Design quality improvement measures

Develop medication use evaluation criteria and other quality improvement measures to assess the use of drug therapy by other providers. Design, conduct, and coordinate clinical research projects under FDA guidelines and procedures of the institutional review board. 

In this chapter we focused on metrics designed to improve the quality of a compound library. Each metric can be rationalized most can be measured. Serendipity is not necessarily... 

A failure modes and effects analysis is a systematic analytical technique for identifying potential failures in a design or a process, assessing the probability of occurrence and likely effect, and determining the measures needed to eliminate, contain, or control the effects. Action taken on the basis of an FMEA will improve safety, performance, reliability, maintainability and reduce costs. The outputs are essential to balanced and effective quality plans for both development and production as it will help focus the controls upon those products, processes, and characteristics that are at risk. It is not the intention here to give a full appreciation of the FMEA technique and readers are advised to consult other texts. 

We will eliminate all duplication of effort within our PSM and ESH systems by integrating the elements, programs, and management processes wherever possible. We will achieve this integration by using Quality Management principles to design new systems. We will measure our improvement in terms of fewer resources, quicker response to new demands and improved PSM and ESH performance. 

Measurements of individual laboratory performance provides for comparisons between laboratories. It then follows to ask why some laboratories report data that are more accurate and precise than do their peers, and a well designed external quality assessment scheme allows investigation of some of the important factors (see below). A comparison of performance between individual laboratories also helps to stimulate those who are not so successful to improve (or abandon the assay) and those who do well to continue with their expertise. Finally, changes of performance may be monitored as a consequence of some new factor, e.g. purchase of a new piece of equipment, work carried out by a different analyst, change to the methodology etc. 

In terms of confidence limits the two Grand Means can be written as 38.5 + 6.4 mg/m2 for the EC plot and 49.9 + 32.7 mg/m for the GF plot at the 90 level. This statement emphasizes the extent to which sampling variability can affect the confidence with which an analytical result is known. Unless the sampling program is designed to measure and identify the source of the variability much effort towards improvement of the quality of the chemical analyses can be wasted (4). The difficulty of improving the sampling procedures to reduce the variability is illustrated by calculation of the number of samples that would have to be analyzed to obtain estimates known to have an uncertainty less than 10 at the 90 confidence level (4). This would require 106 analyses from the EC plot and 2140 from the GF. Both sample sizes... 

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