SBB - Quality and Compliance fully solved 2024

SBB - Quality and ComplianceWhich of the following is a component of a quality management system? - correct answer Components of a quality management system are: organizational structure, responsibilities, policies, processes, procedures, and resources needed. It is the responsibility of executive manage- ment to address these elements for QA. Which of these organizations is a regulatory agency? - correct answer FDA and the Centers for Medicare and Medicaid Services (CMS) If a unit is released for distribution, which of the follow- ing is a reportable event to the FDA? - correct answer All blood establishments, regardless of status, must report devia- tions from cGMP regulations to the FDA Center for Biologics Evaluation and Research (CBER). Deviations of cGMP impact the safety, purity, or potency of a blood product. For example, if arm preparation is not performed, then the collected unit has increased potential for microbial contamination, which is a patient safety issue. Quality assurance (QA) includes which of the following? - correct answer QA activities are not directly tied to the performance of a pro- cess. The purpose of QA is to control processes, detect unwanted shifts or trends that may require correction, and identify opportunities for process improvement. QA activities include reviewing procedures and policies for compliance with regulatory and accrediting agency expecta- tions, reviewing operational performance data, reviewing