ASTM C1068-21 - 1.10.2021
 
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. Scope

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 Fig. 1). Qualification helps to assure that the data produced will meet established requirements.

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4?This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

 
2. Referenced Documents

JCGM-200

International Vocabulary of Metrology-Basic and General Concepts and Associated Terms (VIM)

C859-24

Standard Terminology Relating to Nuclear Materials

C1009-21

Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry

C1128-23

Standard Guide for Preparation of Working Reference Materials for Use in Analysis of Nuclear Fuel Cycle Materials

C1156-18

Standard Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials

E2655-14(2020)

Standard Guide for Reporting Uncertainty of Test Results and Use of the Term Measurement Uncertainty in ASTM Test Methods

C1210-21

Standard Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within Nuclear Industry

C1297-18

Standard Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials

E177-20

Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods

E2554-18e1

Standard Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart Techniques (Includes all amendments and changes 10/7/2019).

ISO/IEC 17025

General Requirements for the Competence of Testing and Calibration Laboratories

ASME 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.

IEEE/ASTM SI 10

American National Standard for Metric Practice Available from Institute of Electrical and Electronics Engineers, Inc. (IEEE), 445 Hoes Ln., Piscataway, NJ 08854-4141, http://www.ieee.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.