10 Questions
What is the purpose of the procedure mentioned in the text?
To determine, describe, and document the risk of software development
Who does the mentioned procedure apply to?
Various departments within the company
What is the definition of 'Risk' according to the text?
The combination of probability of occurrence of harm and the severity of that harm
When is the mentioned procedure required within the regulated environment?
To evaluate software development for new or existing software which has not been validated
What is the scope of the mentioned procedure?
It applies to various departments within the company as well as may be used for systems outside the regulated environment at the discretion of the local IT department.
This procedure is not required within the regulated environment to evaluate software development for new or existing software which has not been validated.
False
The procedure may be used for systems falling outside the regulated environment at the discretion of the local COOK Company’s Information Technology (IT) department.
True
The likelihood a negative effect will occur is the definition of Severity according to the text.
False
The combination of the probability of occurrence of harm and the severity of that harm is the definition of Risk according to the text.
True
The text mentions a document titled 'Document Naming Structure' with reference D00059595(QSI0502).
True
Test your knowledge about determining, describing, and documenting the risk of software development as well as the validation plan to mitigate the risk. Assess your understanding of procedures, documentation, and responsible job functions related to software development risk assessment.
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