ASTM C1068-21

Standard Guide for Qualification of Measurement Methods by a Laboratory Within the Nuclear Industry

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.
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.

General Information

• Status: Published
• Publication Date: 30-Sep-2021
• ICS: 17.240 - Radiation measurements
• Technical Committee: C26 - Nuclear Fuel Cycle
• Drafting Committee: C26.08 - Quality Assurance, Statistical Applications, and Reference Materials

Standards Content (Sample)

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.
Designation:C1068 −21
Standard Guide for
Qualification of Measurement Methods by a Laboratory
1
Within the Nuclear Industry
This standard is issued under the fixed designation C1068; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope C1009 Guide for Establishing and Maintaining a Quality
AssuranceProgramforAnalyticalLaboratoriesWithinthe
1.1 This guide provides guidance for selecting, validating,
Nuclear Industry
and qualifying measurement methods when qualification is
C1128 Guide for Preparation of Working Reference Materi-
required for a specific program. The recommended practices
als for Use in Analysis of Nuclear Fuel Cycle Materials
presented in this guide provide a major part of a quality
C1156 Guide for Establishing Calibration for a Measure-
assurance program for the laboratory data (see Fig. 1). Quali-
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
fication helps to assure that the data produced will meet
rials
established requirements.
C1210 Guide for Establishing a Measurement System Qual-
1.2 Theactivitiesintendedtoassurethequalityofanalytical
ity Control Program for Analytical Chemistry Laborato-
laboratory measurement data are diagrammed in Fig. 1. Dis-
ries Within Nuclear Industry
cussion and guidance related to some of these activities appear
C1297 Guide for Qualification of Laboratory Analysts for
in the following sections:
the Analysis of Nuclear Fuel Cycle Materials
Section
E177 Practice for Use of the Terms Precision and Bias in
Selection of Measurement Methods 5
ASTM Test Methods
Validation of Measurement Methods 6
E2554 Practice for Estimating and Monitoring the Uncer-
Qualification of Measurement Methods 7
Control 8
tainty of Test Results of a Test Method Using Control
Personnel Qualification 9
Chart Techniques
1.3 This standard does not purport to address all of the
E2655 Guide for Reporting Uncertainty of Test Results and
safety concerns, if any, associated with its use. It is the
Use of the Term Measurement Uncertainty inASTM Test
responsibility of the user of this standard to establish appro-
Methods
priate safety, health, and environmental practices and deter- 3
2.2 ISO Standards:
mine the applicability of regulatory limitations prior to use.
ISO/IEC 17025 General Requirements for the Competence
1.4 This international standard was developed in accor-
of Testing and Calibration Laboratories
dance with internationally recognized principles on standard-
2.3 Other Standards:
ization established in the Decision on Principles for the
ASME NQA-1 QualityAssurance Requirements for Nuclear
Development of International Standards, Guides and Recom-
4
Facility Applications
mendations issued by the World Trade Organization Technical
IEEE/ASTM SI 10 American National Standard for Metric
Barriers to Trade (TBT) Committee.
5
Practice
JCGM 100 Evaluation of Measurement Data – Guide to the
2. Referenced Documents
6
Expression of Uncertainty in Measurement (GUM)
2
2.1 ASTM Standards:
JCGM 200 International Vocabulary of Metrology – Basic
6
C859 Terminology Relating to Nuclear Materials
and General Concepts and Associated Terms (VIM)
1 3
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Assurance, Statistical Applications, and Reference Materials. Available from American Society of Mechanical Engineers (ASME), ASME
Current edition approved Oct. 1, 2021. Published October 2021. Originally International Headquarters, Two Park Ave., New York, NY 10016-5990, http://
approved in 1986. Last previous edition approved in 2015 as C1068 – 15. DOI: www.asme.org.
5
10.1520/C1068-21. Available from Institute of Electrical and Electronics Engineers, Inc. (IEEE),
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 445 Hoes Ln., Piscataway, NJ 08854-4141, http://www.ieee.org.
6
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Available from International Organization for Standardization (ISO), ISO
Standards volume information, refer to the standard’s Document Summary page on Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
the ASTM website. Switzerland, https://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshoh
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: C1068 − 15 C1068 − 21
Standard Guide for
Qualification of Measurement Methods by a Laboratory
1
Within the Nuclear Industry
This standard is issued under the fixed designation C1068; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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.
1.2 The activities intended to assure the quality of analytical laboratory measurement data are diagrammed in Fig. 1. Discussion
and guidance related to some of these activities appear in the following sections:
Section
Selection of Measurement Methods 5
Validation of Measurement Methods 6
Qualification of Measurement Methods 7
Control 8
Personnel Qualification 9
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 safety, health, and healthenvironmental 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
2
2.1 ASTM Standards:
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
Nuclear Industry
C1297 Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials
1
This guide is under the jurisdiction of ASTM Committee C26 on Nuclear Fuel Cycle and is the direct responsibility of Subcommittee C26.08 on Quality Assurance,
Statistical Applications, and Reference Materials.
Current edition approved June 1, 2015Oct. 1, 2021. Published June 2015October 2021. Originally approved in 1986. Last previous edition approved in 20112015 as
C1068 – 03 (2011).C1068 – 15. DOI: 10.1520/C1068-15.10.1520/C1068-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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C1068 − 21
FIG. 1 Quality Assurance of Analytical Laboratory Data
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
3
2.2 ISO Standards:
ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
2.3 Other Standards:
4
ASME NQA-1 Quality Assurance Requirements for Nuclear Facility Applications
5
IEEE/ASTM SI 10 American National Standard for Metric Practice
6
JCGM-100JCGM 100 Evaluation of Measurement Data – Guide to the Expression of Uncertainty in Measurement (GUM)
6
JCGM-200JCGM 200 International Vocabulary of Metrology – Basic and General Concepts and Associated Terms (VIM)
3. Terminology
3.1 Except as otherwise defined herein, definitions of terms are as given in Terminology C859.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 fitness for purpose, n—degree to which data produced by a measurement process
...