ASTM C1210-18

Standard Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the 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. The basic elements of a laboratory quality assurance program are organization, quality assurance program, training and qualification, procedures, laboratory records, control of records, control of procurement, control of measuring equipment and materials, control of measurements, and deficiencies and corrective actions. 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 procedu...
SCOPE
1.1 This standard 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  
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: Historical
• Publication Date: 31-Oct-2018
• 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)

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: C1210 − 18
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 C1128 Guide for Preparation of Working Reference Materi-
als for Use in Analysis of Nuclear Fuel Cycle Materials
1.1 This standard provides guidance for establishing and
C1156 Guide for Establishing Calibration for a Measure-
maintaining a measurement system quality control program.
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
Guidance is provided for general program considerations,
rials
preparation of quality control samples, analysis of quality
C1297 Guide for Qualification of Laboratory Analysts for
control samples, quality control data analysis, analyst
the Analysis of Nuclear Fuel Cycle Materials
qualification, measurement system calibration, measurement
E2554 Practice for Estimating and Monitoring the Uncer-
method qualification, and measurement system maintenance.
tainty of Test Results of a Test Method Using Control
1.2 This guidance is provided in the following sections:
Chart Techniques
Section
3
2.2 ANSI Standards:
General Quality Control Program Considerations 5
Quality Control Samples 6 ANSI/ASQ B1 Guide for Quality Control Charts
Analysis of Quality Control Samples 7
ANSI/ASQ B2 Control Chart Method of Analyzing Data
Quality Control DataAnalysis 8
ANSI/ASQB3 ControlChartMethodofControllingQuality
Analyst Qualification 9
During Production
Measurement System Calibration 10
Measurement Method Qualification 11
Measurement System Maintenance 12
3. Terminology
1.3 This international standard was developed in accor-
3.1 For definitions of terms used in this guide but not
dance with internationally recognized principles on standard-
defined herein, see Terminology C859.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom- 3.2 Definitions:
mendations issued by the World Trade Organization Technical
3.2.1 measurement system, n—set of all components used to
Barriers to Trade (TBT) Committee. produce an analytical result.
3.2.1.1 Discussion—Components may include, for example,
2. Referenced Documents
equipmentorinstrumentationusedtopreparesamples,perform
2
2.1 ASTM Standards: the analytical measurement, perform any needed data
manipulations, and record results in printed or electronic form,
C859 Terminology Relating to Nuclear Materials
C1009 Guide for Establishing and Maintaining a Quality or both.
AssuranceProgramforAnalyticalLaboratoriesWithinthe
3.2.2 quality control program, n—documented system of
Nuclear Industry
activities utilizing quality control samples and appropriate
C1068 Guide for Qualification of Measurement Methods by
acceptance criteria to ensure that measurement systems are
a Laboratory Within the Nuclear Industry
producing results that are suitable for their intended purpose.
3.2.3 quality control sample, n—a sample used to verify and
1
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel monitor measurement system performance and reliability.
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality
3.2.3.1 Discussion—Quality control samples may include
Assurance, Statistical Applications, and Reference Materials.
knowns, unknowns, blinds, blanks, duplicates, matrix spikes,
Current edition approved Nov. 1, 2018. Published December 2018. Originally
and so forth.
approved in 1991. Last previous edition approved in 2012 as C1210 – 12. DOI:
10.1520/C1210-18.
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
3
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036.
Copyright ©ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA19428-2959. United States
1

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C1210 − 18
3.2.3.2 Discussion—Qualitycontrolsamplesmaybeusedto siderations.Otherelementsoflaboratoryqualityassurancealso
estimate bias in the measurement system or analytical method. impact the laboratory quality control program. These elements
or requirements include (1) chemical analysis procedures and
4. Significance and Use
procedure control, (2) records storage and retrieval
requirements, (3) internal audit requirements, (4) o
...

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 − 12 C1210 − 18
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 standard 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
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
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
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
3. Terminology
3.1 For definitions of terms used in this guide, see Terminology C859.
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, 2012Nov. 1, 2018. Published July 2012December 2018. Originally approved in 1991. Last previous edition approved in 20062012 as
C1210 – 06.C1210 – 12. DOI: 10.1520/C1210-12.10.1520/C1210-18.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
C1210 − 18
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 measurement system, n—set of all components used to produce an analytical result.
3.2.1.1 Discussion—
Components may include, for example, equipment or instrumentation used to prepare samples, perform the analytical
measurement, perform any needed data manipulations, and record results in printed or electronic form, or both.
3.2.2 quality control program, n—documented system of activities utilizing quality control samples and appropriate acceptance
criteria to ensure that measurement systems are producing results that are suitable for their intended purpose.
3.2.3 quality control sample, n—a sample used to verify and monitor measurement system performance and reliability.
3.2.3.1 Discussion—
Quality control samples may include knowns, unknowns, blinds, blanks, duplicates, matrix spikes
...