Safety-Related Systems CTAL-TTA Practice Questions (Page 2)

Questions 6–10

1. 6application · medium

   During an FMEA workshop for a medical infusion pump, the team identifies a failure mode where a software fault causes the pump to deliver an incorrect dose. The team rates the severity as catastrophic, the occurrence as low, and the detectability as high. According to risk-based testing principles, how should the Technical Test Analyst prioritize testing for this failure mode?

   • ALow priority, because the low occurrence and high detectability reduce the overall risk.
   • BHigh priority, because the catastrophic severity combined with any occurrence warrants rigorous testing.
   • CNo additional testing, because FMEA analysis is sufficient to mitigate the risk.
   • DMedium priority, because high detectability means the fault will be caught before patient harm.
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2. 7foundation · medium

   Which artifact is commonly used to document the relationships between requirements, design, and tests?

   • ATraceability matrix
   • BTest plan
   • CDefect report
   • DRisk register
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4. 8foundation · medium

   What is the purpose of tool qualification in safety-related testing?

   • ATo provide evidence that a tool is suitable for use in a safety-related context.
   • BTo train testers on how to use the tool.
   • CTo ensure that all testing tools are purchased from certified vendors.
   • DTo verify that the tool is compatible with the operating system.
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5. 9foundation · medium

   How does a higher Safety Integrity Level (SIL) typically impact the testing effort for a safety-related system?

   • AIt reduces the number of test cases needed because the system is more reliable.
   • BIt has no impact on testing; it only affects hardware design.
   • CIt requires that all testing be performed using automated tools.
   • DIt increases the required testing rigor, such as higher coverage criteria and more formal techniques.
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6. 10foundation · medium

   In a safety-critical context, what is the key difference between verification and validation?

   • AVerification ensures the system is safe, while validation ensures it is secure.
   • BVerification is done by developers, while validation is done by testers.
   • CVerification is performed only after validation is complete.
   • DVerification checks that the product is built correctly, while validation checks that the correct product is built.
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