ASTM D4621 Standard Guide for Quality Management in an Organization That Samples or Tests Coal and Coke
17. Reviewing and Reporting Results
17.1 All results are reviewed to be certain that all information requested has been determined and that the work has been performed in accordance with specified test methods.
17.1.1 Only one individual or a limited number of individuals is responsible for these validation activities.

17.1.2 The responsible individual(s) has the authority, if incorrect data are suspected, to institute retesting or to check calibrations.

NOTE 14 - Often, the validity of data can be checked by assessing whether different parameters are consistent with each other. For instance, laboratories that analyze coal from one mine or source can check whether specific energy (calorific value), volatile matter, and other compositional values are consistent with averages from earlier analyses when calculated to a dry, ash-free basis. Determined specific energy should agree with specific energy calculated from elemental analyses (where available). Data for certification of sample properties can often be checked against data from samples that have been collected and tested for on-line control of the quality of coal being produced or out-loaded. Data from a lot out of a consignment can also be checked for consistency with other lots, especially, where appropriate, when calculated to a dry, ash-free basis.

17.2 The results of each test, or series of tests carried out by the laboratory are reported accurately, clearly, unambiguously, and objectively in a test report or test certificate that includes information necessary for the interpretation of the test results, including (unless it would be inappropriate):
17.2.1 A title, for example, "Test Report", or "Test Certificate";

17.2.2 The name and address of the laboratory, and the location where any test was carried out if different from the address of the laboratory;

17.2.3 Unique identification of the certificate or report (such as a serial number) and page numbers and reference to the total number of pages;

17.2.4 The name and address of the client;

17.2.5 An unambiguous identification of the sample(s) tested and any information about the sample condition that could result in questionable results;

17.2.6 Date of report, date of receipt of the test sample, and date(s) of performance of test(s);

17.2.7 Identification of the test method(s) used, or unambiguous description (as an attachment if necessary) of any agreed-upon, nonstandard method used;

17.2.8 Reference to the sample collection procedure;

17.2.9 Any deviations from, additions to, or excursions from the test method, and any other information important and relevant to a specific procedure, such as environmental conditions during sample collection;

17.2.10 An unambiguous indication of the basis (as-received, dry, or dry and ash-free) on which the data are reported (Practice D3180);

17.2.11 A signature and title, or an equivalent identification of the person accepting responsibility for the content of the certificate or report, however produced, and an indication of how the responsible person can be contacted by the customer;

17.2.12 A statement to the effect that the results relate only to the sample(s) tested;

17.2.13 A statement that the certificate or report shall not be reproduced except in full, without the written approval of the laboratory; and

17.2.14 Clear identification of results of any test methods performed by subcontractors (Section 20).

17.3 The certificate or report is arranged so that the user can easily assimilate important points. The format is carefully and specifically designed for each type of test carried out, but the headings are standardized as far as possible.

17.4 If material amendments to a test report or test certificate are required after issue, they are made only in the form of a follow-up document (or data transfer). The statement "Supplement to Test Report or Test Certificate, serial number... (or as otherwise identified)", or equivalent wording, is used. Amendments meet all the relevant requirements of this guide.

17.5 The laboratory has in place a procedure to notify clients promptly, with written confirmation, of any event that casts doubt on the validity of results given in any test report or test certificate or amendment to a report or certificate (such as the discovery of defective measuring or test equipment).

17.6 Where clients require transmission of test results by telephone, telex, facsimile, or other electronic or electromagnetic means, the laboratory follows documented procedures that adhere to the requirements of this guide and that preserve confidentiality.

18. Document Control and Record Maintenance
18.1 The laboratory maintains a readily available master document control list that defines the current revision status of all reference documents, practices, procedures, and standards in use.
18.1.1 All documents generated by the laboratory are uniquely identified, including the date of issue and revision, the revision number, the total number of pages, and the authority for issue.

18.1.2 The laboratory reviews its documented practices and procedures on a routine schedule to evaluate their suitability for the tasks undertaken.

18.1.3 Obsolete documents are promptly removed from all points of issue or use or are otherwise precluded from unintended use.

18.2 The following documentation and records are maintained and readily accessible:
18.2.1 Standard operating procedures for sample collection, sample preparation, sample testing, safety, administration, quality assurance, and quality control;

18.2.2 Records of quality control activities, especially proficiency test results, control charts (calibration and control material tests), and discrepancy reports (Appendix X3);

18.2.3 Equipment maintenance logs;

18.2.4 Personnel training and competency records;

18.2.5 Records of client complaints and their disposition; and

18.2.6 Records of all instances of nonconformance and their disposition;

18.2.7 Audit and review documents.

18.3 The laboratory retains records of test results and sample logs to suit its particular circumstances and to comply with any applicable regulations (Note 15).

NOTE 15 - It is good practice to retain each analytical test report for a minimum of one year, and all original observations, calculations, and derived data until the customer has had a reasonable opportunity to submit questions concerning the results and to request return of the samples. Ninety days after the analyses have been completed and reported to the customer is normally adequate time for the analytical results to be reviewed and rechecked if necessary.

18.4 Client-related records, including data held on computers, are held secure and in confidence to the client.

19. Audits and Reviews
19.1 Audits - At appropriate intervals, the activities of the laboratory are formally audited to verify that its operations comply with the requirements of the quality management system.
19.1.1 A document in the quality manual describes the audit policy(s).

19.1.2 Knowledgeable personnel who are not directly involved with the daily activities conduct internal audits on a predetermined, fairly frequent schedule (for example, quarterly). Internal audits are scheduled so that different parts of the system are audited at different times. Internal audits are carried out with the aid of a checklist (see Practice D4182 for an example).

19.1.3 Audits by external examiners are conducted on a more long-term basis (for example, yearly), and may also use a checklist.

19.1.4 The laboratory has in-place procedures to take corrective action immediately when audit findings cast doubt on the correctness of practices or the validity of any test results, and immediately notifies, requesting written confirmation, any client whose samples or results may have been affected.

19.1.5 A written procedure defines who is responsible for taking action when an audit identifies a problem. This procedure also defines who is responsible for ensuring that the action is taken; that is, there is a specific "sign-off" process.

19.1.6 Records are retained of the results of audits, including specific actions taken to correct deficiencies.

19.2 Reviews - A written policy provides for an annual review of the quality management program by the laboratory management. This is commonly done in conjunction with an audit, and uses audit results. The policy defines specifically the procedures that management should follow to maximize the effectiveness of the review.
19.2.1 The review takes into account reports from managerial and supervisory personnel, the outcome of audits performed since the last review, calibration and quality control results (especially the results of interlaboratory comparisons or proficiency tests), any changes in volume and type of work performed, feedback from clients, and other factors.

19.2.2 Results are used in corporate planning programs, including setting goals, objectives, and action plans for the following year.

19.2.3 Review results and any corrective actions that arise from them are documented. The person responsible for quality shall ensure that these actions are discharged within an agreed upon time frame.

20. Subcontracting Tests to Outside Agencies
20.1 The laboratory advises its clients in writing of its intention to subcontract any portion of the testing to another laboratory.

20.2 The laboratory assures itself that a subcontractor is competent to perform the activities in question and that it complies with the same criteria of competence as the laboratory in respect to the work being subcontracted.

20.3 Wherever possible, subcontracts are placed with organizations that use good quality management practices.

20.4 The laboratory documents details of its investigation of the competence and compliance of its subcontractors and maintains a register of all capable subcontractors.

21. Outside Support
21.1 Where the laboratory procures outside services in support of tests, the laboratory uses only those services that are of adequate quality to sustain confidence in the laboratory's results.

21.2 Where no independent assurance of the quality of outside support services is available, the laboratory has or develops procedures to ensure that the outside organization complies with requirements specified by the laboratory.

21.3 The laboratory maintains records of the performance of all organizations from whom it obtains support services required for tests.

22. Complaints
22.1 The laboratory has documented policies and procedures for the resolution of complaints received from clients or other parties about the laboratory's activities.

22.2 A record is maintained of all complaints and of the actions taken by the laboratory to resolve them.

22.3 Where a complaint, or any other circumstance, raises doubt concerning the laboratory's compliance with its policies or procedures, or with the requirements of this guide or otherwise concerning the quality of the laboratory's tests, the laboratory promptly audits those areas of activity and responsibility.

23. Keywords
23.1 quality assurance; quality control; quality management