Questioning standard operating procedures

Similarly, ethos, the testimonial dependent upon the expertise and credibility of the witness, is critical. Evidence supplied by an impartial and credentialed observer may estabhsh comphance with control standard operating procedures (SOPs), accuracy of documentary evidence, and suitability of code design. Whereas the accuracy of logos transcends its interpretation, however, ethos proof must be evaluated on the basis of its source. Who said so , How does he or she know , and Why should he or she be trusted become the key questions. It is upon the importance of ethos that the important issues of independent, quality assurance (QA), and confirmatory investigation hes. Most ethos testimony takes the form of reports, observational records, and certifications. 

Standard operating procedures are often referred to as SOPs and include all the written protocols and procedures in place within a pharmacy. They state the way the pharmacy expects tasks to be carried out to ensure a quality service is provided. They will include, for example, the questions that must be asked of a patient so that their needs can be correctly identified and appropriate action taken. 

Figure 1.3 contains an example of a standard operating procedure for the professional check of a dispensed prescription form within a community pharmacy. Using this information (and the example in Figure 1.2) fill out the audit question document in Figure 1.4 for the audit of prescription form returns from the Prescription Pricing Division (PPD) (see Section 3.3.8) with the questions you would ask. 

Figure 1.6 contains an example of a standard operating procedure for the label generation and assembly of prescription items within a community pharmacy. Figure 1.7 contains an example of the corresponding audit form. Look at the questions in the audit. Which objectives are satisfied by adherence to these processes ... 

Confirmatory trials are intended to provide firm evidence in support of claims and hence adherence to protocols and standard operating procedures is particularly important unavoidable changes should be explained and documented, and their effect examined. A justification of the design of each such trial, and of other important statistical aspects such as the principal features of the planned analysis, should be set out in the protocol. Each trial should address only a limited number of questions. 

However, what is true for a carcinogenicity study may be wrong for an analytical chemistry study what can be applied to an in vitro genotoxicity study could be completely out of question for a field study. Therefore, it would seem to be important to interpret these definitions flexibly and with well considered regard to the study type and the experimental activities connected with it. Thus, it would seem that in order to arrive at a clear situation, the Standard Operating Procedures for the conduct of the various study types, or at least the study plan, should address these issues and define the dates in a concrete way. 

All of these questions can be incorporated into an inspection form that can be filled out at regular intervals. Even if the question may not apply at first, it may become relevant if there is a change from the standard operating procedures. Using a checklist is a good way to be sure nothing is overlooked. Employers should develop a checklist for each operation. ... 

Every standard operating procedure in the laboratory requires precautionary measures that must be taken in order to execute each procedure safely The operator must read and understand the procedure thoroughly (especially procedures involving toxic substances) before proceeding. Any questions regarding the safe execution of the procedure must be addressed before attempting to execute the procedure. Adherence to all safety work practices outlined below is a must to assure safety in the laboratory... 

What-If Analysis What-If/ Checklist Review Scenario- based Inductive By what-if question and/or checklist item Relatively standard operations Good for both procedure-based and continuous operations Mostly appropriate for simpler processes, although capable of developing and analyzing multiple-safeguard scenarios Only looks at causes prompted by checklist and what-if questioning Moderate... 

The format of a procedure is critical to its appropriate usage and efficacy and is an important consideration when developing procedures. Several considerations should be addressed when determining the appropriate format for a procedure, including the task in question, its complexity, the context in which the procedure is likely to be invoked, users that the procedure is intended for, the users familiarity with the task, and the level of instruction and assistance required. Procedures can be presented in various formats, including checklists, step-by-step instructions, decision trees, standard operating instructions, and flowcharts. 

The purpose of this study is to answer following question can the LARA method be used as a holistic risk management technique in different academic environments and what are the main differences when comparing to the results obtained by industrial risk analysis techniques In order to answer these questions, risk analyses of different procedures were performed using LARA, Failure Mode, Effects, and Criticality Analysis (FMECA), and HAZOP. The experiments andyzed are standard operations performed at University of Pardubice and at EPFL. The main differences of the results using the different methods will be pointed out and compared. 

It is assumed in the course of the calculation procedure that for the same molar quantities of the two compounds the intensities of both molecular ions are identical. This is obviously not true for most compounds. To establish the quantitative relationship between the intensity of the molecular ion of an internal standard and that of the compound in question, a calibration procedure based on measuring standard samples is performed. These standard samples contain both the internal standard and the compound in question in known quantities (two standard samples for each of about 5 different amounts within the expected operating range). Assuming the above quantitative relationship, the content of the compound in question is calculated for each standard sample giving a calculated and an observed (actual) value. A regression line is calculated for the whole calibration set of pairs of expected and observed quantities. From the equation for the regression line a corrected amount of the internal standard is calculated. The corrected internal standard is subsequently used in all experimental samples to calculate the amount of the compound in question. 

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