Elements of Effective Procedures

This chapter provides a starting point for developing a list of ctiteiia for writing effective procedures to meet your facility s needs. Due to your operating, maintenance, and regulatory concerns, you may want to add facility-specific procedure criteria to this list, or delete criteria not applicable to your situation. This chapter also discusses the importance of these criteria and who will use them. A summary of these criteria is included in 

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Some Elements of Effective Procedures and Procedure Management Systems 15... 

Use lists or tables to simplify presentation of information. If you have three or more items or clauses in a sentence or procedure step, list the items. This is illustrated in detail in Chapter 5, Elements of Effective Procedures. 

Conditioning. A Pavlovian explanation of placebo effects has been based on the traditional model of classical conditioning active ingredients serve as unconditional stimuli and the vehicles in which they are delivered (pills, injections), particularly the elements of therapeutic procedures, function as conditional stimuli. After repeated pairing of unconditioned and conditioned stimuli, the conditional stimulus elicits a conditional response even if the conditioned stimulus (e.g. the pill) is presented alone (without active ingredient). 

Development and timely execution of corrective action procedures for out-of-control conditions is one of the most critical elements of effective implementation of process control. Corrective action procedures must be documented and should include the following information ... 

Composition. The results of elemental analyses are almost always included among the specifications for a commercial catalyst. Depending on the accuracy desired and whether or not the catalyst can be rendered soluble without great difficulty, elemental analysis may be performed by x-ray methods, by one of the procedures based on atomic absorption, or by traditional wet-chemical methods. Erequentiy it is important to determine and report trace element components that may have an effect on catalyst performance. 

Failure Mode and Ejfect Analysis (FMEA) This is a systematic study of the causes of failures and their effects. All causes or modes of failure are considered for each element of a system, and then all possible outcomes or effects are recorded. This method is usually used in combination with fault tree analysis, a quantitative technique. FMEA is a comphcated procedure, usually carried out by experienced risk analysts. 

The various elements of the error management program such as the development of high quality procedures and training and effective feedback and communications systems need to be supported by policies and standards to implement these policies. The development of these policies is an important strategic aspect of the implementation process. 

Professor Martel s book addresses specifically some of the more technical eispects of the risk assessment process, mainly in the areas of hazard identification, and of the consequence/effect analysis elements, of the overall analysis whilst where appropriate setting these aspects in the wider context. The book brings together a substantial corpus of information, drawn from a number of sources, about the toxic, flammable and explosive properties and effect (ie harm) characteristics of a wide range of chemical substances likely to be found in industry eind in the laboratory, and also addresses a spectrum of dangerous reactions of, or between, such substances which may be encountered. This approach follows the classical methodology and procedures of hazard identification, analysing material properties eind... 

In addition to these basic elements of informed consent, IRBs shall also require that information shall be provided, where indicated, to the effect that (1) the particular treatment or procedure being tested may involve risks to the subject that are currently unforeseeable (2) foreseeable circumstances may exist under which continued participation by the subject may be terminated by the investigator without regard to the subject s consent (3) additional costs to the subject may results from participation in the research (4) the consequences of a decision to withdraw and (5) significant findings that may influence a subject s continued participation will be related to the subject. 

In the last decade, quantum-chemical investigations have become an integral part of modern chemical research. The appearance of chemistry as a purely experimental discipline has been changed by the development of electronic structure methods that are now widely used. This change became possible because contemporary quantum-chemical programs provide reliable data and important information about structures and reactivities of molecules and solids that complement results of experimental studies. Theoretical methods are now available for compounds of all elements of the periodic table, including heavy metals, as reliable procedures for the calculation of relativistic effects and efficient treatments of many-electron systems have been developed [1, 2] For transition metal (TM) compounds, accurate calculations of thermodynamic properties are of particularly great usefulness due to the sparsity of experimental data. 

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