ASTM D4621-99
(Guide)Standard Guide for Quality Management in an Organization That Samples or Tests Coal and Coke
Standard Guide for Quality Management in an Organization That Samples or Tests Coal and Coke
SCOPE
1.1 This guide describes the essential aspects including the development of statistical process control (SPC) charts of an accountability and quality control program for a coal analysis laboratory.
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 limitations prior to use.
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Designation: D 4621 – 99
Standard Guide for
Quality Management in an Organization That Samples or
Tests Coal and Coke
This standard is issued under the fixed designation D 4621; 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 2013 Method for Preparing Coal Samples for Analysis
D 2234 Practice for Collection of a Gross Sample of Coal
1.1 This guide describes the essential activities that are
D 3180 Practice for Calculating Coal and Coke Analyses
required to establish and operate a quality management system
from As-determined to Different Bases
in a laboratory or organization that provides services in sample
D 3302 Test Method for Total Moisture in Coal
collection, sample preparation, or testing of coal, coke, or
D 4182 Practice for Evaluation of Laboratories Using
combustion residues from coal and coke.
ASTM Procedures in the Sampling and Analysis of Coal
NOTE 1—The word “laboratory” is used throughout this guide when 2
and Coke
referring to an organization that provides services in coal sampling or
E 177 Practice for Use of the Terms Precision and Bias in
testing, or both. It is recognized, however, that the word may not be
ASTM Methods
appropriate to an organization that does not perform actual laboratory
E 456 Terminology Relating to Quality and Statistics
sample testing.
E 548 Guide for General Criteria Used for Evaluating
1.2 The principles of this guide are suggested as being the
Laboratory Competence
minimum acceptable requirements for the management of
E 882 Guide for Accountability and Quality Control in the
quality in a coal or coke sampling or testing organization,
Chemical Analysis Laboratory
although some elements may not be necessary or appropriate
E 1187 Terminology Relating to Laboratory Accreditation
for organizations that provide limited services.
E 1323 Guide for Evaluating Laboratory Measurement
1.3 Laboratories meeting the requirements of this guide may
Practices and Statistical Analysis of the Resulting Data
or may not meet the requirements of the ISO 9000 series of
E 1579 Guide for Ensuring Data Integrity in Highly Com-
standards.
puterized Laboratory Operations
NOTE 2—An accrediting body may also impose other nontechnical
2.2 Other ASTM Document:
requirements such as payment of fees or submittal of quality documenta-
Manual on Presentation of Data and Control Chart Analy-
tion for review.
ses, ASTM Manual 7, 1996
1.4 This guide is based upon many of the issues presented in
2.3 ISO Document:
Guide E 548. The user may also consult Guide E 882 for other Guide 25 General Requirements for the Competence of
items that may be pertinent. ISO Guide 25 has also been
Calibration and Testing Laboratories
extensively consulted.
3. Terminology
1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the 3.1 control limits, n—limits on a control chart which are
responsibility of the user of this standard to establish appro- used as criteria for signaling the need for action, or for judging
priate safety and health practices and determine the applica- whether a set of data does or does not indicate a state of
bility of regulatory limitations prior to use. statistical control
3.1.1 Discussion—Action may be in the form of investiga-
2. Referenced Documents
tion of the source(s) of an “assignable cause,” making a
2.1 ASTM Standards:
process adjustment, or terminating the use of a process.
D 346 Practice for Collection and Preparation of Coke (E 456)
Samples for Laboratory Analysis
Annual Book of ASTM Standards, Vol 14.02.
1 4
This guide is under the jurisdiction of ASTM Committee D-5 on Coal and Coke Annual Book of ASTM Standards, Vol 03.06.
and is the direct responsibility of Subcommittee D05.30 on Editorial Review and The procedure described herein was adapted from Basic Statistics—Tools for
Quality Assurance. Continuous Improvement, M. J. Kiemele and S. R. Schmidt, Air Academy Press,
Current edition approved Dec. 10, 1999. Published April 2000. Originally Colorado Springs, CO, 1991.
published as D 4621 – 86. Last previous edition D 4621 – 94. Manual on Presentation of Data and Control Chart Analyses, ASTM Manual 7,
Annual Book of ASTM Standards, Vol 05.06. American Society for Testing and Materials, 1996.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
D 4621
3.2 calibration, n—the set of operations which establishes, 3.13 standard operating procedure (SOP), n—any written
under specified conditions, the relationship between values procedure describing a specific test method or any other aspect
of the laboratory operation, including quality practices.
indicated by a measuring instrument or measuring system, or
values represented by a material measure, and the correspond-
3.14 standard reference material, n—Because this term has
ing known values of a measurand. (E 548) been used in a variety of ways in this guide, it is not defined or
used herein, although it is understood by some persons to be
3.2.1 Discussion—The act of calibration is also sometimes
equivalent to certified reference materials.
referred to as standardization. The result of a calibration is
sometimes expressed as a calibration factor, or as a series of
4. Significance and Use
calibration factors in the form of a calibration curve.
3.3 certified reference material, CRM, n—a reference ma- 4.1 This guide describes the elements of a quality manage-
ment system for an organization that samples, analyzes, or tests
terial, one or more of whose property values are certified by a
coal, coke, or their products.
technically valid procedure, accompanied by or traceable to a
certificate or other documentation that is issued by a certifying 4.2 The quality management system stresses the use of
documented accountability and quality control procedures that
body.
serve to assure the laboratory personnel and its clients that
3.4 certifying agency, n—an agency that, by virtue of its
adequate accuracy and precision are achieved in the routine
technical capability, reliability, and leadership, is recognized as
performance of its sampling and testing activities, and that
capable of producing one or more reference materials, and
reported data were obtained from the samples submitted.
certifying the magnitude of selected properties of the materials
4.3 A laboratory may use this guide to develop its quality
after testing or analyzing them using a reference method.
management system.
3.5 control, statistical, n—a process is in statistical control
4.4 Laboratory clients, regulatory authorities, and organiza-
if the variations between the observed test results from it can be
tions or individuals that evaluate the competency of testing
attributed to a constant system of chance causes. (E 177)
laboratories may find this guide useful. Specific guidelines for
3.6 control material, CM, n—a material of known property
evaluating a laboratory can be found in Practice D 4182.
values, that is analyzed or tested concurrently with test samples
4.5 Other accountability and quality control procedures can
or at specified intervals to evaluate the accuracy of a measure-
be developed and may be considered equivalent if they provide
ment process.
all of the benefits previously outlined.
3.7 quality assurance, for laboratories, n—the activity of
providing the evidence needed to establish confidence that
5. Components of a Quality Management System
laboratory data are of the requisite accuracy. (Precision and
5.1 A laboratory quality management system consists of the
Bias) (E 1187)
following principal components, which are described in detail
3.8 quality control, n—the process through which a labora-
in subsequent sections of this guide:
tory measures its performance (of analyses and tests), com-
5.1.1 An organizational structure and management commit-
pares its performance with standards, and acts on any differ-
ment designed to ensure that services are performed in a timely
ences. (E 1187)
and accurate fashion.
3.9 quality manual, n—a document stating the quality
5.1.2 A quality manual that documents all aspects of the
policy, and describing the quality management system and
quality management system;
quality practices of an organization.
5.1.3 A staff that has well-defined responsibilities and is
3.9.1 Discussion—The quality manual may incorporate by
trained not only in the technical procedures of sample collec-
reference other documentation relating to the laboratory’s
tion, sample preparation, or sample testing, but also in the
quality arrangements.
philosophy and methods of the quality management system;
3.10 reference material, RM, n—a material or substance,
5.1.4 Physical facilities and environments that are suitable
one or more properties of which are sufficiently well-
for the performance of the tasks required;
established to be used for the calibration of an apparatus, the
5.1.5 Equipment and supplies that provide the capability to
assessment of a measurement method, or for assigning values
perform the services;
to materials. (E 1187)
5.1.6 A quality assurance program that ensures that the
3.10.1 Discussion—Reference materials should bear suffi-
laboratory constantly monitors and improves its performance;
cient resemblance to the material to be analyzed or tested so
5.1.7 Well-defined (that is, documented) procedures for (as
that no significant differences in procedures or corrections (for
appropriate) sample intake or collection, sample management,
example, for interferences or interelement effects) are required.
sample preparation, sample testing, and the calculation and
3.11 reference method, n—a method that has been specified reporting of test results;
as capable, by virtue of recognized accuracy and authority, of
5.1.8 A quality control program that constantly ensures that
providing reference data, which when verified by existing the testing procedures do provide accurate data;
reference materials of the same or similar matrix, can be used
5.1.9 Procedures to ensure that reports accurately reflect the
to characterize reference materials.
test data, and attribute them to the appropriate sample;
3.12 standard, n—a means established by authority, of 5.1.10 A document control system to ensure that only the
determining the measure of quantity, quality, extent, or value. latest approved version of procedures are in use;
D 4621
5.1.11 A record-keeping system that defines what records 7.3 The quality manual is readily available for use by the
are required and the length of time that they must be main- staff.
tained; 7.4 There is a well-defined procedure for keeping the
5.1.12 A program that provides for audits and reviews of the manual current by modifying the manual whenever any quality
activities of the organization to ensure that the quality man- system provision is changed. The individual(s) who has/have
agement system is performing as designed. the authority to make changes is/are identified.
7.5 The quality manual or formal quality documents refer-
6. Organization and Management
enced by the manual contain:
6.1 Proper organization and management of the laboratory
7.5.1 A quality policy statement, including the purpose of
requires the following:
the quality management system and the commitments to it by
6.1.1 The laboratory is a legally identifiable entity organized
laboratory or institutional management;
and operated in such a way that its permanent, temporary, and
7.5.2 A description of the organization and management
mobile facilities meet the requirements of this guide;
structure of the laboratory, its place in any parent organization,
6.1.2 The laboratory is organized in such a way that there is
and all relevant organizational charts;
confidence in its independence of judgment and integrity at all
7.5.3 Documentation of the responsibility, authority, and
times;
interrelation of all personnel who manage, perform, or verify
6.1.2.1 The laboratory ensures that its personnel are free
work affecting the quality of calibrations and tests;
from any commercial, financial, or other pressures that might
7.5.4 Identification of the laboratory’s authorized signato-
adversely affect the quality of their work;
ries (where this concept is appropriate);
6.1.2.2 The laboratory has documented policies and proce-
7.5.5 An outline of the documentation used in the quality
dures to protect clients’ confidential information and propri-
management system;
etary rights;
7.5.6 A description of procedures for control and mainte-
6.1.3 The laboratory has the staff needed to carry out the
nance of documentation (Section 18);
laboratory’s functions, and specifies and documents the re-
7.5.7 Procedures to ensure that the laboratory has the
sponsibility, authority, and interrelations of all personnel who
appropriate facilities and resources before commencing any
manage, perform, or verify work affecting the quality of
new test or contract;
sample collection, preparation, and testing;
7.5.8 Descriptions of or reference to a document that
6.1.4 The laboratory has a technical manager (however
describes the major equipment and equipment maintenance
named) who has overall responsibility for the technical opera-
schedules and procedures;
tions;
7.5.9 A list of procedures and tests that the laboratory
6.1.5 The laboratory has a quality manager (however
performs routinely (Section 15);
named) who has responsibility for the quality management
7.5.10 Documented, standard operating procedures (SOPs),
system and its implementation.
or references to same, for each procedure and test that is
NOTE 3—The quality manager has direct access to the highest level of routinely conducted by the laboratory. Appropriate ASTM
management at which decisions are taken on laboratory policy or
standards are referenced and, if the laboratory deals with
resources, and has direct access to the technical manager. In some
international customers, international standards are referenced;
laboratories, the quality manager may also be the technical manager or a
deputy technical manager. NOTE 4—The terms “standard operating procedure” and “SOP” are
used in this guide to designate any written procedure whether it applies to
6.1.5.1 The laboratory has a well-defined procedure to
a specific test method or to a procedure that is used in any other aspect of
nominate deputies in case of absence of the technical or quality
the laboratory operation, including quality elements. The
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