ASTM C1068-15

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

General Information

• Status: Historical
• Publication Date: 31-May-2015
• 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)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:C1068 −15
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 ment Method Used to Analyze Nuclear Fuel Cycle Mate-
rials
1.1 This guide provides guidance for selecting, validating,
C1210 Guide for Establishing a Measurement System Qual-
and qualifying measurement methods when qualification is
ity Control Program for Analytical Chemistry Laborato-
required for a specific program. The recommended practices
ries Within the Nuclear Industry
presented in this guide provide a major part of a quality
C1297 Guide for Qualification of Laboratory Analysts for
assurance program for the laboratory data (see Fig. 1). Quali-
the Analysis of Nuclear Fuel Cycle Materials
fication helps to assure that the data produced will meet
E177 Practice for Use of the Terms Precision and Bias in
established requirements.
ASTM Test Methods
1.2 Theactivitiesintendedtoassurethequalityofanalytical
E2554 Practice for Estimating and Monitoring the Uncer-
laboratory measurement data are diagrammed in Fig. 1. Dis-
tainty of Test Results of a Test Method Using Control
cussion and guidance related to some of these activities appear
Chart Techniques
in the following sections:
E2655 Guide for Reporting Uncertainty of Test Results and
Section
Use of the Term Measurement Uncertainty inASTM Test
Selection of Measurement Methods 5
Methods
Validation of Measurement Methods 6
3
Qualification of Measurement Methods 7
2.2 ISO Standards:
Control 8
ISO/IEC 17025 General Requirements for the Competence
Personnel Qualification 9
of Testing and Calibration Laboratories
1.3 This standard does not purport to address all of the
2.3 Other Standards:
safety concerns, if any, associated with its use. It is the
ASME NQA-1 QualityAssurance Requirements for Nuclear
responsibility of the user of this standard to establish appro-
4
Facility Applications
priate safety and health practices and determine the applica-
IEEE/ASTM SI 10 American National Standard for Metric
bility of regulatory limitations prior to use.
5
Practice
2. Referenced Documents JCGM-100 Evaluation of Measurement Data – Guide to the
6
2
Expression of Uncertainty in Measurement (GUM)
2.1 ASTM Standards:
JCGM-200 International Vocabulary of Metrology – Basic
C859 Terminology Relating to Nuclear Materials
6
and General Concepts and Associated Terms (VIM)
C1009 Guide for Establishing and Maintaining a Quality
AssuranceProgramforAnalyticalLaboratoriesWithinthe
3. Terminology
Nuclear Industry
C1128 Guide for Preparation of Working Reference Materi- 3.1 Except as otherwise defined herein, definitions of terms
als for Use in Analysis of Nuclear Fuel Cycle Materials
are as given in Terminology C859.
C1156 Guide for Establishing Calibration for a Measure-
3.2 Definitions of Terms Specific to This Standard:
1
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
3
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Assurance, Statistical Applications, and Reference Materials. 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Current edition approved June 1, 2015. Published June 2015. Originally Available from American Society of Mechanical Engineers (ASME), ASME
approved in 1986. Last previous edition approved in 2011 as C1068 – 03 (2011). International Headquarters, Two Park Ave., New York, NY 10016-5990, http://
DOI: 10.1520/C1068-15. www.asme.org.
2 5
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Institute of Electrical and Electronics Engineers, Inc. (IEEE),
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 445 Hoes Ln., Piscataway, NJ 08854-4141, http://www.ieee.org.
6
Standards volume information, refer to the standard’s Document Summary page on Available from International Organization for Standardization (ISO), 1, ch. de
the ASTM website. la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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C1068−15
there may be situations in which only a selected portion would
be required. Care should be taken, however, that the effective-
ness of qualification is not reduced when applying these
practices selectively. The recommended practices in this guide
aregeneric;ba
...

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 − 03 (Reapproved 2011) C1068 − 15
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 and health practices and determine the applicability of regulatory
limitations prior to use.
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
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
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
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, 2011June 1, 2015. Published June 2011June 2015. Originally approved in 1986. Last previous edition approved in 20032011 as
C1068 – 03.C1068 – 03 (2011). DOI: 10.1520/C1068-03R11.10.1520/C1068-15.
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.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Available from American Society of Mechanical Engineers (ASME), ASME International Headquarters, Two Park Ave., New York, NY 10016-5990, http://
www.asme.org.
5
Available from Institute of Electrical and Electronics Engineers, Inc. (IEEE), 445 Hoes Ln., Piscataway, NJ 08854-4141, http://www.ieee.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
C1068 − 15
FIG. 1 Quality Assurance of Analytical Laboratory Data
JCGM-100 Evaluation of Measurement Data – Guide to the Expression of Uncertainty in Measurement (GUM)
JCGM-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
...