by M. Jordan Smith and John L. Schwarz
On October 14, 2014, the Environmental Monitoring Laboratory (EML) of Edgewood Chemical Biological Center, became the first laboratory in the United States to meet the requirements of the Department of Defense (DoD) Environmental Laboratory Accreditation Program (ELAP) when testing for chemical warfare agents (CWA).
An EML chemist loads sample extracts into an autosampler for a GC-MS system.
Established in 2009, ELAP provides a unified program for laboratories supporting the DoD to demonstrate conformance to ISO/IEC 17025, the main standard for testing and calibration of laboratories.
Preparation for accreditation required strategic planning. The quality system for EML had to be robust and fully realized to achieve accreditation.
Realization required a review of the entire quality system, development of a quality manual, standardization of processes, expansion of the quality team, and more, all conducted while EML operated full-time at various sites across the globe.
-To further meet the needs of its customers, the Environmental Monitoring Laboratory (EML) of Edgewood Chemical Biological Center sought ISO 17025 accreditation.
-The laboratory helps the U.S. Department of Defense establish quality control requirements when testing for chemical warfare agents (CWA).
-In preparation for accreditation, EML created or modified more than 60 controlled documents.
-The laboratory became the first lab of its kind to achieve ISO 17025 accreditation for CWA in October 2014.
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Unique to this accreditation journey was the dearth of standards and quality control requirements for analysis of CWA by gas chromatography-mass spectrometry (GC-MS).
GC-MS is a technique used for the analysis and quantitation of volatile and semi-volatile compounds by separating the components of a sample in the chromatograph, detecting each in the spectrometer, and identifying using the preceding information. Examples of CWA include blister agents such as mustard and nerve agents such as sarin.
This image shows the locations within the United States where EML has provided services via its mobile labs and support sites.
Because of this circumstance, EML could collaborate with ELAP management—the Environmental Data Quality Workgroup (EDQW)—to define the quality control requirements for CWA.
EML and EDQW worked within the framework of ISO 17025 to combine the CWA expertise and experience of EML with EDQW’s familiarity with quality systems and accreditation to produce Table 14, Chemical Warfare Agents by GC-MS, in version 5.0 of the quality systems manual (QSM). Click here to download the QSM Version 5.0 from the DoD to view Table 14.
This collaboration highlights the strength of the ELAP accreditation process; laboratories can provide practical experience to refine technical requirements without influencing policies set forth by the accrediting body.
EML is a supporting branch within the Chemical Biological Application and Risk Reduction (CBARR) business unit, located in the Edgewood Area of Aberdeen Proving Ground in Maryland. The Edgewood Chemical Biological Center operates within the framework of the Research Development and Engineering Command of the U.S. Army.
A full-service, rapidly reporting laboratory that processes more than 20,000 samples per year, EML staff manage an average reporting turnaround time of 48 hours. Qualitative and quantitative analysis includes chemical agents, degradation products (ABP), industrial compounds, and metals. Core laboratory services are available to support research, development, testing, and evaluation missions. Additionally, the EML supports environmental remediation investigations, feasibility studies, health and safety monitoring, and demilitarization and testing operations for chemical agents and industrial compounds. EML offers all services at fixed laboratories at Edgewood. Using mobile laboratories and analytical platforms, EML offers all of its services anywhere in the world.
EML sought accreditation with two goals in mind. First, EML wanted to respond to customer requests. Although it is one of only a handful of laboratories with the authorization to handle CWA and ABP, EML could have easily ignored the requests for accreditation, demonstrating the rigorousness of its quality system and processes and responding to customers through successful accreditation was an obvious value-added choice.
Second, management wanted to benchmark the progression of the laboratory. A concerted effort was expended to broaden the technical expertise of the laboratory, increase the breadth of analytical capability, and develop top-tier talent in the years before accreditation. EML desired to challenge the improvements by seeking accreditation.
An EML senior chemist prepares a solution.
Accreditation afforded EML the opportunity to subject its quality system to a stringent third-party accrediting body. Third-party accreditation is the gold standard for laboratory assessment. Technical experts and experienced assessors provide ethical, fair, and honest evaluation customers can use as benchmarks when seeking laboratory services. By engaging this process, EML increased its competitiveness in the testing field.
EML also took advantage of the time spent preparing for accreditation. Important in any industry are operational costs, market share and competitiveness, and resource readiness.
Working within the confines of the federal procurement system forced EML to remain vigilant concerning supply chain of critical resources, e.g., because fiscal year budgets required lengthy approval processes with little opportunity for future revising, correctly projecting the necessary consumable material received greater import. The experience gained from preparation proved useful when EML added an accredited mobile laboratory to its scope.
Although the choice to pursue accreditation was easy to make, the process was not void of hurdles.
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M. Jordan Smith is the deputy quality assurance coordinator for EML. He graduated from the University of Florida College of Pharmacy. Smith has more than a decade of experience in biological and chemical laboratory settings performing research, audits, and quality assurance and quality control.
John L. Schwarz is the analytical chemistry manager for EML. Schwarz has more than 15 years of experience providing laboratory services and operations expertise to varying investigations worldwide for CWA. In his career, Schwarz has provided analytical support to nearly 50 remedial investigations for the U.S. Army Corps of Engineers.
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