1、Designation: D6792 13 An American National StandardStandard Practice forQuality System in Petroleum Products and LubricantsTesting Laboratories1This standard is issued under the fixed designation D6792; the number immediately following the designation indicates the year oforiginal adoption or, in th
2、e 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 the essentials of a quality
3、system in laboratories engaged inthe analysis of petroleum products and lubricants. It is de-signed to be used in conjunction with Practice D6299.NOTE 1This practice is based on the quality management conceptsand principles advocated in ANSI/ISO/ASQ Q9000 standards, ISO/IEC17025, ASQ Manual,2and AST
4、M standards such as D3244, D4182,D4621, D6299, D6300, 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 theresponsibility of the user of this standard to establish app
5、ro-priate safety and health practices and determine the applica-bility of regulatory requirements prior to use.2. Referenced Documents2.1 ASTM Standards:5D3244 Practice for Utilization of Test Data to DetermineConformance with SpecificationsD4182 Practice for Evaluation of Laboratories UsingASTMProc
6、edures in the Sampling and Analysis of Coal andCoke (Withdrawn 2010)6D4621 Guide for Quality Management in an OrganizationThat Samples or Tests Coal and Coke (Withdrawn 2010)6D6299 Practice for Applying Statistical Quality Assuranceand Control Charting Techniques to Evaluate AnalyticalMeasurement Sy
7、stem PerformanceD6300 Practice for Determination of Precision and BiasData for Use in Test Methods for Petroleum Products andLubricantsD6617 Practice for Laboratory Bias Detection Using SingleTest Result from Standard MaterialD7372 Guide for Analysis and Interpretation of ProficiencyTest Program Res
8、ultsE29 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 Used for Evaluating Labo-ratory Competence
9、 (Withdrawn 2002)6E882 Guide for Accountability and Quality Control in theChemical Analysis LaboratoryE994 Guide for Calibration and Testing LaboratoryAccredi-tation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 andRecognition (Withdrawn 2003)6E1301 Guide for Proficiency Testing by InterlaboratoryCompa
10、risons (Withdrawn 2012)6E1323 Guide for Evaluating Laboratory Measurement Prac-tices and the Statistical Analysis 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 C
11、alibration LaboratoriesISO 4259 Petroleum ProductsDetermination and Applica-tion of Precision Data in Relation to Methods of TestANSI/ISO/ASQ Q9000 Quality Management System Stan-dards3. Terminology3.1 Definitions:3.1.1 accepted reference value, ARV, n a value that servesas an agreed upon reference
12、for comparison, and which is1This practice is under the jurisdiction of ASTM Committee D02 on PetroleumProducts and Lubricants and is the direct responsibility of Subcommittee D02.94 onCoordinating Subcommittee on Quality Assurance and Statistics.Current edition approved May 15, 2013. Published July
13、 2013. Originallyapproved in 2002. Last previous edition approved in 2007 as D6792 07. DOI:10.1520/D6792-13.2“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
14、.asq.org.3ASTM STP 15D, ASTM Manual on Presentation of Data 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, orconta
15、ct ASTM Customer Service at serviceastm.org. For Annual Book 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.7Available from American National Standards Institute
16、(ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1derived as: (1) a theoretical or established val
17、ue, 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 work under the auspices of a scien
18、tific 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 system procedure and related activities by an internal orexternal team to determine whether these proced
19、ures or activi-ties are implemented according to the documented system.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 for a relevant property, issued by or traceable to anat
20、ional 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 property values are certified bya technically valid procedure,
21、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 so as to be considered not a part of the set. D63003.1.9
22、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 testing or crosscheck programs.3.1.10.1 DiscussionOne examp
23、le 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 which is to provide to the producer and user of aproduct,
24、 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 system of activi-ties whose purpose is to provide a level
25、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 andhomogenous material having physical or chemical properties
26、,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 material (RM), na material with acceptedreference value(s)
27、, 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 reference values are established usingaccepted standard proc
28、edures.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 material.It is defined as the difference between two such resu
29、lts 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 when applying the same method. It is thendefined as the 95
30、 % 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 be expected to occur witha probability of approximately
31、 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 location practicing the same test method on a singlemea
32、surement system using test specimens taken at randomfrom 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 standard whereby it can be related tostated references, usual
33、ly 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 repeatability and reproducibility. The PR for a givenstandard test meth
34、od 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 approximate mea-sure of a laboratorys testing capability, de
35、fined as the ratio oftest method reproducibility to site precision.3.3 Acronyms:3.3.1 NISTNational Institute of Standards and Technology(formerly called National Bureau of Standards), Gaithersburg,MD.4. Significance and Use4.1 A petroleum products and lubricants testing laboratoryplays a crucial rol
36、e in product quality management andD6792 132customer satisfaction. It is essential for a laboratory to providequality data. This document provides guidance for establishingand maintaining a quality system in a laboratory.5. General Quality Requirements for the Laboratory5.1 Establishment and mainten
37、ance of a quality system shallinclude stated objectives in the following areas: a laboratorysadherence to test method requirements, calibration and main-tenance practices, and its quality control program. Laboratoryquality objectives should encompass the laboratorys continu-ous improvement goals as
38、well as meeting customer require-ments.5.2 Management shall appoint a representative to imple-ment and maintain the quality system in the laboratory.5.3 Laboratory management shall review the adequacy ofthe quality system and the activities of the laboratory forconsistency with the stated quality ob
39、jectives at least annually.5.4 The quality management system shall have documentedprocesses for:5.4.1 Sample management (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 Se
40、ction9),5.4.5 Quality control (see Section 10),5.4.6 Audits and proficiency testing (see Section 11),5.4.7 Corrective and preventive action (see Section 13),5.4.8 Ensuring that procured services and materials meet thecontracted requirements, and5.4.9 Ensuring that personnel are adequately trained to
41、obtain quality results (see Section 15).6. Sample Management6.1 The elements of sample management shall include at aminimum:6.1.1 Procedures for unique identification of samples sub-mitted to the laboratory.6.1.2 Criteria for sample acceptance.6.1.3 Procedures for sample handling.6.1.4 Procedures fo
42、r sample storage and retention. Items toconsider when creating these procedures include:6.1.4.1 Applicable governmentlocal, state, or nationalregulatory requirements for sample retention period, shelf life,and time-dependent tests that set product stability limits,6.1.4.2 Type of sample containers r
43、equired to preserve thesample,6.1.4.3 Control of access to the retained samples to protecttheir validity and preserve their original integrity,6.1.4.4 Storage conditions,6.1.4.5 Required safety precautions, and6.1.4.6 Customer requirements.6.1.5 Procedures for sample disposal in accordance withappli
44、cable government regulatory requirements.NOTE 2This may be handled through a separate chemical hygiene orwaste disposal plan.7. Data and Record Management7.1 Reports of Analysis:7.1.1 The work carried out by a laboratory shall be coveredby a certificate or report that accurately and unambiguouslypre
45、sents the test results and all other relevant information.NOTE 3This report may be an entry in a Laboratory InformationManagement System (LIMS) or equivalent system.7.1.2 The following items are suggested for inclusion inlaboratory reports:7.1.2.1 Name and address of the testing laboratory,7.1.2.2 U
46、nique identification of the report (such as serialnumber) on each page of the report including version identifi-cation if the report has been updated,NOTE 4Occasionally, a report may be updated and a version identi-fication will enable one version of the report to be distinguished fromanother. This
47、is necessary to determine which report version was theoriginal and which is the most current. Simple conventions such as lastupdated date are useful means of version identification.7.1.2.3 Name and address of the customer,7.1.2.4 Order number,7.1.2.5 Description and identification of the test sample
48、including comments on the sample condition particularly if it islikely to have an adverse effect on the sample integrity,7.1.2.6 Date of receipt of the test sample and date(s) ofperformance of test, as appropriate,7.1.2.7 Identification of the test specification, method, andprocedure,7.1.2.8 Descrip
49、tion of the sampling procedure, whererelevant,7.1.2.9 Any deviations, additions to or exclusions from thespecified test requirements, and any other information relevantto a specific test,7.1.2.10 Disclosure of any nonstandard test method orprocedure utilized,7.1.2.11 Measurements, examinations, and derived resultsincluding units of measurement, supported by tables, graphs,sketches, and photographs as appropriate, and any failuresidentified,7.1.2.12 Minimum-maximum product specifications, ifapplicable,7.1.2.13 Astatement of the measurement unce
