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

Examples of Events can include:

  • Non Conformances

  • Deviations

  • Incidents / Near misses

  • Complaints

  • CAPA

Non Conformances, Complaints and Incidents come as standard with Events. You can customize the Events you're provided by contacting support or on your own following the guidelines outlined in How to Create & Manage Event Templates.

User Roles in Events

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

Normal Users: Create an event, detail & sign off on event steps/actions & approve each step (in collaboration with at least one Quality User).

Quality Users: Can perform all actions that can be done by Basic and Normal users, as well as manage Event workflows via the Organization Settings>Quality Events.

Generating an Issue

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

Note: If you are not able to access Events/are only seeing a video when clicking "Events" on the top ribbon, please message Support.

...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 issue 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 an Issue

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 Issue.
The process is laid out for you as steps to complete in order of top to bottom, for example a Non-conformance/Non-conformity comprises of:

Investigation
Plan
Actions
Resolution

Note: that different types of Events will have different steps to resolution. These steps will be determined by the Event's template (see How To: Create & Manage Event Templates)

It's important to note that when working with Events, there are multiple types of steps available - Content, Actions and Validation.

Content steps are very similar to Qualio Documents. Almost all of the rules that apply to documents apply to content steps. Content steps do not require training, they do not require change control and Event steps are never retired. Otherwise, all of the same rules apply to Content steps. See here to find out more.

Actions steps allows users to map out tasks such such as investigative tasks or corrective action tasks and require the assignee to upload/document objective evidence of the task they have completed.

Validation steps are content steps with additional features. One of the feature is an optional time delay. The time delay is intended to prevent users from sending the final step for approval before a specified timeframe (in days) passes. This allows end-users to successfully verify the effectiveness of any actions taken, where required.

Any type of event can have any configuration of steps - it's down to how the workflow should be set up.

In our current example, the below Non-conformance/non-conformity use two content, one action and one validation (all types of event are required to have at least one step and that step is a validation step). All but the validation step can be approved/signed-off in any order/sequence. The validation step must always be completed (approved) last.

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.

Note: At least one Quality User needs to be selected as an Approver.

After the approver(s) has been selected, click the "Content" tab to navigate to the content of that particular step. This will reflect the current sections that have been created in the Event template.

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(s) 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 (see below). Outstanding approvals will also appear on the approver's Dashboard for visibility.

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

Once the approval has been made, continue to complete the remaining steps in the Issue using the process outlined above. All but the validation step can be approved/signed-off in any order/sequence. The validation step must always be completed (approved) last.

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 an Issue. 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. Tasks will appear in the assignee's Dashboard once they are assigned. 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. These comments are also date and time stamped. When the task is completed, these comments will be purged.

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.

Note: This comment will be what is displayed when the task is completed. Add all necessary information that is needed to justify completion of the task into this section (investigation findings, attachments, customer feedback, etc.)

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 Event 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 you have completed all preceding steps and tasks, you can proceed to complete the final step (Validation). Please note the final step (validation) must be completed after previous steps have been approved/signed-off.

The validation is a special step that has an optional time delay. When the time delay is active, this step cannot be sent for approval until after a review period has passed (see validation step time delay setting in the Organization Settings).

Where required, this ensures enough time passes for you to successfully verify the effectiveness of any actions taken.

An issue closed successfully will display with green check marks on each step.

Closing an issue unsuccessfully/prematurely

In the event that an issue needs to be closed due to an unforeseen issue or lack of information, 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 electronic 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.

An issue closed unsuccessfully/prematurely will display with the prohibited symbol on each step.

Reopening an Issue

Reopening an an issue closed unsuccessfully

When an issue has been closed early, if more information comes available down the line, a Quality user can reopen a closed issue to allow the team to record the additional information

When you reopen an issue, you must revert the relevant step(s) to record the additional record the additional data received.

All Actions steps will open and will require signing off again. If there are no tasks required in light of the new information, the actions step can be signed off without generating new tasks.

Closing a reopened issue successfully

When you have completed all preceding steps and tasks, you can proceed to complete the final step (Validation).

Please note: you will need to 'revert' the Validation step, update it based on the additional information recorded in the earlier steps and then send it for approval again. The final step (validation) must be completed after previous steps have been approved/signed-off.

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