In quality assessment

Quality assessment includes the statistical tools used to determine whether an analysis is in a state of statistical control and, if possible, to suggest why an analysis has drifted out of statistical control. Among the tools included in quality assessment are the analysis of duplicate samples, the analysis of blanks, the analysis of standards, and the analysis of spike recoveries. 

A Donabedian. Explorations in Quality Assessment and Monitoring The Definition of Quality and Approaches to Its Assessment. Vol. 1, Ann Arbor, MI Health Administration Press, 1980. 

Yurek, D. A., Branch, D. L., and Kuo, M. S. (2002) Development of a system to evaluate compound identity, purity, and concentration in a single experiment and its application in quality assessment of combinatorial libraries and screening hits. 

Mosandl, A. 1992. Capillary gas chromatography in quality assessment of flavors and fragrances. J. Chromatogr. 624 267-292. 

Several modifications of the method are described in the literature (Artursson and Karlsson 1991 Hidalgo and Borchardt 1989 and many others). Modifications include cell culture medium, time of cultivation and frequence of medium change, variations of trypsinization methods and others. In an industrial environment cell cultivation methods are maintained over many years constant to reduce variability and ensure constant results in quality assessment protocols. Additionally to quality control parameters like TEER and permeability markers expression levels of major enzymes and transporters are checked. 

The know how in quality assessment has grown over the last few years. Quality management systems are improving and validation procedures are being optimized. But the problem that validation procedures are time consuming still remains. Often validations are performed too late. Especially in a development environment where the advance from one development step to the next is based on a decision resulting from the previous step. Therefore, valid analytical data is needed directly after each method development. 

Yurek DA, Branch DL, and Kuo M-S. Development of a System To Evaluate Compound Identity, Purity, and Concentration in a Single Experiment and Its Application in Quality Assessment of Combinatorial Libraries and Screening Hits. J Comb Chem 2002 4 138-148. 

Dave G, Field test of ammunition (TNT) dumping in the ocean, in Quality Assessment and Management Insight and Progress, Munawar, M, Ed., Aquatic Ecosystem Health and Management Society, Washington, DC, 2003, 213. 

Donabedian, A. (1992), The Role of Outcomes in Quality Assessment and Assurance, Quality Review Bulletin, pp. 356-360. 

J. Tiihaas, P.V. Nielsen, Electronic nose technology in quality assessment Monitoring the ripening process of Danish blue cheese. J. Food Sci. 70, E44-E49 (2005)... 

Traditionally, infection control programs have played a major role in quality assessment. The shift of emphasis from QA to CQI methodology will require their continued involvement. How should an institution organize and implement a CQI program to reduce the occurrence of nosocomial pneumonia (Fig. 2)7 The first step is to form a dedicated, multidisciplinary committee to address this issue. Team members should include representatives from respiratory ther-... 

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