1、Designation: D 3856 95 (Reapproval 2006)Standard Guide forGood Laboratory Practices in Laboratories Engaged inSampling and Analysis of Water1This standard is issued under the fixed designation D 3856; the number immediately following the designation indicates the year oforiginal adoption or, in the
2、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 provides information on consensus goodlaboratory practices for laboratories
3、that provide services in thesampling and analysis of water. As consensus standards, theseare the minimum criteria that all laboratories should consider inestablishing their good laboratory practices.1.2 This guide is designed to be used by those responsiblefor the selection, operation, or control of
4、 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 and control ofthe features described in 1.3 and
5、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 and Guide 25 1990 (1).21.6 The values stated in inc
6、h-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 this standard to establish appro-priate safety and
7、 health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:3D 1129 Terminology Relating to WaterD 1193 Specification for Reagent WaterD 2777 Practice for Determination of Precision and Bias ofApplicable Test Methods of Committe
8、e D19 on WaterD 3370 Practices for Sampling Water from Closed ConduitsD 3694 Practices for Preparation of Sample Containers andfor Preservation of Organic ConstituentsD 4210 Practice for Intralaboratory Quality Control Proce-dures and a Discussion on Reporting Low-Level Data4D 4375 Practice for Basi
9、c Statistics in Committee D19 onWaterD 4447 Guide for Disposal of Laboratory Chemicals andSamplesD 4840 Guide for Sample Chain-of-Custody ProceduresD 4841 Practice for Estimation of Holding Time for WaterSamples Containing Organic and Inorganic ConstituentsD 5172 Guide for Documenting the Standard O
10、peratingProcedures Used for the Analysis of WaterD 5847 Practice for Writing Quality Control Specificationsfor Standard Test Methods for Water AnalysisE 456 Terminology Relating to Quality and StatisticsE 548 Guide for General Criteria Used for EvaluatingLaboratory Competence43. Terminology3.1 For d
11、efinitions of terms used in this guide, refer toTerminologies D 1129, D 4375, and E 456, Guide E 548, andASTM MNL 7 (2).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 operation of a laboratory.4
12、.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 composition and chara
13、cteristics of water arefrequently used to evaluate the health and safety to humans andthe environment.1This guide is under the jurisdiction of ASTM Committee D19 on Water and isthe direct responsibility of Subcommittee D19.02 on General Specifications,Technical Resources, and Statistical Methods.Cur
14、rent edition approved Feb. 15, 2006. Published February 2006. Originallyapproved in 1988. Last previous edition approved in 2000 as D 3856 95 (2000).2The boldface numbers in parentheses refer to the list of references at the end ofthis guide.3For referenced ASTM standards, visit the ASTM website, ww
15、w.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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United
16、States.5.2 Moreover, such data are frequently used for processcontrol or to ascertain compliance with regulatory statutes thatplace limits on acceptable compositions and characteristics ofwaters.5.3 Laboratories that conduct water sampling and generateanalytical data, and those persons who have the
17、responsibilityfor selecting a laboratory to perform water quality studies, needto use criteria, guidelines, and recommendations that have beendeveloped by consensus and are well accepted in making thisselection.5.4 Demonstration and documentation by a laboratory thatthere was judicious selection and
18、 control of organization,facilities, resources, and operations will enhance the credibilityof the data produced and promote its acceptance.6. Aspects of Quality Assurance6.1 GeneralThe function of a laboratory is to provideanalytical results and related information which are adequatefor the intended
19、 use. This function is achieved through effec-tive use of a quality assurance program. Every laboratoryshould develop a written quality assurance program, plan, ormanual that demonstrates the effectiveness of its proceduresand practices in assuring this quality. In addition to addressingany applicab
20、le regulatory requirements, the program shouldconsider the following:6.2 Organizational StructureA table of the organizationshould be available which shows the lines of authority, areas ofresponsibility, and job functions. The laboratory should alsoprovide a description of its capabilities. Laborato
21、ry manage-ment should demonstrate and foster a positive quality assur-ance attitude and provide the analytical staff with a writtenpolicy to carry out a defined quality assurance program.6.2.1 Human Resources The key personnel of the orga-nization should be described by means of personal rsumspresen
22、ting the education and work experience appropriate tothe table of organization and the qualifications of the position.For each employee, provision should be made for update ofrecords to reflect additional education, work experience, andcontinuing training.6.2.2 Physical ResourcesThe laboratory facil
23、ities shouldprovide a working environment that is clean, comfortable, andsafe. The instrumentation and equipment must be suitable forthe operational needs of the laboratory.6.3 Methodology Written procedures should be readilyavailable to personnel.6.3.1 Written sample collection, handling and storag
24、e re-quirements should be followed.6.3.2 Analytical procedures should be written.6.3.3 There should be a document control system to trackthe currency and completeness of procedures.6.4 MetrologySystems for making measurements shouldhave the following:6.4.1 Written calibration procedures, including t
25、raceabilityand schedule.6.4.2 Written preventive maintenance procedures withscheduled intervals.6.4.3 Records available to document any repair or service ofequipment, replacement or change of reagents, or modificationof procedures.6.5 Data Recording The laboratory should keep recordsof sample source
26、 disposition and analyses to provide informa-tion on sample collection and preservation, analytical proce-dures and results, and the persons responsible for the samplingand analysis. All laboratory data sheets should be dated andsigned by the analyst and his supervisor or a suitable colleague.6.6 Da
27、ta Validation To assess and demonstrate a suitablelevel of analytical performance, the laboratory should keeprecords of audit procedures, reference sample programs, andinterlaboratory tests. One criterion for measurement of analyti-cal performance should be the precision and bias data con-tained in
28、the analytical method being used. Where applicable,quality control charts as described in Practice D 4210 shouldbe used.6.7 Trouble Shooting The organization should provide theauthority and the responsibility to a designated person orpersons for investigation of out-of-control results and forinformi
29、ng the laboratory management of any problems thatoccur.6.7.1 A current log should be kept of analytical deficienciesand the action taken to correct them.7. Organization7.1 GeneralThe production of reliable data is effectedthrough the effort of everyone involved with the service. It isparamount, ther
30、efore, 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 as applied to the individual. Aformal document describing objectives, staff functions andresponsibili
31、ties, should be distributed and explained to all staffmembers.7.1.1 The personnel in a laboratory will vary with thespecific functions that are to be served, but minimal qualifica-tions and duties generally will be as described in 7.2 through7.3.5.11.7.2 Human Resources/Personnel Duties and Responsi
32、bili-ties:7.2.1 The Director The director should have a workingknowledge of the laboratory and its scope of activities. Thedirector should have earned a baccalaureate degree in scienceor engineering from an accredited college or university or theequivalent (Note 1) and have at least five years exper
33、ience inlaboratory work.NOTE 1The purpose of the “equivalent” requirement 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 requirecar
34、eful judgment by the user of these guidelines. Certification byprofessional boards is to be encouraged.The laboratory director or manager should be a full-timeemployee that operates the laboratory with at least the respon-sibilities outlined in 7.2.1.1-7.2.1.6.7.2.1.1 Establishment of long-term prog
35、ram plans andshorter term work plans and assignments to meet the programobjectives.7.2.1.2 Operation and maintenance of the physical plant(building, equipment, instrumentation, services, etc.).7.2.1.3 Selection, training, and development of personnel.D 3856 95 (Reapproval 2006)27.2.1.4 Overview and
36、approval of methods of sampling andanalyses.7.2.1.5 Development and implementation of a quality assur-ance (QA) program to monitor and maintain the quality oflaboratory performance. In larger laboratories, this function isfrequently delegated to an individual or organization separatefrom the laborat
37、ory operation. 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 demonstrate the worthof a good q
38、uality assurance program to upper management orregulator agencies. A QA program also provides each labora-tory staff member with a copy of the quality assurance plan forthe laboratory, which documents responsibilities and kind andfrequency of quality control checks. The plan should alsospecify the m
39、onitoring and overview responsibilities of man-agement.7.2.1.6 Establishment of a development and operationalperformance appraisal system for the staff and an individualcareer development plan for each staff member. Performancestandards should be developed and agreed to jointly by eachstaff member a
40、nd 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-the-job or off-site training. This joint development of performancestandards is key
41、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 perfor-mance. These standards should be used to evaluateperformance frequently but info
42、rmally, and formally on a lessfrequent (annual or semiannual) basis.7.2.2 Senior Staff The senior professional staff of thelaboratory conduct the difficult and non-routine sampling andanalyses, resolve analytical problems, and modify and developanalytical procedures.7.2.2.1 Senior staff supervise an
43、d assist the technical staff inanalyses, other laboratory operations and training.7.2.2.2 Senior staff members should have earned a bacca-laureate degree in science or engineering from an accreditedcollege or the equivalent (see Note 1) and have at least twoyears experience at the bench level in a w
44、ater laboratory.7.2.3 Technical Staff The technical staff are personnelwho perform routine and specialized sampling and analyses.7.2.3.1 Where appropriate, technical staff members shouldhave formal training in the sampling and analytical methodol-ogy, and quality control, as applied to the specific
45、sample typesand concentration levels of analytes which are of interest to thelaboratory.7.2.3.2 Technical staff may be required to satisfactorilycomplete analytical tests to qualify initially and to periodicallyrequalify throughout their work career. Qualification should bebased on the generation of
46、 analytical results with precision andbias recovery within limits known to be possible for theparticular method and which meet the data users requirements.7.2.4 Laboratory Support StaffThe support staff are non-technical workers who perform routine field and laboratoryservices in support of the prof
47、essional and technical staff. Inthe field, they may collect samples, and they may transport,handle and maintain records of collection and storage, includ-ing chain of custody. The support staff also maintains samplingand other field equipment.7.2.4.1 In the laboratory, they wash glassware, operatela
48、boratory reagent water systems, autoclaves, drying ovens,and incubators. The support staff also receives, stores, andships samples, materials, and laboratory equipment.7.2.5 Offce Support StaffThe office staff are nontechnicalclerical or secretarial personnel who are trained either on thejob or by f
49、ormal schooling in keyboarding, filing, recordkeep-ing, communications by telephone or personal visits, payroll,travel, or some combination thereof.7.2.5.1 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.7.3 Physical Resources and Related Operating Procedures:7.3.1 GeneralThe laboratory environment can signifi-cantly affect the results of water analyses; therefore, thelaboratory facility should be carefully designed and periodi-cally inspected and r
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