ASTM C1297-18
(Guide)Standard Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials
Standard Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials
SIGNIFICANCE AND USE
4.1 This is one of a series of guides designed to provide guidance for implementing activities that meet the requirements of a sound laboratory quality assurance program. The first of these, Guide C1009, is an umbrella guide that provides general criteria for ensuring the quality of analytical laboratory data. Other guides provide expanded criteria in various areas affecting quality, producing a comprehensive set of criteria for controlling data quality. The approach to ensuring the quality of analytical measurements described in these guides is depicted in Fig. 1.
FIG. 1 Quality Assurance of Analytical Laboratory Data
4.2 The training and qualification of analysts is one of the elements of laboratory quality assurance presented in Guide C1009, which provides some general criteria regarding qualification. This guide expands on those criteria to provide more comprehensive guidance for qualifying analysts. As indicated in Guide C1009, the qualification process can vary in approach; this guide provides one such approach.
4.3 This guide describes an approach to analyst qualification that is designed to be used in conjunction with a rigorous program for the qualification and control of the analytical measurement system. This requires an existing data base which defines the characteristics (precision and bias) of the system in routine use. The initial development of this data base is described in Guide C1068. The process described here is intended only to qualify analysts when such a data base exists and the method is in control.
4.4 The qualification activities described in this guide assume that the analyst is already proficient in general laboratory operations. The training or other activities that developed this proficiency are not covered in this guide.
4.5 This guide describes a basic approach and principles for the qualification of laboratory analysts. Users are cautioned to ensure that the qualification program implemented meets the needs and requi...
SCOPE
1.1 This guide covers the qualification of analysts to perform chemical analysis or physical measurements of nuclear fuel cycle materials. The guidance is general in that it is applicable to all analytical methods, but must be applied method by method. Also, the guidance is general in that it may be applied to initial qualification or requalification.
1.2 The guidance is provided in the following sections:
Section
Qualification Considerations
5
Demonstration Process
6
Statistical Tests
7
1.3 This standard does not apply to maintaining qualification during routine use of a method. Maintaining qualification is included in Guide C1210.
1.4 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.
1.5 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
Relations
Buy Standard
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:C1297 −18
Standard Guide for
Qualification of Laboratory Analysts for the Analysis of
1
Nuclear Fuel Cycle Materials
This standard is issued under the fixed designation C1297; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope C1068Guide for Qualification of Measurement Methods by
a Laboratory Within the Nuclear Industry
1.1 This guide covers the qualification of analysts to per-
C1128Guide for Preparation of Working Reference Materi-
form chemical analysis or physical measurements of nuclear
als for Use in Analysis of Nuclear Fuel Cycle Materials
fuel cycle materials. The guidance is general in that it is
C1156Guide for Establishing Calibration for a Measure-
applicable to all analytical methods, but must be applied
ment Method Used toAnalyze Nuclear Fuel Cycle Mate-
method by method.Also, the guidance is general in that it may
rials
be applied to initial qualification or requalification.
C1210Guide for Establishing a Measurement System Qual-
1.2 The guidance is provided in the following sections:
ity Control Program for Analytical Chemistry Laborato-
Section
ries Within the Nuclear Industry
Qualification Considerations 5
C1215Guide for Preparing and Interpreting Precision and
Demonstration Process 6
Bias Statements in Test Method Standards Used in the
Statistical Tests 7
Nuclear Industry
1.3 This standard does not apply to maintaining qualifica-
3
2.2 ISO Standards:
tion during routine use of a method. Maintaining qualification
ISO Guide 30Reference materials – Selected terms and
is included in Guide C1210.
definitions
1.4 This standard does not purport to address all of the
ISO Guide 33Reference materials – Good practice in using
safety concerns, if any, associated with its use. It is the
reference materials
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
3. Terminology
mine the applicability of regulatory limitations prior to use.
3.1 For definitions of terms used in this test method but not
1.5 This international standard was developed in accor-
defined herein, refer to Terminology C859.
dance with internationally recognized principles on standard-
3.2 Definitions of Terms Specific to This Standard:
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom- 3.2.1 qualification, n—demonstration by a laboratory ana-
lyst of acceptable knowledge, skills and experience for a
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee. specific analytical method to generate data with the stated bias
and precision as determined using guidance in Guide C1068.
2. Referenced Documents
2 4. Significance and Use
2.1 ASTM Standards:
C859Terminology Relating to Nuclear Materials 4.1 This is one of a series of guides designed to provide
C1009Guide for Establishing and Maintaining a Quality guidance for implementing activities that meet the require-
AssuranceProgramforAnalyticalLaboratoriesWithinthe ments of a sound laboratory quality assurance program. The
Nuclear Industry first of these, Guide C1009, is an umbrella guide that provides
generalcriteriaforensuringthequalityofanalyticallaboratory
data. Other guides provide expanded criteria in various areas
1
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
CycleandisthedirectresponsibilityofSubcommitteeC26.08onQualityAssurance, affecting quality, producing a comprehensive set of criteria for
Statistical Applications, and Reference Materials.
controlling data quality. The approach to ensuring the quality
CurrenteditionapprovedJuly1,2018.PublishedJuly2018.Originallyapproved
of analytical measurements described in these guides is de-
in 1995. Last previous edition approved in 2011 as C1297–03 (2011). DOI:
picted in Fig. 1.
10.1520/C1297-18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright ©ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA19428-2959. United States
1
---------------------- Page: 1 ----------------------
C1297−18
5.1.1 Analyst selection should
...
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: C1297 − 03 (Reapproved 2011) C1297 − 18
Standard Guide for
Qualification of Laboratory Analysts for the Analysis of
1
Nuclear Fuel Cycle Materials
This standard is issued under the fixed designation C1297; 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 covers the qualification of analysts to perform chemical analysis or physical measurements of nuclear fuel cycle
materials. The guidance is general in that it is applicable to all analytical methods, but must be applied method by method. Also,
the guidance is general in that it may be applied to initial qualification or requalification.
1.2 The guidance is provided in the following sections:
Section
Qualification Considerations 4
Qualification Considerations 5
Demonstration Process 5
Demonstration Process 6
Statistical Tests 6
Statistical Tests 7
1.3 This standard does not apply to maintaining qualification during routine use of a method. Maintaining qualification is
included in Guide C1210.
1.4 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.
1.5 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
C1068 Guide for Qualification of Measurement Methods by a Laboratory 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
C1215 Guide for Preparing and Interpreting Precision and Bias Statements in Test Method Standards Used in the Nuclear
Industry
3
2.2 ISO Standard:Standards:
ISO Guide 30 Terms and Definitions Used in Connection with Reference MaterialsReference materials – Selected terms and
definitions
ISO Guide 33 Reference materials – Good practice in using reference materials
1
This guide is under the jurisdiction of ASTM Committee C26 on Nuclear Fuel Cycleand is the direct responsibility of Subcommittee C26.08 on Quality Assurance,
Statistical Applications, and Reference Materials.
Current edition approved June 1, 2011July 1, 2018. Published June 2011July 2018. Originally approved in 1995. Last previous edition approved in 20032011 as
C1297 - 03.C1297 – 03 (2011). DOI: 10.1520/C1297-03R11.10.1520/C1297-18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. 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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
C1297 − 18
3. Terminology
3.1 For definitions of terms used in this test method but not defined herein, refer to Terminology C859.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 qualification, n—demonstration by a laboratory analyst of acceptable knowledge, skills and experience for a specific
analytical method to generate data with the stated bias and precision as determined using guidance in Guide C1068.
4. Significance and Use
4.1 This is one of a series of guides designed to provide guidance for implementing activities that meet the requirements of a
sound laboratory quality assurance program. The first of these, Guide C1009, is a
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.