ASTM C1009-13
(Guide)Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
SIGNIFICANCE AND USE
4.1 The mission of an analytical laboratory is to provide quality analyses on nuclear fuel cycle materials. An analytical laboratory QA program is comprised of planned and systematic actions needed to provide confidence that this mission is conducted in an acceptable and consistent manner.
4.2 The analytical laboratories involved in the analysis of nuclear fuel cycle materials are required to implement a documented QA program. Regulatory agencies may mandate some form of control requirements for all or a part of a laboratory's operation. A documented QA program is also necessary for those laboratory operations required to comply with ASME NQA-1 or ISO/IEC 17025, or the requirements of many accreditation bodies. Even when not mandated, laboratory QA programs should be established as a sound and scientific technical practice. This guide provides guidance for establishing and maintaining a QA program to control those analytical operations vital to ensuring the quality of chemical analyses.
4.3 Quality assurance programs are designed and implemented by organizations to assure that the quality requirements for a product or service will be fulfilled. The quality system is complementary to specific technical requirements. Each laboratory should identify applicable program requirements and use standards to implement a quality program that meets the appropriate requirement. This guide may be used to develop and implement an analytical laboratory QA program. Other useful implementation standards and documents are listed in Section 2 and Appendix X1.
4.4 The guides for QA in the analytical laboratory within the nuclear fuel cycle have been written to provide guidance for each of the major activities in the laboratory and are displayed in Fig. 1. The applicable standard for each subject is noted in the following sections.
FIG. 1 Quality Assurance of Analytical Laboratory Data
4.5 Although the Standard Guide describes “Recommended Practices” and “Recommendations”...
SCOPE
1.1 This guide covers the establishment and maintenance of a quality assurance (QA) program for analytical laboratories within the nuclear industry. Reference to key elements of ASME NQA-1 provides guidance to the functional aspects of analytical laboratory operation. When implemented as recommended, the practices presented in this guide will provide a comprehensive QA program for the laboratory. The practices are grouped by functions, which constitute the basic elements of a laboratory QA program.
1.2 The essential, basic elements of a laboratory QA program appear in the following order:
Section
Organization
5
Quality Assurance Program
6
Training and Qualification
7
Procedures
8
Laboratory Records
9
Control of Records
10
Control of Procurement
11
Control of Measuring Equipment and Materials
12
Control of Measurements
13
Deficiencies and Corrective Actions
14
General Information
Relations
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
Designation: C1009 − 13
Standard Guide for
Establishing and Maintaining a Quality Assurance Program
1
for Analytical Laboratories Within the Nuclear Industry
This standard is issued under the fixed designation C1009; 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 C1210 Guide for Establishing a Measurement System Qual-
ity Control Program for Analytical Chemistry Laborato-
1.1 This guide covers the establishment and maintenance of
ries Within the Nuclear Industry
a quality assurance (QA) program for analytical laboratories
C1215 Guide for Preparing and Interpreting Precision and
within the nuclear industry. Reference to key elements of
Bias Statements in Test Method Standards Used in the
ASME NQA-1 provides guidance to the functional aspects of
Nuclear Industry
analytical laboratory operation. When implemented as
C1297 Guide for Qualification of Laboratory Analysts for
recommended, the practices presented in this guide will pro-
the Analysis of Nuclear Fuel Cycle Materials
vide a comprehensive QA program for the laboratory. The
D1193 Specification for Reagent Water
practices are grouped by functions, which constitute the basic
D4840 Guide for Sample Chain-of-Custody Procedures
elements of a laboratory QA program.
E29 Practice for Using Significant Digits in Test Data to
1.2 The essential, basic elements of a laboratory QA pro-
Determine Conformance with Specifications
gram appear in the following order:
E178 Practice for Dealing With Outlying Observations
Section
E542 Practice for Calibration of Laboratory Volumetric
Organization 5
Apparatus
Quality Assurance Program 6
E617 Specification for Laboratory Weights and Precision
Training and Qualification 7
Procedures 8
Mass Standards
Laboratory Records 9
E694 Specification for Laboratory Glass Volumetric Appa-
Control of Records 10
ratus
Control of Procurement 11
Control of Measuring Equipment and Materials 12
E1578 Guide for Laboratory Information Management Sys-
Control of Measurements 13
tems (LIMS)
Deficiencies and Corrective Actions 14
2.2 Other Standards:
ISO 1042 Laboratory Glassware—One-Mark Volumetric
2. Referenced Documents
Flasks
2
2.1 ASTM Standards:
ISO/IEC 17020 General Criteria for the Operation of Vari-
C859 Terminology Relating to Nuclear Materials
ous Types of Bodies Performing Inspection
C1068 Guide for Qualification of Measurement Methods by
ISO/IEC 17025 General Requirements for the Competence
a Laboratory Within the Nuclear Industry
of Testing and Calibration Laboratories
C1128 Guide for Preparation of Working Reference Materi-
ANSI N15.41 Derivation of Measurement Control
als for Use in Analysis of Nuclear Fuel Cycle Materials
Programs—General Principles
C1156 Guide for Establishing Calibration for a Measure-
ANSIN15.51 MeasurementControlProgram—NuclearMa-
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
terials Analytical Chemistry Laboratory
rials
JCGM 20:2008 International Vocabulary of Metrology—
Basic and General Concepts andAssociated Terms (VIM)
ASME NQA-1 QualityAssurance Requirements for Nuclear
3
1
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
Facility Applications
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality
Assurance, Statistical Applications, and Reference Materials.
3. Terminology
Current edition approved Jan. 1, 2013. Published February 2013. Originally
approved in 1996. Last previous edition approved in 2006 as C1009 – 06. DOI: 3.1 For definitions of pertinent terms not listed here, see
10.1520/C1009-13.
Terminology C859.
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 from American Society of Mechanical Engineers (ASME), ASME
the ASTM website. International Headquarters, Three Park Ave., New York, NY 10016-5990.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
C1009 − 13
3.2 Definitions of Terms Specific to This Standard: establishing and maintaining a QA program to control those
analytical operations vital to ensuring the quality of chemical
3.2.1 condition adverse to quality, n—an all-inclusive term
analyses.
used in reference to any of the following: failures,
malfun
...
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: C1009 − 13 C1009 − 13
Standard Guide for
Establishing and Maintaining a Quality Assurance Program
1
for Analytical Laboratories Within the Nuclear Industry
This standard is issued under the fixed designation C1009; 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 establishment and maintenance of a quality assurance (QA) program for analytical laboratories within
the nuclear industry. Reference to key elements of ASME NQA-1 provides guidance to the functional aspects of analytical
laboratory operation. When implemented as recommended, the practices presented in this guide will provide a comprehensive QA
program for the laboratory. The practices are grouped by functions, which constitute the basic elements of a laboratory QA
program.
1.2 The essential, basic elements of a laboratory QA program appear in the following order:
Section
Organization 5
Quality Assurance Program 6
Training and Qualification 7
Procedures 8
Laboratory Records 9
Control of Records 10
Control of Procurement 11
Control of Measuring Equipment and Materials 12
Control of Measurements 13
Deficiencies and Corrective Actions 14
2. Referenced Documents
2
2.1 ASTM Standards:
C859 Terminology Relating to Nuclear Materials
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
C1297 Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials
D1193 Specification for Reagent Water
D4840 Guide for Sample Chain-of-Custody Procedures
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E178 Practice for Dealing With Outlying Observations
E542 Practice for Calibration of Laboratory Volumetric Apparatus
E617 Specification for Laboratory Weights and Precision Mass Standards
E694 Specification for Laboratory Glass Volumetric Apparatus
E1578 Guide for Laboratory Information Management Systems (LIMS)
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 Jan. 1, 2013. Published February 2013. Originally approved in 1996. Last previous edition approved in 2006 as C1009 – 06. DOI:
10.1520/C1009-13.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
C1009 − 13
2.2 Other Standards:
ISO 1042 Laboratory Glassware—One-Mark Volumetric Flasks
ISO/IEC 17020 General Criteria for the Operation of Various Types of Bodies Performing Inspection
ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
ANSI N15.41 Derivation of Measurement Control Programs—General Principles
ANSI N15.51 Measurement Control Program—Nuclear Materials Analytical Chemistry Laboratory
JCGM 20:2008 International Vocabulary of Metrology—Basic and General Concepts and Associated Terms (VIM)
3
ASME NQA-1 Quality Assurance Requirements for Nuclear Facility Applications
3. Terminology
3.1 For definitions of pertinent terms not listed here, see Terminology C859.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 condition adverse to quality, n—an all-inclusive term used in reference to any of the following: failures, malfunctions,
deficiencies, defective items, and non-conformances. ASME NQA-1
3.2.2 custody, n—physical possession or control. A sample is under custody if it is in possession or under
...
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