Approach to QMS Registration Audits

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 One of the registrars we audit for has asked us to respond to a few questions posed by a potential audit client.   Each question (in bold font) is followed by our response (in italic font).  Feel free to share your thoughts here in a comment. 

(1)      Which one or two areas of the Quality Manual (of the 8 required areas) does your registrar focus  heavily on during the initial certification audit and why?

We view the Quality Manual as a road map to the QMS.  It describes the core elements of the QMS and provides direction to related documentation.  We use this Manual to help us understand how the QMS operates.  The Manual is the point of departure while we go about the work of collecting objective evidence to show that the organization is meeting the requirements of ISO 9001:2008.  Therefore, the Manual itself is not the focus of our process approach to auditing.  Rather, we use it to point us to the evidence of conformance that we need to observe and record during the audit.  We do not treat any areas of the Manual as priority.  We use the Quality Manual more for navigation of the QMS to help us find the evidence we need to determine the QMS effectiveness at enabling continual improvement.

(2)      Which one or two processes of the required six does your registrar focus heavily on during the initial certification audit and why?

All of the QMS processes are important; thus, during our assessment of an organization’s QMS, we focus on all processes, not just a few.   If any of the elements of the QMS are absent (unless design is legitimately excluded,) the system will not be effective. It is therefore imperative to view the QMS as a whole when drawing a conclusion about both its effectiveness and its conformance to ISO 9001:2008.

 More mature and ready organizations initially focus their attention on the following areas when implementing and registering a QMS:

 8.2.3 Monitoring and Measurement of Processes

 Organizations should identify the key performance indicators that they use as metrics of the performance of the organization’s QMS.  We like to explore these metrics to understand why the organization chose them, how the measurements are made, and how the results of the measurements are conveyed to management.

 8.5 Improvement

 The ability of an organization to solve problems is another area we like to explore.  What are the processes used to solve problems?  How does the organization investigate problems so they understand causality?  Although organizations are not required to do so by ISO 9001:2008,  we like to investigate to what degree they have embraced formal problem-solving techniques like 5Y, 8D, Lean Six Sigma, or others.

 An organization’s ability to solve problems is key to continual improvement. However, during an initial audit, it is sometimes difficult to find much direct evidence of the effectiveness of these techniques.  Evidence of the effectiveness of the organization’s problem-solving techniques becomes clearer with time, as the organization works through correcting nonconformances or customer-related issues. 

Green Tier Audits, Stakeholder Confidence, and Business in Wisconsin

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Recently, we were privileged to address the Green Tier Advisors on the difference between the Green Tier audit process and other internationally accepted processes for certifying conformance of an organizations EMS.  A copy of the presentation handout is posted at the WDNR Green Tier website (  http://dnr.wi.gov/org/caer/cea/environmental/advisors/documents/20100917powerpoint.pdf)

The purpose of our presentation was to ask the Green Tier advisors to consider important questions three important questions as follows:

1.  Is the Green Tier audit process adequate to assure stakeholders (citizens, WDNR and others) a reasonable level of confidence that the superior environmental performance claims by participants are valid?

2.  Why is there a gap between what the international community considers to be adequate EMS audits and what has been the practice in Wisconsin for Green Tier audits.

3.  Should WDNR be endorsing unverified claims of superior environmental performance made by Green Tier applicants?

Ideally we would like to try to stimulate some discussion here about these questions to help WDNR and the Green Tier advisors as they consider if enhancing the Green Tier audit process would be beneficial or if the audit process is adequate as it is.  You are encouraged to participate in the discussion and can do so anonymously or contribute representing yourself or your organizations. 

We intend to make additional related postings here shortly to flesh out these issues and provide information and resource to help interested parties better understand the questions. 

You are also welcome to call us with any questions about Green Tier or Green Tier audits at 920-648-4134

When Is a Coal Sample a Sample?

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By ML Juszczak, Project Manager, ECSI GHG Programs

The USEPA has issued its Greenhouse Gas Rule in the form of 40 CFR Part 98.  Companies subject to the rule must begin reporting annual greenhouse gas emissions for the year beginning on January 1, 2010.   Although the rule fills hundreds of pages in the Federal Regiater,  it still leaves important questions unanswered.  For example, what is  the proper way to sample coal for laboratory analysis?

Coal must be analyzed for calorific value to determine the fuel’s high heat value, or HHV, in two of the four CO2 emission calculation methodologies defined in the rule (specifically, Tier 2 and Tier 3).  A facility choosing either of these methodologies must sample and analyze each lot of coal that it receives (a lot being a “shipment or delivery of a single fuel comprised of a shipload, barge load, group of trucks, or group of rail cars”.)   The rule also specifies in §98.34 that ASTM D 5865-

07a – Standard Test Method for Gross Calorific Value of Coal and Coke be used.  If you read no further, you may think this is a fairly simple and straightforward matter.  As is often the case, however, this matter is neither simple nor straightforward.

The difficulty that arises does not concern the analysis of the sample, but rather how to compose a sample, how often to compose it and, how to prepare it prior to analysis.  Two other ASTM standards enter the picture:

  • ASTM D 2013-07 – Standard Practice for Preparing Coal Samples for Analysis
  • ASTM D2234/D2234M-09a – Standard Practice for Collection of a Gross Sample of Coal

 These are incorporated into the rule by reference in §98.7(e), and they are interrelated as follows:

  • ASTM Method D5865-07 references  ASTM D 2013-07, and
  • ASTM D 2013-07 in turn references ASTM D2234/D2234M-09a.

ASTM D2234 requires that 15 “increments” of mechanically cleaned coal, or

35 “increments” of raw coal, be gathered at separate times from each lot to form a “gross sample.”  There are three increment quantities:

1 pound for coal with a top size of ?“

 3 pounds for coal with a top size of 2“

 7 pounds for coal with a top size of 6“

Therefore, a gross sample can be from 15 pounds all the way up to 245 pounds. 

ASTM D2234 also defines a lot as 1,000 tons of coal.  If a true lot is larger than

1,000 tons, sampling increments are either increased proportionately, or the total quantity is subdivided and each sub-lot is sampled individually.  This is a significant difference from the EPA’s definition of a lot found in §98.34.

ASTM D 2013-07 prescribes how the gross sample is to be ground, mixed, and divided using milling and rifling equipment (rifling is a type of sorting process) to yield a quantity that remains representative of the whole, while being suitable in size for analysis.  The test method in ASTM D 5865-07a calls for 0.8 grams to 1.2 grams of material with a particle size of ?250 micrometers. 

The simple matter of gathering a sample of coal and sending it to the laboratory now has become quite an arduous procedure requiring some sophisticated and specialized apparatus—apparatus that many facilities may not have access to.  And, it may need to be done much more frequently than once per shipment.   While

40 CFR Part 98 does not specifically prescribe the above sampling and preparation methods, it names no alternative protocol either.  A valid conclusion would then be that the ASTM standards are intended to be part of the rule, and not adhering to them could result in a violation of the law.  Alternative interpretations will no doubt be made as the regulated community grapples with this new rule.  What procedures a company ultimately uses will need to be supported by sound reason, and tempered by its tolerance for risk. 

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Integrated Management Systems Internal Auditor Training

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Recently we were asked to deliver an encore edition of a four day IMS Internal Auditor training course for one of our clients. They are a large manufacturing facility surviving the recession and gaining market share, in part because of their robust management systems. This organization has chosen to invest in the competence of their internal auditor staff,  recognizing the value and importance of the “checking” part of their management system.

The course is three days of intense classroom and actual on the floor auditing. This learn-by- doing course includes review of the similarities and differences of the ISO14001, 9001 and OHSAS 18001 standards and includes numerous activities. Actual department audits are performed, findings written and a closing meeting with management is held at the end of the course actual audit. Student competence is evaluated during the course through observation of each individual’s performance by the course instructors.

This updated version of the course includes a new section focusing on the Lean Six Sigma programs used at the facility and what internal auditors need to know to ensure the gains made from Lean Six Sigma projects are sustained by the organization. The fourth day of the training is targeted to the more experienced Lead Auditors and helps develop leadership skills and attributes. The course includes a test at the end to check the auditor’s knowledge of the subject matter and to help confirm that the auditors possess  adequate competence to perform value-added effective IMS audits.

Cap and Trade – Another Perspective

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A recent conference in Milwaukee held by the U.S. State Department received public comments on the U.S. position on global warming to be presented by the U.S  State Department at the United Nations Framework Convention on Climate Change in Copenhagen, Denmark this December (see http://unfccc.int/2860.php). This is an important convention where the U.S.  along with other nations may commit to reducing global GHG emissions. From the tone of the meeting it sounds like the State Department is more willing to cooperate with global GHG emission reduction initiatives than it was at previous meetings but very few details were provided on what the U.S. was willing to try to negotiate in Copenhagen.

The conference audience was a good mix between manufacturing, business and academic interests. The meeting began with the State Department representatives making a statement to the effect that there was “no longer any reason to doubt the scientific basis for global warming and the role GHG emissions play”. Many in the audience were  quick to challenge this statement insisting that the science was not at all-conclusive and expressing the opinion that there was little evidence that GHG emission cause global warming.  Most in the audience also expressed the concern that cap and trade regulation would seriously damage affected U.S. businesses’ competiveness with developing nations who would not likely adhere to GHG control requirements.

This is the same debate that has persisted for at least the last 30 years and is likely to continue for at least another 30. Personally,  I am not convinced that there is a concrete, demonstrable link between GHG emissions and global warming. I think it is plausible that such a link exists but have not yet seen compelling indisputable evidence of the connection. But I really don’t think that a concrete link is needed for us to want to control GHG emissions, especially those associated with energy use.

There are other strategic issues with potential global warming that I believe should be driving our efforts to reduce these emissions. I believe that the security of our nation, which relies heavily on non-renewable sources of energy to sustain its standard of living,  is not as strong as a nation that is less reliant on non-renewable energy. If the United States continues to delay development of technology to improve our use of renewable energy, and we continue to deplete limited supplies of non-renewable energy, there may come a time when we have reached the  tipping point. A point where we are unable to sustain our standard of living and no longer have the resources to invest in development of alternate renewable energy sources

If cap and trade is able to create additional incentive to limit the use of non-renewable energy in this country I believe that may be a good thing. If we can also hedge our bets about whether or not GHG emissions are causing global warming it seems like a no-lose strategy. It seems there is more to gain than to lose by controlling the use of non-renewable energy and if cap and trade will help us we should look past fears of change and move ahead on reducing GHG emissions here in the U.S. and around the world.

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ECSI Now Offers GHG Voluntary Inventory Reporting Assistance.

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Organizations wanting to be prepared for the USEPA mandatory GHG Emission Inventory requirements coming this  November now have a source of information and assistance to guide their efforts.  Our role  as ANSI GHG Verification and Validation program Lead Auditors has given us unique insight into how USEPA and others will be operating GHG inventory and Cap and Trade programs.  Equipped with our unique insight we are now offering assistance to organizations for submission to the following GHG Inventory and Offset Trading programs:

 Call us for more information at 920-648-4134 or email us at ghgprograms@envcompsys.com

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ISO 14001 Registration – How it Works

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The process of becoming registered to ISO 14001 can be confusing. Common questions we are asked include the following:

 – Who is qualified to issue ISO 14001 Registration Certificates?

 – Who is qualified to perform the registration audits?

 – How long is a certificate good and what is the registration process?

These are a few common questions asked by organizations considering implementing an EMS which will be explained here.

What Organizations are Qualified to Issue ISO 14001 Certifications?

Authority to issue internationally recognized ISO 14001 certificates are linked to the International Accreditation Forum. The International Accreditation Forum, Inc. (IAF) is the world association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar programs of conformity assessment. Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for a business and its customers by assuring them that accredited certificates may be relied upon. IAF members accredit certification or registration bodies that issue certificates attesting that an organization’s management, products or personnel comply with a specified standard (called conformity assessment).

In the United States ANAB is the main accrediting body for the registrars who actually issue the ISO 14001 Certificates. ANAB is a member of the International Accreditation Forum and a signatory of the IAF multilateral cooperative arrangements (MLAs) for QMS and EMS. Through the IAF MLAs and the Multilateral Cooperative Accreditation Arrangement, ANAB cooperates with other accreditation bodies around the world to provide value to its accredited CBs and their clients, ensuring that accredited certificates are recognized nationally and internationally. The global conformity assessment system ensures confidence and reduces risk for customers engaging in trade worldwide.
At last count ANAB had accredited 45 organizations (28 located in the USA) to issue ISO 14001 registration Certificates.

Registrars have been accredited to issue ISO 14001 certificates by ANAB. ANAB evaluates each registrar against the requirements ISO/IEC 17021 Conformity Assessment – Requirements for Bodies Providing Audit and Certification of Management Systems when determining if the registar should be authorized to issue ISO 14001 Certificates. Accredited registrars hire competent auditors to perform the registration audits and provide a record of the evidence reviewed as part of the auditor’s recommendation for or against registration of the organizations being audited.

Which Individuals are Qualified to Perform ISO 14001 Registration Audits for Registrars?

One of the requirements of ISO 17021 which must be met by all registrars is that the auditors performing audits on behalf of the registrar are competent to do so.

7.2.5 The certification body shall have a process to achieve and demonstrate effective auditing skills, including the use of auditors and audit team leaders possessing generic auditing skills and knowledge, as well as skills and knowledge appropriate for auditing in specific technical areas. This process shall be defined in documented requirements drawn up in accordance with the relevant guidance provided in ISO 19011.

ISO 19011 is specific guidance for registrars on how to establish audit programs and determine auditor competence.

Auditors can demonstrate they have achieved a level competence through personal certification by RABQSA International which is itself accredited by JAZ-ANZ. However, this certification alone is not sufficient evidence to ANAB that auditors working for registrars are competent to perform audits. In addition the registrar must, at a minimum observe the auditor’s performance during an actual audit before they are deemed competent by the registrar.

Figure 1 shows the links between the various organizations making up the registration process.

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How is the ISO 14001 Registration Process Performed?

ISO 14001 Certificates are good for a period of three years assuming the organization successfully completes a series of surveillance audits during that three year period. The registration process begins with a documentation review performed by the auditor to determine if the organization has addressed all the elements of the ISO 14001 Standard. The outcome of the document review can be a recommendation by the auditor to proceed to the registration audit process or a recommendation to delay the registration process until the organization has addressed deficiencies identified by the auditor during the Document Review.

The registration audit begins with what is often referred to as a Stage 1 assessment. The lead auditor visits the site for a day or so to review the organization’s environmental aspects and verify conformance with some of the basic ISO 14001 requirements that could not be verified during the Document Review. The purpose of the Stage 1 audit is also to provide the auditor with additional information about the facility to enable them to prepare a plan for the Stage 2 assessment. The Stage 1 audit is also is a final check on the readiness of the organizations to undergo the Stage 2 Assessment.

The Stage 2 assessment is of longer duration (several auditors on site for several days) than the Stage 1 assessment this is a deeper drilling into the organization’s EMS that is performed in either the Document Review or the Stage 1 Assessment. The Stage 2  Assessment is where the audit team collects and records the evidence of the organization’s conformance to the requirements of ISO 14001 and the organization’s own EMS. This is the evidence that the audit team will submit to the registrar supporting their recommendation for registration.

Successful completion of the registration audit begins three year period that the ISO 14001 certificate is valid. During that three year period the registrar will perform periodic surveillance audits (at least once per year) to confirm that the EMS has sustained effectiveness in the ability of  the organization to continually improve its environmental performance. At the end of the three year period the re-registration assessment is performed which is of similar duration and scope to the original registration audit.