Organizations can be an Internal Facility, External Organization, or External Site.
Internal Facility is used for any internal sites and is required throughout the system, so it should be one of the first things you create. They can be used to indicate the owning facility on documents, QMS records, and audits and are used when creating Learners. If your organization does not have multiple sites, you can just create one internal facility with your organization’s name.
External Organizations and External Sites can be tagged on documents and can be audited. The difference between the two is that an External Organization represents the overall organization, which may need to be tagged in document metadata (for example, a Quality Agreement) or on QMS records, while External Sites are individual locations of the organization, which may be audited or qualified.
Note QA Users can create External Organizations and External Sites from the Audits & Organizations tab on the QMS tab collection. This allows QA Users to create External Organizations/Sites on their own (without requesting an Admin add them).
This is useful when the QA user knows that an External Site will be qualified as a provider of one or more materials and/or services via Supplier Quality Management (SQM). If SQM is used, External Organizations/Sites can be created from either place (Quality Admin or QMS).
Tagging an organization makes it easier to search and find what you’re looking for in Vault.
Create an Organization
To create a new organization:
Navigate to Quality Admin > Quality Data > Organizations and click Create.
Select the Organization Type and click Continue.
Enter an Organization Name for the organization.
Optional: Enter the Legal Name of the organization and any necessary contact information.
Optional: For External Organizations and External Sites, select the Type of external organization/site.
For External Sites, select the Parent External Organization.
Click Save. Vault creates the new organization in the Initiated state.
Define Team
To define the team that will work on the external site qualification:
- Navigate to the External Site you will be qualifying.
- Expand the Team section and click Manage Team.
- Add the Qualification Owner. The qualification owner is responsible for the qualification analysis, providing the risk classification, and determining if the external site qualification should be approved or not approved.
- Add one or more QA Approver(s). The QA Approvers are responsible for performing the quality review and approval of the external site qualification determination.
- Click Save.
Add Audit Details
This task is optional. It can help when you’re building your audit schedule but it does not automatically create any audits or send out any tasks.
To add audit details for an organization:
- Navigate to the Organization record.
- Click Edit.
- Select the Frequency at which you plan to audit the organization.
- If you do audit the organization, the system will automatically populate the Last Audit Date field and calculate the Next Audit Date based on the selected frequency. You can update these dates if needed.
Add Attachments
You can optionally add attachements to an organization record.
To add attachments to an organization:
- Navigate to the Organization record.
- Drag and drop files.
Edit an Organization
To edit an existing organization:
- Navigate to Quality Admin > Quality Data > Organizations and click the Organization Name of the organization you want to edit.
- Click Edit ().
- Edit the Organization Name and any other information as needed. Click Save.
Retire an Organization
If you are using the Supplier Quality Management (SQM) module, the process for retiring an organization will vary, depending on if you are qualifying it or not.
Use these instructions to retire an organization in the Initiated state:
- Navigate to Quality Admin > Quality Data > Organizations and click the Organization Name of the organization you want to retire.
- Select Mark as Retired from the Workflow menu.
- Click Start. The organization changes to Retired. To return the organization to Initiated, select Reopen Organization from the Workflow menu.