After creating the External Site and defining the team that will work on the qualification, the next step is to send the site for qualification.
Qualification
To send an External Site for qualification:
Navigate to QMS > Audits & Organizations > External Organizations and select the External Site you want to send for qualification.
Select Send for Qualification from the Workflow menu.
Enter the Qualification Due Date.
Click Start.
The External Site changes to In Qualification. The Qualification Owner will receive a task to complete qualification.
Requalification
Over time you may perform routine evaluations of your sites. When you do this, the site needs to be sent for requalification. Requalification also gives you the opportunity to make changes to the qualification status of a site or add additional qualifications if needed.
To send an External Site for requalification:
Navigate to QMS > Audits & Organizations > External Organizations and select the External Site you want to send for qualification.
Select Send for Requalification from the Workflow menu.
Enter the Qualification Due Date.
Click Start.
The External Site changes to In Qualification. The Qualification Owner will receive a task to complete qualification.
Retirement
If you are using the Supplier Quality Management (SQM) module, the process for retiring an organization will vary, depending on if it has been qualified or is in the process of being qualified.
Retire an External Organization or External Site in Initiated State
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.
Retire an External Site Beyond Initiated
To retire an organization that has been qualified or is in the process of being qualified:
Navigate to QMS > Audits & Organizations > External Organizations and select the External Site you want to send for retirement approval.
Select Send for Retirement Approval from the Workflow menu.
Enter the Retirement Reason and click Start.
The External Site changes to In Retirement Approval. The QA User(s) will receive a task to approve the organization retirement.
Note Lifecycle states for Qualifications, External Sites, and External Organizations roll up. If an External Site is Retired, the associated Qualifications are also Retired. When all External Sites associated to a Parent External Organization are retired, the Parent External Organization will also be Retired.