ASTM D3856-2011 Standard Guide for Management Systems in Laboratories Engaged in Analysis of Water《进行水分析的实验室中管理系统标准指南》.pdf

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1、Designation: D3856 11Standard Guide forManagement Systems in Laboratories Engaged in Analysisof Water1This standard is issued under the fixed designation D3856; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revis

2、ion. 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 provides information on consensus goodlaboratory practices for laboratories that provide services in thesampling and

3、analysis of water. As consensus standards, theseare the minimum criteria that all laboratories should consider inestablishing their good laboratory practices. This guide maynot be applicable to certain types of laboratories (e.g., micro-bilogical).1.2 This guide is designed to be used by those respo

4、nsiblefor the selection, operation, or control of laboratory organiza-tions engaged in sampling and analysis of water.1.3 This guide presents features of organization, facilities,resources, and operations which affect the usefulness of thedata generated.1.4 This guide presents criteria for selection

5、 and control ofthe features described in 1.3 and also makes recommendationsfor the correction of unacceptable performance.1.5 This guide describes methodology and practices in-tended to be completely consistent with the InternationalOrganization for Standardization (ISO) 9000 series of stan-dards an

6、d Guide 25 1990 (1).21.6 The values stated in inch-pound units are to be regardedas the standard. The values given in parentheses are forinformation only.1.7 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of t

7、his standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:3D1129 Terminology Relating to WaterD1193 Specification for Reagent WaterD2777 Practice for Determination of Precision

8、and Bias ofApplicable Test Methods of Committee D19 on WaterD3370 Practices for Sampling Water from Closed ConduitsD3694 Practices for Preparation of Sample Containers andfor Preservation of Organic ConstituentsD4210 Practice for Intralaboratory Quality Control Proce-dures and a Discussion on Report

9、ing Low-Level Data4D4375 Practice for Basic Statistics in Committee D19 onWaterD4447 Guide for Disposal of Laboratory Chemicals andSamplesD4840 Guide for Sample Chain-of-Custody ProceduresD4841 Practice for Estimation of Holding Time for WaterSamples Containing Organic and Inorganic ConstituentsD517

10、2 Guide for Documenting the Standard OperatingProcedures Used for the Analysis of WaterD5847 Practice for Writing Quality Control Specificationsfor Standard Test Methods for Water AnalysisE456 Terminology Relating to Quality and StatisticsE548 Guide for General Criteria Used for Evaluating Labo-rato

11、ry Competence43. Terminology3.1 For definitions of terms used in this guide, refer toTerminologies D1129, D4375, and E456, Guide E548, andASTM MNL 7(2).1This guide is under the jurisdiction of ASTM Committee D19 on Water and isthe direct responsibility of Subcommittee D19.02 on Quality Systems, Spec

12、ification,and Statistics.Current edition approved Nov. 15, 2011. Published December 2011. Originallyapproved in 1988. Last previous edition approved in 2006 as D3856 95 (2006).DOI: 10.1520/D3856-11.2The boldface numbers in parentheses refer to the list of references at the end ofthis guide.3For refe

13、renced 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 ASTM website.4Withdrawn. The last approved version of this historical standard is r

14、eferencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4. Summary of Guide4.1 This guide describes the criteria, guidelines, and recom-mendations for physical and human resources and data valida-tion for the operati

15、on of a laboratory.4.2 Although, philosophically, this guide is intended toapply to all analyses of water, there may be certain testmethods to which parts of this guide are not applicable due tothe nature of the samples, for example, microbiological analy-ses.5. Significance and Use5.1 Data on the c

16、omposition and characteristics of water arefrequently used to evaluate the health and safety to humans andthe environment.5.2 Moreover, such data are frequently used for processcontrol or to ascertain compliance with regulatory statutes thatplace limits on acceptable compositions and characteristics

17、 ofwaters.5.3 Laboratories that conduct water sampling and generateanalytical data, and those persons who have the responsibilityfor selecting a laboratory to perform water quality studies, needto use criteria, guidelines, and recommendations that have beendeveloped by consensus and are well accepte

18、d in making thisselection.5.4 Demonstration and documentation by a laboratory thatthere was judicious selection and control of organization,facilities, resources, and operations will enhance the credibilityof the data produced and promote its acceptance.6. Organization6.1 GeneralThe production of re

19、liable data is effectedthrough the effort of everyone involved with the service. It isparamount, therefore, that personnel have a clear understand-ing of their duties and responsibilities and their relationship tothe product produced. Management has the responsibility fordefining function and goals

20、as applied to the individual. Aformal document describing objectives, staff functions andresponsibilities, should be distributed and explained to all staffmembers.6.1.1 The personnel in a laboratory will vary with thespecific functions that are to be served, but minimal qualifica-tions and duties ge

21、nerally will be as described in 7.2 through7.3.2.6.2 Laboratory DirectorMust have a BS or BA degreewith a strong chemistry emphasis and with at least 5 yearslaboratory experience including supervisory roles or equiva-lent.NOTE 1The purpose of the equivalenti requirement is to allow theassignment of

22、persons who have comparable skills obtained throughqualified training which did not result in the award of a baccalaureatedegree. Interpretation of the term equivalenti will necessarily requirecareful judgment by the user of these guidelines. Certification byprofessional boards is to be encouraged.6

23、.2.1 The laboratory director or manager should be afull-time employee who operates the laboratory with at leastthe responsibilities outlined below.6.2.1.1 Establishment of long-term program plans andshorter term work plans and assignments to meet the programobjectives.6.2.1.2 Operation and maintenan

24、ce of the physical plant(building, equipment, instrumentation, services, etc.).6.2.1.3 Selection, training, and development of personnel.6.2.1.4 Overview and approval of methods of sampling andanalyses.6.2.1.5 Oversee development and implementation of aQuality Assurance (QA) program to monitor and m

25、aintain thequality of laboratory performance. This includes ensuring staffparticipation in appropriate interlaboratory quality controlactivities, intercalibration checks, performance audit programs,etc. Such interlaboratory checks are the most effective measureof comparative performance and should d

26、emonstrate the worthof a good QA program to upper management or regulatoryagencies. A QA program also provides each laboratory staffmember with a copy of the QA plan for the laboratory, whichdocuments responsibilities and kind and frequency of qualitycontrol checks. The plan should also specify the

27、monitoringand overview responsibilities of management. This responsi-bility is implemented by the Quality Assuranace Manager orCoordinator.6.2.1.6 Establishment of a development and operationalperformance appraisal system for the staff and an individualcareer development plan for each staff member.

28、Performancestandards should be developed and agreed to jointly by eachstaff member and their supervisor. The director should beresponsible for assuring a periodic review of performance of allstaff members by supervisors, for rewarding good qualityperformance, and for implementing and encouraging on-

29、the-job or offsite training. This joint development of performancestandards is key to obtaining an understanding between theworker and the supervisor, as to what is expected for satisfac-tory performance. It also paves the way for rewarding out-standing performance or identifying unsatisfactory perf

30、or-mance. These standards should be used to evaluateperformance frequently but informally, and formally on a lessfrequent (annual or semiannual) basis.6.2.2 Quality Assurance Manager or Coordinator Reportsdirectly to the Laboratory Director.6.2.2.1 Develops and implements the QA Plan as describedabo

31、ve.6.2.2.2 Investigates any quality issues and reviews on aregular basis the quality of all work performed by the labora-tory.6.2.2.3 Hosts third party laboratory assessments and respon-sible for seeing that all findings are addressed and correctiveactions completed.6.2.2.4 Implement intra- and inte

32、r-laboratory QA perfor-mance testing programs and evaluate results and taking cor-rective actions as necessary.The laboratory shall have one or more of the following staffor persons responsible for multiple roles.6.2.3 Senior StaffThe senior professional staff of thelaboratory conduct the difficult

33、and non-routine sampling andanalyses, resolve analytical problems, and modify and developanalytical procedures.6.2.3.1 Senior staff supervise and assist the technical staff inanalyses, other laboratory operations and training.D3856 1126.2.3.2 Senior staff members should have earned a bacca-laureate

34、degree in science or engineering, with a strongchemistry emphasis, from an accredited college or the equiva-lent (see Note 1) and have at least two years experience at thebench level in a water laboratory.6.2.4 Technical StaffThe technical staff are personnel whoperform routine and specialized analy

35、ses.6.2.4.1 Where appropriate, technical staff members shouldhave formal training in the analytical methodology, and qualitycontrol, as applied to the specific sample types and concentra-tion levels of analytes which are of interest to the laboratory.6.2.4.2 Technical staff may be required to satisf

36、actorilycomplete analytical tests to qualify initially and to periodicallyre-qualify throughout their work career. Qualification shouldbe based on the generation of analytical results with precisionand bias recovery within limits known to be possible for theparticular method and which meet the data

37、users requirements.6.2.5 Laboratory Support StaffThe support staff are non-technical workers who perform routine field laboratory ser-vices in support of the professional and technical staff.6.2.5.1 In the laboratory, they wash glassware, operatelaboratory reagent water systems, autoclaves, drying o

38、vens,and incubators. The support staff also receives, stores, andships samples, materials, and laboratory equipment.6.2.6 Offce Support StaffThe office staff are nontechnicalclerical or secretarial personnel who are trained either on thejob or by formal schooling in computer programs, filing,recordk

39、eeping, communications by telephone or personal vis-its, payroll, travel, or some combination thereof.6.2.6.1 The laboratory or office support staff may be anintegral part of the laboratory or may be provided as part of theadministrative function in a larger organization.6.3 Physical Resources and R

40、elated Operating Procedures:6.3.1 The laboratory environment can significantly affectthe results of water analyses; therefore, the laboratory facilityshould be carefully designed and periodically inspected andreevaluated. In general, the physical conditions in the labora-tory should comply with the

41、applicable U.S. OSHA require-ments, and other regulatory safety and legal requirements.6.3.2 Equipment and SuppliesThe specific instrumenta-tion, equipment, materials, and supplies needed for the perfor-mance of a standard test method are usually described in awritten standard operating procedure (S

42、OP). If the laboratoryproposes to perform a new analytical procedure, it must beprepared to acquire the necessary instrumentation, supplies andspace, and to conduct an appropriate training period prior to itsroutine use.6.3.3 Laboratory EnvironmentThe laboratory should bekept as free from environmen

43、tal contamination as possible inorder to protect the samples and instrumentation. Specificprocedures should be established for assuring the quality of thelaboratory reagent water per method specifications or Specifi-cation D1193. By doing so, the laboratory ensures the oppor-tunity to produce qualit

44、y data. The production of valid data notonly depends on the collection of representative samples, butalso on maintaining such samples as closely as possible to theiroriginal condition through careful handling and storage. If thesample cannot be analyzed at once, it should be preserved andstored as r

45、equired for the analytes of interest. Recommendedprocedures for collecting, transporting and handling water andwastewater samples are described in this guide or in PracticesD3370 and D3694. Recommended chain of custody proceduresare described in Guide D4840. Whenever sample holding timesmust be dete

46、rmined, recommended procedures are described inPractice D4841.6.3.4 Ventilation SystemLaboratories should be well ven-tilated and free of dust, drafts, and extreme temperaturechanges. Central air conditioning is recommended because: 1)incoming air is filtered, reducing the likelihood of airbornelabo

47、ratory contamination; 2) uniform temperature is conduciveto stable operation of instrumentation and equipment; and 3)low humidity reduces moisture problems with hygroscopicchemicals, samples, and corrosion problems with analyticalbalances and other instrumentation.6.3.4.1 In order for the hoods to b

48、e effective in removingfumes and aerosols from the laboratory environment, they mustbe operating at their designed capacity. Proper hood perfor-mance cannot be assumed. Hoods should be tested periodicallyfor proper air flow by qualified support staff or a professionalmaintenance contractor. Hoods sh

49、ould not be located in areasof countervailing drafts, such as between two open doors.Under usual operating conditions, hoods require from 50 to125 CFM/ft2(15 to 38 (m3/min)/m2) of face area. For a moredetailed treatment of ventilation consult IndustrialVentilationA Manual of Recommended Practice (4) .6.3.5 FacilitiesIdeally, the areas provided for cleaning ofglassware and portable equipment should be separated from thelaboratory working area but located close enough for conve-nience.6.3.5.1 Laboratories conducting trace organic analyseswhich use organic solvents