ASTM D3856-2011(2015) Standard Guide for Management Systems in Laboratories Engaged in Analysis of Water《从事水分析的实验室管理系统标准指南》.pdf

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1、Designation: D3856 11 (Reapproved 2015)Standard 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

2、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 provides information on consensus goodlaboratory practices for laboratories that provide services i

3、n thesampling and 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 u

4、sed by those responsiblefor 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 crit

5、eria for selection 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 serie

6、s of stan-dards and 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 theresponsibilit

7、y of the user of this 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 Determina

8、tion of Precision 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 Di

9、scussion on Reporting Low-Level Data(Withdrawn 2002)4D4375 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 Orga

10、nic and Inorganic ConstituentsD5172 Guide for Documenting the Standard Operating Pro-cedures 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 Cr

11、iteria Used for Evaluating Labo-ratory Competence (Withdrawn 2002)43. 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 responsi

12、bility of Subcommittee D19.02 on Quality Systems, Specification,and Statistics.Current edition approved Dec. 15, 2015. Published December 2015. Originallyapproved in 1988. Last previous edition approved in 2011 as D3856 11. DOI:10.1520/D3856-11R15.2The boldface numbers in parentheses refer to the li

13、st of references at the end ofthis guide.3For 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 ASTM website.4The last approved v

14、ersion of this historical standard is referenced onwww.astm.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14. Summary of Guide4.1 This guide describes the criteria, guidelines, and recom-mendations for physical and human resource

15、s and data valida-tion for the operation 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.

16、 Significance and Use5.1 Data on the composition 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 accep

17、table compositions and characteristics 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 beendevel

18、oped by consensus and are well accepted 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. Organ

19、ization6.1 GeneralThe production of reliable 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 responsi

20、bility fordefining function and goals 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

21、 minimal qualifica-tions and duties generally 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 equivalent requ

22、irement is to allow theassignment of persons who have comparable skills obtained throughqualified training which did not result in the award of a baccalaureatedegree. Interpretation of the term equivalent will necessarily requirecareful judgment by the user of these guidelines. Certification byprofe

23、ssional boards is to be encouraged.6.2.1 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 programobject

24、ives.6.2.1.2 Operation and maintenance 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 Ass

25、urance (QA) program to monitor and maintain 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

26、comparative performance and should demonstrate 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 check

27、s. The plan should also specify the 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 deve

28、lopment plan for each staff member. 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

29、for implementing and encouraging on-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 performanc

30、e or identifying unsatisfactory perfor-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 im

31、plements the QA Plan as describedabove.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 complet

32、ed.6.2.2.4 Implement intra- and inter-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

33、thelaboratory conduct the difficult and non-routine sampling andanalyses, resolve analytical problems, and modify and developanalytical procedures.D3856 11 (2015)26.2.3.1 Senior staff supervise and assist the technical staff inanalyses, other laboratory operations and training.6.2.3.2 Senior staff m

34、embers should have earned a bacca-laureate 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 personn

35、el whoperform routine and specialized analyses.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.

36、2 Technical staff may be required to satisfactorilycomplete 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 th

37、eparticular method and which meet the data 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

38、reagent water systems, autoclaves, drying ovens,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 sch

39、ooling in computer programs, filing,recordkeeping, communications by telephone or personalvisits, 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

40、organization.6.3 Physical Resources and Related 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 i

41、n the labora-tory should comply with the applicable U.S. OSHArequirements, and other regulatory safety and legal require-ments.6.3.2 Equipment and SuppliesThe specificinstrumentation, equipment, materials, and supplies needed forthe performance of a standard test method are usually de-scribed in a w

42、ritten standard operating procedure (SOP). If thelaboratory proposes to perform a new analytical procedure, itmust be prepared to acquire the necessary instrumentation,supplies and space, and to conduct an appropriate trainingperiod prior to its routine use.6.3.3 Laboratory EnvironmentThe laboratory

43、 should bekept as free from environmental 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 ensu

44、res the oppor-tunity to produce quality 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,

45、 it should be preserved andstored as required 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. Whe

46、never sample holding timesmust be determined, 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, r

47、educing the likelihood of airbornelaboratory 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 instrumentati

48、on.6.3.4.1 In order for the hoods to be 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 profes

49、sionalmaintenance contractor. Hoods should 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 org