QUALITY ASSURANCE and QUALITY CONTROL DATA STANDARD
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1 QUALITY ASSURANCE and QUALITY CONTROL DATA STANDARD Standard No.: EX January 6, 2006 This standard has been produced through the Environmental Data Standards Council (EDSC). The Environmental Data Standards Council (EDSC) is a partnership among US EPA, States and Tribal partners to develop and agree upon data standards for environmental information collection and exchange. More information about the EDSC is available at
2 Foreword The Environmental Data Standards Council identifies, prioritizes and pursues the creation of data standards for those areas where information exchange standards will provide the most value in achieving environmental results. The Council involves Tribes and Tribal Nations, state and federal agencies in the development of the standards and then provides the draft materials for general review. Business groups, non-governmental organizations, and other interested parties may then provide input and comment for Council consideration and standard finalization. Draft and final standards are available at INTRODUCTION This Quality Assurance and Quality Control Data Standard (QA/QC) identifies quantitative statistics and qualitative descriptors that are used to interpret the degree of acceptability or utility of data to the user. The standard provides a common set of data components and data elements to specify Quality Control elements that may be acquired during field or laboratory analysis. These data components and data elements provide a reusable template for Quality Control Information. This standard does not establish a new reporting requirement for the regulated community or new data collection requirements for US EPA programs. It does however require that information exchanges of quality control information conform to the standard once US EPA and its partners adopt and implement the standard. 1.1 Scope This standard provides and describes quantitative statistics and qualitative descriptors that are used to interpret the degree of acceptability or utility of data to the user. 1.2 Revision History Date Version Description January 6, 2006 EX Initial Environmental Data Standards Council Adoption 1.3 References to Other Data Standards None. January 6, 2006 Page 2
3 1.4 Terms and Definitions For the purposes of this document, the following terms and definitions apply. Term Quality Assurance (QA) Quality Control (QC) Definition The system implemented by an organization which assures outside bodies that the data generated is of proven and known quality and meets the needs of the end user. This assurance relies heavily on documentation of processes, procedures, capabilities, and monitoring of such. Those operations undertaken in the laboratory or field to ensure that the data produced are within known measures of accuracy and precision. These operations may include calibration, method blanks, matrix spikes, blank spikes, surrogates, duplicates, system checks, as well as others. 1.5 Implementation Users are encouraged to use the XML registry housed on the Exchange Network Web site to download schema components for the construction of XML schema flows ( 1.6 Document Structure The structure of this document is briefly described below: a. Section 2.0 Quality Assurance and Quality Control Diagram, illustrates the principal data groupings contained within this standard. b. Section 3.0 Quality Assurance and Quality Control Data Standard Table, provides information on the high level, intermediate and elemental Quality Control and Quality Assurance data groupings. Where applicable, for each level of this data standard a definition, XML tag, note(s), example list of values and format are provided. The format column may include the number of characters for the associated data element, where A specifies alphanumeric, N designates numeric, and G and D are used for grouping and date respectively. c. Data Element Numbering. For purposes of clarity and to enhance understanding of data standard hierarchy and relationships, each data group is numerically classified from the primary to the elemental level. d. Code and Identifier Metadata: Metadata, defined here as data about data or data elements, includes their descriptions and/or any needed context setting information required to identify the origin, conditions of use, interpretation, or understanding the information being exchanged or transferred. (Adapted from ISO/IEC :1999 Information Technology Vocabulary Part 17: Databases metadata). Based on the business need, additional metadata may be required to sufficiently describe an identifier or a code. A note regarding this additional metadata is included in the notes column for identifier and code elements. Additional metadata for identifiers may include: Code List Identifier, which is a standardized reference to the context or source of the set of codes Additional metadata for codes may include: Code List Identifier, which is a standardized reference to the context or source of the set of codes Code List Version Identifier, which identifies the particular version of the set of codes. Code List Version Agency Identifier, which identifies the agency responsible for maintaining the set of codes January 6, 2006 Page 3
4 Code List Name, which describes the corresponding name for which the code represents e. Appendix A, Quality Assurance and Quality Control Data Standard Structure Diagram illustrates the hierarchical classification of the QA/QC data standard. This diagram enables business and technical users of this standard to quickly understand its general content and complexity. Appendix B, lists the references for the Quality Assurance and Quality Control Data Standard. 2.0 QUALITY ASSURANCE AND QUALITY CONTROL DATA STANDARD DIAGRAM This diagram specifies the major data groups that may be used to identify the characteristics and/or to catalog quality assurance and quality control. Quality Assurance and Quality Control Data standard 1.0 Data Quality Indicator January 6, 2006 Page 4
5 3.0 QUALITY ASSURANCE AND QUALITY CONTOL DATA STANDARD TABLE 1.0 Data Quality Indicator Definition: The quantitative statistics and qualitative descriptors that are used to interpret the degree of acceptability or utility of data to the user. Relationships: None. Notes: XML Tag: None. DataQualityIndicator Data Element Name Data Element Definitions Notes Format XML Tags 1.1 Precision Value A measure of mutual agreement among individual measurements of the same property usually under prescribed similar conditions. Note: This measure is the random component of error. Example: Relative Percent Difference (RPD or d i ), where X is the primary value and Y is the duplicate: N PrecisionValu e di Yi Xi = 100 ( Yi + Xi) / Bias Value The systematic or persistent distortion of a measurement process which causes error in one direction. Note: Bias will be determined by estimating the positive and negative deviation from the true value as a percentage of the true value. N BiasValue Example: Percent Difference, where X is the known or spiked amount, and Y is the measured concentration: di Yi Xi = 100 Xi January 6, 2006 Page 5
6 Data Element Name Data Element Definitions Notes Format XML Tags 1.3 Confidence Interval Value A range of values constructed so that this range has a specified probability of including the true population mean. Note: This range is symmetric about the sample mean, the specified probability is called the confidence level, and the end points of the confidence interval are called the upper and lower confidence limits. N ConfidenceInt ervalvalue Confidence limit may be calculated as: X ± ( t_ value* stdev/ n) 1.4 Upper Confidence Limit Value 1.5 Lower Confidence Limit Value Value of the upper end of the confidence interval. Value of the lower end of the confidence interval. See 1.3 Confidence Interval N UpperConfide ncelimitvalu e See 1.3 Confidence Interval N LowerConfide ncelimitvalu e January 6, 2006 Page 6
7 Appendix A Quality Assurance and Quality Control Data Standard Structure Diagram Quality Assurance and Quality Control Data Standard 1.0 Data Quality Indicator 1.1 Precision Value 1.2 Bias Value 1.3 Confidence Interval Value 1.4 Upper Confidence Limit Value 1.5 Lower Confidence Limit Value January 6, 2006
8 Appendix B References i. ISO/IEC :1999 Information Technology Vocabulary Part 17: Databases January 6, 2006 Page 8
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QUALITY MANAGEMENT IN VETERINARY TESTING LABORATORIES
NB: Version adopted by the World Assembly of Delegates of the OIE in May 2012 CHAPTER 1.1.4. QUALITY MANAGEMENT IN VETERINARY TESTING LABORATORIES SUMMARY Valid laboratory results are essential for diagnosis,