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Within systems engineering, quality attributes are realized non-functional requirements used to evaluate the performance of a system. These are sometimes named architecture characteristics, or "ilities" after the suffix many of the words share.
The Software Engineering Institute recommends Quality Attribute Workshops for this effort. [7] It has been suggested to keep architecture analysis and design lightweight and flexible; quality attribute trees for certain application genres and technology domains can support such approaches. [8]
CTQs represent the product or service characteristics as defined by the customer/user. Customers may be surveyed to elicit quality, service and performance data. They may include upper and lower specification limits or any other factors. A CTQ must be an actionable, quantitative business specification. CTQs reflect the expressed needs of the ...
Critical to quality is an attribute of a part, assembly, sub-assembly, product, or process that is literally critical to quality or more precisely, has a direct and significant impact on its actual or perceived quality. [1]
In this stage all production processes and manufacturing equipment is proofed to confirm quality and output capabilities. Critical quality attributes are evaluated, and critical process parameters taken into account, to confirm product quality. Once the process qualification stage has been successfully accomplished, production can begin.
Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process. CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes. Those attributes with a higher impact on CQAs should be ...
Broadly, functional requirements define what a system is supposed to do and non-functional requirements define how a system is supposed to be.Functional requirements are usually in the form of "system shall do <requirement>", an individual action or part of the system, perhaps explicitly in the sense of a mathematical function, a black box description input, output, process and control ...
It involves defining the Critical Process Parameters (CPPs) of the equipment used to make the product, which affect the Critical Quality Attributes (CQAs) of the product and then controlling these CPPs within defined limits. This allows manufacturers to produce products with consistent quality and also helps to reduce waste & overall costs.