ASTM D6809-20a
ASTM D6809-20a
for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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D6809 − 20a
information is provided as a QA/QC system guide for D16 testing precision should be compared periodically with ASTM
standard users who do not have an active QA/QC process in method precision (as developed using Practice E691) where
their laboratory. possible. If the QC test precision is considerably worse than the
ASTM method precision, continuous improvement activity
5. Significance and Use should be initiated to improve the QC test precision.
5.1 Quality Control and Quality Assurance practices are 6.5 Out-of-Control Data Points—Any QC sample data point
important for the optimum operation of testing laboratories outside the upper or lower control limits, or that violates any
using D16 methods for aromatic hydrocarbons and related other valid statistical rule being used in the facility (for
materials. Quality procedure guidelines, like those described in example, Western Electric SQC Handbook), should be consid-
this document or other suitably correct QA/QC-related ered out-of-control. Such a result should trigger an investiga-
reference, can be useful to optimally perform these methods. tion to determine the root cause, and the implementation of
6. Quality Procedure Guidelines appropriate corrective action(s).
6.1 Statistical Control—To establish the statistical control 6.6 Frequency of QC Sample Testing—For routine testing
status of the testing process since the last valid calibration, (for example, plant quality control), QC testing frequency is
quality control (QC) samples should be regularly tested as if dependent on the criticality of the parameter being measured,
they were routine samples. Results should be recorded and the demonstrated stability of the testing process, and customer
immediately analyzed by control charts, as described in MNL7, requirements. Generally, QC samples should be analyzed at a
or other statistically equivalent techniques. Any out-of-control defined frequency with samples. Additional QC sample testing
data should provide an immediate trigger for an investigation is also recommended after a change is made relating to the
of root cause(s) that might require corrective action. method (for example, replenishment of reagents, change of
analyst, maintenance of instrument, etc.). For non-routine
6.2 Selection of the QC Sample—Choose an ample quantity testing (for example, R&D process development), the analyst
of a homogeneous material that is representative of the should determine an appropriate QC testing frequency to
sample(s) routinely being tested with the testing process, and meaningfully monitor test performance.
capable of being stored without degradation over the intended
period of use. Carefully consider the matrix, interfering 6.7 Interlaboratory Testing—A program that includes mul-
species, and analyte concentration/value. Primary standard tiple laboratories analyzing the same samples that allows
materials may be used to characterize the precision and bias of laboratories to compare their results with other laboratories.
the method, as described in Practice E177. This is particularly important when a producer is selling the
product to customers or the laboratory is analyzing the product
6.3 Control Charting—Use any valid statistical charting for acceptance. Producers and customers need to have confi-
technique for variables (for example, individuals/range, dence that results from different laboratories are comparable.
CUSUM, subgroups, moving averages, etc., as described in Participation in such a program is strongly encouraged. ASTM
MNL7) where appropriate. currently has a Proficiency Testing Program that sends a
6.4 QC Material Statistics—Obtain a minimum of 16 data sample of mixed xylenes, p-xylene, and benzene to multiple
points (24 is better) when a new QC material is started or an laboratories twice a year for testing. Other programs are
existing QC material requires replacement (for example, due to acceptable.
contamination or depleted supply), to establish a statistically-
acceptable mean, and upper and lower control limits. Fewer 7. Keywords
data points will produce less acceptable control determinations, 7.1 aromatic hydrocarbons; quality; quality assurance; qual-
and are acceptable only if absolutely necessary. QC material ity control
SUMMARY OF CHANGES
Committee D16 has identified the location of selected changes to this standard since the last issue (D6809 –
20) that may impact the use of this standard. (Approved October 1, 2020.)
Committee D16 has identified the location of selected changes to this standard since the last issue (D6809 –
02 (Reapproved 2016)) that may impact the use of this standard. (Approved June 1, 2020.)
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D6809 − 20a
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