In CBM T6, how should testing be prioritized?

• A. Test all components equally regardless of risk
• B. Prioritize tests by potential impact on patient safety and quality, allocating more resources to high-risk areas
• C. Only test after a defect is found
• D. Test only regulatory-required items

Answer: (B)

Prioritizing testing based on risk to patient safety and product quality ensures that what could do the most harm gets the most scrutiny. By evaluating how likely a failure is and how severe its consequences would be, you direct testing effort toward components and processes that are most critical to safe and effective patient care. This risk-based approach helps you gather convincing evidence where it matters most, strengthens verification and validation activities, and makes the best use of limited resources by concentrating them on high-risk areas first. It also aligns with established quality and risk management practices, so important safety and performance features are verified early rather than discovered only after a defect appears.

Other approaches miss the mark because they either waste resources on testing everything equally, which dilutes focus from critical risks; wait for a defect to appear and test reactively, which leaves safety and quality gaps; or test only regulatory-required items, which may overlook non-regulatory but still essential risks to patient safety and care quality.