Since the introduction of FSMA, food safety has been under a much-needed magnifying glass. Standards for hygiene and accountability are increasing, and companies are implementing more measures to keep consumers safe. One of the ways in which businesses are being proactive is through implementing color-coding plans. If you have not heard of this type of plan yet, it’s time to get schooled; and if you have, this article will provide a quick refresher on why companies are expanding their spectrum on contamination prevention—by literally implementing the color spectrum in their plants and businesses.
What Is A Color-Coded Plan?
A strategy for a plant or business that designates certain colors for a specific area or purpose designed to promote safety and cleanliness.
Example Plans. Although color-coding plans vary by the needs and demands of each plant, the following are the most popular types of color-coding plans currently being practiced in food manufacturing.
Color coding a cleaning brush can help employees make the distinction when dealing with allergens and potential contamination. All images courtesy of Remco/Vikan
Allergen/Potential Contaminant Distinction
Food Processors and manufactures usually have identified potential allergens and contaminants that pose a risk to the production process. Color distinction for equipment or instruments that come into contact with these potential contaminants is an ideal tool for food safety. Determining the amount of items that fall into this category within your facility is the first step to selecting the appropriate amount of colors to implement. The most basic color-coding plan for this purpose would be to select one color to represent tools that come into contact with a particular risk agent and one color to represent those tools that may be used elsewhere. If a plant has more than one risk agent, this plan may be expanded to include several colors. It is important to remember, however, that simplicity is key in color coding and that additional colors should be implemented strictly on an as-needed basis.
Zone Distinction
Many plants already have identified zones in place based on what is produced in each zone or simply due to operating a large plant. This presents an ideal opportunity to color code zones to keep tools in their proper place.
Shift Distinction
Certain plants that have a large number of employees working different shift times should also consider color coding. Color coding by shift can hold each shift responsible for proper tool use and storage. This approach also allows management to see where work habits may be falling short and where the cost of tool replacement is highest.
Assembly Process Distinction
Plants that have assembly line-like processes can implement color coding if necessary to differentiate tools that belong to each step. For example, this becomes particularly important in plants that deal with products such as meat; obviously you do not want to use the same tools with raw and processed meat. Color coding eliminates the question of whether or not a tool is meant for each step in the process.
Implement a two-color-coding plan to distinguish between tools used for cleaning versus sanitation.
Cleaning Purpose Distinction
For many food plants, cleaning and sanitizing are processes that are considered different in purpose and practice. Often, there is a specific list for cleaning and then a separate plan for sanitizing. Implementing a two color-coding plan can distinguish tools that are meant for each process.
Why You Need A Color-Coded Plan
It helps meet FSMA requirements. A major part of complying with FSMA regulations is having proper documentation to prove safety measures. Color-coding plans do exactly that, and most providers of these products can provide you with the necessary documentation.
It reduces pathogens and allergens contamination. For food producers, this is the most important reason to implement color coding. There is nothing worse for a company than experiencing product contamination or a recall; this is one step that may prevent such events from occurring.
It is easy to understand. Color coding works so well because it is so simple. All employees, even those who may not speak the same language or are unable to read posters and manuals that dictate proper procedures, can easily comprehend it.
It creates a culture that holds employees accountable. Managers enjoy color-coding practice because it is a simple measure that really works to hold employees accountable in the proper use of tools. It becomes much more obvious when a brightly colored tool is out of place, and thus workers are more likely to follow proper procedure.
To understand why an integrated informatics solution is important to manufacturers in the food and beverage industry, it helps to first consider the unique challenges this industry faces. Simply put, food production has scaled into a global business so rapidly that oversight has hardly kept pace. Even the stricter regulatory stances taken by the FDA and the European Union in the past decade are effectively catch-up efforts.
The broader food industry, which for purposes of this article will also comprise the beverage industry, has globalized quickly and, many would argue, haphazardly. It actually wasn’t that long ago that the products we purchased in our local food store were produced locally or regionally. Seasons determined selections as well—if you wanted a tomato in November, you would pay a premium for that indulgence.
Seasons and geography no longer constrain what we can buy and when. By far the world’s largest industry—with a combined revenue of more than $4 trillion, the food industry has used its massive scale to overcome historical limitations. We now take for granted that our grocery carts can be filled with fresh products that may come from thousands of miles away. And those products may have been grown, processed and shipped in multiple countries before they reach our local grocer.
The complexity and scale of this modern food supply chain is the industry’s greatest challenge and regulators’ greatest worry (on consumers’ behalf). How can growers, producers, processors, packagers, shippers and others in the global supply chain secure a food chain that’s so distributed? How can regulators ensure safety without restricting choice or inflating prices?
The Bits and “Bytes” of Food Safety
The food industry—and its regulators—would likely agree on one thing: A system this massive cannot operate on trust alone, as it once did. The grower with generations of experience on the land, for example, is now too far removed from end consumers. A finished product may contain one farmer’s product and those from five others, all from different regions worldwide.
Integrated informatics may seem like an unlikely fix for modernizing a highly distributed food chain, but it’s actually perfectly suited. An integrated informatics platform provides access to massive amounts of information in a timely fashion, dramatically improving decision-making. It does this by making information rapidly available to many stakeholders and by ensuring that it’s reliable.
Consider this example. A hypothetical lab uses an analytical instrument to detect pesticides in barley, and regulation dictates that this data be compared to allowable maximum residue limits (MRLs). If the barley sample exceeds allowable MRLs, the manufacturer must identify everywhere that ingredient is being used, quarantine it and determine who produced it. All this must happen quickly and according to strict procedures.
Procedures are critical. Not only must the lab have a process for checking against current limits for a pesticide, for example, but also that analytical information must be carefully tracked with the appropriate sample, and the method used to deliver the result must be consistent between different samples and users. Without an integrated informatics solution, adhering to these procedures, defending the quality of the data, and making it usable would be nearly impossible.
The Role of Informatics in Compliance
Gathering the bits and bytes of data, following procedures and making the data useful enterprise-wide is important, but regulatory compliance is where most industry attention is focused today. This is another area where integrated informatics provides significant benefits.
As mentioned above, food industry growth significantly outpaced regulatory oversight in the past decade. Globalization was rapid and inevitable, but so too were food safety breaches, and with progress came stories of tainted fruits, vegetables, meats, cereals, nut butters and much more. Suddenly we had a trust issue. With a food chain that’s distributed across many borders and jurisdictions, how is the public’s trust best protected and by whom?
From the Food Safety Modernization Act (FSMA) to EU Regulation No. 178/2002, we’ve seen a heightened regulatory focus, and the most common themes are traceability, authenticity and risk-based approaches. The common denominator here is food chain security.
So what does all of this mean for multinational food and beverage producers? It means having to conform to multiple regulatory requirements for each distribution market, and there are often many. And this is a data management and reporting headache. Fortunately, however, common standards such as ISO 22000 exist that enable companies to standardize their processes enterprise-wide, achieving levels of operational rigor and quality that satisfy multiple regulatory authorities at once.
So where do informatics fit into this regulatory compliance landscape? In a typical multinational food producer, a significant amount of the quality data is delivered by the laboratory. Raw materials are analysed for pesticides, herbicides, nutritional content and so on. Packaged products are monitored for shelf-life compliance. Plant hygiene is monitored using microbiological samples taken from across the facility. Records from all of these distinct, but interrelated activities are critical for demonstrating compliance.
Defending Data
The shift in recent years has been toward prevention instead of crisis response. Regulators now focus on auditing food and beverage producers to assess their practices prior to any adverse event. For companies with good systems in place, time-consuming audits will be less frequent, so it pays to have systems in place that demonstrate that data is reliable and defensible.
Audits can be daunting. The producer must prove that activities were carried out correctly, that records are properly collected and that supporting information is accurate. Auditors typically pick a starting point in a process and follow the trail. They may start by looking at the data associated with a released batch of product; perhaps quality assurance samples; follow the trail to cleaning validation, and then review individual laboratory results, including entire methods, instrument calibration, user training, etc. At each point of the audit, producers must show evidence of compliance—even the smallest details.
With an integrated informatics solution, all evidence resides in a single platform. Hierarchies and relationships within the data records are automatically recorded and retained. Everything—from relationships between lots or batches of material; the connection between methods, specifications and results; the history of an instrument configuration, maintenance and calibration; and user training records—is in one place for easy retrieval and reporting.
Having one system of record not only codifies data capture, it also helps labs create standard operating procedures (SOPs). Establishing SOPs does several important things:
It ensures that all lab users are following the same process—no personal preferences for carrying out a specific test.
It makes sure that all necessary data is collected—by enforcing a series of data entry steps, labs can prevent a method from being marked complete until everything has been entered.
Labs can roll out updates to their processes by updating the method for all users at the same time.
Managing lab execution activities in this way means that data is more consistent; it is being collected in the same way for all users. It is also prone to fewer errors because users move stepwise through each stage of the measurement process, and they can stop a test whenever they encounter a problem.
Achieving Traceability
Traceability, the ability to verify the history, location or application of an item using documented information, has become increasingly more important for the food industry. And traceability is closely linked to compliance and data defensibility. Fortunately, traceability is another strength of an integrated informatics solution.
In practical terms, to demonstrate traceability we must be able to go either backwards or forwards within a set of process items and understand the complicated relationships. An integrated informatics solution lets us map relationships between “child” and “parent” batches, information that can also come from integrating ERP or process or production information management (PIMS) systems. By integrating all this information, manufacturers can trace a product back through intermediate products and raw materials and then forward again to any resultant batches that may be contaminated. In other words, with an integrated informatics solution, traceability is built in.
Brand Protection
Because of its size and fragmentation, the global food and beverage industry is a target for adulteration and counterfeiting. The Grocery Manufacturers Association estimates that these activities cost the industry $10–15 billion each year.
While the risk to consumers of adulteration can be deadly, as in the case of milk solids adulterated with melamine in China, much of the impact comes in the form of trust erosion and fraud. An example is Manuka honey, a premium product with purported health benefits that commands a high price. The entry of fraudulent producers into the market affects legitimate producers by creating uncertainly about all products, depressing sales and lowering prices.
Having access to data from all critical points in the food production chain is the most important safeguard against product recalls and loss of revenue for food manufacturers. Having an integrated informatics solution in place provides data when it is needed for quality checks in the production process, for management metrics reporting or to adhere to regulatory requirements. (Click to enlarge)
This is only one example, but it illustrates the larger problem: Once consumer trust erodes, it’s hard to regain. As it happens, however, honey has unique chemical markers that can be used to determine whether it has been adulterated. But isolating these markers involves complex analysis, including ultra- high-performance liquid chromatography (UHPLC), and methods that are highly specific, consistent and defensible.
Consistency and defensibility are hallmarks of an integrated informatics solution. For the honey producers, an informatics solutions, such a LIMS, can automate processes so that no non-conforming product is missed, establish compliance rules and checks for instrument calibration so that results are defensible, and standardize methods through built-in laboratory execution system (LES) capability.
Conclusion
An integrated informatics solutions is designed to address multiple business needs in the food and beverage industry, from compliance and data defensibility to traceability and brand protection. The complexity and scale of the modern food supply chain demands it.
Growers, producers, processers, packagers, shippers and others in the global supply chain are now interdependent, but not necessarily integrated. The only way to protect consumers, however, is to achieve this integration through a combination of voluntary and imposed compliance. And to achieve this compliance without undue burden on the industry and imposing higher costs on consumers, we need technology that is built for integration at scale—and informatics solutions have proven they are more than capable.
The upcoming implementation of FSMA will likely result in increased scrutiny of contaminants in food products. If the foreign matter can be identified, steps can be taken to eliminate the source of contamination and avoid future losses of product. Small foreign particles are sometimes observed in drums of bulk granular or powdered raw materials. While these foreign particles may be seen as dark specks in the product, they are often too small for standard QA/QC methods of analysis. Microanalytical techniques, however, can be used to isolate and identify the specks. This article describes a case study of dark particles in a granulated sugar sample.
Microscope Exam
Ideally, when conducting contaminant analysis, all sample manipulations take place in a cleanroom to eliminate the chance for contamination by extraneous environmental debris. This is especially important when working with small contaminant particles, which may consist of environmental debris such as metal particles, fibers and other types of dirt. If the unknown particles are identified as common environmental debris, the analyst must be certain that he or she did not introduce any debris while handling the unknown sample.
Figure 1. Granulated sugar with dark foreign particles, 13X (Click to enlarge)
The first step in the identification process involves examination of the sample under a stereomicroscope. Figure 1 is a photomicrograph of dark brown particles, less than 1 mm in size, in the sugar sample. Particles of this size must be isolated from the bulk product prior to analysis in order to correctly identify them.
Since all of the dark particles are visually similar, only a few representative particles need to be isolated. The contaminants can be isolated by removing a small glob of tacky adhesive (50 µm or smaller) from a piece of tape with the pointed tip of a fine tungsten needle. The adhesive-coated needle tip is gently touched to the surface of one of the dark particles, causing the particle to adhere to the needle, and the particle is transferred to a glass slide or other substrate for further examination.
Figure 2. Isolated dark foreign particles, 63X. (Click to enlarge)
Figure 2 is a photomicrograph of three dark particles, isolated from the sugar granulation. The dark brown particles have a smooth, shiny appearance with conchoidal (shell-shaped) fracture surfaces, and are visually consistent with glass. However, when probed with the tungsten needle, the particles are found to be brittle and fragile, and this texture is not consistent with glass. Therefore, chemical analysis is needed to identify the brown particles.
Micro-FTIR Analysis to Identify Organic Components
Most organic compounds (and some inorganic materials) can be identified by Fourier transform infrared (FTIR) spectroscopy. For the analysis of small particles, a microscope is coupled with a standard FTIR system; this method of analysis is known as micro-FTIR analysis. The micro-FTIR system passes a beam of infrared radiation through the sample and records the different frequencies at which the sample absorbs the light, producing a unique infrared spectrum, which is a chemical fingerprint of the material. By comparing the spectrum of the sample with spectra of known compounds from a reference library through an automated computer search, the sample can often be identified.
In order for the FTIR analysis to work, the sample must be transparent, or thin enough to transmit light. In the case of the particles from this case study, this is achieved by applying pressure to a ~50 µm portion of the sample until it forms a thin transparent film. This film is placed on a salt crystal for micro-FTIR analysis.
An FTIR spectrum of crystalline sugar is shown in Figure 3, and a spectrum of a brown particle is shown in Figure 4. The spectrum of the brown particle has some similarities to sugar, but there are fewer peaks, and the remaining peaks are rounded, consistent with a loss of crystallinity. The loss of crystallinity, coupled with the brown color of the particles, suggests charred sugar.
Figure 3. FTIR spectrum of granulated sugar. (Click to enlarge)
Figure 4. FTIR spectrum of a dark foreign particle. (Click to enlarge)
SEM/EDS to Identify Inorganic Compounds
The FTIR method does not provide complete information about the presence or absence of inorganic materials in the contaminant. To complete the analysis of the brown particles, scanning electron microscopy (SEM) combined with an energy dispersive X-ray spectrometer (EDS) detector is needed. Using the SEM/EDS method, two types of information are obtained: SEM provides images of the sample, and the EDS identifies the elements that are present.
Figure 5. SEM/EDS analysis of a dark foreign particle
A brown particle was mounted on a beryllium stub with a small amount of adhesive, and submitted for SEM/EDS analysis. Figure 5 includes an SEM image of the particle, and a table of EDS data. The SEM image provides some information about the composition of the particle. This image was acquired using backscattered electron mode, in which heavier elements appear lighter in color. The image displays light colored specks scattered across the surface of the particle, indicating that more than one type of material is present. The light-colored circle on the SEM image shows the area that was included in the EDS analysis (the entire particle was analyzed). Looking at the column in the table for weight percent (Wt%), the particle consists primarily of carbon and oxygen, with small amounts of chlorine and iron. Carbon and oxygen are chemical constituents of sugar, but chlorine and iron are not.
Figure 6. SEM/EDS analysis of specks on a dark foreign particle
The EDS system can also be used to focus on individual small areas on the particle. Figure 6 includes EDS data from five specific light-colored specks on the surface of the brown particle. The specks contain major amounts of iron with small amounts of chlorine, and sometimes chromium and silicon, plus contributions from carbon and oxygen from the surrounding sugar matrix. The composition of the specks indicates steel corrosion, likely from low alloy steel. The presence of chlorine suggests that a chlorinated substance was the initiator for the corrosion process.
In some cases, steel corrosion can be the sole cause of brown or dark discoloration of small particles. In the case of this brown particle, the SEM image shows that the iron-rich particles are not evenly distributed throughout the particle, but are only scattered on the surface. Charring is the most likely cause of the overall brown color of the particle.
Conclusion
When examined under the microscope, the dark particles in the sugar sample had the visual appearance of glass. However, chemical microanalysis of the particles revealed that they were not glass at all, highlighting the importance of microanalytical methods in determining the identity of the foreign matter. The brown particles were ultimately identified as charred sugar particles with scattered specks of steel corrosion (likely from low alloy steel) on the surface. This information can be used to narrow down the search for possible sources of the brown particles in the bulk sugar sample. As part of a root cause investigation, samples of dark particles from various locations in the manufacturing and packaging processes can be studied by the same techniques to look for a match.
For consumers and manufacturers, product quality and cleanliness are a preeminent priority. Product recalls resulting from manufacturing errors in sanitation often warrant national headlines and cause widespread mistrust and panic among consumers.
After a tumultuous spring and summer, Blue Bell Creameries, a Texas-based ice cream manufacturer, will be restocking its products in select grocery store freezers in five phases. The popular brand was forced to recall its products due to Listeria contamination, which has been blamed for the deaths of three people.
Learning from these instances can greatly reduce the number of sanitation-related issues in the future. Investing in sanitation not only increases safety but does wonders for performance and efficiency.
How can sanitation be a competitive advantage and not a troublesome necessity? It’s all about OEE.
Investing in sanitation efficiency now will pay off later. Image courtesy of Myrtle Consulting Group
While not investing in sanitation may save you a little money in the short-run, neglecting it can cause exponentially larger costs down the road, including elevated food scrap, equipment reliability failures, excessive non-value adding to production time, expensive recalls, remediation costs, potential legal liability, and destroyed consumer trust.
A focus on Overall Equipment Effectiveness (OEE) will increase capacity without investment or additional resources, and it does not need to be overly difficult or expensive. However, OEE management does require detailed process analysis, process rethinking, reconstructing of resource assignments, and installation of management control and reporting systems. When equipment is scheduled to run, it’s running at the correct rate, using the right number of resources and at the right level of quality. This will not only boost the efficiency of your operation, but the safety and quality of it as well.
An Important Piece of the Puzzle
Adopting lean techniques into your sanitation plan is an effective and efficient way to improve process time. With this approach, you can determine:
Using LEAN will allow you focus in on three essential areas: the elimination of waste, reduction in variability and reduction of inflexibility. When these factors come together, work can be completed in a standardized, efficient and sanitary manner.
Study. Streamline. Standardize.
Product recalls due to manufacturing errors in sanitation cause mistrust among consumers. Image courtesy of Myrtle Consulting Group
Study. To incorporate, improve or ensure sanitation, the first step is to evaluate what you’re working with. Take the time to examine existing protocols and contracts. Conducting a detailed study of the current processes can help you define the areas that need work, which may include equipment effectiveness, supervisory staff and materials used.
Streamline. Once you obtain the initial result of the study, goals and plans can be determined to streamline the process and make everything run more efficiently. It is not unusual to discover at least 30% of non-valued time within the existing process, mainly due to poor planning, poor coordination or the use of overly cumbersome methods.
Standardize. After creating a plan to improve effectiveness and sanitation, swift and certain implementation of these ideas are critical to maintain commitment and realize results. With a detailed plan, sanitation of machines and other supplies can be executed in an exact, timely fashion.
Placing Sanitation Operation First
One of the biggest mistakes that can be made in manufacturing is viewing sanitation operations as secondary in importance. This attitude can lead to all kinds of oversight and carelessness, which can cause costly mistakes. Clear expectations, clear roles and responsibilities, and measured performance are the hallmarks of well-executed operations and an effective way to make sanitation a priority.
Dramatic Improvements, Significant Savings
Making these changes to increase efficiency and sanitation have yielded dramatic improvements for manufacturers. A large U.S. food manufacturer installed this system in five of their plants and quickly cut costs while boosting productivity. One of the plants was able to repatriate production outsourced to a co-manufacturer at a savings of approximately $500,000. Another replaced its entire 50+ person sanitation crew with a subcontract cleaning crew, reducing its labor cost from $22 to $11.47 an hour, while at the same time increasing the work effectiveness of the crew and performing 15% more sanitation work within the same time frame.
Manufacturing isn’t only about quantity; it involves ensuring a level of quality that builds consumer loyalty and efficiency. When your product potentially poses risk for the consumer, it also poses a danger to your business and its success. Remember, you don’t have to risk using unsanitary methods for the sake of saving money or increasing efficiency. In fact, sanitation and efficiency are easily attainable when they are brought together in a strategic plan. Putting in the time and dedication to create an effective sanitation plan will help you avoid negative consequences and bring you to the top of your game. Stay clean.
Laboratory testing is an integral part of the cannabis industry for the same reasons it is important in the food industry. To ensure the consumer is ingesting a safe product, accurate testing should be required for microbials, pathogens, pesticides, heavy metals, and perhaps most importantly dosage. Unfortunately, however, the problem is that testing requirements are not quite there yet in the handful of states that have legalized marijuana for recreational or medical purposes. This creates a degree of uncertainty in the marketplace, which is detrimental to the growth of the industry as a whole.
Cannabis samples are liquified in strong acid in a pressurized microwave prior to evaluation for heavy metal content. Image courtesy of Digipath, Inc.
Lauren Finesilver, Executive Chef at Sweet Grass Kitchen, sits on a counsel for compliance with C4 (Colorado Cannabis Chamber of Commerce). Finesilver believes “We are a food manufacturer first and foremost so we need to ensure we sell a final product that is safe for the public and [one] that consumers know is coming from a responsible manufacturer.” Ahead of marijuana rule changes that are soon to come, Colorado’s Marijuana Enforcement Division (MED) announced five new rulemaking working groups, one of which will address testing, packaging, and labeling.
Some states, including Colorado and Nevada, have made impressive strides in implementing proper testing regulations.
“Nevada has done a really good job from the start in designing a program where they have at least addressed some of the issues with product quality including testing, labeling, and potency requirements,” says Tobias Paquet, Chief Scientific Officer of C3 Labs, LLC (Cannabis Chemistry Consulting).
Paquet, who previously worked at Waters Corporation as a field chemistry specialist, cites potential contamination at almost every step of the cannabis supply chain from seed to sale. “Some of the biggest concerns with contamination during cultivation or extraction are pesticides, heavy metals, and microbial contamination,” he says, adding that he is most concerned about two microbial carcinogens—mycotoxin and aflatoxins.
“We aim to provide reliable and consistent labeling that is accurate and reflects the contents of that product,” says Paquet. “This comes with a validated method on qualified instruments and laboratory accreditation.”
Determining the moisture content in a dried cannabis sample for adjusting potency numbers and checking for appropriate curing. Image courtesy of Digipath, Inc.
Much like the food industry, accurate testing across the board is needed for consumers to feel safe ingesting edibles containing marijuana. Laboratories that operate in states where marijuana is already legal need to utilize good laboratory practices and standards to ensure consistency.
“We have been working to create an accreditation process that is accepted on a national level,” says Roger Brauninger, biosafety program manager at the American Association for Laboratory Accreditation (A2LA). “Without firm state laboratory accreditation regulatory requirements in place, the possibility exists that people may shop laboratories to get the results they want. So if applied across the board, ISO 17025 accreditation would help reduce that, thereby helping to create greater consistency of tests results between laboratories, ultimately helping to reduce marketplace confusion.”
The cannabis industry has the momentum to become a safe and regulated marketplace as state reforms continue, with testing and analytics acting as the wind behind its sails.
Matt Karnes, founder and managing partner of GreenWave Advisors, LLC, suggests that by 2020, assuming full legalization occurs in all 50 states and D.C., the lab testing industry could easily reach $850 million (this figure includes testing, data analytics and consulting services). The firm provides an analysis of each state’s potential market size which is predicated on its U.S. retail marijuana forecast of $35 billion (again, assuming full legalization by 2020). Karnes was recently cited in a Forbes article suggesting that cannabis testing is one of a handful of top new technology investment opportunities.
Karnes’ predictions echo that of many when discussing the cannabis analytics space. “More states are becoming focused on standardized laboratory testing requirements,” he says. “There is really no consistency, which is something that needs to be worked out.”
While a handful of states work toward achieving good laboratory standards, players in the cannabis industry, including laboratories, dispensaries, and cultivators, continue to self-regulate when it comes to safety and quality.
CannabisIndustryJournal.com, our newest publication, will be launched in late September. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!
In America’s food supply chain, food is sourced globally. Since ingredients often come from multiple countries, inspection and quality control is challenging, as regulations, policies and processes differ in each country. Product management begins with the suppliers, from the fields where the foods are grown, to the pesticides and fertilizers used, to harvesting, washing, shipping, storing, and processing (manufacturers), and finally, to packaging and delivery to consumers.
Figure 1. LIMS will facilitate FSMA by providing complete traceability from farm to table, in addition to accelerating collaboration, communication and providing operational insight. (Click to enlarge)
Figure 1 shows each step of the product management process can introduce contamination due to unsafe practices or other risks. As such, test data and traceability must begin in the field and end when the final product is delivered to the consumer. The Laboratory Information Management System (LIMS) captures all information to ensure that quality data is effectively managed, communicated, and easily and quickly accessible in the event of a contamination issue. The LIMS allows producers to provide authorities with the required sampling and testing documentation to prove compliance.
U.S. consumers expect their food products to be affordable, consistent, safe and unadulterated. Consumers have seen numerous food recalls in the news, and it has shaken their confidence. The CDC estimates that about one in six Americans (or 48 million people) get sick, 128,000 are hospitalized, and approximately 3,000 die of foodborne diseases each year. Global food directives for international food initiatives include CODEX, ISO (International Standards Organization), and the Global Food Safety Initiative (GFSI).
The U.S. Government has implemented various food safety programs, from Hazard Analysis & Critical Control Points (HACCP) to FSMA in order to identify and correct potential contamination in the food supply. In fact, one of the primary focuses of FSMA is preventive action based on risk assessment.
The food landscape has changed significantly, especially over the past decade, as consumers demand year-round fresh fruits, vegetables and juices, along with more exotic foods. The fact that U.S. food is globally sourced has resulted in numerous challenges in quality assurance, shipping, traceability, labeling, storage, blending, testing, and reporting.
Use LIMS to track and manage information in a relational SQL Server LIMS database. (Click to enlarge)
For example, upon reading the labeling on an apple juice can, it is not uncommon to learn the juice has been possibly sourced from numerous countries including the United States, China, Brazil, Argentina, Chile and many other countries from the European Union. Oftentimes, labels state that ingredients may come from some of the countries listed, but it does not specify what percentage comes from each country or exactly from which country the product was sourced. Figure 2 shows how LIMS can track and manage this information in a relational SQL Server LIMS database.
A similar scenario is true for tracking hamburger meat: The meat that was used to make burgers can come from multiple ranches and hundreds of cows. Many consumers don’t understand why their food/beverage is blended in large ton batches, and producers want to reach the required final product specifications, while offering a consistent product and experience to the consumer. Blending has become commonplace in the food industry, and it makes traceability much more challenging. The same is true in blending different meats, for example regulators have found pork in products marked 100% beef, this has led to the use of molecular tests to determine if meat has been adulterated.
FSMA and Traceability
FSMA focuses on a preventive approach rather than reaction and response to foodborne outbreaks. A central focus is on traceability, involving a complete understanding of the complex food chain and conducting testing at the key control points that can introduce contamination. It is important to understand the source of all the raw ingredients that make up a final product as well as the details of where they are sourced, the CoA (Certificate of Analysis) report, other test results, and all associated documentation. These elements are especially important, because each region of the world has different approved testing methods and is challenged with different potential contaminants and processes. As a result, food manufacturers must manage a significant amount of information on all raw materials that they receive, along with the associated paperwork, which includes the CoA, confirmatory test data, and all plant, production and final product test data.
Case example. As operations scale, so does the testing. In order to manage all the testing, most laboratories turn to LIMS and laboratory automation to manage high throughput screening. A client that was performing nearly 1,000 Listeria tests per day was using an automated microbiological screening platform to complete this testing. They were struggling to hire more resources to manage and run the instrument, as the time was short and the increased sample volume was imminent. The goal was to automate testing from the nine plants that were submitting samples to the main laboratory, such that the entire process could be automated from the laboratory knowing how many samples were coming from each plant and from deploying pre-configured worklists to upload to the instruments. The instruments would then run the samples and send the result back into the LIMS. This integration alone saved more than six hours per day. In addition, the electronic data transfer was fast and error-free, and since the data was imported into the LIMS, any positives were automatically flagged in real time. This approach allows immediate action.
In addition, all data from shelf life studies and additional testing on the food product (i.e., pesticide testing, environmental testing for Listeria sp., mold, yeast, etc., formulations, and blending) can be managed in the LIMS, one centralized database.
How LIMS Supports FSMA
Over the years some manufacturers have relied on less-robust tools to manage and maintain testing data, from multiple Excel spreadsheets to paper log books. Challenges with using these tools include data corruptions, data loss, typographical errors, and accidental or malicious data changes. These systems are often costly, especially from a resource standpoint (i.e., data errors, hours spent interacting with the data for calculations, tracking samples, and manual report creation alone). In addition, creating reports for regulating authorities can be time-consuming and because there is no control over changes to the Excel sheets or logbooks, there is typically no audit trail, and because the data is not in the database, querying the data can be very difficult.
A quality LIMS will ensure that the organization is bullet-proof when it comes time for regulatory audits. It also provides a complete and secure solution to manage, track and monitor batches of product from farm to table. LIMS not only helps clients manage their regulatory compliance goals, but it also facilitates communication across the organization and provides laboratory intelligence that gives buyers insight into the best suppliers to purchase from, based on final product specification, consistency and pricing. Managers can also better understand when it is time to outsource testing based on workload data, allowing them to maximize their resources and profitably through more efficient operations. The system also accelerates communication: As soon as testing is completed, reports can be automatically emailed and alerts sent to cell phones, if any issues arise.
When dealing with perishable products, time is of the essence, LIMS save time. Table 1 lists just a few of major benefits of the LIMS in FSMA regulatory compliance.
Process/Requirement
Advantage
Sample tracking and management
Integrated barcode support (both 1D and 2D), manage all batch data, tests, from raw materials, in process testing to final packaged product testing
21 CFR Part 11
Compliance with electronic signature requirements
CoA
Easily, automatically generate the CoA report once testing is completed, validated and approved
Specification Management
Manage final product, supplier and customer specifications and pricing
Document Management
Link all paperwork to Work Order for ready access and retrieval
Full Chain of Custody
Automatically generated and linked to the order
Records data and all paperwork associated with product
All paperwork that arrived with the raw ingredients, CoA, and shipping documentation or additional test data
Records all test results
Automatic data import from instruments as well as hand entered data
Shelf-life Studies
Setup, manage and track all aspects of shelf life studies
Formulations and Blending
Manage and track as components and specifications for final product blends, and leverage predictive tools for optimal purchase options from suppliers
Audit Trail
Track actions in the system and generate a report of all audits made to any result data
CAPAs (Corrective and Preventative Actions)
Track and manage open CAPAs in the LIMS, and tie to testing results for easy management to increase customer satisfaction
Traceability back to the source (farm, country) and forward to the store that it was shipped to, with key data (lot number, ship date, etc.)
Users can view all components and associated test results, along with any notes on the final product, back to the supplier and forward to locations that offer the product to the consumer
Employee Training
Manage employee training records and view Standard Operating Procedures online to ensure access to work instruction and provide evidence for audits
Instrument Management
Manage all quality control data on the instruments used in the testing, as well as documented calibration data, maintenance, any repairs, or any issues. Users can link the PDF manual in the LIMS
Enterprise integration (ERP, SAP, SCADA, MES, SAS JMP)
Data sharing allows users with permissions access to data when they need it, so that they can quickly view and monitor information they need to perform their job. Users can also view data with integrated statistical tools to view trends that may not be readily evident
Table I
A LIMS is a critical tool to the success of food companies. It organizes and securely manages all aspects of food testing, facilitates regulatory compliance, enhances communication within the organization, and maximizes productivity. Many food producers are concerned about protecting their brand and providing a high quality, consistent, and safe product to consumers while operating efficiently and at a profit. An LIMS allows them to meet these goals.
Part two of Food Safety Tech’s interview with Alan Baumfalk, lead auditor and technical manager for Eurofins food safety systems, discusses how companies can reduce their chances of having a food crisis. “Sometimes we forget that part of our crisis management team is part of food defense,” says Baumfalk.
Food Safety Tech: Can you discuss the importance of the food defense plan within crisis management?
Alan Baumfalk: We need to defend the product within our facility, and we need to determine as part of the food defense plan the methods that we’re going to implement to prevent adulteration of product.
We need to step up and watch this: The process literally travels from farm to fork; from the crop through processing through distribution and to the final consumer. As part of our food defense plan we need to protect sensitive processing points from intentional adulteration, and we must watch for potential accidental adulteration.
It is important to carefully control the activities in the plant. Part of that involves limiting employee, subcontractor and visitor access to production equipment, manufacturing, and storage areas by designating access points.
These steps can help to eliminate issues involved in causing a crisis:
Secure the storage of raw materials, packaging equipment and hazardous chemicals
Control all chemicals within the facility, because they can be used to deliberately or accidentally contaminate food.
Hold finished products in secure storage.
Control transportation. Apply seals to the full truckload.
Ahead of the launch of our newest publication, CannabisIndustryJournal.com, I interviewed Stephen Goldner, President of Regulatory Affairs Associates, regarding the possibility of federal oversight in the cannabis industry, namely direct FDA involvement via regulations.
With experience as a forensic toxicologist and attorney, Stephen Goldner has worked over 35 years as a regulatory professional in the healthcare space. He has contributed to the approval of 230 drugs and medical devices serving as an FDA advisor. Steve is credited with the development of the liquid dose form of methadone and various screening tests for drug abuse.
We discussed the current regulatory frameworks in place for legal marijuana in the United States and found that there are some gaps in understanding when it comes to regulating the plant. Here is a snapshot of our conversation discussing federal involvement in the cannabis industry:
Food Safety Tech: Are state governments and marijuana businesses working jointly to handle the regulatory framework succeeding? Can you see, in the handful of states that have already legalized marijuana, a need for FDA regulatory guidance?
Steve: To many people’s surprise, the states that have legalized marijuana are doing very well setting up a regulatory framework. Plus, the legitimate operations really want to succeed in business and provide safe and effective recreational and drug products. I’m surprised to hear myself say it, but FDA might be best served if it stayed out of this issue for a while.
FST: What are some reasons why the FDA might want to get involved in the cannabis industry?
Steve: Certainly if there were reports of injuries, but so far the marijuana products seem to be much less hazardous than other common recreational substances like beer and wine. But FDA also gets involved when there are outrageous claims that products cure diseases like cancer. I expect FDA will act against cannabis distributors who make those claims, even if they only distribute their marijuana within one state.
FST: What are some reasons why the FDA might want to let this social experiment run a little longer?
Steve: Thousands of people have gone to jail or otherwise had their life ruined because of small amounts of this product being used or being sold. If it turns out, as the data appears to show, that marijuana is not a ‘gateway drug’ to other drugs, and it’s use is fairly harmless, then FDA stepping in will probably just send most of the users and growers into the black market and then nothing will have been gained.
FST: What actions might you suggest the FDA take in the near future as more states continue to legalize marijuana?
Steve: Great question! FDA is excellent at monitoring data, along with the CDC. If FDA sees a real health hazard problem, it can convene a panel of experts to offer solutions. And then monitor the situation to see if growers and producers of marijuana edibles can adopt those solutions into their business practices.
Ahead of a number of state reforms and initiatives to legalize the recreational use and sale of the plant in 2016, The New York Timespublished an op-ed by The Editorial Board in favor of removing marijuana from the Controlled Substances Act. While Goldner, along with many others, believe that states are making great strides with regulatory measures, The New York Times believes “State legalization efforts are not uniformly well thought out, which is another reason for Congress and the president to act.”
With the 2016 elections fast approaching, we hope to see major changes coming soon in the federal government’s position on marijuana.
We want to hear your thoughts! Do you think the federal government should step up their involvement? What actions or inactions would you like to see the federal government take? Do you think the FDA should chime in? Post your questions or thoughts in the comments section below.
A control point breakdown can lead to a food safety recall. Here’s what to expect, what to do, and how to move forward. But most importantly, this discussion with Alan Baumfalk, lead auditor and technical manager for Eurofins food safety systems, will focus on prevention and re-evaluating whether your company’s current plans will be effective in the wake of a recall.
Food Safety Tech: What is the role of the crisis management plan as it relates to a company’s food safety program?
Alan Baumfalk: The crisis management plan is an interwoven topic. Some people use crisis management or business continuity interchangeably, but they tend to have a bit of a different focus.
First of all, a crisis management plan usually goes together with a food safety plan, and in some cases, it is part of a food safety plan. We are all familiar with the food safety plan, which includes a HACCP plan (Hazard Analysis and Critical Control Points). HACCP consists of seven principles. We’re all involved in HACCP everyday; it’s related to everything we do. We identify the hazards that might be involved in the food we’re producing; we identify the hazards that might be involved in our daily lives (for example, we choose no to drive in rush hour traffic because of the potential hazards that might be involved).
This all fits into our food safety program where we try to eliminate risk through risk assessment. We establish critical limits of what we will and will not accept, and then we monitor and verify them. We take corrective actions when something we monitor is not within that critical limit. Verification involves verifying that what we’re monitoring is indeed being monitored, and finally, there is record keeping.
The crisis management team wants to prevent a recall, which is a crisis to the business, to the brand, and to the health and welfare to the public. No one wants to have a recall. When putting together this plan, you need to make sure you have a multidisciplinary team. It cannot consist of all sales people, nor can it be solely quality control people. You have to bring in people with certain expertise: Include people that are from legal, media/communications, and the business group.
FST: In preparing for a crisis, where does business continuity planning fit into the picture?
Baumfalk: Crisis management has two additional components—the business continuity plan and the food defense plan. They are not exactly the same, and they are not necessarily interchangeable. The business continuity plan is related to how you are going to continue your business if you have a situation that occurs. It can be a crisis that involves a buyer, an environmental hazard, or a physical hazard, for example.
Sometimes people will consider what is happening in the media right now. What happens if there’s an incidence at the local school and your employees have children there. What are you going to do and how will you respond? How will you continue to do business in a safe way?
When putting together a business continuity plan, you need to ask yourself, how are you going to cope with the business crisis and continue doing business.
Designate a senior manager who is in control of handling the organization and making the necessary decisions.
Identify a multidisciplinary crisis management team. Each person should have a specific responsibility (i.e., medical, regulatory services, contacting customers, suppliers and internal/external communications). Each team member should be prepared to respond to food safety issues.
Develop a contact list that includes legal and various experts in the industry.
Train employees.
Devise a worst-case scenario and practice, practice, practice. The plan should be tested rigorously and on an annual basis.
When we talk about a mock recall, one of the biggest deficiencies is that people don’t rigorously test it. The number one priority should be to have the plans in place and test them, and identify the weaknesses that you can correct. One of the biggest problems that may eventually cause a recall is complacency. The employees think they got it all covered. It’s important to note that an ounce of prevention is worth a pound of cure.
In Part II of this series, Baumfalk will make the connection between crisis management planning and food defense.
With cannabis-infused edibles gaining a bigger market share in 2014 (See the marijuana edibles regulatory update here), it comes as no surprise that cannabis-infused beverages are growing in popularity. Some of these beverage manufacturers operate in a very interesting legal environment because of the differentiation between compounds found in hemp and marijuana, two different varieties of cannabis.
“Under federal legislation, there is an exemption for hemp and as long as we process our CBD (Cannabidiol) molecules from the hemp plant, we are allowed to sell our products federally,” says Chris Bunka, CEO of Lexaria, a company that makes a hemp-infused tea.
Lexaria’s ViPova black tea infused with CBD oil made from industrial hemp
A number of scientific research studies have suggested that the compound CBD has medical properties that can help mitigate symptoms like inflammation, anxiety, chronic pain, and much more.
Because of the federal exemption for hemp, Lexaria can enjoy interstate commerce and other freedoms that manufacturers using marijuana flowers do not, such as access to banking services. Dried marijuana flowers contain the psychoactive compound, Tetrahydrocannabinol (THC). This compound is responsible for the regulatory and legal schism between the states that have legalized marijuana and the federal government, which still considers it to be a Schedule I narcotic.
Much unlike a number of marijuana edibles manufacturers operating in states where marijuana is currently legal, hemp-infused beverage manufacturers operate in full FDA compliance.
Michael Christopher, founder of Loft Tea, is working with a laboratory and bottler that are both 100% FDA compliant. “We definitely operate up to and abide by all FDA best practices with our laboratory and as far as producing and handling material we use best manufacturing practices and processes,” says Christopher.
“We have to partner with a bottler and laboratory who have the reputation to build trust with our brand as an industry leader in safety and quality,” says Christopher. “Until the FDA gives us complete guidelines on cannabis-infused products, we will continue to operate above and beyond best manufacturing practices with our infusions.”
Because these manufacturers view their hemp tea as a health and wellness product, it is only a matter of time before we see these types of products lining the shelves of health-food stores nationally. However, before this happens, an FDA regulatory framework specific to hemp-infused products is needed to address this growing industry.
“The hemp infusion industry has a lot of opportunity when presented in the right framework,” Christopher says. “There is still education needed in the marketplace to get it to the point where it will be on the shelves in stores like Whole Foods.”
Until that time comes, expect to see a steady growth of interest and inquiry from consumers, manufacturers, and regulators alike in the cannabis industry, whether federally legal or not.
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