaches its Listeria control equation (Figure 1).
FIGURE 1. Listeria Control Equation (Source: North American Meat Institute Listeria control workshop)
An approach that corresponds to this equation can be applied to the prevention of foreign materials in finished product (Figure 2). The critical components of the equation are:
- Food safety culture
- Facility and equipment design
- Supplier programs
- Predictive process measurement
- Root-cause analysis with preventive actions implemented
FIGURE 2. Foreign Material Prevention Equation
Food Safety Culture
The foundation of the foreign material prevention equation is the creation, implementation, and daily practice of a food safety culture that values and requires a preventive approach to foreign materials. Using Listeria control developed for the meat industry as an existing model, organizations should promote an aggressive “seek and destroy” mentality against foreign materials by asking the following:
- What are possible foreign material sources?
- Where are they located?
- How can they be eliminated or effectively managed?
This approach provides the seed to develop a preventive mindset. No facility should ever use finding foreign materials in finished product to learn about their risk; it must be fully identified and addressed via a foreign material risk assessment before issues arise. This mentality of foreign material prevention begins with strong plant operational leadership. The operations team, as the “boots on the ground,” must take ownership of foreign material prevention by creating, leading, and engaging a cross-functional team within the facility to address foreign material prevention. The goals of the foreign material team should be to:
- Identify potential foreign material sources
- Design processes that eliminate and prevent foreign material sources
- Create leading indicators of foreign material risk that cannot be eliminated
The team must intimately understand the entire process, including raw materials, suppliers, employee equipment, process equipment, and process environment.
A mature food safety culture is required for foreign material prevention to be successful, and a strong preventive mindset will aid in its development. Cultural maturity fosters an environment where the hourly production workforce is actively engaged in reporting foreign material risk to supervisory management. This must include operations, maintenance, food safety/quality assurance (FSQA), and sanitation, as all these individuals are uniquely familiar with the process through their job functions. Their contributions/suggestions should not be dismissed; rather, they should be actively sought to assist in a sustainable organizational approach to foreign material prevention. Additionally, a mature culture will look not to facility inspections (or monthly facility audits as they are sometimes called) to identify risk. These opportunities, through equipment and facility risk assessments by the foreign material team, will already have been identified, considered, and eliminated or managed with leading indicators. A leading indicator of risk would be analogous to the use of indicator sites in Listeria control in a meat plant. Microbial indicator sites do not demonstrate a food safety failure but rather identify a risk of potential failure. The facility must identify its foreign material indicators so that it recognizes and addresses risk before failure occurs. For example, the measurement of dust from an in-line magnet can be an indicator of equipment wear within the process. Finally, a strong food safety culture will not create a “punish the messenger” mentality. Conversely, it should reward employees at all levels, management and hourly, for having the courage to rapidly report any potential foreign material issues. The result of these notifications should not be anger or assignment of blame. It should praise individuals for recognizing and understanding foreign material risk and bringing issues to management attention immediately and then pivot toward eliminating the risk. The cultural mindset should create a “run with bad news” environment.
Facility and Equipment Design
The second aspect of the foreign material prevention equation is facility and equipment design. For years, animal-handling expert Dr. Temple Grandin has spoken about how she sees the animal’s path during handling through the animal’s eyes. She sometimes gets down on her hands and knees to create better understanding and help design systems that prevent an animal’s flight response. The same tactic works with foreign materials: See the process from the product’s viewpoint. This approach will assist in identifying potential foreign material sources and will allow the cross-functional team to design preventive control measures.
Once more, consider applying the meat industry’s Listeria control equation through zoning principles. Develop barriers to the entry of certain materials into open product areas. Create wood-free zones in the plant where wood pallets are eliminated beyond a certain point. If wood pallets do not get in open product zones, potential wood contamination is prevented. Similarly, designate areas of the process where plastic liners, bags, and other nondense plastics are not allowed. Consider different packaging options from your suppliers. Bulk-packaged spices rather than individual bags of spices can limit exposure to possible foreign materials on the processing floor. Beyond wood and plastic, each production environment has risk presented by those notorious “extra” items every plant has and must account for in their preventive programs. Consider how you monitor and control frocks, gloves, plastic sleeves, pens, timekeeping devices, phones, activity trackers, tools, clipboards, and other job-duty items within the facility. Effective use of 5S principles (a place for everything and everything in its place) can reduce or eliminate the risk of these “extra” items finding their way into your product stream.
It is imperative to think critically about equipment risk. As the organization progresses in food safety culture maturity, equipment design factors will be considered and addressed with the original equipment manufacturer before equipment purchase orders are issued, and design improvements will be completed prior to installation. Equipment and infrastructure must undergo a complete and imaginative risk assessment. The North American Meat Institute’s Sanitary Equipment Design Principles: Checklist and Glossary is a guide for evaluating equipment for hygienic design issues relating to microbial risk. Using that document as a model, plants should develop an equipment review for foreign material risk. Seek-and-destroy teams regularly disassemble equipment completely to identify hard-to-clean areas and potential microbial growth niches. Organizations with a preventive mindset will consider foreign material risk concurrently. As with Listeria, what can drip, draw, or drain into the product flow? What are your zone 1 risks? What is your foreign material niche waiting to expose its harborage? Where are the wear parts? Where are the gaskets and seals located? Are they detectable? When are they available for inspection and accounting? When things break or fail, what suddenly could enter the product stream that normally might escape scrutiny? Do not forget the not-so-readily apparent sources of foreign materials such as water, air, and clean-in-place lines.
The seek-and-destroy exercise is the opportunity for all stakeholders to have input into identification and understanding of foreign material risk. Such an event will enhance the development of a monitoring process for all wear parts and allows for the identification of preventive maintenance, periodic cleaning, and preoperational inspection tasks. The on-site maintenance team begins to understand the equipment it is charged with maintaining. Sanitation determines daily and periodic disassembly needs for cleaning access. FSQA grasps what to look for in the preoperational inspection tasks. Preventive maintenance completion rates should be a facility key performance indicator that is rigorously tracked and reported weekly for compliance. Periodic equipment cleaning should be accompanied by extensive examination of parts for wear or damage. Beyond preventive maintenance, items or locations that must be inspected at a given frequency should be identified. For example, the location, type, size, weight, color, and detectability of every gasket or seal in the process should be mapped and recorded. An unused example of each gasket or seal located in the facility should be retained in an in-plant library to aid in source identification should a failure occur. All gaskets and seals should be categorized as to the frequency at which they are exposed for inspection. This may be daily and can be incorporated into a daily pre- and postoperational accounting program. Conversely, they may be exposed only weekly or monthly. This inspection should then be accounted for as part of the preventive maintenance and/or periodic cleaning tasks.
Supplier Programs
A critical third aspect of the foreign material prevention equation is supplier programs. Internal risks are significant, but a comprehensive preventive approach also considers the risk presented via the supply chain. Supplier programs must include clear specifications and expectations regarding foreign material prevention. A supplier’s control measures should be known and understood to allow for proper risk assessment of the supplier and what preventive actions must be taken when handling the supplier’s materials. This includes inbound product monitoring with data collection regarding number and type of objects found. The data must be analyzed, with findings reported back to the supplier at a regular frequency. At a minimum, high-quality photographs of items found, including size references (e.g., a ruler), must be shared if not the object itself.
It is important to realize that any foreign materials received from a supplier indicate that their product is adulterated. Your inspection is a measurement of their foreign material prevention control process. You must work with your supply chain to adopt foreign material risk assessments and prevention activities analogous to those you are instituting in your own production facility. Your supplier is required to communicate timely and completed preventive actions, not just corrective actions. The objective should be identifying the root cause of the incident and implementing effective preventive actions to eliminate or effectively monitor the hazard. If it is not eliminated, it may reoccur.
Predictive Process Measurements
With a mature food safety culture in place, excellent equipment and facility design, and robust supplier programs enacted, the next step is to get predictive in foreign material prevention. The goal is to determine indicators that will signal potential loss of foreign material process control. Just as meat plants use aerobic plate counts to indicate environmental microbial risk, there are production process measurements that can indicate a shift or drift toward unacceptable operating conditions before an event occurs. The foreign material team must critically examine the process to identify and define these measurements to indicate a potential process failure. Once a baseline for each measurement and expected variation is established, continued monitoring of the indicators will catch a potential failure, allowing the team to take action before it occurs. Some indicators demonstrating the potential loss of foreign material control are:
- The quantity of wood debris found in open product production zones
- In-line magnets to measure metal dust accumulation
- Heat measurement of bearings using infrared thermometers
- Equipment vibrations during operations
- Shaft alignments
- Ultrasonic measurements of equipment walls or pieces
The critical aspect of indicator measurements is establishing baseline condition parameters, so drift from baseline can be recognized. Regular in-process information gathering and analysis will aid in the establishment of critical values for selected indicators. For example, measuring heat generated by a bearing during operations can indicate if it is nearing failure. This may allow processors to run certain pieces of equipment to near failure, creating a more robust data set that can optimize the preventive maintenance process and reduce downtime for both expected and unexpected maintenance. Plants can optimize the preventive maintenance process by making repairs during planned downtime or at convenient times. Data analysis using aforementioned indicators may make it possible to modify a recommended 6-month preventive maintenance task to 8 months, for example. Conversely, measurements showing a bearing beginning to fail at 4 months may trigger earlier-than-scheduled preventive maintenance to limit foreign material exposure and unforeseen downtime during critical production periods.
Sanitation and preoperational inspection also can serve as preventive tasks. Sanitation has access to equipment at its most basic and fundamental level. Training sanitors on what is a normal baseline condition and what is not leads to having another set of eyes watching for abnormal equipment wear conditions or signs of impending failure. Similarly, FSQA technicians performing preoperational inspections can be on the lookout for these signs. Educating these employees and encouraging them to actively participate and point out potential issues is another part of a robust prevention program and mature food safety culture.
Root-Cause Analysis with Preventive Actions Implemented
The final component of the foreign material prevention equation is successful root-cause analysis with effective preventive actions implemented. Root-cause analyses are undertaken as a result of process control failures. If a metal detector or X-ray machine rejects a package of product, or a customer reports a finding, the foreign material process control (analogous to a Listeria positive in a plant verification program) has failed. You produced adulterated product. Not all adulterated product creates a food safety hazard (e.g., very large visible pieces of white, dense plastic in a package of ground beef). However, they are a failure of the food processor to meet the consumer’s basic expectation of producing acceptable product to feed one’s family. Injuries to an individual consumer may not occur, but the headlines and loss of confidence can be devastating to a brand. Consumers expect perfection, particularly when feeding their family.
When a foreign material control process does fail, it is imperative that the foreign material team identifies a project team that includes both foreign material team and non-foreign material team members to conduct an extensive root-cause analysis. The team members should include both management and hourly employees. The foreign material team will issue to the project team a project scope with results expected and a timeline for reporting updates. The results expected will center on the elimination of the hazard or creation of an indicator measurement to manage the risk and identify failure before it occurs. The leader of this task team preferably should be a member of the operations or maintenance staff with strong leadership skills and knowledge of effective root-cause analysis tools such as five whys or fish bone diagrams. The leader must facilitate teamwork, involvement, and actions of the team. Sitting around a conference room table talking will not solve the issue. Ideas must be discussed, time must be spent on the floor in the operation, and follow-up actions must occur. Once an effective root cause has been identified, the emphasis is on preventive actions and not corrective. By definition, corrective actions imply an immediate or short-term fix. These are what processors do to determine whether a failure will occur again and to bridge the gap until a process can be changed to eliminate a risk or manage it with an indicator measurement. Corrective actions alone without effective and successful preventive actions will perpetuate foreign material process control failures and firefighting. The focus must be on properly researched, discussed, and implemented preventive actions that will ensure that harmful events do not reoccur. When preventive actions are implemented, a robust internal auditing process will ensure that the implemented action continues to occur and is effective.
Conclusion: Prevention Is Key
The goal of any foreign material control program must be prevention. Using the foreign material prevention equation consisting of strong food safety culture, facility and equipment design, supplier programs, predictive process measurements, and effective root-cause analysis and preventive actions will create a pathway to success. The foreign material prevention equation will similarly protect companies against the unthinkable—the finding of adulterated product in commerce resulting either in injury or recall. Prevention will not only eliminate the highly visible and consequential issues related to consumers and regulatory bodies but will also limit plant downtime and the costs associated with first-pass quality failures. Foreign material prevention is neither just a nice feature to have in food production plants nor just a program on paper that passes a third-party audit. A robust program that prevents foreign material contamination and a food safety culture that actively seeks preventive solutions and creates indicator sites for monitoring and predicting risk is a fundamental business requirement. Prevention and prediction saves money, promotes customer confidence, and creates an environment with engaged and informed employees.
Mark Seyfert is director of food safety and quality assurance at Kenosha Beef International.
