Auditing Commercial Laboratory Quality Systems in Malaysia and Indonesia

Environmental Standards, Inc. (Environmental Standards) is an industry leader in the performance of on-site laboratory quality audits, performing over 100 audits of commercial, municipal, and industrial laboratories each year on behalf of our clientele. The vast majority of these audits are domestic laboratory facilities, which generally follow the quality system requirements as detailed in The NELAC Institute (TNI) Standard. However, there is a growing interest by our multi-national clients to assess the quality of their analytical service providers around the globe. In 2017, Environmental Standards performed two commercial laboratory audits in Southeast Asia; one facility located in Kuala Lumpur, Malaysia, and another facility located in Bogor, West Java, Indonesia. As experiences auditing commercial laboratories in Brazil were published in a previous blog, let’s take a look at the environmental laboratory approach to quality systems that is used in both Malaysia and Indonesia and compare that with the US approach.

Kuala Lumpur, Malaysia city skyline. Photo: Adobe Stock

The majority of commercial analytical laboratories that are accredited in the United States operate under the consensus standards and accreditation system currently operated through TNI. In addition, many state environmental agencies offer accreditation through a number of programs for analytical laboratories that perform analysis for environmental programs specific to that state.

In the region of Southeast Asia audited, a collection of accreditation standards are used to evaluate laboratory quality systems, including The American National Standard for General Requirements for the Competence of Testing and Calibration Laboratories (ANSI/ISO/IEC 17025:2005), as well as several standards published by regional authorities, such as the Asia Pacific Laboratory Accreditation Cooperation and the Skim Akreditasi Makal Malaysia (Laboratory Accreditation Scheme of Malaysia or SAMM), as well as information detailed in the latest edition of Standard Methods for the Examination of Water and Wastewater (Standard Methods).

Our general observations on the procedures currently in use noted that the quality systems are built around the requirements proposed in the various SAMM directives, while the quality assurance associated with each method is specific to the requirements contained in the particular published methods being employed by the laboratory.

The SAMM accreditation scheme is documented through the use of different classes of documents that specify the requirements and criteria for laboratory accreditation. A number of “Specific Criteria” documents present the general requirements for accreditation for different classes of testing, such as chemical, microbiological, veterinary, forensics, etc. These documents include the specific quality criteria for each field, and are comparable to the TNI standard with respect to content, including requirements for quality administration such as document control, control of non-conforming work, internal audits and managerial review, as well as technical requirements such as calibration, method validation, and measurement traceability.

The next level of document specificity is the “Specific Technical Requirements” documents, which provide an increasingly detailed set of requirements for more specific fields of laboratory testing, including requirements for such diverse fields as household pesticide bioefficacy, toxicity testing, electromagnetic compatibility, nucleic acid testing, and controlled substances.

Finally, SAMM also publishes policies and circulars that contain specific directives and clarifications. These documents provide additional clarification on specific requirements as necessary.

This collection of documents from the various agencies provides a solid framework that is in most respects quite similar to the TNI Standard commonly used in the United States for environmental quality systems guidance. The issues that were observed during the audit were common issues observed during any audit: issues of standard interpretation, consistent quality implementation, and method compliance. One of the unique challenges faced by the Malaysian and Indonesian laboratories is procurement of equipment and standards. Both have very restrictive import policies and lengthy impound periods. Orders from laboratory suppliers can take months to reach their final destinations, which can make it difficult for the laboratory personnel to replace damaged equipment and expired standards.

The quality systems that form the basis for the environmental laboratory accreditation were quite adequate, if a little bit cumbersome to evaluate, and very consistent to the national TNI Standard currently in use in the United States.

Environmental Standards’ Celebrates 30 Years!

On Thursday, October 12th, a crowd of 150 gathered at the Phoenixville Foundry to celebrate Environmental Standards’ 30th year in business. Guests included colleagues, clients, friends and family. The theme of the night was a Venetian Carnival Masquerade and guests donned masks that ranged from traditional Venetian style to those inspired by Phantom of the Opera and the steampunk genre. The evening began with an aerial bartender pouring champagne to the sounds of a talented string quartet from CAPA, The Philadelphia High School for the Creative and Performing Arts. DJ, Aaron DeAngelo kept the dance floor alive while other guests engaged in friendly competition up in the mezzanine around craps, blackjack and roulette tables. A great time was had by all!

Thank you to all for attending! Cheers to the next 30 years!

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

US EPA Brownfields Grant News Updates

FY 2018 RFP for Brownfields Assessment, Cleanup, and Revolving Loan Fund Grants Announced

On September 18, 2017, the U.S. Environmental Protection Agency (US EPA) announced the fiscal year (FY) 2018 Request for Proposals (RFP) for Brownfields Assessment, Revolving Loan Fund, and Cleanup Grants.  These grants may be used to address sites impacted by petroleum and hazardous substances, pollutants, or contaminants (including hazardous substances co-mingled with petroleum).  The Proposal submission deadline is November 16, 2017.  Specific grant-funding opportunities for FY 2018 include:

  • Assessment Grants (funded over 3 years) Community-wide or Site-Specific Applicants:  Applicants may apply for up to $200,000 in hazardous substances funding, $200,000 in petroleum funding, or a combined $300,000 for hazardous substances and petroleum funding.  Assessment Coalition Applicants may apply for up to $600,000 in hazardous substances funding and/or petroleum funding.
  • Revolving Loan Fund Grants (funded over 5 years) Revolving Loan Fund (RLF) Grants provide funding to capitalize an RLF program.  RLF programs provide loans and sub-grants to eligible entities to carry out cleanup activities at brownfield sites impacted with hazardous substances or petroleum.  Eligible applicants may apply as individual entities or as RLF Coalitions comprised of two or more entities.  RLF applicants may apply for up to $1,000,000 in funding.
  • Cleanup Grants (funded over 3 years) Applicants may apply for up to $200,000 per brownfield site and may submit up to three separate, site-specific Cleanup Grant Proposals.Environmental Standards has a long history of helping clients identify and apply for various grant-funding opportunities.  We have prepared numerous successful grant applications on behalf of clients resulting in multiple funding awards to be used for environmental assessment, planning, remediation, and capitalization of RLF programs.  Over the past 5 years alone, we have helped clients prepare successful RLF and Assessment Grant applications that have resulted in awards of $1.65 million.

For more information, please contact Joe Kraycik or Gerry Kirkpatrick at (610) 935-5577.

To assist applicants with their proposals, US EPA will host its annual National Guideline Outreach Webinar on October 5, 2017 at 1:30 p.m. Participants can join the webinar at http://epawebconferencing.acms.com/app18/ and/or via conference call at 1-866-299-3188/ access code: 202-566-1817.

International Environmental Laboratory Assessment and the Brazilian Quality Systems

For many years, Environmental Standards, Inc. (Environmental Standards) has conducted approximately 100 commercial laboratory audits each year for its clients.  These are at-the-bench audits – we cover both general laboratory operations, but also spend considerable time with Analysts to go through their procedures step by step.  By far, the majority of these audits are performed at domestic United States (US) analytical facilities.  However, there is a growing interest from our multi-national clients to assess the quality of their analytical service providers around the globe.  Within the past month, I had the opportunity to perform two laboratory audits in Brazil, while my colleague provided audits in Indonesia and Malaysia.  Let’s take a look at the environmental laboratory approach and quality system that is used in Brazil and compare that with the US approach.

The majority of commercial analytical laboratories that are accredited in the US perform  under the consensus standards and accreditation system currently operated through The NELAC Institute (TNI).  Though this is not universally true, as some US States have developed their own accreditation system and standards, the TNI program (formerly known as NELAP) is the most widely followed environmental accreditation program within the US.  In Brazil, the National Institute of Metrology, Quality and Technology (Inmetro/cgre) is the laboratory accreditation agency, and like the TNI system, Inmetro’s is  based upon the ISO 17025 standard.  Note that Inmetro also accredits Brazilian laboratories for non-environmental services using other ISO standards and the Good Laboratory Practices.

We often hear the term “data of known and acceptable quality” as the standard for a quality system with environmental laboratories.  The “known” refers to having procedures, following those procedures, and proving that they are followed and this is the primary emphasis of ISO 17025.  “Acceptable quality” implies that metrics have been established so that the data can be evaluated again for general or project-specific objectives.  The TNI standards are written at a level of detail beyond that found in the ISO standards, providing method-level metrics for this assessment.  As Chemists, it is these instrument, method, and data analysis minutiae where we focus our time.  To do so in an audit, we compare the quantitative and qualitative method requirements to what is being performed at the laboratory on the bench.  In Brazil, the environmental laboratories cite a published method, such as published by the US EPA, Standard Methods (SM), or ASTM.  However, the during my auditing in Brazil, it was clear that laboratories were not required to follow the published methods to the letter; it was up to Inmetro and its Auditors to decide what method steps were required to meet their accreditation.

For example, US EPA Method 8260B includes very specific steps for the initial calibration, including the use of a relative response factor and linearity evaluation for all target analytes and a different metric for the calibration check compounds.  The method also includes, with minimum response factor, objectives for a set select of system performance check compounds.  Brazilian laboratories use linear regression as the default approach, unlike Method 8260B where relative standard deviation is first evaluated.  Likewise their calibration check compounds may include reasonable recovery limits to span the full set of analytes, with a subset analyzed after every 10 samples.  This use of a check standard within a set of samples is more common for gas chromatography methods and provides added control for evaluation.

For methods that do not explicitly describe common interferences, the laboratories in Brazil may or may not have this information at hand, and may not take precautions to account for interferences.  For example, the cyanide methods in SM 4500 CN, cite interferences, but their discussion is intertwined among the various SM method versions.  Brazilian laboratories that don’t have an extensive understanding of the method complexities as they relate to interferences may not incorporate the spot-checks for chlorine interference.

The use of performance test (PT) samples is part of the Inmetro environmental laboratory accreditation program.  However, it is likely the PT sample analysis frequency at a Brazilian laboratory is significantly less than that in the US.  This may be due to the significant cost of reference materials and PT samples in Brazil.  Inmetro has a very limited set of Material de Referência Certificado, so oftentimes reference materials/PTs must be purchased from companies outside of Brazil.

It is refreshing to know that, as a general rule within the Brazilian quality system, laboratory Analysts are prevented from having access to client and sample information.  Sample containers at the bench have no client or source information, as a means of ensuring impartiality. They do not have any clue that a sample may be a field blank, or duplicate.  This reduces the chance for treating samples unequally, and thus, provides a more realistic evaluation of laboratory operations if blind QC samples are used by the client.

It was my experience that even though ISO 17025 is the normative reference for the Brazilian environmental laboratory accreditation, they do go beyond just a “documented quality” approach.  However, the rigor of the “acceptable quality” varied with method and laboratory.  Ultimately, an Auditor must have the technical background to look at specific operations and calculations to understand the extent of the quality program and controls, along with a top-down perspective to evaluate the Brazilian laboratory and system relative to project or program quality needs.  Direct comparison of their operation to the US system, such as TNI, is insufficient and biased.

US EPA Offers Buyout Program to Reduce Staff

The US EPA is offering its employees a buyout program to reduce staff, according to an internal memo. The memo sent to all US EPA employees by Acting Deputy Administrator Mike Flynn (the  other Mike Flynn, not the former United States National Security Advisor) on June 1, 2017, did not give a dollar figure for the buyouts or say how many employees US EPA administrators hoped would take the offer. However, the Voluntary Separation Incentive Payment Authority (VSIP) allows agencies that are downsizing or restructuring to offer employees lump-sum payments up to $25,000 as an incentive to voluntarily separate, according to the Office of Personnel Management.

The memo stated that the Voluntary Early Retirement Authority (VERA) and VSIP, which are frequently referred to as early outs and buyouts, “can help us realign our workforce to meet changing mission requirements and move toward new models of work. The authority encourages voluntary separations and helps the Agency complete workforce restructuring with minimal disruption to the workforce.”

Politico reported in February 2017 that the White House had proposed reducing US EPA’s budget by about a quarter and eventually eliminating 1 in 5 of the agency’s workers. That proposal would set US EPA’s budget at $6.1 billion, down from $8.1 billion. Reuters reports the US EPA would see the biggest cuts of any federal agency in the 2018 budget proposal, with a 31 percent reduction in budget and the elimination of over 3,200 employees. The US EPA employs about 15,000 people.

In the memo, Flynn said the White House Office of Management and Budget must still approve the buyout plan. The US EPA and other federal agencies have offered buyouts to employees from time to time in the past.

VERAs allow federal employees to retire before they hit the standard combinations of age and years of service. According to the Government Accountability Office, the government has an average retirement eligibility rate of 34 percent. While some of the large agencies are at or below that average, US EPA is close to 45 percent.

The memo states that employees accepting a VERA/VSIP must leave the agency by early September 2017. Once a buyout is accepted, that employee may not return to federal employment within five years. Commonly, buyouts are paired with early retirement offers.

In May 2017, it was widely reported that the US EPA was setting aside $12 million of its fiscal 2017 budget allocation for the employee buyout and incentives effort.