Who is this for?
Quality Event Owner - assessment activities, access, CAPA decisions
Author - maintaining the Quality Event content
How to do it
A Quality Event begins in the Assessment stage. During assessment, the document is authored, access is assigned, Vigilance Reporting is completed (see Vigilance Reporting), and the need for a CAPA is determined.
Create the Quality Event
From an escalated Observation
Escalate the Observation (see Evaluating an Observation). The system opens the new Quality Event in the Assessment state and records the source under Originating Observation.
The Quality Event created from an escalated Observation.
Creating a Quality Event directly
A Quality Event can also be created without an originating Observation, provided you are an Allowed Creator for the Quality Event type.
Go to Events → Quality Events from the sidebar.
Select + New Quality Event.
Complete the Create Quality Event dialog and select Create. The Quality Event ID is generated and version 1 opens in Assessment (working document state Draft).
The Create Quality Event dialog.
Create Quality Event
Field name | Description | Note |
Name* | The Quality Event title. |
|
Type* | The configured Quality Event type. | Determines whether Vigilance Reporting, Due Date, Severity and other custom fields apply. |
Process* | The applicable Quality Process. |
|
📝Note: Complete all required properties before routing the Quality Event. Required fields like Due Date or Severity must be set before actions such as Create CAPA, Send for review or Send for approval become available.
Set Quality Event Access (Quality Event Owner)
In Quality Event Access, select the edit pencil icon.
Search for and add the required people, groups or sites, then select the roles required by the approved workflow and select Save.
Assigning people and roles in Quality Event Access.
Quality Event Access roles
Role | Activity in this work instruction |
Viewer | Can view the Quality Event. |
Owner | Completes the assessment activities, including Vigilance Reporting and access assignment; can send for review, close a review, archive, and manage CAPAs. |
Author | Maintains the Quality Event content and sends it for review and approval. The author is a major contributor to the assessment of the issue. |
Reviewer | Marks the review as completed in the Review state. |
Approver | Approves the Quality Event in the Approval state. |
Author the Quality Event (Author)
The Quality Event content is authored in the working copy. The assigned author contributes to the owner's decisions by drafting important parts of the Quality Event document such as describing the scope or performing a root cause analysis. In this stage the owners and authors collaborate on an effective analysis of the issue at hand.
Select Check Out, then open the working copy in Microsoft Word.
Information from the property card of the document can be loaded into the document content via the SimplerQMS Add-In.
Open the SimplerQMS Add-in, and sign in with your SimplerQMS credentials.
Insert relevant data in the document content and complete the draft of the document itself.
Check in the document.
📝Note: Your templates may already be preconfigured to include all necessary data that the system can read from the property card. In that case, you need to open the SimplerQMS Add-In to sync the latest available data in the document content but do not need to add additional fields from the add-in.
Create a CAPA from the Quality Event
The Quality Event Owner determines whether the Quality Event requires a CAPA. The Quality Event remains in its own workflow after the CAPA is created.
Create CAPA from Quality Event (Quality Event Owner)
Enter the Due Date of the Quality Event.
Select Create CAPA, enter the CAPA Name, select the severity, then select Create CAPA.
📝Note: The CAPA Types available depend on the CAPA type configuration of your organization.
Creating a CAPA from the Quality Event.
3. The Quality Event state displays Handled by CAPA, and the generated CAPA is shown as Linked CAPA in Details and listed under Referenced Items with reference type CAPA (Generated). As the CAPA progresses, its status is reflected under Referenced Items (for example Approval, Pending Effectiveness Assessment, Closed).
The linked CAPA shown in Details and Referenced Items.
Link or unlink an existing CAPA (Quality Event Owner)
A CAPA does not need to be generated directly from a Quality Event. In the case a single CAPA is created to handle multiple Quality Events, you have the option to link an existing CAPA to the Quality Event.
Under the three-dot menu, select Manage CAPAs and choose a CAPA to link.
Linking an existing CAPA via Manage CAPAs.
2. To unlink, enter a Reason for unlinking and confirm; the Details and Referenced Items sections update accordingly.
Unlinking a CAPA with a reason.
❗Not every Quality Event needs a CAPA. A correction (immediate containment) is not the same as a corrective action (addressing root cause to prevent recurrence). Open a CAPA when investigation and prevention of recurrence are warranted.
💡Tip: Set required fields such as Due Date and Severity early. The Due Date is reflective on when the document is expected to be closed, meaning that the final approval is captured. Actions like Create CAPA, Send for review and Send for approval stay unavailable until every required property is complete.