Development Assurance process types

In any case, there is a system of our safety concern during the safety assurance process. To describe a system comprehensively, we may have varied types of information developed, refined and updated throughout its life cycle, e.g. functions, architecture, task profiles, operation modes, use scenarios, functional and non-functional properties. It has been observed as commonplace that system description of various levels of details can be used for shaping the higher level argument structure in safety cases. Some generic strategies formulated from this information source include ... 

Control charts were originally developed in the 1920s as a quality assurance tool for the control of manufactured products.Two types of control charts are commonly used in quality assurance a property control chart in which results for single measurements, or the means for several replicate measurements, are plotted sequentially and a precision control chart in which ranges or standard deviations are plotted sequentially. In either case, the control chart consists of a line representing the mean value for the measured property or the precision, and two or more boundary lines whose positions are determined by the precision of the measurement process. The position of the data points about the boundary lines determines whether the system is in statistical control. 

In problem solving and process studies, the front-end work is important. Proper definition and direction developed at the beginning will assure meeting corporate goals in a timely fashion. This section establishes the type of study example to be used for illustrating principles and philosophy, and presents the basic items necessary to begin such a study. 

Although a thorough validation cannot rule out all potential problems, the process of method development and validation would address the most common ones. Examples of typical problems that can be minimized or avoided include interferences that coelute with the analyte in liquid chromatography (LC), a particular type of column that no longer produces the separation needed because the supplier of the column has changed the manufacturing process, an assay method that is unable to achieve the same detection limit after a few weeks, or a quality assurance audit of a validation report that finds no documentation on how the validation was performed. 

The sterilization process for any equipment or supplies that are sterilized prior to introduction into the controlled environment must be validated, with sterilization records and verifications included in all product batch histories. Validation of sterilization equipment, alone, is not sufficient to assure sterility. Because the types of materials being sterilized, and the arrangement of articles within the sterilizer can effect results, standardized load configurations must be developed and validated. 

YMC Inc. has simplified the process of scaling up an analytical separation for preparative isolation by developing matched R D column sets. Each R D column set contains an analytical methods development column and a preparative isolation column packed from the same lot of packing material. This provides assurance that any separation developed on the analytical column will scale-up directly on the matched preparative column without further method modification. The use of these column sets eliminates potential selectivity differences caused by different types of silica and different particle and pore size packings by providing matched columns. 

While thus the term and the use of process-based inspections have been defined, the applicability of this inspection type with regard to study types may seem less clear. Therefore it is of utmost importance to define clearly and unequivocally those study types which would qualify for this facilitation of the Quality Assurance function. To this end, the Quality Assurance has to develop SQPs which should primarily define the circumstances under which process-based inspections may be performed and which should also present a final list of the respective study types. It probably needs not to be especially mentioned that it would certainly be advisable to develop these SQPs in collaboration with the respective Study Directors and on the basis of historical data regarding study frequencies. 

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