ASTM D6792-02
(Guide)Standard Guide for A Quality System in Petroleum Products and Lubricants Testing Laboratories
Standard Guide for A Quality System in Petroleum Products and Lubricants Testing Laboratories
SCOPE
1.1 This guide covers the establishment and maintenance of the essentials of a quality system in laboratories engaged in the analysis of petroleum products and lubricants. It is designed to be used in conjunction with Practice D 6299.
Note 1—This guide is based on the quality management concepts and principles advocated in ISO 9000 standards, ISO Guide 17025, ASQC Manual, and ASTM standards such as D 3244, D 4182, D 4621, D 6299, D 6300, E 29, E 177, E 456, E 548, E 882, E 994, E 1301, E 1323, STP 15D, and STP 1209.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.
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Standards Content (Sample)
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
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An American National Standard
Designation: D 6792 – 02
Standard Guide for
A Quality System in Petroleum Products and Lubricants
Testing Laboratories
This standard is issued under the fixed designation D 6792; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope D 6617 Practice for Laboratory Bias Detection Using
Single Test Result from Standard Material
1.1 This guide covers the establishment and maintenance of
E 29 Practice for Using Significant Digits in Test Data to
the essentials of a quality system in laboratories engaged in the
Determine Conformance with Specifications
analysis of petroleum products and lubricants. It is designed to
E 177 Practice for Use of the Terms Precision and Bias in
be used in conjunction with Practice D 6299.
ASTM Test Methods
NOTE 1—This guide is based on the quality management concepts and 9
E 456 Terminology Relating to Quality and Statistics
principles advocated in ANSI/ISO/ASQ Q9000 standards, ISO Guide
E 548 Guide for General Criteria Used for Evaluating
17025, ASQC Manual, and ASTM standards such as D 3244, D 4182,
Laboratory Competence
D 4621, D 6299, D 6300, E 29, E 177, E 456, E 548, E 882, E 994,
3 4
E 691 Practice for Conducting an Interlaboratory Study to
E 1301, E 1323, STP 15D , and STP 1209 .
Determine the Precision of a Test Method
1.2 This standard does not purport to address all of the
E 882 Guide for Accountability and Quality Control in the
safety concerns, if any, associated with its use. It is the
Chemical Analysis Laboratory
responsibility of the user of this standard to establish appro-
E 994 Guide for Calibration and Testing Laboratory Ac-
priate safety and health practices and determine the applica-
creditation Systems General Requirements for Operation
bility of regulatory requirements prior to use.
and Recognition
E 1301 Guide for Proficiency Testing by Interlaboratory
2. Referenced Documents
Comparisons
2.1 ASTM Standards:
E 1323 Guide for Evaluating Laboratory Measurement
D 3244 Practice for Utilization of Test Data to Determine
Practices and the Statistical Analysis of the Resulting Data
Conformance with Specifications
2.2 ISO Standards:
D 4182 Practice for Evaluation of Laboratories Using
ISO Guide 30 Terms and Definitions Used in Connection
ASTM Procedures in the Sampling and Analysis of Coal
with Reference Materials
and Coke
ISO Guide 17025 General Requirements for the Compe-
D 4621 Guide for Quality Management in an Organization
tence of Calibration and Testing Laboratories
that Samples or Tests Coal and Coke
ISO Standard 4259 Petroleum Products—Determination
D 6299 Practice for Applying Statistical Quality Assurance
and Application of Precision Data in Relation to Methods
Techniques to Evaluate Analytical Measurement System
of Test
Performance
ANSI/ISO/ASQ Q9000 Quality Management System Stan-
D 6300 Practice for Determination of Precision and Bias
dards
Data for Use in Test Methods for Petroleum Products and
Lubricants
3. Terminology
3.1 Definitions:
This guide is under the jurisdiction of ASTM Committee D02 on Petroleum
3.1.1 accepted reference value, ARV, n—a value that serves
Products and Lubricants and is the direct responsibility of Subcommittee D02.94 on
as an agreed upon reference for comparison, and which is
Quality Assurance and Statistics.
Current edition approved April 10, 2002. Published August 2002.
derived as: (1) a theoretical or established value, based on
“Quality Assurance for The Chemical and Process Industries: A Manual of
scientific principles, (2) an assigned value, based on experi-
Good Practices,” 1987, available from American Society for Quality Control, 611 E.
mental work of some national or international organization
Wisconsin Ave., Milwaukee, WI 53292.
ASTM STP 15D, “ASTM Manual on Presentation of Data and Control Chart
Analysis,” available from ASTM International Headquarters.
4 8
ASTM STP 1209, “ASTM Manual on Total Quality Management,” available Annual Book of ASTM Standards, Vol 05.04.
from ASTM International Headquarters. Annual Book of ASTM Standards, Vol 14.02.
5 10
Annual Book of ASTM Standards, Vol 05.02. Annual Book of ASTM Standards, Vol 03.06.
6 11
Annual Book of ASTM Standards, Vol 05.06. Available from American National Standards Institute, 25 W. 43rd St., 4th
Annual Book of ASTM Standards, Vol 05.03. Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
D6792–02
such as the U.S. National Institute of Standards and Technol- accepted standard procedures.
ogy (NIST), or (3) a consensus value, based on collaborative 3.1.14 repeatability, n—the quantitative expression of the
experimental work under the auspices of a scientific or random error associated with a single operator in a given
engineering group. E 456 laboratory obtaining repetitive results with the same apparatus
3.1.2 accuracy, n—the closeness of agreement between a under constant operating conditions on identical test material.
It is defined as the difference between two such results at the
test result and an accepted reference value. E 456
95 % confidence level. D 6300
3.1.3 audit, n—a systematic examination of a laboratory’s
3.1.15 reproducibility, n—a quantitative expression of the
quality system procedure and related activities by an internal or
random error associated with different operators using different
external team to determine whether these procedures or activi-
apparatus, and so forth, each obtaining a single result on an
ties are implemented according to the documented system.
identical test sample when applying the same method. It is the
3.1.4 bias, n—the difference between the population mean
defined as the 95 % confidence limit for the difference between
of the test results and an accepted reference value. E 456
two such single and independent results. D 6300
3.1.5 calibration standard, n—a material with a certified
3.1.16 site precision (R8), n—the value below which the
value for a relevant property, issued by or traceable to a
absolute difference between two individual test results obtained
national organization such as NIST, and whose properties are
under site precision conditions may be expected to occur with
known with sufficient accuracy to permit its use to evaluate the
a probability of approximately 0.95 (95 %). It is defined as 2.77
same property of another sample.
times the standard deviation of results obtained under site
3.1.6 certified reference material, CRM, n—a reference
precision conditions. D 6299
material one or more of whose property values are certified by
3.1.17 site precision conditions, n—conditions under which
a technically valid procedure, accompanied by a traceable
test results are obtained by one or more operators in a single
certificate or other documentation which is issued by a certi-
site location practicing the same test method on a single
fying body. ISO Guide 30
measurement system using test specimens taken at random
3.1.7 outlier, n—a result far enough in magnitude from
from the same sample of material over an extended period of
other results so as to be considered not a part of the set.
time spanning at least a 15 day interval. D 6299
D 6300
3.1.18 traceability, n—property of the result of a measure-
3.1.8 precision, n—the closeness of agreement between test
ment or the value of a standard whereby it can be related to
results obtained under prescribed conditions. E 456
stated references, usually national or international standards,
3.1.9 proficiency testing, n—determination of a laboratory’s
through an unbroken chain of comparisons all having stated
testing capability by evaluating its test results in interlaboratory
uncertainties.
exchange testing or crosscheck programs.
3.2 Definitions of Terms Specific to This Standard:
3.1.9.1 Discussion—One example is the ASTM D02 com-
3.2.1 test performance index, TPI, n—an approximate mea-
mittee’s proficiency testing programs in a wide variety of
sure of a laboratory’s testing capability, defined as the ratio of
petroleum products and lubricants, many of which may involve
test method reproducibility to site precision.
more than a hundred laboratories.
3.3 Acronyms:
3.1.10 quality assurance, QA, n—a system of activities, the
3.3.1 NIST, n—National Institute of Standards and Technol-
purpose of which is to provide to the producer and user of a
ogy (formerly called National Bureau of Standards), Gaithers-
product, measurement, or service the assurance that it meets
burg, MD.
the defined standards of quality with a stated level of confi-
dence.
4. Significance and Use
3.1.10.1 Discussion—Quality assurance includes quality
4.1 A petroleum products and lubricants testing laboratory
planning and quality control.
plays a crucial role in product quality management and
3.1.11 quality control, QC, n—a planned system of activi-
customer satisfaction. It is essential for a laboratory to provide
ties whose purpose is to provide a level of quality that meets
quality data. This document provides guidance for establishing
the needs of users; also the uses of such a system.
and maintaining a quality system in a laboratory.
3.1.12 quality control sample, QC sample, n—for use in
5. General Quality Requirements for the Laboratory
quality assurance program to determine and monitor the
precision and stability of a measurement system; a stable and
5.1 Establishment and maintenance of a quality system shall
homogenous material having physical or chemical properties,
include stated objectives in the following areas: a laboratory’s
or both, similar to those of typical samples tested by the
adherence to test method requirements, calibration and main-
analytical measurement system. The material is properly stored
tenance practices, and its quality control program. Laboratory
to ensure sample integrity, and is available in sufficient quantity
quality objectives should encompass the laboratory’s continu-
for repeated long-term testing. D 6299
ous improvement goals as well as meeting customer require-
3.1.13 reference material, RM, n—a material with accepted ments.
reference value(s), accompanied by an uncertainty at a stated
5.2 Management shall appoint a representative to imple-
level of confidence for desired properties, which may be used ment and maintain the quality system in the laboratory.
for calibration or quality control purposes in the laboratory.
5.3 Laboratory management shall review the adequacy of
3.1.13.1 Discussion—Sometimes these may be prepared the quality system and the activities of the laboratory for
“in-house” provided the reference values are established using consistency with the stated quality objectives at least annually.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
D6792–02
5.4 The quality system shall have documented processes specified test requirements, and any other information relevant
for: to a specific test,
5.4.1 Sample management (see Section 6), 7.1.2.10 Disclosure of any nonstandard test method or
5.4.2 Data and record management (see Section 7), procedure utilized,
5.4.3 Producing accurate, reliable, and properly represented 7.1.2.11 Measurements, examinations and derived results,
test results (see Section 8), supported by tables, graphs, sketches, and photographs as
5.4.4 Audits and proficiency testing (see Section 9), appropriate, and any failures identified,
5.4.5 Corrective and preventive action (see Section 11), 7.1.2.12 Minimum-maximum product specifications, if ap-
5.4.6 Ensuring that procured services and materials meet the plicable,
contracted requirements, and 7.1.2.13 A statement of the measurement uncertainty (where
5.4.7 Ensuring that personnel are adequately trained to relevant),
obtain quality results. 7.1.2.14 Any other information which might be required by
the customer,
6. Sample Management
7.1.2.15 A signature and job title of person(s) accepting
6.1 The elements of sample management shall include at a technical responsibility for the test report and the date of issue,
minimum: and
6.1.1 Procedures for unique sample identification. 7.1.2.16 A statement on the laboratory policy regarding the
6.1.2 Criteria for sample acceptance. reproduction of test reports.
6.1.3 Procedures for sample handling. 7.1.3 Items actually included in laboratory reports should be
6.1.4 Procedures for sample storage and retention. Items to specified by laboratory management or agreements with cus-
consider when creating these procedures include: tomers, or both.
6.1.4.1 Applicable government—local, state, or national— 7.1.4 Procedures for corrections or additions to a test report
regulatory requirements for shelf life and time-dependent tests after issue shall be established.
that set product stability limits, 7.2 Reporting and Rounding the Data:
6.1.4.2 Type of sample containers required to preserve the 7.2.1 The reporting requirements specified in the test
sample, method or procedure shall be used.
6.1.4.3 Control of access to the retained samples to protect 7.2.2 If rounding is performed, the rounding protocol of
their validity and preserve their original integrity, Practice E 29 should be used unless otherwise specified in the
6.1.4.4 Storage conditions,
method or procedure.
6.1.4.5 Required safety precautions, and 7.3 Records of Calibration and Maintenance:
6.1.4.6 Customer requirements.
7.3.1 Procedures shall be established for the management of
6.1.5 Procedures for sample disposal in accordance with instrument calibration records. Such records usually indicate
applicable government regulatory requirements.
the instrument calibrated, method or procedure used for cali-
bration, the dates of last and next calibrations, the person
NOTE 2—This may be handled through a separate chemical hygiene or
performing the calibration, the values obtained during calibra-
waste disposal plan.
tion, and the nature and traceability (if applicable) of the
7. Data and Record Management
calibration standards (that is, certified values). Records may be
electronic.
7.1 Reports of Analysis:
7.3.2 Procedures shall be established for the management of
7.1.1 The work carried out by a laboratory shall be covered
instrument maintenance records. Such r
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