Have you updated Your Lithium Battery Shipping Instructions?

Have you updated your procedures to include the New Lithium Battery Shipping Guidelines that took place January 2019?

Key changes to be aware of:

1.  Packaging Requirement: A New label is required to be on shipments of lithium batteries or on shipments of equipment containing Lithium Batteries.

2.  Often overlooked is Resale equipment shipped out via eBay, Amazon, or other is required to have the new Lithium Battery Label. 

 3.  Changes to the UN Numbers.  The Proper UN Number is required to be on your Label:

UN3480, Lithium ion batteries including Lithium polymer.

UN3481 Lithium ion batteries contained in equipment including Lithium polymer or Lithium ion batteries packaged with equipment including Lithium polymer.

UN3090, Lithium metal batteries including lithium alloy batteries.

UN3091, Lithium Metal batteries contained in equipment including lithium alloy batteries or Lithium metal batteries packed with equipment including lithium alloy batteries.

4.  A Telephone Number is also required to be added to the New Lithium Battery Label. The telephone number should be of a person knowledgeable about the shipment but is not intended to be for the purposes of obtaining immediate emergency response guidance and is therefore not required to be monitored at all times that the package is in transit. It is acceptable for the number to be monitored during the company’s normal business hours in order to provide product-specific information relative to the shipment.

See – www.ISO45001-Support.com

If you have questions about proper shipping and packaging of Lithium Batteries please reach out to EHS Management Strategies.

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DOT Hazardous Materials Update

During our ISO 14001 and EHS compliance audits we continue to write findings for organizations that do not fully understand the training requirements under the DOT and RCRA Hazardous Waste regulations.  Here is a brief regulatory discussion and our training program.

DOT HMR rules defines who is considered a “Hazardous Materials Employee” at 49 CFR 171.8 and the required training at 49 CFR 172.704. 49 CFR 172.704 (d) says  “the hazmat employer must create records of Certification that the hazmat employee has been trained and tested, as required by this subpart”

RCRA Hazardous Waste training requirements are define based on the Generator Status of the organization (Large Quantity, Small Quantity, or Very Small Quantity) and the specific training requirements can be found at:

Large Quantity Generators: 

  • Hazardous waste personnel must be trained within six months of hire/assignment and may not work unsupervised until training is complete [40 CFR 262.17(a)(7)(ii)].
  • Hazardous waste training must be repeated annually [40 CFR 262.17(a)(7)(iii)].
  • Employers must keep records of hazardous waste training [40 CFR 262.17(a)(7)(iv)].

Small Quantity Generators ( < 1000 kg per month )

  • Hazardous waste personnel must be “thoroughly familiar” with their responsibilities for hazardous waste management compliance [40 CFR 262.16(b)(9)(iii)].

Very Small Quantity Generators ( < 100 kg per month )

  • No regulatory required training. However, ISO 14001 does require employees with these responsibilities to be “competent” based on training, education, and experience.

On May 14 we are offering online training to support your compliance in both of these areas:

  • DOT General Awareness Training – 2 hours – The 2-hour webinar will provide a brief overview of the DOT Hazardous Materials regulation (49 CFR 172), material classification using the Hazmat Table, package selection, labeling / marking, shipping papers and placarding requirements. This introductory program designed to meet DOT requirements for general awareness requirements.
  • RCRA Hazardous Waste Training – 2 hours – This webinar will provide an overview of the RCRA hazardous waste management regulations and requirements for Large, Small, and Very Small Hazardous Waste Generators. Training will include:
    •    Hazardous waste characterization (some exemptions)
    •     Universal Waste Management
    •     Determining generator status
    •     Accumulation requirements
    •     Container Labeling
    •     Per-transpiration
    •     Manifesting
    •     Inspections
    •     Record Keeping
    •     Emergency response requirements
    •     Common non-compliance issues

The schedule for future classes can be found at – DOT/RCRA Webinar. We are planning to schedule these webinars quarterly.

Each course will provide electronic copies of the training materials, brief quiz, and training certificate.

Please SHARE with other who may be interested. Thank you!!!

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Ways to reduce hazardous waste and save $$$

Many chemical products and formulations are identified as hazardous waste with a P- or U-code and/or because they exhibit one or more of RCRA’s four hazardous waste characteristics—ignitability, corrosivity, reactivity or toxicity.

This can include products like:

  • Cleaning solvents
  • Glues and adhesives
  • Paints and coatings
  • Production ingredients
  • Pesticides
  • Lab products
  • Calibration products

By thinking critically about how you manage these products at your site, you can optimize your ordering, use, and disposal practices to prevent these chemicals from entering RCRA’s jurisdiction in the first place.

Meet EPA’s annual hazardous waste training mandate. The RCRA Hazardous Waste Management Workshop returns to Houston, Dallas, Detroit, Pittsburgh, Cleveland, and Cincinnati in May 2019.

Waste Minimization Strategy 1: Inventory Management

By managing your inventory properly, you can significantly reduce this waste stream. Consider these strategies:

  • Centralize purchasing! If employees have carte blanche to buy whatever they want, it is certain there will be duplication, overages, and spoilage.
  • Establish a digital inventory tracker for the company intranet so workers know what’s on-hand elsewhere onsite.
  • Create a “haz-mart” for unwanted inventory where workers can “purchase” chemicals and products for use-at-home. This can be a physical location or a virtual listing.
  • Connect purchasing with your company’s waste management and production divisions so everyone is on the same page.
  • Institute a bar coding system that is integrated with a “just-in-time” automatic purchasing plan.

Materials Exchanges (cheaper to give it away)

A lot of CCP is discarded because it is expired or off-spec. That problem can be minimized by stocking shelves properly and adhering to a first-in, first-out policy. Be careful of how your standard operating procedures (SOPs) are worded.

If your SOPs state the expiration date signals the material is destined for disposal, it means the product becomes a waste on that day and must be appropriately managed. However, the EPA does not require you to automatically discard a material as of its expiration date.

What are some options, then, for managing your unwanted materials, that don’t get them regulated as waste? You may hold on to them for later use. Or donate or sell them. To find someone who wants them, visit this website to link to more than 50 waste exchange lists across the country: mxinfo.org/list.cfm .

The Materials Exchange Information website:

  • Acts as a central repository and resource for information regarding materials exchanges; and
  • Provides easy-to-use tools so that materials exchange managers can keep their information up-to-date.

Product Take-Backs (doesn’t hurt to ask)

Finally, see if the manufacturer of a product will take it back. Even if they do so without refunding what you paid, returning chemicals can still be a cost-saving option compared to treatment and disposal.

Even when the product must be reworked to recover a usable component (i.e., reclaimed), a bonus of this option is the CCP is excluded as a solid waste when reclaimed, and therefore, by definition, cannot be a hazardous waste. [40 CFR 261.2(c)(3)]

Checkout our RCRA and DOT training programs.

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Proper Disposal of Aerosol Cans

Process for the proper disposal of waste aerosol cans.

Review how your facility manages these wastes.

Typically, the drum used to collect the vapors and liquids will be subject to the hazardous waste disposal rules in your state.

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EPA Proposes Adding Aerosols to Universal Waste Program

EPA’s proposal to add hazardous waste aerosol cans to the RCRA universal waste program appeared in the Federal Register on Friday, March 16, 2018. This will be a significant improvement in how these wastes are classified and help companies maintain compliance.

US EPA has signed a proposed rule to expand its RCRA universal waste program to cover hazardous waste aerosol cans.

Adding aerosol cans to the universal waste program may simplify things for generators—who currently manage aerosols under a patchwork of State-level laws, regulations, policies, and guidance documents. However, as with all new Federal environmental reliefs, authorized States may now choose to adopt the new universal waste rules into their State programs (or not).

For individual facilities, managing hazardous waste aerosol cans as universal waste could result in a change in generator status (from large to small or from small to very small).

Proposed Universal Waste Requirements for Aerosol Cans

The proposed rule adds a definition for “aerosol can” at 40 CFR 260.10 to read “an intact container in which gas under pressure is used to aerate and dispense any materials through a valve in the form of a spray or foam. It also adds “(5)Aerosol cans described in 273.6 of this chapter” to the definition of Universal Waste.

The proposed rule would also explicitly allow universal waste handlers to “treat” cans on-site using a commercial puncturing or crushing device specifically designed for that purpose. To take advantage of this relief, handlers must “establish a written procedure detailing how to safely puncture and drain universal waste aerosol cans…” and follow other rules.


Despite the reliefs proposed here—facilities still must meet the universal waste marking and labeling, employee training, release response, and other requirements found in 40 CFR 273. These rules apply to both large quantity and small quantity handlers of universal waste.

Large quantity universal waste handlers—those that handle 5,000 kilograms or more of universal wastes—are also responsible for tracking universal waste shipments per 40 CFR 273.39.

Background on RCRA Universal Waste Rules

Created in 1995, EPA’s universal waste rules provide a streamlined hazardous waste management system for common industrial wastes like batteries, pesticides, mercury-containing equipment, and lamps. The universal waste standards allow generators to escape the full burden of RCRA Subtitle C hazardous waste requirements that would otherwise apply. EPA estimates in its proposal that 18,000 facilities in 18 industries will benefit from the relaxed standards for managing aerosols.

Aerosol cans are common at modern industrial facilities. They contain paint, lubricants, glues, pesticides, and many other chemicals that may be hazardous—not to mention the propellant that makes the can spray, which itself may be hazardous. The wide variety of aerosol cans at a typical facility, the different products they contain, and other unique qualities have made aerosols a challenge to manage under the Resource Conservation and Recovery Act (RCRA) hazardous waste regulations.

Guess we will wait to see what the states will do?

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DOT Hazardous Materials Training – who requires training? Detailed analysis

This has been a widely misunderstood requirement for many organizations that we have audited.  The DOT requirements for shipping hazardous materials can be found at 49 CFR 171-177.

49 CFR 172.700 defines the requirements for “Hazmat Employees”.  The definition of a Hazmat Employee can be found at 49 CFR 171.8 and includes:

(1) (i) Employed on a full-time, part time, or temporary basis by a hazmat employer and who in the course of such full time, part time or temporary employment directly affects hazardous materials transportation safety;

(ii) Self-employed (including an owner-operator of a motor vehicle, vessel, or aircraft) transporting hazardous materials in commerce who in the course of such self-employment directly affects hazardous materials transportation safety;

(iii) A railroad signalman; or

(iv) A railroad maintenance-of-way employee.

(2) This term includes an individual, employed on a full time, part time, or temporary basis by a hazmat employer, or who is self-employed, who during the course of employment:

(i) Loads, unloads, or handles hazardous materials;

(ii) Designs, manufactures, fabricates, inspects, marks, maintains, reconditions, repairs, or tests a package, container or packaging component that is represented, marked, certified, or sold as qualified for use in transporting hazardous material in commerce.

(iii) Prepares hazardous materials for transportation;

(iv) Is responsible for safety of transporting hazardous materials;

(v) Operates a vehicle used to transport hazardous materials

This section outlines who is considered a Hazmat Employee that requires training.  Please remember that a “hazardous material” is only regulated in the context associated with it being transported. So the “loading, unloading, and handling” are activities directly associated with the transportation of a regulated “hazardous material’.

Many organizations will provide training to their shipping supervisors, forklift operators, and any one signing a shipping paper (or hazardous waste manifest).  Organizations whose only hazardous material is hazardous waste and they have a contractor who loads the materials may choose to only train the employee who signs and certifies the manifests.  It is the employer who must define whom they consider a “Hazmat Employee”.

The scope of the required training is defined at 49 CFR 172.700 and includes:

(b) Scope. Training as used in this subpart means a systematic program that ensures a hazmat employee has familiarity with the general provisions of this subchapter, is able to recognize and identify hazardous materials, has knowledge of specific requirements of this subchapter applicable to functions performed by the employee, and has knowledge of emergency response information, self-protection measures and accident prevention methods and procedures (see § 172.704).

(c) Modal-specific training requirements. Additional training requirements for the individual modes of transportation are prescribed in parts 174, 175, 176, and 177 of this subchapter.

Here the training requirements are very general, and it references the requirements at 49 CFR 172.704 and these include:

  • General awareness/familiarization training
    • Familiarity with the requirements of this subchapter
    • Enable the employee to recognize and identify hazardous materials
  • Function-specific training
    • DOT requirements specifically applicable to the functions the employee performs
      • Material classification
      • Container selection
      • Container marking and labeling
      • Preparation and certification of shipping papers
  • Safety training.
    • Emergency Response
      • Spill and Medical Response
      • Must be site specific
    • Safety / Self Protection
      • Basic PPE and Hazard Communications
    • Methods to avoid accidents / Proper Material Handing
      • Fork Lift Training
  • Security awareness training.
  • In-depth security training
    • Only facilities that are required to have DOT security Plans
    • Must be site specific

Again, the regulation does not specify a specific length of training or specific contents of the training program, and it is the employer’s responsibility to certify and document the above training.  

As you can see, it is really not possible for an external generic training program would not address the site-specific components of all these training requirements.  Most external DOT Hazardous Materials Training should clearly cover the requirements of General awareness/familiarization, Function-specific, and Security awareness raining.  Typically, the requirements of Safety Training and In-depth security training (if required) will be met through your onsite safety program and review of your site-specific DOT security plan (if required) with hazmat employees. 

49 CFR 172.704 (d) requires the Employer to maintain records of compliance to all of the above requirements that includes:

  • The hazmat employee’s name;
  • The most recent training completion date of the hazmat employee’s training;
  • A description, copy, or the location of the training materials used to meet the requirements in paragraph (a) of this section;
  • The name and address of the person providing the training; and
  • Certification that the hazmat employee has been trained and tested, as required by this subpart.

Again, most certificates from external training programs will meet this requirement with the exception of the site-specific training that is required.

Now the $1,000,000 question is am I a Hazardous Materials Employer? The term hazardous materials employer is defined at 49 CFR 171.8.

Hazmat employer means:

(1) A person who employs or uses at least one hazmat employee on a full-time, part time, or temporary basis; and who:

(i) Transports hazardous materials in commerce;

(ii) Causes hazardous materials to be transported in commerce; or

(iii) Designs, manufactures, fabricates, inspects, marks, maintains, reconditions, repairs or tests a package, container, or packaging component that is represented, marked, certified, or sold by that person as qualified for use in transporting hazardous materials in commerce;

(Partial Definition. See 49 CFR 171.8)

So, is a company who only ships hazardous waste and no other DOT hazardous materials required to provide DOT hazardous materials training? The correct answer is YES.

Now who is required to be trained? Anyone who meets the definition of a “Hazmat Employee”. Anyone who has responsibility for classification of the material, selection of the container, marking & labeling the container prior to shipments, and preparing and signing the waste manifest. Also, employees that may be loading the materials on the transportation vehicle.  To limit the employees, you need to train you can limit those with responsibilities for the above activities.  At a minimum the person who signs (ie. Certifies) the waste manifest needs to be trained.

Hope this helps better understand the DOT requirements for training employees.  We provide both public webinar and site-specific instructor led training programs.  Please contact us at EHS Management Strategies.

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ISO 19011 Update

ISO 19011:2018 – Guidelines for auditing management systems has been updated. The standard applies to organizations that need to conduct internal or external audits of management systems and manage audit programs. The standard covers:

  • The principles of auditing;
  • Managing an audit program;
  • Conducting management system audits;
  • Guidance on evaluating the competence of personnel involved in the audit process.

All new management system standards including ISO 9001, ISO 14001, ISO 27001 and ISO 45001 are based on Annex SL format and terminology. Annex SL was developed to ensure that all future ISO management system standards share a common format irrespective of the specific discipline to which they relate.

Annex SL prescribes a high-level structure, identical core text, and common terms and core definitions and greatly facilitates the integration of management systems.  As a result of the introduction of these new standards, there is a need to consider a broader approach to management system auditing, as well as providing guidance that is more generic in nature. Audit results can provide input to the analysis aspect of business planning and can contribute to the identification of improvement needs and opportunities.

Planning is an integral part of all management systems. Effective planning is concerned with prevention by identifying, eliminating and controlling hazards and risks.

Annex SL requires that when planning for any management system (clause 6.1), the organisation should take into account the following:

  • The organization and its context (clause 4.1);
  • The needs and expectations of interested parties (clause 4.2);
  • The scope of the management system (clause 4.3).

Planning should be proportionate to the level of risk identified and this principle resonates with ISO 19011.

The main changes introduced by ISO 19011:2018 are as follows:

  • Addition of the risk-based approach to the principles of auditing;
  • Expansion of guidance on managing an audit programme, including audit program risk;
  • Expansion of the guidance on conducting an audit, particularly the section on audit planning;
  • Expansion of the generic competence requirements for auditors;
  • Adjusted terminology to reflect the process approach to auditing;
  • Removal of the annex containing competence requirements for auditing specific management system disciplines (due to the large number of individual management system standards, it would be impractical to include competence requirements for all disciplines);
  • Expansion of Annex A to provide guidance on auditing (new) concepts such as organizational context, leadership and commitment, virtual audits, compliance and supply chain.

The standard provides guidance for all sizes and types of organizations and audits of varying scopes and complexities, including those conducted by large audit teams, typically of larger organizations, and those by single auditors, whether in large or small organizations. The guidance should be adapted as appropriate to the scope, complexity and scale of the audit program.

The standard concentrates on internal audits (first party audits) and audits conducted by organizations on their external suppliers and other external interested parties (second party audits). The standard is also useful for external audits conducted for purposes other than third party management system certification. ISO/IEC 17021-1 provides requirements for auditing management systems for third party certification and ISO 19011 can provide useful additional guidance.

ISO 19011:2018 does not follow the annex SL model but does have a risk-based approach. It contains the following main clauses:

  • Clause 4 describes the principles on which auditing is based. These principles help the user to understand the essential nature of auditing and are important in understanding the guidance set out in clauses 5 to 7;
  • Clause 5 provides guidance on establishing audit program objectives, determining and evaluating audit program risks and opportunities, and implementing, monitoring, reviewing and improving the audit program;
  • Clause 6 provides guidance on initiating the audit, preparing and conducting audit activities, preparing and distributing the audit report, completing the audit and conducting audit follow-up;
  • Clause 7 provides guidance on determining auditor competence, establishing auditor evaluation criteria, selecting appropriate auditor evaluation methods, conducting auditor evaluation and maintaining and improving auditor competence.;
  • Annex A provides additional guidance for auditors planning and conducting audits.

An audit can be conducted against a range of audit criteria, separately or in combination, including but not limited to:

  • requirements defined in one or more management system standards;
  • policies and requirements specified by relevant interested parties;
  • statutory and regulatory requirements and other requirements;
  • one or more management system processes defined by the organization or other parties;
  • management system plans relating to the provision of specific outputs of a management system (e.g. quality plan, project plan, etc.).

A new seventh principle of auditing has been added to Clause 4 to complement existing principles of integrity, fair presentation, due professional care, confidentiality, independence and evidence-based approach, which are inherited from the 2011 version of the standard. Auditors will now be expected to employ a ‘risk- based approach’ in order to substantively influence the planning, conducting and reporting of audits such that audits are focused on matters that are significant for the auditee and for achieving the audit program objectives.

Clause 5: Managing the audit program now requires that consideration be given to the organizations identified risks and opportunities and the actions taken to address them when preparing the audit programme.

Clause 5.3 Determining and evaluating audit program risks and opportunities states that there are risks and opportunities, and internal and external issues associated with an audit program that can affect the achievement of its objectives. The person managing the audit program should present to management the risks and opportunities considered when developing the audit program and its resource requirements.

Annex A, ‘Additional guidance for auditors for planning and conducting audits’ has been expanded to include the following auditing topics:

  • 1 Applying audit methods
  • 2 Process approach to auditing
  • 3 Professional judgement
  • 4 Performance results
  • 5 Verifying information
  • 6 Sampling
  • 7 Auditing compliance within a management system
  • 8 Auditing context
  • 9 Auditing leadership and commitment
  • 10 Auditing risks and opportunities
  • 11 Life cycle
  • 12 Audit of supply chain
  • 13 Preparing audit work documents
  • 14 Selecting sources of information
  • 15 Visiting the auditee’s location
  • 16 Auditing virtual activities and locations
  • 17 Conducting interviews
  • 18 Audit findings

In summary, ISO 19011:2018 is a welcome addition to the auditing canon and should contribute to a substantial improvement in the conduct of management system and other audits. Please contact with any questions or if we can support your internal audit process.

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Outsourcing Internal Audits – does this make sense?

Many organizations are choosing to “outsource” their Internal Auditing process. On the surface, this seems to go against the intent of the ISO standards. However, the cost of maintaining a qualified pool of internal auditors can be expensive. Also, considering the turnover in many organizations, the effectiveness of the audits may be poor and systemic non-conformances may go undetected.

The benefits of outsourcing your internal audits include:

  • Highly qualified auditor is more likely to detect systemic non-conformances resulting in fewer non-conformances during the registration audit.
  • Provides a coaching opportunity for on site management and good preparation for registration audit.
  • Keeping internal staff focused on their core area of responsibility.
  • Can be cost-effective when compared to the cost of training auditors.
  • Outside perspective can identify opportunities for improvement and risk reduction.

Outsourcing internal audits can also be effective when upgrading your management systems to meet new requirements. So companies upgrading to IATF 16949, ISO 14001:2015 or ISO 9001:2015 may wish to outsource their internal audits to gauge their readiness for recertification to the new requirements.

Please let US know how we can help support your internal audit process.

Check out options for performing Management System Audits.

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EMS Performance Monitoring – Energy Usage (ISO 14001:2015 9.1.1)

Many organizations have identified Energy Usage as a significant environmental aspect (impact) of their operations.  They then track their usage try to evaluate their performance.  However, there are many variables that can impact their usage:

  • Production Levels
  • Hours Worked
  • Weather – Hot or Cold
  • Addition / Subtraction / Replacement of Equipment

Tracking usage can help organizations understand and control their usage and be used to establish performance or effectiveness of their usage.

When trying to understand and control usage one effective tool is to chart both this year’s usage and last years usage to identify any irregularities and negative trends that cannot be accounted. This type of tracking serves as a process to control the usage through a monitoring process.  Section 9.1.1 of the ISO 14001:2015 standard requires that the criteria against which the organization will evaluate its environmental performance, and appropriate indicators;”.  In this case, the organization could establish a performance criterion such as current year usage within +/- 5% of prior year usage”. This would be appropriate for an organization not planning to implement any programs to reduce usage, but this does set a performance criterion as required.

Another way to monitor your usage is to track usage against your monthly energy cost budget.  Your accounting department has already set a monthly energy cost based on forecasted production activities and historical usage.  So, your performance criteria could be to “control usage to meet monthly energy budget”.  This can easily be reviewed monthly by management and the determination of performance can be established. I like this approach because it’s something that other are already doing and better integrates the EMS performance into your overall management system. 

We haven’t even discussed the many ways this data can be normalized to better understand impacts of production levels, I will save this for another blog.  I hope this helps when trying to develop the “performance criteria” for your energy metrics.  Please contact EHS Management Strategies with any questions.

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FREE Webinar Series – ISO 45001 and ISO 14001

FREE – What is an ISO 45001:2018 certified Occupation Health & Safety Management System (OHSMS)

The International Organization for Standardization (ISO) has finalized the ISO 45001 Occupational Health & Safety Management Systems standard that will replace the previous OSHAS 18001:2007 standard.  This webinar will provide a brief overview of the ISO 45001:2018 standard and benefits of a certified OHS management system. We will also explain how this can be integrated with your environmental management system (EMS) and quality management system (QMS).

The FREE webinar will be offered November 5, 2018 from 3:00 to 4:00 PM.  To register for the webinar simply click this link – ISO 45001 Overview- Nov 5th

FREE – I’m certified to ISO 14001:2015, now what?

So you upgraded your EMS to meet the requirements of the ISO 14001:2015 standard and your registration company has certified you to the new standard. It is likely that your registration company suggested additional changes to your EMS and there may be other areas that your system could more clearly meet the requirements.  This webinar will provide a brief overview if these key areas and provide you with suggestions on how to improve your EMS’s conformance to ISO 14001:2015.  We will share some best practices in several areas.

The FREE webinar will be offered November 5, 2018 from 1:00 to 2:00 PM.  To register for the webinar simply click this link – ISO 14001:2015 Next Steps – Nov 5th

Get Certified to ISO 45001:2018 in 120 days

GET Certified to ISO 45001 in 120 days. This course will provide an element by element overview of the ISO 45001 standard and examples of how to implement the requirements.  The course will show how to integrate your existing OSHA based compliance programs into an effective P-D-C-A management system and how to integrate these requirements into your existing quality and environmental programs.  We will provide a clear plan for how to get certified in 120 days (electronic action plan template provided). This program will provide all the information needed to get started building your OHSMS system.

This webinar is being offered November 9, 2018  from 10:00 AM to 4:00 PM. To register click Get Certified to ISO 45001:2018 in 120 days – Nov 9th

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What are the new requirements for risks and opportunities according to ISO 45001?

With the release of ISO 45001:2018, there are new requirements for assessing risks and opportunities in the Occupational Health & Safety Management System (OHSMS). So, how does this differ from the previous requirements for assessing hazards and risks in OHSAS 18001, and are these requirements still in the standard? In short, these requirements in ISO 45001 cover two different types of risk for the individual processes and for the overall OH&SMS, and both assessments are needed for a good OH&SMS.

What is required for hazards and risks?

The previously existing requirements in the OHSAS 18001:2007 standard were quite simply written, even though the task was rather large. In brief, for all of your activities, processes and work areas, you must identify what hazards exist for the occupational health and safety of all involved (including contractors and visitors). Once these hazards were identified, you would then identify what risks exist for the hazards and what controls you needed to put in place to mitigate the risks present.

For example, if you had a large machine, you might identify that there is a pinch point hazard when the machine was running. The risk of this pinch point could be injury to any worker, contractor or visitor who put their hand in the way of the machine while it was running. To mitigate this risk, you could put a guard in place to prevent hands from entering the pinch point and have a lock-out/tag-out procedure to ensure that the machine could not run without the guard in place during maintenance.

The requirements to assess risks of the processes are still part of the planning for the OHSMS. Controlling the risk from your processes is an important part of ensuring the health and safety of people within your facilities. As the backbone of the OHSMS, this assessment of the hazards and risks posed by the organization’s activities is still a critical part of what is needed to improve occupational health & safety performance.

What do you need to consider with new conditions for assessing the risks and opportunities?

Along with the above requirements, there are new conditions for assessing the risks and opportunities of the overall Occupational Health & Safety Management System. These new requirements come from the standard ISO format for all management systems, called Annex SL. This format includes the assessment of the context of the organization with respect to the purpose of the management system, including the internal and external issues that affect it. The next step in the standard is to identify all of the interested parties for your management system, and what their needs and expectations are.

Finally, taking these issues, interested parties and expectations into account, the company must assess what risks and opportunities exist for the company with respect to the management system. For the OH&SMS this means the risks and opportunities that could affect the company’s ability to enhance OH&S performance, fulfill compliance obligations and achieve OH&S objectives. Many companies have a strategic planning function which addresses these requirements of the standard. If you have more than one management system in place (such as a quality management system or environmental management system), this same process can be used for all of them.

For instance, as part of your ongoing assessment of legal requirements, you may have learned that there is an upcoming change in the law that will make it illegal to use a certain cancer-causing chemical that is needed for creating your product. As this is the case, you have an opportunity to make changes to your product that allow you to find a replacement chemical that is less hazardous to the occupational health & safety of your workforce. There is also a risk that the replacement chemical is actually more hazardous to the people who need to use it. It is these risks and opportunities that you will need to address.

Likewise, if you identify that a company is introducing a new type of machine guard that will make it much easier to prevent accidents you may start investigating how this could be incorporated into your machinery ahead of the government approval for the product. You would not install the new guard, but instead start the process so that it could be more quickly implemented once the approval for the guard was granted.

Risk and Opportunity assessment: An important part of OH&SMS

Any company that has implemented an Occupational Health & Safety Management System knows that the assessment of risk, and the management of the controls to address risk, is critical for managing occupational health & safety. Assessment of risks and determining what needs to be done about them has always been a part of the OH&SMS, and this has not changed. The only real change is to include an additional focus for the important task of risk assessment, and the assessment of opportunities that can be pursued to benefit your company, which can help you with OH&S improvement.

Let EHS Management Strategies, LLC help you setup your OHSMS and get ready for certification in  120 days.

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Wow… We got upgraded to ISO 14001:2015, now what??

Many organizations have been audited to the ISO 14001:2015 by their registration company and are now certified to the ISO 14001:2015 standard, so what’s next.

That depends how you upgraded your program and how well you addressed the following areas:

  • Risk Identification & Management
  •  Management Leadership
  • Identified Aspects – Design/engineering, Purchasing, Transportation
  • Operational Controls – Management of Change, Outsourced Processes
  • System Integration – Quality, Environmental, Safety, Operations
  • Performance Monitoring

This is no longer a process focused on Significant Aspects but a broader focus on Risk. You will need to continually look at these areas and determine how effective your program is managing these issues.

Don’t fool yourself that everything is good because you passed your upgrade audit. Many parts of the standard are still a little soft on requirements and unless your auditor is firm in auditing these new requirements your processes could still be less than effective.

You will need to continue to integrate the EMS requirements into your business processes and continue to identify risks related to your environmental activities. This will put more pressure on your internal audit process to review these areas and identify findings that will drive improvements in these processes. This again, this will test the knowledge and competency of your internal auditors.

We have developed some tools to help companies improve these processes:

We can help you improve and integrate these requirements into your business and get you better prepared for your next registration audit.

Please think of EHS Management Strategies as a resource to help improve your management systems.

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Get ISO 45001:2018 certified in 120 days

This course will provide an element by element overview of the ISO 45001 standard and examples of how to implement the requirements.  The course will show how to integrate your existing OSHA based compliance programs into an effective P-D-C-A management system and how to integrate these requirements into your existing quality and environmental programs.  We will provide a clear plan for how to get certified in 120 days (electronic action plan template provided).

Cost: $599
Date: June 22, 2018
             August 7, 2018
            September 17, 2018
Time: 10:00 to 4:00 PM

This course may be offered at your location with as few as five(5)
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BMW asking for ISO 45001 Certification

BMW in their “BMW Group International Terms and Conditions for the Purchase of Production Materials and Automotive Components”  dated March 31, 2018 has included a section on Social Responsibility (see section 21).  In section 21.1 they ask suppliers to  implement “a  certified occupational health and safety management system in accordance with OHSAS 18001 or ISO 45001 or a recognized and certified occupational health and safety management system”.

It would appear that the automotive manufacturing companies will begin asking suppliers to implement and certify their process to management certified occupational health and safety. We see many of our large multi-site clients implementing an ISO 45001 Occupational Health and Safety Management System (OHSMS) and planing to either seek certification or self-certify their programs. From a supplier management perspective this makes commons sense because a serious injury or fatality can easily shut down production for many days if not longer.

So what does this mean for a company with a well document and functioning OSHA based compliance system? The ISO 45001:2015 will simply be a Plan-Do-Check-Act overlay of the OSHA program that will drive the management of the process. Companies will need to improve the documentation of their hazard identification and risk assessment process, processes for consultation and participation, development of leading OHS indicators, and OHS continual improvement process.

Please see our ISO 45001:2018 overview on You Tube.  We are also offering the following webinar “GET ISO45001:2018 CERTIFIED in 120 DAYS“.  This program provides a detailed overview of the ISO 45001:2018 standard and tools to implement the requirements. Please contact us with any questions on how to develop a certified OHSMS.

James Charles
EHS Management Strategies, LLC
(616) 666-5490
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Introduction to Quality Core Tools – just the basics

Introduction to Quality Core Tools

In the highly competitive environments of Automotive / Manufacturing, organizations are challenged with three simultaneous and equally momentous goals:

  1. Provide high quality products meeting or exceeding customer expectations
  2. Produce sustainable volume
  3. Deliver on time

To be successful in all three, the Quality Management System (QMS) standard IATF 16949 has evolved to provide guidance to these industries. The specific expectations of IATF 16949 are supported by the Quality Core Tools. When applied properly, the Quality Core Tools are the value-added methods and techniques that make it possible for an organization to achieve all three goals. How can these processes be applied to an ISO 14001:2015 environmental management system (EMS)?

What are the Quality Core Tools

The Quality Core Tools are defined as five supplemental techniques and/or methods which support the expectations of IATF 16949. These tools are documented separately through the publication of five manuals available through Automotive Industry Action Group (AIAG). The traditional five core tools are listed in their order of use when designing products or processes:

  • Advanced Product Quality Planning (APQP)
  • Failure Mode and Effects Analysis (FMEA)
  • Measurement Systems Analysis (MSA)
  • Statistical Process Control (SPC)
  • Product Part Approval Process (PPAP)

An additional core process included in Quality Core Tools discussions by Quality-One is:

  • Special Characteristics

What is Advanced Product Quality Planning

Advanced Product Quality Planning (APQP) is a tool box of methods and techniques which are used to assure product quality by communicating requirements, specifications and risks. APQP is a structured approach to product and process design which facilitates communication between suppliers, design communities and customers.  APQP supports the never ending and relentless continuous improvement intent of IATF 16949. There are five sections or phases of APQP with an additional Input phase:

  1. Pre-Planning or Input
    • The Pre-Planning phase supports investigation of lessons learned and the establishment of assumptions which are used to assure success.
  2. Plan and Define
    • The reliability, quality and design goals are established, linking Voice of the Customer (VOC) to written and achievable requirements.
    • Preliminary design concepts are used to establish a Bill of Material (BOM) facilitating Product and Process Planning.
  3. Product Design and Development
    • The product design phase inserts reliability and quality tools into the project timeline intended to discover technical risks. Technical risk is the substitute for failure. Actions directed against identified risks are beneficial in preventing failure of products in both testing and use.
    • Design Failure Mode and Effects Analysis (DFMEA) is one of many tools used in Section 2, which can identify risks for preventative action.
    • Special Characteristics are refined and provided to the manufacturing and assembly activities, concurrently working in Section 3 Process Design and Development.
  4. Process Design and Development
    • Manufacturing and assembly design is also a source for failure. Section 3 reveals risks, which if unchecked, could result in dissatisfied customers, late deliveries and production bottlenecks.
    • Process Failure Mode and Effects Analysis (PFMEA) is one tool used in Section 3 to identify areas of risk requiring action prior to commitment to build tooling and equipment.
    • All Special Characteristics are evaluated for prevention actions using Error Proofing, Statistical Stability / Capability or Mistake Proofing.
  5. Product and Process Validation
    • The purpose of Section 4 is to produce evidence that the planning activities of Sections 1-3 were productive.
    • Measurement Systems Analysis (MSA) is used to assure the evaluation and measurement system can determine product integrity.
    • A first production trial run is used to determine quality through dimensional layout and use of Statistical Process Control (SPC). Special Controls and Control Methods are validated and documented in the Control Plan.
    • The Production Part Approval Process (PPAP) documentation may be submitted for approval at the close of Section 4.
  6. Feedback Assessment and Corrective Action
    • The product or service is now in full production. Lessons Learned captured from each phase are placed in a retrievable database for future reference.
    • Experiences deemed beneficial are used to establish new levels of Standard Work and shared across the organization.
    • Internal and External monitoring of performance for delivery, quality and continuous improvement (e.g. Risk Priority Number (RPN) reduction) follows the procedures required by IATF 16949.
    • When failure is experienced, Root Cause Analysis (RCA) and Eight Disciplines of Problem Solving (8D) are utilized to find the root cause with the intent to correct it permanently.

What is Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA) is a structured approach which identifies potential failure modes and resulting effects, coupling them with potential causes of failure. A technical risk level is assigned to each combination. When risk is deemed to be too great for the product or process being studied, actions are identified to mitigate the risk. FMEA also reviews the testing and evaluation techniques which can determine product design integrity and reliability (Design FMEA) or product quality (Process FMEA).

Evaluating risk and taking mitigating action is beneficial by preventing a failure before it is ever experienced. Several factors are utilized in the development of FMEA:

  • Severity: Denotes how much danger or dissatisfaction exists for the failure and resulting effect
  • Occurrence: Probability assessment of individual causes which have been linked to the failure mode
  • Detection: Ranking of the effectiveness of catching either a design flaw prior to release of the design (DFMEA), or the ability of a process control at either preventing or detecting a defective condition which does not meet design intent (PFMEA)
  • Risk Priority Number (RPN): The product of the three rankings for any one combination of potential failure/cause mechanism.
    • An RPN threshold is not to be used to determine when to take an action
    • Purpose of RPN is to assign an action and re-rank after action status is confirmed
    • Setting arbitrary thresholds for RPN drives poor behavior of the team responsible for FMEA development
  • Criticality: The combination of Severity and Occurrence, which may indicate an unacceptable risk

The use of FMEA permits other team members to review the work of the Design or Manufacturing / Process Engineer. Subject Matter Experts (SME) use their experience to judge the potential for failure at a time in the product / process development where changes can still be performed without much impact on program cost or timing.

What is Measurement Systems Analysis (MSA)

Measurement Systems Analysis (MSA) is an experimental process which determines the viability of an evaluation / measurement technique for use on a specific part characteristic. The need to make good quality decisions is the most important aspect of quality assurance and control. If the measurement system selected has too much variation or is unstable, an unacceptable product could be approved, resulting in customer dissatisfaction or worse. Conversely, acceptable product could be rejected, applying additional pressure on the organization to react to a condition that does not require action. Error in the measurement system is inevitable. Many assume that the measurement is absolute, which unfortunately is not true. Many times, the measurement system may be completely unacceptable and requires replacement or considerable improvement.

MSA looks at five distinct parameters:

  1. Bias: Most associated with calibration, bias is the amount of deviation of a measurement obtained from the system between a standard traceable to a standards organization (e.g. National Institute for Standards and Technology (NIST) or equivalent)
  2. Linearity: Refers to the difference of expected measurement bias over the range of the gage or device
    • The device accuracy or bias does not remain the same throughout its useful measurement range
  3. Stability: The ability of a gage to provide the same measurement on the same product being measured over time
    • The gage is not stable if it demonstrates a drift from previous measurements of the same part
  4. Repeatability: The measurement system is said to be repeatable if the same operator and gage, studied under the same conditions, can repeat the same result
    • Poor repeatability would mean the operator uses the same part, measures it and obtains a different result from previous measurements (in identical conditions)
  5. Reproducibility: The system is considered reproducible if multiple operators can get the same or similar readings on the same parts

Guidelines for acceptance are based on two principles:

  1. Percent Error to Tolerance: The total variation of the blended repeatability and reproducibility divided into the total tolerance. This evaluation is used to validate a gage system initially.
  2. Percent Error to Variation: The total variation of the blended repeatability and reproducibility divided into the total variation of the product/process. This evaluation is used to determine if SPC can be reduced or eliminated when combined with high capability results (Cpk=1.33 or greater).

The guidelines for acceptance are as follows:

  • 10% error or less preferred
  • 10-30% error acceptable depending on factors such as cost to measure, severity of the effect of a failure or cost to repair the gage
  • If greater than 30%, the gage system is unacceptable and requires improvement or replacement

What is Statistical Process Control (SPC)

Developed by Walter Shewhart at Bell Telephone, Statistical Process Control (SPC) is a collection of statistical techniques intended to understand the behavior of a system. SPC uses the primary statistical principles of Central Tendency (Mean, Median and Mode) and Variation (Spread or Standard Deviation). A process under study will reveal if it is operating in a stable and predictable way or in control.

The Normal Distribution

SPC is generally based upon the normal distribution. The Normal Distribution depicts a bell shape with known percentages in the area under the curve. The location of the curve (the central tendency) directly relates to the specification of the characteristic being measured. The spread of the curve is determined by adding 3 standard deviations (sometimes referred to as sigma) on each side of the central tendency. The percentage of product fitting under the curve can be applied to the process under study. For example:

  • ± 1 sigma from the central tendency has 68.26%
  • ± 2 sigma from the central tendency has 95.5%
  • ± 3 sigma from the central tendency has 99.73%

If a process is running normally, its output will fit this percentage model. SPC utilizes the control chart to show the output “in real time”, shortening the reaction time if something does not agree with a previously proven process.

Control Charts

Control Charts are typically used to indicate patterns which may be different than the expected bell curve percentages. When a pattern is observed, the process is out of control and actions to investigate are common. Control Charts fall into two categories, variable and attribute. Variable Control Charts utilize data which, when plotted on the chart, can be interpreted. Attribute Control Charts show performance of a Go / No Go data set.

Variable control charts typically come in pairs; one for the central tendency and another for the spread. Each chart has a line drawn for the measurement of central tendency and control limits, equidistant lines on either side of the central tendency. The control limit lines equate to the expected spread at ±3 standard errors based on the sample size of the group or subgroup.

Samples are chosen at specified frequencies and the two points, one for central tendency, the other for spread, are plotted. The plotted points are evaluated along with up to six previous points. The stability of the process is determined through the following criteria:

  • Point outside the control limit line
  • 7 points in a row on either side of the central tendency lines
  • 6 or 7 points in the same direction
  • 7 points in a row that hug the central tendency

When this criterion is used, the chart can indicate what will likely come next. Out of control does not relate to bad product, just different from previous experience. A chart may indicate an out of control condition but upon close examination, the analyst may want to keep it that way and establish a new best case.

Attribute control charts only depict conditions which are unacceptable. Actions are performed to improve the undesirable state.  Attribute control charts are often linked to continuous improvement because they can be excellent visual aids to show progress.

What is Production Part Approval Process (PPAP)

Production Part Approval Process (PPAP) is a standardized process in the automotive and aerospace industries.  PPAP demonstrates through documentation that as manufactured, the product and process perform as specified by design intent and purchasing requirements. The elements of PPAP are related to APQP in that they are created at key times during product and process design. The evidence of conformance is collected and provided as validation of proper planning. PPAP promotes a clearer understanding of the requirements to manufacturers and suppliers. PPAP also helps to ensure that the processes selected to manufacture parts can consistently reproduce the parts at planned production volumes. For automotive industry suppliers, the PPAP process is currently governed by the PPAP manual published by the Automotive Industry Action Group (AIAG).

PPAP is deployed at five levels based on risk. The lowest risk levels are 1 and 2 and are reserved for simple designs and well respected suppliers / manufacturers. Level 3 is the default, which requires all applicable elements be provided. Level 4 is the customized selection, used when specific changes require closer examination. Level 5 is reserved for the greatest risk parts and suppliers. When level 5 is indicated, additional supplier-customer collaboration is required. Level 5 often results in customer visitation during key core tool development and possibly during the first production trial run. The PPAP submission is similar to sample submissions used in many industries, however PPAP documentation must include prevention tools in addition to those which show product and process conformance.

A Cross Functional Team (CFT) is needed to complete PPAP documentation, as there are elements requiring input from:

  • Supplier Procurement and Subcontracts
  • Design Engineering
  • Process and Manufacturing Engineering
  • Quality Assurance and Control
  • Manufacturing Operations
  • Laboratory Activities

Why Use Quality Core Tools

The Quality Core Tools are used during the Product and Process Development phases of New Product Introduction (NPI) and during certain events such as experienced failure or engineering changes. The Quality Core Tools methodology from Quality-One harmonizes and links the inputs and outputs of the core tools to one another. Unlike many who see the tools as independent, linked tools increases their value to one another and reduces overall workload.

The main goals for any project are:

  1. Provide high quality products meeting or exceeding customer expectations
  2. Produce sustainable volume
  3. Deliver on time

APQP and FMEA assure quality through prevention activities related to risk. APQP additionally supports on time delivery through planning and enhanced communication. Evidence of achieved quality is gathered by using superior gage systems validated through MSA and data collected and analyzed using SPC. Reviewing the Quality Core Tools, from inputs to outputs, an analyst would observe:

  • APQP provides requirements, specifications, reliability / design goals, preliminary special characteristics, timing and guidance for all activities and tools, including the remaining Quality Core Tools, involved in product and process prevention and control
  • Design FMEA Risk Assessment provides refined special characteristics, inputs to testing and design improvements
  • Process FMEA Risk Assessment considers possible process weaknesses, improved process performance and control strategies on special characteristics
  • MSA validates the gage systems used for measurements of special characteristics, which are critical for proper identification of product quality failures
  • SPC demonstrates process stability and capability for special characteristics originally derived from DFMEA and PFMEA
  • PPAP demonstrates that all special characteristics have achieved a level of acceptable stability and capability (Cpk) and / or development of special controls

The common thread that all Quality Core Tools share are the Special Characteristics. Each tool receives Special Characteristics and either refines them, treats them or eliminates the need for them. Progress is measured based on the number of risks discovered and mitigated prior to PPAP.

How to Apply Quality Core Tools

Quality Core Tools are applied sequentially and collaboratively. Collaborative Product Process Design (CPPD) depicts both a timing overlap of activities and a cross-functional communication between engineering communities.

Each Quality Core Tool’s output is linked to other tools in the Product Quality Plan. The timing for Quality Core Tools should be early product / process development as practical. Waiting until the last minute is not efficient and has low / no impact on quality. The creation of the paperwork to “check the box” has no redeeming benefit to an organization.

An example of the value-added linkage can be demonstrated using the DFMEA and PFMEA relationships:

  1. The design team will identify specific dimensions, material properties and tolerances, including the severity and effect on the customer. This is what is meant by a Special Characteristic. The type of characteristic is dependent on the DFMEA severity (Critical, Significant, High Impact, etc.)
  2. Special Characteristics are provided to the Manufacturing / Process Engineer well in advance of a finished design or drawing being available
    • Timing for this transfer is critical; the transfer or collaboration must be as soon as possible
  3. Once received by the Manufacturing / Process engineer, the Special Characteristic is linked to a process technology from the process flow chart
  4. Special Characteristics are then transferred into the PFMEA as Failure Modes for the related Process Step(s)
  5. Risk analyzed of process failure resulting in the Special Characteristic being produced incorrectly
  6. Manufacturing / Process team will collaborate with the design team to discuss Design for Manufacturability or Design for Assembly (DFM/A)
  7. Control Plan is created with special controls to either error proof, mistake proof or detect the failure or cause
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US Companies Beware Tough Penalties in EU for Sustainability Non-compliance

US companies operating in Europe face tough penalties for not publishing Sustainability Reports or publicly disclosing Corporate Responsibility data.

The EU Directive on Non-financial and Diversity Information (Directive 2014/95/EU) can greatly affect North American corporations operating in any of the European Union Member States.  The European Commission (EC) objective is to raise to a similarly high level across all Member States the transparency of social and environmental information provided by companies operating in all sectors.

A “similarly high level” does not mean THE SAME.  Each member state can modify the directive to comply with national laws.  Corporations which meet the minimum requirements in multiple states, must file a report for each Member State, requirements which can differ significantly.

Reports must cover:

  • Environmental impact including GHG emissions scope 1,2 and 3
  • Social and employee matters
  • Respect for human rights
  • Anti-corruption and bribery concerns

Reports must include:

  • description of the company’s business model;
  • description of relevant policies implemented, including due diligence processes;
  • outcome of those policies;
  • company’s principal risks, including business relationships, products or services, and how the company manages those risks;
  • non-financial key performance indicators relevant to the business.

There are many benefits to adhering to the EU directive.  Reporting increases stakeholder trust.  Companies learn from the reporting process.  The effort generates continuous improvements in a business’s impact.  And, the requirement to make the report public helps company’s highlight their business integrity.

Another advantage – guidance on incorporating the United Nations Sustainable Development Goals (SDGs). They are the EC’s major policy priority. Addressing the 17 SDGs sustainability challenges, including climate change, human rights, corruption, poverty, inequalities and justice, tops the EU agenda.

The directive applies to Member State-defined “large undertakings which are public-interest entities” having an average of 500 or more employees within a Member State.  Each state can also specify: report topics and content, reporting framework, disclosure format, level of auditing and independent assurance, penalties for non-compliance, including the Safe Harbour Principle and including diversity reporting.  For companies meeting the 500-employee minimum in multiple countries, the reporting requirements can be quite complex!

How different can requirements be?  By country, fines range as low as $1,650 to as high as $12 million! Fines can be applied to an individual or the company.  Some states impose a prison sentence, with durations ranging from 2 years to 6 years.  There are 30 different variations of reporting. If you oversee compliance, you do not want to get this wrong!

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ISO 45001:2018 – Occupational Health & Safety Management Systems – has been released

The ISO 45001:2018 – Occupational Health & Safety Management Systems standard was released by the International Organization for Standardization. Many organizations have been waiting for this standard to seek certification of the OHSMS.

You can learn more about the standard in our FREE Webinar April 16th. Click the link below to register.

ISO 45001:2018 Overview Webinar – April 16, 2018

We have been helping companies take their OSHA compliance based program to the next level by implementing an OHSMS.  Please contact us if you have any questions about how to get started. Thanks!!!

GET Started on ISO 45001:2018


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Environmental Management System (EMS) Scope – ISO 14001:2015

Section 4.3 of the ISO 14001:2015 requires organization to document the scope of their EMS.  The requirements for defining the scope include

a) the external and internal issues referred to in 1;

b) the compliance obligations referred to in 2;

c) its organizational units, functions and physical boundaries;

d) its activities, products and services;

e) its authority and ability to exercise control and influence (Outsourced Services).

 The documented scope needs to be available to interested parties.  The question is what information should be included in your scope description.

I do believe that your documented scope shuold address the topics in a-e. Ask yourself the question “if an interested party” asked for your scope what would your give them?

Please email if you would like a template to document your EMS scope.





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Heat Treated Pallets – environmental requirement?

International Standards For Phytosanitary Measures No. 15 (ISPM 15) is an International Phytosanitary Measure developed by the International Plant Protection Convention (IPPC) that directly addresses the need to treat wood materials of a thickness greater than 6mm, used to ship products between countries. Its main purpose is to prevent the international transport and spread of disease and insects that could negatively affect plants or ecosystems. ISPM 15 affects all wood packaging material (pallets, crates, dunnages, etc.) requiring that they be debarked and then heat treated or fumigated with methyl bromide and stamped or branded,[1] with a mark of compliance. This mark of compliance is colloquially known as the “wheat stamp”. Products exempt from the ISPM 15 are made from an alternative material, like paper, plastic or wood panel products (i.e. OSB, hardboard, and plywood).

This does seem to be a compliance obligation related to an environmental issue.  So yes, this requirement should be referenced within your compliance obligation process if you ship materials internationally.

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ISO 45001: Anticipating March 2018 Publication Date

According to the Internal Organization for Standardization (ISO), the much-anticipated ISO 45001 standard on occupational health and safety management systems may not be published until March 2018.

Here’s the latest timeline based on the working group’s progress to date:

  • February 2017: WG1 meeting to complete a review of comments
  • March 2017: DIS2 to be edited and prepared
  • April/May 2017: DIS2 released for translation
  • June/July 2017: DIS2 ballot held
  • September 2017: PC283 and WG1 meeting to review DIS2 ballot results

“If DIS2 is approved and a final draft international standard (FDIS) is not required, ISO 45001 could be published as early as October/November 2017. In the case that an FDIS is required, publication is likely to occur in March 2018.” Read the complete article here. Visit ASSE’s ISO 45001 resource website to learn more about the potentially game-changing standard.

ISO 45001 Webinar – February 2018

ASSE ISO 45001 Page

ISO 45001:2018

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Upgrading your EMS to ISO 14001:2015 – time is running out

Your running out of time to upgrade your EMS certification to the ISO 14001:2015 standard.  All ISO 14001:2004 certificates expire September 14, 2018.

The good news is that even though there are many substantial changes to the standard, with some updates in key areas, linkage to your quality system, and a crystal-clear understanding of the requirements, you can quickly get your program in conformance with the ISO 14001:2015 standard.

We have developed some programs that can quickly accomplish these tasks over a short period of time.

  • Step 1 – provide training to the core team (The “Complete” ISO 14001:2015 Transition Course)
  • Step 2 – understand the changes needed (Quick UpgradeTM)
  • Step 3 – EMS templates / tools (The EMS Power ToolsTM)
  • Step 4 – Leadership Training (EMS Leaders ProgramTM)
  • Step 5 – Internal Audit

The “Complete” ISO 14001:2015 Transition CourseTM – This POWER course can be delivered onsite or via webinar. This program will cover the ISO 14001:2015 standard in detail and explain the differences and how to upgrade your program. We will explain all the new terminology and how to explain these to your leadership team.

Quick UpgradeTMThis is a 1-1/2 to 2-day onsite program to review your existing programs and develop an action plan to update your documentation and how to link to the existing processes within your quality program.  We will interview key site managers to explain their role in the EMS program and what will be expected from your registration company. At the conclusion of this assessment, we will present an overview of key EMS requirements and identified action items. We will also make recommendations on the support needed from various departments.

The EMS Power ToolsTM – We will provide the templates for procedures, forms and work instructions needed to demonstrate conformance.  Whether you only need an updated aspects process or new EMS manual we can provide the tools you need. The goal will be to use your existing EMS programs and to provide enhancements were needed.

EMS Leaders ProgramTM – This is a 1-hour program we can deliver to your management team and supervisors. We will explain the new EMS requirements and how they can demonstrate leadership, commitment and accountability.

Internal Audit – This will be a 1-1/2 to 3-day internal audit of your EMS to the ISO 14001:2015 standard.  In addition to the internal audit, we will provide coaching to onsite staff in preparation for your registration audit.  We will take all the guess work out of the upgrade process and insure the success of your program.

We have helped sites with as little as 4-weeks’ time successfully pass their ISO 14001:2015 upgrade audit.  The sooner we can begin the better.  We can mix and match these services to meet your budgetary and time constraints.  Please contact us at (616) 666-5490 or James.Charles@ISO14001-training.com.

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Outsourcing Internal Audits – does this make sense?

Many organizations are choosing to “outsource” their Internal Auditing process.

On the surface, this seems to go against the intent of the ISO standards. However, the cost of maintaining a qualified pool of internal auditors can be expensive. Also, considering the turnover  in many organizations, the effectiveness of the audits may be poor and systemic non-conformances may go undetected.

The benefits of outsourcing your internal audits include:

  • Highly qualified auditor is more likely to detect systemic non-conformances resulting in fewer non-conformances during the registration audit.
  • Provides a coaching opportunity for on site management and good preparation for registration audit.
  • Keeping internal staff focused on their core area of responsibility.
  • Can be cost-effective when compared to the cost of training auditors.
  • Outside perspective can identify opportunities for improvement and risk reduction.

Outsourcing internal audits can also be effective when upgrading your management systems to meet new requirements. So companies upgrading to IATF 16949, ISO 14001:2015 or ISO 9001:2015 may wish to outsource their internal audits to gauge their readiness for recertification to the new requirements.

Please let US know how we can help support your internal audit process.

ISO 14001 2015 Services

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ISO 14001:2015 – 9.1.2 Evaluation of compliance – anything new??

I have been asked many times recently has this requirement changed? My answer is that they haven’t changed but the “process” needs to be more clearly and completely defined.

The organization shall establish, implement and maintain the process(es) needed to evaluate fulfilment of its compliance obligations.

Step 1 – define the process. The following items need to be defined:

  • determine the frequency that compliance will be evaluated;
    • This may vary for each type of requirement – regulatory,  customer, community, etc.
      • Regulatory Audits – every 1 to 3 years
      • Customer requirements – PPAP/quality internal audits – annually
      • Other
  • evaluate compliance and take action if needed;
    • How compliance will be evaluated
    • Resources – qualifications of persons doing compliance evaluation
    • How evaluation(s) shall be documented
    • How results will be reported and corrected
  • maintain knowledge and understanding of its compliance status.
    • Reference any inspections that you may do on regular basis – safety, emergency prep, 5S, etc.
    • Reference use of preventative maintenance system to track requirements – SPCC inspections, Air Permit Equipment, Storm Water Inspections, etc.
    • Reference internal audits of work instructions – universal waste, aerosol cans, haz waste, etc.
    • Process to keep current with regulatory changes (see 6.1.3) and how these are reported to management (this should be an input to management review).

The third item is not really new but does require the process be more clearly defined.  There may be some gaps in this area in organizations that don’t do many formal inspections.

Remember it is up to the “organization” (that’s you) to define the process NOT your registration company. So if you have defined the process and implemented it, you CONFORM to the requirements. Your registration company may offer “opportunities for improvement” but these should not be non-conformance’s.

Please contact us with any questions. 






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Elementary Neutralization: Treatment Without a Permit

Treating your hazardous waste without a permit?! Is that really possible? Yes! Yes, it is. While the EPA generally prohibits you from treating hazardous waste without a permit, there are exceptions. Under certain conditions you can neutralize your corrosive hazardous waste and pipe it out as sewage rather than containerize it and freight it to an expensive treatment facility. [See 40 CFR 270.1(c)(2)(v).]

How Do I Qualify?

Hazardous wastes eligible for this exclusion can be unused products, off-spec mixes, residue from spills, cleanup or storage, or any byproduct or cogenerated materials, as long as they meet two conditions:

  1. The waste is hazardous ONLY because of the corrosivity characteristic (D002).
  2. The waste is neutralized in a tank, tank system, container, transport vehicle, or vessel as defined in 40 CFR 260.10.

What Are The Advantages?

Treating hazardous waste in an elementary neutralization unit (ENU) does NOT require a RCRA treatment permit. [40 CFR 270.2(c)(2)(v)] This is the primary advantage. Although elementary neutralization systems are usually tanks or containers, ,these units are not subject to the waste storage management standards codified in 40 CFR Parts 264 and 265. [40 CFR 264.1(c)(10), 265.1(c)(10)]

If you manage to store the hazardous waste in the elementary neutralization unit IMMEDIATELY upon generation, you do not need to count it when counting hazardous waste towards your generator status, as it is “not subject to substantive regulation.” [40 CFR 261.5(c)(2), 262.10(b)] This reduction in your facility’s hazardous waste total may class down your generator status and provide flexibility for your other hazardous wastes. Keep in mind that this hazardous waste must still be recorded and included on your Biennial Report, should you be required to file one.

What Rules Do I Still Have to Follow?

Any wastes generated from the neutralization process (precipitated solids, etc.) must be managed appropriately. If these residues exhibit any characteristic, then they are hazardous waste and must be managed accordingly. Otherwise, comply with state/local regulations for industrial wastes. [40 CFR 261.3(d)(1), 261.3(g)(2)(ii)]

Since the waste was hazardous at the initial point of generation, the land disposal restrictions (LDRs) may still apply even after neutralization. The presence of underlying hazardous constituents (UHCs) in excess of the LDR threshold may require additional treatment, either on site or at an off-site facility. Either way, there are significant recordkeeping requirements. [40 CFR 268.7, 268.9]

What Do I Do With My ENU Waste?

Once you have neutralized the waste, extracted the residuals, and treated for UHCs, you still have a large quantity of wastewater and need to dispose of it somehow. In many areas, you may be able to negotiate with the waterworks and simply pour the neutralized wastewater into a sewer. In other areas, you may have to get a wastewater discharge permit or arrange for the wastewater to be trucked or piped away.

Characterizing hazardous waste

Elementary Neutralization: A RCRA Exclusion

The ENU exclusion is distinct from other relief provided for hazardous waste treatment, such as EPA’s longstanding interpretation that a hazardous waste generator may treat-while-accumulating hazardous waste in units managed in accordance with 40 CFR 262.34.

As always, state authorities may have more specific or limited allowances for elementary neutralization. So, it is important to see how your state views elementary neutralization prior to changing your current practices.

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EPA Turns Up the Heat on Refrigerant Regulation

Refrigeration and cooling systems face expanded and tighter regulation under a final rule recently signed by EPA Administrator Gina McCarthy.  The rule revises and expands EPA’s regulations for “Ozone-Depleting Substances” (ODS), which erode the stratospheric ozone layer that protects the Earth from harmful ultraviolet radiation.

Most ODS are used as refrigerants in industrial process refrigeration (e.g., in chemical, electronics, and food manufacturing), commercial refrigeration (e.g., supermarkets, refrigerated storage, and transport), or comfort-cooling/air conditioning systems. Since the 1990s, the ODS regulations (40 CFR Part 82) have mandated various practices to minimize or prevent the release of refrigerants during operation, maintenance, and disposal of refrigerant-containing equipment, and to maximize refrigerant recapture and recycling. The regulations also require certification of technicians working with ODS systems, and subject to certain exemptions, restrict ODS sales to certified technicians.

But here’s the tricky part: not only does the recently revised rule expand and tighten these requirements for ODS, it also extends them to non-ODS refrigerants used as substitutes for ODS. This extension is based not on the protection of the ozone layer, but on preventing global warming caused by such substitutes. The extension primarily targets hydrofluorocarbons (HFCs), a family of non-ODS refrigerants that have been widely used to replace ODS but have since been found to have significant global warming potential.1

In addition to extending the ODS regulations to non-ODS refrigerants, the recent revisions also include the following:

  • Lowered thresholds for leak repair requirements: Under the existing regulations, the owner or operator of a refrigeration and air conditioning system that contains at least 50 pounds of refrigerant must repair and test the system or retire it when it is found to have leaked beyond certain annualized rates. Here are the existing and revised leak rates thresholds:
Type of equipment Under existing regulations Under revised regulations
Industrial process refrigeration 35% 30%
Commercial refrigeration 35% 20%
Comfort cooling 15% 10%
  • New requirements for leak inspections or automatic detection monitors: Cooling systems that have exceeded the leak rates specified above must now be inspected either quarterly (for industrial process refrigeration and commercial refrigeration systems with a full charge of at least 500 pounds) or annually (for such systems with a full charge of at least 50 pounds but less than 500 pounds, and for comfort cooling systems). These inspection requirements can be avoided by continuously monitoring the system with an automatic leak detector that is audited or calibrated annually.
  • Release reporting for elevated release levels: If a system with a full charge of at least 50 pounds of refrigerant has leaked 125% or more of the full charge in a calendar year, the owner or operator must submit a report to EPA. The report must describe efforts to identify the leaks and repair the equipment.
  • Recordkeeping for refrigerant recovery: Technicians must now keep a record of refrigerant recovered during disposal of refrigerant and cooling systems with a full charge of 5-50 pounds. (This closes a gap in the existing regulations, which had not required such recordkeeping for this size category.)
  • Updated and expanded certification requirements for refrigeration technicians.

The revisions also make extensive organizational and wording changes intended to improve readability.

Compliance deadlines for the various new requirements range from January 1, 2017 to January 1, 2019. In the meantime, court challenges to the rule – and particularly EPA’s authority for expanding the rule to non-ODS – seem likely.

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Arc Flash Risk Management – a very real threat to your employees

An arc flash occurs amongst the live conductors or between a conductor and the ground. The current from any of the live conductor leaves its normal directional flow, travels through air and enters another conductor or to the ground. The radiant energy released by an electric arc is capable of permanently injuring or killing a human being at distances of even up to 20 feet. The workers can be thrown against a wall due to the extreme pressure of a blast. The hospitalization records indicate that the arc flash incidents are frequent in throughout the US. A simple reason can contribute to serious arc blast incidents. The US Bureau of Labor Statistics reports of the previous 10 years reflect 2,000 fatal and more than 24,000 non-fatal electrical injuries sustained from an arc flash.

The extent of the injuries depend on

  • Distance of the worker from the hazard
  • Heat
  • Tripping time of the circuit.

The typical results of an Arc Flash are:

  • Heat from more than 35,000 degrees F temperature.
  • Flying molten metal objects can injure others present in the line of fire.
  • Burns (The ordinary clothing shall burn on to the skin of a worker).
  • Rapidly spreading fire into the building or an installation.
  • High pressures more than 2,000 lbs. per sq. inch that create a blast.
  • Higher level sound more than 140 dB, which is as loud as a gun.

Arc Flash Risk Management

People are required to carry out maintenance, diagnostics and testing works on or near energized electrical circuits. Therefore, it is important to calculate the arc flash distance for all locations where the voltages used are more than 50 volts. There are two methods used to determine the protection and Personal Protective Equipment requirements in each situation. i.e. engineering analysis and a table method.

Best Practices for Complying with NFPA 70E standards

  1. Preventive Maintenance
  2. Risk Assessment
  3. Labeling and Hazard Communication Plan
  4. Design and Method Reviews
  5. Accurate Single-Line Diagrams
  6. Short Circuit and Coordination Studies
  7. Electrical Safety Program Review/Development
  8. Arc Flash Training Program and PPE Plan Development
  9. Documentation
  10. Periodic Reviews

High level risk is associated when it comes to working on an electrical system. The electricity is an invisible energy. The incidents can be spontaneous and anyone in the vicinity could be at risk. The employers should prioritize, maintain their systems up to date and as far as possible fully de-energize the system to a zero potential during the maintenance. But if it is unavoidable and working on live system is essential, the employer is required to confirm it in advance so that the level of protection and safe system of work can be established in a proactive manner. The international organizations such as OSHA and NFPA have become increasingly proactive about providing and enforcing guidelines and standards for mitigating the risk and ensuring worker safety.

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Heat Stress – keeping your employees safe

As we transition to warmer temperatures, it’s important to revisit your workplace’s Heat Illness Prevention Program to ensure your employees are equipped to combat heat-related stress and illnesses. Heat is the number one cause of weather-related fatalities in the United States despite the fact that most heat-related deaths are preventable.

Average high temperatures have seen a steady increase across the country over the past couple of decades. The Environmental Protection Agency (EPA) anticipates that average temperatures will continue to increase, and heat waves will become more frequent and impactful. This prediction should encourage all businesses to look at how their employees are exposed to high temperatures, and what they can do to accommodate.

Businesses with employees who perform work in moderate to high temperatures or humid conditions, especially where increased heart rate and perspiration are concerned, must be given the necessary tools to recognize, understand, and prevent heat stress illnesses.

Essentially, heat stress prevention comes down to workplace design, employee training, and effective work procedures. Design and procedures will vary greatly depending on geographical location and the type of work being performed. Businesses should keep in mind that heat stress can occur regardless of the time of year, in both outdoor and indoor conditions. Required personal protective equipment (PPE) can also have a significant impact on the body’s ability to expel heat. Workers involved with hazardous waste operations or asbestos removal, for example, are often required to wear impermeable protective equipment which can trap heat close to the body. A thorough risk assessment will help businesses identify risk elements such as these.

A strong working knowledge of how the body regulates heat, and how personal factors can affect that regulation, is an extremely valuable tool in prevention. The human body needs to maintain a core temperature between 96.8 (36) and 100.4 (38) degrees Fahrenheit to function at peak performance. Weather conditions, manual labor, and personal factors can cause the core temperature to increase, which can lead to the development of a series of heat-related illnesses.

To regulate internal temperature, the body uses two basic mechanisms. The first is to increase the heart rate which assists in moving blood and heat away from vital organs to the skin. The second is perspiration, during which the body expels heat in moisture through the pores, which then evaporates and carries heat away in the process. Personal factors, such as acclimatization, caffeine and alcohol consumption, hydration replenishment, general health, age, and certain prescription medications can affect how well these mechanisms work and should be taken into consideration before performing work in high temperatures. Perspiration is the more effective of the two mechanisms, which means that proper hydration to replenish fluids lost as sweat is absolutely essential.

There are four common disorders which surface as a result of heat stress, ranging from mild discomfort to life-threatening conditions:

Heat rash is the most common ailment which occurs while working in the heat. It is also called “prickly heat.” Symptoms include red, blotchy, itchy skin, particularly in areas of the body with high perspiration, and a prickling sensation. Rashes which aren’t cleaned thoroughly and frequently may become infected. Moving to a cool environment, cleaning the affected area with cool water, and complete drying are often effective treatments.

Heat cramps occur as a result of salt being lost through perspiration. They are painful muscle spasms causing lumps in the affected muscles, usually the back, legs, and arms. The pain can be severe enough to greatly inhibit movement. Workers should cease activities to tend to cramps as soon as they feel them. Stretching and massaging the affected muscle as well as replacing salt by drinking electrolyte replacement fluids are useful techniques in tending to heat cramps.

Heat exhaustion is a dangerous result of heat stress which can lead to a heat stroke if not treated promptly with first aid. It happens when the body is so overexerted that it cannot supply blood simultaneously to vital organs and the skin for temperature regulations. Inflicted workers may experience weakness, headache, breathlessness, nausea, vomiting, faintness, or loss of consciousness. Call 911 and move workers exhibiting these symptoms to a cool place and give them water to drink. Remove any clothing that isn’t necessary and loosen other clothing. Shower or sponge them down with cool water. It will take at least 30 minutes for the body to cool down after experiencing heat exhaustion.

Heat stroke is a disorder which requires immediate medical attention, and can lead rapidly to fatality if not treated quickly. A person experiencing a heat stroke may experience confusion, hot, dry skin, high body temperatures, lack of sweating, irrational behavior, convulsions, and/or a loss of consciousness. Call 911 right away and take the victim to a cool area to immerse or shower them with cool water. Wrap them in wet sheets and fan them until you can transport them to a hospital or an ambulance arrives.

Knowledge can mean the difference between life and death during a critical victimization of heat stress. Workers should understand the nature and symptoms of heat-related illnesses both in a sense of recognizing them in themselves, and when a coworker is suffering. In many cases, a quick and efficient response can save a heat stress victim from numerous long-term effects that would have otherwise occurred had symptoms gone untreated. Proper training and a strong Heat Stress Prevention Program will help protect worker health year round.



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Webinar – Identifying Risks and Opportunities from a Life Cycle Perspective

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Aerosol Can Disposal – what is required?

During management system audits or compliance audits the management of aerosol cans is one issue that is seldom management consistently. The disposal of aerosol cans depends on the condition of the can and the hazardous waste generator status of the site.  The condition of the can can be:

  • Empty
  • Partially Empty

An empty aerosol can is one where the contends of the can have been emptied and the pressure inside the can is atmospheric.  These cans under the federal rules (check for state specific rules) can be place in the general trash or recycled.

For example, some states, such as Colorado, treat aerosol cans containing product as universal waste. In Wisconsin, there are special requirements for “empty” aerosol cans. So please check your stated specific rules.

Waste Management LampTracker(R)


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ISO 14001:2015 Tool Box

As you plan for  2017 and upgrading your EMS please see how EHS Management Strategies can help streamline your EMS………

ISO 14001:2015 Tool Box

2017 is the year to upgrade to ISO 14001:2015 – let us help!!

The International Organization for Standardization (ISO) has finalized a significant revision to the ISO 14001 standard (ISO 14001:2015) on September 14, 2015 and your existing ISO 14001:2004 certificate will expire on September 14, 2018. Don’t wait until the last minute.

Click to see more…..

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