ASTM C1297-03(2011)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:C1297 −03 (Reapproved 2011)
Standard Guide for
Qualification of Laboratory Analysts for the Analysis of
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 C1210Guide for Establishing a Measurement System Qual-
ity Control Program for Analytical Chemistry Laborato-
1.1 This guide covers the qualification of analysts to per-
ries Within the Nuclear Industry
form chemical analysis or physical measurements of nuclear
C1215Guide for Preparing and Interpreting Precision and
fuel cycle materials. The guidance is general in that it is
Bias Statements in Test Method Standards Used in the
applicable to all analytical methods, but must be applied
Nuclear Industry
method by method.Also, the guidance is general in that it may
2.2 ISO Standard:
be applied to initial qualification or requalification.
ISO Guide 30Terms and Definitions Used in Connection
1.2 The guidance is provided in the following sections: 3
with Reference Materials
Section
Qualification Considerations 4 3. Significance and Use
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.
2. Referenced Documents 3.2 The training and qualification of analysts is one of the
elements of laboratory quality assurance presented in Guide
2.1 ASTM Standards:
C1009, which provides some general criteria regarding quali-
C1009Guide for Establishing and Maintaining a Quality
fication. This guide expands on those criteria to provide more
AssuranceProgramforAnalyticalLaboratoriesWithinthe
comprehensive guidance for qualifying analysts. As indicated
Nuclear Industry
in Guide C1009, the qualification process can vary in ap-
C1068Guide for Qualification of Measurement Methods by
proach; this guide provides one such approach.
a Laboratory Within the Nuclear Industry
C1128Guide for Preparation of Working Reference Materi-
3.3 Thisguidedescribesanapproachtoanalystqualification
als for Use in Analysis of Nuclear Fuel Cycle Materials that is designed to be used in conjunction with a rigorous
C1156Guide for Establishing Calibration for a Measure-
program for the qualification and control of the analytical
ment Method Used toAnalyze Nuclear Fuel Cycle Mate- measurementsystem.Thisrequiresanexistingdatabasewhich
rials
defines the characteristics (precision and bias) of the system in
routine use. The initial development of this data base is
1 described in Guide C1068. The process described here is
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
CycleandisthedirectresponsibilityofSubcommitteeC26.08onQualityAssurance, intended only to qualify analysts when such a data base exists
Statistical Applications, and Reference Materials.
and the method is in control.
Current edition approved June 1, 2011. Published June 2011. Originally
approved in 1995. Last previous edition approved in 2003 as C1297-03. DOI: 3.4 The qualification activities described in this guide as-
10.1520/C1297-03R11.
sumethattheanalystisalreadyproficientingenerallaboratory
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 Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
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C1297−03 (2011)
processes, has the potential for undetected errors. There are two types of
errors that occur. One is to fail an individual who should have been
determined to be qualified. The other error is to pass an individual who
should not have been determined to be qualified. The potential for these
errors to occur and the potential consequences to the laboratory should be
carefully considered when determining the laboratory’s qualification
methodology. A statistical approach includes choosing the significance
level at which the determination of qualification will be made. This
produces a quantitative value of the two possible risks. This is described
further in Appendix X1.
5. Demonstration Process
5.1 The suggested approach to practical demonstration for
analyst qualification that is described in the remainder of this
guide involves a comparison of the performance of the analyst
with the performance of all qualified analysts on a particular
analytical method. The performance is measured by the analy-
sis of reference materials (see ISO Guide 30) and comparison
of the results to the data base for the analytical method. This
approach requires a data base that describes method perfor-
mance. The comparison described in this guide is statistical in
natureandthereforestatisticiansshouldbeinvolvedearlyonin
the process of defining qualification. Other types of compari-
sons may serve to qualify equally well; however, such com-
FIG. 1 Quality Assurance of Analytical Laboratory Data
parisonsarenotaddressedinthisguide.Ifused,theyshouldbe
defined and documented.
operations. The training or other activities that developed this
5.2 Thedatabaseforagivenanalyticalmethodisgenerated
proficiency are not covered in this guide.
byallqualifiedanalystswhorunreferencematerialsampleson
3.5 Thisguidedescribesabasicapproachandprinciplesfor
an established schedule or frequency. The data base is used to
the qualification of laboratory analysts. Users are cautioned to
establishthebiasandprecisionofthemethodasroutinelyused
ensure that the qualification program implemented meets the
in the laboratory. The data base is established through a
needs and requirements of their laboratory.
measurement control program as presented in Guide C1210.
Foranewmethod,adatabaseshouldbeestablishedaccording
4. Qualification Considerations
toGuideC1068andtheanalystshouldbequalifiedagainstthat
4.1 When a qualification program is being established,
data base.
consideration should be given to analyst selection criteria, the
5.3 Ifchangesinamethodoccurorchangesintheexecution
trainingprogram,andpracticaldemonstration.Thecriteriathat
of a method occur that render the existing data base represen-
govern when qualification is achieved should be documented
tation of the method questionable, the qualification of analysts
alongwithmethodsfordeterminingtheknowledgeandskillof
should be suspended until the data base is verified or a new
the analyst.
data base is generated.When a new data base is generated, the
4.1.1 Analyst selection should be based on established
olddatabaseshouldbearchived(retainedforfuturereference)
criteria that are related to the complexity of the method that
as a part of the documentation of the laboratory quality
analysts are expected to perform. Criteria should include the
assurance program.
minimumeducationrequired,anyprerequisitetraining,andthe
5.4 A predetermined number of reference material samples
overall experience required. The selection criteria should be
should be selected for the analyst after training has been
defined and documented.
completed. The analyst should analyze the samples over
4.1.2 The method-specific analyst training program should
several days, and not in a single session, to simulate more
be an established program with a prescribed training proce-
realistically the conditions under which the data base was
dure.Somemechanismsuchasanoralorwrittentestshouldbe
established.
used to allow an analyst to demonstrate knowledge and
understanding of the chemical, physical, instrumental, and
5.5 Since the samples may be at different concentration
mathematical concepts used to execute the method. It is
levels,theanalyst’sdemonstrationresultsarenormalizedusing
advisabletomonitorprogressduringtrainingtoensurethatthe
established parameters from the existing data base for each
analyst has a reasonable chance of passing the qualification
control stand
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