ASTM D4621 Standard Guide for Quality Management in an Organization That Samples or Tests Coal and Coke
1. Scope
1.1 This guide describes the essential activities that are required to establish and operate a quality management system in a laboratory or organization that provides services in sample collection, sample preparation, or testing of coal, coke, or combustion residues from coal and coke.

NOTE 1 - The word "laboratory" is used throughout this guide when referring to an organization that provides services in coal sampling or testing, or both. It is recognized, however, that the word may not be appropriate to an organization that does not perform actual laboratory sample testing.

1.2 The principles of this guide are suggested as being the minimum acceptable requirements for the management of quality in a coal or coke sampling or testing organization, although some elements may not be necessary or appropriate for organizations that provide limited services.

1.3 Laboratories meeting the requirements of this guide may or may not meet the requirements of the ISO 9000 series of standards.

NOTE 2 - An accrediting body may also impose other nontechnical requirements such as payment of fees or submittal of quality documentation for review.

1.4 This guide is based upon many of the issues presented in Guide E 548. The user may also consult Guide E 882 for other items that may be pertinent. ISO Guide 25 has also been extensively consulted.

1.5 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.

2. Referenced Documents
2.1 ASTM Standards:
D346 Practice for Collection and Preparation of Coke Samples for Laboratory Analysis
D2013 Practice for Preparing Coal Samples for Analysis
D2234/ D2234M Practice for Collection of a Gross Sample of Coal
D3180 Practice for Calculating Coal and Coke Analyses from As-determined to Different Bases
D3302 Test Method for Total Moisture in Coal
D4182 Practice for Evaluation of Laboratories Using ASTM Procedures in the Sampling and Analysis of Coal and Coke
E 177 Practice for Use of the Terms Precision and Bias in ASTM Methods
E 456 Terminology Relating to Quality and Statistics
E 548 Guide for General Criteria Used for Evaluating Laboratory Competence
E 882 Guide for Accountability and Quality Control in the Chemical Analysis Laboratory
E 1187 Terminology Relating to Conformity Assessment
E 1323 Guide for Evaluating Laboratory Measurement Practices and Statistical Analysis of the Resulting Data
E 1579 Guide for Ensuring Data Integrity in Highly Computerized Laboratory Operations

2.2 Other ASTM Document:
Manual on Presentation of Data and Control Chart Analyses, ASTM Manual 7, 1996

2.3 ISO Document:
Guide 25 General Requirements for the Competence of Calibration and Testing Laboratories

3. Terminology
3.1 control limits, n - limits on a control chart which are used as criteria for signaling the need for action, or for judging whether a set of data does or does not indicate a state of statistical control.
3.1.1 Discussion - Action may be in the form of investigation of the source(s) of an "assignable cause", making a process adjustment, or terminating the use of a process.

3.2 calibration, n - the set of operations which establishes, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a measurand.
3.2.1 Discussion - The act of calibration is also sometimes referred to as standardization. The result of a calibration is sometimes expressed as a calibration factor, or as a series of calibration factors in the form of a calibration curve.

3.3 certified reference material, CRM, n - a reference material, one or more of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation that is issued by a certifying body.

3.4 certifying agency, n - an agency that, by virtue of its technical capability, reliability, and leadership, is recognized as capable of producing one or more reference materials, and certifying the magnitude of selected properties of the materials after testing or analyzing them using a reference method.

3.5 control, statistical, n - a process is in statistical control if the variations between the observed test results from it can be attributed to a constant system of chance causes.

3.6 control material, CM, n - a material of known property values, that is analyzed or tested concurrently with test samples or at specified intervals to evaluate the accuracy of a measurement process.

3.7 quality assurance, for laboratories, n - the activity of providing the evidence needed to establish confidence that laboratory data are of the requisite accuracy. (Precision and Bias)

3.8 quality control, n - the process through which a laboratory measures its performance (of analyses and tests), compares its performance with standards, and acts on any differences.

3.9 quality manual, n - a document stating the quality policy, and describing the quality management system and quality practices of an organization.
3.9.1 Discussion - The quality manual may incorporate by reference other documentation relating to the laboratory's quality arrangements.

3.10 reference material, RM, n - a material or substance, one or more properties of which are sufficiently well-established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials.
3.10.1 Discussion - Reference materials should bear sufficient resemblance to the material to be analyzed or tested so that no significant differences in procedures or corrections (for example, for interferences or interelement effects) are required.

3.11 reference method, n - a method that has been specified as capable, by virtue of recognized accuracy and authority, of providing reference data, which when verified by existing reference materials of the same or similar matrix, can be used to characterize reference materials.

3.12 standard, n - a means established by authority, of determining the measure of quantity, quality, extent, or value.

3.13 standard operating procedure (SOP), n - any written procedure describing a specific test method or any other aspect of the laboratory operation, including quality practices.

3.14 standard reference material, n - Because this term has 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 equivalent to certified reference materials.

4. Significance and Use
4.1 This guide describes the elements of a quality management system for an organization that samples, analyzes, or tests coal, coke, or their products.

4.2 The quality management system stresses the use of documented accountability and quality control procedures that serve to assure the laboratory personnel and its clients that adequate accuracy and precision are achieved in the routine performance of its sampling and testing activities, and that reported data were obtained from the samples submitted.

4.3 A laboratory may use this guide to develop its quality management system.

4.4 Laboratory clients, regulatory authorities, and organizations or individuals that evaluate the competency of testing laboratories may find this guide useful. Specific guidelines for evaluating a laboratory can be found in Practice D4182.

4.5 Other accountability and quality control procedures can be developed and may be considered equivalent ifthey provide all of the benefits previously outlined.