ASTM D5847-02(2007)
(Practice)Standard Practice for Writing Quality Control Specifications for Standard Test Methods for Water Analysis
Standard Practice for Writing Quality Control Specifications for Standard Test Methods for Water Analysis
SIGNIFICANCE AND USE
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.
SCOPE
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.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.
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 Resul...
General Information
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:D5847 −02(Reapproved 2007)
Standard Practice for
Writing Quality Control Specifications for Standard Test
1
Methods for Water Analysis
This standard is issued under the fixed designation D5847; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.4 This practice contains the primary requirements for QC
of a specific test method. In many cases, it may be desirable to
1.1 This practice provides specific, mandatory requirements
implement additional QC requirements to assure the desired
for incorporating quality control (QC) procedures into all test
quality of data.
methods under the jurisdiction of Committee D-19.
1.5 The specific requirements in this practice may not be
1.2 ASTM has adopted the following:
applicable to all test methods. These requirements may vary
Policy on implementation of requirements for a quality control
depending on the type of test method used as well as the
section in standard test methods generated by Committee D-19
analyte being determined and the sample matrix being ana-
on Water.
lyzed. See Explanation 1 in Appendix X1.
GENERAL—By July 29, 1998, or at the next reapproval or revision,
1.5.1 Iftherearecompellingreasonswhyanyofthespecific
whichever is later, every D-19 Standard Test Method shall contain a
QC requirements listed in this practice are not applicable to a
QC section that is in full compliance with the requirements of this
specific test method, these reasons must be documented in the
practice.
NEW COLLABORATIVE TESTING —As of July 29, 1998, each
QC section of the test method.
collaborative study design shall include a QC section as part of the
1.5.2 With the approval of Committee D-19 on the recom-
method to be tested. Prior to approval of the study design, the
Results Advisor shall ascertain the appropriateness of the QC mendation of the D-19 Results Advisor and the Technical
section in meeting the requirements of this Practice and Practice
OperationssectionoftheExecutiveSubcommittee,astatement
D2777, and shall advise the designer of the study of any changes
giving the compelling reasons why compliance with all or
needed to fulfill the requirements of these practices. Before a collab-
orative study may be conducted, approval of the study design by the specificpointsofthispracticecannotbeachievedwillmeetthe
Results Advisor must be obtained.
requirements of both ASTM and this practice.
OLDER VALIDATED METHODS —Standard test methods that were
1.5.3 Test Methods developed prior to the approval of this
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 practice with a QC Section that meet the requirements of
best information from the historical record. Where appropriate, infor-
Specification D5789 are considered in compliance with this
mation derived from the record of the collaborative study shall be
Practice.
utilized for this purpose. The introduction of the QC section into
these standard test methods shall not be construed as a requirement
1.6 This practice is for use with quantitative methods and
for a new collaborative study, though the Subcommittee may opt for
may not be applicable to qualitative test methods.
such a study. Any information available regarding QC or precision/
bias testing shall be included in the appropriate sections of the pub-
1.7 Presently, this practice is applicable primarily to chemi-
lished method.
cal test methods. It is intended that, in future revisions, the
1.3 Required QC sections in all applicable test methods are
practice will be expanded to include other methods such as
intended to achieve two goals. First, users of Committee D-19
microbiological methods.
test methods will be able to demonstrate a minimum compe-
tency in the performance of these test methods by comparison
2. Referenced Documents
with collaborative study data. Second, all users of test methods
2
2.1 ASTM Standards:
will be required to perform a minimum level of QC as part of
D1129 Terminology Relating to Water
proper implementation of these test methods to ensure ongoing
D1193 Specification for Reagent Water
competency.
D2777 Practice for Determination of Precision and Bias of
Applicable Test Methods of Committee D19 on Water
D3648 Practices for the Measurement of Radioactivity
1
This practice is under the jurisdiction ofASTM Committee D19 on Water and
is the direct responsibility of Subcommittee D19.02 on Quality Systems,
2
Specification, and Statistics. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved April 15, 2007. Publi
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