In validation, Risk Assessments document the allocation of validation resources towards the high risk sections of a program. Risk Assessments are not generally required in validation projects, but they do serve a useful function to justify allocation of validation resources and can streamline the testing process. They also serve as a forum for users, developers, system owners and quality to discuss the system which can have other intangible benefits.
There are many methods for Risk Assessment, but they generally all include rating risk for each requirement in at least three specific categories:
- Criticality - How important the function is to system functionality. Low criticality means that the system can continue to function relatively normally, even if the function is completely compromised. High risk means that if the function is damaged, one of the primary functions of the system cannot be accomplished.
- Detectability - The ease of detecting an issue arising with a particular function. It is more risky if there is a low chance of detectability; high chances of detectability correspond to lower risk.
- Probability - The probability of an issue arising with the particular function. Low probability means there is little chance that the function will fail; high probability means there is a high change that the function will fail.
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Assigning risk should be a multi-disciplinary function. System owners, key end users, system developers, information technology, engineers and Quality should all participate if they are involved with the system. The Risk Assessment should be signed by the personnel who participated in the assessment.
Acronyms
Risk Assessment, RA
Additional Resources
Validation Document Resources
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