Batch Life Cycle

 

 

State	Description	Notes
Initial	Initial status for a Raw Material Batch.	The initial status is specified in the Batch Template.
Received	Indicates that the Batch has been Received at the facility (such as when a Raw Material arrives at the loading dock).	Note that is not the same as "Sample Receipt", which occurs when the Sample is already in the laboratory. • The Initial → Receive transition is a manual operation using the "Receive" button on the Active Batch List page. • Batches with a Batch Type of "Finished Goods" need not be Received. They start from the Active state. • Data Entry may be conducted prior to Receiving (Initial → Enter Data (remains in Initial state) → Receive). This allows personnel Receiving the Batch to record information about the Sample prior to sending it to the laboratory. • Although Initial → Receive is a manual operation, Received → Active automatically occurs when one of the Samples is Received in the laboratory.
Active	Indicates that Samples are Received or being tested in the Lab.	• A Batch is created with an "Active" status if the Batch Type (which is defined by the Batch Template) is "Finished Goods". • Batch status automatically transitions to Active when Samples in a Batch are "Received" or at least one of the Samples in the Batch is "In Progress" (Data Entry is in process).
Pending Release	Indicates that all testing is Finished.	• A Batch automatically transitions to this state when all Samples in the Batch are "Finished", where "Finished" is defined by the Sample's SampleReviewRequiredFlag (which is typically set in the Sample Template): If SampleReviewRequiredFlag = "Yes", the "Pending Release" transistion occurs when all Samples are Reviewed. If SampleReviewRequiredFlag = "No", the "Pending Release" transistion occurs when all Samples are Completed. Note that in either case, transition to "Pending Release" can occur only after all Data Entry and Data Approval have been done. • Skip Lot Batches transition to this state after being Received (they contain no Samples).
Preliminary Release	An optional state to allow certain Samples to be Released prior to completing their required testing. "Preliminary Release" is typically followed by an official release.	Transition to this state is a manual operation using the "Preliminary Release" button in Active and Pending Batch List pages.
Released	Final completion point for a Batch, indicating satisfactory completion of all operations.	• Approvals are required to Release a Batch. Approval Types are specified by the Batch Template. • If you want to decide whether to Fail or Pass a Batch based on testing against Specifications, transition to this state is a manual operation using the SDI Approval mechanism from the Batches Pending Release List page. • However, if you want to fail a Batch if any associated Specifications fail, "Auto Release Batch" can be used by specifying it in the Product associated with the Batch. In this case, Batches are automatically Released when all Specifications associated with the Product have passed. • If a Specification fails for a Sample, Auto Release is prevented. Batch Status transitions to "Pending Release". From this point, the Batch can be manually Released by the appropriate user.
Rejected	Indicates that the Batch was not Released.	A Batch is Rejected by failing the Approval during the Release process, or by manually setting status to "Rejected" using the "Reject" button on the relevant List page.
OnHold	Indicates that the Batch has been placed On Hold.	A Batch can be manually put On Hold using the "Hold" button on the relevant Batch List page. Sample testing continues even if a Batch is On Hold.

 

"Automatic Status Transitions" describe automatic transition of Batch Status statrting from the "Received" State.

Transition	Occurs when...
Received → Active	Any sample in the Batch is Received or InProgress.
Active → PendingRelease	All Samples in the Batch are finished (see Finished Samples below).
PendingRelease → Active	Any finished Sample is UnReleased or UnReviewed, i.e., InProgress.
Active → Released	Auto Release is enabled in the Product associated with the Batch. In this case, when all Samples in the Batch are finished, the Batch is released by (system).

 

In the context of Samples, the word "Finished" is not a status. "Finished" means "Samples are done", based on whether or not Samples require Review. This is controlled by the s_sample.ReviewRequiredFlag, and is typically specified in the Sample Template.

•	If Sample Review is not required, the Sample is considered "Finished" when Sample status is "Completed" (Completed = Finished).
•	If Sample Review is required, the Sample is considered "Finished" when Sample status is "Reviewed" (Completed → Reviewed = Finished).

This is summarized in the table below:

ReviewRequiredFlag	Last Sample status transition	Batch Status	Notes
No	Goes to Completed	Transitions to Pending Release
Yes	Goes to Completed	Stays at Active	Sample is not finished until Reviewed
Yes	Goes to Reviewed	Transitions to Pending Release

 

The "Batch Disposition" indicates whether or not a Batch was successfully tested. Many Skip Lot and Reduced Testing rules (controlled by the Product Variant Rule) are based on the Batch Disposition.

•	During Auto Release, "Batch Disposition Status" is automatically set to "Passed" or "Failed" based on the Approval status of the Batch when it is Released.
•	During Manual Release, "Batch Disposition Status" is manually set by the user.
•	"Batch Disposition Status" is used by the Transition Rules associated with the Sampling Plan.

 

Batches can be automatically Released by specifying this behavior in the Product associated with the Batch.

Batch Auto Release controls when a Batch transitions to "Pending Release". Batch status transitions to "Released" if all Samples have passed their Specifications.

In the Batch SDC, the ReleasedDt and ReleasedBy columns store the "who" and "when" for the "Release" operation. When a Batch is Auto Released, these are set to "now" and "(system)".

This is summarized in the table below:

Auto Release Flag	When Batch transitions to Pending Release	Batch Status
No	All Sample Specifications Pass	Stays at Pending Release, waiting for Manual Release
	At least one Specification does not Pass	Stays at Pending Release, waiting for Manual Release
Yes	All Sample Specifications Pass	Transitions to Released
	At least one Specification does not Pass	Stays at Pending Release, waiting for Manual Release