A method for synthesizing a quality function to optimize data about process and product parameters when implementing a «Quality by Design» strategy
Journal Title: Телекомунікаційні та інформаційні технології - Year 2017, Vol 103, Issue 2
Abstract
The subject of the article is the area (space) of product quality development – Design Space (QbDstrategy), when a certain combination of several process parameters affecting the desired property (quality) of the product is considered. Based on the results of a multifactorial experiment / simulation of the proposed process function, the permissible ranges of variability of each process parameter are established on the basis of degree of its influence on the expected specification of product quality. The above corresponds to the third stage of QFD Quality Management System. The article refers to the field of information technology and digital data processing systems when solving the tasks of quality management in accordance with the requirements of standards (ISO, GMP, ICH). The article suggests a method for synthesizing a function and determining product quality parameters based on the uniformly-best Chebyshev approximation to a given multidimensional quality function by generalized polynomials in a system of linearly independent basis functions. The problem of the Chebyshev approximation on the set of points in the Design Space according to the QbD strategy makes it possible to obtain for the quality function the smallest possible value of the uniform approximation measure, which is resistant to deviations of the defining parameters (process-design parameters).
Authors and Affiliations
Volodymyr Nakonechnyi, Anton Tereshchenko
Keywords
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