1、Designation: D 6809 02 (Reapproved 2007)Standard Guide forQuality Control and Quality Assurance Procedures forAromatic Hydrocarbons and Related Materials1This standard is issued under the fixed designation D 6809; the number immediately following the designation indicates the year oforiginal adoptio
2、n or, in the 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 contains non-mandatory Quality Assurance/Quality Control (QA/QC
3、) activities 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 c
4、oncerns, 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:2D 4790 Terminology of Aromatic Hydr
5、ocarbons and Re-lated ChemicalsE 177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE 691 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
6、3: Control 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,
7、expressed 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 de
8、terminations. D 47903.1.2 quality assurance, nthe general activity of provid-ing evidence needed to establish confidence that the qualityfunction is being effectively performed; may include qualityplanning, quality control, quality improvement, quality audit,and reliability. Jurans Quality Control H
9、andbook3.1.3 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 beconsi
10、dered for reference 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 Assuran
11、ce practices 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-related refer-ence, can be useful to optimally perform these
12、 methods.1This guide is under the jurisdiction of ASTM Committee D16 on AromaticHydrocarbons and Related Chemicals and is the direct responsibility of Subcom-mittee D16.06 on Statistical Procedure.Current edition approved June 1, 2007. Published June 2007. Originallyapproved in 2002. Last previous e
13、dition approved in 2002 as D 6809 - 02.2For 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.3Available from ASTM I
14、nternational, 100 Barr Harbor Drive, West Consho-hocken, PA 19428-2959.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available from McGraw-Hill Inc, St. Louis, MO.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, W
15、est Conshohocken, PA 19428-2959, United States.6. Quality Procedure Guidelines6.1 Statistical ControlTo establish the statistical controlstatus of the testing process since the last valid calibration,quality control (QC) samples should be regularly tested as ifthey were routine samples. Results shou
16、ld 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 corrective action.6.2 Selection of the QC SampleChoose an am
17、ple 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, interfering spe-cies, and analyte concentration/value. Primary s
18、tandard mate-rials may be used to characterize the precision and bias of themethod, as described in Practice E 177.6.3 Control ChartingUse any valid statistical chartingtechnique for variables (for example, individuals/range,CUSUM, subgroups, moving averages, etc., as described inMNL7) where appropr
19、iate.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-acceptable mean, and upper and lower control limits. Fe
20、werdata 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 E 691) wherepossible. If the QC test precision is considerably worse
21、 than theASTM method precision, continuous improvement activityshould be initiated to improve the QC test precision.6.5 Out-of-Control Data PointsAny QC sample datapoint outside the upper or lower control limits, or that violatesany other valid statistical rule being used in the facility (forexample
22、, 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 testing(for example, plant quality control), QC
23、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 sample testingis also recommended after a change is
24、 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 the validity of any patent rights asserted in co
25、nnection 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 is subject to revision at any time by the respo
26、nsible 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 Headquarters. Your comments will receive careful
27、 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 standard is copyrighted by ASTM International,
28、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).D 6809 02 (2007)2
