ASTM C1068-03
(Guide)Standard Guide for Qualification of Measurement Methods by a Laboratory Within the Nuclear Industry
Standard Guide for Qualification of Measurement Methods by a Laboratory Within the Nuclear Industry
SIGNIFICANCE AND USE
Because of concerns for safety and the protection of nuclear materials from theft, stringent specifications are placed on chemical processes and the chemical and physical properties of nuclear materials. Strict requirements for the control and accountability of nuclear materials are imposed on the users of those materials. Therefore, when analyses are made by a laboratory to support a project such as the fabrication of nuclear fuel materials, various performance requirements may be imposed on the laboratory. One such requirement is often the use of qualified methods. Their use gives greater assurance that the data produced will be satisfactory for the intended use of those data. A qualified method will help assure that the data produced will be comparable to data produced by the same qualified method in other laboratories.
This guide provides guidance for qualifying measurement methods and for maintaining qualification. Even though all practices would be used for most qualification programs, there may be situations in which only a selected portion would be required. Care should be taken, however, that the effectiveness of qualification is not reduced when applying these practices selectively. The recommended practices in this guide are generic; based on these practices, specific actions should be developed to establish a qualification program.
SCOPE
1.1 This guide provides guidance for selecting, validating, and qualifying measurement methods when qualification is required for a specific program. The recommended practices presented in this guide provide a major part of a quality assurance program for the laboratory data (see ). Qualification helps to assure that the data produced will meet established requirements.
1.2 The activities intended to assure the quality of analytical laboratory measurement data are diagrammed in . Discussion and guidance related to some of these activities appear in the following sections:SectionSelection of Measurement Methods5Validation of Measurement Methods6Qualification of Measurement Methods7Control8Personnel Qualification9
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: C1068 – 03
Standard Guide for
Qualification of Measurement Methods by a Laboratory
1
Within the Nuclear Industry
This standard is issued under the fixed designation C1068; 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 provides guidance for selecting, validating,
and qualifying measurement methods when qualification is
required for a specific program. The recommended practices
presented in this guide provide a major part of a quality
assurance program for the laboratory data (see Fig. 1). Quali-
fication helps to assure that the data produced will meet
established requirements.
1.2 Theactivitiesintendedtoassurethequalityofanalytical
laboratory measurement data are diagrammed in Fig. 1. Dis-
cussion and guidance related to some of these activities appear
in the following sections:
Section
Selection of Measurement Methods 5
Validation of Measurement Methods 6
Qualification of Measurement Methods 7
Control 8
Personnel Qualification 9
1.3 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
FIG. 1 Quality Assurance of Analytical Laboratory Data
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
C1210 GuideforEstablishingaMeasurementSystemQual-
2. Referenced Documents
ity Control Program forAnalytical Chemistry Laboratories
2
2.1 ASTM Standards:
Within the Nuclear Industry
C1009 Guide for Establishing a QualityAssurance Program
C1297 Guide for Qualification of Laboratory Analysts for
for Analytical Chemistry Laboratories Within the Nuclear
the Analysis of Nuclear Fuel Cycle Materials
Industry
3. Terminology
C1128 Guide for Preparation of Working Reference Mate-
rials for Use in Analysis of Nuclear Fuel Cycle Materials
3.1 Definitions of Terms Specific to This Standard:
C1156 Guide for Establishing Calibration for a Measure-
3.1.1 qualification—a formal process to provide a desired
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
level of confidence that measurement methods used will
rials
produce data suitable for their intended use. The methods must
meet established criteria prior to use and must be used under
conditions established for qualifications.
1
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality Assur- 4. Significance and Use
ance, Statistical Applications, and Reference Materials.
4.1 Because of concerns for safety and the protection of
Current edition approved July 10, 2003. Published August 2003. Originally
e1
nuclear materials from theft, stringent specifications are placed
approved in 1986. Last previous edition approved in 1996 as C1068 – 96 . DOI:
10.1520/C1068-03.
on chemical processes and the chemical and physical proper-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
tiesofnuclearmaterials.Strictrequirementsforthecontroland
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
accountability of nuclear materials are imposed on the users of
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. those materials. Therefore, when analyses are made by a
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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C1068 – 03
laboratory to support a project such as the fabrication of impurities in materials since impurity concentrations may
nuclear fuel materials, various performance requirements may fluctuate to a greater extent than other constituents. It is
be imposed on the laboratory. One such requirement is often important that the measurement technique used discriminates
the use of qualified methods. Their use gives greater assurance adequately between concentration levels encountered. The
that the data produced will be satisfactory for the intended use lowestconcentrationlevelthatcanbemeasuredreliablyshould
of those data.Aqualified method will help assure that the data be clearly established (detection limit).
produced will be comparable to data produced by the same 5.2.4 Reliability of Method—The method must be capable
qualified method in other laboratories. of producing data that will meet the bias and precision
4.2 This guide provides guidance for qualifying measure- requirements established for the required analysis under the
ment methods and for maintaining qualification. Even tho
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