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Significance and Use
4.1 Because of concerns for safety and the protection of nuclear materials from theft, stringent specifications are placed on chemical processes and the chemical and physical properties of nuclear materials. Strict requirements for the control and accountability of nuclear materials are imposed on the users of those materials. Therefore, when analyses are made by a laboratory to support a project such as the fabrication of nuclear fuel materials, various performance requirements may be imposed on the laboratory. One such requirement is often the use of qualified methods. Their use gives greater assurance that the data produced will be satisfactory for the intended use of those data. A qualified method will help assure that the data produced will be comparable to data produced by the same qualified method in other laboratories.
4.2 This guide provides guidance for qualifying measurement methods and for maintaining qualification. Even though all practices would be used for most qualification programs, there may be situations in which only a selected portion would be required. Care should be taken, however, that the effectiveness of qualification is not reduced when applying these practices selectively. The recommended practices in this guide are generic; based on these practices, specific actions should be developed to establish a qualification program.
1.1 This guide provides guidance for selecting, validating, and qualifying measurement methods when qualification is required for a specific program. The recommended practices presented in this guide provide a major part of a quality assurance program for the laboratory data (see ). Qualification helps to assure that the data produced will meet established requirements.
1.2 The activities intended to assure the quality of analytical laboratory measurement data are diagrammed in . Discussion and guidance related to some of these activities appear in the following sections:
Selection of Measurement Methods
Validation of Measurement Methods
Qualification of Measurement Methods
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
C859 Terminology Relating to Nuclear Materials
C1009 Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
C1128 Guide for Preparation of Working Reference Materials for Use in Analysis of Nuclear Fuel Cycle Materials
C1156 Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials
C1210 Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the Nuclear Industry
C1297 Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E2554 Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart Techniques
E2655 Guide for Reporting Uncertainty of Test Results and Use of the Term Measurement Uncertainty in ASTM Test Methods
ISO StandardsISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
Other StandardsASME NQA-1 Quality Assurance Requirements for Nuclear Facility Applications Available from American Society of Mechanical Engineers (ASME), ASME International Headquarters, Two Park Ave., New York, NY 10016-5990, http://www.asme.org. JCGM-100 Evaluation of Measurement Data-Guide to the Expression of Uncertainty in Measurement (GUM) Available from International Organization for Standardization (ISO), 1, ch. de la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org. JCGM-200 International Vocabulary of Metrology-Basic and General Concepts and Associated Terms (VIM)
ICS Number Code 17.240 (Radiation measurements)
UNSPSC Code 15131500(Nuclear fuel)
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ASTM C1068-15, Standard Guide for Qualification of Measurement Methods by a Laboratory Within the Nuclear Industry, ASTM International, West Conshohocken, PA, 2015, www.astm.orgBack to Top