ASTM C1297-03
(Guide)Standard Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials
Standard Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials
SIGNIFICANCE AND USE
This is one of a series of guides designed to provide guidance for implementing activities that meet the requirements of a sound laboratory quality assurance program. The first of these, Guide C 1009, is an umbrella guide that provides general criteria for ensuring the quality of analytical laboratory data. Other guides provide expanded criteria in various areas affecting quality, producing a comprehensive set of criteria for controlling data quality. The approach to ensuring the quality of analytical measurements described in these guides is depicted in Fig. 1.
The training and qualification of analysts is one of the elements of laboratory quality assurance presented in Guide C 1009, which provides some general criteria regarding qualification. This guide expands on those criteria to provide more comprehensive guidance for qualifying analysts. As indicated in Guide C 1009, the qualification process can vary in approach; this guide provides one such approach.
This guide describes an approach to analyst qualification that is designed to be used in conjunction with a rigorous program for the qualification and control of the analytical measurement system. This requires an existing data base which defines the characteristics (precision and bias) of the system in routine use. The initial development of this data base is described in Guide C 1068. The process described here is intended only to qualify analysts when such a data base exists and the method is in control.
The qualification activities described in this guide assume that the analyst is already proficient in general laboratory operations. The training or other activities that developed this proficiency are not covered in this guide.
This guide describes a basic approach and principles for the qualification of laboratory analysts. Users are cautioned to ensure that the qualification program implemented meets the needs and requirements of their laboratory.
FIG. 1 Quality Assurance of Analytical Labor...
SCOPE
1.1 This guide covers the qualification of analysts to perform chemical analysis or physical measurements of nuclear fuel cycle materials. The guidance is general in that it is applicable to all analytical methods, but must be applied method by method. Also, the guidance is general in that it may be applied to initial qualification or requalification.
1.2 The guidance is provided in the following sections:SectionQualification Considerations4Demonstration Process5Statistical Tests6
1.3 This standard does not apply to maintaining qualification during routine use of a method. Maintaining qualification is included in Guide C 1210.
1.4 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: C1297 – 03
Standard Guide for
Qualification of Laboratory Analysts for the Analysis of
1
Nuclear Fuel Cycle Materials
This standard is issued under the fixed designation C1297; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope ityControlProgramforAnalyticalChemistryLaboratories
Within the Nuclear Industry
1.1 This guide covers the qualification of analysts to per-
C1215 Guide for Preparing and Interpreting Precision and
form chemical analysis or physical measurements of nuclear
Bias Statements in Test Method Standards Used in the
fuel cycle materials. The guidance is general in that it is
Nuclear Industry
applicable to all analytical methods, but must be applied
2.2 ISO Standard:
methodbymethod.Also,theguidanceisgeneralinthatitmay
ISO Guide 30 Terms and Definitions Used in Connection
be applied to initial qualification or requalification.
3
with Reference Materials
1.2 The guidance is provided in the following sections:
Section
3. Significance and Use
Qualification Considerations 4
Demonstration Process 5
3.1 This is one of a series of guides designed to provide
Statistical Tests 6
guidance for implementing activities that meet the require-
1.3 This standard does not apply to maintaining qualifica- ments of a sound laboratory quality assurance program. The
tion during routine use of a method. Maintaining qualification first of these, Guide C1009, is an umbrella guide that provides
is included in Guide C1210. generalcriteriaforensuringthequalityofanalyticallaboratory
1.4 This standard does not purport to address all of the data. Other guides provide expanded criteria in various areas
safety concerns, if any, associated with its use. It is the affecting quality, producing a comprehensive set of criteria for
responsibility of the user of this standard to establish appro- controlling data quality. The approach to ensuring the quality
priate safety and health practices and determine the applica- of analytical measurements described in these guides is de-
bility of regulatory limitations prior to use. picted in Fig. 1.
3.2 The training and qualification of analysts is one of the
2. Referenced Documents
elements of laboratory quality assurance presented in Guide
2
2.1 ASTM Standards:
C1009, which provides some general criteria regarding quali-
C1009 GuideforEstablishingaQualityAssuranceProgram fication. This guide expands on those criteria to provide more
for Analytical Chemistry Laboratories Within the Nuclear
comprehensive guidance for qualifying analysts. As indicated
Industry in Guide C1009, the qualification process can vary in ap-
C1068 GuideforQualificationofMeasurementMethodsby
proach; this guide provides one such approach.
a Laboratory Within the Nuclear Industry 3.3 Thisguidedescribesanapproachtoanalystqualification
C1128 Guide for Preparation of Working Reference Mate-
that is designed to be used in conjunction with a rigorous
rials for Use in Analysis of Nuclear Fuel Cycle Materials program for the qualification and control of the analytical
C1156 Guide for Establishing Calibration for a Measure-
measurementsystem.Thisrequiresanexistingdatabasewhich
ment Method Used to Analyze Nuclear Fuel Cycle Mate- defines the characteristics (precision and bias) of the system in
rials
routine use. The initial development of this data base is
C1210 GuideforEstablishingaMeasurementSystemQual- described in Guide C1068. The process described here is
intended only to qualify analysts when such a data base exists
and the method is in control.
1
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
3.4 The qualification activities described in this guide as-
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality Assur-
sumethattheanalystisalreadyproficientingenerallaboratory
ance, Statistical Applications, and Reference Materials.
Current edition approved July 10, 2003. Published August 2003. Originally
operations. The training or other activities that developed this
´1
approved in 1995. Last previous edition approved in 1995 as C1297-95 . DOI:
proficiency are not covered in this guide.
10.1520/C1297-03.
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
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