Self‐inspection of blood establishments

Abstract

Background and ObjectivesBlood Establishments (BE) within the European Union, are legally obliged to conduct self inspections, as defined in the Commission Directive 2005/62/EC[3]. These self inspections are considered to be an essential part of the Quality Management System, allowing the BE to continuously improve their processes. Furthermore different BE's have developed different self inspection schemes based on a wide range of regulations and standards. Implementing an efficient and effective self inspection scheme can be a challenge.Materials and MethodsClear references to self inspections within blood establishments are made in the national and international regulation, as well as in other commonly used international standards. Because the defined inspection criteria are different within these standards, the European Blood Inspection Project (EuBIS[9]) was initiated by the European Commission in collaboration with the European Blood Alliance, resulting in pan‐European standards and criteria for self inspections.ResultsBased on the EuBIS criteria, a self inspection scheme can be put in place as a tool to evaluate the adherence and the effectiveness of the Quality Management System (QMS) of a blood establishment. This self inspection scheme is incorporated in the QMS and focuses on continuous improvement, root cause analysis, process optimalisation and efficacy, finally resulting in the prevention of quality failures by introducing remedial actions where necessary.ConclusionAs an essential part of management review and QMS improvement, a solid self inspection scheme within blood establishments can detect areas for improvement within the organization.