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Electrostatic Intervention Technology: An Effective and Efficient Future for Food Safety

By Mark Swanson
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Technology, apple, Birko

Using electrostatic technology in food processing isn’t a new idea. It has been around for years, but no one has been able to effectively harness the possibilities of this method for pathogen reduction. That’s all changing thanks to the research and dedication of a food safety group made up of experts and leading protein processors.

Now, food companies of all types stand to benefit from an innovation with the potential to revolutionize the industry. For the first time, there is a way to use electrostatics to deliver antimicrobial intervention with a high level of efficacy and minimal resources.

Less water, less chemical and better coverage—it almost sounds too good to be true. But it’s a reality, and it came from a focus on providing better protection with precision application.

The Basics of Electrostatics in Food Safety

The ultimate goal of using electrostatic technology in food processing is to achieve a high level of transfer efficiency. In terms of antimicrobial use on food products, that concerns how well a processor is able to cover products with a solution over a 360-degree surface.

There’s a large amount of waste, or very low transfer efficiency, that comes with current antimicrobial intervention methodologies. Most food processing operations either use a lot of water and chemical solution to cover a less-than-ideal surface area, or they use an enormous amount in an attempt to get better coverage.

The hope for electrostatics has been that it could improve transfer efficiency by applying opposite charges to food products and antimicrobial solutions. Opposites attract. Positively charged particles are drawn to negatively charged particles, and so, an antimicrobial intervention, such as peracetic acid (PAA), should better adhere to protein products if the two have opposite charges.

In theory, the science seems very simple. But in practice, finding ways to use electrostatics effectively was an extensive, eye-opening journey. It took a team of scientists, food safety thought leaders, and participation as well as funding from three top beef processors to find the answer.

Research and Development

The food safety group, which included Keith Belk, Ph.D. of the Colorado State University Center for Meat Quality & Safety, spent years experimenting, testing and fine tuning electrostatic application technology to make it as precise as possible.

In the beginning, there was no clear indication whether the efforts would produce results. The group didn’t know which type of electrostatic technology would work, what parameters should be used or if any of it would be effective. Just as Thomas Edison experienced many failed attempts while inventing the electric lightbulb, our group went through a series of exercises that eventually led to the right type of electrostatic application. Yet just as importantly, we discovered many methods that did not work.

For example, testing showed that applying a charge at the spray nozzles was not a good way to harness the potential of electrostatics. The charge was too difficult to control using this approach. Eventually, researchers found the best way to achieve transfer efficiency was to apply a negative charge directly to the source of the antimicrobial intervention. This allowed the negatively charged solution to effectively adhere to the positively-charged meat product with maximum control of the operating parameters.

Interestingly, while the group explored a variety of ways to apply antimicrobial intervention using electrostatics, applying a charge to the source proved to be the only technique that worked. The rest had virtually no impact.

After identifying the right approach, there were still big questions researchers wanted to answer. One such question was what happens when a vacuum is applied to the process? Would it work better, worse or have no bearing on the results?

Theoretically, the group thought a vacuum might aid in the process by opening up the surface of the meat, allowing for deeper penetration and further reduction of pathogens. However, tests revealed that applying the antimicrobial solution with electrostatics in a vacuum provided no additional benefits.

The next step was developing a prototype system to support both beef and poultry processing. Finding ways to control electrostatics and achieving transfer efficiency in a pass-through system proved to be challenging. Food production lines don’t stop, which means antimicrobial intervention can’t be done in batch mode.

The final equipment design included a conveyor system that slowly rotates to expose all surfaces of the product as it moves through the line while maintaining constant line speeds.

The Results

In-plant testing at beef processing facilities proved just how much of a difference electrostatic technology will make for food companies looking to improve efficiencies and strengthen food safety efforts.

During recent tests, researchers ran the system at a high volume between 265 and 700 pounds per minute using peracetic acid at approved levels between 1600 and 1800 parts per million (ppm). The results showed a log reduction in the range of 2.1 to 2.6 with an average of 2.4 on a series of tests. That is outstanding, especially considering many facilities typically achieve a log reduction of around 1.0 to 1.5. Plus, most food manufacturers are using substantially more antimicrobial solution to achieve that sort of pathogen reduction.

Results from laboratory studies show the technology provided equal coverage to a dip tank, but it used 95% less solution. Dip tanks are common in poultry processing, but they are very inefficient and waste a tremendous amount of water and chemical. Poultry facilities switching to electrostatic intervention technology would use a fraction of the water and chemistry, greatly improving efficiency.

Beef and pork processing facilities use sprayers for antimicrobial solutions and are much less likely to use dip tanks, as they’re not a viable intervention method for an operation of that scale. However, sprayers alone may not provide adequate coverage, creating the possibility for food safety risks.

Beef and pork plants could achieve better coverage with electrostatics while using the same or even less solution. That’s because the preciseness of this innovative approach also eliminates waste that comes from over spraying.

The Potential Benefits of Adopting Electrostatic Technology

How much of an advantage a food processing facility gets from implementing electrostatics into its antimicrobial intervention process is very dependent on the type and size of the operation as well as its current approach to food safety. There are, however, several major benefits that any food company will realize after adopting the technology.

  1. Improved food safety. Processors can be confident they are achieving 360-degree coverage while bolstering efforts to eliminate pathogens on food products.
  2. Efficient use of water and chemical. The precision achieved from utilizing electrostatics has the potential to dramatically reduce waste without compromising food safety. High transfer efficiency means processors save money and resources.
  3. Reduced water treatment costs. Protein processing facilities have large amounts of waste water that need to be treated in-house. More efficient use of antimicrobial solution significantly reduces money and resources needed for water treatment.
  4. Reduced repair and maintenance costs. Because of the acidic nature of food safety chemicals such as PAA, overspray of antimicrobial solution can unintentionally land on other surfaces and equipment. The low pH levels can lead to corrosion and damage, requiring repairs or additional maintenance. But, precise application with an electrostatic method within an enclosed space reduces the overspray problem.
  5. Better indoor air quality (IAQ). Another side effect from over spraying is chemical odors in the plant. Here again, protection with precision offers a unique benefit. Minimization of overspray improves IAQ, producing a safer and healthier environment for workers.

An additional benefit of electrostatic intervention technology is that it allows for precise measurement of the degree of the charge applied at the source, the concentration of the chemical in the solution and the overall transfer efficiency. While the original food consortium involved members of the protein industry and was optimized for use by meat processors, produce and fresh-cut facilities also stand to benefit from implementing electrostatic technology.

Changing the way your plant operates may feel risky, and being among the first to adopt an innovation can come with some uncertainty. However, in this case, avoiding early adoption could put you at a disadvantage, and the food safety risks are greater than those associated with pursuing this opportunity.

Electrostatic technology for antimicrobial interventions provides impressive advances in efficiency while offering protection–for both the public’s health and safety as well as brand reputation. The future of food safety looks precise.

Angela Anandappa, Alliance for Advanced Sanitation

Advances in Hygienic Design

By Angela Anandappa, Ph.D.
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Angela Anandappa, Alliance for Advanced Sanitation

The industry is taking notice and being more proactive in hygienic design thinking. Hygienic design is not a very new concept; in fact, it’s been around for almost a century when the dairy industry realized standardization was helpful with different parts. When the 3-A Sanitary Standards Inc. (3-A SSI) was established in 1920, the ideals for hygiene revolved around dairy handling equipment. But today, these hygienic design principles have been adapted by other industries, and new expectations for cleanability and standards have been developed by both 3-A and the European Hygienic Engineering and Design Group (EHEDG).

Geometry Is at the Core of Cleanliness

One of the most important factors that have helped the food industry in improving hygienic design is the use of geometry. How does math play such as huge role in hygiene? Hygiene, in the context of hygienic design for the food industry, takes the form of advanced materials formed into specific geometric positions to prevent the adhesion of particles and bacteria. A fraction of a degree angle changed in a cutting edge can make the difference between a smooth cut on a vegetable that allows it to swiftly slide off, thereby allowing the same cutting edge to be reused many more times than a cutting edge with a slightly different angle. This offers a functional benefit in achieving the optimal product quality while also reducing contact with the product and extending the time where buildup needs to be cleaned. The minimum radius of a corner for equipment parts and flooring are well defined for optimal water drainage. Similarly, the slope of a surface, the distance to angle ratios for otherwise horizonal liquid handling tubing, or the height and vertical sloping angles of a drain suitable for a processing zone are all key criteria that define hygiene. The scientific basis for why a certain angle works better than another for a specific purpose is continually being investigated to further improve design.

Standards and Guidelines Converge for Global Harmony

The effort by 3-A and EHEDG to harmonize design standards and guidelines respectively, is bringing about a convergence of approaches that benefits equipment manufacturers. EHEDG with its network of research institutes is capable of providing strong scientific principles upon which standards could potentially be developed or further enhanced. By working together to harmonize standards and guidelines, equipment manufacturers have even more incentive to adopt hygienic design principle. The 3-A SSI offers the 3-A Symbol authorization which helps third parties readily recognize that the equipment conforms to a given 3-A Sanitary Standard for equipment. So an original equipment manufacturer (OEM) is then not only encouraged to adopt hygienic standards, but also incentivized by the breadth of technical data available to them, making the excuse of costs associated with adhering to 3-A standard or EHEDG approval a thing of the past. Given that food safety depends on preventing contamination, new equipment or modifications that do not work to maintain hygiene are risks to the product.

In this new age, an equipment purchase that lacks the third-party nod of approval by a hygienic standards organization is a liability.

Equipment designed to be more easily wet cleaned by allowing for rapid disassembly while not always integrated into standards, is generally understood as a must for modern equipment. Moving equipment in and out of a single-use room for multiple processes is another benefit provided by equipment designed to accommodate quick changeovers. Accessibility is the key to cleaning success, as operators need to be able to fully access, clean and inspect the cleanliness of the equipment. Specifications for easements around equipment for cleanability are important.

Regulatory Requirements Should Inspire Equipment Design

FSMA brought sweeping changes to finally update the federal requirements for food safety that pointed to key areas that promote the use of sanitary conditions for producing, handling and transporting food. Prior to this, the meat industry had already been driving numerous best practices to cleaning equipment that have brought USDA inspected facilities a long way. The dairy industry’s focus on hygiene has been the gold standard for liquid handling, and the Pasteurized Milk Ordinance (PMO) set expectations for makers and inspectors to be familiar with good hygienic design, requiring it when it was absent.

But regulations always seek to provide broad guidance that is better executed by non-profits, NGOs and companies that serve to encourage adherence to standards, or those playing a pivotal role in buying decisions. Closely examining the U.S. Code of Federal Regulations and its references to sanitary design points to a vision for improving the state of equipment, facilities and transportation conditions to meet a higher threshold for hygiene that needs to be integrated into engineering designs by the OEM.

Materials Make All the Difference

Stainless steel has been used for over a century and is the standard metal used widely due to its corrosion resistance, formability and ability to be polished and renewed. The Nickel institute reports that two thirds of global nickel production is used in manufacturing stainless steel, forming an alloy that is suitable for food contact equipment and in healthcare.

The hygienic character of the material is directly proportional to the cleanability, moisture resistance and corrosion resistance. Rounded corners, super smooth finishes, slopes and numerous other criteria have been defined for a variety of equipment, surfaces, flooring, etc., in combination with a plethora of materials that provide water resistance, antimicrobial activity, metal detectable or flexible disposable seals, novel elastomers that provide heat resistance for O rings and joints have brought design to a higher level of sophistication than ever before.

Similarly, metallurgy is another area in which innovative alloys have been developed for softer or harder parts of a variety of equipment. Not all stainless steel is the same and while a 304 grade stainless steel works for most food contact equipment, other grades of stainless steel find their best uses in certain other parts of a hygienic facility. And pulling it all together, the design criteria for metal joints, especially those that come into contact with food, are best put together by skilled technicians who understand micro resistance design that promotes food safety.

Education and Awareness

The revolutionary aspect of today’s hygienic design really has more to do with a concerted effort to focus the industry on prevention. Several noteworthy contributions to this effort lay in the hands of organizations like the American Institute of Baking (AIB), North American Meat Institute (NAMI), American Frozen Food Institute (AFFI), and Commercial Food Sanitation (CF-SAN) that have individually or through partnerships with other key organizations, elevated the level of knowledge, accessibility of training and awareness that solid hygienic design for facilities and equipment are the foundations for prevention. And so, as we move forward, this really is an exciting time to be a student of good design and apply engineering talents to the food industry.

Third-Party Assessments

Hygiene can be defined as a set of activities or behaviors geared at preventing disease. Some of the earlier well documented instances of hygiene (or lack thereof) relating to food have their roots in cholera, dysentery associated with the industrial revolution and the need for human beings clustering into smaller and more populated regions, namely cities. But the notion of personal hygiene is inextricably joined to the production of food and will remain so for the foreseeable future. Assessing the hygienic condition of a food production environment is not the same as a food safety audit. To elaborate, a hygienic assessment requires comprehensive knowledge of sanitation systems, equipment design and evaluation criteria, which although included in general terms, are not well scoped in any of the GFSI schemes. In fact, facilities that have passed certain GFSI audits frequently fall seriously short on their ability to produce safe food.
A specialized hygienic assessment is a worthwhile option for big buyers, food service giants and large-scale processors to drive for predictable quality. These specialized audits conducted by organizations that have developed a focus for equipment design are being more frequently utilized as a preventive measure. When done right, they can also be powerful tools for driving positive food safety culture and developing long-term supplier relationships.

How ERP Can Help Ensure Food Safety in the Cannabis Edibles Market

By Daniel Erickson
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The popularity of cannabis edibles and infused beverages as a socially accepted and convenient method of marijuana consumption has grown exponentially for consumers in states with a legalized market for both recreational and medicinal cannabis. The edibles industry’s success has been met with many challenges however, as the absence of federal regulation has provided little guidance regarding food safety practices. With consumers generally expecting these products to have the same safety expectations as they do with other food and beverages they consume, many manufacturers have elected to follow FSMA best practices to ensure cannabis edibles’ integrity in the marketplace. Proactive cannabis growers, processors and dispensaries are seeking out ERP software solutions in greater numbers to utilize the technological tools and vendor experience in the food and beverage market to establish greater accountability and plan for current and future compliance requirements.

Cannabis Edibles Defined

Cannabis-derived edibles are food or beverage products that are made with cannabis or infused with cannabis extract—either consumed recreationally or to manage or alleviate health concerns. Cannabis extractions used in edibles include tetrahydrocannabinol (THC), which is psychoactive, and cannabidiol (CBD), which is not, as well as many derivatives when speaking of “whole plant” benefits. While there are a variety of edibles including gummies, candies, cookies, energy drinks, teas and chocolates, the defining characteristic of these products is that they are meant for human consumption. Public perception is that these products are held to the same safety and quality considerations as mainstream food and beverage products available in the market. With these expectations and lack of oversight, the responsibility falls on the manufacturer to meet those expectations and ensure a safe, consistent, quality edible product.

Safety and Quality Concerns

An unregulated industry at the federal level has resulted in a lack of consistency, predictability and safety in the edibles market. Frequently, it has been found that edibles don’t always produce the same experience from one consumption to the next, resulting from inconsistent appearance, taste, texture and potency. These variances pose a problem from a marketing perspective, as it impacts brand recognition, loyalty and returning customers. Similar to the food and beverage industry, foodborne illnesses, outbreaks, undeclared ingredients and inaccurate labeling provide further concern in an unregulated manufacturing environment. Specific safety issues of the cannabis industry include extraction processes, mold and bacteria growth, chemical exposure, pest and pesticide contamination, employee handling of products and the unintentional ingestion of cannabis edibles. With the high risks associated with this market, it is necessary for proactive growers, processors and dispensaries to adequately address quality and safety concerns that mitigate risk until the eventuality of regulatory oversight.

How ERP Can Help

Implementing an industry-specific ERP software solution that provides security and standardizes and automates business functions helps support cannabis manufacturers by providing the proper tools to track operations from seed-to-sale. With support for best practices and streamlined and documented processes, companies can incorporate safety and quality initiatives from cultivation to the sale of edible products and beyond. Utilizing the expertise of ERP vendors in the area of food safety management, edible manufacturers are provided with the same benefits that food and beverage companies have experienced for decades with ERP solutions. Cannabis ERP software allows your company to track all aspects of growing, manufacturing, packaging, distribution and sales—providing functionality that manages inventory, traceability, recipes and labeling to support quality initiatives.

The following areas supported by ERP can lead cannabis edible manufacturers to succeed in the realm of food safety:

Inventory Control. ERP’s automatic recording and tracking of inventory attributes, including balances, expiration dates, plant tag ID’s, serial and lot numbers and end-to-end traceability, allows cannabis edible manufacturers to maintain appropriate raw material and product levels, reduce waste, evaluate inventory flow, facilitate rotation methods and avoid overproduction. It provides accurate ingredient and cost tracking throughout the greenhouse operations and supply chain by use of barcode scanning that links product information to batch tickets, shipping documents and labels. Maintaining real-time and integrated information facilitates the ability to locate items in the event of contamination or recall. This detailed level of continuous monitoring mitigates the risk of unsafe consumables entering the market.

Labeling. Accurate product labeling is essential for food safety in the cannabis edibles industry, and its importance cannot be understated. Proper labeling and transparency ensure that consumers are provided a consistent experience and also help to mitigate unintentional consumption of cannabis-infused products. Certain states have enacted labeling requirements to increase accountability and mitigate the misrepresentation of cannabis edibles on the label with unverified, misleading or inaccurate information. Employing an automated ERP system assists with label creation that includes nutrient analysis, ingredient and allergen statements, testing notification for bio-contaminants and pathogens and expiration dates to ensure quality—providing a faster and more efficient method for labeling. Accurate labeling is also an imperative component of product recall planning, as traceability and labeling history documented in ERP software helps to identify and locate items quickly in the event of a recall.

Recipe and Formulation Management. To achieve consistency of products in taste, texture, appearance, potency and intended results, complex recipe and formula management are maintained with a real-time ERP solution that delivers tightly managed control. Raw material data, version and revision information and production notes are documented for each batch. The monitoring of key quality specifications such as THC and CBD percentage, containment and impurities testing, etc. are readily handled within the system and allows for the scalability of recipes as needed. Direct access to the calculation of specific nutritional values, which includes ingredient and allergen information, provides accurate labeling and consumer information for product packaging—a valuable asset in the cannabis edibles market. R&D functionality supports the creation of new and innovative edibles and marijuana-infused beverages in a sandbox environment to meet the demands of this consumer-driven market.

Approved Supplier Relationships. Assurance of cannabis edible safety is enhanced through the acquisition of quality raw materials from trusted vendors. An ERP solution plays an essential role in the process as it maintains a supplier list by documenting detailed supplier information and test results to assure in-house qualifications and potency standards are met. A fully-integrated ERP system regulates quality control testing to ensure consistent and approved materials are being used and undeclared substances, harmful chemicals and impure ingredients are unable to infiltrate the supply chain. Failure to meet quality control standards results in ingredients being quarantined, removed from production and disposed of safely, and indicates that a search for alternate vendors is needed. This detailed level of documentation is a best practice for maintaining current and accurate supplier information in the event of a product recall.

Current Good Manufacturing Practices (cGMPs). As the bedrock for the food and beverage industries, following cGMPs establishes an important foundation for the edibles market. An ERP efficiently documents processes to ensure safe and sanitary manufacturing, storage and packaging of food for human consumption. This includes monitoring equipment status, establishing cleaning and hygienic procedures, training employees, reporting illnesses, maintaining food and cannabis handling certifications and eliminating allergen cross-contact risks. Validating procedures within an ERP solution automates documentation of an audit trail and addresses food safety concerns more efficiently than manual methods.

Hazard Analysis Critical Control Points (HACCP) Requirements. Establishing a food safety team that develops a HACCP plan to enact procedures that protect consumers from the biological, chemical and physical dangers of edibles is a recommended best practice for quality assurance, despite the current lack of federal regulations. Critical control points recorded within an ERP solution prevent and control hazards before food safety is compromised. Parameters within the ERP system can be utilized to identify potential hazards before further contamination can occur. Applying these best practices historically used by food and beverage manufacturers can provide an enhanced level of food safety protocols to ensure quality, consistent and safe consumables.

Food Safety Plan. As a requirement of FSMA, a food safety plan provides a systematic approach of identifying and addressing food safety hazards by implementing preventative food safety procedures throughout the manufacturing, processing, packing and storage of products. With a trained Preventative Control Qualified Individual (PCQI) at the helm to coordinate the company-specific plan, an ERP solution automates and records preventative controls, full forward and backward lot traceability, recall plans and employee training records within an integrated system to ensure that food safety policies and procedures are being followed.

With the growth of the edibles and infused beverage market expected to skyrocket over the next four years, the success of growers, processors and manufacturers will continue to thrive off of technological tools and established best practices. Employing the industry experience of ERP software providers that have implemented food safety and quality control procedures will follow suit of the market and be a sought-after resource when federal regulations are imposed. Proactive cannabis businesses are already experiencing a return on investment in their ability to provide quality, consistent products that meet cannabis enthusiasts’ high expectations and keep them ahead of this trending market.

PDCA

Training Vs. Education: Understanding the role of TWI (Part II)

By Debby L. Newslow, Alan Lane
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PDCA

The TWI: 2018 Training Management System Standard addresses various aspects of an organization’s Management System and identifies, explains and standardizes some of the best-known practices for ensuring that supervisor-to-operator relationships are strong and true. It also confirms that all training is performed in the most cost efficient, effective and safe manner possible. The standard provides guidance and tools for companies and organizations that want to ensure their products and services consistently meet customer’s requirements, while the quality remains top-notch.

TWI: 2018 sets out the criteria for an organization to integrate TWI practices into their management system and, when implemented properly, is the standard that can be certified (this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. It is equally as effective in service companies, as manufacturing or healthcare.

Read Part I: How training within industry empowers employees & facilitates continuous improvementThis standard is based on several quality management principles including a strong customer focus, motivation and implication of top management and process approach and continual improvement. Using TWI: 2018 helps ensure that customers consistently get good quality products and services, which in turn, brings many business benefits, and significant return on investment.

The adoption of TWI and the associated training modules into an organization’s management system must be a conscience decision and embraced as a business management strategy by the senior management team. TWI helps the organization see meaningful overall performance improvements and ensures the sustainability of the initiative.
Traditionally, the potential benefits of implementing TWI into their management system based on this international standard, are measured using the following Key Performance Indicators, (KPI):

  • Increased Productivity
  • Reduced Training time
  • Reduced Labor-hours
  • Reduced Scrap
  • Reduced Grievances

The TWI: 2018 Training Management System International Standard can be used by internal and external parties. The standard’s requirements are intended to be complimentary to the organization’s current management system for product and service realization.

This standard employs the process approach, which incorporates the Plan-Do-Check-Act, (PDCA) cycle, as well as, risk-based thinking. This Process Approach enables an organization to plan its processes and their interactions.

The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that the opportunities for improvement are determined and acted upon.

Risk-based thinking enables an organization to determine the factors that could cause its processes and management system to deviate from the planned results. It also allows a company to put preventive controls in place to minimize negative effects and to make maximize opportunities as they arise.

As it all comes down to working with and through people, it is imperative that the development of an organization’s personnel is adequately addressed. This includes, but is not limited to:

  1. Identifying and hiring the right people
  2. Appropriate and effective on-boarding of new employees
  3.  New, as well as, refresher training
  4. Adequate Succession Planning
  5. Supervisor skills and knowledge training
  6. Effective problem solving
  7. On-going and effective safety training for a safe workplace

TWI training modules utilize a 4-Step Process to make the training consistent, standardized and easy to understand and comprehend. This process is time proven and meant to be rather rigid by design. The method looks much easier than it is to do, and requires, like any other skill, practice to perfect it. This standard DOES NOT include the actual methodology, but rather, documents the required elements of implementing TWI into business systems to ensure the integration of TWI into the organization’s culture and to achieve the highest return on investment. Appropriate TWI methods are identified throughout this standard.

TWI Training Management System Principles

This international standard is based on the quality management system principles described in the ISO 9001:2015 International System. It= is not intended to replace or supersede the ISO standard, but rather, to integrate with your current management system standard or GFSI-approved CPO. The focus is on enhancement by addressing the essential supervisor skills needed to “manage” the people aspect of doing business. By patterning it after the format of ISO, it is the intention of the TWI-Institute to make the TWI principles and training easier to integrate into an organization’s current management system.

The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principles, and examples of typical actions to improve the organization’s performance when applying the principles.

The TWI Principles are based on The Five Needs Model for Good Supervisors:

  1. Knowledge of the work
    1. This refers to the kind of information that makes one business different from another (i.e.,materials, products, services, processes, equipment, operations, people, etc.)
  2. Knowledge of Responsibilities
    1. This refers to the organization’s situation regarding policies, regulations, rules, agreements, schedules, organizational structure, etc.
  3. Skill in Instructing
    1. This will assist supervisors in developing a well-trained workforce.
  4. Skill in Improving Methods
    1. This deals with utilizing materials, machines and manpower more effectively by having supervisors study each operation in order to eliminate, combine, rearrange, and simplify details of the job.
  5. Skill in Leading
    1. This helps the supervisor to improve his or her ability to work with people.

NOTE: Throughout this international standard, “Supervisor” is defined as anyone in charge of, or who directs the work of others. Therefore, “Supervisors can be identified by many titles: Supervisor, Manager, Foreman, Lead, Cell Leader, Director, VP, President, etc. “

The Process Approach

The TWI: 2018 – Training Management System International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of the management system and the supervision of people, to enhance customer satisfaction by meeting customer requirements and expectations.

Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced. Maintaining good employee relations, providing effective and efficient training, and making the daily habit of reviewing processes in order to continually improve them, must be integral to the organization’s culture and a primary strategic initiative.

The process approach involves the systematic definition and management of processes, and their interactions, to achieve the intended results in accordance with the organization’s policy statement and strategic direction. Management of the processes and the complete system can be achieved using the PDCA cycle (See Figure 1), with an overall focus on risk-based thinking aimed at taking advantage of opportunities and preventing undesirable results.

The application of the process approach in a training management system enables:

  1. An understanding and consistency in meeting requirements of necessary training
  2. The consideration of the processes of training, in terms of added value
  3. The achievement of an effective training process performance
  4. Improvement of training processes based on evaluation of data and information, (i.e., KPI’s).
PDCA cycle
Figure 1. The PDCA cycle can be applied to all processes, including managing people, and to the overall management system.

The PDCA cycle can be summarized as follows:

  • PLAN: Establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements, (in this case, the employees of the organization), and the organization’s policies, and identify and address risks and opportunities.
  • DO: Implement what was planned.
  • CHECK: Monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results.
  • ACT. Act to improve performance, as necessary to correct deviations, or to continually improve the processes. (Note: See Appendix A for an example of an implementation plan using a PDCA cycle.)

Risk-Based Thinking

Risk-based thinking is essential for achieving an effective management system and the proper training and development of the people. By using Risk-based thinking, management can carry out preventive actions to eliminate the potential negative effects of an unforseen occurrence (i.e., untrained personnel trying to complete a task, action or process step).

To conform with TWI: 2018, an organization needs to plan, implement and measure actions in order to address risks and opportunities associated with the training and development of the people. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, including training and developing people, achieving improved results and preventing negative effects.

Relationship with Other Management System Standards

The TWI: 2018 – Training Management System International Standard is intended to allow seamless integration into an organization’s existing management system. To meet that end, this international standard was patterned after the ISO 9001:2015 International Standard since it is universally accepted, as setting the bar for management systems. Note: While the international standard is patterned after the ISO 9001:2015 International Standard, it is not dependant on compliance to that, or any other, management system format.

TWI: 2018 may, however, be implelented as a stand-alone training management system and does not include requirements specific to other management systems, such as those for environment, food safety, financial, or occupational health and safety management.

Summary

Virtually every process or problem has a human element as part of the equation. Unfortunately, we continually find that some organizations fail to connect the logic of TWI and its underlying principles to the actual daily realities of running the operation. If you don’t continually manage and practice the process, then it won’t sustain itself in the long run. The key to sustaining programs is to get off on the right foot with a solid plan. If you create a plan emphasizing the activities discussed above, along with problem solving and strong daily operational management, we know you’ll have greater success and increase your odds of sustaining an effective and efficient training program that will yield a significant ROI.

Resources

  • ASQ/ANSI/ISO 9001:2015. Quality Management Systems-Requirements. ASQ. Milwaukee, WI.
    Newslow, Debby. Food Safety Management Programs Applications, Best Practices, and Compliance. CRC Press. C2014.
  • TWI: 2018, Training Management System International Standard. The Central New York Technology Development Organization (TDO). Liverpool, NY.

Training Vs. Education: Understanding the role of TWI (Part I)

By Debby L. Newslow, Alan Lane
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Related to training requirements, GFSI approved CPOs and the ISO standards place a strong emphasis on the evaluation of qualifications, competency, and the effectiveness of training. It is critical to make sure that today’s associates are aware of the importance of their actions and how they contribute to the overall achievement of measurable food safety, quality and system objectives. Records that document training results, both positive and negative, must be maintained. Although follow-up and documentation take time, the overall positive impact on the business and success of the organization is well worth the extra effort.

It is important that each associate understands the role that he or she plays in his or her company’s success. Individual roles are established by upper management and communicated to the staff. It requires the cooperation and communication of all operational levels to result in an effective and value-added management system. If the necessary lines of communication are developed and a proper work environment is established, then the results should be the production of a safe product with product conformity and all the records to prove it.

Necessary provisions of a successful management system include: Applicable job assignments for personnel and identifying all training needs while providing the appropriate training. It is critical that management apply the proactive approach to training, rather than being reactive after something goes wrong. Without a structured, proactive, effective program established to communicate and educate employees, the organization will be putting its products at risk. Products will be at a food safety risk, as well as, pose a risk to basic business success.

When defining the necessary competencies, management must consider how each position affects the processes and the system overall. Written, well-defined job requirements are necessary to identify competencies and qualifications. Job requirements should at least define the following aspects:

  • Criteria for each area of responsibility as it affects the management system and the needs of the organization
  • Criteria based on related documentation (procedures and work instructions)
  • New hire orientation training
  • Requirements for the compliant management system
  • Specific training needs
  • Records necessary to demonstrate conformance with training and education requirements
  • Competency of associates to be evaluated, recorded, effective, and defined in a manner that is appropriate for the organization.

The training, competence and awareness program must focus on educating the associates. “Education” is a critical term that communicates sharing the knowledge and explains reasons why an activity must be done in the manner presented. Training is communicating the required actions and showing how these actions are important.

Education” is the act or process of imparting or acquiring general knowledge, developing the powers of reasoning and judgment; the act or process of imparting or acquiring specific knowledge or skills.

Training” is to develop or form the habits, thoughts, or behavior of by discipline and instruction and to make proficient by instruction and practice, as in some art, profession, or work.
A favorite example when comparing these two terms is how Pavlov’s dog was trained to respond to the ringing bell for food, but education is understanding that it is necessary to perform an action in a specific manner.

The training program must be developed and presented in a manner that effectively educates associates. Each associate, at a minimum, should have an overview of the compliance requirements of the management system and how he or she impacts the goals of the organization.

Training Within Industry – Did You Know?

Training Within Industry’s (TWI) rich history originated in the United States in the 1940s where the program was an unqualified success, boosting industrial production of war material beyond expectations. Training Within Industry (TWI) leverages the role of supervisors and team leaders to do the following:

  • Standardize work
  • Increase productivity & quality
  • Reduce training time
  • Work safely
  • Improve morale
  • Solve problems

TWI is an essential element of lean and lean six sigma programs, as it provides frontline personnel with the skills and organizational framework for standard work along with continuous improvement.

The 5 TWI Program Modules:

  1. Job Instruction (JI): Quickly training employees to do a job correctly, safely, and efficiently
    The demands of developing a flexible workforce and training employees are best accomplished with standardized best practices. Job Instruction teaches how to effectively break down a job and deliver the necessary instructions for individual tasks. By developing and delivering training in this structured fashion, the process becomes more consistent and efficient throughout the company. JI results in reduced training time, less scrap and rework, fewer accidents and increased job satisfaction.
  2.  Job Relations (JR): Building positive employee relations, increasing cooperation and motivation, and effectively resolving conflict
    Job Relations teaches the foundations of positive employee relations, preventing potential problems and earning loyalty and cooperation. It utilizes a proven method of resolving problems, therefore, resulting in increased productivity, improved attendance, better morale, and higher employee retention rates.
  3.  Job Methods (JM): Improving the way jobs are done for continual improvement
    Job Methods focuses on producing greater quantities of quality products, in less time, by making the best use of the people, machines and materials currently available. Jobs are broken down into their constituent operations. Every detail should be questioned in a systematic manner to generate ideas for improvement. JM yields significant benefits including reduced cost through productivity gains, increased throughput, and reduced work in process.
  4. Job Safety (JS): Creating a safe workplace
    Job Safety provides the framework through which supervisors can engage employees in identifying potential hazards and eliminating them based on their training and knowledge in OSHA and EPA regulations. This provides supervisors a viable method to use when analyzing the events leading to accidents and hazardous situations. JS stresses that the relationship of the supervisor to the employees plays a pivotal role in a safe and environmentally responsible workplace.
  5.  Problem Solving (PS): Providing supervisors and other leaders with higher-level problem-solving skills
    Problem Solving is the next step for an organization wanting to advance to the next level, after implementing one or more “J” classes. This final process seamlessly incorporates the other four steps. Results include proper identification of problem points, effective solutions, and continuous improvement.

TWI: History

The Central New York Technology Development Organization (TDO), a member of the U.S. Manufacturers Extension Partnership (MEP), successfully reincarnated the original TWI programs in 2001. They subsequently formed the TWI Institute to oversee the global deployment of the program.

The TWI Institute is the center for education, trainer certification and connections in the TWI community of practitioners and trainers. It is a large, rapidly expanding network of certified trainers delivering the TWI Program in the United States and across the globe. The TWI Institute, USA Southern Region, was recently established to serve the southern region of the United States. This region is currently busy introducing the new TWI: 2018-Training Management System International Standard. This standard focuses on training as an integral part of any quality management system. It ultimately defines what all companies need to ensure that their training programs will be effective.

TWI has seen a lot of success throughout its 70+ years, both nationally and internationally, but there has been one common complaint over the years: It is difficult to sustain the training over the long haul.

This can be said for most initiatives undertaken in the lean manufacturing world of continuous improvement elements, whether it is SS, SUR, TPM or any of the other acronyms for the many tools in the lean toolbox. Regardless of the initiative, training must be done to bring everyone up to speed. The success of the training will determine the effectiveness and value of the initiative.

In part two of this series, we will examine the newly released TWI:2018 Training Management System International Standard. We will examine the outcomes to determine how this standard will provide a company with safe, efficient and effective training standards that will provide a lasting benefit.

2018

The Future of Food Safety: A Year in Review

By Mahni Ghorashi
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2018

We started this Q&A series earlier this year with a clear vision—to gather the success stories, best practices, hurdles and achievements from the best in our industry. Our hope is that as the series expands and evolves, food safety professionals everywhere will be informed and inspired by what the future holds.

Over the course of the year, I had the pleasure of interviewing three such experts: Bob Baker, corporate food safety science and capability director at Mars, Inc, Frank Yiannas, vice president of food safety at Walmart, and Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill.

I encourage you to read the interviews for their unique perspectives, but here are a few of the biggest insights that we can all take with us into 2019.

The Continued Rise of New Technologies

Mike Robach: I am very excited about the application of new technology to our food safety programs. In-line, real-time testing gives an opportunity to manage our processes and make immediate adjustments to assure process control. This allows us to prevent product that is out of control from reaching the marketplace.

Frank Yiannas: The emergence of blockchain technology has also enabled food system stakeholders to imagine being able to have full end-to-end traceability at the speed of thought. The ongoing U.S.-wide romaine lettuce E.coli outbreak showed us, once again, that our traditional paper-based food tracking system is no longer adequate for the 21st century. An ability to deliver accurate, real-time information about food, how it’s produced, and how it flows from farm to table is a game-changer for food safety.

Blockchain has the potential to shine a light on all actors in the food system. This enhanced transparency will result in greater accountability, and greater accountability will cause the food system to self-regulate and comply with the safe and sustainable practices that we all desire.

The Most Exciting Shifts

Baker: What’s encouraging is we’re seeing is a willingness to share information. At Mars we often bring together world experts from across the globe to focus on food safety challenges. We continue to see great levels of knowledge sharing and collaboration.

There are also new tools and new technologies being developed and applied. Something we’re excited about is a trial of portable ‘in-field’ DNA sequencing technology on one of our production lines in China. This is an approach that could, with automated sampling, reduce test times.

Yiannas: While there is no doubt that there are numerous new and emerging challenges in food safety, the many advancements being made should give us hope that we can create a safer, more efficient and sustainable food system.

There is progress being made on many fronts: Whole genome sequencing is becoming more accessible; new tools are being developed for fraud detection; and FSMA is introducing stringent public-health surveillance measures that have dramatic implications for U.S. retailers and suppliers and our import partners.

Most importantly, consumers are now overwhelmingly interested in transparency. People today are further removed from how food is grown, produced and transported than at any other time in human history. Plus, they increasingly mistrust food and food companies due to the food outbreaks and scares we have faced in recent years.

Recalls and the Role of Regulation

Robach: I think FSMA implementation is going okay right now. There’s still a long way to go, and I am always concerned about making sure investigators are applying the rules and regulations in a consistent manner. I see the intentional adulteration rule as an upcoming challenge. It is one thing to conduct a vulnerability assessment and adjust your programs based on the results. It’s another to develop and implement a program that will prevent intentional adulteration as you would to reduce or prevent microbiological contamination.

I believe that food safety management programs are constantly improving and that our food is as safe as it has ever been. However, we still have a lot of work to do. At GFSI, we are continually improving our benchmarking requirements and increasing transparency in the process. We have better public health reporting and our ever-improving analytical technology allows us to detect contaminants at lower and lower levels. The industry is working collaboratively to share best practices and promote harmonized food safety management systems throughout the supply chain.

Baker: At Mars, quality is our first principle and we take it seriously—if we believe that a recall needs to be made in order to ensure the safety of our consumers, then we will do it. We also share lessons from recalls across our business to ensure that we learn from every experience.

Unfortunately, there does not seem to be a safe place for businesses to share such insights with each other. So although we are seeing more collaboration in the field of food safety generally, critical knowledge and experience from recalls is not being shared more broadly, which may be having an impact.

Looking Ahead

Baker: The food safety challenges facing us all are complex and evolving. Water and environmental contaminants are areas that industry and regulators are also looking at, but all of these challenges will take time to address. It’s about capturing and ensuring visibility to the right insights and prioritizing key challenges that we can tackle together through collaboration and knowledge sharing.

We’re looking forward to continuing our quest in the new year and already have a few exciting experts lined up. Stay tuned!

baby

Keeping Baby Food Safe: Sensitive Pesticide Residue Quantitation Beyond Maximum Residue Levels Using GC-MS/MS

By Paul Silcock
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baby

There are more than 1000 different pesticides in use around the world. While these chemicals are designed to target insects, weeds and other pests, residual amounts can remain on food that is subsequently eaten by consumers. The effects of pesticides on the population can be acute or chronic depending on the exposure. Acute over-exposure can cause poisoning and result in long-term effects such as cancer or reproductive issues. Chronic, lower dose exposure to pesticides has been associated with health issues such as respiratory problems, skin conditions, depression, birth defects, cancer and neurological disorders such as Parkinson’s disease.

People who face the greatest risk for adverse health outcomes from pesticide exposure are those in agricultural roles, who are more likely to come into direct contact with these chemicals. However, developing fetuses, infants and children, as well as pregnant and nursing mothers and women of childbearing age are at increased risk of experiencing negative health effects due to the presence of unsafe levels of pesticides in food. Exposure throughout a child’s development¬–including in the womb, infancy, early childhood, and puberty–can be particularly dangerous, affecting hormone regulation and brain development.

To minimize adverse health effects, the United States Environmental Protection Agency (EPA) and the European Union (EU) impose strict regulations on the amount of pesticides that can be applied to a crop, in order to limit the residue exposure downstream. Pesticides are assigned maximum residue levels (MRLs) depending on their toxicity, with the majority typically set at 10 µg/kg. However, due to the greater risk of certain compounds affecting the healthy development of infants and young children, some pesticides are controlled further: For instance, in the EU, specific pesticides are restricted in baby foods with MRLs of between 3–8 µg/kg.

Triple Quadrupole GC-MS/MS: Meeting the Needs of Pesticide Analysis

In order to test foods for pesticide residues at these very low levels, food safety laboratories require sophisticated analyte detection technologies. Gas chromatography-tandem mass spectrometry (GC-MS/MS) is a powerful analytical technique that offers the sensitivity and selectivity required to detect and identify pesticide residues at levels that often go beyond those mandated by regulatory authorities, even in complex sample matrices such as baby food. Indeed, GC-MS/MS can detect multiple residues within samples at levels as low as 0.025 µg/kg, much lower than the MRLs of regulated pesticides.

The sensitivity of the latest triple quadrupole GC-MS/MS systems is enabling levels of detection so low that many food testing laboratories have been able to adopt more efficient and universally-applicable sample preparation procedures based on QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) methods. Combining these modern GC-MS/MS systems with QuEChERS sample preparation techniques allows food samples to be analyzed directly, significantly reducing workflow complexity. Furthermore, the specificity of triple quadrupole GC-MS/MS can easily compensate for the additional matrix components or residual acetonitrile carried over from sample preparation.

EU SANTE Criteria for Pesticide Residue Quantitation

When it comes to the detection of pesticides in baby foods, workflows must comply with rigorous quality control and method validation standards. The EU SANTE/11813/2017 criteria outline three specific requirements that pesticide residue analysis methods must satisfy to achieve compliance.

Firstly, a minimum of two product ions must be detected for each pesticide with a peak signal-to-noise ratio greater than 3 (or in case noise is absent, a signal must be present in at least five subsequent scans), and the mass resolution for precursor ion isolation must be equal to or better than unit mass resolution. Secondly, the retention time of an analyte within a sample must not differ by more than 0.1 minutes compared with standards in the same sequence. Finally, the relative ion ratio for each analyte must remain within 30% of the average of calibration standards from the same sequence.

Fortunately, modern triple quadrupole GC-MS/MS systems are ensuring food safety testing laboratories comply with these criteria. In terms of peak detection and resolution, the specificities achieved using the latest triple quadrupole instruments meet or exceed the EU SANTE requirements by providing consistent data points regardless of sample preparation approach or matrix type. Precise detection at the ultra-low concentrations required for pesticide residue quantitation is routinely achieved using modern triple quadrupole GC-MS/MS systems, with analyses offering qualitative identification of each analyte among a large group of residues. Furthermore, the latest systems deliver stable ion ratios that are well within the required 30% range at the default 10 µg/kg MRL across multiple injections.

Ultra-low-level Quantification of Pesticides Using Triple Quadrupole GC-MS/MS

In a recent study that put the capabilities of the latest triple quadrupole GC-MS/MS systems to the test, samples of baby food (carrot/potato and apple/pear/banana) spiked with a mixture of more than 200 pesticides at three concentrations (1.0, 2.5 and 10.0 μg/kg) were analyzed using the Thermo Scientific TSQ 9000 triple quadrupole GC-MS/MS system fitted with an Advanced Electron Ionization (AEI) source. Prior to injection into the instrument, the homogenized spiked samples were prepared for analysis using a QuEChERS method that included an acetonitrile extraction step, a clean-up step involving primary secondary amine (PSA) and dispersive solid phase extraction (dSPE), followed by acidification with 5% formic acid in acetonitrile.

The triple quadrupole GC-MS/MS system met all SANTE criteria at the three spiking concentrations in both food matrices. More than 97% of the target pesticide residues in the 1 μg/kg spiked sample had recoveries in the range of 70%–120%, highlighting the broad applicability of the method. The recoveries of the target pesticides from the apple/pear/banana sample spiked at 10 μg/kg are shown in Figure 1.

GC-MS/MS system, pesticide residue analysis
Figure 1. Recovery and precision data for apple/pear/banana extractions (n=6) at a concentration of 10 μg/kg, obtained using TSQ 9000 triple quadrupole GC-MS/MS system fitted with an advanced electron ionization (AEI) source.
GC-MS/MS system
(Figure 1 continued)

Triple Quadrupole GC-MS/MS: Supporting Exceptional Limits of Detection

To determine the limits of detection of the system, baby food samples prepared by the previously-described QuEChERS method were spiked with the same mixture of pesticides at 14 concentrations ranging from 0.025 to 250 μg/kg. Using the triple quadrupole GC-MS/MS system, the SANTE criteria were met for all of the pesticides targeted at the default MRL of 10 μg/kg. Additionally, more than 90% of the target compounds had a limit of identification (LOI) satisfying all SANTE requirements below 0.5 µg/kg, and more than 60% of the target residues met these criteria below 0.1 µg/kg (Figure 2).

Pesticide residue analysis
Figure 2. Number of target residues satisfying the EU SANTE requirements (carrot/potato sample matrix). IDL, instrumental detection limit; LOI, limit of identification.

Instrumental detection limits (IDLs) were also determined for each pesticide residue by performing 10 replicate injections of the lowest matrix-matched standard of carrot/potato that met all SANTE criteria. IDLs were then evaluated using one-tailed student t-tests, taking into account the concentration and absolute peak area %RSD for each compound. The evaluated IDLs ranged from approximately 5 fg (for chlorobenzilate) to 2.0 pg (for bioallethrin), with over 95% of the residues exhibiting an IDL of less than 500 fg on the column (equivalent to 0.5 µg/kg in each sample extract). These results highlight the exceptional performance of the system, offering quantitative analysis of more than 200 pesticides over up to five orders of magnitude.

Conclusion

Enforcing regulations on the amounts and types of pesticides used is essential to limit our exposure to safe levels. The latest GC-MS/MS systems are capable of detecting and identifying pesticide residues at levels far beyond those required under regulatory standards, helping food testing laboratories efficiently ensure the food our children eat is always safe to consume.

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PCR or LAMP: Food Safety Considerations when Choosing Molecular Detection Methods

By Joy Dell’Aringa, Vikrant Dutta, Ph.D.
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Food microbiology pathogen detection technology is constantly evolving and improving for fast, efficient and accurate analysis. Thanks to the wide commercialization of easy-to-use diagnostic kits, the end-user no longer needs a deep understanding of the intricacies of diagnostic chemistries to perform the analysis. However, when navigating the selection process in search of the technology that is best fit-for-purpose, it is critical to understand the key differences in principle of detection and how they can impact both operations and risk. Here, we will explore the difference between two broad categories of molecular pathogen detection: PCR and isothermal technologies such as LAMP.

PCR & LAMP Detection Chemistries: An Overview

PCR detection chemistries have come a long way from non-specific DNA-binding dyes like SYBR Green, to highly precise sequence-specific molecular probes. The efficiency of the real-time PCR reaction today allows for the use of a variety of detection probes, the most popular being Dual-Labeled Fluorescent Probes such as FRET, TaqMan probes, and Molecular Beacon probes.1 The precision of these probes is showcased in their ability to distinguish allelic single-nucleotide polymorphisms (SNPs).2,3 The most prevalent isothermal chemistry, Loop-Mediated Isothermal Amplification (LAMP), typically does not use molecular probes due to the lack of structure and formation consistency in its amplified products. As a result, LAMP mostly relies on detection through non-specific signal generation like ATP bioluminescence or non-specific dyes. In theory, this could come from specific and non-specific amplification events. This also makes LAMP inept to detect the allelic polymorphisms, which in some cases are critical to detecting crucial variations, like between close species, and within serotypes. In the end, the detection chemistries are only as good as the amplified products.

Key Takeaways:

  • PCR technology has improved greatly in detection efficiencies via target specific probes
  • LAMP technology typically does not utilize specific molecular probes, but instead relies on indirect signal generation
  • Target specific probes ensures signal from specific amplification events only
  • Indirect signal can come from specific and non-specific amplification events, which can lead to a reduced specificity and inability to detect in certain cases

PCR & LAMP: Amplification Strategies

Food safety pathogen detection protocols aim to find the single cell of a target organism lurking in a relatively large sample. In order to achieve detection, molecular technologies utilize amplification strategies to increase the concentration of target DNA to a detectable level. Nucleic acid amplifications in both PCR and isothermal technologies start by making a variety of amplified products. These products include non-specific amplifications (NSA), and specific (target) amplifications.4,5,6,7 Ideally, the concentration of the desired target amplified product increases over time to levels above NSA where the detection chemistries are able to provide a detectable signal from the desired amplified product (target). Various reaction components such as: Target DNA concentration, polymerase, buffers and primers play a defining role in maintaining the progressive amplification dynamics, and thereby act as core contributors to the robustness of the reaction. However, none play a more crucial contribution to the success of a reaction than temperature. Herein lies a key difference between the fundamentals of PCR and Isothermal amplification technologies.

Key Takeaways:

  • PCR and LAMP both make a variety of amplification products: Non-Specific (NSA) and Specific (target)
  • Ideally, target products increase above the levels of NSA to reach a reliable detectable signal
  • A variety of factors contribute to the overall robustness of the reaction

What Is the Difference between PCR and Isothermal Detection Technologies?

A key foundational difference between the two technologies lies in the utilization of the thermal profiles. PCR utilizes thermocycling, while isothermal does not. This difference is the tether around how the different amplification chemistries work. In PCR, the cyclical denaturation of DNA during thermocycling separates all dimers (specific and non-specific). As the reaction progresses, this leads to frequent correction of the amplification dynamics away from the NSA and favors amplification of the desired target amplifications. Isothermal chemistries do not have the ability to correct the NSA through thermocycling, so it must rely on alternate mechanisms to achieve the same result. For example, LAMP utilizes “nested” primers where the primer sequences outside the target region are used to create early amplification products. These are subsequently used as a template for the desired target amplifications. The presence of these extra primers, along with the diverse amplified structures formed during the LAMP reaction, creates many more opportunities for NSA production.5,8,9 This causes a less controlled and inefficient amplification, and is perhaps why the preheating of the DNA prior to the LAMP has shown to increase the LAMP sensitivity.10, 11 To the end user, this inefficiency can manifest itself in various ways such as restricted multiplexing, lack of internal amplification control, complex assay design, tedious sample prep methods, and increased chance for inaccurate results (i.e., false positives and false negatives).12 Scientific literature does provide a fair amount of evidence that, under controlled conditions, the isothermal amplification reaction can provide equivalent results to PCR. Isothermal chemistries also usually require simplified instruments and thereby can present interesting opportunities in non-conventional test environments with simple and predictable matrices. This likely explains the early footing of isothermal technologies in the clinical test environment as a “point of care test” (POCT) alternative. However, it must also be noted that recently PCR has also been adapted and successfully commercialized for the POCT format.13,14

Key Takeaways:

  • PCR utilizes thermocycling, Isothermal does not
  • In PCR, thermocycling allows for the reaction to favor the target amplification over the NSA
  • LAMP must rely on alternate mechanisms to correct for NSA and these mechanisms lead to a less controlled and therefore inefficient amplification
  • Under controlled conditions, isothermal technology can provide equivalent results to PCR
  • Low instrumentation requirements make isothermal technologies interesting for non-conventional test environments (i.e. POCT); however, PCR has also been recently adapted as a POCT

Internal Amplification Controls in Molecular Pathogen Detection Technologies: The Value & The Challenges

The purpose of an internal amplification control (IAC) is to provide an indication of the efficacy of the test reaction chemistry. The closer the IAC is to the target DNA sequence, the better view into the inner workings of each reaction. For food microbiology testing, the role of the IAC is more important now than ever. Driven by regulations, industry self-accountability and brand protection initiatives, more food laboratories are testing diverse product types with novel and innovative formulations and ingredients. IAC capability not only helps with troubleshooting, but it also allows for a more confident adoption of the technology for new and diverse food and environmental matrices.

Over the years, PCR has progressively developed into a robust and efficient technology that can provide a dynamic IAC, giving the end user a direct look into the compatibility of the test matrix within the PCR reaction. From a single reaction, we can now make a qualitative assessment of whether the crude DNA prep from a matrix undergoing testing is working with this PCR or if it is inhibiting the reaction. With legacy technologies, including the older generation PCR’s, we were limited to an “it-did-not-work” scenario, leaving the end user blind to any insights into the reason. Since isothermal chemistries typically do not have an IAC, the end user is vulnerable to false results. Even when isothermal chemistries such as nicking enzyme amplification reaction (NEAR) can provide IAC, they typically do not mimic the target reaction and, therefore, are not a direct indicator of the reaction dynamics. This limits the end user back to the “it-did-not-work” scenario. LAMP technology attempts to mitigate the absence of IAC by performing a separate and external reaction with each test matrix. This strategy leaves the final result vulnerable to a number of factors that are otherwise non-existent for IAC: Sampling variations, reagent and machine anomalies, and user error. External control approaches also have a notable impact to the end user, as the burden to demonstrate fit-for-purpose of the method for even the smallest matrix composition change increases both validation and verification activities, which can have a notable financial impact to the laboratory.

There are a few reasons why IAC incorporation is not always plausible for isothermal technologies such as LAMP. First, inefficient, less-controlled amplification reactions leave little room for reliable and meaningful supplementary reactions, like the ones required for IAC. Second, the lack of consistent amplified products make it much more difficult to pinpoint a DNA structure that can be dependably used as an IAC. Third, lack of specific detection mechanisms makes it hard to distinguish signal from the target versus the IAC reaction.

Key Takeaways:

  • Internal amplification controls (IAC) are critical for the food industry due to complex and ever-changing matrix formulations
  • IAC is useful for troubleshooting, optimizing assay performance, and adapting test for novel matrices
  • PCR has evolved to provide dynamic IAC, leading to increased confidence in results
  • LAMP is not able to utilize IAC due to the nature of the amplification products, reaction efficiency, and lack of specific detection mechanisms

Follow the link to page 2 below.

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How Workflow Advances Raise the Bar in LC-MS/MS Veterinary Drug Quantitation

By Ed George
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In the modern world, it’s often taken for granted that consumers can head to their local grocery store and fill their baskets with a broad range of meat, poultry, fish and dairy produce. Yet the plentiful availability of these products is possible, to a large extent, thanks to modern farming methods that rely on veterinary drugs to promote healthy animal growth, protect livestock from contracting diseases, and in some cases provide aesthetic qualities to food.

Despite the important role veterinary drugs play in farming and food production, usage must be carefully controlled, as their inappropriate administration can have adverse effects on animals, the environment and human health. A particular concern is the growing problem of antimicrobial resistance, which can be promoted in the environment by the overuse of some of these veterinary drugs.

As a result, the analysis of veterinary drugs forms an important part of routine food safety and quality control testing. However, the wide range of residue concentrations required to be quantified, along with the diverse sample matrices and chemical properties of multiple classes of veterinary drugs placed in a single analytical method, pose significant analytical challenges. The latest multi-residue, multi-class analytical workflow solutions using a generic sample preparation method and liquid chromatography tandem mass spectrometry (LC-MS/MS) are overcoming these issues to provide a robust, sensitive method for the extraction, detection, confirmation, and quantitation of veterinary drugs below their required maximum residue limits (MRLs).

Meeting the Needs of Veterinary Drug Analysis Workflows

Given the need to accurately and reliably quantify veterinary drugs in food, testing workflows must be both sensitive and operationally robust. Importantly, workflows must be amenable to a variety of different matrices, including meat, fish and dairy, and should be capable of screening for drug molecules with a broad range of physicochemical properties. The sample preparation protocols that are employed must minimize the loss of analytes and be sufficiently simple and cost effective to enable routine laboratory use. Additionally, the separation steps that are employed must be sufficiently rugged and should ideally be able to handle any analyte and matrix. Finally, the methods used to identify and quantify samples must be sufficiently selective and sensitive to detect and confirm drug molecules and their metabolites at trace levels.

Developing methods that can meet all of these criteria for a wide range of drug molecules and food matrices, while minimizing the potential for false positive and negative results, is not straightforward and has proven challenging for the industry. As a result, many analytical methodologies have emerged that are typically limited in scope to a limited number of residues or specific chemical classes, are labor intensive, and require extensive sample preparation and clean-up. Fortunately, ongoing advances in veterinary drug analysis workflows are helping to drive the adoption of standardized protocols that have universal applicability.

QuEChERS: Making Sample Preparation Quick, Easy and Reliable

Sample preparation is a key first step in veterinary drug analysis workflows, but its importance is often overlooked. Even with the most advanced downstream separation and detection technologies, workflows are liable to generate poor quantitative results without reliable residue extraction methods.Having robust sample preparation protocols is especially important given the heterogeneous nature of the sample matrix and the different physicochemical properties of the residues that must be extracted.

Traditional approaches, based on sample homogenization and multi-step solvent extraction procedures, were time-consuming and did not always produce consistent results. The loss of residues during sample grinding or through the formation of insoluble drug-matrix complexes would often impact the accuracy of measurements. Moreover, the need for labor-intensive sample cleanup steps, based on separation methods such as gel permeation chromatography, added additional complexity to workflows.

The widespread adoption of universal sample preparation protocols based on QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) methods has simplified the process of extracting veterinary drugs from matrix samples. These approaches have been specifically designed to be quick and easy to implement, and enable high extraction efficiency with a very broad range of chemical properties from a variety of matrices. As a result, QuEChERS has proven to be a very reliable means of preparing samples for veterinary drug analysis.

The universal suitability of the QuEChERS approach has reduced the complexity of sample preparation workflows to such an extent that many suppliers now offer kits containing pre-weighed reagents that can be used straight from the box. Moreover, because they only require small amounts of sample and solvent, and little in the way of equipment, these easy-to-use methods are helping laboratories minimize waste and make workflows more cost-effective.

Triple Quadrupole MS: Design Improvements Driving Exceptional Sensitivity

LC-MS/MS has rapidly established itself as the go-to technique for sensitive and reliable veterinary drug analysis, with set-ups based on ultra-high performance liquid chromatography (UHPLC) systems and triple quadrupole mass spectrometers proving to be particularly effective. With drug residues typically on the parts per billion scale, these systems have proven to be more than capable of delivering the level of performance that’s required when working with analytes that require low detection limits.

What’s more, recent advances in triple quadrupole mass spectrometer technologies are pushing the limits of quantitation even further. Improved instrument designs based on segmented quadrupoles, more powerful electron multipliers and enhanced ion transmission optics are enabling food analysis laboratories to achieve even greater levels of experimental sensitivity, mass accuracy, selectivity and precision. These performance improvements are allowing analysts to make more confident decisions around every sample.

ion chromatogram, salmon extract sample
Figure 1. Total extracted ion chromatogram of salmon extract sample at 1× STC. Results obtained using a Thermo Scientific Vanquish Flex Binary UHPLC system and a Thermo Scientific TSQ Altis triple quadrupole mass spectrometer. (Click to enlarge)

The capabilities of the latest generation of triple quadrupole LC-MS/MS systems for quantitative veterinary drug analysis were put to the test in a recent study. More than 170 veterinary drugs were added directly to a variety of homogenized matrices, including bovine muscle, milk, and salmon fillet using a QuEChERS sample preparation protocol to create a series of matrix extracted spikes (MES). The concentration of residues in the MES samples referenced a chosen screening target concentration (STC), which was typically one-third to one-quarter of the defined European Union MRL for each residue/matrix combination. Figure 1 presents the total extracted ion chromatogram for an MES sample of salmon fillet at the STC, obtained with a binary UHPLC system and a triple quadrupole mass spectrometer.

For each analyte, calibration curves were constructed using replicate measurements of each of the MES samples at seven concentrations ranging from one-fifth to five times that of the STC. Figure 2 highlights the calibration curve constructed for ethyl violet, a therapeutic dye used in aquaculture, in

Calibration curve, salmon extract
Figure 2. Calibration curve generated for ethyl violet in salmon extract (0.2–5.0 ng/g). (Click to enlarge)

the range 0.2 to 5.0 ng/g (STC = 1 ng/g). The calculated method detection limit of 0.03 ng/g for this compound in salmon fillet demonstrates confidence in the results well below the minimum required performance limit (MRPL).

LC-MS/MS: Leading the Way in Workflow Robustness

With potentially hundreds of samples to analyze every week, veterinary drug analysis workflows not only demand the highest levels of sensitivity, but also exceptional speed and robustness.
One way in which greater throughput can be achieved is by using shorter instrument dwell times, an experimental optimization that allows more compounds to be analyzed within a given timeframe during a chromatographic separation. Traditionally, the use of shorter dwell times would typically require sacrificing some measurement sensitivity. However, the latest advances in triple quadrupole instrument design are ensuring short dwell times no longer come at the expense of analytical performance.

Timed selected dreaction monitoring (SRM) is an effective strategy that allows analysts to overcome this challenge to achieve sensitivity with high throughput. Using timed SRM, data acquisition occurs within a short retention time window. This reduces the number of transitions that are monitored in parallel for each residue peak, while ensuring consistent quantitation even at low concentrations. Instrument control system software can automatically optimize the SRM conditions across the chromatographic run, maximizing operational efficiency with minimal need for manual input.

Instrument uptime is another factor that is of paramount importance for veterinary analysis workflows. With large workloads and tight turnaround times, regular instrument recalibration and frequent maintenance can be a major frustration for busy food testing laboratories. UHPLC is renowned for its operational robustness and suitability for fast-paced routine screening workflows, and the latest instruments are taking this reputation to an even higher level.

Comparison of injections of bovine muscle extract
Figure 3. Comparison of injections of bovine muscle extract MES at 3× STC over 500 injections (A: injection #20; B: injection #260; C: injection #500). Analytes shown: cyromazine (black), ciprofloxacin (red), sulfamethoxazole (green) and flunixin (blue). (Click to enlarge)

Figure 3 compares injections of bovine muscle extract at 3× STC over a 500-injection run that took place over a period of one week, obtained using the experimental set-up described earlier. Despite continuous operation over this extended period, the peak shape, intensity and retention time stability are maintained. These results further highlight the robustness of the LC-MS/MS system for routine veterinary drug testing.

Conclusion

Enforcing the responsible use of veterinary drugs in farming and food production depends upon comprehensive, sensitive, robust and reliable workflows capable of delivering quantitative results. Advances in sample preparation techniques and LC-MS/MS technologies are setting new standards when it comes to confident multi-residue veterinary drug analysis. From the development of reliable easy-to-use QuEChERS protocols, through to robust UHPLC separation methods and sensitive triple quadrupole mass spectrometers, improvements across the workflow are driving exceptional performance—whatever the matrix, whatever the residue.

Melanie Bradley, Partech

Tech Spotlight: Using Technology to Improve Processes in the Supply Chain

By Melanie Bradley
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Melanie Bradley, Partech

Whether driven by regulatory factors or brand protection, the food industry has adopted advanced monitoring and management technologies to maintain and support modern day food safety cultures and operations within companies. This type of technology utilizes checklists and sensors designed to monitor and gather data. Typically, these are built into handheld devices that store collected information in the cloud. The stored data is instantly accessible for management to monitor. Additionally, the FDA demands that two years worth of records be on hand during an inspection. Instead of sorting through copious piles and file drawers of paper, the information can be pulled directly from the database and presented to the inspectors.

In an effort to improve the operation, food companies should adopt new processes to be proactive and ditch the old days of manually tracking and recording temperature data. Utilizing this type of technology ensures consistency, transparency and quality. Not to mention the increase in efficiency and savings over time.

Perhaps the most powerful technological methodology to implement is using the Internet of Things (IoT) to improve processes in the supply chain. How is IoT relevant for a food safety strategy? In an integrated approach to food safety, IoT temperature sensors dispersed throughout the cold and hot food chain, coupled with a food safety/task management system for taking HACCP (Hazard Analysis and Critical Control Points) required food safety temperature measurements, provides unprecedented visibility and traceability, for an end-to-end food safety strategy for grocery stores or restaurants. It’s worth noting that customers are not necessarily looking for an IoT solution when they start the process for acquiring a solution for monitoring coolers/freezers or grills, but for an automated temperature monitoring system whose data is cloud-based and just so happens to be available via the internet.

Data from IoT sensors dispersed through the food chain is continually collected and analyzed to ensure temperatures do not exceed pre-defined limits. These limits are based upon HACCP guidelines. The collected data is then subsequently stored electronically for a period specified by the user, typically up to two years from the collection date per FSMA regulations. If a temperature measurement falls outside pre-defined limits, an alert via text or SMS can be sent to the end-user for corrective actions. Recent developments in IoT have also coupled active monitoring with predictive analytics to determine appliance health.

Should an issue occur in the food chain, food safety data would then be correlated with transactional data to not only define when a limit was exceeded, but to potentially trace the impact to the consumer or in- store sales/profitability. Additionally, high or low sales of a specific item could also be equated to how the item is prepared.

Utilizing checklists that guide operational efficiency, powered by IoT technologies is not only limited to food safety. The capabilities of IoT can be deployed for task management or facilities maintenance practices such as entry/exit applications, facility maintenance/sweep logs, CO2 sensing (beverage and condiment), customer queue length for ordering or check out and incident reporting—when the documentation of an incident is required should a customer or employee incur an injury within the facility.

The implementation of comprehensive end-to-end food safety and task management strategy utilizing remote monitoring based upon IoT promises to provide businesses with a new cornerstone for building a comprehensive and preemptive food safety and facilities plan. By meeting the strict requirements of HACCP regulations, companies can continually reduce operational expenses, decrease waste and potentially predict events that could affect the food chain and subsequently the consumer. An integrated approach to food safety utilizing a food safety/task management system with IoT can positively influence all consumers within the restaurant, grocery and food chain realms.