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Version: 2.3.x (Current)

Risks

Overview​

The Table provides an overview of potential issues identified in the P4SaMD project. Each row in the table represents a P4SaMD Risk entity in Jira.

The risks displayed in the table originate from the integrated ALM, where they are created, updated, and edited. The table dynamically reflects any changes made in the ALM, ensuring up-to-date risk assessment.

Table​

  • Title: A brief description of the identified risk and a link to the Jira Issue represented by its Key.
  • Suggestions: The number of suggestions related to the risk. Visit Insight & Suggestions
  • Probability: A numerical value indicating the likelihood of the risk occurring.
  • Severity: A numerical value representing the potential impact of the risk.
  • Status: the status of the risk (to do, accepted, etc.)
  • Risk Level: The resulting value of risk obtained by the mutiplication of P and S. Levels
  • Residual Risk: The remaining level of risk after the mitigation of RCMs, given by the multiplication of Mitigated P and Mitigated S. Levels
  • RCM: The number of linked risk control measures that mitigate the risk.
  • Software Items: The number of software items affected by the risk.
  • Changes: The number of modifications applied to the risk.

Actions​

Under the last column on the table you can perform the following actions:

  • Link Software Items: by clicking on the link icon, you can link a software item to the risks or unlink an already associated one. The linked software items are displayed in the drawer under the Traceability tab.

Drawer​

Clicking on a row opens a drawer displaying detailed information about the selected risk.

The drawer shows risk related information into three tabs: Details, Traceability and Suggestions.

You can navigate between the linked entities - changes, risks and software items - by selecting them under the Traceability section in the detailed view.

You can browse back to previous entities by accessing the history menu at the top of the detailed view and selecting the entity of interest.

Details​

Beyond the information displayed in the table, this tab shows:

  • Description: A paragraph describing the risk.
  • Hazard: The description of the existing risk.
  • Sequence of events: The conditions leading from the risk to the hazardous situation.
  • Hazardous situation: The specific scenario in which the risk could occur.
  • Harm: The expected damage to the patient.
  • Probability notes: Notes and rationale about the probability value.
  • Mitigated probability: The probability value obtained after the application of RCM.
  • Mitigated severity: The severity value obtained after the application of RCM.

Traceability​

This tab shows the linked issues of the risk grouped by:

Suggestions​

This tab shows related suggestions of the risk.

Levels​

Visual RepresentationRange
alt text≤ 15
alt text11 ≤ value ≤ 15
alt text6 ≤ value ≤ 10
alt text≤ 5

Values​

Visual RepresentationRange
alt textVery High
alt textHigh
alt textMedium
alt textNormal
alt textLow

NB. These probability and severity values are the default configuration of scale: for any custom settings, please contact Mia Care.