Blog

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.

27 Jul

Safety

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Safe + Sound Week: Getting Safety Programs on Track

According to the U.S. Bureau of Labor Statistics, more than 5,000 workers are killed on the job every year (a rate of 14 per day), and more than 3.6 million experience a serious job-related injury or illness.

OSHA’s Safe + Sound Week

Strong safety performance is a cornerstone of any business. Safe facilities, work practices, and training help to attract and retain employees and enable them to go home at the end of the shift without workplace injury or concerns.

For many companies, safety can also make the difference in being qualified to work with customers and successfully expand the business. Workers’ compensation rates and the ability to maintain adequate insurance both depend on an organization’s safety performance. On the other end of the spectrum, repeated safety accidents can lead to potential serious penalties and higher insurance rates for failing to comply with OSHA safety requirements.

Every year, OSHA encourages America’s workplaces to commit to workplace safety and health by participating in Safe + Sound Week, which falls August 10-16, 2020. This nationwide event recognizes the successes of workplace safety and health programs and offers information and ideas on how to keep America’s workers safe.

The Importance of Safety Programs

According to OSHA, implementing safety programs can improve businesses’ safety and health performance, save money, and improve competitiveness. Safety and health programs help businesses:

  • Prevent workplace injuries and illnesses
  • Improve compliance with laws and regulations
  • Reduce costs, including significant reductions in workers’ compensation premiums
  • Engage workers
  • Enhance social responsibility goals
  • Increase productivity and enhance overall business operations

Keeping Your Programs in Check

It is important for companies to regularly assess the level of existing OSHA programs against compliance issues and potential accidents. This requires both short- and longer-term actions. These actions should reveal what may need to change in your OSHA compliance programs to ensure their effectiveness. There will likely be a range of results depending on how well the initial programs were developed, implemented, and updated.

KTL recommends taking the following actions to help assess and improve OSHA programs, as needed:

  • Develop a review plan. Schedule a meeting with key management and safety and health staff to develop a plan to review all OSHA programs for compliance to the standard. It is not uncommon for internal audits and insurance company audits to be based on confirmation of a compliance policy and not the level of detail required in the implementation of the policy. In the meeting, a complete review of programs should be delegated, including a review of the OSHA standards themselves. This should be based on criteria, including the level of detail, training, and updates and supporting logs/records.
  • Review internal and loss prevention reports. This review should consist of the last three years of internal and loss prevention reports, including local fire. The findings of these should be compared against review findings to verify that necessary changes have been implemented.
  • Review OSHA reporting and recordkeeping. Again, review should be based on the past three years of historical records. Not only should these records be verified as accurate and complete, but each accident should have resulted in either a documented corrective action of an unsafe situation or the retraining of an employee. This information should be checked, and any additional actions should be made to fully comply.
  • Ensure proper closure of issues. Should you have had any past OSHA inspections at your facility(ies) that identified corrective actions, you need to ensure that proper actions were taken to close these issues. Again, it is very important to verify and assemble all related records.
  • Conduct multiple physical walkthroughs for all work, personal, and administrative areas for compliance. Update or create a safety inspection checklist for each section, area, and department to confirm that there are no violations in manufacturing, lab, and/or office/administrative areas. Note that one area often missed is the adequate spacing and egress from office cubicles and file rooms.
  • Document corrective actions. Your review should help to determine the corrective actions required for your programs to fully comply with OSHA standards and keep employees safe. These corrective actions should result in safety program updates that should be implemented immediately. Any updates need to be announced and included in employee training, which will also need to be scheduled and documented.
  • Evaluate results. Concurrently, a qualified safety professional should compare the review findings, your accident statistics, and the top OSHA violations. If there are common links to programs, statistics, and OSHA violations report, an added level of scrutiny should be placed on this area and the resulting program updates.
  • Meet requirements. Ensure that all the basic requirements are met and that the company is operating in compliance, including accident/injury records, training records, inspection logs, and a log for all program updates implemented.

Inspection Readiness

When the actions outlined above are done correctly—and on a regular basis—companies can greatly reduce their risk for compliance issues and create a safer work environment for employees. To fully verify safety program changes, a confirming review or audit should be completed within a 30-45-day strict timeframe, and any additional changes or training should be completed immediately. This will also put the company in a much better position for an OSHA inspection should it be required.

Throughout this process, owners and managers need to focus on prevention and on the overall culture of the company in terms of taking the necessary steps to reduce risk and make prevention part of daily operations. Good practice is to examine the workplace broadly, identify and assess hazards, and develop and implement appropriate controls. This helps ensure employees are protected in the workplace and regulatory compliance is achieved.

22 Jul
Navigating Food Safety Regulatory Changes

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

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:

Managing Requirements

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.  

24 Jun
Taking Training Virtual…Or Not

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.

Face-to-Face

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.

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