Risk Assessment Page

This page displays the risk assessment matrix and the list of risks associated with the CAPA.

Important: This app stores personal data in some settings. To follow good personal data management practices, Business Administrators might need to edit these settings to remove personal data, such as names, email addresses, and phone numbers.

To access this page:

  1. From the CAPA Page, click the name of the required CAPA.
  2. Click the CAPA Details tab.
  3. Click the Risk Assessment page tab.

Note: On the CAPA page, if you right-click a CAPA name, you can view the risk list and access the risk assessment page. The risk list is sorted according to RPN with the highest on top.

This topic describes:

This page discusses:

Risk Matrix

This tab displays the risk matrix and the risk table.

Risk Matrix

The risk matrix is a five-row, five-column grid, in which each cell represents a Risk Priority Number (RPN). RPN is the product of the severity of the risk and the probability of occurrence. The values of severity and occurrence range from 1 through 5. The value of RPN ranges from 1 through 25. The number of risks for each RPN is displayed in the corresponding cell. RPN cells with low, medium, and high priorities are displayed in green, yellow, and red colors respectively.

Risk Table

The risk table consists of the following columns.

Column Name Description
State/Level The states of risks and the sum of risks for each level of severity.
High Number of high-severity risks for each state and their sum.
Medium Number of medium-severity risks for each state and their sum.
LowNumber of low-severity risks for each state and their sum.
No RPNNumber of risks without RPN for each state and their sum.
SumThe sum of risks in each state.

Risk Details

Columns

Column Name Description
Name Name of the risk.
State State of the risk. Possible values are Identified, Evaluated, and Controlled.
Title Title of the risk.
Current Sev Severity of the risk.
Current OccProbability of occurrence of the risk.
Current RPN RPN of the risk.
Original SevOriginal severity of the risk.
Original Occ Original probability of occurrence of the risk.
Original RPNOriginal RPN of the risk.
Impact Type Type of impact due to the potential risk.
TasksTasks associated with the risk.
Attached DocumentsDocuments attached to the risk. Click to view or add attachments.
CommentsDescription of the potential impact of the risk.

Actions

Action DescriptionFor More Information
Delete Deletes the selected risks. Click OK to confirm.--
Change Owner Transfers the risk to the selected person. Click and from the Search Results page that appears, select the required user and click Submit.--
Create New Creates a new risk object.See Creating a Risk.
Enable Edit/ Disable EditActivates or deactivates edit mode in which you can modify the Title, Impact Type, and Owner fields. Click Save when done.--