Quality Issues Flashcards
defined by AABB standards: characteristics of a unit of blood or blood component, tissue, derivative, sample, critical material, or service that bear on its ability to meet customer requirements, including those defended during agreement review and required by law
quality
planned and systematic activities implemented within the quality system to give confidence that a product or service will fulfill requirements for quality
quality assurance
quality assurance includes:
developing SOP
personnel training
qualification of materials and equipment
FDA guideline for quality assurance in blood establishments
quality assurance programs must be established and must include steps to prevent, detect, and correct deficiencies that may compromise blood product quality
code of federal regulations title 21 that regulates blood banking practices; ensures that each step in manufacturing process is controlled
Current Good Manufacturing Practices
deviations from Current Good Manufacturing Practices must be reported to who?
FDA Center of Biologics Evaluation and Research (CBER)
areas in a quality assurance program that may affect safety and quality of work being done
critical control points
individual steps within the critical control point
key elements
documented evidence providing a high degree of assurance that a process will consistently produce an acceptable result
validation
defined by AABB standards: testing routinely performed on materials and equipment to ensure their proper function
quality control
application of a quality system to manage a process to achieve maximum customer satisfaction at lowest overall cost to organization while continuing to improve the process
total quality management (TQM)
formalized system that documents the structure, responsibility, and procedures required to achieve effective quality management
quality management system
Standard 1
organization
Standard 2
resources
standard 3
equipment
