CAPA (Questions with 100% correct answers)

Who is responsible for initiating and completing the NOE? correct answers Initiator and Action Owner Who is responsible for initiating and assigning Regulatory Authority Notification Assessment (RANA) correct answers Initiator and Action Owner Who accepts and completes assigned Investigation Actions and MRB Follow Up Actions? correct answers Initiator and Action Owner Who accepts and completes assigned CAPA Action Items correct answers Initiator and Action Owner What does NOE stand for correct answers Notice of Events What does RANA stand for? correct answers Regulatory Authority Notification Assessment Who oversees the completion of Action Items for a CAPA Plan correct answers Initiator and Action Owner Who implements CAPA Plans and completes Effectiveness Check actions? correct answers Initiator and Action Owner Who completes Laboratory Investigation Checklist for OOS or Aberrant/OOT result investigations correct answers Initiator and Action Owner What is the goal of event initiation for a CAPA? correct answers Ensure the Notice of Event (NOE) is clearly documented and is in compliance with applicable SOPs How long does the initatior have to report and document the NOE? correct answers 1 business day from the event. Action Item correct answers Actions identified in support of the overall CAPA Plan. What are the three types of actions on an action plan? correct answers Corrective, Preventive, or continuous. CAPA Plan correct answers Outline of the scope of the CAPA and action items to be implemented. Continuous Improvement Actions (CI) correct answers Continuous improvement of quality and performance focuses on improving internal and/or external customer satisfaction through continuous and incremental improvements to processes and systems.