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Statistical control of the production of blood components by control charts of attribute to improve quality characteristics and to comply with current specifications.

作者信息

Pereira Paulo, Seghatchian Jerard, Caldeira Beatriz, Xavier Sandra, de Sousa Gracinda

机构信息

Department of Research and Development, Portuguese Institute of Blood and Transplantation, Avenida Miguel Bombarda 6, 1000-208 Lisbon, Portugal.

International Consultancy in Blood Components Quality/Safety Improvement, Audit/Inspection and DDR Strategy, London, UK.

出版信息

Transfus Apher Sci. 2018 Apr;57(2):285-290. doi: 10.1016/j.transci.2018.04.009. Epub 2018 May 8.

Abstract

Statistical process control (SPC) is closely related to good quality control practices in the manufacturing process. One of the primary goals is to detect unnatural patterns, allowing the production service to control the conformity of the blood components produced. Despite being recommended by national and international standards, its exercise is not uniform, and sometimes the methodology used is misinterpreted as SPC. When the input data has a Gaussian distribution, control charts for variables are proposed. However, when the data distribution is not normal, control charts for attributes are suggested. This article presents and discusses four statistical procedures for the control of attributes using p-, np-, u-, and c-charts. An empirical demonstration shows these models are reliable for in routine use in the Blood Establishment quality control, as also suggests the use when the control charts for variables are inapplicable.

摘要

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