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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.
Matthew Botos, ConnectFood
FST Soapbox

Food Entrepreneurial Trends

By Matthew Botos
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Matthew Botos, ConnectFood

Over the last two decades I have had the utmost privilege to work with food manufacturers from every sector. From dried goods, meats, poultry, school lunches programs, etcetera. I have seen almost everything. The leading trend I have seen over the last 20 years is the steady rise of beverage companies. Everyone likes a different type of beverage: Water, juice, cold coffee, teas, energy drinks, kombucha… the list goes on. The two most important things a small company entering the market needs to remember is to make sure that first, you can comply with the regulators, and second, that the people you are selling your products to also understand their market (buyers and retailers).

The marketplace loves new and innovative products. We need, as an industry, to continue to support innovation in the beverage industry. Healthcare trends, nutraceuticals, supplements, and “fresh” are some of the many things consumers are looking for in a product. We often have questions such as, “I have the perfect recipe for a new beverage product—how do we get it out into the market?” The first question to ask yourself is: Do you understand your product and its intended use? And, second: Do you understand how the physical properties of this product impact how it will need to be transported as well as stored and used by the final consumer? Both of these questions come back to—and can be answered by—food safety. Companies can have the greatest product ideas; however, if you do not have the ability to make sure it has a safety factor during transportation, as well as the ability to communicate your food safety plan, an entrepreneur can jeopardize the future of their company before it is even allowed to begin.

I have used the analogy that food safety best practices are like a sport—the more you train, practice and focus on the “basics done well,” the better your plan will be on a day-to-day basis. Bottom line: The focus is making the food supply safer. Please take note the transition to new practices does not mean that an existing HACCP plan (Hazard Analysis and Critical Control Points) is invalid! As a matter of fact, HACCP and Good Manufacturing Practices (GMP’s) should be looked at as the foundation of FSMA’s Preventive Controls for Human Food. Local departments of public health still rely on HACCP as their main line of defense for the food safety industry. We have seen so many small processors and restaurants that have inspections where HACCP is still the focus, even though Preventive Controls has some more advanced techniques for protection. Both HACCP and Preventive Controls focus on making sure you have good sanitation practices, employee training, and have done a hazard analysis for biological, chemical and physical hazards. I believe the lines are blurring a bit—companies, academics and regulators don’t often understand the differences between the two and, to be honest, the differences are not that substantial from a fundamental level. Ultimately, companies are responsible for their own food safety best practices.

As we trend toward new and innovative beverage concepts, we need to be partners with both our regulators and our customers. There is so much information across the United States and companies that are in emerging markets will only grow and develop if they have proper food safety plans as a foundation. Emerging companies should get connected early and learn from other companies and organizations, and become more proactively involved in the food safety element of their product.

I believe 2019 will be an incredible year for the rise of food and beverage startups. We have already seen much growth in the knowledge of food supply due to easily accessible information about products. Keeping a transparent conversation with regulatory personnel and customers is key to the success of any food or beverage company.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Bee Careful What You Eat

By Susanne Kuehne
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Susanne Kuehne, Decernis
Food Fraud, honey
These types of records can be found in the Food Fraud Database
Image credit: Susanne Kuehne

One of China’s most famous health brands has been banned from making honey and issued a steep fine in China after selling expired honey. For a long time, the brand’s “Premium” honey was a supposedly safe alternative in China compared to “fake” honey, mixed with sugar syrup.

Resource

Executives of TCM company in trouble over honey
Wen, X. (February 13, 2019). Executives of TCM company in trouble over honey. Accessed February 13, 2019. Retrieved from http://www.chinadaily.com.cn/a/201902/13/WS5c635b26a3106c65c34e8fba.html

Food Safety Consortium - October 1-3, 2019 - Schaumburg, IL

Industry Experts Darin Detwiler and Randy Phebus Join Food Safety Consortium Conference & Expo Advisory Board

By Food Safety Tech Staff
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Food Safety Consortium - October 1-3, 2019 - Schaumburg, IL

EDGARTOWN, MA, Feb. 19, 2019 – Innovative Publishing Co., the publisher of Food Safety Tech and organizer of the Food Safety Consortium Conference & Expo has added two distinguished industry leaders to its Advisory Board for this year’s Consortium event, which takes place October 1–3. Randall Phebus, Ph.D., interim director at the Food Science Institute and professor of food safety & defense at Kansas State University, will serve as chairperson for the Testing track at the Food Safety Consortium Conference & Expo, and Darin Detwiler, lead faculty for regulatory affairs of food and food industry, and assistant teaching professor at Northeastern University, will chair the Food Safety Leadership and Management track. Detwiler and Phebus will have a significant role in organizing these tracks to ensure that the sessions are accurate, relevant and meaningful for attendees.

“The addition of Darin Detwiler and Randy Phebus to the Food Safety Consortium Conference & Expo Advisory Board is an important step in further expanding the wealth of expertise brought to this annual event,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference and Expo. “Darin and Randy are highly respected professionals in this industry, and I am delighted to work with them and to help deliver their insights to Consortium attendees.”

2018 Food Safety Supply Chain Conference, Blockchain
A dynamic panel about blockchain, led by Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University at the 2018 Food Safety Supply Chain Conference

Detwiler has been a member of the Food Safety Tech and Food Safety Consortium Advisory Board for two years and has made strong contributions to the content at the organization’s events, including most recently leading panel discussions on blockchain at last year’s Food Safety Supply Chain Conference and the 2018 Food Safety Consortium. Phebus is joining the Advisory Board for 2019 and will be providing critical perspectives in the area of food microbiology, food safety testing and environmental control.

Detwiler and Phebus join Angela Anandappa, Ph.D., who was announced as the chairperson for the 2019 Food Safety Consortium Conference & Expo’s Sanitation track.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo

The Food Safety Consortium Conference and Expo is a premier educational and networking event for food safety solutions. Attracting the most influential minds in food safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. This year’s event takes place October 1–3 in Schaumburg, IL.

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.

magnifying glass

FDA Report on E. Coli Outbreak in Romaine Lettuce Points to “Significant” Finding of Strain in Sediment of Water Reservoir

By Maria Fontanazza
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magnifying glass

The November 2018 outbreak of E.coli O157:H7 infections linked to romaine lettuce caused 62 illnesses across 16 states. The FDA zeroed in on the Central Coast growing regions of northern and Central California as being responsible for the contamination. The outbreak was declared over on January 9 and yesterday FDA released the report, “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”, which provides an overview of the investigation.

The report states that a sediment sample coming from an on-farm water reservoir in Santa Maria (Santa Barbara County, California) tested positive for the outbreak strain of E. coli O157:H7. Although this particular farm was identified in several legs of the Fall 2018 traceback investigations that occurred in the United States and Canada, as well as being a possible supplier of romaine lettuce in the 2017 traceback investigations, the FDA said that the farm is not the single source of the outbreak, as there is “insufficient evidence”. The traceback suggests that the contaminated lettuce could have come from several farms, because not all tracebacks led to the farm on which the contaminated sediment was found.

“The finding of the outbreak strain in the sediment of the water reservoir is significant, as studies have shown that generic E. coli can survive in sediments much longer than in the overlying water. It’s possible that the outbreak strain may have been present in the on-farm water reservoir for some months or even years before the investigation team collected the positive sample. It is also possible that the outbreak strain may have been repeatedly introduced into the reservoir from an unknown source,” stated FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas in a press announcement.

(left to right) Stic Harris, FDA; Matt Wise, CDC; Dan Sutton, Pismo Oceano Vegetable Exchange; Scott Horsfall, California Leafy Greens Marketing Agreement discuss the first E.coli outbreak involving romaine lettuce during a panel at the 2018 Food Safety Consortium. Read the article about the discussion.

Although the exact route of contamination cannot be confirmed, the FDA hypothesizes that it could have occurred through the use of agricultural water from an open reservoir, which has increased potential for contamination.

The investigation teams also found evidence of “extensive” wild animal activity and animal burrows near the contaminated reservoir, as well as adjacent land use for animal grazing, all of which could have contributed to the contamination.

Although FDA did not directly name the farm in the report, it provided a link about the recall that was initiated by the farm, Adam Bros. Farming, Inc., in December.

Considering the significant effect that the past two E.coli outbreaks involving romaine lettuce have had on both the public as well as the produce industry, FDA made several recommendations on preventive measures that leafy greens growers and industry can take to avoid such pathogenic contamination, including:

For growers:

  • Assessing growing operations to ensure they are in line with compliance to FSMA and good agricultural practices
  • Making sure that any agricultural water that comes into direct contact with the harvestable portion of the crop, food contact surfaces and harvest equipment is safe and sanitary
  • Address and mitigate risks associated with agricultural water contamination that can occur as a result of intrusion by wild animals
  • Address and mitigate risks associated with the use of land near or adjacent to agricultural water sources that can lead to contamination
  • Conduct root cause analysis whenever a foodborne pathogen is identified in the growing environment, agricultural inputs like water or soil, raw agricultural commodities, or “fresh-cut” ready-to-eat produce

For the broader industry:

  • The development of real-time procedures that enable rapid examination of the potential scope, source and route of contamination
  • All leafy green products should have the ability to be traced back to the source in real time, and information include harvest date. In November, FDA requested voluntary labeling [https://foodsafetytech.com/news_article/cdc-alert-do-not-eat-romaine-lettuce-throw-it-out/] to help consumers identify products affected during an outbreak
  • The adoption of best practices in supply chain traceability

Resources

  1. FDA report: “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”
  2. FDA statement from Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas
  3.  FDA investigation of source of E.coli O157:H7 outbreak linked to romaine lettuce
FDA

Routine Produce Inspections to Start in Spring, FDA Offering Compliance Support

By Food Safety Tech Staff
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FDA

After FDA delayed product inspections under FSMA to further prepare industry and ensure there was enough training and education, the agency is reminding farmers and other stakeholders in the produce industry that there are resources available to help them in preparing for the routine inspections—for large farms, these will start in the spring. The inspections will be conducted to verify compliance with the Produce Safety rule.

Resources include the FDA’s produce safety inspections page on its website to serve as a central resource for industry and state partners during the inspection preparation process and the draft guidance, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”.

An FDA Voices blog by FDA Commissioner Scott Gottlieb, M.D., Deputy Commissioner for Food Policy and Response Frank Yiannas and Associate Commissioner of Regulatory Affairs Melinda Plaisier also discussed how the agency has been supporting industry work to comply with the rule, including:

  • Granting 46 states and one territory with more than $85 million through the State Produce Implementation Cooperative Agreement Program to aid in the development of state produce safety systems that offer education, outreach and technical assistance
  • With partners, supporting the training of more than 31,000 produce farmers globally on the Produce Safety rule requirements
  • The sharing of expertise via the FDA’s Produce Safety Network
  • With partners, the creation of a new inspection form that gives farms feedback and observations that occurred during the inspection, regardless of whether non-compliance issues were found, in an effort to help explain what they’re looking at and how observations apply to the produce rule
Karen Everstine, Decernis
Food Fraud Quick Bites

How Food Fraud Happens

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

The food industry has been hard at work over the past few years implementing food fraud mitigation plans in response to Global Food Safety Initiative (GFSI) certification program requirements. GFSI defines food fraud as:

“A collective term encompassing the deliberate and intentional substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, labelling, product information or false or misleading statements made about a product for economic gain that could impact consumer health.” (GFSI Benchmarking Requirements, 2017)

GFSI then further defines the terminology of food fraud by citing seven categories (shown in the following diagram).

GFSI, Food Fraud
Used with permission from GFSI

In the Food Fraud Database, we categorize food fraud records using the following terminology (with examples):

  • Dilution/substitution
    • Substitution of an entire fish fillet or partial dilution of olive oil with another oil
  • Artificial enhancement
    • Addition of melamine to artificially increase the apparent protein content of milk or the addition of coloring agents to spices
  • Use of undeclared, unapproved, or banned biocides
    • The use of chloramphenicol in honeybee populations (where not permitted) or the addition of hydrogen peroxide to milk
  • Removal of authentic constituents
    • The sale of “spent” spice powder (used in the production of an oleoresin) as a whole spice powder
  • Misrepresentation of nutritional value
    • Infant formula that does not contain the required nutritional content
  • Fraudulent labeling claims
    • Misrepresentation of label attributes related to production method (organic, kosher, halal, etc.)
  • Formulation of an entirely fraudulent product (using multiple adulterants and methods)
    • The sale of “100% apple juice” that consists of sugar, water, malic acid, flavor, and color
  • Other
    • This includes counterfeits, theft, overruns, etc.

Harmonization of food fraud terminology is frequently discussed, so I thought it might be useful to provide information on how our definitions relate to the GFSI terminology:

GFSI category “Dilution”: This category maps directly to our category dilution/substitution. The reason we combine these into one category is that the intent is the same: To replace the weight or volume of a product. This can occur either through partial or full substitution of a liquid product, a granulated product, or swapping an entire intact product such as a fish filet. One of the GFSI examples for substitution is “sunflower oil partially substituted with mineral oil”, which could just as accurately be described as dilution.

GFSI category “Substitution”: As noted above, this category maps directly to our category dilution/substitution. However, we would not consider the use of hydrolyzed leather protein in milk (one of the cited examples) to be dilution/substitution because it is not used to replace weight or volume. We would view that as artificial enhancement of the protein content of milk.

GFSI category “Concealment”: We do not include a category focused on concealment because all food fraud involves concealing some aspect of the true contents of the food. One of the examples cited in this category is “poultry injected with hormones to conceal disease.” The use of antibiotics, anti-fungal agents or other substances to reduce bacterial load or mask deterioration would be classified, in our system, as the use of undeclared, unapproved or banned biocides. The use of coloring agents on fruit to improve appearance would also be classified as artificial enhancement.

GFSI category “Mislabeling”: Since all food fraud is, to some extent, mislabeling, we reserve the use of the term fraudulent labeling claims to those label attributes that describe production processes (organic, kosher, etc.). With the exception of falsification of expiration dates, the other examples cited would not be classified by us as mislabeling. The sale of Japanese star anise, which is potentially toxic, as Chinese star anise (a different species) is dilution/substitution and a health risk to consumers. The sale of cooking oil that has been recovered from waste streams and illegally produced is also a form of substitution that poses a potential health risk to consumers.

GFSI category “Unapproved enhancements”: This GFSI category aligns nicely with our category artificial enhancement, and both examples cited are nicely illustrative of the concept, which involves the fraudulent addition of a substance specifically for its function (not as a replacement for weight or volume).

GFSI Category “Gray market production/theft/diversion”: The production and sale of food products through unregulated channels would all be classified in our category called other. Because these forms of food fraud involve the sale of food outside of regulatory control, prevention measures will generally be substantially different from the prevention of fraud within legitimate supply chains.

GFSI Category Counterfeiting: This GFSI category is similar to the gray market production/theft/diversion category in that it involves intellectual property infringement and production outside of regulatory control. It would similarly be classified in our other category.

FDA

FDA Final Guidance Informs Companies on When to Notify Public about Food Recalls

By Food Safety Tech Staff
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FDA

FDA has issued a final guidance that reviews the situations in which a company should warn the public about a voluntary food recall. This includes the appropriate timeframe for issuing the warning and what information a company should include in the warning. The guidance, “Public Warning and Notification of Recalls”, also discusses when the FDA may decide to take action to issue a public warning, should one that a company issues is not sufficient.

In an agency statement, FDA Commissioner Scott Gottlieb, MD., also addresses the buzz around folks feeling that there have been more recalls. “In actuality, for fiscal year 2018, there were a total of 7,420 recalls with 831 that were classified as the highest risk. That figure represents a five-year low in recalls. However, the reason why recall notices might seem to have increased is that our publicizing of these events has become more prominent,” said Gottlieb. “We’re routinely providing more information on recalls and other safety issues that have happened.” He added that the ability to detect, track and trace product issues has improved with the help of technology, including whole genome sequencing.

“Our labs are currently testing cutting-edge technology that can screen for multiple allergens simultaneously and even technology that shrinks the genetic testing of pathogens from machines that were once the size of an entire room to a device that’s smaller than many smart phones. We’ll also be working to improve product traceability by tapping into modern approaches, such as blockchain technology, to further advance our mission of protecting public health.” – Scott Gottlieb, M.D., FDA

In addition, the agency is looking at how new technologies can be used notify consumers about whether a product they purchased has been recalled.

Shawna Wagner, DNV GL
FST Soapbox

How to Strengthen Your Audit Score

By Shawna Wagner
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Shawna Wagner, DNV GL

It is one week before your scheduled audit. Are you running around from department to department crossing the T’s and dotting the I’s, or are you cool, calm and collected, as it is just another audit? More than likely you have been in both cases, but how does one finally get to the collected stage? It is not about being nervous—even as a lead auditor I get nervous (I am human, too)— it is about being ready!

Believe it or not, I can generally gage if the audit is going to flow well within the first hour of arrival. My questions from audit to audit of course change, but overall, I am asking for the same materials and results. If the team is getting baffled by questions in the beginning stages of the audit, I know I am in for a long ride. Why does this happen? If the situation has gone down hill rather quickly, I find that whomever at the plant is responsible for the implementation of the audit standard, has never taken the time to read or review it. That, my friends, is one of the most critical mistakes you can make. I know these standards are not world-class bestselling books that you are dying to binge read by the fireplace with a glass of wine—if this was your view, you would be an auditor already. HA! The standards are not always black and white as far as requirements, but just taking the time to read the standard will enhance your understanding of where the auditor is coming from.

Now you have read the standard, you understand it and are comfortable. You have a 200,000 square-foot facility, 200 employees and four different HACCP plans to watch over. How could you possibly score an excellent, “A”, pass, whatever the top score may be defined as? I am sure you have heard the expression, it is not all about you, and that holds true for audits. So many times I have witnessed that the quality manager (or equivalent) try to undertake the entire audit from start to finish and answer all the questions. This is not a best-practice approach. A good example here would be that many audits now talk about annual objectives and key performance indicators. As an auditor, I expect that your plant manager (or equivalent key person responsible) come talk about these with their senior management. Too often I see the quality department commit to answering these questions, but as an auditor, I am interested in your system and how it works throughout your entire facility. I do not just want to know about the quality department. Get all departments involved. They, too, then get firsthand experience of understanding what the audit requirements are, instead of just reading endless emails of what needs to be accomplished.

Teamwork and understanding are now established—great! How strong are your programs? There are a few programs I want to touch on here, including your internal audit program and procedures. I can not write this article and tell you “X” is the solution, as there is not a one-size-fits-all approach. If you are spending two hours on an annual internal audit for a facility like the one mentioned above, it is possible that your program is lacking robustness. When conducting an internal audit and a requirement is in compliance, do you write what made it in compliance, what you reviewed, and with whom you spoke? This is a great way for you to compare what you see in your plant versus what an auditor sees in your plant, especially if you built your internal audit from an audit standard. How about your sanitation program? I came from a background of meat inspection, so maybe I am a bit biased, but your sanitation is encompassed with other pre-requisite programs in the facility. If your facility has untidy locker rooms, cafeterias and bathrooms, what motivates the employees to be tidy on the production floor? Sometimes it is the small things that go a very long way. In talking about sanitation, I have observed that many site managers never go in to watch your pre-operational inspections that may take place very early in the morning. Just because it is not on first shift, does not mean it is not important, and it also does not mean that it will not be audited. Likely, it will be audited!

Lastly, take all nonconformities that you have found either through internal or external audits, respond to them in a timely fashion, and get the root causes and preventative actions in place! Nothing pains me more then to see sites repeat a nonconformance, just to possibly get a major conformity. It’s like shooting yourself in the foot and your audit score takes an unnecessary plunge that could have been avoided.

Audits are not a fad and are not going away. It does take way more time to get to the cool, calm and collected stage for audits, but in the end, being audit ready all the time looks good on you and your site!