Standard Guide for Establishing a Quality Assurance Program for Analytical Chemistry Laboratories Within the Nuclear Industry

SCOPE
1.1 This guide covers the establishment of a quality assurance (QA) program for analytical chemistry laboratories within the nuclear industry. Reference to key elements of ANSI/ISO/ASQC Q9001, Quality Systems, 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 Records10 Control of Procurement11 Control of Measuring Equipment and Materials12 Control of Measurements13 Deficiencies and Corrective Actions14

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31-Dec-2005
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ASTM C1009-06 - Standard Guide for Establishing a Quality Assurance Program for Analytical Chemistry Laboratories Within the Nuclear Industry
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: C1009 − 06
StandardGuide for
Establishing a Quality Assurance Program for Analytical
1
Chemistry 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 ries Within the Nuclear Industry
C1215 Guide for Preparing and Interpreting Precision and
1.1 This guide covers the establishment of a quality assur-
Bias Statements in Test Method Standards Used in the
ance(QA)programforanalyticalchemistrylaboratorieswithin
Nuclear Industry
the nuclear industry. Reference to key elements of ANSI/ISO/
C1297 Guide for Qualification of Laboratory Analysts for
ASQC Q9001, Quality Systems, provides guidance to the
the Analysis of Nuclear Fuel Cycle Materials
functional aspects of analytical laboratory operation. When
D1193 Specification for Reagent Water
implemented as recommended, the practices presented in this
E29 Practice for Using Significant Digits in Test Data to
guide will provide a comprehensive QA program for the
Determine Conformance with Specifications
laboratory. The practices are grouped by functions, which
E542 Practice for Calibration of Laboratory Volumetric
constitute the basic elements of a laboratory QA program.
Apparatus
1.2 The essential, basic elements of a laboratory QA pro-
E617 Specification for Laboratory Weights and Precision
gram appear in the following order:
Mass Standards
Section
E694 Specification for Laboratory Glass Volumetric Appa-
Organization 5
ratus
Quality Assurance Program 6
2.2 ANSI Standard:
Training and Qualification 7
Procedures 8
ANSI/ISO/ASQC Q9001 Quality Systems—Model for
Laboratory Records 9
Quality Assurance in Design, Development, Production,
Control of Records 10
3
Installation, and Servicing
Control of Procurement 11
Control of Measuring Equipment and Materials 12
2.3 NIST Standard:
Control of Measurements 13
NIST IR74-461 The Calibration of Small Volumetric Labo-
Deficiencies and Corrective Actions 14
4
ratory Glassware (1974)
2. Referenced Documents 2.4 ASME Standard:
2
ASME NQA-1 QualityAssurance Requirements for Nuclear
2.1 ASTM Standards:
5
Facility Applications
C1068 Guide for Qualification of Measurement Methods by
a Laboratory Within the Nuclear Industry
3. Terminology
C1128 Guide for Preparation of Working Reference Materi-
3.1 Definitions:
als for Use in Analysis of Nuclear Fuel Cycle Materials
3.1.1 laboratory quality assurance, n—all those planned
C1156 Guide for Establishing Calibration for a Measure-
and systematic actions necessary to provide adequate confi-
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
dence in each analytical result reported by a laboratory.
rials
C1210 Guide for Establishing a Measurement System Qual-
3.2 Definitions of Terms Specific to This Standard:
ity Control Program for Analytical Chemistry Laborato-
3.2.1 chain of custody, n—a procedure that documents
continuous sample control and security.
1 3.2.2 custody, n—physical possession of a sample by a
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality laboratory.
Assurance, Statistical Applications, and Reference Materials.
Current edition approved Jan. 1, 2006. Published February 2006. Originally
´1
3
approved in 1996. Last previous edition approved in 1996 as C1009 – 96 DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/C1009-06. 4th Floor, New York, NY 10036.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from National Institute of Standards and Technology (NIST), 100
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Bureau Dr., Stop 3460, Gaithersburg, MD 20899-3460.
5
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
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C1009 − 06
3.2.3 laboratory, n—an organization established to provide
analyses of materials.
3.2.4 out-of-control, adj—failingtomeetpreselectedperfor-
mance criteria.
3.2.5 requester, n—the person or organization requesting
analyses.
3.2.6 result, n—a qualitative or quantitative description of a
property obtained from an analysis and reported to a requester.
3.2.7 traveler, n—a laboratory record used to tran
...

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