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26 Feb
Martin Mantz KTL Partnership
KTL Announces Partnership with German Company Martin Mantz

KTL is pleased to announce our partnership with Martin Mantz Compliance Solutions (Martin Mantz), developer of the GEORG Compliance Management System® software. KTL is providing regulatory compliance expertise to the German-based company as it expands its offerings to clients with operations in the United States.

“Martin Mantz has created something unique with the GEORG software in that it simplifies and provides an interpretation of legal and technical requirements in a customer-specific database,” KTL Principal Lisa Langdon states. “KTL’s understanding of industrial operations, as well as U.S. legal and technical requirements (e.g., EPA, OSHA, FDA, ISO), allows us to translate these requirements into simple tasks in the GEORG system that employees can follow to help fulfill regulatory requirements.”

How GEORG Works

GEORG is used to make the requirements of standards and regulations comprehensible and transparent. KTL specializes in the practical mapping of legal requirements and audits. These audits allow KTL to create technical content for the GEORG system based on facility-specific applicability. We then work directly with the company to delegate the identified tasks. If there are revisions in the standards/regulations, KTL works in the system to ensure tasks are updated to meet regulatory requirements.

The benefits of this approach include:

  • Effectiveness – All tasks are assigned, easily formulated, and regularly updated.
  • Efficiency – The effort and expertise required to understand complicated regulations is reduced.
  • Transparency – Responsibilities are clear and easily visible to all employees.
  • Conformity – Compliance status within the system reflects the degree of fulfilment of the related requirements.

Faber-Castell Expands GEORG Implementation to U.S. Subsidiary

Faber-Castell Cosmetics, an internationally renowned Martin Mantz customer with worldwide operations, is already benefitting from the Martin Mantz-KTL partnership. After successful implementation of the GEORG software in their German facilities, Martin Mantz has worked with KTL to expand usage to Faber-Castell’s subsidiary in the U.S.


About Martin Mantz Compliance Solutions
Martin Mantz Compliance Solutions, based in Grosswallstadt and Leipzig, Germany, offers its contractual partners services in the area of ​​legal organization (GEORG) of companies to avoid organizational negligence and compliance violations. This includes consulting and provision of the compliance software GEORG Compliance Management System®, implementation of the technical and legal modules, as well as construction and maintenance of the customer-specific database. https://www.martin-mantz.de/

About Kestrel Tellevate LLC
KTL is a multidisciplinary consulting firm that specializes in providing environmental, health, and safety (EHS) and food safety management and compliance consulting services to private and government clients. Our primary focus is to build strong, long-term client partnerships and provide tailored solutions to address regulatory requirements. KTL’s services include management system development and implementation, auditing and assessments, regulatory compliance assistance, information management solutions, and training. KTL is a Small Business Administration-registered company with headquarters in Madison, WI and Atlanta, GA and offices across the Midwest and Washington, D.C. www.kestreltellevate.com

25 Feb
aerosol cans
Managing Aerosol Cans as Universal Waste

Aerosol cans have long provided regulatory challenges under the U.S. Environmental Protection Agency (EPA)​. Some states have defined aerosol cans as universal waste; some states define it as reactive (D003) waste​. On December 9, 2019, the EPA published a new rule (effective February 7, 2020) adding hazardous waste aerosol cans to the Universal Waste Program under the federal Resource Conservation and Recovery Act (RCRA) regulations.

This change provides a clear, protective system for managing discarded aerosol cans. The streamlined universal waste regulations are expected to ease regulatory burdens on retail stores and others that discard hazardous waste aerosol cans; promote the collection and recycling of these cans; and encourage the development of municipal and commercial programs to reduce the quantity of these wastes going to municipal solid waste landfills or combustors.

Current Review of Universal Waste

The designation of universal waste holds several advantages for generators. Universal waste doesn’t “count” against generator status. It does not have to be manifested and generally requires specific labeling language.

Under EPA’s definition, the following are the current universal waste streams:

  • Batteries (Li, Ni-Cd, Ag, Hg)
  • Mercury-containing equipment (MCE)
  • Electric lamps
  • Cathode ray tubes (in electronics)
  • Pesticides (recalled or farmer-generated)

Adding Aerosol Cans

Adding aerosol cans to the EPA’s Universal Waste Program now provides the option for generators to manage the waste as hazardous or universal. The program addresses emissions with more stringent language​ and allows generators to set up separate management​.

More specifically, the following outlines some basic details of the program for effectively managing aerosol cans as universal waste:

  • If the aerosol can is empty (i.e., at ambient pressure, there is no more liquid inside), it is considered an empty container. It can be recycled as metal or thrown away as solid waste (except for Nebraska, where it is D003).
  • Full and partial aerosols can be recycled.
  • Depending on the vendor, segregation may not be required.
  • If the aerosol can is punctured, contents must be captured, and a hazardous waste determination must be performed.
  • If the waste from the aerosol can is hazardous, the contents count toward generator accumulation.
  • The only benefit to generators occurs if they ship unpunctured cans for recycling.
  • If a household hazardous waste (HHW) facility accepts business aerosols and punctures them, the HHW facility becomes a generator.
  • All emissions must be captured and managed properly; filters may be hazardous.

Regulatory Review

The new program for managing aerosol cans requires a safety program, education, and written documentation. KTL has the experience and expertise to help you evaluate your waste and to properly manage universal waste. Although not as complex as the requirements for proper hazardous waste management, universal waste has nuances that a generator must be aware of to properly meet the regulatory requirements. KTL can help determine how this new regulation applies and if it can help you minimize your regulatory burden, save some money, and manage your waste more efficiently.

24 Feb
Auditor
Principles of Auditing

To ensure companies uphold standards (internal or external) and continuously improve performance, audits are critical. In short, there are three primary purposes of auditing:

  1. Verify conformance with the standard/requirement – Are we doing what the standard/requirement says we must do?
  2. Verify implementation of stated procedures – Are we following the steps in our documented procedures?
  3. Evaluate effectiveness – Are we accomplishing our goals and objectives?

For an audit to be effective, appropriate mechanics must be in place when it comes to planning, execution, and reporting.

PLANNING

As with most things, your execution will only be as good as your plan. All good audits must begin with planning. This involves everything from planning for your team, to planning out the scope of the audit, to planning all the associated logistics.

Auditors: Who Is on the Team?

Depending on the size and complexity of the audits, audit teams need to be selected. These individuals must be independent of the area being audited and trained in the basic elements of the facility’s management system and/or programs. Team members will be led by a trained auditor. The auditor’s responsibilities include the following:

  • Comply with and communicate audit requirements
  • Prepare working documents under the direction of the Lead Auditor
  • Plan and carry out the assigned responsibilities within the scope of the audit
  • Collect and analyze evidence to draw conclusions
  • Document audit observations and findings
  • Report audit results to Lead Auditor
  • Retain and safeguard audit documents
  • Cooperate with and support the Lead Auditor
  • Assist in writing the report

As indicated above, one person on the team is typically designated the Lead Auditor. This individual will coordinate audit assignments and address any questions/concerns that may arise. Specifically, the Lead Auditor has the following responsibilities:

  • Assigns team members specific management system/program elements, functions, or activities to audit
  • Provides instructions on the audit procedure to follow
  • Makes changes to work assignments, as necessary, to ensure the achievement of audit objectives

Audit Objectives, Scope, and Plans: What Are We Auditing?

The audit is all about:

  1. Conformance – auditing sections of the standard/requirements to determine if the system conforms
  2. Implementation – auditing work instructions to see if they are being followed

In determining the audit scope, it is importation to define what is to be audited (e.g., policy, planning, implementation, checking/corrective action, management review). If the organization has more than one physical location, the scope may outline what physical locations and/or organizational activities are to be audited (e.g., production lines or departments). These factors will ultimately also help determine the length of the audit.

Logistics: How Are We Going to Do This?

There are many things to factor into the audit from a logistical standpoint for it to go smoothly. Safety should always be of utmost concern. What precautions do auditors need to take? Is there any PPE that might be necessary? Do auditors need any special safety training introduction or training before conducting the audit? Consider the facility. Auditors need to understand the operation/activity being audited. In line with this, the auditor must also have an understanding of whether there is any equipment or special resources needed, ranging from technical support (e.g., tablets, smartphones) to lunch. Finally, it is important to make sure there are no conflicts of interest when it comes to the auditor and the facility that is being audited.

EXECUTION

Once planned appropriately, audits should be conducted according to the program elements. Interviews and objectives evidence will both provide the support needed to conduct a valid audit.

Program Elements

The auditor must know in advance which elements are being covered in an audit so he/she can:

  1. Control the pace of the audit.
  2. Guide the course of the audit.

That being said, additional audit activities should not be restricted if other issues arise.

Auditing should only be done against current controlled work instructions or procedures related to the program elements. Procedures that are being used in the field must be verified. Historical and/or uncontrolled procedures should not be used.

Auditors must remember that they are creating a record. Notes should include statements, document numbers, identifiers (e.g., department, area), positions. Common pitfalls to be avoided in taking notes include abbreviations, no location identifier for observations, no document references, illegible, pejorative, cryptic. These things all impact the credibility of the audit.

Interviews

The goal of an interview in the audit is to obtain valid information. However, how questions are asked will impact the answer. Auditors must prepare and know what questions need to be asked and how to ask them in advance of the audit. Creating an atmosphere of trust and open communication is key to getting open and honest responses. Remember, the goal is to audit the system, not the interviewee.

The following are good rules of thumb for conducting effective audit interviews:

  • Direct questions to the person who does the job, not to the supervisor.
  • Never talk down to anyone.
  • Speak the person’s language.
  • Speak clearly and carefully.
  • LISTEN!
  • Use who, what, where, when and why in your questioning vs. can or does.

Objective Evidence

Objective evidence provides verifiable information, records, or statements of fact. This is vital in any audit report. Objective evidence can be based on any of the following:

  • Interviews
  • Examination of documents
  • Observation of activities and conditions
  • Results of measurements
  • Tests
  • Other means within the scope of the audit

Evidence should be firsthand evidence based on witnessed fact, not supposition, presumption, hearsay, rumor, or conjecture. It can be qualitative or quantitative, but it should be repeatable.

REPORTING

Findings form the basis of the report. Findings can be classified in one of two ways:

  • Nonconformance is the observed absence of or lapse in a required procedure or the total breakdown of a procedure that can cause a negative impact on the organization’s environmental performance. These can fall into a few categories:
    • Does not meet the requirements of the standard. This may include issues identified with records, procedures, work instructions, and use of controlled documents.
    • Is not fully implemented. Most commonly, these implementation nonconformances may relate to training, communication, and documentation.
    • Is improperly implemented. This is often demonstrated by worker lack of understanding, improper implementation of written work instruction, or missing stated required deadlines.
  • Opportunity for improvement is just that—an opportunity to improve management to either reduce impacts, minimize legal requirements, prevent future nonconformances, or improve business performance.

The following examples and tips can serve as guidelines for writing useful and more concrete findings that will the company to identify opportunities for improvement:

  • Do not overstate conclusions.
    • Poor: The procedure for handling spent light bulbs is being ignored.
    • Better: Three spent fluorescent bulbs were found in the general trash.
  • State the problem clearly and exactly.
    • Poor: Instruments are not being calibrated.
    • Better: The sampling and analytical instruments in the wastewater treatment plant are not calibrated.
  • Avoid generalities.
    • Poor: The area’s empty drum management process is inadequate.
    • Better: The hi-lo driver in the area handling empty drums was not trained on hazardous material handling.
  • Communicate the extent of the problem fully.
    • Poor: All cardboard in the catalytic converter area is being sent to the compactor.
    • Better: None of the cardboard in the catalytic converter area was being stored and/or evaluated for reuse as dunnage.
  • Do not focus on criticisms of individuals.
    • Poor: Jim Jones had no understanding of the safety policy.
    • Better: Discussions with several employees indicated that the safety policy was not fully understood.
  • Give specific references.
    • Poor: Hazardous waste area inspections have not been conducted.
    • Better: Weekly hazardous waste storage area inspections (VMEWP-008) have not been conducted since June 2002.
  • Avoid indirect expressions.
    • Poor: There were occasions when the reports were not filed on time. It appears the air monitoring equipment is not calibrated.
    • Better: Reports were filed late on ten occasions in 2002. There were no records of air monitoring equipment calibrations for 2001 or 2002.

Audits are a skilled activity. They provide the basis for assessment of conformance and, correspondingly, company actions to improve performance. For audits to be valuable, however, the audit process must be consistent and controlled. Clearly and correctly documented nonconformances lead to appropriate corrective actions—the mechanism for translating audits into improvements.

03 Dec
RMP Reconsideration Rule
The Latest on RMP: Reconsideration Rule Finalized

The Environmental Protection Agency’s (EPA) Risk Management Program (RMP) Rule requires facilities storing specific chemicals above certain threshold amounts to develop risk management programs to prevent and mitigate accidents that could release those chemicals into the environment. Just what the RMP rule entails has been the subject of debate since EPA first proposed the RMP Amendments in 2016. Rules related to RMP requirements have been published, petitioned, delayed, vacated, reissued, and reconsidered. As the most recent action in the ongoing RMP saga, EPA Administrator Andrew Wheeler signed the RMP Reconsideration Rule on November 21, 2019.

Reconsideration Rule

According to EPA Administrator Wheeler, the intent of the RMP Reconsideration Rule is to promote “improved coordination between chemical facilities and emergency responders, reduce unnecessary regulatory burdens, and address security risks associated with previous amendments to the RMP rule.”

What does that entail? In the final Reconsideration Rule, many of the major provisions that were added in the RMP Amendments Rule are rescinded, including the following requirements to:

  • Hire a third-party to conduct a compliance audit after an RMP reportable accident. EPA retains the right to still require a third-party audit, when appropriate.
  • Conduct a Safer Technologies and Alternatives Analysis (STAA). Again, this can still be required by EPA but is already encouraged under the rule’s existing Process Hazard Analysis (PHA) provisions.
  • Conduct and document a root cause analysis after an RMP reportable accident/near miss, in efforts to maintain consistency with the OSHA Process Safety Management (PSM) standard.
  • Make very broadly defined information available by facility to the public upon request to alleviate potential security/terrorism threats.

A number of other requirements, particularly as it relates to local emergency coordination and training exercises have been retained and/or modified, as follows:

Retained

  • Requirements that facilities must coordinate annually and document coordination with local response organizations.
  • Annual notification drills to confirm that emergency contact information is accurate.
  • Requirement to perform field and tabletop exercises as a way to train facility personnel and local responders.
  • Frequency of 3-year tabletop exercises to ensure regular emergency training is conducted.

Modified

  • Provision to reduce potential security risks associated with avoiding the open-ended information disclosure provision.
  • Frequency of field exercises by removing the ten-year minimum requirement to reduce burden on local emergency responders.
  • Scope and documentation provisions for field and tabletop exercises to reduce burden.
  • Requirement to hold a public meeting after an incident that has offsite impacts vs. releases with only onsite impacts.

The EPA RMP Website provides additional information and resources, as well as a copy of the complete RMP Reconsideration Rule and the updated requirements.

Risk-Based Approach

According to the EPA RMP Reconsideration Final Rule Fact Sheet, the final rule retains the prevention provisions that have resulted in the trend of fewer significant chemical accidents, which have declined more than 50% since RMP was first published in 1999. With the RMP Reconsideration Rule, EPA’s intent  is to take a more risk-based approach that focuses on the highest risk facilities (i.e., the less than 2% of RMP facilities reporting multiple releases), as opposed to the 90+% of RMP facilities who reported no accidents from 2007-2016.

Industry Reaction

RMP regulates approximately 12,500 facilities, including agricultural supply distributors, waste/wastewater treatment facilities, chemical manufacturers and distributors, food and beverage manufacturers, chemical warehouses, oil refineries and other chemical facilities. As a whole, industry has commended EPA for taking a more risk-based approach to RMP that reduces the regulatory burden on industry:

  • “The RMP program has been working very well. The data clearly shows a continuous reduction in accidents of regulated facilities. It is important for EPA to focus on compliance assistance efforts and promoting enhanced coordination between RMP facilities and local first responders.” Richard Gupton, Senior Vice President of Public Policy and Counsel, Agricultural Retailers Association (ARA)
  • “SOCMA and its members have been actively engaged in the reconsideration of the 2017 RMP Amendments and has been supportive of the Agency’s efforts to delay implementation of the prior rule while it conducted reconsideration proceedings. This final rule will provide much-needed certainty at facilities seeking to understand and achieve their RMP compliance obligations.” Robert Helminiak, Vice President of Legal and Government Relations, Society of Chemical Manufacturers and Affiliates (SOCMA)
  • “We commend the EPA for developing a rule that reflects the extensive feedback the agency received through a comprehensive and thoughtful process to seek public input. The agency wisely incorporated the recommendation to strike the right balance of sharing vital safety information with emergency responders and protecting sensitive security information. EPA also followed the recommendation to utilize the EPA’s latest data to identify areas where more focused compliance assistance is needed to help facilities further reduce the number of reportable safety incidents.” Mike, Walls, Vice President of Regulatory and Technical Affairs, American Chemical Council (ACC)
  • “NACD commends EPA for taking our recommended changes to the 2017 rule seriously and for instead pursuing a commonsense approach that improves facility safety without hamstringing businesses with burdensome requirements that have no proven benefit.” Jennifer Gibson, Vice President of Regulatory Affairs, National Association of Chemical Distributors (NACD)

Implications/What’s Next?

As the regulatory history with the RMP Rule demonstrates, it remains important for impacted companies to stay on top of the requirements, coordinate efforts with local emergency responders, and plan accordingly. For companies impacted by the RMP Reconsideration Rule, it is important to:

  • Understand the hazards posed by chemicals at the facility
  • Assess the impacts of a potential release
  • Design and maintain a safe facility to prevent accidental releases
  • Coordinate with local emergency responders
  • Minimize the consequences of accidental releases that do occur

Kestrel Tellevate LLC (KTL) has experience working with a broad cross-section of industries impacted by RMP, particularly chemical companies. We have created RMP and General Duty Clause audit protocol and conducted audits and investigation/improvement programs following significant release events. We also routinely work with Local Emergency Planning Commissions (LEPCs) to coordinate emergency response efforts and exercises.

Our understanding of the regulations and industry needs spans years of experience and commitment to helping industry comply with regulations and operate more efficiently. For example, KTL developed and implemented the Guidance Manual and Training Modules for the Responsible Care Management System (RCMS) and RC14001, ACC’s management system integrating environmental, safety/process safety and security. KTL is also a Preferred Provider of compliance services for NACD member companies and a recognized NACD Responsible Distribution Adviser, providing in-depth support for members and affiliates during Responsible Distribution implementation and integration with other management systems and EHS compliance initiatives.

Regulatory enforcement-driven projects such as those related to RMP require skills in regulatory strategy, negotiations, expert analysis, presentations and testimony—and, equally important—trust and relationship building. KTL can work with companies to:

  • Identify/understand/prioritize compliance risks
  • Outline steps to improve performance
  • Define organizational roles and responsibilities
  • Streamline compliance methods
  • Plan and conduct required tabletop exercises and coordinate with local emergency response
  • Implement, monitor, and continually improve
15 Nov
Audit Reporting
4 Steps to Reporting Audit Results

The audit report communicates the information, findings and opinions derived from the audit.  The report communicates either acceptability of the current status of the management system or reports non-conformances that need corrective action. The following outlines the suggested steps for reporting audit results.

Step 1. Assess the Status of Current Internal Controls

One of the auditor’s main responsibilities is to evaluate whether the current internal controls that govern the management system are adequate. Do the audits:

  • Highlight areas of concern or hazards that may be a failure waiting to happen?
  • Focus attention of the 20% of the factors that cause 80% of the problems?
  • Help to eliminate ineffective controls or make existing controls better?
  • Aid in the detection and prevention of deficiencies or non-conformances?
  • Look through and investigate possible “homeblindness”?
  • Verify the management system links are supportive and feed each other information to assure continual improvement?

The auditors must constantly challenge the status quo and push the management system forward beyond its comfort level.

Step 2. Prepare Audit Report

Most facilities use a formal audit report system. The audit report format is prescribed and followed by the auditor. The auditor typically states:

  • Date and time of audit
  • Department audited
  • Management system clauses audited to
  • Personnel interviewed
  • Documents reviewed
  • Summary of findings
  • Conformance or non-conformance determination

Step 3. Discuss Audit Findings

The lead auditor will then take the completed audit report and review the contents with the affected department head. Upon acceptance by the department head, the final audit report should then be signed by the department head verifying acceptance and responsibility for any change(s) required.

Step 4. Determine Plan of Action

The entire reason for conducting internal management system audits is to verify conformance and continually improve on the management system. Therefore, it is extremely important that all identified non-conformances are corrected in a timely manner.

Some companies place all audited non-conformances into their corrective/preventive action process for tracking purposes. Others place only critical non-conformances into the corrective/preventive action process. Regardless of the mechanics of tracking the identified audited non-conformances, it is imperative that corrective action is taken.

Once the corrective action is in place, the auditors should review the actions taken and verify the root cause was identified properly and resolved. An accept or reject decision can then be rendered for the change action.

If acceptable, no further action is required, and the issue is considered resolved. If unacceptable, the department head must complete a new root cause analysis, develop a new action plan, and put the new action plan into place. The auditors will now review the new action plan and make a determination of acceptance or rejection.

Audit Team Members

It is advisable to rotate your internal management system audit team members. This will allow for fresh perspective and a new set of eyes to look at the management system. This serves many purposes:

  • Gives a specific timeframe of responsibly for those thinking of enlisting as an auditor
  • Allows for gradual increase of responsibility over time; new auditors learn and perform audits, older auditors become mentors for the new auditors, graduates leave program and are viewed by company personnel as “knowledge experts” on the management system
  • Allows for fresh perspective on auditing
  • Trains numerous employees on the management system
  • Reinforces the concept of continuous improvement

Are You Prepared?

Use your answers to the questions below to evaluate your preparation for reporting audit results.

  • Has the auditor evaluated the current internal controls for suitability, adequacy, and effectiveness?
  • Does the auditor have hard copy evidence of conformance and/or non-conformance?
  • Have all questions prepared prior to the audit been satisfactorily answered and explained?
  • Is the audit report clear, concise, and informative?
  • Does the department head agree or disagree with the findings?
  • Are all identified non-conformances tracked and resolved in a timely manner?
  • Based on audit non-conformances, are procedures and work instructions being changed and improved?
  • Do employees understand the management system is being audited, not the employee?
  • Is change readily accepted by company personnel?

 

12 Nov
waste management best practices
Top 6 Best Practices for Waste Management

BIOTECHNOLOGY FOCUS

Identifying and managing your wastes is not a task to be taken lightly. If waste is incorrectly managed, there are regulatory compliance risks, exposure risks, and potential financial penalties that can impact your business. Given these risks, effective waste management requires investments of time, money, and resources. However, if you are proactive in your efforts to inventory your wastes, understand your requirements, and develop a plan to manage your inputs and outputs, it is possible to turn those investments into value for your organization.

The following six best practices can help ensure you are you managing your waste correctly, efficiently, and cost-effectively—and that you can sustain those efforts for the long term:

1.  Inventory your wastes – Biotech labs and industrial processes traditionally produce many different types of waste that can present significant waste management challenges. A methodical, analytical approach to characterizing and evaluating waste can substantially improve efficiencies when it comes to handling waste and minimize the risks of improper waste management. This is done through an EPA-required waste determination. In addition to reviewing chemicals that are used in processes and the different types of risk they present, a waste determination should evaluate allwaste being generated by processes throughout the facility.

2.  Understand your compliance requirements – The Environmental Protection Agency (EPA) regulates much of the waste generated by industry. Over the past ten years, the Agency has demonstrated an even stronger focus on labs. Additional regulatory agencies that oversee lab and industry operations include the Occupational Safety & Health Administration (OSHA), Department of Transportation (DOT), Department of Homeland Security (DHS), fire department, and others depending upon the type of work being done, chemicals being used, and resulting end products. The waste scenarios seen in labs and industry are countless, and each may hold associated regulatory compliance requirements. While this clearly presents business risks, it also provides a unique opportunity to create strategies to manage wastes more effectively and efficiently, improve safety, and reduce the potential costs of regulatory compliance.

3.  Understand your business processes – Companies who want to proactively manage their waste need to go through the process of understanding where your waste fits into your business processes—and what you need to do with not only your waste, but also your operations, to minimize risk, reduce costs, and ensure compliance. Having business and production processes mapped out helps companies improve the interconnected set of processes, sub-processes, activities, and tasks that allow the business to manage waste most effectively. A thorough review of business and operational processes and the waste being generated further creates the opportunity for a “bottom-to-top” evaluation of all regulatory compliance. It is a process of understanding what you have, where it fits, and what you need to do with it to minimize risk, reduce costs, and ensure compliance.

4.  Get the right parties trained – One of the most common violations identified by both DOT and EPA is failure of personnel signing hazardous waste manifests to have appropriate DOT hazardous waste training. Failure to meet this training requirement can result in substantial financial penalty. Perhaps even more important, lack of training may also impact the understanding of employees in how to correctly—and safely—perform their duties. There are many people who touch waste at various points in the process and they all need to be trained on how to work with it in a manner that is safe and compliant with regulatory requirements.

5.  Develop waste management strategies – Are there waste streams that you are paying too much to manage? Are there alternatives to the reagents or kits you are using that may minimize your risk and improve safety in your lab? Are there strategies that can make waste management simpler, more cost-effective, and more compliant that you could implement in your lab? As key indicators of waste quantities are identified, strategies for internal process changes that can minimize waste generation can be implemented.

When developing your strategies, focus on managing waste as close to the source(s) as possible. There are frequently alternatives to hazardous, universal, biohazardous, and special waste management that will minimize risk and improve financials. These waste minimization strategies need to be identified and evaluated to determine their applicability and potential impacts. Options that Kestrel has investigated and assisted with implementing include:

  • Treating hazardous waste to minimize quantities for disposal
  • Recycling used solvents through evaporation and reclamation strategies
  • Solidifying nonhazardous waste waters with associated subtitle D landfilling

6.  Establish a system to sustain ongoing compliance – Documenting waste management procedures and processes, along with management oversight and continual review and improvement, is key to ensuring ongoing compliance. Technology (i.e., a compliance information management system (IMS), apps, tools) can help create process standardization, operational efficiencies, and, subsequently, consistent and reliable compliance/waste management performance. 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 compliance IMS so they can be managed more efficiently.

Through an evaluation of chemicals onsite, development of an inventory of both chemicals used and waste generated, and identification of processes to efficiently and effectively manage waste, businesses/labs can ensure they understand and meet their EHS regulatory obligations in the most efficient ways possible.

05 Nov
waste management compliance efficiency tools
How Do I Efficiently Sustain Waste Management Compliance?

Understanding your waste requirements and then getting your facility in compliance with those requirements are important steps in your waste management efforts. However, effective waste management is not a one-time effort. It takes ongoing resources and tools to sustain ongoing compliance. Consider the following:

  • How do you track your waste inventory?
  • Do you have ongoing permitting requirements to manage?
  • Does your staff need periodic training?
  • Are there regular (e.g., annual, semi-annual) plans and/or reports you need to submit?
  • Do you have routine inspections and monitoring?
  • How do you maintain your records? Where do you house your documentation?

Managing all these things and effectively resourcing ongoing regulatory compliance needs can quickly become overwhelming—especially for those companies without a dedicated team of full-time environmental, health and safety (EHS) staff.

Technology Tools

Documenting waste management procedures and processes, along with management oversight and continual review and improvement, is key to ensuring ongoing compliance. Technology (i.e., a compliance information management system (IMS), apps, tools) can help create process standardization, operational efficiencies, and, subsequently, consistent and reliable compliance/waste management performance.

However, it must be noted that applying technology to operations isn’t about just finding and buying a software tool. It is about:

  • Understanding the business need;
  • Customizing and integrating the appropriate tool into existing operations; and
  • Deploying it so it is effectively applied.

Scalable Solutions

Virtually every regulatory program, including those related to waste management, has compliance requirements that call for companies to fulfill a number of common compliance activities. While they do not necessarily need to be addressed all at once or from the start, considering the eight functions of compliance when designing compliance efficiency tools helps define the starting point and build a vision for the end result.

Compliance efficiency tools built on an Office 365 platform offer an adaptable/scalable solution that can allow you to more efficiently manage compliance tasks, corrective and preventive actions (CAPAs), and other project activities to ensure you are meeting your compliance requirements. Translating these common compliance functions into modules that can be instrumental in establishing or improving a company’s capability to comply, including:

  • Facility profiles
  • Waste inventories
  • Compliance calendars
  • Assessments & inspections
  • Mobile forms & checklists
  • Audit tracking
  • Permit management/tracking
  • Document and records management

Adding Business Value

In the end, implementing compliance efficiency tools such as this can provide the resources needed to effectively manage your waste management program—plus a number of other lasting benefits to the overall business:

  • Helps improve the company’s capability to comply on an ongoing basis
  • Establishes compliance practices
  • Creates a strong foundation for internal and 3rd-party compliance audits and for answering outside auditors’ questions (agencies, customers, certifying bodies)
  • Helps companies know where to look for continuous improvement
  • Reduces surprises and unnecessary spending on reactive compliance-related activities
  • Informs management’s need to know
  • Enhances confidence of others (e.g. regulators, shareholders/investors, insurers, customers), providing evidence of commitment, capability, reliability and consistency in the company’s waste management program
24 Oct
Federal agency seals
Partnering with Government Agencies to Manage Projects

From time to time, private businesses are faced with the prospect of partnering with a government agency, office, or department in order to accomplish a goal or undertake a project. Reasons vary: the effort may result from an enforcement action, consent order, or settlement agreement, or it may simply be a strategic priority that requires joining forces with a federal, state, or local government office. In any case, working with government agencies presents opportunities and challenges not regularly encountered in a competitive business’s projects.

Reset Your Clock

Government agencies do not move at the speed of competitive business—they typically move much slower. Government budgeting and spending are intentionally lengthy processes that are subject to the political winds. As a result, it is not unusual for agencies to employ (legacy) infrastructure and systems that have worked in the past, regardless of apparent inefficiencies today.

If the agency will be contributing financially to the effort, it may take years for funding to be proposed, studied, discussed, approved in a budget, and then approved to spend. Similarly, any decision-making can be an arduous and lengthy process involving a multitude of managers and influencers.

Understanding how funding and decisions are made and who needs to be involved is critical to managing the time element of projects. Often, the dominant motive for decision-making is protection of the status quo and personal job security, versus “let’s try something new and exciting”. Stakeholder management requires understanding, patience, and persistence.

Take the Lead

Business should expect to take the lead in project management. Most government agencies will advertise successful projects after they are completed, but will keep unproven or work-in-progress low key, pending successful results. Similarly, they will participate as directed in the work but do not usually want to be viewed as driving a public-private partnership, as even the appearance of an overly close relationship with a particular business can compromise the agency’s perceived objectivity. Finally, many public agencies do not have trained project managers on staff to lead such an effort, while a business may.

Find an Agency Champion

Successful execution of the project plan requires timely coordination and cooperation from the agency, and may involve a number of different departments or functions within it. For example, building a joint facility may involve facilities, IT, security, finance, law, and operations departments. In order to get the cooperation needed from the various departments, those staffs will expect someone in their direct chain of command to prioritize the project.

In competitive business, a Vice President acting as project sponsor may have all the authority he/she needs to expect and get cooperation across the property. But in a government agency, a Director or Section Chief over one of the areas may carry absolutely no authority in another department. Government agencies tend to be very silo-ed in their structures, not matrixed. It is important to find a sponsor far enough up the chain to cover all areas involved and to communicate his support of the project to all areas—even if he/she is not regularly directly involved in the project.

Build a Lasting Relationship

So often, the only time business and agencies interact is when one needs something from the other. This can lead to a strained relationship, characterized by avoidance or begrudging interactions. These are the same agencies, however, where a positive working relationship can result in a business competitive advantage. Working closely with these gatekeepers of the regulations and public trust in a non-confrontational setting can set the foundation for a new relationship built upon mutual understanding and achieving common goals.

Government employees fill a valuable role in society by providing services and protecting society. Besides understanding the current enforcement priorities, they interact with customers, competitors and even employees, and can provide valuable information or ideas for businesses to improve efficiencies or help direct the focus of current business efforts.

Case Study: Utility Environmental Management System (EMS)

Kestrel managed a project with an investor-owned utility to design and implement an Environmental Management System (EMS) at a coal-fired power plant. The result of a consent order from the state Natural Resources Department, both the utility and the agency were involved from design and implementation to final auditing and EMS acceptance by the agency. The project and the associated agency interactions brought the plant higher confidence in its environmental plans and operations, and gave local regulators a deeper understanding of the utility business and ownership of the plant’s path forward.

Takeaways

Working with a government agency to manage a project is different than working with a competitive business. However, doing so can be beneficial to achieving both parties’ objectives if the company knows how to successfully navigate the working relationship:

  1. Understand how government funding and decisions are made before project kickoff.
  2. Actively manage government stakeholders—expect to take the lead.
  3. Find a project sponsor with the authority to ensure cooperation from all agency departments involved.
  4. Take advantage of the opportunity to build a positive, long-lasting relationship.
22 Oct
Biotech Manufacturing
How Do Business Processes Impact Waste Management?

Biotechnology Focus

When it comes to digging deeper into your waste management efforts, it’s important to step back from the waste itself and consider how waste fits into operations—and how it may impact your overall business. What’s coming in? What’s going out? And what risks does this present to the business?

In this Q&A with KTL Principal Lisa Langdon, we discuss how a comprehensive review of operations is the foundation to effectively managing waste.

What does a comprehensive review of operations look like?

Companies who want to proactively manage their waste need to first go through the process of understanding:

  1. What waste streams you have;
  2. Where your waste fits into your business processes; and
  3. What you need to do with your waste and operations to minimize risk, reduce costs, and ensure compliance.

The first step in understanding how waste fits into the business is to thoroughly review and map all business processes, keeping focus on the entire production process. This can start with a facility layout diagram, followed by more specific process and sub-process flow diagrams.

Most biotech operations will have their processes mapped in a fair amount of detail, but perhaps not smaller or startup operations. For example, existing diagrams might be found as part of the documents managed under a quality management systems (QMS) (e.g., ISO 9001) or as part of air permitting or other compliance documents.

As an outside consultant, Kestrel reviews and builds off whatever process flows have already been developed internally to ensure they are comprehensive. The review and process flows should reflect production-related activities, including raw materials receiving, raw material entry and processing in production, product finishing, packaging, and shipping. Capability, capacity, programs, and processes to comply are examined as part of this review.

How does this help a company understand and improve waste management?

Defining, understanding, and improving the material and waste flow within major processes, programs, and projects can be challenging. Through in-depth interviews, data analysis, application of disciplined process improvement methods, and facilitation, we are able to demonstrate how all areas interrelate and impact the way an organization functions—as well as the associated business risks.

Having this all mapped out helps companies improve the interconnected set of processes, sub-processes, activities, and tasks that allow the business to manage waste most effectively. With a comprehensive understanding of a process, program or project, it then becomes possible to make changes that reduce variation and remove activities that contribute no value to the end product or service.

What is the goal on a waste management project like this?

Ultimately, our goal is to help companies decide on priorities for change, and then implement efficient business processes to improve operations and waste management practices that our clients can manage on their own. We maintain our focus on increasing efficiency and reliability without sacrificing quality, capacity, safety, or environmental responsibility.

Kestrel’s forte lies in translating strategy into execution, using process as the critical link to help organizations realize measurable results. By providing an objective perspective, we assist company leaders in analyzing, documenting, operationalizing, and sustaining process, program, and project improvements over the long term.

21 Oct
Audit checklist
Top 5 Critical Factors for Value-Added Auditing

Auditing is a management tool that can be used to evaluate and monitor the internal performance and compliance of your company with regulations and standards. An audit can also be used to determine the overall effectiveness of an existing system within your company.

How do you incorporate compliance auditing best practices to help maximize compliance, efficiency, and value of your audit? Here are five critical factors for value-added audits.

1. Goal Aligned with Business Strategy

There are many reasons why companies conduct audits:

  • Support commitment to compliance
  • Avoid penalties
  • Meet management system requirements
  • Meet corporate or customer mandates
  • Support acquisition or divestiture
  • Assess organizational structure and competency
  • Identify cost saving and pollution prevention opportunities
  • Determine alignment with strategic direction

It is vital to define and understand the goal of your compliance audit program before beginning the audit process. Establishing goals enables recognition of broader issues and can lead to long-term preventive programs. Not establishing a clear, concise goal can lead to a waste of resources.

Audit goals and objectives should be nested within the company business goals, key performance objectives, and values. An example of a goal might be to effectively measure environmental compliance while maintaining a reasonable return on investment.

Once the goal is established, it is important to communicate it across all functions of the organization to get company-wide support. Performance measurements should also be communicated and widely understood.

2. Management Buy-in

The audit program must have upper management support to be successful. Management must exhibit top-down expectations for program excellence, view audits as a tool to drive continuous improvement, and work to imbed audits within other improvement processes. Equally important, management must not use audit results to take punitive action against any person or department.

3. Documented Audit Program Systematically Applied

Describe and document the audit process for consistent, efficient, effective, and reliable application. Audit procedures should be tailored to the specific facility/operation being audited. A documented program will include the following:

  • Scope. The scope discusses what areas/media/timeframe will be audited. The scope of the audit may be limited initially to what is manageable and can be done very well, thereby producing performance improvement and a wider understanding and acceptance of objectives. It may also be limited by identifying certain procedural or regulatory shifts and changes. As the program is developed and matures (e.g., management systems, company policy, operational integration), it can be expanded and, eventually, shift over time toward systems in place, prevention, efficiency, and best practices. It is important at the scoping stage to address your timeline. Audits should be scoped to make sure you get them done but also to make sure you have audited all compliance areas in an identified timeframe.
  • Criteria. Compliance with requirements will clearly be covered in an audit, but what about other opportunities for improvement (e.g., pollution prevention, energy savings, carbon reduction)? All facilities need to be covered at the appropriate level, with emphasis based on potential compliance and business risks. Assess the program strengths, redundancy, integration within the organization, and alignment with the program goal. Develop specific and targeted protocols that are tailored to operational characteristics and based on applicable regulations and requirements for the facility. As protocols are updated, the ability to evaluate continuous improvement trends must be maintained.
  • Auditor training (i.e., competency, bias). A significant portion of the audit program should be conducted by knowledgeable auditors (e.g., independent insiders, third parties, or a combination thereof) with clear independence from the operations being audited and from the direct chain of command. For organizational learning and to leverage compliance standards across facilities, it is good practice to vary at least one audit team member for each audit. Companies often enlist personnel from different facilities and with different expertise to audit other facilities. Periodic third-party audits further bring outside perspective and reduce tendencies toward “home-blindness”.

Training should be done throughout the entire organization, across all levels:
+ Auditors are trained on both technical matters and program procedures.
+ Management is trained on the overall program design, purpose, business impacts of findings, responsibilities, corrections, and improvements.
+ Line operations are trained on compliance procedures and company policy/systems.

Consider having auditor training conducted by an outside source to teach people how to decide what to audit and follow a trail. It can also work well to train internal auditors by having them audit alongside an experienced 3rd party.

  • Audit conduct (i.e., positive approach). A positive approach and rationale for the audit must be embraced. Management establishes this tone and sets the expectation for cooperation among all employees. Communication before, during, and after the audit is vital in keeping things positive. It is important to stress the following:
    • Auditor interviews are evaluating systems, not personal behaviors.
    • The audit is an effective tool to improve performances.
    • Results will not be used punitively.
  • Audit reporting. Information from auditing (e.g., findings, patterns, trends, comparisons) and the status of corrective actions often are reported on compliance dashboards for management review. Audit reports should be issued in a predictable and timely manner. It is desirable to orient the audit program toward organizational learning and continual improvement, rather than a “gotcha” philosophy. “Open book” approaches help learning by letting facility managers know in advance what the audit protocols are and how the audits will be conducted. Documentation is essential, and reporting should always align with program goals and follow legal guidance. There is variability in what gets reported and how based on the company’s objects. For example:
    • Findings only vs. opportunities for improvement and best management practices?
    • Spreadsheet vs. long format report?
    • Scoring vs. prioritization of findings (beware of the unintended consequences of scores!)?
    • Recommendations for corrective actions included or left for separate discussion?
  • Corrective and preventive action. Corrective actions require corporate review, top management-level attention, and management accountability for timely completion. A robust root cause analysis helps ensure not just correction/containment of the existing issue, but also preventive action to assure controls are in place to prevent the event from recurring. For example, if a drum is labeled incorrectly, the corrective action is to relabel that drum. A robust plan should be to also look for other drums that might be labeled incorrectly and to add and communicate an effective preventive action (e.g., training or posting signs showing a correctly labeled drum).
  • Follow-up and frequency. Address repeat findings. Identify patterns and seek root cause analysis and sustainable corrections. Communications with management should be done routinely to discuss status, needs, performance, program improvements, and business impacts. Those accountable for performance need to be provided information as close to “real time” as possible. There are several levels of audit frequency, depending on the type of audit:
    • Frequent: Operational (e.g., inspections, housekeeping, maintenance) – done as part of routine day-to-day operational responsibilities
    • Periodic: Compliance, systems, actions/projects – conducted annually/semi-annually
    • As needed: For issue follow-up
    • Infrequent: Comprehensive, independent – conducted every three to four years

4. Robust Corrective Action Program

As mentioned above, corrective actions are a must. If there is no commitment to correction, there is no reason to audit. A robust root cause analysis is essential. This should be a formal, yet flexible, approach. There should be no band-aids. Mistake-proof corrections and include metrics where possible. In the drum example given above, a more robust corrective action program would look at the root cause: Why was the drum mislabeled? Did the person know to label it? If so, why didn’t they do it?

The correction itself is key to the success of the audit program. Establish the expected timeframe for correction (including addressing preventive action). Establish an escalation process for delayed corrections. Corrective actions should be reviewed regularly by upper management using the existing operations review process. There must also be a process for verification that the correction has been made; the next audit cycle may not be sufficient.

Note also that addressing opportunities for improvement, not just non-compliance findings, may increase the return on investment associated with conducting an audit.

5. Sharing of Findings and Best Practices

Audit results should be communicated to increase awareness and minimize repeat findings. Even if conducted under privilege, best practices and corrections can and should still be shared.  Celebrate the positives and creative solutions. Stress the value of the audit program, always providing metrics and cost avoidance examples when possible. Inventory best practices and share/transfer them as part of audit program results. Use best-in-class facilities as models and “problem sites” for improvement planning and training.

Value-Added Audit

An audit can provide much additional value and return on organization if it is planned and managed effectively. This includes doing the following:

  • Align program goal with business strategy to secure top-down buy-in
  • Expand criteria beyond compliance
  • Gain goodwill through positive approach
  • Document program and results
  • Monitor for timely, effective corrective action
  • Share opportunities for improvement
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