Implementing an electronic Quality Management System for a source plasma collection organization.

摘要

Quality is a necessity in the collection, processing, and storage of plasma. Organizations responsible for this important process must implement a solid quality system in order to ensure success.;This project proposes that an electronic deviation management system be implemented at XYZ plasma organization, utilizing the Plan-Do-Study-Act methodology. An electronic Quality Management System (QMS) is not new to the plasma industry; however, an electronic QMS is new to the XYZ Plasma organization.;Certainly, some plasma organizations have implemented an electronic deviation management system, but they have elected not to publish any details regarding the implementation. This project, therefore, may be viewed as the first of its kind in the plasma industry; the project's outcomes, which adhere to the Code of Federal Regulations, can be used as a guide for other service organizations that are similar in nature (blood or tissue collection).