Struggling with risk traceability in your safety critical product designs?

Coming up: the SoftComply Risk Manager!

traceability

In most safety-critical product development projects, the product has to receive external agency approval and/or pass an audit prior to release to market. One of the aims of such an approval is to check whether the product is safe to use.

In order to demonstrate this, it is usually necessary to not only describe how the risk management process works, but also to show evidence to prove this.

Traceability ensures that all product risks have been analysed, mitigated, verified (and re-evaluated in the case of any changes) with the corresponding links between all these actions and items being documented. Building traceability manually is not only time-consuming but also error-prone, potentially crucial in audits. It is also a large amount of work to maintain when design changes are made.

The SoftComply Risk Manager solves this issue by automating traceability across the product development lifecycle for your products.

SoftComply Risk Manager visualizes all links in the risk management chain including:

– The causes of the risk (e.g. a failure)

– The risk mitigation action(s) (e.g. safeguards built into the product)

– The verification of the mitigation action (e.g. test case)

traceability-screenshot-from-RMtable

SoftComply Risk Manager is a JIRA Cloud add-on, available from early 2017!

More information about the SoftComply Risk Manager.

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