ASTM C1210-12

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

SIGNIFICANCE AND USE
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.
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 requir...
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 Considerations5 Quality Control Samples6 Analysis of Quality Control Samples7 Quality Control Data Analysis8 Analyst Qualification9 Measurement System Calibration10 Measurement Method Qualification11 Measurement System Maintenance12

General Information

• Status: Historical
• Publication Date: 31-May-2012
• 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

Relations

• Replaces: ASTM C1210-06 - Standard Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the Nuclear Industry
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1165-23 - Standard Test Method for Determining Plutonium by Controlled-Potential Coulometry in H<inf>2</inf>SO<inf>4</inf> at a Platinum Working Electrode
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1108-23 - Standard Test Method for Plutonium by Controlled-Potential Coulometry
• Effective Date: 01-Jun-2012
• Referred By: ASTM C759-18 - Standard Test Methods for Chemical, Mass Spectrometric, Spectrochemical, Nuclear, and Radiochemical Analysis of Nuclear-Grade Plutonium Nitrate Solutions
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1133/C1133M-10(2018) - Standard Test Method for Nondestructive Assay of Special Nuclear Material in Low-Density Scrap and Waste by Segmented Passive Gamma-Ray Scanning
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1068-21 - Standard Guide for Qualification of Measurement Methods by a Laboratory Within the Nuclear Industry
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1156-18 - Standard Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1009-21 - Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1128-23 - Standard Guide for Preparation of Working Reference Materials for Use in Analysis of Nuclear Fuel Cycle Materials
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1316-08(2017) - Standard Test Method for Nondestructive Assay of Nuclear Material in Scrap and Waste by Passive-Active Neutron Counting Using&#x2009;²⁵²Cf Shuffler
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1297-18 - Standard Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1207-10(2018) - Standard Test Method for Nondestructive Assay of Plutonium in Scrap and Waste by Passive Neutron Coincidence Counting
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1168-15 - Standard Practice for Preparation and Dissolution of Plutonium Materials for Analysis
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1909-21 - Standard Test Method for Moisture Analysis of Plutonium Dioxide (PuO<inf>2</inf>) by Thermogravimetric Mass Spectrometry (TGA-MS)
• Effective Date: 01-Jun-2012
• Referred By: ASTM C1592/C1592M-21 - Standard Guide for Making Quality Nondestructive Assay Measurements
• Effective Date: 01-Jun-2012

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 − 12
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 the Analysis of Nuclear Fuel Cycle Materials
3
2.2 ANSI Standards:
1.1 This standard provides guidance for establishing and
ANSI/ASQ B1 Guide for Quality Control Charts
maintaining a measurement system quality control program.
ANSI/ASQ B2 Control Chart Method of Analyzing Data
Guidance is provided for general program considerations,
ANSI/ASQB3 ControlChartMethodofControllingQuality
preparation of quality control samples, analysis of quality
During Production
control samples, quality control data analysis, analyst
qualification, measurement system calibration, measurement
3. Terminology
method qualification, and measurement system maintenance.
3.1 For definitions of terms used in this guide, see Termi-
1.2 This guidance is provided in the following sections:
nology C859.
Section
General Quality Control Program Considerations 5
4. Significance and Use
Quality Control Samples 6
Analysis of Quality Control Samples 7
4.1 A laboratory quality assurance program is an essential
Quality Control DataAnalysis 8
Analyst Qualification 9 program for laboratories within the nuclear industry. Guide
Measurement System Calibration 10
C1009 provides guidance for establishing a quality assurance
Measurement Method Qualification 11
program for an analytical laboratory within the nuclear indus-
Measurement System Maintenance 12
try. The basic elements of a laboratory quality assurance
2. Referenced Documents
program are organization, quality assurance program, training
2
and qualification, procedures, laboratory records, control of
2.1 ASTM Standards:
records, control of procurement, control of measuring equip-
C859 Terminology Relating to Nuclear Materials
ment and materials, control of measurements, and deficiencies
C1009 Guide for Establishing and Maintaining a Quality
and corrective actions. This guide deals with the control of
AssuranceProgramforAnalyticalLaboratoriesWithinthe
measurements aspect of the laboratory quality assurance pro-
Nuclear Industry
gram. Fig. 1 shows the relationship of measurement control
C1068 Guide for Qualification of Measurement Methods by
with other essential aspects of a laboratory quality assurance
a Laboratory Within the Nuclear Industry
program.
C1128 Guide for Preparation of Working Reference Materi-
als for Use in Analysis of Nuclear Fuel Cycle Materials
4.2 The fundamental purposes of a measurement control
C1156 Guide for Establishing Calibration for a Measure-
program are to provide the with use assurance (real-time
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
control)thatameasurementsystemisperformingsatisfactorily
rials
and to provide the data necessary to quantify measurement
C1297 Guide for Qualification of Laboratory Analysts for
system performance. The with use assurance is usually pro-
vided through the satisfactory analysis of quality control
samples (reference value either known or unknown to the
1
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
analyst). The data necessary to quantify measurement system
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality
performanceisusuallyprovidedthroughtheanalysisofquality
Assurance, Statistical Applications, and Reference Materials.
CurrenteditionapprovedJune1,2012.PublishedJuly2012.Originallyapproved
controlsamplesortheduplicateanalysisofprocesssamples,or
in 1991. Last previous edition approved in 2006 as C1210 – 06. DOI: 10.1520/
both. In addition to the analyses of quality control samples, the
C1210-12.
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 − 12
internal assessments. These assessments should involve labo-
ratory managers, the quality control manager, and laboratory
customers. The quality control program should be audited for
procedure compliance at periodic intervals by the quality
assurance organization.
5.2 The anal
...

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:C1210–06 Designation: C1210 – 12
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 4
General Quality Control Program Considerations 5
Quality Control Samples 5
Quality Control Samples 6
Analysis of Quality Control Samples 6
Analysis of Quality Control Samples 7
Quality Control DataAnalysis 7
Quality Control DataAnalysis 8
Analyst Qualification 8
Analyst Qualification 9
Measurement System Calibration 9
Measurement System Calibration 10
Measurement Method Qualification 10
Measurement Method Qualification 11
Measurement System Maintenance 11
Measurement System Maintenance 12
2. Referenced Documents
2
2.1 ASTM Standards:
C859 Terminology Relating to Nuclear Materials
C1009 Guide for Establishing a QualityAssurance Program forAnalytical Chemistry LaboratoriesWithin 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
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
Applications.
´1
Current edition approved Jan. 1, 2006. Published February 2006. Originally approved in 1991. Last previous edition approved in 1996 as C1210–96 . DOI:
10.1520/C1210-06.on Quality Assurance, Statistical Applications, and Reference Materials.
CurrenteditionapprovedJune1,2012.PublishedJuly2012.Originallyapprovedin1991.Lastpreviouseditionapprovedin2006asC1210 – 06.DOI:10.1520/C1210-12.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. ForAnnualBookofASTMStandards
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, PA19428-2959, United States.
1

---------------------- Page: 1 ----------------------
C1210 – 12
4. Significance and Use
3.1A4.1 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.
3.2The4.2 The fundamental purposes of a measurement control program are to provide the with use assurance (real-time
control) that a measurement system is performing s
...