ASTM C1210-21

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

SIGNIFICANCE AND USE
4.1 A laboratory quality assurance program is an essential program for laboratories within the nuclear industry. Guide C1009 provides guidance for establishing a quality assurance program for an analytical laboratory within the nuclear industry. This guide deals with the control of measurements aspect of the laboratory quality assurance program. Fig. 1 shows the relationship of measurement control with other essential aspects of a laboratory quality assurance program.
FIG. 1 Quality Assurance of Analytical Laboratory Data  
4.2 The fundamental purposes of a measurement control program are to provide the with-use  assurance (real-time control) that a measurement system is performing satisfactorily and to provide the data necessary to quantify measurement system performance. The with-use  assurance is usually provided through the satisfactory analysis of quality control samples (reference value either known or unknown to the analyst). The data necessary to quantify measurement system performance is usually provided through the analysis of quality control samples or the duplicate analysis of process samples, or both. In addition to the analyses of quality control samples, the laboratory quality control program should address (1) the preparation and verification of standards and reagents, (2) data analysis procedures and documentation, (3) calibration and calibration procedures, (4) measurement method qualification, (5) analyst qualification, and (6) other general program considerations. Other elements of laboratory quality assurance also impact the laboratory quality control program. These elements or requirements include (1) chemical analysis procedures and procedure control, (2) records storage and retrieval requirements, (3) internal audit requirements, (4) organizational considerations, and (5) training/qualification requirements. To the extent possible, this standard will deal primarily with quality control requirements rather than overall quality assurance re...
SCOPE
1.1 This guide provides guidance for establishing and maintaining a measurement system quality control program. Guidance is provided for general program considerations, preparation of quality control samples, analysis of quality control samples, quality control data analysis, analyst qualification, measurement system calibration, measurement method qualification, and measurement system maintenance.  
1.2 This guidance is provided in the following sections:    
Section  
General Quality Control Program Considerations  
5  
Quality Control Samples  
6  
Analysis of Quality Control Samples  
7  
Quality Control Data Analysis  
8  
Analyst Qualification  
9  
Measurement System Calibration  
10  
Qualification of Measurement Methods and Systems  
11  
Measurement System Maintenance  
12  
1.3 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: 31-Jan-2021
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 27.120.01 - Nuclear energy in general
• 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: C1210 − 21
Standard Guide for
Establishing a Measurement System Quality Control
Program for Analytical Chemistry Laboratories Within
1
Nuclear Industry
This standard is issued under the fixed designation C1210; 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 C1108 Test Method for Plutonium by Controlled-Potential
Coulometry
1.1 This guide provides guidance for establishing and main-
C1128 Guide for Preparation of Working Reference Materi-
taining a measurement system quality control program. Guid-
als for Use in Analysis of Nuclear Fuel Cycle Materials
ance is provided for general program considerations, prepara-
C1156 Guide for Establishing Calibration for a Measure-
tion of quality control samples, analysis of quality control
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
samples, quality control data analysis, analyst qualification,
rials
measurement system calibration, measurement method
C1297 Guide for Qualification of Laboratory Analysts for
qualification, and measurement system maintenance.
the Analysis of Nuclear Fuel Cycle Materials
1.2 This guidance is provided in the following sections:
E2554 Practice for Estimating and Monitoring the Uncer-
Section
tainty of Test Results of a Test Method Using Control
General Quality Control Program Considerations 5
Chart Techniques
Quality Control Samples 6
3
Analysis of Quality Control Samples 7 2.2 ANSI Standards:
Quality Control DataAnalysis 8
ANSI/ASQ B1 Guide for Quality Control Charts
Analyst Qualification 9
ANSI/ASQ B2 Control Chart Method of Analyzing Data
Measurement System Calibration 10
Qualification of Measurement Methods and Systems 11 ANSI/ASQB3 ControlChartMethodofControllingQuality
Measurement System Maintenance 12
During Production
4
1.3 This international standard was developed in accor-
2.3 ISO Standard:
dance with internationally recognized principles on standard-
ISO/IEC 17025 General requirements for the competence of
ization established in the Decision on Principles for the
testing and calibration laboratories
Development of International Standards, Guides and Recom-
ISO/IEC 17043 Conformity assessment — General require-
mendations issued by the World Trade Organization Technical
ments for proficiency testing
Barriers to Trade (TBT) Committee.
ISO Guide 80 Guidance for the in-house preparation of
quality control materials (QCMs)
2. Referenced Documents
2
2.1 ASTM Standards: 3. Terminology
C859 Terminology Relating to Nuclear Materials
3.1 For definitions of terms used in this guide but not
C1009 Guide for Establishing and Maintaining a Quality
defined herein, see Terminology C859.
Assurance Program forAnalytical LaboratoriesWithin the
3.2 Definitions:
Nuclear Industry
3.2.1 calibration, n—the set of operations that establishes,
C1068 Guide for Qualification of Measurement Methods by
under specified conditions, a metrologically traceable relation-
a Laboratory Within the Nuclear Industry
shipbetweenavaluemeasuredorindicatedbyaninstrumentor
system to a corresponding known value, typically derived from
1
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
appropriate reference standards or established physical con-
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality
stants
Assurance, Statistical Applications, and Reference Materials.
Current edition approved Feb. 1, 2021. Published March 2021. Originally
approved in 1991. Last previous edition approved in 2018 as C1210 – 18. DOI:
3
10.1520/C1210-21. Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 4th Floor, New York, NY 10036, http://www.ansi.org.
4
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 Conshohocken, PA19428-2959. United States
1

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C1210 − 21
3.2.1.1 Discussion—The calibration relationship can be ex- try. This guide deals with the control of measurements aspect
pressed by a statement, function, diagram or table. of the laboratory qua
...

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: C1210 − 18 C1210 − 21
Standard Guide for
Establishing a Measurement System Quality Control
Program for Analytical Chemistry Laboratories Within the
1
Nuclear Industry
This standard is issued under the fixed designation C1210; 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 standardguide provides guidance for establishing and maintaining a measurement system quality control program.
Guidance is provided for general program considerations, preparation of quality control samples, analysis of quality control
samples, quality control data analysis, analyst qualification, measurement system calibration, measurement method qualification,
and measurement system maintenance.
1.2 This guidance is provided in the following sections:
Section
General Quality Control Program Considerations 5
Quality Control Samples 6
Analysis of Quality Control Samples 7
Quality Control Data Analysis 8
Analyst Qualification 9
Measurement System Calibration 10
Measurement Method Qualification 11
Qualification of Measurement Methods and Systems 11
Measurement System Maintenance 12
1.3 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
C1108 Test Method for Plutonium by Controlled-Potential Coulometry
C1128 Guide for Preparation of Working Reference Materials for Use in 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 Nov. 1, 2018Feb. 1, 2021. Published December 2018March 2021. Originally approved in 1991. Last previous edition approved in 20122018 as
C1210 – 12.C1210 – 18. DOI: 10.1520/C1210-18.10.1520/C1210-21.
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

---------------------- Page: 1 ----------------------
C1210 − 21
C1156 Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials
C1297 Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials
E2554 Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart Techniques
3
2.2 ANSI Standards:
ANSI/ASQ B1 Guide for Quality Control Charts
ANSI/ASQ B2 Control Chart Method of Analyzing Data
ANSI/ASQ B3 Control Chart Method of Controlling Quality During Production
4
2.3 ISO Standard:
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
ISO/IEC 17043 Conformity assessment — General requirements for proficiency testing
ISO Guide 80 Guidance for the in-house preparation of quality control materials (QCMs)
3. Terminology
3.1 For definitions of terms used in this guide but not defined herein, see Terminology C859.
3.2 Definitions:
3.2.1 calibration, n—the set of operations that establishes, under specified conditions, a metrologically traceable relationship
between a value measured or indicated by an instrument or system to a corresponding known value, typically derived from
appropriate reference standards or established physical constants
3.2.1.1 Discussion—
The calibration relationship can be expressed by a statement, function, diagram or table.
3.2.1.2 Discussion—
Test Method C1108 is an example of calibration using established physical constants.
3.2.1.3 Discussion—
Additional details on calibration require
...