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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.
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 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]
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.
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 ...
CTQ trees (critical-to-quality trees) are the key measurable characteristics of a product or process whose performance standards or specification limits must be met in order to satisfy the customer. They align improvement or design efforts with customer requirements.
Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. [1] This may include testing equipment at maximum operating capacity to show quantity demands can be met. [2]
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]