Morris Medical: RiskPack Data Type "Sequence of Events"

Welcome back to Morris Medical: a eries for medical device development companies – and companies who are related to such companies – providing useful information about Polarion solutions and Polarion extensions.

Today we will discuss the subject of Polarion’s RiskPack extension, and have a look at RiskPack Data Types.

Data Type “Sequence of Events” (sequenceOfEvents)

Documenting sequences of events that lead to harms is the main task during risk analysis. Therefore, the
RiskPack provides a distinct work item type for sequences of events. A sequence of events can be modelled as
complex or as simple as needed for the device under consideration.

Therefore, a lot of information can be stored in other work items and linked to the sequence of events (in complex cases) or the whole sequence of events can be described within the work item’s description field (in simple cases). However, it is important that the harm the
sequence of events leads to is documented in a separate work item (of type “harm”) and linked with the
“ends_with” linkrole.

To work properly, the RiskPack expects Sequence of Events work items to meet the requirements listed below:

Required Custom Fields:

  • none

Additional Custom Fields:

  • Condition considered (conditionConsidered): Operation condition of the device which this sequence of
    events considers. The following values are possible:

    • normal operation

    • fault condition

Considered Linking Schemes:

  • Starts with (riskpack_starts_with) –> Device or Environment Element (arbitrary workitem type, assigned
    using the Data Type Mapper), e.g. System Item

  • Contains (riskpack_contains) –> Device or Environment Element (arbitrary workitem type, assigned
    assigned using the Data Type Mapper), e.g. Hazard or Hazardous Situation

  • Ends with (riskpack_ends_with) –> Harm (harm)

For more information about Polarion’s RiskPack, please visit this page.

I hope you liked this article and will visit our blog again when there is another Morris Medical Monthly article.


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