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 Events menu on the top navigation bar. Click the Events option and select Event templates. Access to edit templates can be granted to users by the Admin user.
Create an Event Template
Only Quality users can create and modify Event templates. They can modify all Event templates regardless of who created them.
From the Event templates page, click the Create template button.
Provide a Name for this template. “Name” is synonymous with event type. Users will see the template name and 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 and an auto-incrementing number to create the event’s unique ID, e.g. CAPA-XX. Prefixes can contain both letters and numbers.
Note: Once you set your Prefix in newly created Event Template, it can't be changed.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 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.
Determine the visibility and requirements of Fields on the Event creation screen. These options let you determine what should be displayed for the particular event type and whether the information is required for event closure.
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: Form, Content, Tasks, Validation.
Form: The form step allows you to build in locked fields with help text. You can select a single line or rich text field, dates, numeric fields, yes/no options, and an attachment upload field.
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 for 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. A validation step can either be a content or form-type step.
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 Step name and clicking Edit.
Add section(s) as needed and give each section a Title (ex: Report Details, Risk Assessment, etc.). Click next to progress to Default content.
Add default content in the text editor, such as instructions, tables, or lists of questions for Step authors to consider.
Click the Update template button when finished.
Repeat for all other Content and Validation steps.
Validation Step
If one of the sections within the Validation step is selected as “Resolution,” that section will only show the ability to select “Pass” or “Fail” when users complete the step and will not display any content entered into this section within the template.
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.
If template fields such as Product, Root Cause, Risk, or Related Supplier have been adjusted, you’ll be prompted with a yellow banner to update any open events using that template.
If the content of the event template has been adjusted, 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, provide an explanation in the comments, and 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 Event Templates page.
Identify which template to archive and click the kebob menu (⋮) to select Archive.
You’ll receive a notification letting you know the template has been archived and it will be removed from the list of Effective templates.
Restoring a Template
For any template has been archived, you’ll have the option to restore the template if you need to at a later date. This option will be available in the Event template menu by selecting “Archived” view and clicking the kebab 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.