The food system is rapidly evolving—from new foods, to new formulations, to new production and delivery methods. As a whole, the industry is pushing into untapped areas, facing supply chain challenges, and responding to unique market demands, including those that have quickly emerged as a result of the COVID-19 pandemic (e.g., e-commerce, new delivery models, virtual inspections).
To keep pace with all this change, the Food & Drug Administration (FDA) announced the New Era of Smarter Food Safety in April 2019. On July 13, 2020 (delayed from Spring 2020 due to COVID-19-related issues), the Administration subsequently published the New Era of Smarter Food Safety Blueprint. This blueprint outlines the approach FDA will take create a New Era of Smarter Food Safety that evolves along with food technologies and systems—and the impacts these changes will have on the food industry and consumers alike.
New Era: What to Expect
According to FDA, “The New Era of Smarter Food Safety represents a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.” That being said, the Administration further notes that “smarter food safety is about more than just technology. It’s also about simpler, more effective, and modern approaches and processes. It’s about leadership, creativity, and culture.”
Correspondingly, the New Era is built on four core elements to support FDA’s ultimate goal of reducing foodborne illness:
- Tech-Enabled Traceability
- Smarter Tools and Approaches for Prevention and Outbreak Response
- New Business Models and Retail Modernization
- Food Safety Culture
Importantly, the New Era does not replace or negate the progress of the Food Safety Modernization Act (FSMA). Rather it builds on FSMA’s science and risk-based protections and uses them as the foundation for integrating more data, better analytics, and technological advancements going forward. FSMA’s full implementation remains a priority for the FDA. In FDA’s words, the New Era is “people-led, FSMA-based, and technology-enabled”.
Building the Blueprint
The New Era of Smarter Food Safety Blueprint is the roadmap FDA will follow to build its New Era and further food safety modernization under the FSMA rules. The blueprint includes goals to:
- Enhance traceability
- Improve predictive analytics
- Respond more rapidly to outbreaks
- Address new business models
- Reduce contamination of food
- Foster the development of stronger food safety cultures
Each of these goals is addressed by the core elements and the following actions, as outlined in the blueprint, which will be implemented over the next decade:
Core Element 1: Tech-enabled Traceability. Food traceability is the ability to track any food through all stages of the supply chain—production, processing, distribution—to ensure food safety and operational efficiency. The objective of Tech-enabled Traceability is to use technology to create traceability advancements, including implementing rapid tracebacks, identifying specific sources, and helping to quickly remove products from the marketplace when necessary. Beyond technology, part of this effort involves harmonizing efforts to follow food from farm to table by creating similar data standards across government and industry. As public health agencies increasingly rely on electronic data in outbreak investigations, quality and compatibility must be addressed to more quickly and accurately trace the origin of contaminated food. Blueprint actions include:
- Developing foundational components
- Encouraging and incentivizing industry adoption of new technologies
- Leveraging the digital transformation
Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response. One of the most powerful resources available to create this New Era is data. However, that power lies in collecting better quality data, conducting more meaningful analysis, and transforming data into more strategic, prevention-oriented actions. The blueprint seeks to strengthen procedures and protocols for conducting root cause analyses to identify how a food became contaminated and then for using predictive analytics to prevent future outbreaks. As under FSMA, the focus is on the preventive nature of modern food safety approaches. Blueprint actions include:
- Invigorating root cause analysis
- Strengthening predictive analytics capabilities
- Developing domestic mutual reliance
- Developing inspection, training, and compliance tools
- Improving outbreak response
- Implementing recall modernization
Core Element 3: New Business Models and Retail Food Modernization. How food is getting from farm to table is continually evolving. The recent pandemic is a prime example, as it has brought huge growth in distribution channels, including e-commerce and food delivery, carryout, and pickup. The FDA and industry must be prepared for new business models that continue to emerge with marketplace demands and consumer needs. The address this, blueprint actions include:
- Ensuring safety of food produced or delivered using new business models
- Modernizing traditional retail food safety approaches
Core Element 4: Food Safety Culture. According to the Safe Food Alliance, “Food safety culture refers to the specific culture of a facility: the attitudes, beliefs, practices, and values that determine what is happening when no one is watching. A strong culture of food safety helps a facility both to prevent and catch deviations in their processes that impact the safety, quality, and legality of their products.” Improvements in food safety, foodborne illness, and outbreaks depend largely on food safety culture, even more than technology. A strong food safety culture has always been a prerequisite to effective food safety management and that will continue in the New Era. Blueprint actions include:
- Promoting food safety culture throughout the food system
- Further promoting food safety culture throughout the Agency
- Developing and promoting a Smarter Food Safety consumer education campaign
Incorporating into Operations
As FDA has recognized, there is a real need for more “real-time, data-driven, nimble approaches to help ensure a strong and resilient food system”. The New Era of Smarter Food Safety Blueprint is FDA’s way to get there. It will be up to players in the food industry to take the core elements of the blueprint and begin to incorporate them into operations. As FDA rolls out this initiative, organizations should consider doing the following:
- Implement an information management system to help coordinate, organize, control, analyze, and visualize the information necessary to remain in compliance and operate efficiently.
- Conduct third-party assessments to provide an outside perspective of food safety systems and compliance/certification.
- Explore technological advancements that allow for further digitization and promote more timely and accurate collection and management of important data.
- Conduct root cause analysis, as needed, to identify underlying issues and ensure similar problems do not occur in the future.
- Build a strong food safety culture that focuses on changing from a reactionary to a preventive mindset that promotes safety and quality.
Location: Chicago, Illinois
KTL is seeking a Consultant with 5-7 years of professional food safety consulting or relevant food industry experience to join our team. This individual will work under the direction of KTL Project Managers and Senior Consultants to manage and execute tasks for KTL’s food safety projects and meet client expectations. The Food Safety Consultant must have working knowledge of FDA, USDA, and GFSI requirements as they apply to food/food packaging manufacturing, processing, and distribution, and experience implementing/maintaining food safety documents and plans.
Responsibilities and tasks include the following:
- Providing HACCP, SOP, and SSOP development and implementation support
- Conducting gap assessments to FDA, USDA, and GFSI (i.e., IFS, BRC, FSSC22000, SQF) requirements
- Conducting relevant food safety training for clients
- Researching FDA, USDA, and GFSI regulatory requirements and maintaining standards updates
- Researching labeling regulatory review
- Interpreting third–party regulatory audits
- Reviewing, recommending, and coordinating efforts for environmental contaminants and pathogen testing program
- Working with clients and KTL senior staff to identify Food Safety Management System (FSMS) and program gaps and implement solutions for continuous improvement
- Maintaining and updating documents to ensure conformance and compliance consistency
- Participating in the development and management of KTL’s SharePoint® tools
- Assisting in growing clients and other business development efforts, as requested
- B.S. degree in food science, biology, chemistry, technology, microbiology, or other related life science
- 5-7 years of related food industry experience in Quality Assurance/Control; experience in cooking, processing, manufacturing dairy, low-acid canned food, meat, or seafood preferred
- Excellent communication and presentation skills
- Excellent research, analytical, writing, and organizational skills
- Microsoft SharePoint® and information management systems experience
- High–risk food or ingredients experience
- Understanding of food safety in food packaging
How to Apply
Forward a resume to firstname.lastname@example.org.
KTL is a management consulting firm providing EHS, sustainability, food safety, and quality consulting services to a wide range of industry, municipal, university, and government clients. Our focus is to build strong, long-term client partnerships and provide value-added solutions that simplify management systems, improve compliance, and establish more sustainable operations. KTL specializes in developing and implementing strategies, processes, and tools that complement our clients’ investments in existing programs and resources. Our highly qualified personnel have an in-depth knowledge of U.S. federal, state, and international EHS requirements; global food safety compliance; ISO management systems; and information management tools. Our consultants possess the education, work experience, and professional registrations necessary to provide value-adding consulting services to our clients.
Regulatory, customer, and industry standards require that Food Safety Management Systems (FSMS) and programs must be current at all times. They also require that any changes be verified and validated. Third-party assessments provide a means of confirming compliance specific to key programs, particularly when many certification audits are being postponed or limited in scope due to COVID concerns.
Focused Activity, Desired Results
As a focused activity, third-party assessments support food safety compliance and certification and respond directly to a company’s needs:
- Third-party assessments provide more direct coverage to evaluate specific program effectiveness and allow for a more focused understanding of existing strengths and improvement areas.
- Enlisting a qualified outside firm further provides an unbiased assessment, offers an opportunity to work with local resources, and allows for a more flexible timeframe.
- The assessment typically results in a report developed by a qualified source focused on closing corrective actions.
- It minimizes the overall disruption in business compared to a full certification-level audit.
Major Program Assessments
While third-party assessments are not uncommon in the food industry, they are generally not interwoven with industry certification audits. That being said, an FSMS is comprised of major programs or sections that are prime subjects for third-party assessment, including the following.
A Hazard Analysis and Risk-Based Preventive Controls (HARPC) third-party assessment is based on a customized workplan, as well as the updated HARPC/Preventive Controls for Human or Animal Food rule. Aligning the assessment with internal audit programs supports verification by providing direct recommendations for corrections and improvements. This approach provides the following benefits:
- Assessment can be completed and delivered more directly with the Food Safety Team.
- Recommendations from findings can be more directly implemented and issues can be closed.
- Results can be verified and validated internally, providing a record of corrections to be implemented, meeting regulatory requirements, and demonstrating alignment with the internal audit program.
- The assessment provides a means to confirm timing of program updates and to determine the next scheduled assessment.
Current Good Manufacturing Practices (cGMP) compliance extends to FDA Section 117 requirements, which must be maintained under FSMA as part of the Food Safety Plan. A gap assessment of existing cGMPs confirms programs are complete and current, provides verification of updates, and validates programs are documented. Independent verification can be scheduled on a more flexible timeframe using qualified resources based on preference. Focused assessments of cGMPs provide a fresh look at programs, improvement recommendations, and direct corrective actions that are in line with the company’s internal audit processes.
Building and equipment assessments support site commissioning requirements for food and handling. Typically, building elements are not a major focus; however, assessing building and equipment is imperative, as it provides for opportunities to correct risks not always identified by the audit:
- Drills down to maintenance practices and provides a clear focus on preventive maintenance.
- Provides a perspective on physical plant processes that allows for planned improvements and hygienic design implementations.
- Ensures the integrity of physical food plant and site asset conditions.
Supplier program assessment provides a stronger level review of the organization’s suppliers. This assessment provides an opportunity to update supplier criteria and ratings and bring a pragmatic perspective for change based on qualified vs. underperforming suppliers. A clear benefit of the assessment is the ability to highlight established supplier performance in a more detailed way than is typically included in an audit to generate possible improvements.
Training should be an established food program and cGMP from the initial implementation of an FSMS. In the past, training was looked at as more casual than formal. As requirements have progressed, training has become more challenging. A focused assessment determines effectiveness and consistency of training by:
- Drilling down to job level
- Identifying alternatives to make training more effective
- Incorporating a broader level of industry observations
- Providing for planned training processes and program improvements
- Addressing culture and language barriers
Recently, KTL Principal Bill Bremer and Thomas Paraboschi, DNV GL’s Supply Chain and Digital Assurance Services Manager, joined International Food Safety & Quality Network (IFSQN) for a Food Safety Friday Webinar to discuss the benefits of increasing safety and quality through non-certification assessments. Join the replay of their conversation and learn more about this topic.
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There is no question about it—organizations across nearly every industry are relying more heavily on information technology (IT) to carry out daily tasks, connect staff, and manage operations. Technology can also play a vital role in managing compliance requirements.
For example, we recently shared a case study demonstrating how leveraging a simple Microsoft SharePoint®-based Compliance Management System (CMS) has provided Southeast Missouri State University (SEMO) with access to the data, documents, systems, and processes required to help employees effectively manage compliance requirements—even when working remotely.
Tips to Design a Successful CMS
A CMS is used to coordinate, organize, control, analyze, and visualize information to help organizations remain in compliance and operate efficiently. When building a CMS, it is important to follow a process to design a system that provides the functionality to meet current requirements and the flexibility to anticipate future needs.
The following eight tips can help ensure you end up with the right CMS and efficiency tools to support your organization for the long term:
- Inventory your existing systems – Identify how you are currently managing your compliance needs/requirements. What’s working well? What isn’t working? Do the systems work together? Do they all operate independently? This inventory should evaluate the following:
- Current systems and tools
- Status and functionality of existing processes
- Data sources and ability to pull information from various sources
- Organizational complexity
- Compliance status
- Existing management systems
- Determine your business drivers – Are you looking to save time? Create efficiencies? Provide access to enable employees to work from home? Reduce the number of resources required? Have better access to real-time information? Answer to senior management? Respond to regulatory requirements? These drivers will also drive the decisions you make when it comes to module development, dashboard design, reporting, and more.
- Understand the daily routine of the individuals using the system – Systems and modules should be built according to existing daily routines, when possible, and then implemented and rolled out in a way that encourages adoption. Having a solid understanding of routine tasks and activities will ensure the system is built in a way that works for the individuals using it—and for the way they will be accessing it.
- Understand your compliance requirements – Do you have permitting requirements? Does your staff need training? How do you maintain your records? Are there regular (e.g., annual, semi-annual) plans and/or reports you need to submit? Do you have routine inspections and monitoring? All these things can and should be built into a CMS so they can be managed more efficiently.
- Get the right parties involved – There are many people that touch a CMS at various points in the process. The system must be designed with all these users in mind: the end user entering data in the field, management who is reading reports and metrics, system administrator, office staff, etc. A truly user-friendly system will be something that meets the needs of all parties. If employees are frustrated by lack of understanding, if the system isn’t intuitive enough, if it is hard to put data in or get metrics out, the system will hold little value.
- Make your wish list – While you may start your project one module at a time, it is important to define your ultimate desired end state. In a perfect world, how would the CMS operate? What parts and components would it have? How would things work together? What type of interfaces would users have? You may build piece by piece, but you must develop with the end in mind.
- Set your priorities, budget, and pace – What is the most important item on your list? Do you want to develop modules one at a time or as a fully functional system? It often makes sense to start where you already have processes in place that can be more easily transitioned into a new system to encourage user buy-in. Priorities should be set based on ease of implementation, compliance risk, business improvement, and value to your company.
- Select the right consultant – For a CMS, it is valuable to have a consultant who doesn’t just understand technology but also understands your operational needs, regulatory obligations, and compliance issues. More than likely, off-the-shelf software will not be a silver bullet compliance solution. A consultant who can understand the bigger picture of where you want to go and will collaborate to design the right CMS and efficiency tools will bring the most value to your organization.
These tips can help ensure any organization designs and develops the right CMS—one that works within the organization’s operating environment—to reduce compliance risk, create efficiencies, provide operational flexibility, and generate business improvement and value.
Tom Paraboschi from DNV GL’s Supply Chain and Digital Assurance Services and KTL Principal, Food Safety, Bill Bremer will discuss the benefits of increasing safety and quality through non-certification assessments at this free webinar, including:
- Overview and examples of regulatory, assessments, GMP, etc. prior to certification
- Real examples of supply chain management from food and beverage companies
- Digital solutions available in traceability and assessments
Increasing Food Safety & Quality through
Friday, September 11, 2020
9:00 AM – 10:00 AM CT
During the life of a food or food material plant, periods may exist where interruptions in normal operations occur. Whether the plant is partially shut down, idled, or completely shut down, it is essential that the physical plant, equipment, and processes be adequately maintained to eventually resume operations.
In order to restart, companies must ask:
- What practices must be followed to ensure proper condition for food and food contact materials manufacturing?
- How should recommissioning proceed?
- To what level should assessments be conducted to ensure proper operating conditions that protect against any potential contamination or risks?
Avoiding Catastrophic Consequences
Historically, re-startup after extended shutdown, maintenance, or upgrades with idle periods and/or equipment not being maintained for an extended period can cause significant and sometimes catastrophic issues. While some of these issues may not occur during a market-level shutdown, attention to recommissioning the site and plant needs to follow the same high level of inspection, review, and corrections, even from a non-critical event. That being said, particular attention must be given if shutdown follows an emergency response (e.g., an incident where bodily fluid is released; a building issue like fire, flood, storm; major catastrophic damage).
Plants must verify their capacity to restart according to all regulatory and compliance requirements. Each area or zone of the site/plant must be maintained or brought back up to the proper standards. A large part of this involves identifying vulnerabilities at actionable process steps within a facility, including sanitation, employee requirements, equipment, and operations. For each point, step, or procedure in the facility’s process, elements must be evaluated for Hazard Analysis and Critical Control Points (HACCP) compliance, including rates, operations to hygiene, and critical time/temperature (e.g., will line speeds impact cooking and kill steps?).
Consider severity and scale of any potential impacts/vulnerabilities on health, including such areas as the volume of product or the number of servings to the number of exposures that could occur from contaminated condensates. Consider broader issues like how fast the food moves through the distribution system and possible number of illnesses and deaths. These broader factors should be used to determine significance, severity, and likelihood and to then update controls for hygiene, sanitation, and disinfection.
It may also be prudent to conduct enhanced inspections and maintenance for unexpected issues associated with limited operations or shutdown periods. It is important to ensure the following:
- Condition of premises and site meet requirements of business licenses.
- External building conditions, including all mechanicals, roofs, exterior walls, drainage, and pest control are functioning according to design and food safety systems.
- Internal building envelope (non-exposed food), utilities, and general controls (e.g., air filtration/conditioning, waste, lighting, pest control, security, intentional adulteration controls) are inspected, maintained, and operating at approved levels.
- Food processing and storage, including temperature controls, cooler operations, and sanitation have been tested and verified.
- Food Safety Management System (FSMS) is established and maintains all changes via Management of Change (MOC) procedures, verification, and records.
Based on the data gathered through vulnerability assessments and enhanced inspections, companies can determine what changes need to be implemented prior to safely resuming operations. Best practices to integrate into operations may include the following:
- Modify maintenance and inspections, as appropriate, but do not disrupt preventive maintenance programs.
- Include test or performance validation runs of all utilities and equipment on a scheduled basis and with time to ensure proper operations.
- Train facility personnel working in all operations to conduct test runs, monitor results, approve, and complete reporting.
- Establish updated procedures for all personnel, contractors, drivers, and approved visitors prior to site/plant entry.
- Establish and implement any new personnel, health, and PPE requirements and work rules (e.g., work area separation, quarantine periods, doctor release notes, closed campus, social distancing).
- Upgrade new controls to meet OSHA bloodborne pathogen, PPE, and respiratory programs.
- Modify employee areas to encourage proper hygiene (e.g., handwashing, hand sanitation, PPE, and waste management).
- Determine new, EPA-approved sanitizers and disinfectants, and use appropriate sanitizers in all areas, including shared surfaces like touchscreen covers and their general location.
- Increase environmental monitoring of all possible sources, including coolers/fans/ducts.
- Base operating conditions on enhanced operational inspections: pre-, during, and post-.
Monitoring and Communicating
Final steps must be taken to ensure the proper implementation of updated programs, plans, and strategies during modified operations or shutdown. Monitoring the updated strategies, actions, and conditions must happen through management team review and all levels of organizational responsibility. In addition, facilities must maintain records for changed operations, corrective actions, and verification activities.
And before the plant can open, any updated site programs must be communicated, and personnel must receive appropriate training to ensure safe food and positive worker welfare.
A wider reaching global supply chain exposes our food—and those companies within the food supply chain—to increased risk. As a result, food companies are operating in an increasingly complex world with changing regulations and requirements that require careful monitoring and review. Like many industries, the global pandemic not only complicates many facets of operations, it has also impacted many regulatory and certification requirements.
The following websites provide excellent resources for companies within the food industry to stay on top of the latest regulatory and certification changes. Our advice? Bookmark these sites, sign up for automated emails, and take advantage of the resources available to companies to help navigate the ongoing changes.
U.S. Department of Agriculture (USDA): Food Safety and Inspection Service (FSIS)
This USDA FSIS Regulations, Directives & Notices site gives users access to the Code of Federal Regulations (CFR)), Federal Register (FR), FSIS Directives, and FSIS Notices. Users can sign up with an email address to receive the latest news from USDA and FSIS. These email updates include recall alerts and FSIS directives and notices. This allows users to be “in the know” instantly and to keep ahead of changing regulations.
The “AskUSDA” and “AskFSIS” features, located on the USDA FSIS homepage, further allow users to look up common questions or submit any question to USDA or FSIS for answers. These features offer a quick turnaround, with responses provided by specialized USDA/FSIS employees.
- AskFSIS: Find answers or ask questions on inspection-related polices, programs, systems, and procedures.
- AskUSDA: Find answers or ask questions about safe food handling at home or food safety in general.
The USDA’s dedicated COVID-19 site breaks down information by topic area, including food supply chain, to answer frequently asked questions about COVID-19.
U.S. Food and Drug Administration (FDA)
The FDA’s Food Safety Modernization Act (FSMA) impacts every aspect of the U.S. food system, from farmers to manufacturers to importers. Keeping up with changes to the FSMA rules is vital. Users can sign up for automatic emails from the Center for Food Safety and Applied Nutrition (CFSAN) to receive updates, including regulatory changes and recalls. Users can select settings for what product(s) they would like to receive notifications.
Users can also research and submit questions related to FSMA to the Technical Assistance Network (TAN). Inquiries are answered by FDA Information Specialists or Subject Matter Experts, based on the complexity of the question. Responses are usually timely, based on the complexity of the question.
In addition, FDA has a dedicated COVID-19 site. To see the latest COVID-19 information from FDA related to the food industry, select “Food & Beverages” from the drop-down “Topic” menu.
Electronic Code of Federal Regulations (e-CFR)
The e-CRF is a currently updated version of the Code of Federal Regulations (CFR). It allows users to look up all sections of the CFR. CFR is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government produced by the Office of the Federal Register (OFR) and the Government Publishing Office (GPO).
Regulations.gov provides an online resource for users to find, review, and submit comments on federal rules that are open for comment and published in the Federal Register.
Global Food Safety Initiative (GFSI)
The GFSI News & Resources section directs users to articles, publications, videos, and news releases on topics related to GFSI and certification.
Beyond that, as GFSI states on their website, “the pandemic has fundamentally affected the management and assurance of food safety in all retailers and manufacturers, globally. We recognise the COVID-19 outbreak continues to create audit restrictions, which has an impact on the certification status of certain sites.” As such, GFSI has created a COVID-19 site to keep companies abreast of certification requirements in light of changing needs and demands. Users can also enroll to receive the GFSI newsletter to stay updated on the latest updates from GFSI.
For resources related to each of the GFSI-benchmarked standards, users can visit the following sites:
There are many great resources available to stay current on the latest regulatory changes and requirements. However, just knowing the requirements is not enough—companies need to be able to manage them to ensure compliance.
Technology-enabled business solutions can help simplify this task. Compliance efficiency tools and document management systems allow companies to:
- Maintain standards, programs, and regulatory requirements in one place
- Outline a plan for meeting each requirement
- Create alignment and consistency between different standards and requirements
- Update requirements as regulations—or company operations—change
- Provide a compliance calendar and tracking to manage and monitor compliance activities
Technology solutions can be instrumental in establishing or improving a company’s capability to efficiently and effectively manage compliance and business processes.
Over the past several months, many companies have had to prioritize business activities given restrictions on travel and social distancing guidelines. Despite these restrictions, however, certain compliance activities are still required, including training.
Training is a key component for maintaining ongoing compliance—whether with regulatory requirements, supply chain mandates, or internal policies. While some training can be postponed, putting training on the backburner can have its consequences, ranging from unprepared employees, to noncompliance, to preventable injuries or worse.
Much like with audits, there are alternatives to meeting training requirements and ensuring employees are well-instructed and prepared to do their jobs, even with current government and/or company restrictions. Online and virtual training are not necessarily new options, but their popularity is most certainly on the rise. In-person, online, and virtual training can all provide quality options if you understand your training needs and understand what type of training works best in different scenarios.
As we have experienced, sometimes there is no substitute for doing things face-to-face. For certain types of training, in-person is clearly the best alternative for a number of reasons:
- It is designed for people who need to genuinely know the material inside and out and for those who would benefit from a more tailored, interactive learning experience.
- With in-person training, learners are able to ask specific questions and get them answered immediately.
- In-person training provides a focused, immersive learning experience, where attendees can have interaction, discussion, and live input.
- Trainers get to know attendees and can adjust training (e.g., material, learning speed, examples) to the group’s learning style.
- In-person training allows attendees to develop relationships with the trainer and other attendees, which can prove beneficial on future projects.
As many organizations have discovered, particularly lately, while in-person training may offer a great alternative, it is not always possible. Beyond travel and social distancing restrictions, in-person training can also be cost-prohibitive. In addition, scheduling of in-person training can present more challenges, as timing is based on the instructor and is not flexible.
Best suited for: Multi-day classes where demonstration of competency is needed, and participants are building skills they will use frequently; introductory classes where participants need to understand new material.
The Online Option
At the other end of the spectrum, we have online training (not to be confused with virtual, which is discussed below). Online training involves an online module that allows participants to watch and/or listen to a pre-recorded class. Generally speaking, online training works best when individuals already know the material (e.g., refresher training) and is most appropriate when the attendee does not have to be an expert in the subject matter (i.e., awareness level vs. functional expertise).
In addition, online training is generally cheaper since it is not customized and does not require travel or an onsite trainer. It can also be faster and more flexible, as attendees can work at their own pace and have the ability to pick their own schedule.
While there are certain benefits to online training, it is not suitable for all types of training. Because online training does not involve a live instructor, attendees are generally unable to ask questions effectively and there is little opportunity for follow-up input on areas covered. This is no opportunity for hands-on learning and interaction. For example, something like 24-hour HAZWOPER training would be difficult to do as an online course, as a hands-on component is valuable in helping participants demonstrate competency, as required. Finally, because of a potentially diverse audience, online training tends to be generic and not tailored to the specific needs.
Best suited for: Courses where participants have had many, many years of experience and just need refreshers, such as HAZWOPER 8-hour, DOT General Awareness, or RCRA refresher training.
Taking It Virtual
Finally, virtual training provides a bridge between online and in-person training. Like online training, virtual training is done via technology (e.g., Zoom, WebEx); however, it takes place live with instructors engaged in the training as it is occurring. Virtual has many of the same advantages as in-person training since it is being done live. Learners can get more in-depth training and benefit from live interaction, questions, and discussion to help develop specialized expertise. Virtual training works best when travel is limited but students still need to have real-time input from the instructor.
That being said, virtual training cannot completely replace in-person training. With screens, it may be difficult for the trainer to read the crowd and accurately interpret learning needs. Hands-on opportunities become more limited—though not impossible—and require cooperation, coordination, and open-mindedness from all attendees. Finally, technology and logistics are critical for this type of training. A computer with good internet access is critical. If internet connections are slow or sound quality is poor, training can quickly become ineffective.
Best suited for: Refresher training (as with online options), more detailed training that can be customized to the specifics of the class (i.e., site-specific, industry-specific), or training for those with less experience who may need to ask questions.
Consider Learning Styles
People learn very differently. Some people are aural learners and can hear material and develop understanding. Others are visual learners so just reading material on a screen “sticks.” Others are tactile learners and need to participate in physical interaction to understand content. It is important to keep this in mind when choosing the best platform, as well:
- With in-person classes, all learner types can be addressed.
- With online classes, typically only visual learners retain the information unless there is audible training coordinated with the material.
- With virtual learning and coordination with the site prior to the training program, all three learner types can be addressed.
While some training can be rescheduled with minimal impacts to the business, many training requirements cannot. Companies need to know their workers are retaining the information, particularly given OSHA requirements that employees must demonstrate understanding and competency. To ensure that training not only “checks the box” but is also effective, it is important to evaluate not just the training, but the delivery options. In-person, online, and virtual all have their strengths based on the training needs and individual learning styles.
The second annual World Food Safety Day (WFSD) returns on June 7, 2020 under the theme “Food safety, everyone’s business.”
WFSD was originally declared by the United Nations on June 7, 2019, to draw global attention and inspire action to help prevent, detect and manage foodborne risks, contributing to food security, human health, economic prosperity, agriculture, market access, tourism and sustainable development.
This year’s celebration focuses on food safety being a shared responsibility—from farm to table—including governments, to producers, to consumers.
A wider reaching global supply chain exposes our food and those companies within the food supply chain to increased risk. KTL is committed to supporting companies in our increasingly complex world with effectively operating across the food supply chain, while managing food safety and quality risks.
Both the U.S. Food and Drug Administration (FDA) and World Health Organization (WHO) offer a number of resources for companies and individuals to participate in World Food Safety Day and help reduce food safety risks.
Audits provide an essential tool for improving and verifying compliance performance. Audits may be used to capture regulatory compliance status, management system conformance, adequacy of internal controls, potential risks, and best practices.
Most regulations, standards, and guidance require audits to be conducted with some established frequency. For many companies, figuring out how to meet these audit requirements amongst travel restrictions, new company safety protocol, and government quarantines related to COVID-19 presents a significant new challenge.
The Online Alternative
Companies come in a variety of sizes with a range of different needs. Because of this, auditing standards remain fairly flexible by design. Fortunately, this allows for online/remote/virtual audits as a viable alternative to onsite audits—provided the audits:
- Are planned well;
- Appropriately leverage technology; and
- Are executed by a team who understands the facility and the requirements.
The ultimate objective of a virtual audit remains the same as an in-person audit: To obtain credible audit evidence to accurately assess compliance/conformance with identified requirements/specifications. The difference lies in the means in which that evidence is collected (i.e., live stream video, surveillance cameras, group web meetings, electronic document review).
Weighing Risks vs. Rewards
Audits can be conducted onsite, remotely, or a combination of the two. In many cases, companies may already be having portions of the audit (e.g., document review) done remotely. Moving the entire audit to the virtual world allows credible evidence to be obtained in unique ways that can offer significant benefits to a company when onsite audits aren’t possible—and even when they are:
- Reduced cost – Online audits eliminate the expenses associated with travel (i.e., mileage, flights, hotels, meals), which can add up depending on the location and duration of the audit.
- Flexible schedule – Remote audits can be conducted on a more flexible time schedule. Auditors do not have to complete work onsite in a set number of days, as is required when traveling to a facility. The auditor can also review areas in question remotely after the audit is technically over. Note that a more flexible time schedule does not necessarily mean less time involved to conduct the audit.
- Social distancing – As CDC guidelines have recommended, it is currently safest to work remotely, when possible, or to remain six feet of social distance to avoid potential transmission of COVID-19. Through the use of technology, virtual audits provide a social distancing extreme.
- Improved systems – Preparing for a virtual audit provides the “push” some organizations need to improve electronic storage systems. To conduct a virtual audit, documents and records must be retained in an organized manner that facilitates easy/quick access. Being able to access all documents remotely is necessary—paper records or documents stored on individual computers/network drives no longer cut it.
At the same time, there are some potential risks to conducting a completely virtual audit, particularly since this practice is relatively new to many organizations:
- Observation/technology limits – Observation of site conditions is limited by the ability to direct live stream video remotely. Technology can create limitations. If the camera can’t see it, neither can the auditor. Poor video quality can impede visual clarity. You don’t know what you don’t know.
- Communication confusion – It can be difficult to read body language and/or interpret emails and phone conversations to make sure communication is clear. This can require revisiting topics/findings several times to ensure accurate evidence is collected.
- Time barriers – There may be time zone and associated scheduling barriers depending on the location of the auditor and the facility.
Considerations and Best Practices
Regardless of the type of audit a facility conducts (i.e., remote, onsite, combination), standard audit best practices should be followed to ensure that audit results are comprehensive and credible. If the company opts for a virtual audit—for any reason—there are a number of considerations and best practices to ensure that the audit effectively fulfills its objectives and alleviates the risks outlined above to the extent possible:
- Site Familiarity – Virtual audits work best if auditors are familiar with the industry and/or operations. While it is not necessary for the auditor to have visited the site before, that type of familiarity with the facility provides the best-case scenario, especially for compliance audits, as it prepares the auditor to know what to look for (and where) and what questions to ask.
- Careful Planning – Much like onsite audits, virtual audits require careful upfront planning on the part of the auditor and the facility—and perhaps to an elevated degree.
- The facility needs to collect all documents and records prior to the audit and determine best way to present that information remotely (e.g., email/transfer ahead of time, allow access to company Intranet/shared directory space, share during a web meeting).
- Interviews are best scheduled in advance to ensure availability; however, they can be conducted on an ad hoc basis as need arises.
- It is best to plot out route and areas of specific focus for the audit ahead of time using a site map as a guide to ensure that all areas are covered and that the audit can be conducted as efficiently as possible using the allocated facility resources. An audit site guide must be assigned who is familiar with the entire facility.
- Technology needs and requirements must be evaluated, and logistics and access should be tested prior to the audit. It is vital that all cameras, web meetings, shared document space, WiFi, and other technology is working appropriately prior to the audit or a lot of time can be wasted troubleshooting issues.
- Video – Videos should be live. Site walks should be led by a site guide/employee along the planned route with smart phones, iPads, etc., with live streaming capabilities. It is important to ensure that live streaming works within the facility being audited so auditors have a clear view of site conditions. Auditors can also take advantage of any in-house surveillance cameras (e.g., security or quality systems) to provide additional footage of operations, when necessary. In most cases, surveillance footage cannot replace live video.
- Web Meetings – Opening, closing, and daily briefings can be conducted via web meeting. Remote audits provide the flexibility to conduct the audit in segments, with briefings following each segment. This allows the auditor to review video footage, evaluate records, and generate questions to ensure the information collected is accurate and complete.
Companies all over the world are working through a transition period right now, where they are trying to establish what a new “normal” looks like when it comes to operating practices, employee health and safety, business continuity, and compliance. Audits are one piece of the overall puzzle that can be transitioned somewhat seamlessly with the right planning and technology in place to ensure ongoing compliance.