The EDQM has made available on its website the proceedings of two of its recent training sessions on Quality Management Systems (QMS) and Statistical Process Control (SPC) for Blood Establishments.
These proceedings provide Blood Establishments in Europe with the latest knowledge on Quality Management applicable in the field and on how to implement integrated QMSs. The topics covered during the training sessions include process mapping, management of a quality documentation system, validation and qualification and risk management, corrective and preventive actions (CAPA) management and continuous improvement.
With respect to proceedings on SPC, a detailed and user-friendly overview is provided – including information on requirements, and concepts and terminology, which will certainly be of use to Blood Establishments for understanding how to apply and make the best use of SPC in their daily work. In particular, the proceedings offer a comprehensive overview of quantitative control charts, such as IMR Charts, X-R Charts and Cusum charts, as well as of process capability measures, including Cp, Cr and Cpk.
Implementation of Quality Management is required by EU Directives, including the Good Practice Guidelines (GPG), and prescribed in the Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components. Millions of units of whole blood and blood components are collected annually in Europe and the procedures encompass many stages: blood collection, testing, processing, release and distribution. Each stage has intermediate, prequalification quality specifications that ultimately ensure the quality of the blood components produced. QMSs driven by SPC are instrumental for Blood Establishments to efficiently mitigate risks and ensure the efficacy, quality and safety of blood components.
The EDQM working group responsible for Blood Quality Management (B-QM) has developed these ad hoc training series in order to efficiently support the needs of Blood Establishments in Europe, harmonise practices and provide a common and consistent approach for developing a sustainable QMS. These initiatives also play a role in promoting mutual confidence across European countries in the quality and safety of their respective blood components.
The proceedings of the 1st European Training Course: Quality Management for Blood Establishments and of the 1st European Training Course: Quality Management for Blood Establishments can be accessed for free under Quality Management for Blood Establishments.