Judgement procedures

Where drugs have been found ineffective, most have been taken off the market using the summary judgement procedure. A few manufacturers have succeeded in requiring an administrative hearing, but none has prevailed before an administrative law judge, the Commissioner, or the courts. 

Evaluating the evidence of biological hazard often requires skilled scientific judgement. Procedures for assessing biological effects are set out in other parts of this book detailed descriptions of some of the procedures involved in human health assessment and evaluation have been published elsewhere [10-13]. 

This clause does not require suppliers to establish procedures for identifying personnel certification requirements. While unnecessary in most situations, personnel certification is necessary for special processes (see Part 2 Chapter 9 under Special processes). Certification would also be necessary for teachers, lecturers, and other personnel upon whose judgement the determination of quality depends. 

The assessment of the performance of a method is commonly checked by means of a (C)RM. In those cases where there is no RM available, considerable effort is requested from the laboratory to assess the performance of their own methods. The aspect of traceability of the certified value(s) is also of great importance whenever necessary, the laboratory will make modifications in its procedures if the result of a measurement using the RM appears to be imsatisfactory. If the traceabihty of the values to other references is not fully established, then this judgement may be clouded by doubts about the certified value (s). 

The correct choice of the basis for a calculation will often determine whether the calculation proves to be simple or complex. As with the choice of system boundaries, no all-embracing rules or procedures can be given for the selection of the right basis for any problem. The selection depends on judgement gained by experience. Some guide rules that will help in the choice are ... 

It should be noted that all the formatting knowledge required to run auto analysis is also required to run a user analysis. In this case one is sinply overriding the computer s "better judgement" in terms of procedural protocol. 

Many other extrapolation techniques have been used in manipulation of animal lethality data in an effort to generate a reasonable human estimate. By taking a conservative approach with data on deaths at low doses, one can derive estimates for man that are modest and in keeping with clinical judgement. Such methods depend on procedures developed and applied in toxicology. 

Under no circumstances should this SOP be construed to supplant or replace the judgement of the medical officers in the selection procedures, who may deviate from these guidelines at their discretion. Deviation from the SOP may also be done in a systematic way... 

The two principal tray-by-tray procedures that were performed manually are the Lewis and Matheson and Thiele and Geddes. The former started with estimates of the terminal compositions and worked plate-by-plate towards the feed tray until a match in compositions was obtained. Invariably adjustments of the amounts of the components that appeared in trace or small amounts in the end compositions had to be made until they appeared in the significant amounts of the feed zone. The method of Thiele and Geddes fixed the number of trays above and below the feed, the reflux ratio, and temperature and liquid flow rates at each tray. If the calculated terminal compositions are not satisfactory, further trials with revised conditions are performed. The twisting of temperature and flow profiles is the feature that requires most judgement. The Thiele-Geddes method in some modification or other is the basis of most current computer methods. These two forerunners of current methods of calculating multicomponent phase separations are discussed briefly with calculation flowsketches by Hines and Maddox (1985). 

This method makes use of a test battery to derive a toxicity index that can be employed to classify effluents as a function of their overall toxicity. A formula is given as an example and a procedure to calculate the index using expert judgements and a PLS (Partial Least Square) regression procedure is described using data on 30 effluents. 

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