Morris Medical: RiskPack Data Type ‘Harm’

by 1 year ago
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Welcome back to Morris Medical: a series 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 “Harm” (harm)

ISO 14971 defines “harm” as a physical injury or damage to the health of people, damage to property, or the
environment. For documenting harms within the RiskPack, a distinct work item type is needed. For being able to
work properly, the RiskPack expects Harm work items to meet the requirements listed below.

Required Custom Fields:

  • Harm Severity (harmSeverity): This value defines the severity of the harm. It will be used to place
    associated risks in the corresponding cell of the Risk Control Table. The values can be freely configured
    using the Severity Categories Editor.

Additional Custom Fields:

  • Harm Type (harmType): Enumeration with values:
    • harm to the health of the patient (harm_to_patient)
    • harm to the health of the operator (harm_to_operator)
    • harm to other person(s) (harm_to_3rd_person)
    • harm to property (harm_to_property)
    • harm to the environment (harm_to_environment)

Considered Linking Schemes:

  • None

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

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