Explain Common Safety Risk Management Approaches. ITP-110 Practice Questions (Page 3)

Questions 11–15

1. 11foundation · easy

   What is the first step in a typical CAPA process?

   • AImplement the corrective action
   • BConduct root cause analysis
   • CVerify the effectiveness of the action
   • DIdentify the problem or nonconformity
   Reveal Solution Discussion Select an answer first
2. 12foundation · easy

   Which technique systematically examines each component of an IoT system to identify potential failure modes and their effects on the overall system?

   • ARoot Cause Analysis (RCA)
   • BFailure Mode and Effects Analysis (FMEA)
   • CFault Tree Analysis (FTA)
   • DHazard and Operability Study (HAZOP)
   Reveal Solution Discussion Select an answer first
4. 13expert · hard

   A smart factory's robotic arm malfunctioned and injured a worker. The investigation found that a sensor sent incorrect position data, causing the arm to move unexpectedly. The sensor was found to be miscalibrated. The technician who calibrated it said they followed the manual. The manual was found to have an incorrect calibration procedure. The team is debating whether to fix the sensor, update the manual, or retrain the technician. According to root cause analysis principles, what is the most appropriate action?

   • AReplace the sensor with a new one, as the sensor is the component that failed.
   • BRetrain the technician on the correct calibration procedure, as the technician is responsible for the error.
   • CRecalibrate the sensor and return the robotic arm to service, as the immediate issue is the miscalibrated sensor.
   • DUpdate the calibration manual and verify that the revised procedure is correct, as the incorrect manual is the root cause of the technician's error.
   Reveal Solution Discussion Select an answer first
5. 14foundation · easy

   What is the difference between corrective action and preventive action in CAPA?

   • ACorrective action is optional; preventive action is mandatory
   • BCorrective action is proactive; preventive action is reactive
   • CCorrective action addresses existing problems; preventive action addresses potential problems
   • DCorrective action is reactive; preventive action is also reactive
   Reveal Solution Discussion Select an answer first
6. 15application · medium

   A smart appliance manufacturer received multiple customer complaints about a specific model's Wi-Fi module disconnecting from the network. The team used a fishbone diagram to identify potential causes and determined that the antenna was poorly shielded, causing interference. They have implemented a fix. What is the next step in the CAPA process?

   • AClose the CAPA record immediately since the root cause was found and a fix was implemented.
   • BVerify the effectiveness of the fix by monitoring customer complaints and testing the updated module in real-world conditions.
   • CUpdate the fishbone diagram to include the fix that was implemented.
   • DSend a notification to all customers about the fix.
   Reveal Solution Discussion Select an answer first