Значение и использование

In order to be certain that the end user of analytical results obtained from using an ASTM Committee D-19 test method can be confident that the values have been obtained through a competent application of the test method, a demonstration of the proficiency of the analytical system must be performed. Appropriate proficiency is demonstrated by achievement of performance criteria derived from results of the test method collaborative study. The QC measures specified in this practice must be included in each ASTM test method, as applicable, to ensure the quality of measurements.

In order for users of D-19 test methods to achieve consistently valid results, a minimum level of QC must be performed. This minimum level of QC is stipulated in this practice and by the taskgroups developing D-19 test methods. If the specific requirements outlined in this practice are not applicable to the test method, alternative QC must be defined in the test method.

Область применения

1.1 This practice provides specific, mandatory requirements for incorporating quality control (QC) procedures into all test methods under the jurisdiction of Committee D-19.

1.2 ASTM has adopted the following:

Policy on implementation of requirements for a quality control section in standard test methods generated by Committee D-19 on Water. GENERALBy July 29, 1998, or at the next reapproval or revision, whichever is later, every D-19 Standard Test Method shall contain a QC section that is in full compliance with the requirements of this practice. NEW COLLABORATIVE TESTINGAs of July 29, 1998, each collaborative study design shall include a QC section as part of the method to be tested. Prior to approval of the study design, the Results Advisor shall ascertain the appropriateness of the QC section in meeting the requirements of this Practice and Practice D2777, and shall advise the designer of the study of any changes needed to fulfill the requirements of these practices. Before a collaborative study may be conducted, approval of the study design by the Results Advisor must be obtained. OLDER VALIDATED METHODSStandard test methods that were validated using D-2777-77, D-2777-86, or D-2777-94, when ballotted for reapproval or revision, shall contain a QC section based upon the best information from the historical record. Where appropriate, information derived from the record of the collaborative study shall be utilized for this purpose. The introduction of the QC section into these standard test methods shall not be construed as a requirement for a new collaborative study, though the Subcommittee may opt for such a study. Any information available regarding QC or precision/bias testing shall be included in the appropriate sections of the published method.

1.3 Required QC sections in all applicable test methods are intended to achieve two goals. First, users of Committee D-19 test methods will be able to demonstrate a minimum competency in the performance of these test methods by comparison with collaborative study data. Second, all users of test methods will be required to perform a minimum level of QC as part of proper implementation of these test methods to ensure ongoing competency.

1.4 This practice contains the primary requirements for QC of a specific test method. In many cases, it may be desirable to implement additional QC requirements to assure the desired quality of data.

1.5 The specific requirements in this practice may not be applicable to all test methods. These requirements may vary depending on the type of test method used as well as the analyte being determined and the sample matrix being analyzed. See Explanation 1 in Appendix X1.

1.5.1 If there are compelling reasons why any of the specific QC requirements listed in this practice are not applicable to a specific test method, these reasons must be documented in the QC section of the test method.

1.5.2 With the approval of Committee D-19 on the recommendation of the D-19 Results Advisor and the Technical Operations section of the Executive Subcommittee, a statement giving the compelling reasons why compliance with all or specific points of this practice cannot be achieved will meet the requirements of both ASTM and this practice.

1.5.3 Test Methods developed prior to the approval of this practice with a QC Section that meet the requirements of Specification D5789 are considered in compliance with this Practice.

1.6 This practice is for use with quantitative methods and may not be applicable to qualitative test methods.

1.7 Presently, this practice is applicable primarily to chemical test methods. It is intended that, in future revisions, the practice will be expanded to include other methods such as microbiological methods.