In what is being called a groundbreaking decision, a federal judge sentenced three executives from the Peanut Corporation of America (PCA) to a combined 53 years in jail for their role in the 2008-2009 Salmonella outbreak. Stewart Parnell, former CEO of the no-longer-operating PCA, has been sentenced to 28 years; his brother, Michael Parnell, was handed 20 years; and Mary Wilkerson, quality assurance manager of the plant, was given 5 years. Convicted last year on 71 counts, Stewart Parnell was facing up to 803 years in prison, but at the age of 61, 28 years is essentially a life sentence.
The culprit of the fatal 2008 Salmonella outbreak was tainted peanut butter paste manufactured by PCA. Nine Americans died, and more than 700 people across 47 states were sickened. The outbreak led to the recall of more than 2,100 products. It was one of the largest food recalls in U.S. history, and the case has garnered national attention.
During yesterday’s sentencing, victims and their families asked U.S. District Court Judge W. Louis Sands to deliver a life sentence to Stewart Parnell; his daughter, Grey Adams, addressed the room, “My dad’s heart is genuine…” and said that her father and their family are “profoundly sorry” for the deadly outbreak. As Parnell addressed the victims in the Georgia courtroom, he made mention of the problems at the plant but did not comment on the emails and company records that indicate he had knowingly shipped tainted product or tampered with any lab records.
Earlier this year STOP Foodborne Illness’ Darin Detwiler commented on the significance of the sentencing in a video interview with Food Safety Tech, stating, “His actions resulted in technically more deaths than that of Charles Manson.”
Moving forward, the bar for accountability at the executive level has been set much higher. Victims, their families, and food safety advocates are applauding the sentencing. What do you think about the decision and its impact on the industry?
After receiving input from federal, state, and local regulatory officials, along with industry and trade associations, academia, and consumers, FDA issued its Voluntary National Retail Food Regulatory Program Standards last week. The standards address “what constitutes a highly effective and responsive retail food regulatory program,” according to the document.
The Retail Program Standards include:
Promoting the adoption of science-based guidelines from the FDA Food Code
Promoting improvement of training programs to ensure local, state, tribal, and territorial staff have the necessary skills, knowledge and abilities
Implementing risk-based inspection programs
Developing outbreak and food defense surveillance plans to enable systematic detection and response to foodborne illness or food contamination
The 2015 edition contains new worksheets that are intended to assist regulatory programs in looking at how their programs line up with the 2013 Food Code. This includes helping them assess the consistency and effectiveness of their enforcement activities, and a verification tool to help independent auditors with these self-assessments. Although jurisdictions can use the worksheets and other materials without enrolling in the Retail Program Standards, FDA encourages them to do so, as enrollment allows them to apply for FDA funding. The agency also lists the jurisdictions enrolled in the program here.
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.
From sanitation and processing to testing and analysis to transportation and imports, government requirements of companies in the food industry are changing. Many companies are already prepared for the transformation that FSMA will bring. Within food testing and analysis, expectations will be higher than ever. Companies should be able to more accurately and rapidly identify contamination in order to take immediate action. What are some of the biggest concerns in testing and analysis? What changes can we expect? In a roundtable discussion with Sample6 executives, Michael Koeris, Ph.D., founder and vice president of operations, Tim Curran, CEO, and Jim Godsey, vice president of research & development, share their perspective on the hurdles that industry is facing and how innovative technology plays an important role in the future of food safety.
Key trends:
Focus in testing shifts from not just testing and recording data, but also analyzing and communicating results. Having data analysis and reporting skills will be a critical function for the next generation of food safety professionals.
Be proactive, not reactive. If you’re finding problems at the finished product level, it’s too late.
The need for stronger partnerships between industry and government, especially relating to providing industry with the tools to effectively gather and analyze data in a timely manner.
Food Safety Tech: What are the current industry challenges, especially related to advances in pathogen detection technology?
Tim Curran, CEO of Sample6
Tim Curran: When I look at food companies and food safety managers, [their jobs] have become harder to do well, instead of easier. The environment in which they’re working is more challenging, and the pressures are increasing. There’s more regulatory scrutiny, whether we talk about FSMA or the regulatory environment [in general], and there are more testing and inspection [expectations].
Second, the nature of the foods that we need make for the U.S. population (and I think it is a trend around the world): Ready-to-eat products. We’re producing products that are more convenient for families where they won’t necessarily have a cook step down the road. The kinds of foods in demand have a higher risk profile.
Third is the globalization of food supplies. Raw materials are coming in from all different directions, and there is an increasing number of shipping points. That creates more pressure, and from a food safety perspective, that is a bad thing.
“It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there.” -Michael KoerisFinally, there’s social media. There’s a lot of scrutiny from the public. Information around any kind of fear or recall is rapidly disseminated.
These factors add up to higher pressure, a higher bar, and a harder job to accomplish—and the tools and methods available to keep the plant safe and food safe are not keeping pace.
Although I think food plants want to test more at the point of contamination, it’s just not possible. Unless they have a sophisticated lab, most food companies ship out samples because enrichment is required. As a result, they’re getting feedback on the safety of their plant and food in two, three, or four days, depending on where they fall as a priority to that outside lab.
Jim Godsey: With FSMA, testing is decentralizing from the larger lab, which is typically staffed with experienced personnel, to the facility where those personnel don’t exist. Having a test with a workflow that can be easily accommodated by someone with a high school education is absolutely critical for the field.
Michael Koeris, Ph.D., founder and vice president of operations
Michael Koeris: Visibility of data is generally extremely poor, because many people touch individual data points or pockets of data. The hand-off between the different groups is usually shaky, and the timeliness of delivering data to the operators has been a huge issue. This has been an opportunity for us: Our control offering is an operating system for environmental control. It’s an open system, so it accepts both our data and other people’s data, enabling visibility across an entire corporate infrastructure. Plant managers and other [users] of these systems can generate timely reports so they can see what is happening on a daily basis.
FST: In considering professional development, what skills are necessary to ensure that employees will be well equipped to address the issues discussed here?
Godsey: The role of the food safety manager becomes a much more critical and challenging role. To support that, they need better tools; they need to know with a high degree of confidence that their facility has been tested, that the testing was done at the proper times and intervals, and that the data has been analyzed in a timely manner. It’s not just assay/analysis [or] reporting results anymore; it’s the holistic review of those results and translating that [information] into whether or not the plant is safe at that point in time.
Koeris: The persona of the food safety manager is changing. They need to see themselves as the brand protection manager. If you have food safety issues, your brand is at risk. We need to empower the food safety manager at the local level to act, remediate and change processes.
Jim Godsey, vice president of research & development
There also has to be fundamental change in the industry in how results are viewed. Not all tests are created equal. It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there. This is not a pharmaceutical production facility. Setting the wrong goals at the corporate level of zero positives disincentivizes operators to not look hard enough. You have to actually understand the plant and then make sure that you’re safe with regards to your control plan.
FST: How do you expect the final FSMA rules and implementation process will impact industry?
Koeris: Most of the larger food players are already doing what FSMA mandates or will mandate. The medium and smaller processors will have to adapt and change. They have to implement better standards and more standards, more surveillance, and implement more rigorous processes. The [key] is to help them do this on a tight budget.
FSMA has increased awareness of food safety across the supply chain. It is still focused on the processors, but we know it doesn’t stop there; it doesn’t stop at the distributor or the retailer. Food safety has to be throughout that supply chain.
Having an understanding and awareness of all of the challenges that exist downstream—that will [lead to] the real innovation and increase in foods safety.
Having the ability to detect and identify contamination and adulteration in product is a top priority for companies, especially when working with foreign suppliers. In a discussion with Food Safety Tech, Craig S. Schwandt, Ph.D., director of industrial services at McCrone Associates, discusses how companies, especially those with limited resources, can use technologies to improve contamination detection to be ahead of the FSMA implementation curve.
Food Safety Tech: From your perspective, what key elements of FSMA will have a big impact on manufacturers and processors?
Craig Schwandt: For U.S. manufacturers, more and more of their ingredients are coming from foreign countries. [Companies] are responsible for reporting to FDA what measures they have taken to assure food safety in all aspects. Participating in the Foreign Supplier Verification Program will be critical to [their awareness of] whether their foreign suppliers are meeting those obligations. That critical element hasn’t been realized yet.
FST: Is navigating the foreign supplier relationship more of a challenge for smaller businesses versus larger companies?
Schwandt: Global companies have the resources to address contamination concerns and can monitor the processing that takes place in foreign countries. It’s the small companies that don’t have the financial resources to be present in foreign countries. There will be many more issues for them to address—are they really receiving product that they’re paying for? Is the testing that is being conducted in foreign countries really meeting the requirements.
FST: What steps can small companies take to ensure they have testing programs in place to meet requirements?
Schwandt: This ties in with the difference between testing and investigational analysis. Testing involves identification methods that are done to ascertain what is present—it might be an elemental concentration basis or an organic molecule basis—but they’re bulk analysis that determines whether the product is meeting the expected composition.
Then there might be components for which there are actionable levels, if the concentration exceeds actionable levels. But with bulk analysis testing methods, they only understand that they have a component in their product that exceeds an action level, and those methods don’t really specify where that component might be introduced into the product. This is where microscopy-based investigational analysis can assist smaller companies with understanding at what point the contaminant might have been introduced into the product. It can be isolated in individual particles, establishing a forensic pathway for stage of the process in which the contaminant might have been introduced.
FST: Can you expand on the technologies and methods that can be used to detect fraud or adulterated product?
Schwandt: In the case of intentional adulteration and fraud, current technologies include ultrahigh pressure liquid chromatography, liquid chromatography, and mass spectrometry, and the food industry is doing a great job of using them.
In the case of intentional adulteration or fraud, the level of adulteration has to be fairly high, otherwise there isn’t an economic incentive to adulterate it. A great example is with pomegranate juice—if you’re going to intentionally adulterate pomegranate juice with grape juice to cut it down, a fairly large percentage of the final juice will be grape juice in order to make that intentional adulteration process economically motivating. It’s not really so difficult to identify it with [current] technologies.
Where the technologies need to be improved is in instances in which there might be more unintentional adulteration or contamination at trace levels:
When there are solid phase particulate contaminants, use of microscopy-based methods (which isn’t new technology) where you isolate the contaminant particles of interest; they occur at trace level. Because we isolate them from the matrix, we can analyze them and [detect] if there were metal particles from processing machinery; we can identify them to the alloy level and give clients a way to trace back to what part in the process stream those particles may have originated.
Likewise, Liquid chromatography and mass spectrometry, especially for pesticide residue analysis, will be increasingly more valuable using the QuEChERS program FDA has outlined for quick, safe, reliable and easy analysis of trace contaminants in food products.
FST: What factors are contributing to under-use of microscopy-based methods?
Schwandt: I think the expensive–instrument vendors would like you believe it is as simple as pushing a button to receive your complete quantitative answer. In many cases, the instruments, even though they might be designed with the best intentions, actually do require expert chemists to use them for complete success. There’s a push on the part of instrument manufacturers to provide instrumentation that they sell as providing the complete answer. And there’s a willingness in the food industry to believe it would be as simple as putting a less-skilled person in front of the instrument to run the analysis, push the button, and get the answer, as opposed to hiring an analyst with a lot of expertise.
FST: What industry partnerships/collaborations are essential in testing and analysis?
Schwandt: The partnerships are productive in this area when they’re between production and quality assurance branches of companies and third-party laboratories that can offer niche solutions and third-party verification.
The company is voluntarily recalling approximately 242,000 cases of select code dates and manufacturing codes of the Original flavor of Kraft Macaroni & Cheese Dinner – due to the possibility that some boxes may contain small pieces of metal.
Kraft Foods Group is voluntarily recalling approximately 242,000 cases of select code dates and manufacturing codes of the Original flavor of Kraft Macaroni & Cheese Dinner – due to the possibility that some boxes may contain small pieces of metal.
Approximately 6.5 million boxes of original flavor Kraft Macaroni & Cheese are involved in the recall.
The recalled product is limited to the 7.25-oz. size of the Original flavor of boxed dinner with the “Best When Used By” dates of September 18, 2015 through October 11, 2015, with the code “C2” directly below the date on each individual box. The “C2” refers to a specific production line on which the affected product was made.
Some of these products have also been packed in multi-pack units that have a range of different code dates and manufacturing codes on the external packaging (box or shrink-wrap), depending on the package configuration (see table).
Recalled product was shipped to customers in the U.S. and several other countries, excluding Canada. The affected dates of this product were sold in only these four configurations:
7.25 oz. box, Original flavor
3-pack box of those 7.25 oz. boxes Original flavor
4-pack shrink-wrap of those 7.25 oz. boxes, Original flavor
5-pack shrink-wrap of those 7.25 oz. boxes, Original flavor
No other sizes, varieties or pasta shapes and no other packaging configurations are included in this recall. And no products with manufacturing codes other than “C2” below the code date on the individual box are included in this recall.
Kraft has received eight consumer contacts about this product from the impacted line within this range of code dates and no injuries have been reported. The recalled product was shipped by Kraft to customers nationwide in the U.S. The product was also distributed to Puerto Rico and some Caribbean and South American countries — but not to Canada.
Consumers who purchased this product should not eat it. They should return it to the store where purchased for an exchange or full refund. Consumers also can contact Kraft Foods Consumer Relations at 1-800-816-9432 between 9 am and 6 pm (Eastern) for a full refund.
A new hand-washing device, the SaniTimer, helps ensure bacteria-free hands and clean food.
A new award-winning device attaches easily to any standard hand washing sink faucet to ensure your staff rinse, lather and wash their hands for the full 20 seconds recommended by the CDC and taught in food handlers and health code courses nationwide to avoid the spread of harmful bacteria.
The SaniTimer® automatically begins a 30-second countdown — the extra 10 seconds account for an individual’s preferred hand-wash prep — shown on an easy-to-read LED display as soon as the water is turned on. At the end of the cycle, the SaniTimer beeps to alert the hand washing user and resets itself to 30 seconds for the next member. The device works with pedal sinks as well as hands-free sinks for ease of installment and operation with your existing system.
The SaniTimer is a simple and straight forward, yet very effective tool in food service as statistics show that improper hand hygiene timing could account for up to 84 percent of food poisoning in food service establishments. The truth is as infectious as the negative results of poor hand hygiene and your employees, customers, and staff should know that this is a priority for you in your establishment.
Zachary Eddy, the inventor and patent holder is a professional chef of over 15 years and worked in countless commercial kitchens around the country and was constantly a witness to poor hand hygiene standards. “Food service staff have a lot on their plate but this is one step they can’t afford to overlook and is crucial to a quality product and experience. There has to be an effortless way to make sure health code regulations actually get adhered to each and every time to stop the spread of bacteria,” says Eddy.
The SaniTimer is the most effective and low-cost way to raise hand hygiene compliance and awareness in your facility today, period! When it comes to quality control, clean hands should be at the top of the list and the SaniTimer creates a great habit in a professional setting.
Whether mycotoxins or microbiological values, heavy metals or pesticides – independent sampling and testing provide an objective and comprehensive overview of what food products contain and help comply with food safety regulations.
Nuts containing mould, frozen strawberries contaminated with hepatitis pathogens, and pesticide-laden vegetables – more than 3,000 products were objected by EU authorities in 2013. With increasing government, industry and consumer concerns about the hazards of food contaminants, and the risks they pose, food manufacturers, governments and non-governmental agencies, are implementing policies and processes to monitor and reduce contaminants.
Key food contaminants
Food contaminants cover a wide range of potential substances including:
Dioxins: Produced as unintentional by-products of industrial processes such as waste incineration, chemical manufacturing and paper bleaching, dioxins can be found in the air, in water and contaminated soil.
Allergens: Virtually all of the known food allergens are proteins that can subsist in large quantities and often survive food processing.
Genetically modified organisms (GMOs): Banned in a number of countries, controversy still exists with regard to the use of GMOs. Selling food and/or feed that is non-GMO in restricted markets places the burden of proof on the supply chain.
Heavy metals: Whilst heavy metals, such as lead (Pb), cadmium (Cd), mercury (Hg) and arsenic (As), can be found in nature, industrial and environmental pollutants have resulted in their increased presence in food and feed.
Hormones: Commonly used in animal husbandry to promote growth, hormone residues can be found in the food supply.
Melamine: Harmful to animal and human health, melamine is not a permitted food additive.
Mycotoxins: Produced by several strains of fungi found on food and feed products, mycotoxins are often invisible, tasteless, and chemically stable both at high temperatures and during long periods of storage.
Pesticide residues: Over-use of pesticides can lead to dangerous levels of hazardous chemicals entering the food chain with fresh fruit and vegetables being most susceptible to pesticide residues.
Polychlorinated biphenyls (PCBs): Used in many products, some PCBs are toxic and stable enough to resist breaking down even when released into the environment.
Radiation contamination: There are three ways that foodstuffs can become contaminated by radiation: surface, ground and water contamination.
Veterinary drug residues: Used in the treatment of animals, veterinary drugs can leave residues in animals subsequently sent into the food chain. The impact of contaminants varies. Depending on their toxicity and the level of contamination their effects can range from causing skin allergies, to more serious illnesses (including cancers and neurological impairments) and, in the most extreme cases, death.
To ensure that your food and feed products are fit for consumption, you need to test for specific contaminants throughout the value chain. For example, in concentrated levels, melamine, antibiotics and hormones can be harmful to animals and humans. Only thorough contaminant testing will determine if the above-mentioned impurities, among others, are present. After identification the relevant goods can be eliminated from the production and distribution chain.
Maximum levels and regulations
In order to protect consumers, maximum levels permitted in food products have been set by food safety legislation in many countries. Disappointingly, and despite efforts in some product areas, maximum levels are rarely harmonized across national borders. This inconsistency places responsibility for compliance firmly with the food supply chain. A comprehensive testing program can verify that your products meet maximum levels and the safety standards they represent.
In the European Union (EU), it is the food business operator who carries primary responsibility for food safety and the General Food Law Regulation (EC) 178/20022 is the primary EC legislation on general food safety. More specific directives and regulations compliment this, for example, EU regulations concerning non-GMO/GMO products, include Directive 2001/18/EC and regulations 1829/2003 and 1830/2003.
The U.S. Food and Drugs Administration has overseen the development and signing into law of the Food Safety Modernization Act (FSMA). Within the U.S., state regulators retain the right to apply additional regulations and laws. As result, rules regarding maximum levels, for example, vary from state to state.
In China, the Food Safety Law (FSL) was passed into law by the Chinese government in 2009. It introduced enhanced provision for monitoring and supervision, improved safety standards, recalls for substandard products and dealing with compliance failures.
Brazil’s food safety agency, Anvisa, coordinates, supervises and controls activities to assure health surveillance over food, beverages, water, ingredients, packages, contamination limits, and veterinary residues for import. No specific restrictions have been established yet for export.
Monitoring
Monitoring programs are frequently used to identify any contamination issues. From seeds, through the growing process and harvest, transportation, collection, storing and processing to the market channel, independent monitoring delivers credible and independently collected data on both quality and contaminants.
With so many policies and standards, both nationally and internationally, anyone involved in the food industry needs to be sure of accurate and up-to date information on food contaminant regulations. Whether mycotoxins or microbiological values, heavy metals or pesticides – independent sampling and testing provide an objective and comprehensive overview of what grain and food products contain.
The management of Food Safety and Quality Assurance (FSQA) system is a key business function that plays a very important role in the sustenance of the food industry. Its primary objective is to produce and serve safe quality food to consumers, through compliance with all relevant Federal, State and Local regulatory laws. It assists in the reduction of food wastage or food spoilage, and thus has a strong impact on the bottom line. Proper management of the FSQA system protects business brands, ensuring that they don’t become part of the gloomy statistics on foodborne disease outbreaks and damaging recalls. In all cases, the protection of the entire public health remains sacrosanct, and in fact, closely aligns with the primary business objective of getting a reasonable return-on-investment. Inevitably, businesses rely on a timely and cost-effective project management to ensure that their FSQA system remains relevant and sustainable for a continuous business growth.
Potential sources of new FSQA projects
Projects intended for the improvement of an FSQA system may be identified and initiated based on input from the following sources:
Regulatory compliance with applicable Federal, State and Local laws;
Voice of customers through complaints obtained by customer calls;
Technology-driven continuous improvement to upgrade to a smarter method, process, equipment or service;
Voice of business franchise operators, owners, managers and team members aimed at improving operational efficiency; and
Operational challenges observed by corporate staff during field visits.
Examples of FSQA projects that require testing and evaluation
At every stage, there will be tons of very important projects requiring urgent attention and competing for limited resources with corporate advertising and brand campaigns which have fixed budgets. Some of these projects may be as simple as putting a new dish-washing scrub pad in the system. This project may have been initiated following several reports by team members that current green scrub pad is not effective and also releases greenish color with scrub pad debris reported in ready-to-eat (RTE) foods. The associated risk is that foreign material in food constitutes a health hazard while improper washing of dish wares may lead to cross-contamination and outbreak of foodborne illness. This is easy but still requires testing to confirm that the new scrub pad is the best cost-effective option. Other projects however may be as complex as introducing a new produce (fruits & vegetables) safety system that includes a pathogen kill-step, instead of the regular cold water rinse. This will provide an extra layer of produce safety at the retail level, in case the system fails at the processing plant facility level, for instance, in the case ofthe multistate Listeria outbreak involving Cantaloupes from Jensen Farms, Colorado in 2011.
Another new initiative could be working with suppliers to validate a new method for detecting bone fragments and physical contamination of boneless poultry meat. Revamping the automated dish-washing room to improve food code compliance is a multifaceted project that requires a lot of resources and planning for a successful testing and evaluation.
Testing and evaluation milestones
A systematic approach is required to properly test and evaluate new FSQA products or services before a chain-wide roll-out is authorized by management. Depending on whether we are looking to introduce a new product or service into the system, some of the testing and evaluation milestones may include a combination of:
R&D to determine and evaluate options to resolve issue;
Review of options for industry best practices by FSQA team;
Cross-functional team evaluation by stakeholders to determine impact on key business functions, including a robust business analysis to determine cost implications;
Vendor verification to certify compliant business status;
Execution of a Non-Disclosure Agreement (NDA) or Master Vendor Agreement (MVA) between corporate and vendor partner, to legally protect all parties;
Preliminary testing at the corporate Technical Center for proof of principle and to evaluate product safety and potential OSHA requirements at a controlled environment;
One store test to determine operational feasibility in an actual business environment;
Three to 10-store testing to evaluate operational dynamics in a larger number of stores;
Thirty to 60 store-market testing in different markets to carefully monitor usage and operational outcome and ensure compliance and expectations, and extrapolate results to mimic a national chain wide roll-out;
Performance survey of test stores, data collation, analysis and review of results, followed by management approval;
Chain-wide roll-out by a cross functional team representing all impacted areas of the business; and
Post-chain-wide roll-out follow-up to monitor usage and resolve any lingering issue, namely:
Adequate SOP training to reinforce proper use;
Vigorous marketing campaign to increase chain-wide usage and compliance;
Effective ordering and delivery logistics; and
Potential short term and long term quality issues.
Developing an FSQA project matrix template
Certainly, the need to initiate new FSQA projects will increase as the various parts of the new Food Safety Modernization Act (FSMA) come into full force. Since FSMA brings a new regulatory burden on the food industry, its full implementation will require new ways of doing business, and most likely will affect the overall cost. This calls for a smarter management strategy to keep costs down and customers happy. The massive number of legitimate but competing food safety projects literally begging for attention can be overwhelming for Managers, especially with resources always in short supply. With this scenario, it is critical for the Manager to develop an FSQA project matrix template that delineates the level of importance of each project based on overall risk assessment, cost-benefit ratio, regulatory food code requirements, and buy-in by stakeholders, including management and final end-users.
FSQA project implementation and recipe for success
Testing and evaluation can be an expensive venture considering the test duration, number of test stores involved and capacity utilization for test products. The good news however is that most vendors are willing to fund substantial portion or even the entire test. This is essentially because vendors want to demonstrate that their product works, are in compliance, certified and approved by relevant federal, state and local agencies, and fulfills all obligations as outlined in the statement of work. It is a win-win situation for both vendor and corporate because once a product is approved for chain wide roll-out, it can stay in use for several years until an upgraded becomes available. Thus, corporate funding commitment may be minimal and restricted only to staff time for overseeing the testing process. It is important to mention that training is a critical component at every stage of the testing process. Standard operating procedures, training video clips and on-site training are required to ensure that test product is used according to manufacturer’s instruction and in compliance with all relevant regulations. Due diligence and proper training of end-users including store managers, team members and associates will ensure that the roll-out of a food safety tool to mitigate an existing risk does not introduce a new risk in food service operations. An example is the introduction of a new disinfectant to comply with a new regulation that requires a Norovirus approved disinfectant grade chemical for cleaning playgrounds. The disinfectant however is not approved for food contact surfaces since it’s not a regular strength sanitizer.
Consequently, any inadvertent cross-usage on food contact surfaces may constitute a serious food safety risk. Similarly, an SOP training gap may result in higher risk if associates using yellow color-coded aprons for raw food processing cross-contaminates the RTE food board areas with raw chicken/beef contaminated aprons. For instance, the Costco Rotisserie Chicken recall of late 2013 appears to have been linked with Salmonella cross-contamination after the cooking process in the food preparation area. Thus, proper training on the useof food safety tools and processes is critical both during product testing and post-chain-wide roll-out, to accurately evaluate and monitor risk mitigation practices.
To enable success, food retail chains employ the services of third party consultants to assist in-house staff and bring project-specific subject matter expertise to the table for rigorous risk assessment and risk mitigation. This strategy will also assist in timely communication that support buy-in by senior management and other relevant stakeholders. In addition, the implementation of such projects will remain effective and efficient, freeing up valuable time for corporate staff to continue supporting the business in the most critical areas of providing seamless customer services. Most importantly, a third party working in concert with vendors and corporate staff will bring an unbiased product testing and evaluation standard that cannot be left entirely at the discretion of vendor partners.
Proper documentation is required at every stage to ensure that all potential confounding factors are considered and evaluated at every level. Surveys, feedback compilation and analysis by a third party will assist in building credibility for test data, and enable management have the right set of data to make an informed business decision. Some level of customization may be involved as issues raised by stakeholders are addressed during the testing process. Open communication is important to keep all parties in the loop and encourage honest discussion of issues and how best to resolve them in a cost-effective manner.
Conclusion
Testing of new FSQA tools and services is a cost saving process that helps Managers to completely resolve potential issues upfront before introducing products into the system. Improperly tested food safety products may lead to a breach in the system down the road. Ordinarily, the use of transparent plastic wrap to cover raw chicken pans during the thawing process is an excellent barrier against cross-contamination of food-contact and non-food contact surfaces with raw chicken juice. However, the transparent nature of the plastic wrap makes it extremely difficult to see a torn piece of plastic wrap inside the raw chicken pan. Due diligence during testing should identify such aberration and resolve it by customizing into easily identifiable yellow color coded plastic wrap. This test-mode corrective action will ensure that torn pieces of plastic wrap won’t get into food served to customers after chain-wide roll-out.
While proper testing, evaluation and roll-out of new FSQA products and services may be laborious, time consuming and somewhat expensive, it is still considered one of the industry best practices that supports the delivery of safe quality food to customers and protects the business brand. Overall, it benefits businesses in the long run to budget enough resources for this very important business function, instead of postponing or scrapping risk mitigation programs until crisis situation that may hurt customers, business brand and undermine return-on-investment.
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