Practical approaches to CAPA in blood service organizations: Using errors to prevent future occurrences.

摘要

Blood banking, because of increasing technological advances in the industry, is in a constant state of fluidity. However, an efficient system for error management is both a regulatory and a business necessity. Corrective Action/Preventive Action (CAPA) practices must be optimally performed and maintained so that errors are treated as symptoms of problems and are utilized to make continuous improvements in systems. This study is designed to illustrate the integration between change management and process improvement and re-design techniques under the CAPA umbrella. Methods for root cause analysis, process improvement, process re-design, and change management are applied to blood banking in this study. In addition, the principles of lean thinking and change management are incorporated into the blood banking industry. A synergistic relationship between CAPA, process improvement and re-design, and change management is customized into an effective program.