ASTM D6792-17 Standard Practice for Quality Management Systems in Petroleum Products, Liquid Fuels, and Lubricants Testing Laboratories.pdf

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1、Designation: D6792 17 An American National StandardStandard Practice forQuality Management Systems in Petroleum Products, LiquidFuels, and Lubricants Testing Laboratories1This standard is issued under the fixed designation D6792; the number immediately following the designation indicates the year of

2、original adoption 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. Scope*1.1 This practice covers the establishment and maintenanceof t

3、he essentials of a quality management system in laborato-ries engaged in the analysis of petroleum products, liquid fuels,and lubricants. It is designed to be used in conjunction withPractice D6299.NOTE 1This practice is based on the quality management conceptsand principles advocated in ANSI/ISO/AS

4、Q Q9000 standards, ISO/IEC17025, ASQ Manual,2and ASTM standards such as D3244, D4182,D4621, D6299, D6300, D7372, E29, E177, E456, E548, E882, E994,E1301, E1323, STP 15D,3and STP 1209.41.2 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is ther

5、esponsibility 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.1.3 This international standard was developed in accor-dance with internationally recognized principles on standard-ization establ

6、ished in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:5D86 Test Method for Distillation of Petroleum Products andLiquid

7、 Fuels at Atmospheric PressureD3244 Practice for Utilization of Test Data to DetermineConformance with SpecificationsD4057 Practice for Manual Sampling of Petroleum andPetroleum ProductsD4182 Practice for Evaluation of Laboratories UsingASTMProcedures in the Sampling and Analysis of Coal andCoke (Wi

8、thdrawn 2010)6D4621 Guide for Quality Management in an OrganizationThat Samples or Tests Coal and Coke (Withdrawn 2010)6D5191 Test Method for Vapor Pressure of Petroleum Prod-ucts (Mini Method)D5842 Practice for Sampling and Handling of Fuels forVolatility MeasurementD5854 Practice for Mixing and Ha

9、ndling of Liquid Samplesof Petroleum and Petroleum ProductsD6299 Practice for Applying Statistical Quality Assuranceand Control Charting Techniques to Evaluate AnalyticalMeasurement System PerformanceD6300 Practice for Determination of Precision and BiasData for Use in Test Methods for Petroleum Pro

10、ducts andLubricantsD6617 Practice for Laboratory Bias Detection Using SingleTest Result from Standard MaterialD6708 Practice for Statistical Assessment and Improvementof Expected Agreement Between Two Test Methods thatPurport to Measure the Same Property of a MaterialD7372 Guide for Analysis and Int

11、erpretation of ProficiencyTest Program ResultsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE456 Terminology Relating to Quality and StatisticsE548 Guide for General Criteria

12、Used for Evaluating Labo-ratory Competence (Withdrawn 2002)6E882 Guide for Accountability and Quality Control in theChemical Analysis LaboratoryE994 Guide for Calibration and Testing LaboratoryAccredi-tation Systems General Requirements for Operation and1This practice is under the jurisdiction of AS

13、TM Committee D02 on PetroleumProducts, Liquid Fuels, and Lubricants and is the direct responsibility of Subcom-mittee D02.94 on Coordinating Subcommittee on Quality Assurance and Statistics.Current edition approved May 1, 2017. Published June 2017. Originallyapproved in 2002. Last previous edition a

14、pproved in 2013 as D6792 13. DOI:10.1520/D6792-17.2“Quality Assurance for The Chemical and Process Industries: A Manual ofGood Practices,” 1987, available fromAmerican Society for Quality (ASQ), 600 N.Plankinton Ave., Milwaukee, WI 53203. www.asq.org.3ASTM STP 15D, ASTM Manual on Presentation of Dat

15、a and Control ChartAnalysis, ASTM International, W. Conshohocken, PA.4ASTM STP 1209, ASTM Manual on Total Quality Management, ASTMInternational, W. Conshohocken, PA.5For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Bo

16、ok of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.6The last approved version of this historical standard is referenced onwww.astm.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor D

17、rive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations

18、issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1Mon Apr 30 24 Recognition (Withdrawn 2003)6E1301 Guide for Proficiency Testing by InterlaboratoryComparisons (Withdrawn 2012)6E1323 Guide for Evaluating Laboratory Measurement Prac-tices and the Statistical Analysis

19、of the Resulting Data2.2 ISO Standards:7ISO Guide 30 Terms and Definitions Used in Connectionwith Reference MaterialsISO/IEC 17025 General Requirements for the Competenceof Testing and Calibration LaboratoriesISO 4259 Petroleum ProductsDetermination and Applica-tion of Precision Data in Relation to

20、Methods of TestANSI/ISO/ASQ Q9000 Quality Management System Stan-dards2.3 Other Standards:40 CFR 80 Regulation of Fuels and Fuel Additives83. Terminology3.1 Definitions:3.1.1 accepted reference value, ARV, n a value that servesas an agreed upon reference for comparison, and which isderived as: (1) a

21、 theoretical or established value, based onscientific principles, (2) an assigned value, based on experi-mental work of some national or international organizationsuch as the U.S. National Institute of Standards and Technol-ogy (NIST), or (3) a consensus value, based on collaborativeexperimental wor

22、k under the auspices of a scientific orengineering group. E4563.1.2 accuracy, nthe closeness of agreement between atest result and an accepted reference value. E4563.1.3 audit, na systematic examination of a laboratorysquality management system documentation and related activi-ties by an internal or

23、 external team to determine conformanceto the applicable quality management system standard, such asdescribed in this practice.3.1.4 bias, nthe difference between the population meanof the test results and an accepted reference value. E4563.1.5 calibration standard, na material with a certifiedvalue

24、 for a relevant property, issued by or traceable to anational organization such as NIST, and whose properties areknown with sufficient accuracy to permit its use to evaluate thesame property of another sample.3.1.6 certified reference material, CRM, n a referencematerial one or more of whose propert

25、y values are certified bya technically valid procedure, accompanied by a traceablecertificate or other documentation which is issued by a certi-fying body. ISO Guide 303.1.7 measurand, nthe measurable quantity subject tomeasurement.3.1.8 outlier, na result far enough in magnitude from otherresults s

26、o as to be considered not a part of the set. D63003.1.9 precision, nthe closeness of agreement between testresults obtained under prescribed conditions. E4563.1.10 proficiency testing, ndetermination of a laborato-rys testing capability by evaluating its test results in interlabo-ratory exchange tes

27、ting or crosscheck programs.3.1.10.1 DiscussionOne example is the ASTM D02 com-mittees proficiency testing programs in a wide variety ofpetroleum products and lubricants, many of which may involvemore than a hundred laboratories.3.1.11 quality assurance (QA), na system of activities, thepurpose of w

28、hich is to provide to the producer and user of aproduct, measurement, or service the assurance that it meetsthe defined standards of quality with a stated level of confi-dence.3.1.11.1 DiscussionQuality assurance includes qualityplanning and quality control.3.1.12 quality control (QC), na planned sy

29、stem of activi-ties whose purpose is to provide a level of quality that meetsthe needs of users; also the uses of such a system.3.1.13 quality control sample (QC sample), n for use inquality assurance program to determine and monitor theprecision and stability of a measurement system; a stable andho

30、mogenous material having physical or chemical properties,or both, similar to those of typical samples tested by theanalytical measurement system. The material is properly storedto ensure sample integrity, and is available in sufficient quantityfor repeated long-term testing. D62993.1.14 reference ma

31、terial (RM), na material with acceptedreference value(s), accompanied by an uncertainty at a statedlevel of confidence for desired properties, which may be usedfor calibration or quality control purposes in the laboratory.3.1.14.1 DiscussionSometimes these may be prepared“in-house” provided the refe

32、rence values are established usingaccepted standard procedures.3.1.15 repeatability, nthe quantitative expression of therandom error associated with a single operator in a givenlaboratory obtaining repetitive results with the same apparatusunder constant operating conditions on identical test materi

33、al.It is defined as the difference between two such results at the95 % confidence level. D63003.1.16 reproducibility, na quantitative expression of therandom error associated with different operators using differentapparatus, and so forth, each obtaining a single result on anidentical test sample wh

34、en applying the same method. It is thendefined as the 95 % confidence limit for the difference betweentwo such single and independent results. D63003.1.17 site precision (R), nthe value below which theabsolute difference between two individual test results obtainedunder site precision conditions may

35、 be expected to occur witha probability of approximately 0.95 (95 %). It is defined as 2.77times the standard deviation of results obtained under siteprecision conditions. D62993.1.18 site precision conditions, nconditions under whichtest results are obtained by one or more operators in a singlesite

36、 location practicing the same test method on a singlemeasurement system using test specimens taken at random7Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.8Available from U.S. Government Printing Office, Superintendent o

37、fDocuments, 732 N. Capitol St., NW, Washington, DC 20401-0001, http:/www.access.gpo.gov.D6792 172Mon Apr 30 24 from the same sample of material over an extended period oftime spanning at least a 15 day interval. D62993.1.19 traceability, nproperty of the result of a measure-ment or the value of a st

38、andard whereby it can be related tostated references, usually national or international standards,through an unbroken chain of comparisons all having stateduncertainties.3.2 Definitions of Terms Specific to This Standard:3.2.1 precision ratio (PR), nan estimate of relative mag-nitude of repeatabilit

39、y and reproducibility. The PR for a givenstandard test method can provide information on the relativesignificance between variation caused by different operatorsand laboratories compared to a single operator in a laboratoryperforming the standard test method.3.2.2 test performance index (TPI), nan a

40、pproximate mea-sure of a laboratorys testing capability, defined as the ratio oftest method reproducibility (R) to site precision (R).3.3 Acronyms:3.3.1 NISTNational Institute of Standards andTechnology, Gaithersburg, MD.4. Significance and Use4.1 A petroleum products, liquid fuels, and lubricants t

41、est-ing laboratory plays a crucial role in product quality manage-ment and customer satisfaction. It is essential for a laboratoryto provide quality data. This document provides guidance forestablishing and maintaining a quality management system ina laboratory.4.1.1 The word customer can refer to b

42、oth customersinternal and external to the laboratory or organization.5. General Quality Requirements for the Laboratory5.1 Establishment and maintenance of a quality manage-ment system shall include stated objectives in the followingareas: a laboratorys adherence to test method requirements,calibrat

43、ion and maintenance practices, and its quality controlprogram. Laboratory quality objectives should encompass thelaboratorys continuous improvement goals as well as meetingcustomer requirements.5.2 Management shall appoint a representative to imple-ment and maintain the quality management system in

44、thelaboratory.5.3 Laboratory management shall review the adequacy ofthe quality management system and the activities of thelaboratory for consistency with the stated quality objectives atleast annually.5.4 The quality management system shall have documentedprocesses for:5.4.1 Sampling and sample man

45、agement (see Section 6),5.4.2 Data and record management (see Section 7),5.4.3 Control and implementation of test methods (seeSection 8),5.4.4 Equipment calibration and maintenance (see Section9),5.4.5 Quality control (see Section 10),5.4.6 Audits and proficiency testing (see Section 11),5.4.7 Corre

46、ctive and preventive action (see Section 13),5.4.8 Handling of customer complaints (see Section 14),5.4.9 Ensuring that procured services and materials meet thecontracted requirements, and5.4.10 Ensuring that personnel are adequately trained toobtain quality results (see Section 15).6. Sampling and

47、Sample Management6.1 When samples are obtained by laboratory staff, thesesamples shall be obtained in accordance with applicableindustry standards.6.2 The elements of sample management shall include at aminimum:6.2.1 Procedures for unique identification of samples sub-mitted to the laboratory.6.2.2

48、Criteria for sample acceptance.6.2.3 Procedures for sample handling.6.2.3.1 In cases where industry standards for sample han-dling (for example, Practoce D5854) are applicable and refer-enced within industry standard test methods, they shall beutilized.6.2.4 Procedures for sample storage and retenti

49、on. Items toconsider when creating these procedures include:6.2.4.1 Applicable governmentlocal, state, or nationalregulatory requirements or customer contract agreements.6.2.4.2 Type of sample containers required to preserve thesample,6.2.4.3 Control of access to the retained samples to protecttheir validity and preserve their original integrity,6.2.4.4 Storage conditions,6.2.4.5 Required safety precautions, and6.2.4.6 Customer requirements.6.2.5 Procedures for sample disposal in accordance withapplicable government regulatory requi