My father had a shop in the garage and he loved to work with wood in his spare time. He made furniture, toys, and even built a crib for my cousin’s firstborn. He lived by the adage “Measure twice, cut once.” I’ve carried that philosophy with me throughout my professional and personal life (I, too, have a shop in my garage). When tasked with improving the capability of a process, I like to break it down into smaller sections and begin to measure each section multiple times to gain a better understanding of what the system is capable of. Once I have the data to determine what the norm is, I can begin to develop an understanding of what is causing the process deviations and then initiate the process improvement continuum. When we apply that measurement model to a specific deviation we are focused on, we can begin to determine what the contributors are, how the indicator elements present themselves, and what magnitude a failure will have on the process. This discussion is focused on the aspects of implementing a comprehensive, verifiable, and measurable foreign material prevention program (FMPP) in the red meat processing industry.
Why a Foreign Material Prevention Program?
The first question that is normally asked when someone proposes a new concept to address an existing issue is “Why”?
My “why” came early in my career. I was employed by a company in a supplier-auditing role. I happened to be in the corporate office one week and was walking by a conference room where a group of marketing people were listening to a recorded consumer complaint. The voice still haunts me today. A female voice pierced my soul with one sentence emanating from the replay device. In a tone that was fraught with hurt and anger, the consumer described herself as the mother of a 6-year-old child who had purchased our products to provide her child an after-school snack. She exclaimed how much her child looked forward to our products: He would speak of them during his breakfast. Her voice reached a crescendo when she detailed how he had bitten into the product, only to scream out in pain. To her horror, a piece of stainless steel wire had punctured the roof of his mouth. My children were close to the age of her child and consumed the products we manufactured as well. We identified the wire as a piece of freezer belt but not the location of the source. My focus became apparent, and I am still as diligent today as I was the day I heard that mother’s voice.
Foreign material (FM) is one of the three categories reviewed in a Hazard Analysis; however, the focus of food safety professionals then was on microbial and chemical contamination because of the severity of those hazards to our health. The focus is beginning to shift because of the litigious nature of FM contamination, which is driving an increase in the number of recalls initiated by FM incidents.
A review of this past year’s data of U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) recalls for extraneous material and comparison with the previous year’s data disclose a disturbing trend. In 2017, 43 percent of all FSIS-tracked recalls were for extraneous materials; in comparison, 11 percent of total pounds recalled were for extraneous material in 2016.1 That is a 291 percent increase in one year. If we isolate meat products, there was a 30 percent increase in pounds of meat product recalls from 2016 to 2017. In any statistical review, we must take into consideration variables that influence the frequency of the occurrence we are measuring. Is there more focus on FM than in previous years, or is there a lower tolerance for FM by the customer and/or regulatory agencies? Does it matter why there is an increase? In my opinion, no. As a food safety professional, my job is to implement an effective strategy to significantly reduce the risk of FM in the products I manufacture. If you think like I do, then let’s get started with the basic concepts of an FMPP, and then we will detail what the components are that make up the program.
Key Process Indicators
There are two types of key process indicators, lagging and leading. A lagging indicator is discovered after the fact, usually at the end of the process and most likely when a customer/consumer complains about the issue. A leading indicator is a “real-time” indicator that identifies a potential situation as it is happening or in some cases just prior. When you have developed key indicator sites that generate data prior to an incident’s occurring, you are in the predictive-mode spectrum of processing. This is not an easy accomplishment, and you will deserve the accolades and increased business associated with that achievement.
An effective key processing indicator is performing a bone detection inspection at the incoming raw material entry point of the process. Utilizing screening technology, vision systems, or manual inspection performed by production employees to prevent larger bones entering a grinding operation is a leading indicator for the grinder, and a lagging indicator for their supplier. Pieces of poly liner entering the product stream, created by the combo dumping operator using a stainless fork to pull the fresh trim out of the combo, and found by the customer and/or consumer of a grinding operation would be a lagging indicator for the grinder. A leading indicator would be requiring the dumping operator to inspect the liner for missing pieces prior to releasing the trim from the dump station or removing the fork and replacing it with a metal-detectable plastic spade. Where do you want to be in the lagging/leading indicator continuum?
Are You Purchasing FM or Creating FM?
In general terms, there are two ways FM is introduced into the value stream. The first method for FM to enter the facility is via raw materials, and the second common way is generated internally by the production process. They offer different challenges and each requires specific strategies to address them.
Let’s start with a discussion on incoming raw materials and the risks associated with them, and then we will focus on the internal factors that contribute to FM contamination.
You Need to Know What You Are Buying
How many times have you heard the phrase “you can’t inspect quality in”? I agree with that; however, through inspection, we can gain an understanding of what risks are associated with the sample size, and in most instances, what are the challenges with suppliers’ processes. The best method for introducing a strategy to reduce FM is to set up an acceptable quality limit (AQL) program. If you have purchasing leverage, you can require the supplier to perform this data collection process at their factory. Either way, you need to have an initial understanding of what type of FM is coming in and what your rejection parameters are. AQL inspections at the further processor can increase financial claims back to the supplier because of rejections.
Technology-based screening systems are highly recommended for incoming raw materials, especially for a grinding operation. Once a contaminant hits the grinder, the level of detectability falls significantly because of the reduction in piece size. Many years ago, a wise food safety professional said to me, “Finding it bigger is better.” That piece of advice was about a lead shot and bone detection discussion we were having during a root-cause analysis investigation. We were both involved in an incident that caused 4,000 cases of finished product to be placed on hold. Our corrective action was to screen all material using X-ray technology in-line at raw receiving and utilize the data collected to drive improvement into our suppliers’ processes. At that time, X-ray was not used as an in-process screening device; the technology was still utilized in salvage operations. With the advancement of algorithms in X-ray systems, we are beginning to see processors place redundant systems within a production line to increase detection capabilities.
When based on FM risk analysis data, multiple detection systems can be strategically placed throughout the production process. The systems must be on a schedule of monthly maintenance by the manufacturer’s approved technician, calibrated daily by the in-house technician, and validated hourly by the production/quality assurance (QA) employees. Screening technology requires a managed approach of calibration to the density of the product being screened in comparison with the FM, the line speed of the process, and regular maintenance. Only then can a screening device provide optimum detection capabilities and verification of the FMPP. Just remember, a screening device is neither a “set it and forget” operation nor a catchall.
All the systems mentioned above provide data collection, data analysis, and summary-reporting capabilities; however, to maximize the effectiveness of the prevention program, you must have an effective means to communicate the data back to the supplier. The supplier must utilize the lagging indicator data to implement an FMPP at their location to develop the systems to provide leading indicators and eventually move into a predictive-mode continuum.
The Power of a Robust Internal Auditing Program
The challenge for red meat further processors is managing the equipment that manipulates the raw material into finished products, which can potentially generate FM. Dumping stations, augers, conveyors, grinders, formers, stuffers, freezer belts, overhead rail systems, poly liners, and corrugate can all contribute to FM contamination. With so many potential sources, how do we keep up? It’s doable but not easy. Internal audits conducted by a cross-functional team that identifies potential FM-generating components, processes, and conditions are the most effective program to prevent FM contamination.
A critical component of an effective FMPP consists of assembling a designated cross-functional team. Depending on the size of the operation, you may have your food safety team performing this role as well. I recommend at least one of each: senior manager, process engineer, maintenance technician, production employee, product development, and finance. Why not QA? In my opinion, this is not a QA function, but providing guidance to the team is a QA function. Helping with the data collection, analysis of the data, reviewing the Standard Operating Procedures (SOPs), and keeping the team on point are QA functions. The following is a suggested list of tasks for the team to focus on:
• Conduct internal audits
• Identify potential FM risks
• Verify FM risk via data collection
• Identify root causes
• Implement corrective actions
• Validate that corrective actions are effective
The key to a successful internal auditing scheme is to break the production line down into smaller, more manageable sections for the audit team to focus on. The purpose of the audit is to identify every potential contributor to FM and create a simple data collection system to verify that the audit team is correct in its evaluation of the potential risk.
Setting up an effective data collection process is not an insurmountable task; however, at minimum it should include, but not be limited to:
• Inspecting areas directly above product zones
• Performing magnet checks postgrind
• Checking belts for abnormal wear
• Weighing grinder blades prior to and after use
• Assessing metal-on-metal contact surfaces
• Keeping track of temporary repairs
• Checking tools and utensils pre- and post-shift change
Once the FM high-risk contributors have been identified and verified, the next step is to implement the corrective actions. Some of these require minimum effort and expense; however, normally there are corrections that will require investment of time and capital. That is the reason I recommend including a finance professional and a process engineer as part of the team, to collaborate on the capital request(s).
When I evaluate a potential supplier, one of the critical records I want to review is the internal auditing team findings, corrective action requests, and completion rate of the corrective actions. The completion rate tells me about the management commitment of the supplier.
When a condition is verified as a high-risk contributor to FM, management commitment is critical. Without management to provide the resources to eliminate the potential FM contributor, the audits become an activity and not a risk-mitigation opportunity.
Once the corrective action is in place, the validation step is critical. Did the corrective action mitigate the FM risk and/or did the correction create an additional threat? Implementing a data-driven validation process to ensure the corrective action is effective and did not contribute to increased FM risk is vital to the FMPP. Once the validation is completed and approved, the next step is to create the system to ensure the corrective action is followed.
Set the Standard
An effective method to establish behavioral norms that support the corrective actions that are implemented is to create simple, clearly defined visual SOPs. These standards help employees understand and evaluate potential risks associated with a process or piece of equipment. The goal of the SOPs is to educate, remind, and verify that the employee is performing the preventive assessment of the potential FM indicator site.
One method I recommend is to create a laminated placard that can attach to the equipment (preferably below the product zone) with visual imagery depicting what the employee(s) needs to inspect prior to start-up and monitor throughout the shift. This is an effective means to alert the production employee to the key indicators that require monitoring. Visual placards can depict proper gowning procedures, tool/equipment storage, cleaning standards, screening device verification, equipment assembly, and verification procedures. Placards are effective when they are clear, easily understood, and available.
Another method to consider for verification that the corrective actions implemented are followed as intended is to incorporate a review of the equipment repair and preventive maintenance programs into the internal auditing team’s schedule. A consistent assessment of how the equipment is performing and maintained is a leading key process indicator. Fulfilling equipment repair requests in a timely manner and adhering to a preventive maintenance program based on the manufacturer’s recommendations can also be used for the verification of corrective actions. This type of focus can provide a basis to prevent disruptions to production from breakdowns and product contamination.
We have discussed multiple methods to create, implement, validate, verify, and sustain an FMPP. The bottom line to the success of any process improvement program is management commitment. The resources must be provided for any program to function to its full capability. A systematic, data-driven, pragmatic approach toward incrementally removing, replacing, and reengineering FM-generating conditions and processes can provide remarkable results and prevent injuries to those that trust us to keep them safe.
Dr. John W. Raede is the chief food safety officer for National Cortina, an Importer of Record for grass-fed beef, individually quick-frozen vegetables, and edible oils. He has 30 years of food industry and food safety experience, spanning from meat animal production to individual quick-freezing vegetable processing. He spent 20 years with Nestlé USA in global supply chain quality. During his time at Nestlé, he earned his master’s and doctorate degrees in business management. Dr. Raede specializes in food safety supply chain process improvement, risk mitigation, and FM assessment and prevention.