Adequacy of Procedures

In discharging their review and approval responsibilities, QA must review the adequacy of procedures, methods, sample plans, test methods, and internal and external specifications and approve SOPs, specifications, methods, validation plans and results. 

Confkm the adequacy of procedures for process observation and monitoring in confkrning the destruction of CW... 

Adequacy of procedures (the accuracy, completeness, comprehensiveness, clarity, and appropriateness of procedures as well as the ease of selection and use of procedures)... 

Proof Testing A run through the process substituting nonhazardous materials (e.g., water) to check for the adequacy of the equipment e.g., heating/cool-ing load, and to verify procedural steps. 

Once a decision to use QRA has been made, you must decide whether frequency and/or consequence information is required (Steps 6 and 7). In some cases you may simply need frequency information to make your decision. For example, suppose you wish to evaluate the adequacy of operating procedures and safety systems associated with a chemical reactor. The main hazard of concern is that the reactor could experience a violent runaway exothermic reaction. You believe that you know enough about the severe consequences of a runaway and nothing more will be gained by quantifying the consequences of potential run-... 

The audit includes a review of the process safety information, inspection of the physical facilities, and interviews with all levels of plant personnel. Using the procedures and checklist, the team systematically analyzes compliance with the PSM Rule and any other relevant corporate policies. The training program is reviewed for adequacy of content, frequency and effectiveness of training. Interviews determine employee knowledge and awareness ofthe safety procedures, duties, rules, and emergency response assignments. The team identifies deficiencies in the application of safety and health policies, procedures, and work authorization practices to determine live actions. 

This technique sets out to collect data about near-incidents or critical events that have been experienced by the operating team but that are unlikely to be documented. The basic premise of the technique is that events that could have led to serious consequences would tend to be remembered by the workers. Through individual or group interviews, significant events are recalled which are then analyzed in order to generate useful information about the difficulties involved in the performance of a task, the adequacy of the operating procedures, any problems with the equipment or control panel design and so on. The technique can be used in three areas ... 

The general assessment indicates that the pharmaceutical industry experiences problems with transparency of dmg registration in two out of the 10 countries— Cypms and Uganda. The main problems cited involve communication between the DRA and the industry regarding clarity of procedures and adequacy of official explanations for the rejection of an application. In Cypms, the Dmg Council also raised issues concerning the fairness of treatment of foreign versus domestic industry, and the arbitration of contradictory quality analysis results provided by different laboratories, both belonging to the Dmg Council. 

Continued decline in performance indicates a membrane cleaning or compatibihty issue. The adequacy of the cleaning step is determined by the recovery of at least 80 percent of the initial normalized water flux. Although some variability in water flux is typical, any consistent dechne reflects an inadequate cleaning procedure. 

Unlike most static design procedures, dynamic design requires a trial and error approach. Only in the verification of shear capacities and in the design of support connections can member proportions be directly determined. For the dynamic analysis, the needed nonlinear response properties are determined from a trial section. The analysis results then indicate the adequacy of the trial section. Experience on the part of the designer will help in reducing the number of iterations. The use of simple computer based design approaches help to reduce the time required for each analysis iteration. 

Before the analysis is complete, we must examine the adequacy of the model to fit the data. Since this procedure is described in Section IV as well as in Reference (B14), this aspect of the fitting will not be pursued here. We have simply demonstrated here how the experimenter can be led from an inadequate model to an adequate model by the data analysis. 

In order to evaliiate each integral in Equation 14, the values of Wgi i(z) must be known as a function of z, in the form of Equation 13. Therefore, the general analytical solution of Equation 14 is impossible. Instead, the computer solutions may be obtained by first substituting Equation 9 into Equation 12 to obtain W.2 as a function of z, Wg2(z) as Equation 13 and then substituting Wg2(z) into Equation 12 again to obtain Wg3(z). This procedure is repeated until Wgi(z) is obtained. In this method, it is assumed that the values of u, L,A X, andc( are constant. The deviation of the predicted results from the actual distribution for each zone pass depends mainly on the adequacy of the expression, and would be magnified as the number of... 

Since the scale factor is considered an unknown in the least-squares procedure, its estimate is dependent on the adequacy of the scattering model. Other parameters that correlate with k may be similarly affected. In particular, the temperature factors are positively correlated with k, the correlation being more pronounced the smaller the sin 0//. range of the data set, as for a small range the scale factor k and the temperature factor exp ( —fl sin 02ft.2) affect the structure factors in identical ways. 

The valence-shell populations are scaled after completion of the refinement by use of Ptj = Py/k. If the procedure is successful, the sum of FfJ should be close to the total number of valence electrons. The difference between these two quantities is used as a test of the adequacy of the valence density functions. 

The layout and design of production areas and equipment should permit effective cleaning and decontamination (e.g. by fumigation). The adequacy of cleaning and decontamination procedures should be validated. 

Applebaum and Grisso (1995) identified four central criteria to consider when assessing the adequacy of informed consent procedures ... 

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