Risk items in the QMS module are created to document the risk analysis on process level.
Creating and organizing RISK items
Risk items can either be created from a process (see section on PROC items) or by clicking on the main category folder RISK and then Create Risk.
Just like all other items in the tree on the left, Risk items can be dragged and dropped to change their order or to organize them in different subfolders.
Customizing (predefined) risks
The QMS module has already a set of predefined risks. These should be reviewed and if needed adapted or deleted.
A RISK item exists of
- The description of the Hazard (what can lead to a bad situation?)
- A sequence of events
- A harm. The Harm is a dropdown of possible things that can go wrong. When you select a harm, automatically the severity is completed as well.
- Furthermore, you need to complete the Probability of Occurrence of the Hazard and the Probability of occurrence of the Harm.
The Risk Index is calculated by multiplying the Probability of Occurence x Probability of Harm x Severity.
Please note that the color indication does not necessarily mean you should not try to reduce the risk.
The idea about risk analysis is that you try to reduce the risk by either reducing once of the probabilities or the severity.
This is done through risk control measures. You can add a risk control measure by clicking on Create Risk Control or Select Existing (if a relevant Risk Control measure already exists). For more information on Risk Control items, please see section RC Items.
When you created or selected the proper risk control measures, you should indicate which factor is reduced and by how much by using the dropdown next to the link.
You will see that the Risk Index is automatically recalculated.
Important note: all the elements in the risk analysis (text fields, values of probability/severity, formulas, etc) are customizable through the admin client, in Item categories and then Risks.
When you cannot further reduce the risk, you can indicate this through the checkbox. As well you can do a risk/benefit consideration by checking the checkbox and completing a the justification text field.
If you want to adapt the Risk configuration, please refer to the admin section.