1、Designation: C1009 13aStandard Guide forEstablishing and Maintaining a Quality Assurance Programfor Analytical Laboratories Within the Nuclear Industry1This standard is issued under the fixed designation C1009; the number immediately following the designation indicates the year oforiginal adoption o
2、r, 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 ofa quality assurance (QA)
3、 program for analytical laboratorieswithin the nuclear industry. References to key elements ofASME NQA-1 and ISO 9001 provide guidance to the func-tional aspects of analytical laboratory operations. When imple-mented as recommended, the practices presented in this guidewill provide a comprehensive Q
4、A program for the laboratory.The practices are grouped by functions, which constitute thebasic elements of a laboratory QA program.1.2 The essential, basic elements of a laboratory QA pro-gram appear in the following order:SectionOrganization 5Quality Assurance Program 6Training and Qualification 7P
5、rocedures 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 Relating to Nuclear MaterialsC1068 Guide for Qualifi
6、cation of Measurement Methods bya Laboratory Within the Nuclear IndustryC1128 Guide for Preparation of Working Reference Materi-als for Use in Analysis of Nuclear Fuel Cycle MaterialsC1156 Guide for Establishing Calibration for a Measure-ment Method Used to Analyze Nuclear Fuel Cycle Mate-rialsC1210
7、 Guide for Establishing a Measurement System Qual-ity Control Program for Analytical Chemistry Laborato-ries Within the Nuclear IndustryC1215 Guide for Preparing and Interpreting Precision andBias Statements in Test Method Standards Used in theNuclear IndustryC1297 Guide for Qualification of Laborat
8、ory Analysts forthe 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 toDetermine Conformance with SpecificationsE178 Practice for Dealing With Outlying ObservationsE54
9、2 Practice for Calibration of Laboratory VolumetricApparatusE617 Specification for Laboratory Weights and PrecisionMass StandardsE694 Specification for Laboratory Glass Volumetric Appa-ratusE1578 Guide for Laboratory Information Management Sys-tems (LIMS)2.2 Other Standards:ISO 9001 Quality Manageme
10、nt SystemsRequirementsISO 1042 Laboratory GlasswareOne-Mark VolumetricFlasksISO/IEC 17020 General Criteria for the Operation of Vari-ous Types of Bodies Performing InspectionISO/IEC 17025 General Requirements for the Competenceof Testing and Calibration LaboratoriesANSI N15.41 Derivation of Measurem
11、ent ControlProgramsGeneral PrinciplesANSI N15.51 Measurement Control ProgramNuclear Ma-terials Analytical Chemistry LaboratoryJCGM 20:2008 International Vocabulary of MetrologyBasic and General Concepts and Associated Terms (VIM)ASME NQA-1 QualityAssurance Requirements for NuclearFacility Applicatio
12、ns31This guide is under the jurisdiction of ASTM Committee C26 on Nuclear FuelCycle and is the direct responsibility of Subcommittee C26.08 on QualityAssurance, Statistical Applications, and Reference Materials.Current edition approved April 1, 2013. Published May 2013. Originallyapproved in 1996. L
13、ast previous edition approved in 2013 as C1009 13. DOI:10.1520/C1009-13a.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe A
14、STM website.3Available from American Society of Mechanical Engineers (ASME), ASMEInternational Headquarters, Three Park Ave., New York, NY 10016-5990.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13. Terminology3.1 For definitions of
15、 pertinent terms not listed here, seeTerminology C859.3.2 Definitions of Terms Specific to This Standard:3.2.1 condition adverse to quality, nan all-inclusive termused in reference to any of the following: failures,malfunctions, deficiencies, defective items, andnon-conformances. ASME NQA-13.2.2 cus
16、tody, nphysical possession or control. A sampleis under custody if it is in possession or under control so as toprevent tampering or alteration of its characteristics. D48403.2.3 customer, nthe entity requesting analytical servicesfrom the laboratory.3.2.3.1 DiscussionA customer may be a person or a
17、norganization, and may be internal to the organization of whichthe laboratory is a part, or may be an external entity.3.2.4 laboratory, nan organization established to provideanalyses of materials.3.2.5 laboratory quality assurance, nall those plannedand systematic actions necessary to provide adequ
18、ate confi-dence in each analytical result reported by a laboratory(adapted from ASME NQA-1).3.2.6 primary measurement standard, nmeasurementstandard established using a primary reference measurementprocedure, or created as an artifact, chosen by convention.(VIM)3.2.7 result, na qualitative or quanti
19、tative description of aproperty obtained from an analysis and reported to a customer.3.2.8 sample, na portion of a process or product matrixthat is collected and used to determine the characteristics ofthat matrix (adapted from Guide D4840).3.2.9 sample chain-of-custody, nthe process whereby asample
20、 is maintained under physical possession or controlduring its entire life cycle, that is, from collection to disposal.D48403.2.10 significant condition adverse to qualitya condition(see 3.2.1) that, if uncorrected, could have a serious effect onsafety or operability. ASME NQA-13.2.11 traveler, na la
21、boratory record used to transmitinformation and data through the laboratory during processing.4. Significance and Use4.1 The mission of an analytical laboratory is to providequality analyses on nuclear fuel cycle materials. An analyticallaboratory QAprogram is comprised of planned and systematicacti
22、ons needed to provide confidence that this mission isconducted in an acceptable and consistent manner.4.2 The analytical laboratories involved in the analysis ofnuclear fuel cycle materials are required to implement adocumented QA program. Regulatory agencies may mandatesome form of control requirem
23、ents for all or a part of alaboratorys operation. A documented QA program is alsonecessary for those laboratory operations required to complywith ASME NQA-1 or ISO/IEC 17025, or the requirements ofmany accreditation bodies. Even when not mandated, labora-tory QA programs should be established as a s
24、ound andscientific technical practice. This guide provides guidance forestablishing and maintaining a QA program to control thoseanalytical operations vital to ensuring the quality of chemicalanalyses.4.3 Quality assurance programs are designed and imple-mented by organizations to assure that the qu
25、ality requirementsfor a product or service will be fulfilled. The quality system iscomplementary to specific technical requirements. Each labo-ratory should identify applicable program requirements and usestandards to implement a quality program that meets theappropriate requirement. This guide may
26、be used to developand implement an analytical laboratory QA program. Otheruseful implementation standards and documents are listed inSection 2 and Appendix X1.4.4 The guides for QAin the analytical laboratory within thenuclear fuel cycle have been written to provide guidance foreach of the major act
27、ivities in the laboratory and are displayedin Fig. 1. The applicable standard for each subject is noted inthe following sections.4.5 Although the Standard Guide describes “RecommendedPractices” and “Recommendations” and uses suggestive ratherthan prescriptive language (for example, “should” as oppos
28、edto “shall”), the elements being addressed should not beinterpreted as optional. An effective and comprehensive labo-ratory quality assurance/quality control program completelyand adequately considers and includes all elements listed inSections 5-14 of this guide.5. Organization5.1 SummaryAn organi
29、zational structure is the frameworkwithin which functional responsibilities, authorities, and inter-faces are established. From a QA viewpoint, the subjectsincluded as recommended practices in 5.2 are areas in whichFIG. 1 Quality Assurance of Analytical Laboratory DataC1009 13a2administrative contro
30、ls should be defined. This is particularlytrue for laboratories having multiple functional groups.5.2 Recommended Practices:5.2.1 Organizational StructureEach laboratory should de-fine its internal structure and its position within the largerstructure when the laboratory exists within a larger organ
31、iza-tion. For small laboratories, defining an internal structure maynot be necessary.5.2.2 Functional ResponsibilitiesFunctional responsibili-ties should be clearly established for job classifications andfunctional groups within a laboratory. Functional responsibilitydefines how work is accomplished
32、 in the laboratory in terms ofwho does it and where it is done. This helps to establishrelationships and interfaces within the laboratory.5.2.3 Levels of AuthorityAuthority to carry out workresponsibilities, particularly those involving technical andoperational decisions, should be clearly establish
33、ed. Authorityincludes decision making and approval of actions, extendingfrom the working level up to the manager of the laboratory andbeyond if the laboratory is a part of a larger organization. Theactions requiring approval and the types of decisions permittedshould be established for job classific
34、ations at each organiza-tional level.5.2.4 CommunicationsMethods of communication, bothformal and informal, should be clearly established betweenworking groups within a laboratory and, particularly, betweenthe laboratory and outside organizations interacting with thelaboratory.6. Quality Assurance P
35、rogram6.1 SummaryQA becomes a formal, visible program for alaboratory when a document that (1) prescribes the QArequirements applicable to operation of the laboratory and (2)describes how those requirements are implemented, is preparedand approved. This document should be reviewed on anestablished f
36、requency and updated as necessary.6.2 Recommendations:6.2.1 Quality Assurance Program DescriptionOnce QArequirements have been selected and existing laboratory prac-tices evaluated with respect to those requirements, proceduresshould be written to describe how those QA requirements areimplemented in
37、 laboratory operations. These QA procedures,either added to existing laboratory documents or assembledinto a separate laboratory QAmanual, define the laboratory QAprogram.6.2.2 ImplementationOnce the QA program documenta-tion has been prepared, reviewed, and approved, new ormodified practices should
38、 be implemented by training person-nel in their use. In addition, personnel should receive anoverview of the contents of the QA program and specificinstruction in elements applicable to their responsibilities.6.2.3 Assessment ProgramThere should be a procedureestablished whereby the adequacy of labo
39、ratory managementand operations is assessed regularly. This procedure shouldensure that problems and deficiencies are identified,documented, analyzed, resolved, and followed up. Correctiveand preventive actions should be identified, evaluated, andresolved as described in Section 14. Assessment progr
40、amsshould consist of at least two components: management andindependent assessment. Personnel performing assessmentsshould be technically qualified and knowledgeable in the areasassessed.6.2.3.1 Management AssessmentAll levels of manage-ment should critically assess work under their cognizance andde
41、termine whether they are meeting established quality objec-tives.6.2.3.2 Independent AssessmentIndependent assessmentsshould be performed to focus on issues that affect the organi-zations performance. They should be planned and conductedto measure item and service quality, to measure the adequacyof
42、work performance, and to promote improvement. Indepen-dent assessment personnel should have sufficient authority andorganizational independence to carry out their responsibility.Independent assessment personnel may act as advisors tosenior management to assess quality and process effectiveness.6.2.3
43、.3 ReportingAssessment procedures should includeprovisions for reporting the results to those responsible forensuring correction of the problems identified.6.2.4 Quality ImprovementInformation obtained throughQA program implementation, assessments, periodic reviews,corrective and preventive actions
44、should be used to continu-ously improve the effectiveness of the program.7. Training and Qualification7.1 Summary:7.1.1 An important factor affecting all laboratory activitiesis the training and qualification of those doing the work,including chemists, technicians, clerical workers, and othersupport
45、 personnel. Training can vary from direct, on-the-jobtraining by a more experienced person to a formal programinvolving both classroom and on-the-job training. The extentof training required depends on the complexity of the work,educational background, demonstrated level of competence,previous work
46、experience, and the customers requirements.Training should be ongoing and laboratory personnel should beencouraged to attend seminars, courses, and professionalmeetings as appropriate. Analysts should be qualified beforebeginning the analysis of samples, or should be working underthe direct supervis
47、ion of a qualified analyst.7.1.2 Qualification includes not only specific training, butalso the review and verification of applicable education andexperience. All operations should be performed by adequatelytrained and qualified people. The requirements for qualificationof each person performing ana
48、lyses should be defined bymanagement (see Fig. 1).7.2 Recommendations:7.2.1 TrainingProviding training is a basic managementresponsibility. The need for training and the type of trainingused should be a management decision based on the factorsmentioned previously. Management should establish a docu-
49、mented training system to ensure that persons are trainedadequately and that they remain trained as changes in workpractices occur. Such a program should be developed based onjob requirements relating to skills, knowledge, and levels ofcompetency required for adequate job performance. Qualityassurance training should be included.C1009 13a37.2.2 QualificationAnalysts should be qualified in accor-dance with qualification requirements established for eachmethod. As with training, management is responsible for thequalification process, which can rang
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