Blog

15 Oct
Staff Spotlight on Liz Hillgren

Get to know our KTL team! This month, we are catching up with Senior Consultant Liz Hillgren. Liz brings over 20 years of environmental experience in both industry and consulting to the KTL team. She is based in Ann Arbor, Michigan.

Tell us a little bit about your background—what are your areas of expertise?

My background is in hazardous waste. I worked for transfer, storage, and disposal facilities (TSDFs) for 20 years. I have worked at a landfill, a stabilization facility, a fuel blender, a used oil recycler, and a wastewater treatment facility. I have managed technical groups but also customer service throughout my career in industry.

What types of clients do you work with? What are the biggest issues you see them facing right now?

My KTL customers are largely manufacturing facilities. Most of them are mid-sized, so they don’t always have tons of money—but they do have real regulatory issues.

What would you say is a highlight of your job?

I like to help my customers solve problems, because I feel like I am part of their team. I also like to learn new things—my job always has something new to think about.

What do you like to do in your free time?

I am a gardener, and I enjoy being outside. I live in an old house full of projects and potential. I like to sew. I just started beekeeping, so that is currently where all my time and money are spent!

Read Liz’s full bio.

06 Oct
FDA’s New Era of Smarter Food Safety

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.
29 Sep
EHS Experts Roundtable

We recently sat down with three of KTL’s environmental, health, and safety (EHS) experts, Becky Wehrman-Andersen, Liz Hillgren, and Jake Taylor, to talk about all things EHS. The three Senior Consultants shared what they are seeing in the marketplace, as well as some of their best advice and lessons learned for managing EHS compliance.

What are some of the biggest EHS issues you see your clients facing right now?

Collectively, there are a few trends we see time and again, which generally can be tied back to many EHS “departments” (which often consist of just one person) lacking the resources—financial and personnel—to manage the sheer number of EHS requirements they are required to comply with.

We find that EHS personnel are being asked to manage a lot—and often in areas that may be outside their education/expertise/experience. So while they may have knowledge, in part, of EHS regulations, they often don’t have a comprehensive enough knowledge to always even know what they are missing. Add to this the fact that there is almost “too much” information available, and it can very quickly become overwhelming to determine what is applicable and what needs to be done to comply.

We see this creating several common scenarios:

  • Entire compliance programs are being missed because customers do not realize they are subject to some requirements. In some cases, companies just don’t know what they don’t know.
  • Frequently, companies may not understand the thought process of what needs to be in place to satisfy a standard’s requirements. For example, they may have OSHA training programs in place to meet requirements; however, they do not have the accompanying site-specific written programs and/or documentation that are also required for compliance.
  • Often customers do not take the time or have the knowledge to identify the riskiest chemicals or processes onsite, which leads to elevated challenges in keeping employees and the surrounding environment safe.

How have you seen COVID impacting industry/your clients?

The majority of our clients have really adapted and responded to COVID as best they can. Many have remained busy and are doing just fine. However, the pandemic has resulted in operational challenges—from expanding shifts to separate people more, to having more “virtual workers,” to managing internal safety cost increases, to developing plans to juggle outbreaks. In some cases, this has slowed some policy/program development and impacted company culture. In addition, we are seeing a few companies experiencing supply chain challenges but to a lesser extent than anticipated. Understandably, there is also an element of frustration as guidance remains in flux, as well as concern as facilities “button up” for winter due to the elevated risks associated with closed spaces with little air circulation.

At the same time, companies are learning how to work with fewer people and conduct some business activities virtually. And many have been pushed into using technology that may have been available in the past but was never a necessity of doing business. Even though there have been some “bumps” in the road, people are catching on. In fact, KTL has been conducting audits, assessments, and training virtually, and our clients are seeing the benefits of a virtual approach on many levels. We anticipate some of this will continue as the new norm due to the business efficiencies it presents.

Are there any recent regulatory developments (or any on the horizon) that industry should be preparing for?

EPA has a provision as part of the 2016 Hazardous Waste Generator Improvements Rule that will be affecting small quantity generators (SQG) in 2021. The Agency is now requiring SQGs to renotify EPA or their state agency about their hazardous waste activities every four years. The first renotification is due by September 2021. Since this is the first time EPA is requiring this of SQGs, many are not as aware of the Hazardous Waste Generator Improvements regulations and this specific renotification requirement. It is one that will impact many. Read more from EPA.

Other regulatory changes on the forefront will likely depend largely on the outcomes of the election this November, and it is just too soon to predict.

Based on your experience, what are some best practices you would recommend to help companies ensure ongoing EHS compliance and meet business objectives?

  • Conduct a comprehensive gap assessment to ensure you are meeting the requirements of all applicable EHS regulations. This should be the starting place for understanding your regulatory obligations and current compliance status.
  • Organize your records. Know what records you need. Document your inspections and your training. Develop standard operating procedures (SOPs) so people know what to do.
  • Seek third-party oversight. Having external experts periodically look inside your company provides an objective view of what is really going on, helps you to prepare for audits, and allows you to implement corrective/preventive actions that ensure compliance.
  • Perform a comprehensive onsite risk assessment with associated risk minimization planning and plan/conduct annual spill drills to practice emergency response for hazardous chemical incidents.
  • Create an integrated management system (e.g., ISO 9001/14001/45001, Responsible Distribution) by finding commonalities between the standards and leveraging pieces of each to develop a reliable system that works for your organization. 
  • Develop a relationship with someone you trust to do things in your best interest, understanding that EHS should be a process of continuous improvement. Use them to help you understand what regulations apply. Let them help you prioritize your compliance plan. Use them to do your annual training. Rely on them as a part of your team.
  • Get senior leadership commitment. It is often clear how an organization prioritizes EHS with little digging. Even with the best EHS personnel, the organization and its EHS system will only be as good as the top leadership and what is important to them.

Do you have any good “lessons learned” to share about what to do when it comes to EHS compliance?

Just start! It is better to do some than none. Get organized. Determine what you need, break it down, set a schedule, use your consultant to keep you on target, and just get started. Something is definitely better than nothing.

KTL has coached several companies from a “zero to compliance” status and has also actively assisted in OSHA and EPA penalty negotiations. One company went from an anticipated $300,000 – $500,000 in penalty to ZERO penalty, reduced their generator status from large quantity generator (LQG) to very small quantity generator (VSQG), and achieved a more than 70% reduction in waste management costs simply through process changes and risk reduction strategies. 

How important is technology when it comes to EHS compliance?

EHS personnel are starting to see the possibilities of how incorporating technology solutions can help them become more efficient in their operations and compliance processes. As stated above, COVID has pushed some technology innovations to the forefront as a means for companies to continue operating in different ways.

For example, technology tools can be very helpful with tracking requirements and documents—but it also requires good organization and communication. Custom apps for conducting inspections and regular checklists can be a simple way to create operational efficiencies, particularly for smaller organizations who may lack the initial financial resources to undertake an entire system implementation. Once that initial investment is made, companies often see the value of technology and the potential to implement a centralized compliance information management system to help manage and track compliance obligations, activities, and performance/status.

With technology, it is no longer a question of IF, it is just a matter of WHEN companies decide to jump on board. Technology and “Big Data” can—and should—be a focus of any EHS compliance program. The investment will pay off in the end.

What value do you see KTL providing?

We serve as an extension of a company’s EHS staff—from completing small tasks that never seem to get done to identifying large gaps in compliance and building systems to resolve those non-compliance issues. We are there to support, answer questions, provide technical knowledge, and help our customers achieve compliance. We are teachers, trainers, a sounding board, and an EHS support system. We have a great team of experts who know EHS, understand industry, and excel at creating solutions and tools to meet our clients’ needs. Trust is critical and we strive to be trustworthy. That is who KTL is.

15 Sep
Maintaining Food Safety Compliance: Third-Party Assessments

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.

10 Sep
Functionality for Today…Flexibility for the Future

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:

  1. 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
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.

25 Aug

Safety

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Preparing for OSHA Workplace Inspections

Did you know that….

Every establishment covered by the Occupation Safety & Health (OSH) Act is subject to inspection by OSHA Compliance Safety & Health Officers (CSHOs)?

OSHA has an updated framework for conducting these workplace inspections in light of COVID-19?

Even with OSHA’s updates, your facility could still be subject to a workplace inspection—without any advanced notice?

Inspections and COVID-19

According to OSHA’s Updated Interim Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19), OSHA will continue to ensure safe and healthy conditions pursuant to the following framework:

  • Where community spread of COVID-19 has significantly decreased, OSHA will return to the inspection planning policy relied on prior to the start of the COVID-19 health crisis. OSHA will use non-formal phone/fax investigations or rapid response investigations where the Administration has historically performed such inspections (e.g., to address formal complaints), as necessary.
  • In areas experiencing either sustained elevated or a resurgence in COVID-19 community transmission, Area Directors will exercise their discretion to continue prioritizing COVID-19 fatalities and imminent danger exposures for inspection. Particular attention for onsite inspections will be given to high-risk workplaces. In addition, OSHA will use non-formal phone/fax investigation where doing so can address the relevant hazard(s).

What does this mean? Essentially, OSHA workplace inspections are still being conducted—whether in person or remotely—so it remains important for companies to be prepared.

Inspection Priorities

OSHA focuses its inspection priorities on the most hazardous workplaces—even more so now given the risks associated with COVID-19. OSHA prioritizes inspections according to the following:

  1. Imminent danger involves any condition where there is a reasonable certainty that a danger exists that can be expected to cause death or serious physical harm immediately or before the danger can be eliminated through normal enforcement procedures.
  2. Fatalities and catastrophes involve situations that have resulted in hospitalization of three or more employees.
  3. Programmed high-hazard inspections are targeted at high-hazard industries or workplaces with high rates of injuries and illnesses.
  4. Employee complaints/referrals include allegations of hazards or violations from employees or other agencies, individuals, organizations, or the media that may trigger inspections.

What to Expect

If your workplace is subject to an inspection, there is a certain process you can expect to follow. The official start to any OSHA inspection requires the CSHO to display his/her official credentials. Because many inspections take place without advanced notice, this is important for security purposes. The opening conference then follows to discuss the purpose, nature, and scope of the inspection. At this point, the facility gets to select an employee to accompany the CSHO during the walkaround inspection. Employers should give thought to who this individual will be before an inspection occurs.

During the walkaround, OSHA’s representative has the authority to look at everything. Expect the CSHO to take photos and measurements, as well as conduct interviews with other employees. These are private interviews; however, employees have the right to request an employee representative participate in the interview. As the CSHO asks questions and takes notes, it is equally important that the employer representative is also taking notes and photos, documenting requests, and correcting conditions, as appropriate. Prompt correction, if possible, is considered a sign of good faith on the part of the employer.

Questions that the CSHO may ask include the following—be prepared to respond and locate documentation:

  • Where are your safety and health programs?
  • Who maintains your training records?
  • Who maintains your 300 logs?
  • Do you have a safety committee?
  • How can an employee bring forward a safety issue/concern?
  • How are safety issues resolved?
  • Do you document hazard abatement?
  • Do you have a progressive disciplinary program?
  • Do you perform oversight of contractors?

At the completion of the walkaround, the CSHO will hold a closing conference with facility representatives to discuss all findings.

Following the Inspection

After the inspection, the CSHO may follow-up with the facility for additional information (e.g., programs, training records, additional interviews), will review your company’s OSHA history, and will make recommendations for citations. OSHA may invite additional agencies to investigate, if needed, as well. OSHA then has six months from the date of the opening conference to issue any citations. Citations and Notices of Violation (NOVs) from the inspection are sent by certified mail. The facility must post citations for three days or until the violation is abated, whichever is longer.

Violations are categorized, as follows:

  • Other than Serious Violation has a direct relationship to job safety and health but probably would not cause death or serious physical harm. Penalty up to ~$13,000 is discretionary – per violation, per day. [BBBA proposed maximum penalty increase to $70,000]
  • Serious Violation has substantial probability that death or serious physical harm could result and that the employer knew (or should have known) of the hazard. Penalty up to ~$13,000 is mandatory – per violation, per day. [BBBA proposed maximum penalty increase to $70,000]
  • Willful Violation is an intentional violation of the OSH Act or plain indifference to its requirements. Penalty up to ~$134,000 – per violation, per day. If a violation results in death, penalty up to $250,000 for an individual or $500,000 for a corporation and/or imprisonment up to six months. [BBBA proposed maximum penalty increase to $700,000]
  • Repeated Violation is a substantially similar violation found upon re-inspection. Penalty up to ~$134,000 – per violation, per day. [BBBA proposed maximum penalty increase to $700,000]

Additional violations may include falsifying records, reports, or applications; failing to post requirements; assaulting a compliance officer or interfering with their duties; and failure to abate a prior violation. Violations can result in financial penalties and, in some cases, in imprisonment.

If violations/citations are issued, the employer has a few options to respond:

  • Pay the penalty, provide abatement, and move on.
  • Pursue an Expedited Information Settlement Agreement (EISA) to reduce the OSHA penalty amount in exchange for prompt, documented abatement.
  • Appeal the citation, abatement, or proposed penalty.

Be Prepared

The best way to be prepared for a workplace OSHA inspection is to make sure you have the processes, programs, and systems in place—and documented—to ensure you are always protecting employees’ safety and health and meeting OSH Act requirements. Having a centralized location, like a Compliance  Management System (CMS),  to track and manage all safety-related information will not only help ensure going compliance but will also provide the documentation required should an inspection occur.

It is also wise to consider and regularly review your responses to the following questions, as they will provide a good indication if you are prepared should an OSHA inspector walk into your facility tomorrow:

  • Who is representing your interest?
  • Do you have a procedure?
  • Do you have your programs together?
  • Who will represent your employees?
  • Who has the authority to correct hazards?

Finally, good faith goes a long way. If there are issues, fix them and document them. Abatement efforts matter.

24 Aug
Maintaining Food Operations Following Shutdown Periods

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).

Vulnerability Assessments

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.

Enhanced Inspections

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.

Best Practices

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.

21 Aug
Incorporating Photos into Mobile Inspections

In a recent blog post, KTL discussed checklists as a common—and important—way to collect information. Mobile forms and technology make completing checklists and inspections of almost any type easier and faster in the field. The data provided through these checklists is highly valuable, as it can be easily manipulated and analyzed to inform business decisions.

However, they say that a picture is worth a thousand words, so imagine if those checklists and inspections could be accompanied by photos. This is exactly what KTL has developed to assist clients in conducting various types of inspections—from routine safety checks to environmental reviews to facility-specific inspections.

Photos Tell the Story

In some cases, photos are used strictly to provide visual documentation of inspections conducted. Photos can often highlight best practices and pinpoint concerns better than words. In other cases, photos may be used to help visually document changes over time. A photo log showing daily, weekly, or monthly progression provides the ability to compare photos, making it easier to identify changes that could be missed through regular site visits.

Using Microsoft Power Apps®, KTL has built a custom app that collects typical form data according to the site’s needs, but also has the functionality for site staff to take and upload photos associated with the checklist. These photos have associated latitude and longitude, so photo location can be displayed and reviewed on a map.

Once the photos are taken, they are named, catalogued, and stored directly in Microsoft SharePoint®. As a future enhancement, the app may also be capable of producing PDF reports summarizing the data and incorporating the photos entered into the mobile form.

A More Robust Record

The ability to associate photos with inspections creates a more robust record:

  • Provides a visual representation of site features on a specific date and time
  • Allows for easy comparison based on date and/or location
  • Enables real-time physical monitoring/review/analysis from the office based on photos uploaded from the field
  • Helps identify areas for continuous improvement and then assign required follow-up actions
  • Integrates with an overall compliance management system for a comprehensive view of compliance status

And, importantly, this functionality can easily be expanded to other business needs where visual representation would provide more comprehensive and valuable data.

06 Aug
Join KTL Virtually at ChemEdge 2020

NACD’s 2020 ChemEdge is making the shift to full virtual this year. The conference may look a little different, but it is still filled with all the critical knowledge and networking opportunities chemical distributors expect from ChemEdge.

ChemEdge 2020
Tuesday, September 1 – Thursday, September 3
Register Now!

As always, KTL will be an active participant in ChemEdge 2020. Be sure to join KTL Senior Consultant and Responsible Distribution Adviser Jake Taylor for the following presentations:

+ Digging Up the Roots! Root Cause Analysis Review and Exercise
Tuesday, September 1, 11:00 am-12:15 pm

+ OSHA Top 10 List
Wednesday, September 2, 9:00 am-10:00 am

We look forward to making the most of this virtual event and hope many of our clients and friends will be joining us at ChemEdge 2020 this September.

 

28 Jul
Using CMS to Improve Productivity

For many organizations, the past few months have been anything but “business as usual.” Very few can say that nothing has changed—whether that means new safety protocols for employees, less (or even no) travel, scaled-back operations, or staff working remotely.

Organizations that weren’t previously set up for remote work have had to quickly figure out how to operate under a very different business model, particularly when it comes to managing their regulatory compliance requirements (e.g., environmental, health and safety (EHS), food safety, quality). Some employees are struggling with accessing critical business information, and some work is being postponed, perhaps indefinitely.

Organizations must find ways to overcome these operational challenges, particularly given that compliance requirements still exist and remote work may actually be the new ”business as usual”—whether due to the pandemic or because of the flexibility it can provide if an organization is ready.

The Solution: Compliance Management Systems

Clearly, centralized information technology (IT) is key in connecting staff with business operations when everyone is working in different locations. Technology can facilitate access to critical compliance information, including documents, data, and records needed to manage projects and people. However, IT alone will not make remote work effective or efficient unless there is an underlying Compliance Management System (CMS) to organize it all.

A CMS is used to coordinate, organize, control, analyze, and visualize information to help organizations remain in compliance and operate efficiently. A successful CMS requires thinking beyond just access to documents; it requires managing processes, knowledge, and the work that is critical to help identify and control business risks. That may include:

  • Ensuring the right people can access the right information
  • Consolidating documents and records in a centralized location to provide easy access
  • Setting up formal business practices, processes, and procedures
  • Implementing compliance programs
  • Monitoring and measuring performance
  • Making improvements
  • Documenting decisions and how they are made
  • Capturing institutional knowledge and transferring that into a sustainable system
  • Using task management and tracking tools to understand how people are doing their work

CMS Case Study

For Southeast Missouri State University (SEMO), leveraging a simple CMS solution has provided access to the data, documents, systems, and processes required to allow employees to work more effectively from home.

Like most higher education organizations, SEMO is subject to a wide range of complex EHS requirements, including air permits; Spill Prevention, Control, and Countermeasure (SPCC) plans; hazardous waste regulations; refrigerant management regulations; laboratory safety; and others. With limited EHS staff to manage, maintain, and demonstrate compliance, documenting EHS compliance is challenging. Finding effective information management solutions has been critical.

KTL worked with SEMO to develop a CMS using Microsoft SharePoint® that allows SEMO to effectively manage and communicate EHS information, particularly in remote work situations. Consolidating document, record, and data management into the SharePoint-based CMS has made information more accessible and easier to find. It has provided staff with access to work on their programs remotely when they normally would need to be in their offices. For example, employees have been able to continue compliance assurance work, like creating new inspection documents and records and completing required air permit reports while teleworking.

The SharePoint-based CMS has offered an effective, low-cost technology that can easily be expanded to other areas of the organization that are managing regulatory compliance requirements, documents and records, training, etc., as well. It provides the opportunity to help the entire organization:

  • Identify, understand, and document applicable requirements
  • Implement easy-to-use information management tools
  • Capture institutional knowledge of experienced staff to help ensure operational sustainability
  • Maintain compliance with regulations and standards
  • Ensure employees are productive and efficient regardless of whether they are working in the office or at home

Ensuring Operational Sustainability

Now more than ever, organizations must adopt a forward-thinking perspective—thinking beyond individual efficiency tools, considering the desired state, and determining how technology can be leveraged to ensure operational sustainability, even in uncertain times.

By leveraging our technology and compliance expertise, KTL offers the perspective needed to implement an effective CMS and the technology needed to provide valuable remote solutions. Our EHS, food safety, and IT professionals understand the regulatory obligations, organizational needs, and needs of the users. This drives design and development of 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.

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