Seminar
341
I Seminar 8.1
Quality Control Activities
• Learning objective
To illustrate, via several examples, how analytical quality can be internally
controlled by processing the quantitative data obtained in experiments conducted to this end.
• Planning the Seminar
Compare the results of the different experiments conducted under the
umbrella of Statistics. Use the parameters described in Chap. 2.
• Exercises
(A) CONTROL CHARTS (see Box 3.15). An RM (or CRM) with a value X ± U
is subjected to the routinely applied CMP on a daily basis. Plot the results
and identify the warning and action limits.
(B) BLIND SAMPLES. Insert previously analysed samples or CRMs similar to
the ordinary matrix in the sample set analysed by the laboratory each day.
Compare the previously obtained results for the blind sample with those
provided by the laboratory. Is it advisable that the analyst know what is
being analysed?
(C) PERIODIC GLOBAL VALIDATION OF THE CMP. Subject a CRM similar
to the samples received by the laboratory to the CMP. Systematically compare the accuracy and precision achieved.
(D) CHANGE THE OPERATOR OR INSTRUMENT. Using the same sample,
compare the results obtained by having the CMP conducted by different
analysts or using different analytical tools of identical characteristics.
Discuss the conclusions reached if the results produced are disparate.
Seminar 8.2
Regulatory Frameworks for Implementation of Analytical Quality
• Learning objective
To become acquainted with the use of the framework standards most widely
used in connection with quality of analytical laboratories.
• Material
• ISO 9000 standards.
• ISO Guide 25. General Requirements of Competence for Testing and Calibration Laboratories.
• EN-45000.
• GLPs:
- Decision of 13 May 1981 of the OECD Council about GLPs.
- EU Directives 87/15/CEE and 88/320/CEE (European Communities Official Diaries of 18/12/87 and 6/11188, respectively).
341
I Seminar 8.1
Quality Control Activities
• Learning objective
To illustrate, via several examples, how analytical quality can be internally
controlled by processing the quantitative data obtained in experiments conducted to this end.
• Planning the Seminar
Compare the results of the different experiments conducted under the
umbrella of Statistics. Use the parameters described in Chap. 2.
• Exercises
(A) CONTROL CHARTS (see Box 3.15). An RM (or CRM) with a value X ± U
is subjected to the routinely applied CMP on a daily basis. Plot the results
and identify the warning and action limits.
(B) BLIND SAMPLES. Insert previously analysed samples or CRMs similar to
the ordinary matrix in the sample set analysed by the laboratory each day.
Compare the previously obtained results for the blind sample with those
provided by the laboratory. Is it advisable that the analyst know what is
being analysed?
(C) PERIODIC GLOBAL VALIDATION OF THE CMP. Subject a CRM similar
to the samples received by the laboratory to the CMP. Systematically compare the accuracy and precision achieved.
(D) CHANGE THE OPERATOR OR INSTRUMENT. Using the same sample,
compare the results obtained by having the CMP conducted by different
analysts or using different analytical tools of identical characteristics.
Discuss the conclusions reached if the results produced are disparate.
Seminar 8.2
Regulatory Frameworks for Implementation of Analytical Quality
• Learning objective
To become acquainted with the use of the framework standards most widely
used in connection with quality of analytical laboratories.
• Material
• ISO 9000 standards.
• ISO Guide 25. General Requirements of Competence for Testing and Calibration Laboratories.
• EN-45000.
• GLPs:
- Decision of 13 May 1981 of the OECD Council about GLPs.
- EU Directives 87/15/CEE and 88/320/CEE (European Communities Official Diaries of 18/12/87 and 6/11188, respectively).