ASTM D6809-2002(2016) 0297 Standard Guide for Quality Control and Quality Assurance Procedures for Aromatic Hydrocarbons and Related Materials《芳烃和相关材料的质量控制和质量保证程序的标准指南》.pdf

1、Designation: D6809 02 (Reapproved 2016)Standard Guide forQuality Control and Quality Assurance Procedures forAromatic Hydrocarbons and Related Materials1This standard is issued under the fixed designation D6809; the number immediately following the designation indicates the year oforiginal adoption

2、or, in the case of 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.1. Scope1.1 This guide contains non-mandatory Quality Assurance/Quality Control (QA/QC) a

3、ctivities that may be referenced instandards maintained by ASTM Committee D16 on AromaticHydrocarbons and Related Materials.1.2 This guide does not purport to address all of the issuesthat may be pertinent to an active QA/QC process.1.3 This standard does not purport to address all of thesafety conc

4、erns, 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 requirements prior to use.2. Referenced Documents2.1 ASTM Standards:2D4790 Terminology of Aromatic Hydrocar

5、bons and RelatedChemicalsE177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Method2.2 ASTM Document:MNL7 Manual on Presentation of Data Control ChartAnalysis, 6th Edition, Section 3: Contr

6、ol Charts forIndividuals32.3 Other Documents:Western Electric Company, Inc. Statistical Quality ControlHandbook (1982)4Jurans Quality Control Handbook Fourth Edition (1988)53. Terminology3.1 Definitions:3.1.1 precision, nthe degree of agreement of repeatedmeasurement of the same property, expressed

7、in terms ofdispersion of test results about an arithmetical mean resultobtained by repetitive testing of a homogeneous sample underspecified conditions. The precision of a test method is ex-pressed quantitatively as a standard deviation computed fromthe results of a series of controlled determinatio

8、ns. D47903.1.2 quality assurance, nthe general activity of providingevidence needed to establish confidence that the quality func-tion is being effectively performed; may include qualityplanning, quality control, quality improvement, quality audit,and reliability. Jurans Quality Control Handbook3.1.

9、3 quality control, nthe specific tools, skills, or tech-niques through which the quality function is carried out, can bepart of a control process, for example, product inspection.Jurans Quality Control Handbook4. Summary of Guide4.1 This guide contains non-mandatory information to beconsidered for r

10、eference in all ASTM Committee D16 stan-dards on aromatic hydrocarbons and related materials. Thisinformation is provided as a QA/QC system guide for D16standard users who do not have an active QA/QC process intheir laboratory.5. Significance and Use5.1 Quality Control and Quality Assurance practice

11、s areimportant for the optimum operation of testing laboratoriesusing D16 methods for aromatic hydrocarbons and relatedmaterials. Quality procedure guidelines, like those described inthis document or other suitably correct QA/QC-relatedreference, can be useful to optimally perform these methods.6. Q

12、uality Procedure Guidelines6.1 Statistical ControlTo establish the statistical controlstatus of the testing process since the last valid calibration,1This guide is under the jurisdiction of ASTM Committee D16 on AromaticHydrocarbons and Related Chemicals and is the direct responsibility of Subcom-mi

13、ttee D16.06 on Statistics and Quality.Current edition approved Nov. 1, 2016. Published November 2016. Originallyapproved in 2002. Last previous edition approved in 2012 as D6809 02 (2012).DOI: 10.1520/D6809-02R16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Cu

14、stomer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from ASTM International, 100 Barr Harbor Drive, WestConshohocken, PA 19428-2959, www.astm.org.4Available from American Society for Qualit

15、y (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available from McGraw-Hill Education, Columbus, OH, 43218, http:/.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1quality control (QC) samples should be regularly

16、 tested as ifthey were routine samples. Results should be recorded andimmediately analyzed by control charts, as described in MNL7,or other statistically equivalent techniques. Any out-of-controldata should provide an immediate trigger for an investigationof root cause(s) that might require correcti

17、ve action.6.2 Selection of the QC SampleChoose an ample quantityof a homogeneous material that is representative of thesample(s) routinely being tested with the testing process, andcapable of being stored without degradation over the intendedperiod of use. Carefully consider the matrix, interferings

18、pecies, and analyte concentration/value. Primary standardmaterials may be used to characterize the precision and bias ofthe method, as described in Practice E177.6.3 Control ChartingUse any valid statistical chartingtechnique for variables (for example, individuals/range,CUSUM, subgroups, moving ave

19、rages, etc., as described inMNL7) where appropriate.6.4 QC Material StatisticsObtain a minimum of 16 datapoints (24 is better) when a new QC material is started or anexisting QC material requires replacement (for example, due tocontamination or depleted supply), to establish a statistically-acceptab

20、le mean, and upper and lower control limits. Fewerdata points will produce less acceptable control determinations,and are acceptable only if absolutely necessary. QC materialtesting precision should be compared periodically with ASTMmethod precision (as developed using Practice E691) wherepossible.

21、If the QC test precision is considerably worse than theASTM method precision, continuous improvement activityshould be initiated to improve the QC test precision.6.5 Out-of-Control Data PointsAny QC sample data pointoutside the upper or lower control limits, or that violates anyother valid statistic

22、al rule being used in the facility (forexample, Western Electric SQC Handbook), should be consid-ered out-of-control. Such a result should trigger an investiga-tion to determine the root cause, and the implementation ofappropriate corrective action(s).6.6 Frequency of QC Sample TestingFor routine te

23、sting(for example, plant quality control), QC testing frequency isdependent on the criticality of the parameter being measured,the demonstrated stability of the testing process, and customerrequirements. Generally, QC samples should be analyzed at adefined frequency with samples. Additional QC sampl

24、e testingis also recommended after a change is made relating to themethod (for example, replenishment of reagents, change ofanalyst, maintenance of instrument, etc.). For non-routinetesting (for example, R quality; quality assurance; qual-ity controlASTM International takes no position respecting th

25、e validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard i

26、s subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International He

27、adquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This s

28、tandard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 02 (2016)2