Quality Assurance in Instrumentation

Ludwig Huber, Agilent Technologies GmbH. P.O. Box 1280, D-76337 Waldbronn, Germany 

Preparing for Installation. . 25 with Control Samples and Control Charts 33 

Unfortunately quality standards and regulations are not specific enough to give clear guidelines on what to do on a day-to-day basis. Owing to this lack of clarity, most laboratories found they had to interpret these standards and regulations themselves. Private and public auditors and inspectors experienced similar problems and there have also been situations whereby the regulations have been interpreted differently by different inspectors. 

This chapter discusses aspects of quality assurance of equipment as used in analytical laboratories. It provides guidelines on how to select a vendor and for installation and operational qualifications, ongoing performance control, maintenance, and error detection and handling that contribute to assuring the quality of analytical laboratory data. It refers mainly to an automated chromatography system as an example, but similar principles can be applied to other instrumentation. 

It is not the scope of this chapter to discuss quality measures as applied during development and manufacturing of equipment hardware and software. This cannot be directly influenced by the user. Details on this topic can be found in 

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Kress-Rodgers E., Instrumentation for Food Quality Assurance, in Kress-Rodgers, E., editor. Instrumentation and sensors in the food industry. London Woodhead Publishing Ltd., 1998, p.1-34. 

Two American Chemical Society short courses were instrumental in the development of this manuscript. These were (1) "Quality Assurance in the Analytical Testing Laboratory/ taught by Gillis and Callio, and (2) "Good Laboratory Practices and ISO 9000 Standards Quality Standards for Chemical Laboratories," taught by Mathre and Schneider. 

Instrumental Methods for Quality Assurance in Foods, edited by Daniel Y. C. Fung and Richard F. Matthews... 

The term quality control (QC) is applied to procedures used to provide evidence of quality and confidence in the analytical results. It includes use of blanks, replication, analysing reference materials or other well-defined samples and participation in Proficiency Testing schemes. Several other features of analysis forming part of QC are control of reagents and instrumentation, equipment maintenance and calibration, and procedures for checking calculations and data transfer. It should be noted that what is referred to as quality assurance in the UK is known as quality control in Japan. 

Woolfenden EA (1995) In Subramanian G (ed) Quality assurance in environmental monitoring instrumental methods, VCH, Weinheim, p 133... 

A key feature of quality assurance in analytical chemistry is the adoption and wider implementation of standard methods. Flow analysis has a major role to play in this area due to the inherent attractions of flow-based instrumentation, not least the reproducibility of sample transport and manipulation. This in turn will generate a greater awareness of, and interest in, flow analysis. The challenge is to get such methods adopted by the relevant regulatory agencies. 

COFINO WP (1993) Quality assurance in environmental analysis. In Barcelo D, ed. Environmental Analysis — Techniques, Applications and Quality Assurance (Techniques and Instrumentation in Analytical Chemistry, Vol 13), pp. 359-381. Elsevier, Amsterdam. 

Quality assurance in micro-CE has yet to be studied in detail. Research focuses on practical applications and the transfer of separation problems to a microdevice. One problem is the chip-to-chip variation from manufacturing, another the run-to-mn performance due to reloading, the cleaning of the channel surfaces, the not perfect electrokinetic injection mode, or that instrumental setups are usually still in the trial state and have only been optimized for one purpose [2]. 

Fischbacher, C. 2000. Quality assurance in analytical chemistry. In Encyclopedia of Analytical Chemistry, Applications, Theory and Instrumentation, ed. R. A. Meyers, Vol. 15, pp. 13563-13586. New York John Wiley Sons Ltd. 

In order to establish SIDAs as official reference methods, standard operation protocols have to be developed. In particular, the highly variable mass spec-trometric settings depending on the respective instruments retarded collaborative trials. However, in the area of mycotoxins, isotope dilution assays have been elaborated as reference methods and point to a way to implement SIDAs as official methods also in folate analysis (Rychlik and Asam 2008). This could lead to the establishment of reference materials with certified values obtained by SIDA. Lability of folates is still a roadblock but will be essential for quality assurance in accredited laboratories. 

Subramanian, G., Ed., Quality Assurance in Environmental Monitoring Instrumental Methods, VCH, Weinheim, Germany, 1995. 

We have already seen that the new standards want to ensure that we xise instruments that have a good pedigree. They ask us to establish this either through design and quality assurance in accordance with lEC 61508 or because it is proven in use . 

Hemmila I. A. Time-resolved Fluorimetric Immunoassays Instrumentation, Application, Unresolved Issues, Future Trends. In Resch-Genger U., editor. Springer Series on Fluorescence. Standardization and Quality Assurance in Fluorescence Measurements II. 429-447. 2008. Berlin, Springer Verlag. 

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