Discover the essential measures for rigorous testing in the medical domain. Learn about Failure Mode and Effect Analysis (FMEA), traceability to requirements, and test design techniques for safety-critical systems.
Table of Contents
Question
You are working as a test manager in the medical domain leading a team of system testers. You are currently working on a major release of the product which gives customers many new features and resolves a number of problem reports from previous releases.
Since the system is in the medical domain and therefore in the safety critical area, testing needs to be rigorous and evidence is required that the system has been adequately tested. Identify THREE measures that would typically be part of the test approach in this domain and which are not always applicable in other domains!
A. High level of documentation
B. Failure Mode and Effect Analysis (FMEA) sessions
C. Traceability to requirements
D. Non-functional testing
E. Master test planning
F. Test design techniques
G. Reviews
Answer
B. Failure Mode and Effect Analysis (FMEA) sessions
C. Traceability to requirements
F. Test design techniques
Explanation
B. Failure Mode and Effect Analysis (FMEA) sessions: FMEA is a systematic technique used to identify potential failure modes, their causes, and effects on the system or process. It is an essential practice in safety-critical systems, particularly in the medical domain, to ensure that potential risks are identified and mitigated.
C. Traceability to requirements: In safety-critical systems, it is crucial to establish traceability between requirements, design, implementation, and testing. This traceability ensures that all requirements are adequately tested and that no critical functionality is overlooked. It also aids in impact analysis and regression testing when changes are made.
F. Test design techniques: Safety-critical systems often require the use of specific test design techniques, such as boundary value analysis, equivalence partitioning, and state transition testing, to ensure comprehensive coverage of test scenarios. These techniques help identify edge cases and potential defects that could have severe consequences in a medical system.
The other options, while important in software testing, are not specifically unique to safety-critical domains like the medical field:
A. High level of documentation: Documentation is essential for any software project, regardless of the domain.
D. Non-functional testing: Non-functional testing, such as performance, security, and usability testing, is important across various domains, not just safety-critical systems.
E. Master test planning: Test planning is a fundamental activity in any software testing effort, regardless of the domain.
G. Reviews: Reviews, such as code reviews, design reviews, and test case reviews, are best practices in software development and testing, applicable to all domains.
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