1、Designation: C1009 06C1009 13Standard Guide forEstablishing and Maintaining a Quality Assurance Programfor Analytical Chemistry Laboratories Within the NuclearIndustry1This standard is issued under the fixed designation C1009; the number immediately following the designation indicates the year ofori
2、ginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide covers the establishment and maintenance of a quali
3、ty assurance (QA) program for analytical chemistrylaboratories within the nuclear industry. Reference to key elements of ANSI/ISO/ASQCASME NQA-1 Q9001, Quality Systems,provides guidance to the functional aspects of analytical laboratory operation. When implemented as recommended, the practicespresen
4、ted in this guide will provide a comprehensive QAprogram for the laboratory.The practices are grouped by functions, whichconstitute the basic elements of a laboratory QA program.1.2 The essential, basic elements of a laboratory QA program appear in the following order:SectionOrganization 5Quality As
5、surance Program 6Training and Qualification 7Procedures 8Laboratory Records 9Control of Records 10Control of Procurement 11Control of Measuring Equipment and Materials 12Control of Measurements 13Deficiencies and Corrective Actions 142. Referenced Documents2.1 ASTM Standards:2C859 Terminology Relati
6、ng to Nuclear MaterialsC1068 Guide for Qualification of Measurement Methods by a Laboratory Within the Nuclear IndustryC1128 Guide for Preparation of Working Reference Materials for Use in Analysis of Nuclear Fuel Cycle MaterialsC1156 Guide for Establishing Calibration for a Measurement Method Used
7、to Analyze Nuclear Fuel Cycle MaterialsC1210 Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Withinthe Nuclear IndustryC1215 Guide for Preparing and Interpreting Precision and Bias Statements in Test Method Standards Used in the NuclearIndust
8、ryC1297 Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle MaterialsD1193 Specification for Reagent WaterD4840 Guide for Sample Chain-of-Custody ProceduresE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE178 Practi
9、ce for Dealing With Outlying ObservationsE542 Practice for Calibration of Laboratory Volumetric ApparatusE617 Specification for Laboratory Weights and Precision Mass StandardsE694 Specification for Laboratory Glass Volumetric ApparatusE1578 Guide for Laboratory Information Management Systems (LIMS)1
10、 This guide is under the jurisdiction of ASTM Committee C26 on Nuclear Fuel Cycle and is the direct responsibility of Subcommittee C26.08 on Quality Assurance,Statistical Applications, and Reference Materials.Current edition approved Jan. 1, 2006Jan. 1, 2013. Published February 2006February 2013. Or
11、iginally approved in 1996. Last previous edition approved in 19962006 asC1009 96C1009 06.1 DOI: 10.1520/C1009-06.10.1520/C1009-13.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume informati
12、on, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict
13、 all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428
14、-2959. United States12.2 ANSI Standard:ANSI/ISO/ASQC Q9001 Quality SystemsModel for QualityAssurance in Design, Development, Production, Installation, andServicing32.3 NIST Standard:NIST IR74-461 The Calibration of Small Volumetric Laboratory Glassware (1974)42.2 ASME Standard:Other Standards:ISO 10
15、42 Laboratory GlasswareOne-Mark Volumetric FlasksISO/IEC 17020 General Criteria for the Operation of Various Types of Bodies Performing InspectionISO/IEC 17025 General Requirements for the Competence of Testing and Calibration LaboratoriesANSI N15.41 Derivation of Measurement Control ProgramsGeneral
16、 PrinciplesANSI N15.51 Measurement Control ProgramNuclear Materials Analytical Chemistry LaboratoryJCGM 20:2008 International Vocabulary of MetrologyBasic and General Concepts and Associated Terms (VIM)ASME NQA-1 Quality Assurance Requirements for Nuclear Facility Applications33. Terminology3.1 Defi
17、nitions:3.1.1 laboratory quality assurance, nall those planned and systematic actions necessary to provide adequate confidence ineach analytical result reported by a laboratory.3.1 For definitions of pertinent terms not listed here, see Terminology C859.3.2 Definitions of Terms Specific to This Stan
18、dard:3.2.1 chain of custody, condition adverse to quality, na procedure that documents continuous sample control and security.anall-inclusive term used in reference to any of the following: failures, malfunctions, deficiencies, defective items, andnon-conformances. ASME NQA-13.2.2 custody, nphysical
19、 possession of a sample by a laboratory.or control. A sample is under custody if it is in possession orunder control so as to prevent tampering or alteration of its characteristics. D48403.2.3 customer, nthe entity requesting analytical services from the laboratory.3.2.3.1 DiscussionA customer may b
20、e a person or an organization, and may be internal to the organization of which the laboratory is a part, or maybe an external entity.3.2.4 laboratory, nan organization established to provide analyses of materials.3.2.5 out-of-control, laboratory quality assurance, adjnfailing to meet preselected pe
21、rformance criteria.all those plannedand systematic actions necessary to provide adequate confidence in each analytical result reported by a laboratory (adapted fromASME NQA-1).3.2.6 requester, primary measurement standard, nthe person or organization requesting analyses.measurement standardestablish
22、ed using a primary reference measurement procedure, or created as an artifact, chosen by convention. (VIM)3.2.7 result, na qualitative or quantitative description of a property obtained from an analysis and reported to arequester.customer.3.2.8 sample, na portion of a process or product matrix that
23、is collected and used to determine the characteristics of that matrix(adapted from Guide D4840).3.2.9 sample chain-of-custody, nthe process whereby a sample is maintained under physical possession or control during itsentire life cycle, that is, from collection to disposal. D48403.2.10 significant c
24、ondition adverse to qualitya condition (see 3.2.1) that, if uncorrected, could have a serious effect on safetyor operability. ASME NQA-13.2.11 traveler, na laboratory record used to transmit information and data through the laboratory.laboratory duringprocessing.3 Available from American National St
25、andards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.4 Available from National Institute of Standards and Technology (NIST), 100 Bureau Dr., Stop 3460, Gaithersburg, MD 20899-3460.3 Available from American Society of Mechanical Engineers (ASME), ASME International Headquarters, Th
26、ree Park Ave., New York, NY 10016-5990.C1009 1324. Significance and Use4.1 The mission of an analytical chemistry laboratory is to provide quality analyses on nuclear fuel cycle materials. Ananalytical chemistry laboratory QAprogram is comprised of planned and systematic actions needed to provide co
27、nfidence that thismission is conducted in an acceptable and consistent manner.4.2 The analytical chemistry laboratories involved in the analysis of nuclear fuel cycle materials are required to implement adocumented QA program. Regulatory agencies may mandate some form of control requirements for all
28、 or a part of a laboratorysoperation. When A documented QA program is also necessary for those laboratory operations required to comply with ASMENQA-1 or ISO/IEC 17025, or the requirements of many accreditation bodies. Even when not mandated, laboratory QA programsshould be established as a sound an
29、d scientific technical practice. This guide provides guidance for establishing and maintaininga QA program to control those analytical chemistry operations vital to ensuring the quality of chemical analyses.4.3 Quality assurance programs are designed to meet the needs of the organization. and implem
30、ented by organizations to assurethat the quality requirements for a product or service will be fulfilled. The quality system is complementary to specific technicalrequirements. Each laboratory should identify applicable program requirements and use standards to implement a quality programthat meets
31、the appropriate requirement. This guide may be used to develop and implement an analytical chemistry laboratory QAprogram. Other useful implementation standards and documents are listed in Section 2 and Appendix X1.4.4 The guides for QAin the analytical laboratory within the nuclear fuel cycle have
32、been written to provide guidance for eachof the major activities in the laboratory and are displayed in Fig. 1. The applicable standard for each subject is noted in thefollowing sections.4.5 Although the Standard Guide describes “Recommended Practices” and “Recommendations” and uses suggestive rathe
33、r thanprescriptive language (for example, “should” as opposed to “shall”), the elements being addressed should not be interpreted asoptional. An effective and comprehensive laboratory quality assurance / quality control program should, at minimum, completelyand adequately consider and include all el
34、ements listed in Section 1Sections 5-14 and in the corresponding referenced sections ofthis guide.5. Organization5.1 SummaryAn organizational structure is the framework within which functional responsibilities, authorities, and interfacesare established. From a QA viewpoint, the subjects included as
35、 recommended practices in 5.2 are areas in which administrativecontrols should be defined. This is particularly true for laboratories having multiple functional groups.5.2 Recommended Practices:5.2.1 Organizational StructureEach laboratory should define its internal structure and its position within
36、 the larger structurewhen the laboratory exists within a larger organization. For a laboratory having only a few people, small laboratories, defining aninternal structure may not be appropriate, but defining its position in a larger organization is relevant.necessary.FIG. 1 Quality Assurance of Anal
37、ytical Laboratory DataC1009 1335.2.2 Functional ResponsibilitiesFunctional responsibilities should be clearly established for job classifications and functionalgroups within a laboratory. Functional responsibility defines how work is accomplished in the laboratory in terms of who does itand where it
38、 is done. This helps to establish relationships and interfaces within the laboratory.5.2.3 Levels of AuthorityAuthority to carry out work responsibilities, particularly those involving technical and operationaldecisions, should be clearly established. Authority includes decision making and approval
39、of actions, extending from the workinglevel up to the manager of the laboratory and beyond if the laboratory is a part of a larger organization. The actions requiringapproval and the types of decisions permitted should be established for job classifications at each organizational level.5.2.4 Communi
40、cationsMethods of communication, both formal and informal, should be clearly established between workinggroups within a laboratory and, particularly, between the laboratory and outside organizations interacting with the laboratory.6. Quality Assurance Program6.1 SummaryQA becomes a formal, visible p
41、rogram for a laboratory when a document that (1) prescribes the QArequirements applicable to operation of the laboratory and (2) describes how those requirements are implemented, is prepared andapproved. This document should be reviewed on an established frequency and updated as necessary.6.2 Recomm
42、endations:6.2.1 Quality Assurance Program DescriptionOnce QA requirements have been selected and existing laboratory practicesevaluated with respect to those requirements, procedures should be written to describe how those QA requirements areimplemented in laboratory operations. These QA procedures,
43、 either added to existing laboratory documents or assembled into aseparate laboratory QA manual, define the laboratory QA program.6.2.2 ImplementationOnce the QA program documentation has been prepared, reviewed, and approved, new or modifiedpractices should be implemented by training personnel in t
44、heir use. In addition, personnel should receive an overview of thecontents of the QA program and specific instruction in elements applicable to their responsibilities.6.2.3 Assessment ProgramThere should be a procedure established whereby the adequacy of laboratory management andoperations is assess
45、ed regularly. This procedure should ensure that problems and deficiencies are identified, documented, analyzed,resolved, and followed up. Corrective and preventive actions should be identified, evaluated, and resolved as described in Section14. Assessment programs should consist of at least two comp
46、onents: management and independent assessment. Personnelperforming assessments should be technically qualified and knowledgeable in the areas assessed.6.2.3.1 Management AssessmentAll levels of management should critically assess work under their cognizance and determinewhether they are meeting esta
47、blished quality objectives.6.2.3.2 Independent AssessmentIndependent assessments should be performed to focus on issues that affect the organizationsperformance. They should be planned and conducted to measure item and service quality, to measure the adequacy of workperformance, and to promote impro
48、vement. Independent assessment personnel should have sufficient authority and organizationalindependence to carry out their responsibility. Independent assessment personnel may act as advisors to senior management toassess quality and process effectiveness.6.2.3.3 ReportingAssessment procedures shou
49、ld include provisions for reporting the results to those responsible for ensuringcorrection of the problems identified.6.2.4 Quality ImprovementProcesses to detect and prevent quality problems should be established and implemented. Theprocesses should include identification of the causes of problems and work to prevent recurrence. Quality-related informationshould be reviewed and data analyzed to identify areas of needed improvement, according to the importance of the problem andthe work affected.Information obtained through QA program implem
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