A spec data mapping ties together a specific material, country, and manufacturing site. When you log a batch with that specific combination of values, the corresponding spec data mapping will automatically be assigned and it will create the necessary samples, tests, results, and criteria records.
If you log a batch that doesn’t have an associated spec data mapping, you can still initiate the spec ex, but you will have to send it to QA to assign spec data to it and bring in those samples, test, results, and criteria records.
Initiate the Spec Ex
To initiate the spec ex:
If, when logging a batch, you receive this warning message.
Click Cancel to cancel the batch creation. You can then contact the Design Data Admin and request that the appropriate spec data mapping get created and get it approved before logging the batch.
Click Continue if you want to proceed with initiating the spec ex and sending it for spec data assignment.
If you clicked Continue, the Batch is logged and a Spec Execution record is automatically created, however, it doesn’t have any Samples, Tests, or Limits because there is no Spec Data assigned. Click the Spec Execution record name link.
Select Spec Data Assignment from the Workflow menu.
Select the QA Approver (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.
Assign Spec Data
When a spec ex is sent for spec data assignment, a task is sent to the specified approver(s). Click the task link.
The task may have been sent to more than one person but only one person needs to complete it. Click Accept to accept the task.
Identify the correct Spec Data for the batch associated to this spec execution record and click Continue.
Provide your verdict.
Select Cancel Spec Execution to cancel the Batch and Spec Execution. Provide the Reason for Cancellation, your e-signature, and click Complete.
Note The Batch ID field is unique. If you plan to log another batch with the same Batch ID (for example, because this batch was created with the wrong material), first update the Batch ID before cancelling the spec execution.Select Assign Spec Data, provide your e-signature, assign the correct Spec Data for the batch associated to this spec execution record, and click Complete.
The applicable Samples and Tests will be logged based on what is in the spec data.