After sending an External Site for qualification, the next step is for the Qualification Owner to complete the qualification.
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.
An external site can be qualified as a provider of one or more Materials and/or Services and each is evaluated and marked approved or not approved individually.
Qualification
To complete the external site qualification:
When an External Site is sent for qualification, the Qualification Owner will receive a task. Click the task link.
Click Edit ().
In the Details section, confirm the organization details are correct. Make changes if needed.
To create a qualification for this external site, open the Qualifications section and click Create.
Select the Qualification Type (Material or Service) and click Continue.
Select the Material or Service and click Save. The qualification will be added in the Initiated state.
In the Qualification Details section, provide the Risk Classification, as determined by your organization’s processes.
Provide the Qualification Analysis. This should include details about the method of qualification and results from the qualification effort.
If applicable, check the Conditions on Approval box to indicate that the external site is approved to work with, but there are one or more things they need to fix. If you conditionally approve an external site, you need to provide the Approval Conditions and follow up to make sure the conditions have been met in the agreed timeframe.
Click Save.
Provide your Qualification Decision for each qualification record. Click into the field and select Approved or Not Approved.
Optionally, open the Attachments section and attach documents you want to associate to the organization.
Click Complete to complete the task.
Click Complete.
The Qualification records change to Pending Review and the External Organization changes to In Qualification Review. The QA Approver(s) will receive a task to complete qualification review.
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.
The steps to completing requalification are the same as above.
To complete the external site qualification:
When an External Site is sent for qualification, the Qualification Owner will receive a task. Click the task link.
In the Details section, confirm the organization details are correct. Click Edit () and make changes if needed.
To add an additional qualification for this external site, open the Qualifications section and click Create.
Select the Qualification Type (Material or Service) and click Continue.
Select the Material or Service and click Save. The qualification will be added in the Initiated state.
In the Qualification Details section, update the Risk Classification, Qualification Analysis, and/or Conditions on Approval/Approval Conditions, as applicable.
Click Save.
Provide your Qualification Decision for each qualification record. Click into the field and select Approved, Not Approved.
Note If a qualification was previously Approved, you have the option to retire it here.
You can also requalify an existing qualification. For example, if a material quailfication is Approved and you have determined during a routine reevaluation that it should still be approved, provide a Qualification Decision of Approved. This will update the Qualification Date to the current date.
Optionally, open the Attachments section and attach documents you want to associate to the organization.
Click Complete to complete the task.
Click Complete.
The lifecycle state of each Qualification record remains the same as it was. The Qualification Decision column shows the decisions that you are asking QA to sign off on, but it is not official until that approval is complete. The QA Approver(s) will receive a task to complete qualification review.
