C26.08 - Quality Assurance, Statistical Applications, and Reference Materials

SIGNIFICANCE AND USE
5.1 Certified reference materials (CRMs) prepared from nuclear materials are well characterized, traceable, and sufficiently homogenous and stable for their intended use. Usually they are certified using the most unbiased and precise measurement methods available, often with more than one laboratory being used on a national or international level. CRMs are at the top of the metrological hierarchy of reference materials. A graphical representation of a typical national nuclear measurement system is shown in Fig. 3.
FIG. 3 Typical National Nuclear Measurement System  
5.2 Working reference materials (WRMs) need to have quality characteristics that are similar to CRMs, although the rigor used to achieve those characteristics is not usually as stringent as for CRMs. Similarly, production of WRMs should be in accordance with applicable requirements of ISO 17034. Where possible, CRMs are typically used to calibrate the methods used for establishing reference values assigned to WRMs, thus providing traceability to CRMs as required by ISO/IEC 17025. A WRM is normally prepared for a specific application.  
5.3 Because of the importance of having highly reliable measurement data from nuclear material analysis, particularly for material control and accountability purposes, CRMs are used for calibration when available. However, CRMs prepared from nuclear materials are not always available for specific applications. Thus, there may be a need for a laboratory to prepare nuclear material WRMs to meet specific needs; for example, to match the matrix in process samples. In such cases, a WRM can be tailored to meet specific needs of a process or laboratory. Also, CRM supply may be too limited for use in the quantities needed for long-term, routine use. When properly prepared, WRMs will serve equally well as CRMs for most applications, and using WRMs will help preserve supplies of CRMs.  
5.4 Difficulties may be encountered in the preparation of RMs from nuclear materials becaus...
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1.1 This guide covers the preparation and characterization of working reference materials (WRM) that are produced by a laboratory for its own use in the analysis of nuclear fuel cycle materials. Guidance is provided for proper planning, preparation, packaging, and storage; requirements for characterization; homogeneity and stability considerations; and value assignment. When traceability to SI is desired for a WRM, it will be achieved by a defined, statistically sound characterization process that is traceable to a certified value on a certified reference materials. While the guidance provided is generic for nuclear fuel cycle materials, detailed examples for some materials are provided in the appendixes.  
1.2 This guide does not apply to the production and characterization of certified reference materials (CRM). Refer to ISO 17034 and ISO Guide 35 for guidance on reference material production, characterization, certification, sale, and distribution requirements.  
1.3 The information provided by this guide is found in the following sections:    
Section  
Perform WRM Planning  
6  
Prepare and Process Materials  
7  
Packaging and Storage of Materials  
8  
Perform Homogeneity Study  
9  
Perform Stability Studies  
10  
Characterize Materials  
11  
Perform Uncertainty Analysis  
12  
Produce Documentation  
13  
Carry Out WRM Utilization and Monitoring  
14  
1.4 The values stated in SI units are to be regarded as standard. The non-SI units of molar, M, and normal, N, are also regarded as standard. Any non-SI units of measurement shown in parentheses are for information only.  
1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6...

SIGNIFICANCE AND USE
4.1 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.  
4.2 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.
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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.  
1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 The mission of an analytical laboratory is to provide quality analyses on nuclear fuel cycle materials. An analytical laboratory QA program is comprised of planned and systematic actions needed to provide confidence that this mission is conducted in an acceptable and consistent manner.  
4.2 The analytical laboratories involved in the analysis of nuclear fuel cycle materials are required to implement a documented QA program. Regulatory agencies may mandate some form of control requirements for all or a part of a laboratory's operation. A documented QA program is also necessary for those laboratory operations required to comply with ASME NQA-1 or ISO/IEC 17025, or the requirements of many accreditation bodies. Even when not mandated, laboratory QA programs should be established as a sound and scientific technical practice. This guide provides guidance for establishing and maintaining a QA program to control those analytical operations vital to ensuring the quality of chemical analyses.  
4.3 Quality assurance programs are designed and implemented by organizations to assure that the quality requirements for a process, product or service will be fulfilled. The quality system is complementary to technical requirements that may be specific to a process or analytical method. Each laboratory should identify applicable program requirements and use standards to implement a quality program that meets the appropriate requirement. This guide may be used to develop and implement an analytical laboratory QA program. Other useful implementation standards and documents are listed in Section 2 and Appendix X1.  
4.4 The guides for QA in the analytical laboratory within the nuclear fuel cycle have been written to provide guidance for each of the major activities in the laboratory and are displayed in Fig. 1. The applicable standard for each subject is noted in the following sections.  
FIG. 1 Essential Elements of Analytical Laboratory Quality Assurance System  
4.5 Althoug...
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1.1 This guide covers the establishment and maintenance of a quality assurance (QA) program for analytical laboratories within the nuclear industry. References to key elements of ASME NQA-1 and ISO/IEC 17025 provide guidance to the functional aspects of analytical laboratory operations. When implemented as recommended, the practices presented in this guide will provide a comprehensive QA program for the laboratory. The practices are grouped by functions, which constitute the basic elements of a laboratory QA program.  
1.2 The essential, basic elements of a laboratory QA program appear in the following order:    
Section  
Organization  
5  
Quality Assurance Program  
6  
Training and Qualification  
7  
Procedures  
8  
Laboratory Records  
9  
Control of Records  
10  
Management of Customer Requests and Commitments to Customers  
11  
Control of Procurement  
12  
Control of Measuring Equipment and Materials  
13  
Control of Measurements  
14  
Control of Nonconforming Work  
15  
Candidate Actions  
16  
Preventative Actions  
17  
1.3 Collection of samples and associated sampling procedures are outside the scope of this guide. The user may refer to sampling practices developed by Subcommittee C26.02.  
1.4 Nuclear laboratories are required to handle a variety of hazardous materials, including but not limited to radioactive samples and materials. The need for proper handling of these materials is discussed in 13.2.4. While this guide focuses on the nuclear laboratory QA program, proper handling of nuclear materials is essential for proper function of the QA program.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Tra...

SIGNIFICANCE AND USE
4.1 A laboratory quality assurance program is an essential program for laboratories within the nuclear industry. Guide C1009 provides guidance for establishing a quality assurance program for an analytical laboratory within the nuclear industry. This guide deals with the control of measurements aspect of the laboratory quality assurance program. Fig. 1 shows the relationship of measurement control with other essential aspects of a laboratory quality assurance program.
FIG. 1 Quality Assurance of Analytical Laboratory Data  
4.2 The fundamental purposes of a measurement control program are to provide the with-use  assurance (real-time control) that a measurement system is performing satisfactorily and to provide the data necessary to quantify measurement system performance. The with-use  assurance is usually provided through the satisfactory analysis of quality control samples (reference value either known or unknown to the analyst). The data necessary to quantify measurement system performance is usually provided through the analysis of quality control samples or the duplicate analysis of process samples, or both. In addition to the analyses of quality control samples, the laboratory quality control program should address (1) the preparation and verification of standards and reagents, (2) data analysis procedures and documentation, (3) calibration and calibration procedures, (4) measurement method qualification, (5) analyst qualification, and (6) other general program considerations. Other elements of laboratory quality assurance also impact the laboratory quality control program. These elements or requirements include (1) chemical analysis procedures and procedure control, (2) records storage and retrieval requirements, (3) internal audit requirements, (4) organizational considerations, and (5) training/qualification requirements. To the extent possible, this standard will deal primarily with quality control requirements rather than overall quality assurance re...
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1.1 This guide provides guidance for establishing and maintaining a measurement system quality control program. Guidance is provided for general program considerations, preparation of quality control samples, analysis of quality control samples, quality control data analysis, analyst qualification, measurement system calibration, measurement method qualification, and measurement system maintenance.  
1.2 This guidance is provided in the following sections:    
Section  
General Quality Control Program Considerations  
5  
Quality Control Samples  
6  
Analysis of Quality Control Samples  
7  
Quality Control Data Analysis  
8  
Analyst Qualification  
9  
Measurement System Calibration  
10  
Qualification of Measurement Methods and Systems  
11  
Measurement System Maintenance  
12  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 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 and any associated measurement data. 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.  
FIG. 1 Quality Assurance of Analytical Laboratory Data  
4.2 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.
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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.  
1.2 The guidance information is provided in the following sections:    
Section  
General Considerations  
5  
Calibration Procedure  
6  
Calibration Standard  
7  
Control of Calibrated Equipment  
8  
Documentation  
9  
Keywords  
10  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 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 C1009, 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.  
FIG. 1 Quality Assurance of Analytical Laboratory Data  
4.2 The training and qualification of analysts is one of the elements of laboratory quality assurance presented in Guide C1009, 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 C1009, the qualification process can vary in approach; this guide provides one such approach.  
4.3 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 C1068. The process described here is intended only to qualify analysts when such a data base exists and the method is in control.  
4.4 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.  
4.5 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 requi...
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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:    
Section  
Qualification Considerations  
5  
Demonstration Process  
6  
Statistical Tests  
7  
1.3 This standard does not apply to maintaining qualification during routine use of a method. Maintaining qualification is included in Guide C1210.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 To describe the uncertainties of a standard test method, precision and bias statements are required.3 The formulation of these statements has been addressed from time to time, and at least two standards practices (Practices E177 and E691) have been issued. The 1986  Compilation of ASTM Standard Definitions  (6)4 devotes several pages to these terms. This guide should not be used in cases where small numbers of test results do not support statistical normality.  
4.2 The intent of this guide is to help analysts prepare and interpret precision and bias statements. It is essential that, when the terms are used, their meaning should be clear and easily understood.  
4.3 Appendix X1 provides the theoretical foundation for precision and bias concepts and Practice E691 addresses the problem of sources of variation. To illustrate the interplay between sources of variation and formulation of precision and bias statements, a hypothetical data set is analyzed in Appendix X2. This example shows that depending on how the data was collected, different precision and bias statements are possible. Reference to this example will be found throughout this guide.  
4.4 There has been much debate inside and outside the statistical community on the exact meaning of some statistical terms. Thus, following a number of the terms in Section 3 is a list of several ways in which that term has been used. This listing is not meant to indicate that these meanings are equivalent or equally acceptable. The purpose here is more to encourage clear definition of terms used than to take sides. For example, use of the term systematic error is discouraged by some. If it is to be used, the reader should be told exactly what is meant in the particular circumstance.  
4.5 This guide is intended as an aid to understanding the statistical concepts used in precision and bias statements. There is no intention that this be a self-contained introduction to statistics. Since many analysts have no formal sta...
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1.1 This guide covers terminology useful for the preparation and interpretation of precision and bias statements. This guide does not recommend a specific error model or statistical method. It provides awareness of terminology and approaches and options to use for precision and bias statements.  
1.2 In formulating precision and bias statements, it is important to understand the statistical concepts involved and to identify the major sources of variation that affect results. Appendix X1 provides a brief summary of these concepts.  
1.3 To illustrate the statistical concepts and to demonstrate some sources of variation, a hypothetical data set has been analyzed in Appendix X2. Reference to this example is made throughout this guide.  
1.4 It is difficult and at times impossible to ship nuclear materials for interlaboratory testing. Thus, precision statements for test methods relating to nuclear materials will ordinarily reflect only within-laboratory variation.  
1.5 No units are used in this statistical analysis.  
1.6 This guide does not involve the use of materials, operations, or equipment and does not address any risk associated.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 A laboratory quality assurance program is an essential program for laboratories within the nuclear industry. Guide C1009 provides guidance for establishing a quality assurance program for an analytical laboratory within the nuclear industry. The basic elements of a laboratory quality assurance program are organization, quality assurance program, training and qualification, procedures, laboratory records, control of records, control of procurement, control of measuring equipment and materials, control of measurements, and deficiencies and corrective actions. This guide deals with the control of measurements aspect of the laboratory quality assurance program. Fig. 1 shows the relationship of measurement control with other essential aspects of a laboratory quality assurance program.
FIG. 1 Quality Assurance of Analytical Laboratory Data  
4.2 The fundamental purposes of a measurement control program are to provide the with use assurance (real-time control) that a measurement system is performing satisfactorily and to provide the data necessary to quantify measurement system performance. The with use assurance is usually provided through the satisfactory analysis of quality control samples (reference value either known or unknown to the analyst). The data necessary to quantify measurement system performance is usually provided through the analysis of quality control samples or the duplicate analysis of process samples, or both. In addition to the analyses of quality control samples, the laboratory quality control program should address (1) the preparation and verification of standards and reagents, (2) data analysis procedures and documentation, (3) calibration and calibration procedures, (4) measurement method qualification, (5) analyst qualification, and (6) other general program considerations. Other elements of laboratory quality assurance also impact the laboratory quality control program. These elements or requirements include (1) chemical analysis procedu...
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1.1 This standard provides guidance for establishing and maintaining a measurement system quality control program. Guidance is provided for general program considerations, preparation of quality control samples, analysis of quality control samples, quality control data analysis, analyst qualification, measurement system calibration, measurement method qualification, and measurement system maintenance.  
1.2 This guidance is provided in the following sections:    
Section  
General Quality Control Program Considerations  
5  
Quality Control Samples  
6  
Analysis of Quality Control Samples  
7  
Quality Control Data Analysis  
8  
Analyst Qualification  
9  
Measurement System Calibration  
10  
Measurement Method Qualification  
11  
Measurement System Maintenance  
12  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 Certified reference materials (CRMs) prepared from nuclear materials are generally well characterized and sufficiently homogenous and stable for their intended use. Usually they are certified using the most unbiased and precise measurement methods available, often with more than one laboratory being used on a national or international level, and they are at the top of the metrological hierarchy of reference materials. A graphical representation of a typical national nuclear measurement system is shown in Fig. 3.
FIG. 3 Typical National Nuclear Measurement System  
5.2 Working reference materials (WRMs) need to have quality characteristics that are similar to CRMs, although the rigor used to achieve those characteristics is not usually as stringent as for CRMs. Similarly, producers of WRMs should comply with applicable requirements of ISO 17034, which are less stringent for WRMs than the requirements for producers of CRMs. Where possible, CRMs are typically used to calibrate the methods used for establishing reference values assigned to WRMs, thus providing traceability to CRMs as required by ISO/IEC 17025. A WRM is normally prepared for a specific application.  
5.3 Because of the importance of having highly reliable measurement data from nuclear material analysis, particularly for material control and accountability purposes, CRMs are used for calibration when available. However, CRMs prepared from nuclear materials are not always available for specific applications. Thus, there may be a need for a laboratory to prepare nuclear material WRMs to meet specific needs. Also, CRMs are often too expensive, or their supply is too limited for use in the quantities needed for long-term, routine use. When properly prepared, WRMs will serve equally well as CRMs for most applications, and using WRMs will help preserve supplies of CRMs.  
5.4 Difficulties may be encountered in the preparation of RMs from nuclear materials because of the chemical and physical propertie...
SCOPE
1.1 This guide covers the preparation and characterization of working reference materials (WRM) that are produced by a laboratory for its own use in the analysis of nuclear fuel cycle materials. Guidance is provided for proper preparation, packaging, and storage; requirements for characterization; homogeneity and stability considerations; and establishing traceability of WRMs to certified reference materials by a defined, statistically sound characterization process. While the guidance provided is generic for nuclear fuel cycle materials, detailed examples for some materials are provided in the appendixes.  
1.2 This guide does not apply to the preparation and characterization of certified reference materials (CRM). Refer to ISO 17034 and Guide 35 for those requirements.  
1.3 The information provided by this guide is found in the following sections:    
Section  
Perform WRM Planning  
6  
Select, Collect, Prepare, and Process Materials  
7  
Packaging and Store Materials  
8  
Perform Homogeneity Study  
9  
Perform Stability Studies  
10  
Characterize Materials  
11  
Perform Uncertainty Analysis  
12  
Produce Documentation  
13  
Carry Out WRM Utilization and Monitoring  
14  
1.4 The values stated in SI units are to be regarded as standard. Any non-SI units of measurement shown in parentheses are for information only.  
1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trad...

SIGNIFICANCE AND USE
4.1 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.  
4.2 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.
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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 Methods  
5  
Validation of Measurement Methods  
6  
Qualification of Measurement Methods  
7  
Control  
8  
Personnel Qualification  
9  
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.

SIGNIFICANCE AND USE
5.1 Certified reference materials (CRMs) prepared from nuclear materials are generally of high purity, possessing chemical stability or reproducible stoichiometry. Usually they are certified using the most unbiased and precise measurement methods available, often with more than one laboratory being involved in making certification measurements. CRMs are generally used on a national or international level, and they are at the top of the metrological hierarchy of reference materials. A graphical representation of a national nuclear measurement system is shown in Fig. 3.  
5.2 Working reference materials (WRMs) need to have quality characteristics that are similar to CRMs, although the rigor used to achieve those characteristics is not usually as stringent as for CRMs. Similarly, producers of WRMs should comply with applicable requirements of ISO Guide 34, which are less stringent for WRMs than the requirements for producers of CRMs. Where possible, CRMs are often used to calibrate the methods used for establishing the concentration values (reference values) assigned to WRMs, thus providing traceability to CRMs as required by ISO/IEC 17025. A WRM is normally prepared for a specific application.  
5.3 Because of the importance of having highly reliable measurement data from nuclear materials, particularly for control and accountability purposes, CRMs are sometimes used for calibration when available. However, CRMs prepared from nuclear materials are not always available for specific applications. Thus, there may be a need for a laboratory to prepare WRMs from nuclear materials. Also, CRMs are often too expensive, or their supply is too limited for use in the quantities needed for long-term, routine use. When properly prepared, WRMs will serve equally well as CRMs for most applications, and using WRMs will preserve supplies of CRMs.  
5.4 Difficulties may be encountered in the preparation of RMs from nuclear materials because of the chemical and physical properties o...
SCOPE
1.1 This guide covers the preparation and characterization of working reference materials (WRM) that are produced by a laboratory for its own use in the analysis of nuclear fuel cycle materials. Guidance is provided for establishing traceability of WRMs to certified reference materials by a defined characterization process. The guidance provided is generic; it is not specific for a given material.  
1.2 The information provided by this guide is found in the following sections:    
Section  
Planning  
6  
Preparation  
7  
Packaging and Storage  
8  
Characterization  
9  
Statistical Analysis  
10  
Documentation  
11  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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.

SIGNIFICANCE AND USE
4.1 The mission of an analytical laboratory is to provide quality analyses on nuclear fuel cycle materials. An analytical laboratory QA program is comprised of planned and systematic actions needed to provide confidence that this mission is conducted in an acceptable and consistent manner.  
4.2 The analytical laboratories involved in the analysis of nuclear fuel cycle materials are required to implement a documented QA program. Regulatory agencies may mandate some form of control requirements for all or a part of a laboratory's operation. A documented QA program is also necessary for those laboratory operations required to comply with ASME NQA-1 or ISO/IEC 17025, or the requirements of many accreditation bodies. Even when not mandated, laboratory QA programs should be established as a sound and scientific technical practice. This guide provides guidance for establishing and maintaining a QA program to control those analytical operations vital to ensuring the quality of chemical analyses.  
4.3 Quality assurance programs are designed and implemented by organizations to assure that the quality requirements for a product or service will be fulfilled. The quality system is complementary to specific technical requirements. Each laboratory should identify applicable program requirements and use standards to implement a quality program that meets the appropriate requirement. This guide may be used to develop and implement an analytical laboratory QA program. Other useful implementation standards and documents are listed in Section 2 and Appendix X1.  
4.4 The guides for QA in the analytical laboratory within the nuclear fuel cycle have been written to provide guidance for each of the major activities in the laboratory and are displayed in Fig. 1. The applicable standard for each subject is noted in the following sections.  
FIG. 1 Quality Assurance of Analytical Laboratory Data  
4.5 Although the Standard Guide describes “Recommended Practices” and “Recommendations”...
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1.1 This guide covers the establishment and maintenance of a quality assurance (QA) program for analytical laboratories within the nuclear industry. References to key elements of ASME NQA-1 and ISO 9001 provide guidance to the functional aspects of analytical laboratory operations. When implemented as recommended, the practices presented in this guide will provide a comprehensive QA program for the laboratory. The practices are grouped by functions, which constitute the basic elements of a laboratory QA program.  
1.2 The essential, basic elements of a laboratory QA program appear in the following order:    
Section  
Organization  
5  
Quality Assurance Program  
6  
Training and Qualification  
7  
Procedures  
8  
Laboratory Records  
9  
Control of Records  
10  
Control of Procurement  
11  
Control of Measuring Equipment and Materials  
12  
Control of Measurements  
13  
Deficiencies and Corrective Actions  
14

SIGNIFICANCE AND USE
4.1 The mission of an analytical laboratory is to provide quality analyses on nuclear fuel cycle materials. An analytical laboratory QA program is comprised of planned and systematic actions needed to provide confidence that this mission is conducted in an acceptable and consistent manner.  
4.2 The analytical laboratories involved in the analysis of nuclear fuel cycle materials are required to implement a documented QA program. Regulatory agencies may mandate some form of control requirements for all or a part of a laboratory's operation. A documented QA program is also necessary for those laboratory operations required to comply with ASME NQA-1 or ISO/IEC 17025, or the requirements of many accreditation bodies. Even when not mandated, laboratory QA programs should be established as a sound and scientific technical practice. This guide provides guidance for establishing and maintaining a QA program to control those analytical operations vital to ensuring the quality of chemical analyses.  
4.3 Quality assurance programs are designed and implemented by organizations to assure that the quality requirements for a product or service will be fulfilled. The quality system is complementary to specific technical requirements. Each laboratory should identify applicable program requirements and use standards to implement a quality program that meets the appropriate requirement. This guide may be used to develop and implement an analytical laboratory QA program. Other useful implementation standards and documents are listed in Section 2 and Appendix X1.  
4.4 The guides for QA in the analytical laboratory within the nuclear fuel cycle have been written to provide guidance for each of the major activities in the laboratory and are displayed in Fig. 1. The applicable standard for each subject is noted in the following sections.  
FIG. 1 Quality Assurance of Analytical Laboratory Data  
4.5 Although the Standard Guide describes “Recommended Practices” and “Recommendations”...
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1.1 This guide covers the establishment and maintenance of a quality assurance (QA) program for analytical laboratories within the nuclear industry. Reference to key elements of ASME NQA-1 provides guidance to the functional aspects of analytical laboratory operation. When implemented as recommended, the practices presented in this guide will provide a comprehensive QA program for the laboratory. The practices are grouped by functions, which constitute the basic elements of a laboratory QA program.  
1.2 The essential, basic elements of a laboratory QA program appear in the following order:    
Section  
Organization  
5  
Quality Assurance Program  
6  
Training and Qualification  
7  
Procedures  
8  
Laboratory Records  
9  
Control of Records  
10  
Control of Procurement  
11  
Control of Measuring Equipment and Materials  
12  
Control of Measurements  
13  
Deficiencies and Corrective Actions  
14

SIGNIFICANCE AND USE
To describe the uncertainties of a standard test method, precision and bias statements are required. The formulation of these statements has been addressed from time to time, and at least two standards practices (Practices E177 and E691) have been issued. The 1986  Compilation of ASTM Standard Definitions  (1) devotes several pages to these terms. This guide should not be used in cases where small numbers of test results do not support statistical normality.
ANSI N15.5 attempts to provide “a standard on statistical terminology and notation [that] can benefit communication” among nuclear materials managers. Precision, accuracy, and bias are all discussed. Although these various documents are quite valuable, a simpler document written for analysts appears needed. The intent of this guide is to help analysts prepare and interpret precision and bias statements. It is essential that, when the terms are used, their meaning should be clear and easily understood.  
Appendix X1 provides the theoretical foundation for precision and bias concepts and Practice E691 addresses the problem of sources of variation. To illustrate the interplay between sources of variation and formulation of precision and bias statements, a hypothetical data set is analyzed in Appendix X2. This example shows that depending on how the data was collected, different precision and bias statements are possible. Reference to this example will be found throughout this guide.
There has been much debate inside and outside the statistical community on the exact meaning of some statistical terms. Thus, following a number of the terms in Section 3 is a list of several ways in which that term has been used. This listing is not meant to indicate that these meanings are equivalent or equally acceptable. The purpose here is more to encourage clear definition of terms used than to take sides. For example, use of the term systematic error is discouraged by some. If it is to be used, the reader should be told exac...
SCOPE
1.1 This guide covers terminology useful for the preparation and interpretation of precision and bias statements. This guide does not recommend a specific error model or statistical method. It provides awareness of terminology and approaches and options to use for precision and bias statements.  
1.2 In formulating precision and bias statements, it is important to understand the statistical concepts involved and to identify the major sources of variation that affect results. Appendix X1 provides a brief summary of these concepts.
1.3 To illustrate the statistical concepts and to demonstrate some sources of variation, a hypothetical data set has been analyzed in Appendix X2. Reference to this example is made throughout this guide.
1.4 It is difficult and at times impossible to ship nuclear materials for interlaboratory testing. Thus, precision statements for test methods relating to nuclear materials will ordinarily reflect only within-laboratory variation.
1.5 No units are used in this statistical analysis.
1.6 This guide does not involve the use of materials, operations, or equipment and does not address any risk associated.

SIGNIFICANCE AND USE
A laboratory quality assurance program is an essential program for laboratories within the nuclear industry. Guide C1009 provides guidance for establishing a quality assurance program for an analytical laboratory within the nuclear industry. The basic elements of a laboratory quality assurance program are organization, quality assurance program, training and qualification, procedures, laboratory records, control of records, control of procurement, control of measuring equipment and materials, control of measurements, and deficiencies and corrective actions. This guide deals with the control of measurements aspect of the laboratory quality assurance program. Fig. 1 shows the relationship of measurement control with other essential aspects of a laboratory quality assurance program.
The fundamental purposes of a measurement control program are to provide the with use assurance (real-time control) that a measurement system is performing satisfactorily and to provide the data necessary to quantify measurement system performance. The with use assurance is usually provided through the satisfactory analysis of quality control samples (reference value either known or unknown to the analyst). The data necessary to quantify measurement system performance is usually provided through the analysis of quality control samples or the duplicate analysis of process samples, or both. In addition to the analyses of quality control samples, the laboratory quality control program should address (1) the preparation and verification of standards and reagents, (2) data analysis procedures and documentation, (3) calibration and calibration procedures, (4) measurement method qualification, (5) analyst qualification, and (6) other general program considerations. Other elements of laboratory quality assurance also impact the laboratory quality control program. These elements or requirements include (1) chemical analysis procedures and procedure control, (2) records storage and retrieval requir...
SCOPE
1.1 This standard provides guidance for establishing and maintaining a measurement system quality control program. Guidance is provided for general program considerations, preparation of quality control samples, analysis of quality control samples, quality control data analysis, analyst qualification, measurement system calibration, measurement method qualification, and measurement system maintenance.
1.2 This guidance is provided in the following sections:
Section General Quality Control Program Considerations5 Quality Control Samples6 Analysis of Quality Control Samples7 Quality Control Data Analysis8 Analyst Qualification9 Measurement System Calibration10 Measurement Method Qualification11 Measurement System Maintenance12

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.

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 C1009, 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 C1009, 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 C1009, 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 C1068. 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.
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.

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

SIGNIFICANCE AND USE
Certified reference materials (CRMs) prepared from nuclear materials are generally of high purity, possessing chemical stability or reproducible stoichiometry. Usually they are certified using the most unbiased and precise measurement methods available, often with more than one laboratory being involved in making certification measurements. CRMs are generally used on a national or international level, and they are at the top of the metrological hierarchy of reference materials. A graphical representation of a national nuclear measurement system is shown in Fig. 3.
Working reference materials (WRMs) need to have quality characteristics that are similar to CRMs, although the rigor used to achieve those characteristics is not usually as stringent as for CRMs. Where possible, CRMs are often used to calibrate the methods used for establishing the concentration values (reference values) assigned to WRMs, thus providing traceability to CRMs as required by ISO 17025. A WRM is normally prepared for a specific application.
Because of the importance of having highly reliable measurement data from nuclear materials, particularly for control and accountability purposes, CRMs are sometimes used for calibration when available. However, CRMs prepared from nuclear materials are not always available for specific applications. Thus, there may be a need for a laboratory to prepare WRMs from nuclear materials. Also, CRMs are often too expensive, or their supply is too limited for use in the quantities needed for long-term, routine use. When properly prepared, WRMs will serve equally well as CRMs for most applications, and using WRMs will preserve supplies of CRMs.
Difficulties may be encountered in the preparation of RMs from nuclear materials because of the chemical and physical properties of the materials. Chemical instabilities, problems in ensuring stoichiometry, and radioactivity are factors involved, with all three factors being involved with some materials. Those preparing ...
SCOPE
1.1 This guide covers the preparation and characterization of working reference materials (WRM) that are produced by a laboratory for its own use in the analysis of nuclear materials. Guidance is provided for establishing traceability of WRMs to certified reference materials by a defined characterization process. The guidance provided is generic; it is not specific for a given material.
1.2 The information provided by this guide is found in the following sections:
Section  Planning 6  Preparation 7  Packaging and Storage 8  Characterization 9  Statistical Analysis10  Documentation11
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.

SCOPE
1.1 This guide covers the establishment of a quality assurance (QA) program for analytical chemistry laboratories within the nuclear industry. Reference to key elements of ANSI/ISO/ASQC Q9001, Quality Systems, provides guidance to the functional aspects of analytical laboratory operation. When implemented as recommended, the practices presented in this guide will provide a comprehensive QA program for the laboratory. The practices are grouped by functions, which constitute the basic elements of a laboratory QA program.
1.2 The essential, basic elements of a laboratory QA program appear in the following order:
Section Organization 5 Quality Assurance Program 6 Training and Qualification 7 Procedures 8 Laboratory Records 9 Control of Records10 Control of Procurement11 Control of Measuring Equipment and Materials12 Control of Measurements13 Deficiencies and Corrective Actions14

SCOPE
1.1 This standard provides guidance for establishing and maintaining a measurement system quality control program. Guidance is provided for general program considerations, preparation of quality control samples, analysis of quality control samples, quality control data analysis, analyst qualification, measurement system calibration, measurement method qualification, and measurement system maintenance.
1.2 This guidance is provided in the following sections:
Section General Quality Control Program Considerations4 Quality Control Samples5 Analysis of Quality Control Samples6 Quality Control Data Analysis7 Analyst Qualification8 Measurement System Calibration9 Measurement Method Qualification10 Measurement System Maintenance11

SCOPE
1.1 This guide covers terminology useful for the preparation and interpretation of precision and bias statements.
1.2 In formulating precision and bias statements, it is important to understand the statistical concepts involved and to identify the major sources of variation that affect results. Appendix X1 provides a brief summary of these concepts.
1.3 To illustrate the statistical concepts and to demonstrate some sources of variation, a hypothetical data set has been analyzed in Appendix X2. Reference to this example is made throughout this guide.
1.4 It is difficult and at times impossible to ship nuclear materials for interlaboratory testing. Thus, precision statements for test methods relating to nuclear materials will ordinarily reflect only within-laboratory variation.

SCOPE
1.1 This guide covers the establishment of a Quality Assurance (QA) program for analytical chemistry laboratories within the nuclear industry. Reference to key elements of ANSI/ISO/ASQC Q9001-1994, Quality Systems, provides guidance to the functional aspects of analytical laboratory operation. When implemented, the recommended practices presented in this guide a comprehensive QA program for the laboratory. The recommended practices are grouped by functions, which are the basic elements of a QA program.
WITHDRAWN RATIONALE
This guide covers the establishment of a quality assurance (QA) program for analytical chemistry laboratories within the nuclear industry.
Formerly under the jurisdiction of ASTM Committee C26 on Nuclear Fuel Cycle, this guide was withdrawn in May 2005 in accordance with the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

SCOPE
1.1 This standard provides guidance for establishing and maintaining a measurement system quality control program. Guidance is provided for general program considerations, preparation of quality control samples, analysis of quality control samples, quality control data analysis, analyst qualification, measurement system calibration, measurement method qualification, and measurement system maintenance.
WITHDRAWN RATIONALE
This standard provides guidance for establishing and maintaining a measurement system quality control program.
Formerly under the jurisdiction of ASTM Committee C26 on Nuclear Fuel Cycle, this guide was withdrawn in May 2005 in accordance with the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

SIGNIFICANCE AND USE
Quality assurance provides a planned and systematic approach for establishing practices to meet requirements of safe facility operation and product quality.
In the operation of a uranium conversion facility there are many requirements established by regulatory bodies, codes, customers, and the facility itself. These requirements are identified by facility management and acted upon by various facility groups. Implementation of the practices described in this guide are intended to assist with compliance with these requirements.
In the operation of a uranium conversion facility there is a potential for both chemical and radiological exposure to employees, the public, and the environment. This potential is reduced by implementation of the practices described in this guide. The development of this guide, as part of sound management practice, provides a means for ensuring consistency between facilities, and documentation and formalization of existing practices.  
To establish a quality assurance program for a uranium conversion facility, the practices in use should be evaluated against the recommended practices of this guide. Existing practices may then be modified or new practices implemented to correct any identified deficiencies. This approach highlights the fact that the basic foundation of a quality assurance program is already present.
ANSI/ASME NQA-1 is a quality assurance standard that is being applied broadly across the nuclear industry. NQA-1 was used as guidance in the development of the program elements of this guide.
The program functions detailed in this guide should be selected based on the particular needs and applications at the facility. Those activities or programs to be included in a uranium conversion facility should be defined in that program.
SCOPE
1.1 This guide provides guidance and recommended practices for establishing a comprehensive quality assurance program for uranium conversion facilities.
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 health and safety practices and determine the applicability of regulatory limitations prior to use.
1.2 The basic elements of a quality assurance program appear in the following order:FUNCTIONSECTIONOrganizationQuality Assurance ProgramDesign ControlInstructions, Procedures DrawingsDocument ControlProcurementIdentification and TraceabilityProcesses Inspection Control of Measuring and Test EquipmentHandling, Storage and Shipping Inspection, Test and Operating Status Control of Nonconforming Items Corrective Actions Quality Assurance Records Audits

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.

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 ). 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 . Discussion and guidance related to some of these activities appear in the following sections:SectionSelection of Measurement Methods5Validation of Measurement Methods6Qualification of Measurement Methods7Control8Personnel 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.

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 C 1009, 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 C 1068 (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.
FIG. 1 Quality Assurance of Analytical Laboratory Data
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.
1.2 The guidance information is provided in the following sections:SectionGeneral Considerations4Calibration Procedure5Calibration Standard6Control of Calibrated Equipment7Documentation8Keywords9
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.

SCOPE
1.1 This guide covers the preparation and characterization of working reference materials (WRM) that are produced by a laboratory for its own use in the analysis of nuclear materials. Guidance is provided for establishing traceability of WRMs to certified reference materials by a defined characterization process. The guidance provided is generic; it is not specific for a given material.
1.2 The information provided by this guide is found in the following sections:SectionPlanning6Preparation7Packaging and Storage8Characterization9Statistical Analysis10Documentation 11
1.3 The values stated in SI units are to be regarded as the standard.
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.

SIGNIFICANCE AND USE
Certified reference materials (CRMs) prepared from nuclear materials are generally of high purity, possessing chemical stability or reproducible stoichiometry. Usually they are certified using the most unbiased and precise measurement methods available, often with more than one laboratory being involved in making certification measurements. CRMs are generally used on a national or international level, and they are at the top of the metrological hierarchy of reference materials. A graphical representation of a national nuclear measurement system is shown in Fig. 3.
Working reference materials (WRMs) need to have quality characteristics that are similar to CRMs, although the rigor used to achieve those characteristics is not usually as stringent as for CRMs. Where possible, CRMs are often used to calibrate the methods used for establishing the concentration values (reference values) assigned to WRMs, thus providing traceability to CRMs as required by ISO 17025. A WRM is normally prepared for a specific application.
Because of the importance of having highly reliable measurement data from nuclear materials, particularly for control and accountability purposes, CRMs are sometimes used for calibration when available. However, CRMs prepared from nuclear materials are not always available for specific applications. Thus, there may be a need for a laboratory to prepare WRMs from nuclear materials. Also, CRMs are often too expensive, or their supply is too limited for use in the quantities needed for long-term, routine use. When properly prepared, WRMs will serve equally well as CRMs for most applications, and using WRMs will preserve supplies of CRMs.
Difficulties may be encountered in the preparation of RMs from nuclear materials because of the chemical and physical properties of the materials. Chemical instabilities, problems in ensuring stoichiometry, and radioactivity are factors involved, with all three factors being involved with some materials. Those preparing ...
SCOPE
1.1 This guide covers the preparation and characterization of working reference materials (WRM) that are produced by a laboratory for its own use in the analysis of nuclear materials. Guidance is provided for establishing traceability of WRMs to certified reference materials by a defined characterization process. The guidance provided is generic; it is not specific for a given material.
1.2 The information provided by this guide is found in the following sections:SectionPlanning6Preparation7Packaging and Storage8Characterization9Statistical Analysis10Documentation 11
1.3 The values stated in SI units are to be regarded as the standard.
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.

SCOPE
1.1 This guide provides guidance and recommended practices for establishing a comprehensive quality assurance program for uranium conversion facilities.
1.2 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate health and safety practices and determine the applicability of regulatory limitations prior to use. 
1.3 The basic elements of a quality assurance program appear in the following order: FUNCTION SECTION Organization 5 Quality Assurance Program 6 Design Control 7 Instructions, Procedures ∧ Drawings 8 Document Control 9 Procurement 10 Identification and Traceability 11 Processes 12 Inspection 13 Control of Measuring and Test Equipment 14 Handling, Storage and Shipping 15 Inspection, Test and Operating Status 16 Control of Nonconforming Items 17 Corrective Actions 18 Quality Assurance Records 19 Audits 20

SCOPE
1.1 This practice provides an aid in designing a sampling and analysis plan for the purpose of minimizing random error in the measurement of the amount of nuclear material in a lot consisting of several containers. The problem addressed is the selection of the number of containers to be sampled, the number of samples to be taken from each sampled container, and the number of aliquot analyses to be performed on each sample.  
1.2 This practice provides examples for application as well as the necessary development for understanding the statistics involved. The uniqueness of most situations does not allow presentation of step-by-step procedures for designing sampling plans. It is recommended that a statistician experienced in materials sampling be consulted when developing such plans.  
1.3 The values stated in SI units are to be regarded as the standard.  
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.

SCOPE
1.1 This guide covers terminology useful for the preparation and interpretation of precision and bias statements.
1.2 In formulating precision and bias statements, it is important to understand the statistical concepts involved and to identify the major sources of variation that affect results. Appendix X1 provides a brief summary of these concepts.
1.3 To illustrate the statistical concepts and to demonstrate some sources of variation, a hypothetical data set has been analyzed in Appendix X2. Reference to this example is made throughout this guide.
1.4 It is difficult and at times impossible to ship nuclear materials for interlaboratory testing. Thus, precision statements for test methods relating to nuclear materials will ordinarily reflect only within-laboratory variation.

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 requirements established for those data.
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 Methods 5 Validation of Measurement Methods 6 Qualification of Measurement Methods 7 Control 8 Personnel Qualification 9
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.

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.
1.2 The guidance information is provided in the following sections:  Section General Considerations 5 Calibration Procedure 6 Calibration Standard 7 Control of Calibrated Equipment 8 Documentation 9 Keywords 10
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.

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:  Section Qualification Considerations 4 Demonstration Process 5 Statistical Tests 6
1.3 This standard does not apply to maintaining qualification during routine use of a method. Maintaining qualification is included in Guide C1210.  
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.

SIGNIFICANCE AND USE
Quality assurance provides a planned and systematic approach for establishing practices to meet requirements of safe facility operation and product quality.
In the operation of a uranium conversion facility there are many requirements established by regulatory bodies, codes, customers, and the facility itself. These requirements are identified by facility management and acted upon by various facility groups. Implementation of the practices described in this guide are intended to assist with compliance with these requirements.
In the operation of a uranium conversion facility there is a potential for both chemical and radiological exposure to employees, the public, and the environment. This potential is reduced by implementation of the practices described in this guide. The development of this guide, as part of sound management practice, provides a means for ensuring consistency between facilities, and documentation and formalization of existing practices.  
To establish a quality assurance program for a uranium conversion facility, the practices in use should be evaluated against the recommended practices of this guide. Existing practices may then be modified or new practices implemented to correct any identified deficiencies. This approach highlights the fact that the basic foundation of a quality assurance program is already present.
ANSI/ASME NQA-1 is a quality assurance standard that is being applied broadly across the nuclear industry. NQA-1 was used as guidance in the development of the program elements of this guide.
The program functions detailed in this guide should be selected based on the particular needs and applications at the facility. Those activities or programs to be included in a uranium conversion facility should be defined in that program.
SCOPE
1.1 This guide provides guidance and recommended practices for establishing a comprehensive quality assurance program for uranium conversion facilities.
1.2 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 health and safety practices and determine the applicability of regulatory limitations prior to use.
1.3 The basic elements of a quality assurance program appear in the following order:
FUNCTIONSECTION   Organization 5 Quality Assurance Program 6 Design Control 7 Instructions, Procedures & Drawings 8 Document Control 9 Procurement10 Identification and Traceability11 Processes12  Inspection13  Control of Measuring and Test Equipment14 Handling, Storage and Shipping15  Inspection, Test and Operating Status16  Control of Nonconforming Items17  Corrective Actions18  Quality Assurance Records19  Audits20  
TABLE 1 NQA-1 Basic Requirements Related to Principles of Conversion Facility Quality Assurance
NQA-1 BASIC REQUIREMENTS   Elements of Conversion Facility Quality Assurance12345 678910 1112131415 161718 OrganizationX Quality Assurance ProgramX Design ControlX Document ControlXX Instructions, Procedures & DrawingsX ProcurementX Identification and Traceability X ProcessesX InspectionXX Control of Measuring and Test Equipment X Handling, Storage, and ShippingX Inspection, Test and Operating Status X Control of Non-conforming ItemsX Corrective ActionsX Quality Assurance RecordsX AuditsX
WITHDRAWN RATIONALE
This guide provided guidance and recommended practices for establishing a comprehensive quality assurance program for uranium conversion facilities.
Formerly under the jurisdiction of Committee C26 on Nuclear Fuel Cycle, this guide was withdrawn in June 2017. This standard is being withdrawn without replacement due to its limited use by industry.

SIGNIFICANCE AND USE
Plans for sampling and analysis of nuclear material are designed with two purposes in mind: the first is related to material accountability and the second to material specifications.
For the accounting of special nuclear material, sampling and analysis plans should be established to determine the quantity of special nuclear material held in inventory, shipped between buyers and sellers, or discarded. Likewise, material specification requires the determination of the quantity of nuclear material present. Inevitably there is uncertainty associated with such measurements. This practice presents a tool for developing sampling plans that control the random error component of this uncertainty.  
Precision and accuracy statements are highly desirable, if not required, to qualify measurement methods. This practice relates to“ precision” that is generally a statement on the random error component of uncertainty.
SCOPE
1.1 This practice provides an aid in designing a sampling and analysis plan for the purpose of minimizing random error in the measurement of the amount of nuclear material in a lot consisting of several containers. The problem addressed is the selection of the number of containers to be sampled, the number of samples to be taken from each sampled container, and the number of aliquot analyses to be performed on each sample.
1.2 This practice provides examples for application as well as the necessary development for understanding the statistics involved. The uniqueness of most situations does not allow presentation of step-by-step procedures for designing sampling plans. It is recommended that a statistician experienced in materials sampling be consulted when developing such plans.  
1.3 The values stated in SI units are to be regarded as the standard.
1.4 This standard does not purport to address all of the safety problems, 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.
WITHDRAWN RATIONALE
This practice provides an aid in designing a sampling and analysis plan for the purpose of minimizing random error in the measurement of the amount of nuclear material in a lot consisting of several containers. The problem addressed is the selection of the number of containers to be sampled, the number of samples to be taken from each sampled container, and the number of aliquot analyses to be performed on each sample.
Formerly under the jurisdiction of Committee C26 on Nuclear Fuel Cycle, this test method was withdrawn in June 2012. This standard is being withdrawn without replacement due to its limited use by industry.

SCOPE
1.1 This guide covers a systematic process for the development of training programs. This approach is recommended for use within the nuclear fuel cycle. However, the steps described can be beneficially applied to the development of other technical training programs. It is particularly valuable for promoting the efficiency and safety of a complex technical operation.  
1.2 This guide provides a description of the activities to be considered in developing effective training programs. It is written from the viewpoint of an industrial user. The approach is based on an operating organization (company) using its resources to develop training programs to meet that company's specific needs.  
1.3 The responsible organization or individual who would perform the activities described will differ due to the unique variability in organizational structures of those applying the process. This is, therefore, not addressed in this guide. It is also not within the scope of this guide to prescribe the specific method for performing the activities.  
1.4 There are many associated activities and decisions not considered such as training facility design, audio-visual resources, and documentation systems. However, to reduce the possibility of oversight, it is recommended that the user refer to "A Checklist for Technical, Skills, and Other Training."