Explain Common Safety Risk Management Approaches. ITP-110 Practice Questions (Page 5)

Questions 21–25

1. 21foundation · easy

   An IoT manufacturer wants to implement a QMS standard that specifically addresses safety requirements for medical devices. Which standard is most relevant?

   • AISO 9001
   • BISO 14001
   • CIEC 61508
   • DISO 13485
   Reveal Solution Discussion Select an answer first
2. 22application · medium

   A medical IoT device manufacturer wants to implement a system that ensures consistent product quality and continuous improvement across its design, manufacturing, and post-market surveillance processes. Which approach best fulfills this requirement?

   • AImplement a Quality Management System (QMS) that documents procedures, defines responsibilities, and establishes processes for design control, production, and corrective actions.
   • BIncrease the frequency of final product testing to catch defects before shipment.
   • CHire an external consultant to review the manufacturing process annually.
   • DConduct a one-time safety certification audit of the final product.
   Reveal Solution Discussion Select an answer first
4. 23foundation · easy

   A safety engineer wants to identify all potential hazards in a new IoT-enabled medical device. Which hazard analysis technique is best suited for this proactive, comprehensive identification?

   • AFishbone diagram
   • B5 Whys
   • CPreliminary Hazard Analysis (PHA)
   • DRoot Cause Analysis (RCA)
   Reveal Solution Discussion Select an answer first
5. 24foundation · easy

   Which root cause analysis tool involves repeatedly asking 'why' to drill down from a problem to its root cause?

   • AControl chart
   • BPareto chart
   • CFishbone diagram
   • D5 Whys
   Reveal Solution Discussion Select an answer first
6. 25foundation · easy

   In a CAPA process, what is the purpose of the 'verification of effectiveness' step?

   • ATo document the problem for regulatory purposes
   • BTo confirm that the implemented action resolves the problem without introducing new issues
   • CTo identify new problems
   • DTo assign responsibility for the action
   Reveal Solution Discussion Select an answer first