Working with Quality Teams (QMS)

With Quality Teams, you can manage structured teams of individual users that are responsible for completing specific processes within your Vault. This is helpful when managing change controls, audits, CAPAs, and other quality event related processes.

See Configuring Quality Teams for help creating Quality Teams and Quality Team Roles.

When you create a new record from an object or object type that has a Quality Team configured, you can assign users to specific Quality Team Roles defined by that record’s Quality Team. For example, you might assign someone as a “Change Manager” or a “Subject Matter Expert” on a Change Control record. Hover over a role label to display additional information, if available.

About Constraining Roles

Admins can configure each team role to constrain which team members are available for selection, ensuring you assign the appropriate team member for the job using custom or matching sharing rules.

Assigning Users to a Quality Team

You can assign users to team roles on object records for which there is a configured Quality Team. For example, you may create a new Change Control record that is paired with your Change Control Team, then assign users to that Change Control Team.

You can add, remove, or change members on a Quality Team as long as those role memberships are not constrained. Depending on the team’s configuration, a role’s membership may also be exclusive, meaning that a user in that role cannot be assigned to another role on the same object record. You can also manage Quality Team assignments through the use of bulk operations.

Vault maps these team roles to sharing settings roles. If configured, membership to a team role can also grant users team role membership to related records in the process. For example, in your configuration, when users create a change action from a change control, Vault could attempt to default the same team members from the change control to the change action.

To assign users to Quality Team Roles:

Navigate to an object record via a custom tab or Business Admin. Note that you can only assign users to team roles on object records with a configured Quality Team.
In the Quality Team section, click Manage Team. Note that this section may be labeled differently in your Vault.
Assign users to their designated team roles on the record’s details page.
Click Save.

Depending on your configuration, team member changes may be reflected on related records you create for this Quality Event.

Restoring Inherited Team Members

If you’ve added, removed, or changed members of an inherited Quality Team Role on a related record, you can attempt to restore the inherited team members by clicking Restore and then saving the Quality Team.

For example, after creating a change action from a change control and adding or removing team members in the “Subject Matter Expert” role, you can click Restore to replace them with the current “Subject Matter Expert” team members as inherited from the change control.

Note: If you click Restore and a member which would be inherited is invalid for role membership on that record, Vault alerts you and does not complete the action.

Completing Teams

When you finish assigning all team members to their appropriate roles, your team is complete and Vault can move the record into a state defined by your Admin depending on your configuration.

If your Vault uses Auto-Start Object Workflows, completing a team can begin the workflow for the specified process and assign relevant tasks to your Quality Team members.

About Invalid Team Members

If you have permission to edit the team, Vault indicates when you have invalid team members on a team. Before changing any team assignments on this record, or moving it into a state applying the Verify Quality Team Validity For All Roles entry criteria, you must take corrective action on invalid team members. A team may be invalid because:

A user assigned to a team role has been made Inactive.
A user assigned to an exclusive team role is also assigned to another role. This can occur if an Admin configures a role as exclusive after users have already been assigned to both the now-exclusive role and another role on the object record.
They are in the Quality Team members list but not in the linked constraining sharing settings role. For example, this may happen if your Vault uses sharing or matching rules to populate your constraining lifecycle role and, after team role assignment, one of the fields that defines the membership of that role changes.
They are in the linked lifecycle role but not in the Quality Team members list. For example, this may happen if your Vault allows the assignment of workflow participants directly into sharing settings roles. This is against best practices and, if used to populate members of a Quality Team role’s linked sharing settings role, results in an invalid team assignment.
Your Admin has attempted to configure any type of sharing or matching rule on your team role’s linked sharing settings role.
A team role does not have at least the minimum required number of assignments.

Note: Vault does not support Quality Team roles linked to Sharing Settings roles that use rule based groups (Dynamic Access Control and custom and matching sharing rules).

Managing Invalid Team Members

If you have the correct permission to edit the team, you can take corrective action on invalid team members by clicking Manage Team. This opens the Manage Invalid Team Members dialog, which allows you to remove invalid team members from the record or replace them with valid selections. Select an option for each team role assignment listed in the dialog:

Replace With: This option appears if an assignment is invalid because the User is Inactive, the role is exclusive, or because their assignment in the role conflicts with a constraining role choice in the Quality Team role definition. Note that you cannot leave the replacement selection blank. If there are no eligible users to replace the invalid team member, you can remove the assignment. Reassignment in this manner preserves any open tasks assigned to the invalid user because of their membership to the role. The user they are replaced with will be assigned the task.
Remove: This option appears if the team member is invalid.

Changes made to role assignments in this way are passed down to any records that inherit their team role configurations from this record.

Removing Users from a Quality Team Role

When you remove a user from a Quality Team Role, Vault also removes the user from the team role’s linked sharing settings role. If the user has multiple relevant roles within the participant group, Vault won’t remove her from the participant group until you remove her from all relevant Quality Team memberships. You can also use a bulk operation to remove a single user from multiple Quality Teams.

If configured, any removal of the user from the team role is passed down to any records that inherit their team role configurations from this record.

Task Cancelation

When you remove a user from a Quality Team Role and the user has a task assigned for that role, Vault cancels the task because the user no longer has the correct access.

If you replace a user with another user during the same edit of the team’s membership, the new user will receive the task assigned to the Quality Team Role before the workflow can continue.

Managing Quality Team Assignments in Bulk

If you have permissions to add, remove, and replace Quality Team members, you can also perform these operations in bulk from the Quality Teams Management tab. An Admin must activate this tab and add it to an existing tab collection.

Adding Users to Quality Teams

To add one (1) or more users to multiple Quality Teams:

Navigate to the Quality Teams Management tab.
Select Add User from the drop-down.
Select an Object from the drop-down and select an Object Type if applicable. Click Apply to retrieve records or Clear to clear your previous selections.
Select up to 250 records on which to add the selected user(s). You can filter by record name, lifecycle state, title, or description. Vault only displays team-enabled records of the specified object and object type that are not in locked states. Click Continue.
Add one (1) or more users to the desired roles. The drop-down list does not exclude ineligible users, however, selecting invalid users may result in failures.
Confirm the potential updates to the records listed in the Summary, then click Confirm. Vault adds the specified user(s) to the specified Quality Teams and notifies the administrator once the operation is complete. You can download a CSV file of the results from the Notifications page.

Removing a User from Quality Teams

To remove a single user from multiple Quality Teams:

Navigate to the Quality Teams Management tab.
Select Remove User from the drop-down.
Select a user to remove from Quality Teams.
Select an Object from the drop-down and select an Object Type if applicable. Click Apply to retrieve records or Clear to clear your previous selections.
Select up to 250 records on which to remove the selected user. You can filter by record name, lifecycle state, or application role. Vault only displays team-enabled records that have a role assigned to the selected user and are not in locked states. Click Continue.
Confirm the potential updates to the records listed in the Summary, then click Confirm. Vault removes the specified user from the Quality Teams and notifies the administrator once the operation is complete. You can download a CSV file of the results from the Notifications page.

Replace a User on Quality Teams

To replace a single user on multiple Quality Teams:

Navigate to the Quality Teams Management tab.
Select Replace User from the drop-down.
Select a User to replace on Quality Teams.
Select an Object from the drop-down and select an Object Type if applicable. Click Apply to retrieve records or Clear to clear your previous selections.
Assign a replacement user for each record up to 250 records. The drop-down list does not exclude ineligible users, however, selecting invalid users may result in failures. To assign the same user for all records, populate a replacement user for the first row and click the down arrow. You can filter by record name, lifecycle state, or application role. Vault only displays team-enabled records that have a role assigned to the selected user and are not in locked states. Click Continue.
Confirm the potential updates to the records listed in the Summary, then click Confirm. Vault replaces the specified user on the Quality Teams and notifies the administrator once the operation is complete. You can download a CSV file of the results from the Notifications page.

Deleting Records with Quality Team Assignments

Vault attempts to delete any Quality Team Role assignments whenever a user deletes a team-enabled object record. Vault respects the object relationship’s deletion rule behavior when determining whether the system can delete a team-enabled object record with Quality Team assignments, and how that deletion action will affect any related records or their Quality Team Role assignments.

Reporting on Teams

You can report on your Quality teams and team members to easily assess scope and efficiency. To do so, create a report with an Application Role report type.

Team-Enabled Object: An object you have defined a team for.
Team-Enabled Record: An object type record that leverages a team.
Quality Team Members Object: A system managed object that Vault creates when you create a team. It stores the team role assignments of users for specific team-enabled records.
Quality Team: This component defines a Quality Team you’ve created in your Vault. It defines the structure of the team by associating Quality Team Roles and team behavior as a team-enabled record moves through its processes. It is associated to an object or object type in order to declare records of that object or object type to use a team.
Quality Team Role: A role defining which security rights members have and by which role they are constrained. This component defines the roles that are available or required for object records leveraging the associated Quality Team (Change Owner, Primary Investigator, QA Approver, etc). These roles link to sharing settings roles such as Owner, Reviewer, and Editor. The component further defines the behavior of these roles. For example, you can define the minimum number of users required to complete a team, the maximum number of users allowed on a team, and whether or not you can select users from any group in the Vault or from a specific role on the team-enabled record.

To view the team members section, a user requires Read permission on the relevant team-enabled object.

To add, remove, or otherwise manage Quality Team members, a user requires Edit permission on the relevant team-enabled object.

The ability to edit Quality Teams on team-enabled objects in a given lifecycle state also depends on the lifecycle’s Atomic Security on Relationships or locked state configuration.