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ASTM D 5847 Document Information:
Title
Standard Practice for Writing Quality Control Specifications for Standard Test Methods for Water Analysis
ASTM International
Publication Date:
Jul 10, 2002
Scope:
This practice provides specific, mandatory requirements for
incorporating quality control (QC) procedures into all test methods
under the jurisdiction of Committee D-19.
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.
GENERAL—By 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 TESTING—As 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 D
2777, 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 METHODS—Standard 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.
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.
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.
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.
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.
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.
Test Methods developed prior to the approval of this practice
with a QC Section that meet the requirements of Specification D
5789 are considered in compliance with this Practice.
This practice is for use with quantitative methods and may not
be applicable to qualitative test methods.
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.
Keywords:
- bias
- precision
- quality control
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