How you respond to quality events and issues is subject to intense regulatory scrutiny. As the life science world grows in complexity, innovation, and competition, quality professionals are not only charged with meeting regulatory requirements but also with continuously improving their organization’s ever-changing products and services.
Yet antiquated, manual quality management systems don’t arm quality teams with the visibility and control they need to embed actual continuous sharpening and refinement; information gets missed, responses are unstandardized and duplicated, and the same problems resurface time and again.
Enter Qualio. Now, you can automate and standardize your quality event process and push it into a single source of truth where all actions are tracked, tasks are easily delegated, and event validation is reviewed and approved before closing. Visibility of unresolved and completed events gives quality teams the tools they need to track event trends and make data actionable.
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Anatomy of an Event
What is a Quality Event, and what are the major components of Events in Qualio?
Quality Events are predefined, repeatable workflows that require response and tracking in accordance with regulatory requirements. They can include heightened levels of risk, such as non-conformance events, deviations, incidents, and complaints. Or they can track events with low to zero risk, such as audits and design reviews. They can be simple, one-step events or complex with multiple levels of content, tasks, and validation. Customers create event templates to support their organization’s event processes and procedures.
Next, we’ll define the major components of Events and how they relate. This is important to understand as they are the building blocks used when creating Event Templates.
Event: Think of an Event as a container or workspace.
The container/workspace encapsulates Event Steps.
Events have properties that help Quality Teams keep Events organized like Owner, Product, Root Cause, and important dates (creation and due dates).
Event Steps: There are four types of Event Steps: Content, Forms, Tasks, and Validation. Each type performs a different function of either collecting information, listing tasks, or clarifying event outcomes.
There is no limit to the number of Event Steps that can be added to an Event Template.
Steps cannot be added ad-hoc during Event creation.
The last step must be a Validation Step type, and only one Validation Step is allowed per Event. All preceding Event Steps can be ordered at the customer’s discretion. The Validation step can be either Content or a Form.
Generally, the flow of an Event (Template) is designed to proceed in logical order, but linear progression is not required and Steps can be completed asynchronously.
Step Names are customized to fit your process.
Tasks: Task Steps provide the Event Owner an area to list tasks that can be assigned to team members.
There is no order Tasks must be completed in.
Tasks do not require review and approval.
Comments and attachments can be added to Tasks.
Each task has an prescribed due date
Event Lifecycle
When first getting started with Events, it can be helpful to understand the overall process flow at a high level. Use the flow chart and description below to get a general understanding of the Event lifecycle. Then when you are ready to dive deeper, the Create and Manage Events article has the details.
Qualio Documents provide the foundation for a policy or procedure, while Events record the manifestation of those policies and procedures. Therefore, the first step in the Event lifecycle is documenting the process, procedure, etc. to provide a reference for how things SHOULD be done.
Then, the actual event occurs, or is scheduled if we are talking about an audit, design review or similar scenario. Users will create a new event in Qualio and select the related template that has predefined structure and content, essentially instructing event owners how to handle that specific type of event.
Next, the event owner will add details to the event like additional documentation, analysis, evidence, and when necessary, outline an action plan with tasks that can be assigned to other team members. But what is key here is the event template defines what is needed for this specific type of event.
Some event types may be very simple with one “Event Details” section and one “Validation” step to confirm resolution. Other types of events may require multiple steps for multiple departments to log details, complete tasks, and work cross-functionally on the event resolution. Event templates lay out all these guidelines including default content like tables that act as forms, and lists of questions to be completed.
Just like Qualio Documents, Content and Validation steps are sent for review and approval. This process is collaborative and helps ensure quality is maintained.
When the final Validation Step is approved, the event is automatically closed.
Event Permissions
Initial access to the Events feature must be enabled by a Qualio Admin. These permissions can be set to the default settings or can be adjusted at the Admin's discretion.
Click here for instructions on how to enable the Events feature.
Once access is granted, a user’s permissions settings along with the event, step, and task ownership will determine what functions a user can perform related to the event, step, or task.
Starting at the beginning, a user in any role can create an event. They can remain the owner of the event or assign it to another user. Then, individual event steps and tasks can be assigned to other users. (Note: Only Quality users can assign steps to other users, but event owners in any role can assign tasks to other users.) Indeed, a single event can have multiple users from different teams working together to resolve the event.
Although a user in any role can be the owner of content and validation steps, these steps must be sent for approval to at least one Quality User. This allows the distribution of work among many users, but maintains quality control.
Administrative functions such as template, product, and root cause creation and management are restricted to only Quality Users. For a detailed list of event permissions by user role, view the User Permissions article.
Events Dashboard
Users with access to the Event feature can click the Events tab on the side navigation bar and view all events in their organization minus any event with a restricted tag they do not have access to.
Users can quickly create new Events from the Events page with the prominent Create event button. They can also use the search bar to search by ID or keyword or filter events based on Event type, Status, Product, etc., to view a targeted list of Events. Or they can switch to the Tasks sub-page and search or filter for tasks.