ASTM C1009 - 13a

    Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry

    Active Standard ASTM C1009 | Developed by Subcommittee: C26.08

    Book of Standards Volume: 12.01


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    ASTM C1009

    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.

     Quality Assurance of Analytical Laboratory Data
    FIG. 1 Quality Assurance of Analytical Laboratory Data

    4.5 Although the Standard Guide describes “Recommended Practices” and “Recommendations” and uses suggestive rather than prescriptive language (for example, “should” as opposed to “shall”), the elements being addressed should not be interpreted as optional. An effective and comprehensive laboratory quality assurance/quality control program completely and adequately considers and includes all elements listed in Sections 5-14 of this guide.

    1. Scope

    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



    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    C859 Terminology Relating to Nuclear Materials

    C1068 Guide for Qualification of Measurement Methods by a Laboratory Within the Nuclear Industry

    C1128 Guide for Preparation of Working Reference Materials for Use in Analysis of Nuclear Fuel Cycle Materials

    C1156 Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials

    C1210 Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the Nuclear Industry

    C1215 Guide for Preparing and Interpreting Precision and Bias Statements in Test Method Standards Used in the Nuclear Industry

    C1297 Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials

    D1193 Specification for Reagent Water

    D4840 Guide for Sample Chain-of-Custody Procedures

    E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications

    E178 Practice for Dealing With Outlying Observations

    E542 Practice for Calibration of Laboratory Volumetric Apparatus

    E617 Specification for Laboratory Weights and Precision Mass Standards

    E694 Specification for Laboratory Glass Volumetric Apparatus

    E1578 Guide for Laboratory Information Management Systems (LIMS)

    Other Standards

    ANSIN15.41 Derivation of Measurement Control Programs--General Principles

    ANSIN15.51 Measurement Control Program--Nuclear Materials Analytical Chemistry Laboratory

    ASMENQA-1 Quality Assurance Requirements for Nuclear Facility Applications Available from American Society of Mechanical Engineers (ASME), ASME International Headquarters, Three Park Ave., New York, NY 10016-5990.

    ISO1042 Laboratory Glassware--One-Mark Volumetric Flasks

    ISO9001 Quality Management Systems--Requirements

    ISO/IEC17020 General Criteria for the Operation of Various Types of Bodies Performing Inspection

    ISO/IEC17025 General Requirements for the Competence of Testing and Calibration Laboratories

    JCGM20:2008 International Vocabulary of Metrology--Basic and General Concepts and Associated Terms (VIM)


    ICS Code

    ICS Number Code 27.120.01 (Nuclear energy in general); 71.040.01 (Analytical chemistry in general)

    UNSPSC Code

    UNSPSC Code 81111819(Quality assurance services); 15131500(Nuclear fuel)


    DOI: 10.1520/C1009-13A

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