160
9 Managing the Quality Systems
To summarize, quality management in a chemical laboratory performing tests or
calibrations, comprises two complementary areas:
– Quality assurance (QA) is a set of procedures that creates a system ensuring the
creation of the best possible conditions tailored to the type of tests conducted;
– Quality control (QC) is a systematic supervision over technical activities, encompassing the control of selected parameters (quality indicators).
Systematic evaluation of those parameters will make it possible to ensure that the
system works effectively, and possible deviations will be noticed in time so that they
can be avoided and proper corrective actions could be taken.
9.3 Quality Control
In a laboratory, in which the requirements regarding the quality of results have been
specified, it is necessary to employ a systematic evaluation of performance. The commonly accepted approach used for effective QC, includes a systematic evaluation of
selected quality indicators via comparison with the previously defined requirements.
A well-designed system of QC ensures that the risk of reporting incorrect results is
minimized via an early warning methodology.
QC can be of internal as well external means. External quality management is,
more than anything, the participation of the laboratory in inter-laboratory comparison
and/or in proficiency testing. In that case, the laboratory receives a sample of an
unknown value of a given property (e.g., the substance’s concentration and/or its
identification), conducts a test, sends the results to the ILC/PT providers and finally
is evaluated on the basis of the degree of compliance with the reference value.
As long as the laboratory regularly participates in ILC/PT, it is also possible to
use control charts to monitor the trends. Monitoring the quality of results is made
on the basis of the value of the performance scores; for example, z-, z
-, zeta and En
scores. More details on the external QC, manly via participation in ILC/PT will be
given in Chap. 10.
9.4 Quality Measures
As previously mentioned, the scope of QC, meaning the selection of quality measures
as well as the frequency in which they are checked, should be designed so as to fit to
the kind and number of the tests performed. The proper selection of the study items
involved in the measuring procedure is extreamly important and should undergoes
the entire procedure used in a given laboratory. Thus, the measurement results should
be recorded so as to evaluate whether the analytical system in a single laboratory is
working correctly. It is known that in practice, slight variation of the response occurs;
therefore, the purpose of the quality control is to monitor whether the fluctuation of
9 Managing the Quality Systems
To summarize, quality management in a chemical laboratory performing tests or
calibrations, comprises two complementary areas:
– Quality assurance (QA) is a set of procedures that creates a system ensuring the
creation of the best possible conditions tailored to the type of tests conducted;
– Quality control (QC) is a systematic supervision over technical activities, encompassing the control of selected parameters (quality indicators).
Systematic evaluation of those parameters will make it possible to ensure that the
system works effectively, and possible deviations will be noticed in time so that they
can be avoided and proper corrective actions could be taken.
9.3 Quality Control
In a laboratory, in which the requirements regarding the quality of results have been
specified, it is necessary to employ a systematic evaluation of performance. The commonly accepted approach used for effective QC, includes a systematic evaluation of
selected quality indicators via comparison with the previously defined requirements.
A well-designed system of QC ensures that the risk of reporting incorrect results is
minimized via an early warning methodology.
QC can be of internal as well external means. External quality management is,
more than anything, the participation of the laboratory in inter-laboratory comparison
and/or in proficiency testing. In that case, the laboratory receives a sample of an
unknown value of a given property (e.g., the substance’s concentration and/or its
identification), conducts a test, sends the results to the ILC/PT providers and finally
is evaluated on the basis of the degree of compliance with the reference value.
As long as the laboratory regularly participates in ILC/PT, it is also possible to
use control charts to monitor the trends. Monitoring the quality of results is made
on the basis of the value of the performance scores; for example, z-, z
-, zeta and En
scores. More details on the external QC, manly via participation in ILC/PT will be
given in Chap. 10.
9.4 Quality Measures
As previously mentioned, the scope of QC, meaning the selection of quality measures
as well as the frequency in which they are checked, should be designed so as to fit to
the kind and number of the tests performed. The proper selection of the study items
involved in the measuring procedure is extreamly important and should undergoes
the entire procedure used in a given laboratory. Thus, the measurement results should
be recorded so as to evaluate whether the analytical system in a single laboratory is
working correctly. It is known that in practice, slight variation of the response occurs;
therefore, the purpose of the quality control is to monitor whether the fluctuation of