Explain Common Safety Risk Management Approaches. ITP-110 Practice Questions (Page 4)

Questions 16–20

1. 16application · medium

   During a post-market review, a wearable heart monitor manufacturer found that a batch of devices had a firmware bug that caused incorrect heart rate readings. The company recalled the affected devices and issued a firmware patch. To comply with CAPA principles, which additional action is most important?

   • ANotify the regulatory authority about the recall and the firmware patch.
   • BInvestigate why the bug was not caught during development and update the testing process to prevent similar bugs in future products.
   • CVerify that the firmware patch resolves the incorrect reading issue in the recalled devices.
   • DDispose of the recalled devices that cannot be patched.
   Reveal Solution Discussion Select an answer first
2. 17application · medium

   A manufacturer produces smart thermostats that connect to home Wi-Fi networks. During a design review, the team identifies that a firmware update could fail mid-installation, leaving the device in a state where it cannot control the heating system. The team classifies this as a safety hazard. Which category best describes this hazard?

   • AElectrical hazard
   • BFunctional failure hazard
   • CData privacy hazard
   • DEnvironmental hazard
   Reveal Solution Discussion Select an answer first
4. 18foundation · easy

   What is the primary purpose of root cause analysis (RCA) in the context of an IoT system incident?

   • ATo document the incident for regulatory compliance only
   • BTo assign blame to the responsible individual or team
   • CTo quickly restore service with minimal downtime
   • DTo identify the underlying cause of the incident to prevent recurrence
   Reveal Solution Discussion Select an answer first
5. 19expert · hard

   A manufacturer of smart home security cameras wants to demonstrate compliance with both quality and cybersecurity best practices to enterprise customers. They are considering implementing ISO 9001 and IEC 62443. Which statement accurately describes the relationship between these two standards?

   • AISO 9001 provides the QMS framework, while IEC 62443 provides specific cybersecurity requirements for the product; they are complementary and can be implemented together.
   • BIEC 62443 replaces ISO 9001 for IoT devices, so the company only needs to implement IEC 62443.
   • CISO 9001 is a subset of IEC 62443, so implementing IEC 62443 automatically satisfies ISO 9001 requirements.
   • DThe two standards conflict with each other, so the company must choose one to implement.
   Reveal Solution Discussion Select an answer first
6. 20foundation · easy

   Which standard is commonly used for functional safety of electrical and electronic systems, including IoT devices?

   • AISO 9001
   • BIEC 61508
   • CIEEE 802.15.4
   • DISO 27001
   Reveal Solution Discussion Select an answer first