1、Designation: C 1009 06Standard Guide forEstablishing a Quality Assurance Program for AnalyticalChemistry Laboratories Within the Nuclear Industry1This standard is issued under the fixed designation C 1009; the number immediately following the designation indicates the year oforiginal adoption or, in
2、 the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide covers the establishment of a quality assur-ance (QA) program for analy
3、tical chemistry laboratories withinthe nuclear industry. Reference to key elements of ANSI/ISO/ASQC Q9001, Quality Systems, provides guidance to thefunctional aspects of analytical laboratory operation. Whenimplemented as recommended, the practices presented in thisguide will provide a comprehensive
4、 QA program for thelaboratory. 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 pro-gram appear in the following order:SectionOrganization 5Quality Assurance Program 6Training and Qualification
5、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:2C 1068 Guide for Qualification of Measurement Methodsby a Laborator
6、y Within the Nuclear IndustryC 1128 Guide for Preparation of Working Reference Mate-rials for Use in the Analysis of Nuclear Fuel CycleMaterialsC 1156 Guide for Establishing Calibration for a Measure-ment Method Used to Analyze Nuclear Fuel Cycle Mate-rialsC 1210 Guide for Establishing a Measurement
7、 SystemQuality Control Program for Analytical Chemistry Labo-ratories Within the Nuclear IndustryC 1215 Guide for Preparing and Interpreting Precision andBias Statements in Test Method Standards Used in theNuclear IndustryC 1297 Guide for Laboratory Analysts for the Analysis ofNuclear Fuel Cycle Mat
8、erialsD 1193 Specification for Reagent WaterE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE 542 Practice for Calibration of Laboratory VolumetricApparatusE 617 Specification for Laboratory Weights and PrecisionMass StandardsE 694 Specification for
9、Laboratory Glass Volumetric Appa-ratus2.2 ANSI Standard:ANSI/ISO/ASQC Q9001 Quality SystemsModel forQuality Assurance in Design, Development, Production,Installation, and Servicing32.3 NIST Standard:NIST IR74-461 The Calibration of Small Volumetric Labo-ratory Glassware (1974)42.4 ASME Standard:ASME
10、 NQA-1 Quality Assurance Requirements forNuclear Facility Applications53. Terminology3.1 Definitions:3.1.1 laboratory quality assurance, nall those plannedand systematic actions necessary to provide adequate confi-dence in each analytical result reported by a laboratory.3.2 Definitions of Terms Spec
11、ific to This Standard:3.2.1 chain of custody, na procedure that documentscontinuous sample control and security.3.2.2 custody, nphysical possession of a sample by alaboratory.3.2.3 laboratory, nan organization established to provideanalyses of materials.1This guide is under the jurisdiction of ASTM
12、Committee C26 on Nuclear FuelCycle and is the direct responsibility of Subcommittee C26.08 on QualityAssuranceApplications.Current edition approved Jan. 1, 2006. Published February 2006. Originallyapproved in 1996. Last previous edition approved in 1996 as C 1009 96e12For referenced ASTM standards,
13、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 ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New Y
14、ork, NY 10036.4Available from National Institute of Standards and Technology (NIST), 100Bureau Dr., Stop 3460, Gaithersburg, MD 20899-3460.5Available from American Society of Mechanical Engineers (ASME), ASMEInternational Headquarters, Three Park Ave., New York, NY 10016-5990.1Copyright ASTM Interna
15、tional, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.2.4 out-of-control, adjfailing to meet preselected per-formance criteria.3.2.5 requester, nthe person or organization requestinganalyses.3.2.6 result, na qualitative or quantitative description of aproperty
16、 obtained from an analysis and reported to a requester.3.2.7 traveler, na laboratory record used to transmitinformation and data through the laboratory.4. Significance and Use4.1 The mission of an analytical chemistry laboratory is toprovide quality analyses on nuclear fuel cycle materials. Ananalyt
17、ical chemistry laboratory QA program is comprised ofplanned and systematic actions needed to provide confidencethat this mission is conducted in an acceptable and consistentmanner.4.2 The analytical chemistry laboratories involved in theanalysis of nuclear fuel cycle materials are required to imple-
18、ment a documented QA program. Regulatory agencies maymandate some form of control requirements for all or a part ofa laboratorys operation. When not mandated, laboratory QAprograms should be established as a sound and scientifictechnical practice. This guide provides guidance for establish-ing a QA
19、program to control those analytical chemistryoperations vital to ensuring the quality of chemical analyses.4.3 Quality assurance programs are designed to meet theneeds of the organization. The quality system is complemen-tary to specific technical requirements. Each laboratory shouldidentify applica
20、ble program requirements and use standards toimplement a quality program that meets the appropriate re-quirement. This guide may be used to develop and implementan analytical chemistry laboratory QA program. Other usefulimplementation standards and documents are listed in Section2 and Appendix X1.4.
21、4 The guides for QAin the analytical laboratory within thenuclear fuel cycle have been written to provide guidance foreach of the major activities 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
22、describes “RecommendedPractices” and “Recommendations” and uses suggestive ratherthan prescriptive language (for example, “should” as opposedto “shall”), the elements being addressed should not beinterpreted as optional. An effective and comprehensive labo-ratory quality assurance / quality control
23、program should, atminimum, completely and adequately consider and include allelements listed in Section 1 and in the corresponding refer-enced sections of this guide.5. Organization5.1 SummaryAn organizational structure is the frame-work within which functional responsibilities, authorities, andinte
24、rfaces are established. From a QA viewpoint, the subjectsincluded as recommended practices in 5.2 are areas in whichadministrative controls should be defined. This is particularlytrue for laboratories having multiple functional groups.5.2 Recommended Practices:5.2.1 Organizational StructureEach labo
25、ratory should de-fine its internal structure and its position within the largerstructure when the laboratory exists within a larger organiza-tion. For a laboratory having only a few people, defining aninternal structure may not be appropriate, but defining itsposition in a larger organization is rel
26、evant.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 in the laboratory in terms ofwho does it and where it is done. This helps to e
27、stablishrelationships and interfaces within the laboratory.5.2.3 Levels of AuthorityAuthority to carry out workresponsibilities, particularly those involving technical andoperational decisions, should be clearly established. Authorityincludes decision making and approval of actions, extendingfrom th
28、e 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 classifications at each organiza-tional level.5.2.4 CommunicationsMethods of communicati
29、on, 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 Program6.1 SummaryQA becomes a formal, visible program for alaboratory when a do
30、cument that (1) prescribes the QArequirements applicable to operation of the laboratory and (2)describes how those requirements are implemented, is preparedand approved.6.2 Recommendations:6.2.1 Quality Assurance Program DescriptionOnce QArequirements have been selected and existing laboratory prac-
31、tices evaluated with respect to those requirements, proceduresFIG. 1 Quality Assurance of Analytical Laboratory DataC1009062should be written to describe how those QA requirements areimplemented in laboratory operations. These QA procedures,either added to existing laboratory documents or assembledi
32、nto 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 be implemented by training person-nel in their use. In addition, personnel should receive anoverview o
33、f 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 laboratory managementand operations is assessed regularly. This procedure shouldensure that problems and de
34、ficiencies are identified, docu-mented, analyzed, resolved, and followed up. Assessmentprograms should consist of at least two components: manage-ment and independent assessment. Personnel performing as-sessments should be technically qualified and knowledgeablein the areas assessed.6.2.3.1 Manageme
35、nt AssessmentAll levels of manage-ment should critically assess work under their cognizance anddetermine 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. Th
36、ey should be planned and conductedto measure item and service quality, to measure the adequacyof work performance, and to promote improvement. Indepen-dent assessment personnel should have sufficient authority andorganizational independence to carry out their responsibility.Independent assessment pe
37、rsonnel may act as advisors tosenior management to assess quality and process effectiveness.6.2.3.3 ReportingAssessment procedures should includeprovisions for reporting the results to those responsible forensuring correction of the problems identified.6.2.4 Quality ImprovementProcesses to detect an
38、d pre-vent quality problems should be established and implemented.The processes should include identification of the causes ofproblems and work to prevent recurrence. Quality-relatedinformation should be reviewed and data analyzed to identifyareas of needed improvement, according to the importance o
39、fthe problem and the work affected.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 personnel. Training can vary from dir
40、ect, 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 experience, and the requesters require
41、ments.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.7.1.2 Qualification includes not only specific training, butalso the review and ver
42、ification of applicable education andexperience. All operations should be performed by adequatelytrained and qualified people. The requirements for qualificationof each person performing analyses should be defined bymanagement (see Fig. 1).7.2 Recommendations:7.2.1 TrainingProviding training is a ba
43、sic 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-mented training system to ensure that persons are trainedadequately and that they remain trained as changes in
44、 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.7.2.2 QualificationAnalysts should be qualified in accor-dance with qualificati
45、on requirements established for eachmethod. As with training, management is responsible for thequalification process, which can range from a simple practiceof stating that an analyst is qualified by reason of education,experience, and job knowledge to a formal system requiringpassing tests and routi
46、nely demonstrating proficiency in re-quired job skills. Guide C 1297 provides guidance on thequalification of analysts (see Fig. 1).7.2.3 RecordsTraining and qualification records should bemaintained to give visibility to the training program and toshow the past and current qualification status of e
47、ach persontrained. The extent of the records required will depend on thescope of the qualification process.7.2.3.1 The qualification record should identify the basis ofthe analysts qualification, and those methods for which theanalyst is qualified. Management should verify qualificationbefore assign
48、ing work.7.2.3.2 Qualification should be reviewed and updated, ifrequired, on at least a yearly basis.7.2.3.3 Training and qualification records are QA records,and they should be controlled as prescribed in Section 10.8. Procedures8.1 Summary:8.1.1 Analyses should be conducted in a planned, system-a
49、tic, and controlled manner. Any unauthorized change in theactions or their specified sequence may produce incorrectresults. Documented procedures should be implemented toprovide direction to those performing the work, provideinformation for training analysts, and describe the methods tobe used and their technical basis. Procedures should bewell-written, complete and correct, and should contain criteriafor determining whether the prescribed activity has beencompleted satisfactorily. Qualification of a procedure (method)may be required. Guide C 1068 provides
