ASTM C1068-03(2011)
(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 Fig. 1). 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 Fig. 1. Discussion and guidance related to some of these activities appear in the following sections:
Section Selection of Measurement Methods5 Validation of Measurement Methods6 Qualification of Measurement Methods7 Control8 Personnel 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.
FIG. 1 Quality Assurance of Analytical Laboratory Data
General Information
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Standards Content (Sample)
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
Designation:C1068 −03(Reapproved 2011)
Standard Guide for
Qualification of Measurement Methods by a Laboratory
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 C1210 Guide for Establishing a Measurement System Qual-
ity Control Program for Analytical Chemistry Laborato-
1.1 This guide provides guidance for selecting, validating,
ries Within the Nuclear Industry
and qualifying measurement methods when qualification is
C1297 Guide for Qualification of Laboratory Analysts for
required for a specific program. The recommended practices
the Analysis of Nuclear Fuel Cycle Materials
presented in this guide provide a major part of a quality
assurance program for the laboratory data (see Fig. 1). Quali-
3. Terminology
fication helps to assure that the data produced will meet
established requirements.
3.1 Definitions of Terms Specific to This Standard:
3.1.1 qualification—a formal process to provide a desired
1.2 The activities intended to assure the quality of analytical
level of confidence that measurement methods used will
laboratory measurement data are diagrammed in Fig. 1. Dis-
produce data suitable for their intended use. The methods must
cussion and guidance related to some of these activities appear
meet established criteria prior to use and must be used under
in the following sections:
conditions established for qualifications.
Section
Selection of Measurement Methods 5
Validation of Measurement Methods 6
4. Significance and Use
Qualification of Measurement Methods 7
Control 8
4.1 Because of concerns for safety and the protection of
Personnel Qualification 9
nuclear materials from theft, stringent specifications are placed
1.3 This standard does not purport to address all of the
on chemical processes and the chemical and physical proper-
safety concerns, if any, associated with its use. It is the
tiesofnuclearmaterials.Strictrequirementsforthecontroland
responsibility of the user of this standard to establish appro-
accountability of nuclear materials are imposed on the users of
priate safety and health practices and determine the applica-
those materials. Therefore, when analyses are made by a
bility of regulatory limitations prior to use.
laboratory to support a project such as the fabrication of
nuclear fuel materials, various performance requirements may
2. Referenced Documents
be imposed on the laboratory. One such requirement is often
2.1 ASTM Standards:
the use of qualified methods. Their use gives greater assurance
C1009 Guide for Establishing a Quality Assurance Program
that the data produced will be satisfactory for the intended use
forAnalytical Chemistry Laboratories Within the Nuclear
of those data.Aqualified method will help assure that the data
Industry
produced will be comparable to data produced by the same
C1128 Guide for Preparation of Working Reference Materi-
qualified method in other laboratories.
als for Use in Analysis of Nuclear Fuel Cycle Materials
4.2 This guide provides guidance for qualifying measure-
C1156 Guide for Establishing Calibration for a Measure-
ment methods and for maintaining qualification. Even though
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
all practices would be used for most qualification programs,
rials
there may be situations in which only a selected portion would
be required. Care should be taken, however, that the effective-
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
ness of qualification is not reduced when applying these
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality
Assurance, Statistical Applications, and Reference Materials. practices selectively. The recommended practices in this guide
Current edition approved June 1, 2011. Published June 2011. Originally
are generic; based on these practices, specific actions should be
approved in 1986. Last previous edition approved in 2003 as C1068 – 03. DOI:
developed to establish a qualification program.
10.1520/C1068-03R11.
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
5. Selection of Measurement Methods
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. 5.1 General:
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
C1068−03 (2011)
5.2.3 Range—The method should be capable of responding
adequately across the range of concentration levels that will be
encountered for the constituent to be measured. This require-
ment is most often of concern for methods used to measure
impurities in materials since impurity concentrations may
fluctuate to a greater extent than other constituents. It is
important that the measurement technique used discriminates
adequately between concentration levels encountered. The
lowestconcentrationlevelthatcanbemeasuredreliablyshould
be clearly established (detection limit).
5.2.4 Reliability of Method—The method must be capable
of producing data that will meet the bias and precision
requirements established for the required analysis under the
expected conditions of use. The requirements are usually
established by the user of the data and they should be based on
the concentration levels of the constituents to be measured and
on specification limits set for the constituents.
6. Validation of Measurement Methods
6.1 There are occasions when it is desirable to investigate
FIG. 1 Quality Assurance of Analytical Laboratory Data
the applicability of a method to a particular use. This may be
the case when the method has had limited use or it is being
considered for a new or unique application. To provide some
confidence that a qualification effort would be successful, it
5.1.1 Before qualifying a method for a specific application,
may be desirable to validate the application of the method.
there should be assurance that the method has been properly
Validation is not a mandatory step in the selection and
selected for that application.The guidance given in this section
qualification process, but it can prevent wasted effort from
canbeusedtoassesstheadequacyofthemethod’sapplication.
attempts to qualify inadequate methods.
The guidance can also be used to select a new method when a
new measurement capability is required within a laboratory.
6.2 Validation of a method is usually done by an analyst
5.1.2 Measurement methods generally can be classified as
under controlled conditions. Basically, validation involves
one of three types as follows:
investigating any or all of the selection criteria in 5.2. The
5.1.2.1 Those published as national or international consen-
intent is to define method capability and to determine if the
sus standards,
method can be properly applied as intended. If modification of
5.1.2.2 Those established as acceptable for a specific appli-
the method is required for it to be applicable, validation will
cation based on long-term and wide usage, and
provide the technical information needed for modification.
5.1.2.3 Those having limited use, for example, those used
Validation also provides the experience and information to
only by a few laboratories or those that are relatively new.
write a detailed procedure if necessary. The result of the
5.1.3 For some applications, there is a choice available of
validation process will be either the rejection of a proposed
two or more acceptable methods. In those cases, one method is
method or confidence that it is acceptable for use as intended.
usually recognized as the reference method, particularly if it is
a published standard or if it is capable of producing the least 7. Qualification of Measurement Methods
bias and best precision.
7.1 General:
5.1.4 The selection of a method should be based on the
7.1.1 Although a method is selected based on the criteria in
criteria in 5.2. In situations where a reference method and one
5.2 of this guide, there is no assurance that a laboratory can
or more acceptable methods are available, there should be no
actually obtain the performance expected from the method. In
technical restrictions placed on which method is used.
addition, there may not be sufficient assurance that the method
5.2 Recommended Practices for Method Selection: is in fact adequate for its intended use. To provide those
5.2.1 Technical Basis—The method should be based on assurances, demonstration is included in the qualification
sound technology. This means that proven laboratory and process.
instrumental techniques are used in ways recognized and 7.1.2 Qualificationrequireshavingalaboratorydemonstrate
accepted by the community of users. that a method can produce acceptable data under specified
5.2.2 Interferences—The method should not be adversely conditions of qualification. Demonstration must be done under
affected by components in the matrix of the material to be actual operating conditions and not under ideal test conditions.
analyzed. Knowledge about the method’s limitations and about Aspecified material is analyzed to produce a specified amount
the composition of the material should be used to determine if of data. These data are evaluated by the person or organization
the analysis will be affected by interferences. Other potential that is responsible for approving qualification. The procedure
interferences such as environmental or electrical/electronic established for demonstration should include provisions for
conditions should be considered in the selection process. handling failures in the demonstration and for repeating the
C1068−03 (2011)
demonstration should the method not be used for a specified 7.2.4 Qualification Requirements—A procedure to be fol-
period of time. Demonstration could also include producing lowed during demonstration should be established. The proce-
other evidence such as appropriate literature references that the
durethatwillgovernqualificationshouldincludethefollowing
method is in fact applicable to the material to be analyzed.
criteria:
7.2.4.1 Bias—A
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