Documenting Test Activities in the Safety Case

Demonstrating that significant rigour has been applied to give confidence that the major defects have been found and managed. 

Setting out the rationale and justification for the residual clinical risk associated with any outstanding defects. 

Where in the course of the project the CRM team has noted deficiencies in the test strategy and instigated corrective actions these interventions should not be hidden away but rather brought out in the safety case. A reader will interpret this quite correctly as the application of an honest and diligent process rather than any confession of wrong-doing or slack-handedness. 

A flavour for testing rigour can be communicated by indicating the number of tests executed, especially when this is compared to the number of outstanding defects. For example, showing that 1,000 tests were completed and 10 failed shows a very different picture to circumstances where 15 tests were completed and 10 failed. Where it was not possible to run a test for some reason this should be explicitly recorded. Any decision not to execute a test needs to be underpinned by sound justification and without compromising any evidence on which the safety case may rely. 

An example of a basic defect summary is provided below  

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