ASTM D5172-1991(2010)e1 Standard Guide for Documenting the Standard Operating Procedures Used for the Analysis of Water《水分析用标准操作程序文件编制的标准指南》.pdf

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1、Designation: D5172 91 (Reapproved 2010)1Standard Guide forDocumenting the Standard Operating Procedures Used forthe Analysis of Water1This standard is issued under the fixed designation D5172; the number immediately following the designation indicates the year oforiginal adoption or, in the case of

2、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.1NOTEEditorially added Section 7.2 in March 2010.1. Scope1.1 This guide addresses the need for each laborato

3、ryengaged in the analysis of water and wastewater to develop andmaintain an up-to-date written manual that clearly and com-pletely delineates the exact steps followed in performing everytest method and procedure used in the laboratory, that is, amanual of their standard operating procedures (SOPs).1

4、.2 This guide details the practices necessary to provideclear in-house SOPs and a mechanism whereby the normaldevelopment and evolution of an analytical test method orprocedure can be controlled and properly evaluated for incor-poration into the SOP used in that laboratory.1.3 This standard does not

5、 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 health practices and determine the applica-bility of regulatory limitations prior to use. Specific precau-tionary statements are g

6、iven in the note.2. Referenced Documents2.1 ASTM Standards:2D1129 Terminology Relating to Water3. Terminology3.1 DefinitionsFor definitions of terms used in this guide,refer to Terminology D1129.3.2 Definitions of Terms Specific to This Standard:3.2.1 procedure any process involving sequential steps

7、conducted to achieve a specific objective.4. Summary of Guide4.1 This guide describes suggested practices for developingand maintaining a current compilation of the complete andexact analytical test methods and procedures being used in aparticular laboratory.5. Significance and Use5.1 The exact anal

8、ytical test methods and procedures usedin any laboratory may be unique and affect the usability of theiranalytical results. A general reference to a book of standardanalytical test methods, guides, and practices published by areputable organization such as ASTM is not sufficient toguarantee acceptab

9、le results. As a point of clarification, aprocedure may be part of a test method or it may be any otherroutine process the laboratory personnel must follow, forexample, glassware cleaning, quality control, routine mainte-nance, or data reporting procedures.5.2 A significant part of the variability o

10、f results generatedby different laboratories analyzing the same samples and citingthe same general reference is due to differences in the way theanalytical test methods and procedures are actually performedin each laboratory. These differences are often caused by theslight changes or adjustments all

11、owed by the general reference,but that can affect the final results.5.3 The manual of SOPs is an important component of anylaboratorys quality assurance program. As with all qualityassurance activities, the importance of this manual lies in itsimpact on maintaining uniformity of test method performa

12、nceand the utility of data generated by the laboratory.5.4 Each laboratory should develop and maintain a loose-leaf manual containing an exact step-by-step description ofhow every test method and procedure is performed in thelaboratory to help guarantee uniform performance amongdifferent analysts us

13、ing them.1This guide is under the jurisdiction of ASTM Committee D19 on Water and isthe direct responsibility of Subcommittee D19.02 on Quality Systems, Specification,and Statistics.Current edition approved Feb. 1, 2010. Published March 2010. Originallyapproved in 1991. Last previous edition approve

14、d in 2004 as D5172 91 (2004).DOI: 10.1520/D5172-91R10.2For 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 ASTM website.1Copyri

15、ght ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.5 With adequate documentation of a laboratorys com-plete and exact analytical test methods and procedures, alaboratory will have improved confidence in its ability toreproduce analytical con

16、ditions exactly and thereby generalreproducible results. This manual of SOPs is the cornerstone ofa laboratorys creditability.6. Suggested Steps for Generating a Manual of SOPs6.1 The manual should begin with specification of thepublished references from a standard-setting organization orregulatory

17、agency. An adequate written SOP should then bedrafted in-house for each test method or procedure performedby the laboratory. A standard format should be used that isappropriate to the SOP and is similar in scope to the formatsincluded in this guide as Annex A1 and Annex A2. All aspectsof the test me

18、thod or procedure as actually applied in thelaboratory should be addressed in detail.NOTE 1Caution: When a laboratory is performing an analyticalprocedure in a regulatory or legal environment, it is of vital importancethat the in-house version be maintained within the technical allowances ofthe mand

19、ated procedure. Technical departures from the mandated proce-dure may result in a legal liability. One way to demonstrate consistencywith the mandated procedure is to copy the standard procedure aspublished and add footnotes to fully document the specific in-houseversion.6.2 The basic structure and

20、elements of a test method aretypically present in consensus standards published by groupssuch as ASTM. But, invariably, these published test methodsand procedures must be interpreted for application in eachlaboratory. Published versions of other test methods andprocedures are often very general or c

21、ompletely unavailable.6.3 In generating a draft SOP, it is often helpful to solicitinput from analysts experienced with a test method or proce-dure who are familiar with its vagaries and pitfalls, and canprovide valuable assistance in writing a complete and exactdocument on how the procedure is done

22、 in the laboratory. It isoften useful to have all of the analytical staff review the finaldraft.6.4 After an initial draft to identify the pertinent details ofan SOP, the laboratory should conduct a study to verify itsapplicability to the sample matrices encountered in that par-ticular laboratory. I

23、n addition, the laboratory should verify thatit can, at a minimum, obtain results with precision and biasequivalent to those in published references (if available forsimilar matrices). The precision and bias obtained in the studyshould be recorded for future use relating to evaluation ofquality cont

24、rol (QC) data from the sample matrices studied.6.4.1 This process of verifying the utility of an SOP forgiven sample types is called “method validation” and eachlaboratory needs an SOP detailing how this process is done inthat laboratory. It is a process that should be performedwhenever a new SOP is

25、 first put into practice or whenever anSOP is to be modified or used on new sample matrices.6.5 When the test method involves the selection of variousoptions depending on the sample matrix, it should be organizedinto subsections dealing with each of the optional paths. Eachoptional approach should b

26、e treated as a separate SOP. Mecha-nisms should be established whereby the exact proceduresemployed to generate a result can be identified at a later time.In cases where subsections of a test method for a single analytereflect substantially different chemical bases, a completelyseparate SOP should b

27、e generated from each of these subsec-tions.6.6 The final version should be annotated with an effectivedate, revision number, page numbers out of total number ofpages, and the author(s). The effective date is the date when itwas first used to produce actual data. The final version and allsubsequent

28、revisions should be approved and signed by thelaboratory manager and the quality assurance officer or theirdesignees, and distributed to all analysts for bench use.7. Centralized Files7.1 A master copy of the laboratorys SOPs should be kepton-file under the control of the quality assurance officer.W

29、henever a procedure is modified, the revised version shouldbe documented and the changes highlighted. Copies of therevised SOP should be distributed to the staff to replace theprevious version, that they should destroy, and a new effectivedate for the revision and a revised copy of the SOP should be

30、added to the master file along with an explanation of why therevision was necessary. Out-of-date versions of an SOP shouldbe filed separately by the QA officer for future reference.Through use of such an updating mechanism, the laboratorywill be able to identify the exact procedure being followed at

31、the time a particular result was generated.7.2 Alaboratorys SOPs may be managed through the use ofelectronic documents. Whether through a paper system orelectronic files, the key issue is that there is one, and only one,official SOP document at any moment. “Bench” copies of anSOP or analytical pract

32、ice in the Lab should be referenced tothis official document. If electronic or “computerized” SOPdocuments are employed, they must be adequately controlledwith limited access to assure their integrity.8. Suggested Use and Maintenance8.1 While performing an SOP, the analyst should have acopy of the c

33、urrent documentation readily at-hand and followit to the letter. If the SOP allows for multiple options, theoption employed should be noted with the final results.8.2 When an analyst encounters a situation for which noclear direction is provided in the SOP, possible changes shouldbe discussed with a

34、 qualified supervisor, and approved anddocumented before use.8.3 Records should be maintained of the distribution of thelaboratorys SOPs and their revisions.9. Procedure Audits9.1 For a variety of reasons, procedures as they are actuallyapplied in the laboratory have a tendency to drift away from th

35、eapproved written versions. For this reason, the actual perfor-mance of each analyst while performing a test method orprocedure should be audited by the responsible supervisor orthe quality assurance officer, or both, on a periodic basis,ideally not less than once per year and more frequently during

36、analysts initial training period. Any deviations from thewritten SOP should be noted and evaluated. The analystsperformance should be corrected or the SOP should be modi-fied to incorporate the deviations. When the deviations areD5172 91 (2010)12deemed to be inappropriate, the SOP should be annotate

37、d tospecifically exclude the noted deviation.10. Responsibility for Improvement10.1 Analytical methods and procedures are not static,finished products; they are continually modified in response tochanging demands or to improve performance or efficiency.Every laboratory should emphasize the responsib

38、ility of itsprofessional staff to monitor pertinent scientific publicationsfor new developments relevant to the SOPs under theirjurisdiction.11. Keywords11.1 analysis; documenting; procedure; standard operatingprocedureANNEXES(Mandatory Information)A1. SUGGESTED FORMAT FOR A TEST METHOD SOPA1.1 Reco

39、rd of Approval and UpdateInclude the follow-ing information:Approvals: Laboratory Manager_ Date _QA Officer _ Date _Revision No. _ by _ Effective Date _Total Pages _ Pages Revised _A1.2 TitleThe property, analyte, or class of compoundsbeing measured. It is also useful to include any laboratorycodes

40、used to refer to this test method.A1.3 Principal Reference(s)Apublished reference(s) thatdefines the basic analytical method.A1.4 Scope of ApplicationTypes of sample matrices andthe analytical range to which this test method can be applied.A1.5 Summary of Test MethodA short description high-lighting

41、 the definitive chemical and procedural elements of thetest method.A1.6 InterferencesA general overview of the kinds ofmatrices that cause unacceptable performance and the generalmechanisms for compensating for them. The specific steps fordealing with interferences should be incorporated in theproce

42、dure portion of the test method as options defining aunique method.A1.7 Sample HandlingItemize any concerns relating toproper handling of samples after they are received for analysis.Specifically indicate holding times, storage procedures, andpreservation procedure (applied at or prior to receipt).A

43、1.8 Apparatus:A1.8.1 InstrumentsSpecify model and make.A1.8.2 LabwareSpecify preparation and conditioning,class, assembly instructions, diagrams, etc.A1.9 Chemicals and ReagentsA listing of requiredchemicals, purity grade; instructions for reagent makeup;standardizing, storing, and disposing of reag

44、ents; reagent andchemical shelf life.A1.10 SafetyIdentify at each point in the test methodwhere safety precautions are to be observed; reference thissection or a safety manual.A1.11 ProcedureA detailed description of each stepconsidered essential to the reproducibility and accuracy of thetest method

45、 as actually carried out in the laboratory. Includecalibration procedures. Re-analysis sample preparation stepsshould be specified.A1.12 Short Hand ProcedureA condensed version of thetest method that can be used for quick reference.A1.13 CalculationA description of the mathematicalsteps required to

46、complete the analysis. Include sample calcu-lations and the number of significant figures to report. It is alsohelpful to include a sample of the analytical bench form.A1.14 Data ManagementSpecific instructions on howand where data should be reported, and on what, how, andwhere data should be stored

47、.A1.15 Quality Assurance and Quality Control:A1.15.1 Itemize desirable and mandatory quality assuranceprocedures specific to this test method, especially equipmentand reagent checks, recalibrations, and other system checksthat should be done routinely. This section should be refer-enced in the proce

48、dure section (see A1.11).A1.15.2 Specify statistical quality control parameters: batchsize, reference materials, frequencies, data handling. Thisshould also be referenced in the procedure section (see A1.11).A1.15.3 Lowest Reporting LevelThe concentration belowwhich all results are reported as “less

49、 than,” based on thespecified procedure and sample size. The laboratory shouldadopt a uniform system for determining this limit.A1.15.4 Precision and Bias StatementsA tabulation ofthese statistics as determined using this test method in yourlaboratory, by matrix and concentration level.A1.16 ReferencesA listing of published documents sup-porting the specifics of this test method.A1.17 AppendixesCopies of documents, tables, or graphsthat would be useful to hav