1、Designation: D6792 13D6792 17 An American National StandardStandard Practice forQuality System Management Systems in PetroleumProducts Products, Liquid Fuels, and Lubricants TestingLaboratories1This standard is issued under the fixed designation D6792; the number immediately following the designatio
2、n indicates the year oforiginal 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 establishm
3、ent and maintenance of the essentials of a quality management system in laboratoriesengaged in the analysis of petroleum products products, liquid fuels, and lubricants. It is designed to be used in conjunction withPractice D6299.NOTE 1This practice is based on the quality management concepts and pr
4、inciples advocated in ANSI/ISO/ASQ Q9000 standards, ISO/IEC 17025,ASQ Manual,2 and ASTM standards such as D3244, D4182, D4621, D6299, D6300, D7372, E29, E177, E456, E548, E882, E994, E1301, E1323, STP15D,3 and STP 1209.41.2 This standard does not purport to address all of the safety concerns, if any
5、, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatoryrequirements prior to use.1.3 This international standard was developed in accordance with internationally recognized prin
6、ciples on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:5D86 Test Method for Distillation
7、of Petroleum Products and Liquid Fuels at Atmospheric PressureD3244 Practice for Utilization of Test Data to Determine Conformance with SpecificationsD4057 Practice for Manual Sampling of Petroleum and Petroleum ProductsD4182 Practice for Evaluation of Laboratories Using ASTM Procedures in the Sampl
8、ing and Analysis of Coal and Coke(Withdrawn 2010)6D4621 Guide for Quality Management in an Organization That Samples or Tests Coal and Coke (Withdrawn 2010)6D5191 Test Method for Vapor Pressure of Petroleum Products (Mini Method)D5842 Practice for Sampling and Handling of Fuels for Volatility Measur
9、ementD5854 Practice for Mixing and Handling of Liquid Samples of Petroleum and Petroleum ProductsD6299 Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measure-ment System PerformanceD6300 Practice for Determination of Precision and Bias Data
10、 for Use in Test Methods for Petroleum Products and LubricantsD6617 Practice for Laboratory Bias Detection Using Single Test Result from Standard MaterialD6708 Practice for Statistical Assessment and Improvement of Expected Agreement Between Two Test Methods that Purportto Measure the Same Property
11、of a MaterialD7372 Guide for Analysis and Interpretation of Proficiency Test Program Results1 This practice is under the jurisdiction of ASTM Committee D02 on Petroleum Products, Liquid Fuels, and Lubricants and is the direct responsibility of SubcommitteeD02.94 on Coordinating Subcommittee on Quali
12、ty Assurance and Statistics.Current edition approved May 15, 2013May 1, 2017. Published July 2013June 2017. Originally approved in 2002. Last previous edition approved in 20072013 asD6792 07.D6792 13. DOI: 10.1520/D6792-13.10.1520/D6792-17.2 “QualityAssurance for The Chemical and Process Industries:
13、AManual of Good Practices,” 1987, available fromAmerican Society for Quality (ASQ), 600 N. PlankintonAve., Milwaukee, WI 53203. www.asq.org.3 ASTM STP 15D, ASTM Manual on Presentation of Data and Control Chart Analysis, ASTM International, W. Conshohocken, PA.4 ASTM STP 1209, ASTM Manual on Total Qu
14、ality Management, ASTM International, W. Conshohocken, PA.5 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.6 T
15、he last approved version of this historical standard is referenced on www.astm.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to ade
16、quately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of this standardCopyright ASTM
17、 International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1E29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE177 Practice for Use of the Terms Precision and Bias in ASTM Test MethodsE456 Terminology Relating t
18、o Quality and StatisticsE548 Guide for General Criteria Used for Evaluating Laboratory Competence (Withdrawn 2002)6E882 Guide for Accountability and Quality Control in the Chemical Analysis LaboratoryE994 Guide for Calibration and Testing LaboratoryAccreditation Systems General Requirements for Oper
19、ation and Recognition(Withdrawn 2003)6E1301 Guide for Proficiency Testing by Interlaboratory Comparisons (Withdrawn 2012)6E1323 Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data2.2 ISO Standards:7ISO Guide 30 Terms and Definitions Used in Connec
20、tion with Reference MaterialsISO/IEC 17025 General Requirements for the Competence of Testing and Calibration LaboratoriesISO 4259 Petroleum ProductsDetermination and Application of Precision Data in Relation to Methods of TestANSI/ISO/ASQ Q9000 Quality Management System Standards2.3 Other Standards
21、:40 CFR 80 Regulation of Fuels and Fuel Additives83. Terminology3.1 Definitions:3.1.1 accepted reference value, ARV, n a value that serves as an agreed upon reference for comparison, and which is derivedas: (1) a theoretical or established value, based on scientific principles, (2) an assigned value
22、, based on experimental work of somenational or international organization such as the U.S. National Institute of Standards and Technology (NIST), or (3) a consensusvalue, based on collaborative experimental work under the auspices of a scientific or engineering group. E4563.1.2 accuracy, nthe close
23、ness of agreement between a test result and an accepted reference value. E4563.1.3 audit, na systematic examination of a laboratoryslaboratorys quality management system proceduredocumentation andrelated activities by an internal or external team to determine whether these procedures or activities a
24、re implemented accordingto the documented system.conformance to the applicable quality management system standard, such as described in this practice.3.1.4 bias, nthe difference between the population mean of the test results and an accepted reference value. E4563.1.5 calibration standard, na materi
25、al with a certified value for a relevant property, issued by or traceable to a nationalorganization such as NIST, and whose properties are known with sufficient accuracy to permit its use to evaluate the same propertyof another sample.3.1.6 certified reference material, CRM, n a reference material o
26、ne or more of whose property values are certified by atechnically valid procedure, accompanied by a traceable certificate or other documentation which is issued by a certifying body.ISO Guide 303.1.7 measurand, nthe measurable quantity subject to measurement.3.1.8 outlier, na result far enough in ma
27、gnitude from other results so as to be considered not a part of the set. D63003.1.9 precision, nthe closeness of agreement between test results obtained under prescribed conditions. E4563.1.10 proficiency testing, ndetermination of a laboratorys testing capability by evaluating its test results in i
28、nterlaboratoryexchange testing or crosscheck programs.3.1.10.1 DiscussionOne example is the ASTM D02 committees proficiency testing programs in a wide variety of petroleum products and lubricants,many of which may involve more than a hundred laboratories.3.1.11 quality assurance (QA), na system of a
29、ctivities, the purpose of which is to provide to the producer and user of aproduct, measurement, or service the assurance that it meets the defined standards of quality with a stated level of confidence.3.1.11.1 DiscussionQuality assurance includes quality planning and quality control.3.1.12 quality
30、 control (QC), na planned system of activities whose purpose is to provide a level of quality that meets the needsof users; also the uses of such a system.7 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.8 Available from
31、 U.S. Government Printing Office, Superintendent of Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http:/www.access.gpo.gov.D6792 1723.1.13 quality control sample (QC sample), n for use in quality assurance program to determine and monitor the precision andstability of a measurement s
32、ystem; a stable and homogenous material having physical or chemical properties, or both, similar tothose of typical samples tested by the analytical measurement system. The material is properly stored to ensure sample integrity,and is available in sufficient quantity for repeated long-term testing.
33、D62993.1.14 reference material (RM), na material with accepted reference value(s), accompanied by an uncertainty at a stated levelof confidence for desired properties, which may be used for calibration or quality control purposes in the laboratory.3.1.14.1 DiscussionSometimes these may be prepared “
34、in-house” provided the reference values are established using accepted standard procedures.3.1.15 repeatability, nthe quantitative expression of the random error associated with a single operator in a given laboratoryobtaining repetitive results with the same apparatus under constant operating condi
35、tions on identical test material. It is defined asthe difference between two such results at the 95 % confidence level. D63003.1.16 reproducibility, na quantitative expression of the random error associated with different operators using differentapparatus, and so forth, each obtaining a single resu
36、lt on an identical test sample when applying the same method. It is then definedas the 95 % confidence limit for the difference between two such single and independent results. D63003.1.17 site precision (R), nthe value below which the absolute difference between two individual test results obtained
37、 undersite precision conditions may be expected to occur with a probability of approximately 0.95 (95 %). It is defined as 2.77 times thestandard deviation of results obtained under site precision conditions. D62993.1.18 site precision conditions, nconditions under which test results are obtained by
38、 one or more operators in a single sitelocation practicing the same test method on a single measurement system using test specimens taken at random from the samesample of material over an extended period of time spanning at least a 15 day interval. D62993.1.19 traceability, nproperty of the result o
39、f a measurement or the value of a standard whereby it can be related to statedreferences, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties.3.2 Definitions of Terms Specific to This Standard:3.2.1 precision ratio (PR), nan estimate
40、of relative magnitude of repeatability and reproducibility. The PR for a given standardtest method can provide information on the relative significance between variation caused by different operators and laboratoriescompared to a single operator in a laboratory performing the standard test method.3.
41、2.2 test performance index (TPI), nan approximate measure of a laboratorys testing capability, defined as the ratio of testmethod reproducibility (R) to site precision.precision (R).3.3 Acronyms:3.3.1 NISTNational Institute of Standards and Technology (formerly called National Bureau of Standards),
42、Technology,Gaithersburg, MD.4. Significance and Use4.1 A petroleum products products, liquid fuels, and lubricants testing laboratory plays a crucial role in product qualitymanagement and customer satisfaction. It is essential for a laboratory to provide quality data. This document provides guidance
43、for establishing and maintaining a quality management system in a laboratory.4.1.1 The word customer can refer to both customers internal and external to the laboratory or organization.5. General Quality Requirements for the Laboratory5.1 Establishment and maintenance of a quality management system
44、shall include stated objectives in the following areas: alaboratorys adherence to test method requirements, calibration and maintenance practices, and its quality control program.Laboratory quality objectives should encompass the laboratorys continuous improvement goals as well as meeting customerre
45、quirements.5.2 Management shall appoint a representative to implement and maintain the quality management system in the laboratory.5.3 Laboratory management shall review the adequacy of the quality management system and the activities of the laboratoryfor consistency with the stated quality objectiv
46、es at least annually.5.4 The quality management system shall have documented processes for:5.4.1 Sample Sampling and sample management (see Section 6),5.4.2 Data and record management (see Section 7),5.4.3 Control and implementation of test methods (see Section 8),5.4.4 Equipment calibration and mai
47、ntenance (see Section 9),5.4.5 Quality control (see Section 10),5.4.6 Audits and proficiency testing (see Section 11),D6792 1735.4.7 Corrective 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 the c
48、ontracted requirements, and5.4.10 Ensuring that personnel are adequately trained to obtain quality results (see Section 15).6. Sampling and Sample Management6.1 When samples are obtained by laboratory staff, these samples shall be obtained in accordance with applicable industrystandards.6.2 The elem
49、ents of sample management shall include at a minimum:6.2.1 Procedures for unique identification of samples submitted to the laboratory.6.2.2 Criteria for sample acceptance.6.2.3 Procedures for sample handling.6.2.3.1 In cases where industry standards for sample handling (for example, Practoce D5854) are applicable and referencedwithin industry standard test methods, they shall be utilized.6.2.4 Procedures for sample storage and retention. Items to consider when creating these procedures include:6.2.4.1 Applicable governmentlocal, state,
