A “Quality Event” is an event that requires a pre-defined action or response and tracking in accordance with regulatory requirements.

Examples of Quality Events include:

  • Non Conformances
  • Deviations
  • Incidents / Near misses
  • Complaints
  • CAPA

Non Conformances, Complaints and Incidents come as standard with Quality Events. You can customise the Quality Events you're provided by contacting support.

User Roles in Quality Events

Basic users:  Create an event, define, detail & sign off on event steps/actions. Basic users cannot approve steps/actions, but they can sign-off on tasks.  

Normal Users & Quality Users: Create an event, define the associated steps/actions & approve each step.

Creating a new Quality Event

You can create a new quality event using the "Create New" dropdown menu on the dashboard...

...or from the home page for a particular event type e.g. Create a new NCR from the NCR Dashboard.

You will be presented with a modal window with details to fill out regarding the incident in question:

The "Risk" parameter is calculated using the Impact and Probability values, according to the Risk Strategy in use. In this example, we are using the default.

The time limit pertains to how long the event may be open before being deemed overdue. 

Working with a Quality Event

Once you have completed the creation process, you will be taken to the Issue's workflow screen, where you can see the status and progress of the issue.

This example is of a new, untouched Quality Event.
The process is laid out for you as steps to complete in order of top to bottom, for example an NCR comprises of:

Investigation
Plan
Actions
Resolution

Note that different types of Quality Events will have different steps to resolution.

To begin, first create the Investigation, by clicking on the "Create" button for that step.

You will be redirected to an editor where you will assign an approver for that step and detail the information related to that part of the process.

Once you have finished editing the information for that step, send it off for approval using the "Send for Approval" button in the menu. The approver for that step will be emailed asking for them to approve the document.

Note: Approvals can also be made from the issue screen, as a shortcut.

Finally, approve the document by completing the form in the modal window, with an optional comment if desired.

Once the approval has been made, the next step in the process is unlocked for editing. Continue to complete the remaining steps in the process using the procedure outlined above.

Assigning Tasks within an Issue

The Actions Step- Creating Tasks

It's possible to assign actions to users within the application for them to complete as part of resolving Quality Event. This is done as follows:

With the action step unlocked, click "Create Task"

The following form will display, fill out the details appropriate to the task to be performed.

An email will be sent to the assignee informing them of the task, with a link for them to follow. You can also access the task from the step itself, by clicking on it.

Working with Tasks

Once a task has been created, the assignee can work on it using the view below.
Comments relating to the activity will appear in the stream underneath the description of the task, as a chain.

When you are ready to complete the task, click on "Complete", and fill out the form as appropriate. You can format this text, and add attachments if need be.

Signing off on Tasks

Finally, with all tasks complete (can be deemed a success or a failure), the step can be signed-off by the issue owner.

This is done by clicking on "Sign Off", where you will be presented with the form.

Editing an Existing Issue

You may wish to delegate responsibility of an entire issue. Issues may be delegating in the same manner as documents- by changing ownership. Once one changes ownership an email is sent to the new owner. 

One may change ownership of an Issue by selecting "Change Owner" in the issue overview screen:

Completing an Issue

Closing an issue successfully

When have completed all preceding steps, the resolution step will become unlocked.

This is a special step which cannot be sent for approval until after a review period has passed AND any tasks associated with the issue have been completed, allowing you to detail the outcome of the process ahead of time but cannot forcibly be closed prematurely.

This enforces diligence in the process and ensures that a review has taken place.

Closing an issue unsuccessfully

In the event that an issue needs to be closed due to an unforeseen issue, you can close it using the button at the top right of the issue display screen.

When an issue is closed unsuccessfully, you will be presented with a window asking for your digital signature, and the reason why you're closing this issue.

After you complete the form, the issue will be closed and an entry made in the audit trail stating the fact. 

Any outstanding tasks associated with the issue will be closed automatically.

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