1、Designation: D 6792 07An American National StandardStandard Practice forQuality System in Petroleum Products and LubricantsTesting Laboratories1This standard is issued under the fixed designation D 6792; the number immediately following the designation indicates the year oforiginal adoption or, in t
2、he 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. Scope*1.1 This practice covers the establishment and maintenanceof the essentials of a qualit
3、y system in laboratories engaged inthe analysis of petroleum products and lubricants. It is de-signed to be used in conjunction with Practice D 6299.NOTE 1This practice is based on the quality management conceptsand principles advocated in ANSI/ISO/ASQ Q9000 standards, ISO/IEC17025, ASQ Manual,2and
4、ASTM standards such as D 3244, D 4182,D 4621, D 6299, D 6300, E29, E 177, E 456, E 548, E 882, E 994,E 1301, E 1323, 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 t
5、o establish appro-priate safety and health practices and determine the applica-bility of regulatory requirements prior to use.2. Referenced Documents2.1 ASTM Standards:5D 3244 Practice for Utilization of Test Data to DetermineConformance with SpecificationsD 4182 Practice for Evaluation of Laborator
6、ies UsingASTM Procedures in the Sampling and Analysis of Coaland CokeD 4621 Guide for Quality Management in an OrganizationThat Samples or Tests Coal and CokeD 6299 Practice for Applying Statistical Quality AssuranceTechniques to Evaluate Analytical Measurement SystemPerformanceD 6300 Practice for D
7、etermination of Precision and BiasData for Use in Test Methods for Petroleum Products andLubricantsD 6617 Practice for Laboratory Bias Detection UsingSingle Test Result from Standard MaterialE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE 177 Pract
8、ice for Use of the Terms Precision and Bias inASTM Test MethodsE 456 Terminology Relating to Quality and StatisticsE 548 Guide for General Criteria Used for EvaluatingLaboratory Competence6E 882 Guide for Accountability and Quality Control in theChemical Analysis LaboratoryE 994 Guide for Calibratio
9、n and Testing Laboratory Ac-creditation Systems General Requirements for Operationand Recognition6E 1301 Guide for Proficiency Testing by InterlaboratoryComparisonsE 1323 Guide for Evaluating Laboratory MeasurementPractices and the Statistical Analysis of the Resulting Data2.2 ISO Standards:7ISO Gui
10、de 30 Terms and Definitions Used in Connectionwith Reference MaterialsISO/IEC 17025 General Requirements for the Competenceof Testing and Calibration LaboratoriesISO 4259 Petroleum ProductsDetermination and Appli-cation of Precision Data in Relation to Methods of TestANSI/ISO/ASQ Q9000 Quality Manag
11、ement System Stan-dards3. Terminology3.1 Definitions:3.1.1 accepted reference value, ARV, na value that servesas an agreed upon reference for comparison, and which isderived as: (1) a theoretical or established value, based onscientific principles, (2) an assigned value, based on experi-mental work
12、of some national or international organization1This 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 July 1, 20
13、07. Published August 2007. Originallyapproved in 2002. Last previous edition approved in 2006 as D 679206.2“Quality Assurance for The Chemical and Process Industries: A Manual ofGood Practices,” 1987, available from American 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, orcontac
15、t ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.6Withdrawn.7Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1
16、*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.such as the U.S. National Institute of Standards and Technol-ogy (NIST), or (3) a consensus value, based on collaborativ
17、eexperimental work under the auspices of a scientific orengineering group. E 4563.1.2 accuracy, nthe closeness of agreement between atest result and an accepted reference value. E 4563.1.3 audit, na systematic examination of a laboratorysquality system procedure and related activities by an internal
18、 orexternal team to determine whether these procedures 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. E 4563.1.5 calibration standard, na material with a certifiedvalue for
19、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, na referencematerial one or more of whose property valu
20、es 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 fromother results so as t
21、o be considered not a part of the set.D 63003.1.9 precision, nthe closeness of agreement between testresults obtained under prescribed conditions. E 4563.1.10 proficiency testing, ndetermination of a laborato-rys testing capability by evaluating its test results in interlabo-ratory exchange testing
22、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 which
23、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 system
24、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), nfor use inquality assurance program to determine and monitor theprecision and stability of a measurement system; a stable andhomogeno
25、us 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. D 62993.1.14 reference materia
26、l (RM), na material with ac-cepted reference value(s), accompanied by an uncertainty at astated level of confidence for desired properties, which may beused for calibration or quality control purposes in the labora-tory.3.1.14.1 DiscussionSometimes these may be prepared“in-house” provided the refere
27、nce 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 material
28、.It is defined as the difference between two such results at the95 % confidence level. D 63003.1.16 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 whe
29、n applying the same method. It is thendefined as the 95 % confidence limit for the difference betweentwo such single and independent results. D 63003.1.17 site precision (R8), nthe value below which theabsolute difference between two individual test results obtainedunder site precision conditions ma
30、y 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. D 62993.1.18 site precision conditions, nconditions under whichtest results are obtained by one or more operators in a singlesi
31、te location practicing the same test method on a singlemeasurement system using test specimens taken at randomfrom the same sample of material over an extended period oftime spanning at least a 15 day interval. D 62993.1.19 traceability, nproperty of the result of a measure-ment or the value of a st
32、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
33、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
34、pproximatemeasure of a laboratorys testing capability, defined as the ratioof test method reproducibility to site precision.3.3 Acronyms:3.3.1 NISTNational Institute of Standards and Technol-ogy (formerly called National Bureau of Standards), Gaithers-burg, MD.4. Significance and Use4.1 A petroleum
35、products and lubricants testing laboratoryplays a crucial role in product quality management andcustomer satisfaction. It is essential for a laboratory to providequality data. This document provides guidance for establishingand maintaining a quality system in a laboratory.D67920725. General Quality
36、Requirements for the Laboratory5.1 Establishment and maintenance 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
37、 encompass the laboratorys continu-ous improvement goals as 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
38、 of the laboratory forconsistency with the stated quality objectives at least annually.5.4 The quality system shall have documented processesfor:5.4.1 Sample management (see Section 6),5.4.2 Data and record management (see Section 7),5.4.3 Producing accurate, reliable, and properly representedtest r
39、esults (see Section 8),5.4.4 Audits and proficiency testing (see Section 9),5.4.5 Corrective and preventive action (see Section 11),5.4.6 Ensuring that procured services and materials meet thecontracted requirements, and5.4.7 Ensuring that personnel are adequately trained toobtain quality results.6.
40、 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 for sample storage and retention. Items toco
41、nsider when creating these procedures include:6.1.4.1 Applicable governmentlocal, state, or nationalregulatory requirements for shelf life and time-dependent teststhat set product stability limits,6.1.4.2 Type of sample containers required to preserve thesample,6.1.4.3 Control of access to the retai
42、ned 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 withapplicable government regulatory requirements.NOTE 2This may be handled t
43、hrough 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 unambiguouslypresents the test results and all other relevant information.NOTE 3This
44、 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 Unique identification of the report (such as serialnumber) on each pa
45、ge of the report,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,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
46、,7.1.2.8 Description of the sampling procedure, where rel-evant,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,
47、examinations, and derived results,supported by tables, graphs, sketches, and photographs asappropriate, and any failures identified,7.1.2.12 Minimum-maximum product specifications, if ap-plicable,7.1.2.13 Astatement of the measurement uncertainty (whererelevant or required by the customer),7.1.2.14
48、Any other information which might be required bythe customer,7.1.2.15 A signature and job title of person(s) acceptingtechnical responsibility for the test report and the date of issue,and7.1.2.16 A statement on the laboratory policy regarding thereproduction of test reports.7.1.3 Items actually inc
49、luded in laboratory reports should bespecified by laboratory management or agreements with cus-tomers, or both.7.1.4 Procedures for corrections or additions to a test reportafter issue shall be established.7.2 Reporting and Rounding the Data:7.2.1 The reporting requirements specified in the testmethod or procedure shall be used (unless specifically requiredotherwise by the customer or applicable regulations).7.2.2 If rounding is performed, the rounding protocol ofPractice E29should be used unless otherwise specified in themethod or procedure.7.3 Re
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