Quality Event management within Qualio, like document management, is structured around consistent, easy-to-use templates. Event templates are a simple way to customize different event workflows to meet your organization's needs. Each template acts as a blueprint for all events of a certain type.
Access Event Templates
Event templates can be accessed from the Organization Settings. Click the gear icon, select Organization Settings, then select Quality events on the left-side menu. Only users granted permission to create and modify event templates will have the option to access Quality events from the Organization Settings menu.
Complaints, Incidents and Non Conformances Event templates are included in all new environments as examples, but can be modified.
Create an Event Template
Users granted permission to create and modify Event templates can modify all Event templates regardless of who created them.
From the Quality Events page under Organization Settings, click the Create new Quality Event button.
Provide a Name for this template. “Name” is synonymous with event type. Users will see the template name along with all other template names when creating new events. To learn more about that user experience click here.
Provide a template Prefix for this template. The prefix will be automatically added to every Quality Event created using this template along with an auto-incrementing number to create the event’s unique ID, e.g. CAPA-XX. Prefixes can contain both letters and numbers.
Enter a Time Limit to define the default number of days from when an event is created to when it is deemed overdue. This setting can be overridden when creating events and should be considered as guidance.
Define the Validation step time delay which is the number of days between the Validation step/event creation and when the validation step can be sent for approval. This control measure is designed to provide standardized timelines for validating an event’s solution, ensuring that sufficient time has passed and events are not closed too early. This setting is locked and cannot be edited on individual events.
Add, remove, and move Steps up and down to create a logical sequence for your Event Steps.
Give each Step a Name to fit your process. (Examples: Initial Investigation, Incident Response, Root Cause Analysis, Post Mortem.) Names cannot be modified during Event creation and editing.
Select the Step Type: Content, Tasks, Validation.
Content: Similar to document templates, Content Steps allow you to add default content (tables, instructions, etc.), Send for Review, add comments, and Send for Approval (required). It does not, however, include training assessments, change control records, and is never retired.
Tasks: Provides a space to list tasks as part of investigating or resolving an Event. Tasks can be assigned to other Qualio users (with permissions to Events).
Validation: Included on all event templates by default because every event template must have a Validation step, and iIt will always be the final Step. Otherwise, Validation Steps are exactly like Content Step types.
Click Save to create your template and save the sequence of Steps.
You can then edit Content (when applicable) and Validation Step Types by clicking the Edit content button.
Give each section a Title (ex: Report Details, Risk Assessment, etc.)
Select a Section type from the dropdown.
Summary: Required for all Content Step types. A text area with a text editor designed to summarize information. This type of section will appear in the event content as a header above the default content.
Text: A text area with a text editor designed to capture detailed information. Text sections can also be utilized to create form-like steps as needed.
Attachment: Only attachments can be added in these sections by browsing for the file.
Add default content in the text editor such as instructions, tables, or lists of questions for Step authors to consider.
Add additional sections as necessary.
Click the Save changes button when finished.
Hint: Leverage your sandbox when creating Event Templates to better preview and test your Event template’s workflow and default content.
Editing an Event Template
To edit an Event Template, click to open the template, then make modifications as needed. Click Save when done.
Neither completed nor uncompleted events using that template will be modified in any way. If you deem the template change as critical, and would like existing uncompleted events to be updated, you’ll need to close uncompleted events providing explanation in the comments, then create new events with the updated template.
Archiving & Restoring Event Templates
Event templates can be archived if needed. If the template had been previously used to create events, any existing events using this template (open or closed) would not be affected by archival. Archived Event templates cannot be used to create new Events.
Steps to archive an Event template
Browse to the Organization Settings.
Click Quality Events from the left-side menu.
Identify which template to archive and click the Archive button to the far right.
You’ll be prompted to confirm whether or not you would like to archive this template.
Click Yes to proceed with the archival and No to cancel.
Restoring a Template
For any template that has been archived, you’ll have the option to restore the template if you need to later. This option will be visible in the Event template menu. If a template is restored, it will be available for new Event creation, and the restore action will be reflected in the audit trail.