In a two-question format, the authors discuss pressing issues in food fraud.
1. Where are the current hot spots for food fraud?
Food fraud activities have been known for centuries. For example, in ancient Rome and Athens, there were rules regarding the adulteration of wines with flavors and colors. In mid-13th century England, there were guidelines prescribing a certain size and weight for each type of bread, as well as required ingredients and how much it should cost. In the United States, back in 1906, Congress passed both the Meat Inspection Act and the original Food and Drugs Act, prohibiting the manufacture and interstate shipment of adulterated and misbranded foods and drugs. However, evidence and records of actions taken over those events were not officially collected.
It was not until 1985, when the presence of diethylene glycol (DEG) was identified in white wines from Austria, that authorities, retailers and consumers started to have serious concerns about the adulteration of food and the severity of its impact on consumers. In addition, there was increased interest to regulate, investigate and apply efforts to enforce requirements.
Other examples include the following:
2005: Chili powder adulterated with Sudan (India)
2008: Dairy products adulterated with melamine (China)
2013: Beef substituted with horsemeat (UK)
2013: Manuka honey where it was known that bees were not feeding from pollen of the Manuka bush (New Zealand)
2016: Dried oregano adulterated with other dried plants (Australia)
This list can go on and on.
Lately there have been more cases of food fraud. Fortunately, even limited international databases are helping to identify the raw material origins of products in the supply chain that could be more exposed to adulteration. Also, food manufacturers, brokers and agents are conducting assessments to ensure that they are buying ingredients and products from sources, where food fraud could be prevented. The following products are identified as having more adulteration notifications:
Vegetable products with claims of “Organic”
Honey and maple syrup
Coffee and tea
2. What can companies do to mitigate the risk?
Control measures to prevent food fraud activities include the adequate evaluation and selection of suppliers, as well as the ‘suppliers of the suppliers’. Typical risk matrices of likelihood of occurrence versus consequence can be used to measure risk—and determine priorities for assessing and putting control measures in place. Assessments can be focused on points of vulnerabilities such as food substitution, mislabeling, adulterations and/or counterfeiting, usually due to economic advantages for one or more tiers in food chain production.
Other food fraud activities include effective traceability systems, monitoring current worldwide news and notifications on food fraud using international databases (EU-RASFF, USA- EMA NCFPD and USP, etc.), and product testing.
Product testing is becoming an important tool for the food industry to become confident in sourcing raw materials, ensuring the management of food fraud control measures, fulfilling applicable legal requirements, and ensuring the safety of consumers.
Product testing laboratories offer different kinds of testing methods depending on the required output; for example, if it is possible and requested, a targeted or non-targeted result.
Targeted analysis involves screening for pre-defined components in a sample:
Mass spectrometry (LC-MS and GC-MS)
Nuclear magnetic resonance spectroscopy (NMR).
Non-targeted analysis aims to see any chemical present in the sample:
Isotopic measurement-determination of whether ethanol and vinegar and flavorings are natural or synthetic
Metabolomics: Maturation and shelf life
Proteomics: Testing for pork and beef additives in chicken, confectionery and desserts
Due to the importance of food fraud for a food safety management system, GFSI published Version 7.1 of Benchmarking Requirements, including subjects on food fraud, as vulnerability assessment. In 2018 all certification schemes have incorporated such requirements and started enforcing them.
Fraud cases threat consumer trust in products and services. Companies are learning to “think like a criminal” and put in place measures to prevent fraud and protect their products, their brands and their consumers.
FlexXray will be exhibiting at the 2016 Food Safety Consortium in Schaumburg, IL. At the booth representing FlexXray will be CEO Kevin Fritzmeyer and Project Manager John Hower. They will be discussing their food inspection process and capabilities of foreign material detection.
FlexXray is the leader in Inspection & Recovery Services dedicated to serving food companies. The company X-rays food products for various types of foreign material and contaminants, which it can see down to 0.8 mm or even smaller. Metal, plastic, gasket material, glass, stones and bone are a few of the items our customers ask us to inspect for.
FlexXray provides quick turn IN/OUT service, your truckload of product is inspected, contaminants removed and returned in only 8-12 hours. The company has introduced a new audit program for our customers to conform to the new HACCP and FSMA regulations. It is meant to help catch and prevent problems before recalls occur.
Our goal is to work with food companies to inspect their finished product for foreign material versus their other option, throwing it away. We strive to provide your company a cost-effective option in the event that you have an incident.
Food laboratories in the United States may voluntarily choose to become accredited to an international standard known as ISO/IEC 17025:2005. This standard outlines the general requirements for the competence of testing laboratories.
More recently, the FDA issued a final rule on the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third-Party rule). Effective January 26, 2016, this final rule states that “for a regulatory audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance in the validity and reliability of sampling methodologies, analytical methodologies, and analytical results.” In short, for a segment of food laboratories, accreditation has become a necessary credential. At present, it remains a voluntary activity for most food laboratories.
There are accreditation bodies that accredit food laboratories to the ISO/IEC 17025 standard. The major accreditation bodies report on their individual websites which U.S. food laboratories are accredited under their watch.
To find the number of accredited laboratories, a quick search of the websites of four major food laboratory accreditation bodies, A2LA (American Association for Laboratory Accreditation), AIHA-LAP (American Industrial Hygiene Association – Laboratory Accreditation Programs, LLC), ANAB (American National Standards Institute-American Society for Quality), and PJLA (Perry Johnson Laboratory Accreditation) was performed on February 24, 2016. It yielded some debatable results. Here are some of the reasons for the skepticism:
The numbers are self-posted to individual websites. The frequency with which these websites are reviewed or updated is unknown.
Sites list both domestic and international laboratories. While foreign addresses were excluded from the count, those laboratories could perform testing for U.S. entities.
It can be difficult to separate the names of laboratories performing testing on human food versus animal feed.
There are several ways to duplicate or even exclude numbers. As examples, laboratories may be accredited within a food testing program, but may also be accredited under “biological” and/or “chemical” schemes—or vice versa.
In some cases, it is difficult to discern from the listings which laboratories are accredited for food testing versus environmental or pharmaceutical testing.
With all these caveats, the four major laboratory accreditation bodies accredit approximately 300 food laboratories. A2LA captures the lion’s share of this overall number with approximately 200 laboratories.
But, when it comes to testing our food, experts estimate that less than five percent of the food testing laboratories in the U.S. are accredited according to international standards…
Some believe that FDA will begin requiring accreditation for at least some significant segment of the food testing industry, of which the U.S. has roughly 25,000 laboratories. Whether that’s restricted to third-party labs – numbering roughly 5,000 – or will also include all food manufacturers’ internal labs is yet to be seen.
Using the writer’s sources, simple arithmetic finds 25,000 laboratories multiplied by the estimated 5% accreditation equals roughly 1,250 accredited laboratories in the United States. This, of course, falls far short of the 300 accredited laboratories noted by the major accreditation bodies. This is not to question either the writer’s sources or the websites of the accreditation bodies, but it does highlight an inconsistency in how we account for the laboratories testing our food.
To go a step further, Auburn Health Strategies produced in 2015, a survey of food laboratory directors, technical supervisors and quality assurance managers on the state of food testing. The survey, commissioned by Microbiologics, asked a series of questions, including: “Are the laboratories you use accredited?” The respondents replied that, for their on-site laboratories, 42% were accredited and 58% were not. For their outside, contract laboratories, 90% of respondents stated that these laboratories were accredited and five percent did not know.
A second question asked: “Some laboratories are accredited to an internationally-recognized standard known as ISO 17025. Is this important to you?” Approximately 77% of respondents answered affirmatively. Equally telling, 15% said they did not know or were unsure.
What we do know is that there is not a definitive accounting of food laboratories—accredited or not. This lack of accounting can present very real problems. For example, we do not have a centralized way of determining if a particular laboratory has deficiencies in testing practices or if its accreditation has been revoked. Without knowing where and by whom testing is conducted, we are at a disadvantage in developing nationwide systems for tracking foodborne disease outbreaks and notifying laboratory professionals of emerging pathogens. We most certainly do not know if all food laboratories are following recognized testing methods and standards that affect the food we all consume.
What We Need Now
FSMA includes a provision calling for the establishment of a public registry of accreditation bodies recognized by the Secretary of Health and Human Services. The registry would also contain the laboratories accredited by such recognized organizations. The name and contact information for these laboratories and accreditation bodies would be incorporated into the registry. Rules for the registry have not yet been promulgated by the FDA, but should be. This is a small step toward greater accountability.
By Steven Guterman, Sarah McMullin, Steve Phelan No Comments
The combination of improved digital tracking along the food supply chain, as well as fast, accurate DNA testing will provide modern, state-of-the-art tools essential to guarantee accurate labeling for the ever-increasing quantities of foods and ingredients shipped globally.
The sheer scale of the international food supply chain creates opportunities for unscrupulous parties to substitute cheaper products with false labels. We know fraud is obviously a part of the problem. Some suppliers and distributors engage in economically motivated substitution. That is certain.
It’s equally true, however, that some seafood misidentification is inadvertent. In fact, some species identification challenges are inevitable, particularly at the end of the chain after processing. We believe most providers want to act in an ethical manner.
Virtually all seafood fraud involves the falsification or manipulation of documents created to guarantee that the label on the outside of the box matches the seafood on the inside. Unfortunately, the documents are too often vague, misleading or deliberately fraudulent.
Oceana, an international non-profit focused solely on protecting oceans and ocean resources, has published extensively on seafood fraud and continues to educate the public and government through science-based campaigns.
Seafood fraud is not just an economic issue. If the product source is unknown, it is possible to introduce harmful contamination into the food supply. By deploying two actions simultaneously, we can help address this problem and reduce mistakes and mishandling:
Improved digital tracking technologies deployed along the supply chain
Faster, DNA-based in-house testing to generate results in hours
Strategic collaborations can help industry respond to broad challenges such as seafood fraud. We partner with the University of Guelph to develop DNA-based tests for quick and accurate species identification. The accuracy and portability produced by this partnership allow companies to deploy tests conveniently at many points in the supply chain and get accurate species identification results in hours.
Our new collaboration with SAP, the largest global enterprise digital partner in the world, will help ensure that test results can be integrated with a company’s supply chain data for instant visibility and action throughout the enterprise. In fact, SAP provides enterprise-level software to customers who distribute 78% of the world’s food and accordingly its supply chain validation features have earned global acceptance.
The food fraud and safety digital tracking innovations being developed by SAP will be critical in attacking fraud. Linking paper documents with definitive test results at all points in the supply chain is no longer a realistic solution. Paper trails in use today do not go far enough. Product volume has rendered paper unworkable. Frustrated retailers voice concerns that their customers believe they are doing more testing and validation than they can actually undertake.
We must generate more reliable data and make it available everywhere in seconds in order to protect and strengthen the global seafood supply chain.
Catfish will become the first seafood species to be covered by United States regulations as a result of recent Congressional legislation. This change will immediately challenge the capability of supply chain accuracy. Catfish are but one species among thousands.
Increasingly, researchers and academics in the food industry recognize fast and reliable in-house and on-site testing as the most effective method to resolve the challenges of seafood authentication.
DNA-based analyses have proven repeatedly to be the most effective process to ensure accurate species identification across all food products. Unfortunately, verifying a species using DNA sequencing techniques typically takes one to two weeks to go from sample to result. With many products, and especially with seafood, speed on the production line is essential. In many cases, waiting two weeks for results is just not an acceptable solution.
Furthermore, “dipstick” or lateral-flow tests may work on unprocessed food at the species level, however, DNA testing provides the only accurate test method to differentiate species and sub-species in both raw and processed foods.
Polymerase chain reaction (PCR), which analyzes the sample DNA, can provide accurate results in two to three hours, which in turn enhances the confidence of producers, wholesalers and retailers in the products they sell and minimizes their risk of recalls and brand damage.
New technology eliminates multi-day delays for test results that slow down the process unnecessarily. Traditional testing options require sending samples to commercial laboratories that usually require weeks to return results. These delays can be expensive and cumbersome. Worse, they may prevent fast, accurate testing to monitor problems before they reach a retail environment, where brand and reputational risk are higher.
Rapid DNA-based testing conducted in-house and supported by sophisticated digital tracking technologies will improve seafood identification with the seafood supply chain. This technological combination will improve our global food chain and allow us to do business with safety and confidence in the accuracy and reliability of seafood shipments.
The recent Foods Lab Conference (co-located with Pittcon) was an intersection of compliance, technology and best possible practices. One of the goals of this international symposium was to have laboratories and the food industry recognize one another as part of an effort for a more intentional and collaborative system in the industry, especially in terms of policies and practices.
As a Food Science student from Tallahassee, Florida I ended up at this incredible conference after seeing a blurb for it on LinkedIn and was able to attend as an intern. The two main objectives of my role were to assist with various tasks to help ensure the event transitioned smoothly, as well as further my knowledge base of the enormous realm of food safety. The following are some themes that I heard throughout the two days.
Having the analysis and validation performed or overseen with preventative types of controls from a qualified individual should ideally occur before the food safety plan is implemented. This appears to be desired by the consensus and was a common thread during the conference. If there is a change in a process control, it can have a serious impact on the legitimacy of the documentation if the change is not taken into account. The ISO implementations are food safety management systems and hazard analysis identification, which is the international benchmark for compliance standards.
Analytical scientific instrumentation is absolutely necessary for guaranteeing data and reproducibility on a consistent basis. The scope and complexity of modern technology should be considered when used for repeated trials in which the narrowest margins of results are being demanded by consumers and industry. Microbiologists confirm their peace of mind is reliant on the ability for reproducible experimental trials. In a laboratory, the presence of variables and species must be handled in an extremely controlled manner. All too frequently undesirable organisms appear in foods, and this is often the result of poor food handling practices, fraudulent practices or summed up, lazy shortcuts for the most unthinkable reasons. An effort to decrease these microbes is being made through transparency in supply chains to trace the journey of the food from seed to the table.
Food production is being shaped as a result of FSMA, which is a milestone in food safety. A few features of this legislation are to offer assistance for the food technology sector and address questions about policy and safe handling practices. It has and will continue to influence the process of laboratory accreditation, validation and compliance in order to provide thorough transparency for the development of more modern food systems. There were many fascinating perspectives shared about validation and accreditation for both laboratories and facilities. Many large companies have their laboratories in-house, because it is easier from a production perspective if the product is going to market, to test it repeatedly in order to have less delay in the market launch. There have been times in which carcinogenic fillers or fake foods were portrayed. Examples would be the horse meat and melamine scandals. An additional perspective would be the possibility in protecting the own interests of the company by not disclosing true ingredients, practices, or actual comprehensive food safety evaluation. All are truly unacceptable with regards to mega food base distribution companies. Small- to medium-sized businesses typically source laboratory evaluations to third-party assessors to perform product validation because it’s simply too expensive to implement on their own because of labor, technology and space constraints. Claims of 100% pure olive oil are not true the majority of the time. A sunflower oil and chlorophyll solution can be made to mimic the coloration of pure extra virgin olive oil. So it is commonplace for this sort of solution to be created and combined with pure olive oil at a ratio of 2:1, as a conservative figure. True wording and claims are becoming a thing of the past, because it is way too simple for big food business to engage in such unthinkable practices to maximize their own profits.
A key thread running throughout the conference was the importance of necessitating the collaborative efforts needed to achieve a comprehensive dialogue set in place as a universal type of database. This database would serve as the foundation to ensure safe food practices throughout worldwide food production companies, accredited laboratories, governments, and consumers.
The Food Labs Conference was truly one of fantastic speakers, interesting participants, and fascinating conversation. The advanced topics were explored by professionals who share a deep passion for this vital industry sector. Food Laboratories and the conference, respectively, will become even more revolutionary in terms of future technology, the influence garnered by key publics, and future experts.
Millions of aluminum and tin-plated steel cans enter the marketplace every day, yet despite the extensive efforts of manufacturing plant quality control systems, a small percentage of the cans may have defects that can result in loss of the can integrity and subsequent contamination of the food products. Quality control operations within manufacturing plants typically have limited analytical chemistry capabilities and must rely on the manufacturer’s laboratory or independent laboratories to help identify and characterize the defects and troubleshoot the operations to eliminate the root cause of the defects. This article will present some of the current technology utilized for evaluating metal can defects.
Metal cans made from aluminum for beer and beverage products have been in use for about 50 years, whereas tin-plated steel cans for food products, have been in use for more than 100 years. Throughout that time, many improvements have been made to the design of the cans, the materials used for the cans (metal and internal/external protective organic coatings), the manufacturing equipment, chemical process monitoring, and quality control methods/instrumentation. The can manufacturing plants and their material suppliers are responsible for product integrity prior to distribution of the cans to food and beverage manufacturing operations throughout the world. Incoming quality control and internal quality control are also quite extensive at those manufacturing locations. Many of the can defects that would result in potential consumer issues are quickly eliminated from the consumer pipeline as a result of the rigorous quality control procedures. Occasionally, defective cans find their way into the marketplace, resulting in consumer complaints that must be addressed by the manufacturers.
The cause of the defects must be determined quickly, even if it means shutting down production lines while waiting for answers and corrective actions. Anything that results in a major product recall will have a high priority for the manufacturers to determine the root cause and take corrective actions. Major manufacturers have extensive analytical laboratories with a vast array of instrumentation and technical expertise for troubleshooting the defects. Smaller manufacturers usually have to rely on a network of independent laboratories to assist with their troubleshooting analyses.
Instrumentation and Methodology
Most major can manufacturing plants produce several hundred thousand to several million cans per day, and any can defects detected during quality control inspections will obviously have major implications. Most aluminum and tin-plated steel cans have an organic protective coating applied on the interior surface. One of the major quality control tests is to determine the amount of metal exposure inside the cans. This is done through the use of Enamel Rater instrumentation in which a sampling of cans are filled with an electrolyte. An electrode is immersed into the liquid and external contact is made with the can’s bottom or side wall. When a voltage is applied to the system, the current generated is directly proportional to the amount of exposed metal; a very small amount of exposed metal is acceptable. By reversing the polarity of the system, exposed metal regions produce gas bubbles as a result of the electrochemical reactions. This allows the inspector to identify the location of the exposed metal. When too much metal exposure is encountered, the troubleshooting process begins immediately.
Visual examination of additional cans from the production line is done, followed by examination with a low-power microscope, typically a stereo microscope, in order to characterize metal exposure defects. Typical defects are craters and/or fisheyes, which are seen as circular dewetting (also known as pullback) of the coating from a solid contaminant on the metal (see Figure 1) or an incompatible liquid, such as machine oil mist (fisheye). Additionally, broken blisters in the coating, known as solvent pops, can occur in the curing oven for the coating, resulting in exposed metal. The metal exposure produces two main problems for the filled food product: Metal migration into the product and corrosion of the metal, which eventually results in perforation and product leakage. Manufacturing plants typically do not have the necessary analytical instrumentation available to identify the contaminants and must send selected samples to the laboratory for the analysis.
Another critical test that is conducted in the can manufacturing plants looks for adhesion characteristics of the internal coatings and external coatings (inks and over varnish). A typical adhesion test involves cutting open the sidewalls and immersing the cans into hot water for a period of time. Upon removal from the water, the cans are dried and a tool is used to scribe the coatings. A tape is applied over the scribe marks and rapidly pulled off. If any coating comes up with the tape, the troubleshooting process must begin. Often, over-cure and under-cure conditions can result in coating adhesion failure. The failure can also be caused by a contaminant on the surface of the metal. Loss of internal coating adhesion can result in flakes of the coating contaminating the product and also metal exposure issues. Adhesion failure analysis is typically conducted in the analytical laboratories.
Analytical laboratories are well equipped with a vast array of instrumentation used to identify and characterize various can defects, including:
Optical microscopes, both stereomicroscopes and compound microscopes, are used with a variety of lighting conditions and filters to observe/photograph the defects and in some cases perform microchemical tests to help characterize contaminants. They are also used to examine metal fractures and polished cross sections of metals looking for defects in the metal that may have caused the fractures.
Scanning electron microscope (SEM) equipped with the accessory for energy dispersive X-ray spectrometry (EDS) are used, in conjunction with the optical microscopes, to observe/photograph the defects in the SEM and then obtain the elemental composition of the defect material with the EDS system. This method is typically used for characterizing inorganic materials. Imaging can be done at much higher magnifications compared to the optical microscopes, which is particularly useful for analysis of fractures.
Infrared spectroscopy, commonly referred to as Fourier Transform Infrared (FTIR) spectroscopy, is used mainly to identify organic materials, such as, oils, inks, varnishes, cleaning chemical surfactants that are commonly found in the can manufacturing operations. Solvent extractions from adhesion failure metal surfaces and the mating back side of the coating are often done to look for very thin films of organic contamination.
Differential scanning calorimetry (DSC) instrumentation is often used to determine the degree of cure for protective coatings on cans exhibiting adhesion failure issues.
Other more specialized instrumentation that is more likely available in independent analytical laboratories includes:
X-ray photoelectron spectroscopy (XPS), also known as electron spectroscopy for chemical analysis (ESCA), is used to analyze the outermost molecular layers of materials. The technique is particularly useful for detecting minute quantities of contaminants, typically thin films involved in adhesion failures. Depth profiles can also be done on the metal to determine thickness of oxidation or the presence/absence of surface enhancement chemical treatments. High-resolution binding energy measurements on various elements can provide some chemical compound information as part of the characterization.
Secondary ion mass spectrometry (SIMS) is also an outer molecular layer type of analysis method. Depth profiling also be accomplished with this instrumentation, but one of the major advantages is the ability to detect boron and lithium which are found in some greases and other materials in the manufacturing facility. To help identify organic films that may have resulted in the adhesion failures, it is often crucial to know if boron or lithium is present, which helps identify a potential source.
X-ray diffraction (XRD) instrumentation is used to identify crystalline compounds, mainly inorganic materials but can also be used for certain organic materials. Inorganic materials, isolated from coating craters, are often identified with a combination of SEM/EDS and XRD analyses.
Three case studies are presented to show how analytical lab instruments can be used to identify and characterize metal can defects.Metal can defects can take on numerous forms, some of which have been discussed in this article. Extensive quality control activities in can manufacturing plants often prevent defective cans from entering the marketplace. Characterizing the cause of the defects often requires major troubleshooting activities within the production plants, supplemented by the analytical laboratories with a vast array of instrumentation and personnel expertise. Due to the huge quantities of metal cans produced each day, it is inevitable that some defective cans will make it to the marketplace, resulting in consumer complaints. High priorities must be assigned to consumer complaints to not only identify and characterize the defects, but also to determine how widespread the defective cans are within the marketplace. In this way, decisions can be made regarding product recalls.
Today DuPont announced that the AOAC Research Institute (AOAC-RI) approved a method extension of Performance Tested Method #100201 to include the company’s BAX System X5 PCR Assay for Salmonella detection. Introduced this past July, the PCR assay provides next-day results for most sample types following a standard enrichment protocol and approximately 3.5 hours of automated processing. The lightweight system is smaller and designed to provide more flexibility in testing.
“Many customers rely on AOAC-RI and other third-party certifications as evidence that a pathogen detection method meets a well-defined set of accuracy and sensitivity requirements,” says Morgan Wallace, DuPont Nutrition & Health senior microbiologist and validations leader for diagnostics, in a company release. “Adopting a test method that has received these certifications allows them to use the method right away, minimizing a laboratory’s requirements for expensive, time-consuming in-house validation procedures before they can begin product testing.”
The validation covers a range of food types, including meat, poultry, dairy, fruits, vegetables, bakery products, pet food and environmental samples.
As a result of the finalization of FSMA regulations on September 10, 2015, increasing requirements for procedures, documentation and testing will soon be impacting the food industry. The major effects on the food microbiology testing market will come in the form of an increase in the volume of samples that must be processed in accordance with the new FSMA rules, along with an improved emphasis on accurate and complete record keeping. The goals of FSMA are to create a new safety standard across the entire food chain. Increasing food pathogen testing will minimize possible recalls and the probability that dangerous food outbreaks occur.
Food manufacturers’ testing labs and third-party accredited testing labs can meet the demand for increased testing and improved record keeping in one of two ways: Via facility expansion or via implementing new technologies into the laboratory. While facility expansion might be an ideal long-term solution, it will not address the immediate surge in lab demand brought on by the new FSMA requirements, as it takes time to build new laboratories and hire employees. Implementing new technologies in the lab, then, makes the most sense, and where automation can be introduced into traditionally-manual processes, higher throughput may be realized using existing personnel and facilities. Automation further removes human error and improves the quality of the test being performed. The challenge for lab managers will be to objectively look at the current production bottlenecks in their testing operations and determine where technology may be introduced to increase throughput.
In addition to mandating additional testing, the FSMA regulations will require improved lab record keeping, as well as a new accreditation process that FDA will implement. The food testing industry faces the same dilemma that the healthcare industry faced some years ago in migrating from manual files to electronic health records. Lab notebooks have a real purpose in the lab, but their purpose should be more as a backup system to information that is gathered and stored electronically. While Laboratory Information Management Systems (LIMS) have been around for many years, their full potential in pathogen testing has yet to be realized. A properly designed LIMS provides an electronic database that not only aids in the accreditation process, but also allows samples to be traced throughout the testing facility. This allows positive test results to be screened from false positives or false negatives, and points to which equipment or procedures in the testing process need to be improved upon. LIMS technology for recording digital information can also trace user, operation time and performance specifications more accurately than lab notebook-based processes.
In summary, many changes are coming to the food industry as a result of increased regulations, presenting exciting opportunities to develop new products and technologies to alleviate the pain points within testing labs. The industry of food pathogen testing must change alongside the regulatory atmosphere in order to be competitive in a post-FSMA era.
In order to ensure that a food testing laboratory maintains a quality management system that effectively manages all aspects of laboratory operations that affect quality, there are numerous records, reports and data that must be recorded, documented and managed.
Gathering, organizing and controlling all the data that is generated, managed and stored by food testing laboratories can be challenging to say the least. As the ISO Standards and regulatory requirements for food testing laboratories evolve, so does the need for improved quality data management systems. Historical systems that were very efficient and effective 10 years ago, may no longer meet the demanding requirements for ISO 17025 certification. One way to meet the challenge is to turn to automated solutions that eliminate many of the mundane tasks that utilize valuable resources.
There are many reasons for laboratories to seek this certification, including to enhance reputation, gain a competitive advantage, reduce operational costs, and meet regulatory compliance goals. A major advantage for food testing laboratories to obtain ISO 17025 Certification is that is tells prospective clients that the laboratory has a strong commitment to quality, and they hold the certification to prove it. This certification not only boosts a laboratory’s reputation, but it also demonstrates an organization’s commitment to quality, operational efficiency and management practices. Proof of ISO 17025 Certification eliminates the need for independent supplier audits, because the quality, capability and expertise of the laboratory have been verified by external auditors. Many ISO Certified laboratories will only buy products (raw materials, supplies and software) and services from other ISO-certified firms so that they do not need to do additional work in qualifying the vendor or the products.
There are many areas in which a LIMS supports and promotes ISO 17025 compliance. Laboratories are required to manage and maintain SOPs (standard operating procedures) that accurately reflect all phases of current laboratory activities such as assessing data integrity, taking corrective actions, handling customer complaints, managing all test methods, and managing all documents pertaining to quality. In addition, all contact with clients and their testing instructions should be recorded and kept with the job/project documentation for access by the staff performing the tests/calibrations. With a computerized LIMS, laboratory staff can scan in all paper forms that arrive with the samples (special instructions, chain of custody (CoC), or any other documentation). This can be linked to the work order and is easy assessable by anyone who has the appropriate permissions. The LIMS provides extensive options for tracking and maintaining all correspondence, the ability to attach electronic files, scanned documents, create locked PDFs of final reports, COAs (Certificate of Analysis), and CoCs.
Sample Handling and Acceptance
Laboratories are required to have a procedure that defines all processes that a sample is subjected to while in the possession of the laboratory. Some of these procedures will relate to sample preservation, holding time requirements, and the type of container in which the sample is collected or stored. Other information that must be tracked includes sample identification and receipt procedures, along with acceptance or rejection criteria at log-in. Sample log-in begins and defines the entire analysis and disposal process, therefore it is important that all sample storage, tracking and shipping receipts as well as sample transmittal forms (CoC) are stored, managed and maintained throughout the sample’s analysis to final disposal. To summarize, the laboratory should have written procedures around the following related to sample preservation:
Sample acceptance conditions
Holding timesShipping informationStorage
Results and Reporting
The LIMS must allow capture and tracking of data throughout the sample’s active lifetime. In addition, laboratories are also required to document, manage and maintain essential information associated with the analytical analysis, such as incubator and refrigerator temperature charts, and instrument run files/logs. Also important is capturing data from any log books, which would include the unique sample identifier, and the date and time of the analysis, along with if the holding time is 72 hours or less or when time critical steps are included in the analysis, such as sample preparations, extractions, or incubations. Capturing the temperature data can be automated such that the data can be directly imported into the LIMS. If there is an issue with the temperature falling outside of a range, an email can automatically be spawned or a message sent to a cell phone to alert the responsible party. Automation saves time and money, and can prevent many potential problems via the LIMS ability to import and act on real-time data.
If any instrumentation is used in the analysis, the following information must also be recorded in the instrument identification (to ensure that it is in calibration, and all maintenance and calibration records are current), operating conditions/parameters, analysis type, any calculations, and analyst identification. In addition to analyst identification, laboratories must also keep track of analyst training as it relates to their laboratory functions. For example, if an analyst has not been trained on a particular method or if their certification has expired, the LIMS will not allow them to enter any result into the LIMS for the method(s) that they have not been trained/certified to perform. The LIMS can also send automated alerts when the training is about to expire. Figure 1 shows a screen in the LIMS that manages training completed, scheduled, tests scores, and expiration dates of the training, along with the ability to attach any training certificates, exams, or any other relevant documentation. Laboratory managers can also leverage the LIMS to pull reports that compare analyst work quality via an audit report. If they determine that one analyst has a significant amount of samples that require auditing, they can then investigate if there is a possible training issue. Having immediate access to data allows managers to more rapidly identify and mitigate potential problems.
Another major area that a LIMS can provide significant benefit is around data integrity. There are four main elements of data integrity:
Documentation in the quality management system that defines the data integrity procedure, which is approved (signed/dated) by senior management.
Data integrity training for the entire laboratory. Ensures that the database is secure and locked and operates under referential integrity.
Detailed, regular monitoring of data integrity. Includes reviewing the audit trail reports and analyzing logs for any suspicious behavior on the system.
Signed data integrity documentation for all laboratory employees indicating that they have read and understand the processes and procedures that have been defined.
The LIMS will enhance the ability to track and manage data integrity training (along with all training). The LIMS will provide a definition of the training, the date, time, and topic (description); instructor(s); timeframe in which the training is relevant, reminders on when it needs to be repeated; along with certifications, quiz scores, copies of quizzes, and more. With many tasks, the LIMS can provide managers with automated reports that are sent out at regular time intervals, schedule training for specific staff, provide them with automatic notification, schedule data integrity audits, and to facilitate FDA’s CFR 21 part 11 compliance (electronic signatures). The LIMS can also be configured to automatically have reports signed and delivered via fax or email, or to a web server. The LIMS manages permissions and privileges to all staff members that require access to specific data and have the ability to access that data, along with providing a secure document control mechanism.
Laboratories are also required to maintain SOPs that accurately reflect all phases of current laboratory operations such as assessing data integrity test methods, corrective actions and handling customer complaints. Most commercial LIMS provide the ability to link SOPs to the analytical methods such that analysts can pull down the SOP as they are doing the procedure to help ensure that no steps are omitted. Having the SOPs online ensures that everyone is using the same version of the locked SOPs, which are readily available and secure.
Administrative Records, Demonstration of Capability
Laboratories are required to manage and maintain the following information on an analyst working in the laboratory: Personal qualifications and experience and training records (degree certificates, CV’s), along with records of demonstration of capability for each analyst and a list of names (along with initials and signatures) for all staff that hold the responsibility to sign or initial any laboratory record. Most commercial LIMS will easily and securely track and manage all the required personnel records. Individuals responsible for signing off on laboratory records can be configured in the LIMS to not only document the assignment of responsibility but also to enforce it.
Reference Standards and Materials
Because the references and standards that laboratories use in their analytical measurements affect the correctness of the result, laboratories must have a system and procedures to manage and track the calibration of their reference standards. Documentation that calibration standards were calibrated by a body that can prove traceability must be provided. Although most standards are purchased from companies that specialize in the creation of reference standards, there are some standards that laboratories create internally that can also be traced and tracked in the LIMS. Most commercial LIMS will also allow for the creation, receipt, tracking, and management of all supplies in an inventory module, such that they document the reference material identification, lot numbers, expiration date, supplier, and vendor, and link the standard to all tests to which it was linked.
The ISO 17025 Standard identifies the high technical competence and management system requirements that guarantee your test results and calibrations are consistently accurate. The LIMS securely manages and maintains all the data that supports the Quality Management System.
Key advantages of food testing laboratories that have achieved ISO 17025 Certification with a computerized LIMS that securely and accurately stores all the pertinent data and information:
Proof of ISO 17025 Certification eliminates the need for supplier audits, because the quality, capability and expertise of the laboratory have been demonstrated by the certification.
Knowledge that there has been an evaluation of the staff, methods, instrumentation and equipment, calibration records and reporting to ensure test results are valid.
Verification of operational efficiency by external auditors that have validated the quality, capability and expertise of the laboratory.
Defines robust quality controls for the selection and authentication of methods, analyzing statistics, controlling and securing data.
Clearly defines each employee’s roles, responsibilities and accountability.
Confidence that the regulatory and safety requirements are effectively managed and met in a cost efficient-manner.
Many food safety and quality assurance (FSQA) professionals are constantly on the go in the workplace. They can be found on the floor of a manufacturing facility, off-site conducting supplier audits, or out in the field performing pre-harvest inspections, just to name a few locations during their busy day. “To benefit from food safety automation, these folks need more than the capability of logging into a system through a desktop,” says Levin. “They need a true mobile app that provides automation support out in the field,” says Barbara Levin, senior vice president of marketing and customer community at SafetyChain.
While other industries have been quick to adopt mobile platforms, the food safety industry has been much slower. Adoption is, however, gaining traction. In a recent conversation with Food Safety Tech, Levin talks about the value of FSQA mobile apps in today’s environment, where access to real-time, actionable data is crucial for the food industry.
Food Safety Tech: What common challenges faced by FSQA teams do mobile apps specifically address?
Barbara Levin: Mobile apps allow collection of FSQA at the point of origin, along with immediate access to the information for analysis, CAPA and reporting:
Getting timely feedback on non-compliances for CAPA. When FSQA data is inspected at the end of the shift on paper, finding non-conformances often means rework. The instances in which this happens are too numerous to count. With mobile apps, you receive timely feedback. Information in the system is immediately analyzed to specs, so you’re catching non-compliances at the earliest point possible.
Consistency in following your FSQA programs. This could be your USDA HACCP plan, FSMA HARPC plan, GFSI program, customer quality attributes and other components of your FSQA programs. Program components change all the time (i.e., Specifications, processes, rules in HACCP, GFSI code, forms, workflow, etc). Are FSQA managers confident that everyone is following the most up-to-date program? Is everyone following the workflow and doing everything in the right order? Are they completing tasks accurately? Using the right forms? Unfortunately companies find out that steps are missed or outdated forms were used during an audit; or when missed steps result in expensive rework or in the worst case, a customer rejection, withdrawal or a recall.
Mobile apps will always have the most up-to-date forms, processes, specs and more. They act as a coach, leading the FSQA team member through the proper steps. When you enter incorrect or incomplete information on paper, it may not be detected until the end of the day or shift. A mobile app will issue an alert if incorrect information is entered; and it won’t let you submit a form if all fields aren’t complete. Because all of the updates are made in the system and pushed out to the app, if the specification changes while an FSQA team member is on the plant floor, when he or she logs in, the latest spec will always be there. You’re ensured that only the up-to-date program is being followed and that only the most up-to-date forms are being used.
A lack of information for continuous improvement trending. If you have multiple facilities and products (resulting in mountains of FSQA paper), it’s a huge, manual task to make all of the data useful and relevant. With mobile apps, all FSQA data is entered “once and done,” making it accessible and actionable for immediate FSQA result tracking, daily KPI reporting and continuous improvement.
Audit readiness. Mobile apps take audit readiness to a different level. With FSMA and GFSI, the saying is, if it’s not documented, you didn’t do it. By collecting FSQA data at the point of origin, all data is time and data stamped and uploaded to your permanent FSQA record. There’s no redundant data entry, mistakes are avoided, and there’s greater record efficacy that helps companies be audit ready, on demand.
FST: What is the biggest benefit that FSQA mobile apps offer?
Levin: The first benefit is real-time feedback. If you think about how things were done in the past, using an example of a pre-harvest inspection, you’re out there with a clipboard, making observations and recording non-compliances. Then you have to go back and enter the information into a spreadsheet, or turn it into a PDF, and send it to the food safety manager, who may or may not be sitting at his or her desk. Waiting to get a response equals time lost. And in the food industry, time equals money.
When you’re entering information into a mobile app, it analyzes that information in real-time and according to specifications. When there are non-compliances, alerts are pushed to the FSQA manager – wherever [he or she is located]. The manager can then generate a CAPA, which can then be completed, documented on the mobile device and electronically signed off by the manager. The process is expedited, and expensive rework is avoided.
The second benefit involves data efficiencies. When data is collected on a mobile device, it’s entered only once and is then immediately available for multiple uses, such as a customer’s certificate of analysis, attachment to GFSI code for audit, or to be produced upon demand for a regulatory inspector. With a manual system, there’s a tremendous amount of redundant data entry. We hear this all the time from food safety folks— that they feel like they’re managing paper instead of food safety programs. When data is entered into a mobile app, it’s accessible immediately to FSQA, operations, vendor purchasing, management – any stakeholder who has a need.
“The Power of FSQA Automation Via Mobile Applications” Download the whitepaperFST: What approach should be taken to encourage the investment in and implementation of an on-the-go FSQA mobile platform?
Levin: I would love to think that in an ideal world, the creation of operational efficiencies that enable a higher level of confidence that you are sending out safer food is enough. Food companies are businesses, and they have obligations to consumers, which they take very seriously. But they also have obligations to their shareholders. When we talk to folks who really want this, it’s very easy to create a business case to senior management based on ROI. When you can close the gap by hours and days in the food industry, that time equals money. Avoiding rework also saves money. And there’s ROI in faster sales throughput and increased shelf life by reducing hold and release times. We’ve heard from our customers that the solutions have paid for themselves and started to create ROI within three to six months.
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