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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.

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.