8.7 Supports of Analytical Quality Assurance
335
range, robustness, etc. Validating data entails using a series of chemometric
criteria to screen primary data for acceptance or rejection. As noted earlier,
proper calibration is the basis for traceability of results; Chemometrics provides
a firm support on which this analytical operation can be reliably and efficiently
performed.
One other facet of Qualimetrics of a high interest in the context of analytical
quality is comparison of results and their respective uncertainties. Systems for
quality control and assessment rely on such comparisons. Comparing is thus a
very frequent operation in this context. Chemometrics provides rigorous,
reliable systems for comparing results; such systems produce not only primary
information (whether results are comparable or not) but also secondary information that occasionally facilitates the identification of sources of divergence. In
this way, data obtained from internal quality assessment, which are essentially
quantitative in nature, are compared via control charts, changes in personnel or
equipment, or the use of (usually validated) alternative methods. Chemometrics,
however, also plays a prominent role in comparisons of results, the use of
certified reference materials and interlaboratory studies.
Documenting and archiving activities pose the greatest hindrances to the
institution and maintenance of a quality system in the analytical laboratory, and
are the main source of personnel withdrawal from these processes, which involve
time-consuming, tedious tasks. However, they constitute a key facet and the
usual bottleneck of the Quality Assurance programme (Quality Manual). Any
activity performed by an analytical laboratory under the umbrella of quality
should be documented and recorded in written form. The laboratory should also
record the sample custody chain, the performance of its instruments (e.g. gas
chromatographs) and apparatuses (e.g. refrigerators, stoves) from the time they
are installed; the monitoring of other available means; its operating procedures
(SOPs), primary data, results and reports; and its self-documenting activities.
This is an enormous task that calls for heavy dedication, strict discipline and
rock-solid perseverance. Quality Assurance systems make no sense unless these
activities are performed in a serious, efficient manner. Any document generated
and archived should be ascribable to a specific individual. The system enforced
should provide protection against loss, theft and tampering with. Documenting
and archiving operations should encompass virtually all facets of the activities
of an analytical laboratory, namely:
(a) primary data, results and reports;
(b) analytical process (sample handling, calibration and servicing of instruments and apparatus, calibration of methods);
(c) personnel and its characteristics; and
(d) Quality Assurance programme (Quality Manual, SOPs, etc.).
Documenting and archiving operations are completely consistent with the
tracking facet of the integral concept of traceability discussed in Sect. 3.2.
Establishing the traceability of results, standards, equipment (instruments and
apparatus) and sample aliquots, which are mutually related in a hierarchical
manner (see Fig. 3.16), also entails documenting and archiving.
335
range, robustness, etc. Validating data entails using a series of chemometric
criteria to screen primary data for acceptance or rejection. As noted earlier,
proper calibration is the basis for traceability of results; Chemometrics provides
a firm support on which this analytical operation can be reliably and efficiently
performed.
One other facet of Qualimetrics of a high interest in the context of analytical
quality is comparison of results and their respective uncertainties. Systems for
quality control and assessment rely on such comparisons. Comparing is thus a
very frequent operation in this context. Chemometrics provides rigorous,
reliable systems for comparing results; such systems produce not only primary
information (whether results are comparable or not) but also secondary information that occasionally facilitates the identification of sources of divergence. In
this way, data obtained from internal quality assessment, which are essentially
quantitative in nature, are compared via control charts, changes in personnel or
equipment, or the use of (usually validated) alternative methods. Chemometrics,
however, also plays a prominent role in comparisons of results, the use of
certified reference materials and interlaboratory studies.
Documenting and archiving activities pose the greatest hindrances to the
institution and maintenance of a quality system in the analytical laboratory, and
are the main source of personnel withdrawal from these processes, which involve
time-consuming, tedious tasks. However, they constitute a key facet and the
usual bottleneck of the Quality Assurance programme (Quality Manual). Any
activity performed by an analytical laboratory under the umbrella of quality
should be documented and recorded in written form. The laboratory should also
record the sample custody chain, the performance of its instruments (e.g. gas
chromatographs) and apparatuses (e.g. refrigerators, stoves) from the time they
are installed; the monitoring of other available means; its operating procedures
(SOPs), primary data, results and reports; and its self-documenting activities.
This is an enormous task that calls for heavy dedication, strict discipline and
rock-solid perseverance. Quality Assurance systems make no sense unless these
activities are performed in a serious, efficient manner. Any document generated
and archived should be ascribable to a specific individual. The system enforced
should provide protection against loss, theft and tampering with. Documenting
and archiving operations should encompass virtually all facets of the activities
of an analytical laboratory, namely:
(a) primary data, results and reports;
(b) analytical process (sample handling, calibration and servicing of instruments and apparatus, calibration of methods);
(c) personnel and its characteristics; and
(d) Quality Assurance programme (Quality Manual, SOPs, etc.).
Documenting and archiving operations are completely consistent with the
tracking facet of the integral concept of traceability discussed in Sect. 3.2.
Establishing the traceability of results, standards, equipment (instruments and
apparatus) and sample aliquots, which are mutually related in a hierarchical
manner (see Fig. 3.16), also entails documenting and archiving.