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Understanding End-Users’ Approaches to Ensuring the Quality of Environmental Data
Oral Presentation
Prepared by C. Hiegel
Trihydro Corporation, 1252 Commerce Dr., Laramie, WY, 82072
Contact Information: christinaarthur@hotmail.com; 307-745-4993
ABSTRACT
Key Words: Data Validation, Data Quality, Environmental Data, Environmental Laboratory
Federal and state environmental regulatory and governing bodies have developed protocols or requirements for ensuring the quality of laboratory produced data. These protocols can vary widely and may be dependent upon the decision of the regulator governing the project. Sources for data validation standards include: the United States Environmental Protection Agency (USEPA) National Functional Guidelines (NFG) documents, USEPA Solid Waste – 846 methodology, Department of Defense regulations, National Environmental Laboratory Accreditation Program (NELAP) requirements, and other methods and regulatory guidance documents. Consistently, the regulatory guidance documents are more or at times less stringent than the promulgated methods or SOPs which causes conflicting views between the laboratory and end-user on the quality of the data. The differences between sources make it extremely difficult for the laboratory and data end-user to determine when analytical data is in fact accurate, precise, compliant, and representative.
One of the largest problems with differing data quality requirements is that the laboratories and data end-users are not familiar with each other’s expectations of quality. Often times an end user’s validation or review will result in rejection of data that would be considered valid by the laboratory. Additionally, the end-user’s objectives may not have been met by the laboratory. Understanding the evaluation of quality by the end user will help to improve the quality of results and provide acceptable data that meets both the laboratories and end users’ obligations.
The laboratories process for ensuring quality includes the use of promulgated analytical methods that are used to develop standard operating procedures (SOPs). The SOPs address everything from bottle preparation, analyst training, sample storage, and sample preparation and analyses to data calculations and final report preparation. In addition, most environmental laboratories are under scrutiny of state and third party accrediting agencies who provide certification or accreditation for a given method or process. These agencies evaluate the laboratory processes, SOPs, and data to determine if the laboratory is able to meet the quality requirements set by the accrediting organizations.
In contrast, end users of the analytical reports provided by the laboratories evaluate the quality of the data in a slightly different manner than the laboratory. The overall quality of the data to the end-user is determined by the usability of the data with respect to the project objectives. Therefore, the end-user is looking at more than the individual data results to determine if the objectives of the regulatory agency or client were met. These objectives would include the reporting limits, required quality assurance samples, comparison of blind duplicate samples, condition of samples when they arrived at the laboratory, any major non-conformances that would not allow the data to be reported, or results that are dissimilar to expected results or different than previous results. The end user may perform limited to very complex reviews of the data from basic screening to complex data validation.
Therefore, due to the increased demand for data validation and adherence to the quality standards, it is important for both the laboratories and end users to realize what is required to ensure quality data and more importantly to understand that the requirements that each entity are trying to meet are different. Preparing for and understanding the end-users goals and how they are reviewing the data will help to ensure greater satisfaction by the end-user in the data received from their laboratory.
Oral Presentation
Prepared by C. Hiegel
Trihydro Corporation, 1252 Commerce Dr., Laramie, WY, 82072
Contact Information: christinaarthur@hotmail.com; 307-745-4993
ABSTRACT
Key Words: Data Validation, Data Quality, Environmental Data, Environmental Laboratory
Federal and state environmental regulatory and governing bodies have developed protocols or requirements for ensuring the quality of laboratory produced data. These protocols can vary widely and may be dependent upon the decision of the regulator governing the project. Sources for data validation standards include: the United States Environmental Protection Agency (USEPA) National Functional Guidelines (NFG) documents, USEPA Solid Waste – 846 methodology, Department of Defense regulations, National Environmental Laboratory Accreditation Program (NELAP) requirements, and other methods and regulatory guidance documents. Consistently, the regulatory guidance documents are more or at times less stringent than the promulgated methods or SOPs which causes conflicting views between the laboratory and end-user on the quality of the data. The differences between sources make it extremely difficult for the laboratory and data end-user to determine when analytical data is in fact accurate, precise, compliant, and representative.
One of the largest problems with differing data quality requirements is that the laboratories and data end-users are not familiar with each other’s expectations of quality. Often times an end user’s validation or review will result in rejection of data that would be considered valid by the laboratory. Additionally, the end-user’s objectives may not have been met by the laboratory. Understanding the evaluation of quality by the end user will help to improve the quality of results and provide acceptable data that meets both the laboratories and end users’ obligations.
The laboratories process for ensuring quality includes the use of promulgated analytical methods that are used to develop standard operating procedures (SOPs). The SOPs address everything from bottle preparation, analyst training, sample storage, and sample preparation and analyses to data calculations and final report preparation. In addition, most environmental laboratories are under scrutiny of state and third party accrediting agencies who provide certification or accreditation for a given method or process. These agencies evaluate the laboratory processes, SOPs, and data to determine if the laboratory is able to meet the quality requirements set by the accrediting organizations.
In contrast, end users of the analytical reports provided by the laboratories evaluate the quality of the data in a slightly different manner than the laboratory. The overall quality of the data to the end-user is determined by the usability of the data with respect to the project objectives. Therefore, the end-user is looking at more than the individual data results to determine if the objectives of the regulatory agency or client were met. These objectives would include the reporting limits, required quality assurance samples, comparison of blind duplicate samples, condition of samples when they arrived at the laboratory, any major non-conformances that would not allow the data to be reported, or results that are dissimilar to expected results or different than previous results. The end user may perform limited to very complex reviews of the data from basic screening to complex data validation.
Therefore, due to the increased demand for data validation and adherence to the quality standards, it is important for both the laboratories and end users to realize what is required to ensure quality data and more importantly to understand that the requirements that each entity are trying to meet are different. Preparing for and understanding the end-users goals and how they are reviewing the data will help to ensure greater satisfaction by the end-user in the data received from their laboratory.