ASTM C1156-03(2011)
(Guide)Standard Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials
Standard Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials
SIGNIFICANCE AND USE
Calibration is a fundamental part of making measurements and its effect on the quality of measurement data is significant. Thus, sufficient attention must be given to calibration when it is established for a measurement method so that the data produced will be acceptable. The use of an inappropriate calibration standard, inadequate instructions for calibration, and poor documentation of the calibration process are examples of circumstances that can adversely affect the validity of a calibration. Thus, the calibration process must conform to criteria established to ensure the validity of calibration results. Such criteria are given in Guide C1009, in which calibration is identified as a component of laboratory quality assurance (see Fig. 1). This guide expands upon those criteria to provide more comprehensive guidance for establishing calibration.
The manner of calibration and other technical requirements for calibrating a measurement method are usually established when a method is first introduced into a laboratory, which may be through validation and qualification as defined by Guide C1068 (see Fig. 1). However, calibration involves more than the technical aspects of the calibration process. The other dimension of the process is the operational requirements that are necessary to ensure that calibration results are valid and that they are documented and verifiable should their integrity be questioned. The provisions of this guide provide those operational requirements and should be considered whenever calibration is planned and established.
SCOPE
1.1 This guide provides the basis for establishing calibration for a measurement method typically used in an analytical chemistry laboratory analyzing nuclear materials. Guidance is included for such activities as preparing a calibration procedure, selecting a calibration standard, controlling calibrated equipment, and documenting calibration. The guide is generic and any required technical information specific for a given method must be obtained from other sources.
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Standards Content (Sample)
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Designation: C1156 − 03 (Reapproved 2011)
Standard Guide for
Establishing Calibration for a Measurement Method Used to
Analyze Nuclear Fuel Cycle Materials
This standard is issued under the fixed designation C1156; 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 C1210 Guide for Establishing a Measurement System Qual-
ity Control Program for Analytical Chemistry Laborato-
1.1 Thisguideprovidesthebasisforestablishingcalibration
ries Within the Nuclear Industry
for a measurement method typically used in an analytical
C1215 Guide for Preparing and Interpreting Precision and
chemistry laboratory analyzing nuclear materials. Guidance is
Bias Statements in Test Method Standards Used in the
included for such activities as preparing a calibration
Nuclear Industry
procedure, selecting a calibration standard, controlling cali-
C1297 Guide for Qualification of Laboratory Analysts for
brated equipment, and documenting calibration. The guide is
the Analysis of Nuclear Fuel Cycle Materials
generic and any required technical information specific for a
2.2 ISO Standard:
given method must be obtained from other sources.
ISO 17025 General Requirements for the Competence of
1.2 The guidance information is provided in the following
Calibration and Testing Laboratories
sections:
Section
3. Significance and Use
General Considerations 4
Calibration Procedure 5
3.1 Calibration is a fundamental part of making measure-
Calibration Standard 6
ments and its effect on the quality of measurement data is
Control of Calibrated Equipment 7
Documentation 8 significant. Thus, sufficient attention must be given to calibra-
Keywords 9
tion when it is established for a measurement method so that
1.3 This standard does not purport to address all of the
the data produced will be acceptable. The use of an inappro-
safety concerns, if any, associated with its use. It is the
priate calibration standard, inadequate instructions for
responsibility of the user of this standard to establish appro-
calibration, and poor documentation of the calibration process
priate safety and health practices and determine the applica-
are examples of circumstances that can adversely affect the
bility of regulatory limitations prior to use.
validity of a calibration. Thus, the calibration process must
conform to criteria established to ensure the validity of
2. Referenced Documents
calibration results. Such criteria are given in Guide C1009,in
which calibration is identified as a component of laboratory
2.1 ASTM Standards:
quality assurance (see Fig. 1). This guide expands upon those
C1009 Guide for Establishing and Maintaining a Quality
criteria to provide more comprehensive guidance for establish-
Assurance Program forAnalytical LaboratoriesWithin the
ing calibration.
Nuclear Industry
C1068 Guide for Qualification of Measurement Methods by
3.2 The manner of calibration and other technical require-
a Laboratory Within the Nuclear Industry
ments for calibrating a measurement method are usually
C1128 Guide for Preparation of Working Reference Materi-
established when a method is first introduced into a laboratory,
als for Use in Analysis of Nuclear Fuel Cycle Materials
which may be through validation and qualification as defined
by Guide C1068 (see Fig. 1). However, calibration involves
more than the technical aspects of the calibration process. The
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
other dimension of the process is the operational requirements
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality
that are necessary to ensure that calibration results are valid
Assurance, Statistical Applications, and Reference Materials
and that they are documented and verifiable should their
Current edition approved June 1, 2011. Published June 2011. Originally
integrity be questioned. The provisions of this guide provide
approved in 1990. Last previous edition approved in 2003 as C1156 – 03. DOI:
10.1520/C1156-03R11.
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 from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
C1156 − 03 (2011)
calibration checks, and the criteria that determine when cali-
bration has been achieved (see Guide C1215 Guide).
4.5 The organizational responsibility and authority for cali-
bration should be defined and documented. Normally, respon-
sibility for calibrating an individual method rests with the
analystusingthemethod.Iftheresponsibilityforcalibratingan
instrument or class of instruments is contracted to another
organization,thelaboratoryisstillresponsibleforensuringthat
calibration requirements are being met by the organization
doing the calibration.
5. Calibration Procedure
5.1 Calibrationshouldbeestablishedasawrittenprocedure.
The procedure should provide instructions for those doing the
calibration, and it should document the basis for calibration,
which can be used to substantiate the validity of the calibration
process, should that be required.
5.2 Preparation—Thecalibrationprocedurecanbeprepared
as a separate procedure from the one written for the measure-
ment method or it can be a section of the method’s procedure
as long as the provisions given in 5.3 are addressed. If the
FIG. 1 Quality Assurance of Analytical Laboratory Data
former approach is used, the applicable measurement method
should be clearly identified in the calibration procedure. The
those operational requirements and should be considered
calibration procedure should be reviewed for technical ad-
whenever calibration is planned and established.
equacy and approved by management. The provisions con-
tained in the Procedure section of Guide C1009 regarding the
4. General Considerations
preparation, review, and approval of procedures should be
4.1 The degree of attention and effort given to calibration
considered. Also, calibration procedures should be revised,
should depend on how the measurement data are to be used. In
distributed, and controlled according to the provisions in the
the analysis of nuclear materials, for example, measurement
Procedure section of Guide C1009.
data produced for the control and accountability of nuclear
5.3 Content—The following subjects should be addressed in
material would normally require more attention than data
the procedure:
produced for process control during the processing of that
5.3.1 Identification of the equipment or portion of the
material. The areas in which the level of attention and effort
measurement apparatus that requires calibration,
could vary are: the calibration standard, number of calibration
5.3.2 Identification of the calibration standard or standards
points, frequency of calibration, and frequency of calibration
t
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