ASTM D4621 Standard Guide for Quality Management in an Organization That Samples or Tests Coal and Coke
5. Components of a Quality Management System
5.1 A laboratory quality management system consists of the following principal components, which are described in detail in subsequent sections of this guide:
5.1.1 An organizational structure and management commitment designed to ensure that services are performed in a timely and accurate fashion.

5.1.2 A quality manual that documents all aspects of the quality management system;

5.1.3 A staff that has well-defined responsibilities and is trained not only in the technical procedures of sample collection, sample preparation, or sample testing, but also in the philosophy and methods of the quality management system;

5.1.4 Physical facilities and environments that are suitable for the performance of the tasks required;

5.1.5 Equipment and supplies that provide the capability to perform the services;

5.1.6 A quality assurance program that ensures that the laboratory constantly monitors and improves its performance;

5.1.7 Well-defined (that is, documented) procedures for (as appropriate) sample intake or collection, sample management, sample preparation, sample testing, and the calculation and reporting of test results;

5.1.8 A quality control program that constantly ensures that the testing procedures do provide accurate data;

5.1.9 Procedures to ensure that reports accurately reflect the test data, and attribute them to the appropriate sample;

5.1.10 A document control system to ensure that only the latest approved version of procedures are in use;

5.1.11 A record-keeping system that defines what records are required and the length of time that they must be maintained;

5.1.12 Aprogram that provides for audits and reviews of the activities of the organization to ensure that the quality management system is performing as designed.

6. Organization and Management
6.1 Proper organization and management of the laboratory requires the following:
6.1.1 The laboratory is a legally identifiable entity organized and operated in such a way that its permanent, temporary, and mobile facilities meet the requirements of this guide;

6.1.2 The laboratory is organized in such a way that there is confidence in its independence of judgment and integrity at all times;
6.1.2.1 The laboratory ensures that its personnel are free from any commercial, financial, or other pressures that might adversely affect the quality of their work;

6.1.2.2 The laboratory has documented policies and procedures to protect clients' confidential information and proprietary rights;

6.1.3 The laboratory has the staff needed to carry out the laboratory's functions, and specifies and documents the responsibility, authority, and interrelations of all personnel who manage, perform, or verify work affecting the quality of sample collection, preparation, and testing;

6.1.4 The laboratory has a technical manager (however named) who has overall responsibility for the technical operations;

6.1.5 The laboratory has a quality manager (however named) who has responsibility for the quality management system and its implementation.

NOTE 3 - The quality manager has direct access to the highest level of management at which decisions are taken on laboratory policy or resources, and has direct access to the technical manager. In some laboratories, the quality manager may also be the technical manager or a deputy technical manager.

6.1.5.1 The laboratory has a well-defined procedure to nominate deputies in case of absence of the technical or quality manager;

6.1.6 The laboratory provides supervision by persons familiar with the sample collection or test methods and procedures, the objectives of the tests and the assessment of the results;

6.1.7 The laboratory has written policies for continuous improvement;

6.1.8 The laboratory has well-defined procedures for soliciting customer feedback in a systematic way and for dealing with customer complaints;

6.1.9 The laboratory, if appropriate, has documents readily available attesting that the laboratory is certified or registered by a recognized agency.

7. Quality Manual
7.1 The quality manual documents the elements of the quality policy, the quality management system, and quality practices.

7.2 Contents of the quality manual are communicated to, understood by, and implemented by all of the staff.

7.3 The quality manual is readily available for use by the staff.

7.4 There is a well-defined procedure for keeping the manual current by modifying the manual whenever any quality system provision is changed. The individual(s) who has/have the authority to make changes is/are identified.

7.5 The quality manual or formal quality documents referenced by the manual contain:
7.5.1 A quality policy statement, including the purpose of the quality management system and the commitments to it by laboratory or institutional management;

7.5.2 A description of the organization and management structure of the laboratory, its place in any parent organization, and all relevant organizational charts;

7.5.3 Documentation of the responsibility, authority, and interrelation of all personnel who manage, perform, or verify work affecting the quality of calibrations and tests;

7.5.4 Identification of the laboratory's authorized signatories (where this concept is appropriate);

7.5.5 An outline of the documentation used in the quality management system;

7.5.6 A description of procedures for control and maintenance of documentation (Section 18);

7.5.7 Procedures to ensure that the laboratory has the appropriate facilities and resources before commencing any new test or contract;

7.5.8 Descriptions of or reference to a document that describes the major equipment and equipment maintenance schedules and procedures;

7.5.9 A list of procedures and tests that the laboratory performs routinely (Section 15);

7.5.10 Documented, standard operating procedures (SOPs), or references to same, for each procedure and test that is routinely conducted by the laboratory. Appropriate ASTM standards are referenced and, if the laboratory deals with international customers, international standards are referenced;

NOTE 4 - The terms "standard operating procedure" and "SOP" are used in this guide to designate any written procedure whether it applies to a specific test method or to a procedure that is used in any other aspect of the laboratory operation, including quality elements. The laboratory may refer to such documents by a name other than standard operating procedure. Reference simply to published standards is generally inadequate because they may need to be supplemented by additional information pertaining to quality control activities that are not commonly covered in standard test methods. If an operating procedure deviates from an established standard, data should be available to demonstrate that the modified procedure provides results that are equivalent to those obtained by using the standard procedure.

7.5.11 Calibration procedures and the proper use of reference materials in calibration;

7.5.12 Verification practices, including interlaboratory comparisons or proficiency testing programs, use of reference materials to verify calibrations, and internal quality control procedures;

7.5.13 The laboratory's procedures for achieving traceability of measurements to specific samples (Section 12);

7.5.14 Procedures for recognizing testing discrepancies or nonconforming work or departures from documented policies and procedures, for taking corrective action in such instances, and for communicating the information to key personnel and (where appropriate) to clients;

7.5.15 Procedures to prevent unauthorized tampering with equipment or modification of control or test procedures, a current list of personnel who are authorized to make any required changes, and criteria to be used to determine when changes are required;

7.5.16 A list of persons who are authorized to permit exceptional departures from documented policies and procedures or from standard specifications, and descriptions of the extent of their responsibilities and authority;

7.5.17 Procedures for soliciting customer feedback and for dealing with customer complaints;

7.5.18 Procedures for protecting confidentiality and proprietary rights.

8. Staff
8.1 The laboratory has personnel with appropriate education, training, technical knowledge, and experience to conduct the operations of the laboratory.

8.2 Where appropriate, technical personnel are able to demonstrate a satisfactory knowledge of sample collection and sample preparation procedures, and are capable of collecting and preparing samples in accordance with appropriate methods or practices.

8.3 Where appropriate, technical personnel are able to demonstrate a satisfactory knowledge of test methods and of sample procurement and processing procedures for which they are responsible. Any procedure for which the laboratory claims competence can be performed by at least one capable individual.

8.4 A formal program is used to identify training needs and to train the technical staffto carry out the procedures for which the laboratory claims competence.
8.4.1 There is an ongoing procedure for evaluating the competence of laboratory personnel.

8.4.2 Records are kept of the relevant qualifications, training, skill, and experience of the technical personnel.

8.5 There is a formal program to train the staff in and to maintain its awareness of the quality management system including quality assurance and quality control methods.

9. Facilities and Environment
9.1 Laboratory facilities, including benches, desks, calculators, computers, supplies, energy sources, lighting, heating, ventilation, and cooling, are appropriate for proper performance of laboratory activities.

9.2 The environment in work areas supports the achievement of required accuracy of sampling or testing.
9.2.1 The laboratory monitors and controls environmental conditions. Appropriate attention is paid, for example, to dust, electromagnetic interference, electrical power voltage level and stability, room temperature and humidity, and sound and vibration levels.

9.2.2 There is in place a documented procedure to stop technical activities when environmental conditions might jeopardize results of tests, and a record is maintained of such occurrences.

9.2.3 Particular care is taken when activities are undertaken at sites other than the permanent laboratory premises.

9.3 Adequate measures are taken to ensure good housekeeping in the laboratory.

9.4 Work areas are separated effectively to prevent inadvertent interference or contamination.

9.5 Access to and use of all areas affecting the quality of results is controlled.

NOTE 5 - It is the laboratory's responsibility to comply with relevant health and safety requirements. This aspect, however, is outside the scope of this guide.

10. Equipment and Supplies
10.1 All items of equipment and all supplies required for the proper performance of sample collection, sample preparation, and tests are available in the laboratory. Ifthe laboratory needs to use equipment outside its permanent control, it ensures that the equipment meets the requirements of the appropriate procedure.

10.2 A copy of the manufacturer's instructions (where available) or other instructions are kept in reasonable proximity to the equipment.

10.3 For each major item of equipment, a log is maintained that includes: the name of the item of equipment and an unique identification number; the manufacturer's name; model identification; date received and date placed in service; condition when received (for example, new, used, reconditioned); current location; dates and results of calibrations or verifications and date of the next calibration or verification; details of maintenance carried out to date and planned for the future; and history of any damage, malfunction, modification, or repair.

10.4 All measuring and testing equipment is calibrated or verified for accuracy before being put into service.
10.4.1 Balances are sufficiently sensitive and accurate for the activities in which they are used.

10.4.2 The laboratory has an established program for periodically verifying the calibration status of its measuring and test equipment (Section 14). A record of calibration status is maintained in near proximity to all equipment in use and also, preferably, in the equipment log.

10.5 All equipment is properly maintained according to written procedures and according to a written schedule.

10.6 An updated list of critical parts is maintained and provisions are made to ensure that the list is used to immediately reorder needed spare parts in a timely fashion in order to keep the operation functional.

10.7 Any item of equipment that has produced results suspected to be in error, or that has been discovered to be defective, is immediately taken out of service, clearly marked, and, wherever possible, stored at a specified place until it has been tested, calibrated, or, if necessary, repaired.
10.7.1 The laboratory has well-defined procedures to examine the effect of any defect on previous tests, and is prepared to retest samples that may have been improperly tested because of such defect.

10.8 Unauthorized tampering with or modification of equipment is prohibited. Modifications are made only after a specific problem has been identified and only after approval by an authorized person, for instance, the technical manager. All corrective actions are documented and the equipment is verified for fitness before being placed in service.

10.9 Sufficient supplies (including reference materials) are kept in stock to ensure that all operations can function. A list of the quantities of critical consumable materials and supplies is maintained and routinely updated, and is used to reorder them in a timely manner.
10.9.1 Records are maintained for every reference material used in the laboratory, and include source, date of acquisition, and other information pertinent to their proper use.

10.10 Wherever appropriate, purchased equipment and consumable materials are not used until they have been inspected, calibrated, or otherwise verified as complying with any standard specifications relevant to the tests concerned.

11. Quality Assurance Program
11.1 The laboratory maintains a quality assurance program that continuously controls and evaluates its performance to ensure that test results meet the needs of its users and clients. The critical elements of the quality assurance system are listed as follows, and are discussed in detail in subsequent sections of this guide.

11.2 Sample Identification and Data Control - Documented procedures exist for sample intake or procurement, identification, preparation, and maintenance. Samples and test data are handled in a well-defined and controlled manner (see Sections 12 and 13 for details).

11.3 Calibration of Equipment - Documented procedures ensure the appropriate use of reference materials or standardized test equipment to calibrate equipment and instruments so that they provide accurate results (Section 14).

11.4 Conducting Procedures and Test Methods - Every technical procedure for sample procurement, sample preparation, equipment calibration, or sample testing is performed only in accordance with the latest, approved version of a written standard operating procedure (SOP) (Section 15).

11.5 Quality Control Testing - The on-going quality of results that are provided to clients is ensured by vigorously pursuing a quality control test program. Results of quality control testing are always documented and are reviewed regularly (Section 16 and Appendix X2 and Appendix X3).

11.6 Data Review, Control, and Reporting - There is a documented procedure for data transfer and review to ensure that the result of each test or activity is attributed to the proper sample and is reported accurately, clearly, unambiguously, and objectively (Section 17).

11.7 Documentation - Documentation and record keeping are performed in a timely manner and are adequate to ensure auditors, staff, and customers that key elements of the quality management program are practiced and are accomplishing their objectives (Section 18).

11.8 Audits and Reviews - The laboratory conducts audits of operations (including its quality management program) on a routine basis to ensure that they are operating effectively (Section 19).