ASTM C1297-95e1

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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.
e1
Designation: C 1297 – 95
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Guide for
Qualification of Laboratory Analysts for the Analysis of
1
Nuclear Fuel Cycle Materials
This standard is issued under the fixed designation C 1297; 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 (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—Fig. 1 was corrected editorially in February 1997.
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 appro-
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
2. Referenced Documents
2.1 ASTM Standards:
C 986 Guide for Developing Training Programs in the
2
Nuclear Fuel Cycle
C 1009 Guide for Establishing a Quality Assurance Pro-
gram for Analytical Chemistry Laboratories Within the
2
Nuclear Industry
C 1068 Guide for Qualification of Measurement Methods
2
by a Laboratory Within the Nuclear Industry
C 1128 Guide for Preparation of Working Reference Mate-
rials for Use in the Analysis of Nuclear Fuel Cycle
2
Materials
C 1156 Guide for Establishing Calibration for a Measure-
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
2
rials
C 1210 Guide for Establishing a Measurement System
FIG. 1 Quality Assurance of Analytical Laboratory Data
Quality Control Program for Analytical Chemistry Labo-
2
ratories Within the Nuclear Industry
1. Scope
C 1215 Guide for Preparing and Interpreting Precision and
1.1 This guide covers the qualification of analysts to per-
Bias Statements in Test Method Standards Used in the
form chemical analysis or physical measurements of nuclear
2
Nuclear Industry
fuel cycle materials. The guidance is general in that it is
applicable to all analytical methods, but must be applied
3. Significance and Use
method by method. Also, the guidance is general in that it may
3.1 This is one of a series of guides designed to provide
be applied to initial qualification or requalification.
guidance for implementing activities that meet the require-
1.2 The guidance is provided in the following sections:
ments of a sound laboratory quality assurance program. The
Section
first of these, Guide C 1009, is an umbrella guide that provides
Qualification Considerations 4
Demonstration Process 5 general criteria for ensuring the quality of analytical laboratory
Statistical Tests 6
data. Other guides provide expanded criteria in various areas
affecting quality, producing a comprehensive set of criteria for
1.3 This standard does not apply to maintaining qualifica-
controlling data quality. The approach to ensuring the quality
tion during routine use of a method. Maintaining qualification
of analytical measurements described in these guides is de-
is included in Guide C 1210.
picted in Fig. 1.
3.2 The training and qualification of analysts is one of the
1
This guide is under the jurisdiction of ASTM Committee C-26 on Nuclear Fuel
Cycleand is the direct responsibility of Subcommittee C26.08 on Quality Assurance
Applications.
2
Current edition approved April 15, 1995. Published June 1995. Annual Book of ASTM Standards, Vol 12.01.
1

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NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
Contact¬ASTM¬International¬(www.astm.org)¬for¬the¬latest¬information.¬
C 1297
determining the laboratory’s qualification methodology. A statistical
elements of laboratory quality assurance presented in Guide
approach includes choosing the significance level at which the determi-
C 1009, which provides some general criteria regarding quali-
nation of qualification will be made. This produces a quantitative value of
fication. This guide expands on those criteria to provide more
the two possible risks. This is described further in Appendix X1.
comprehensive guidance for qualifying analysts. As indicated
in Guide C 1009, the qualification process can vary in approach
5. Demonstration Process
and this guide provides one such approach.
5.1 The suggested approach to practical demonstration for
3.3 This guide describes an approach to analyst qualification
analyst qualification that is described in the remainder of this
that is designed to be used in conjunction with a rigorous
guide involves a comparison of the performance of the analyst
program for the qualification and control of the analytical
with the performance of all qualified analysts on a particular
measurement sys
...