Batch Management Overview

 

Batch Management includes all functionality associated with the Batch life cycle of raw material and manufacturing Batches. This section is designed to give the reader a high-level overview of the entire process.

Two notes concerning terminology:

•	The Batch terminology presented here is not to be confused with the QCBatch SDC used by the AQC module for testing a Batch of Samples.
•	An alternate acceptable term for this use of Batch is "Lot". In all cases, the terms "Batch" and "Lot" are synonymous.

The Batch life cycle includes the creation of Batches, Batch Receipt, laboratory Data Entry, Batch Release, and printing of the Batch COAs. The Batch Life Cycle is integrated with the Sample Life Cycle. For example, when the last Sample is Completed, the Batch is ready for Release.

The most important part of the Batch life cycle is Batch creation. When creating a Batch, the system automatically knows which Samples are required based on the Product associated with the Batch. Each Batch is associated with one Product. Each Batch has a Batch Type. Typical Batch Types include Raw Materials and Finished Goods. All Raw Materials and Finished Goods are considered Products. Even intermediate Batches would define separate Products representing the intermediate.

The Product definition affects the Batch and Sample life cycles, as well as rules defining how the Samples are to be Disposed.

During Batch creation, the Product determines the number of Samples and the Tests that are required for the Batch. The simplest scenario is that the Product SDC defines a Count of "n" Samples of a given Sample Template, and enumerates the required Tests and Specifications for Samples of that Product. Then, every time a Batch is created, the set of Samples is automatically created and associated with the Batch.

However, in reality, it is not that simple. Real life adds the following requirements:

•	The number of Samples to create is dependent on the size of the Batch.
•	The Source of the Sample may need to be specified.
•	Some Batches may not require any Samples to be tested.
•	Not all Tests have to be tested on all Samples of all Batches.
•	Different vendors (Manufacturers and Suppliers) may have different testing rules.
•	Testing rules are affected by the history of Batches.
•	Differing strategies for test optimization, such as the lab need not perform all Tests on all Samples of all Batches.

The last point raises a discussion of "Skip Lot" and "Reduced Testing" strategies. What is the difference?

•	"Skip Lot" testing is an optimization strategy where no Samples are taken on some Batches. For example, Samples are tested only on every 10th batch, or on the first Batch of every year.
•	"Reduced Testing" is an optimization strategy where Samples are taken from all Batches, but not all testing is performed on some Batches. For example, only a physical inspection test is done on the majority of the Batches, but once every 10th Batch or at the first Batch of the year, you may need to perform full testing.

With both optimization strategies, the testing performed on a Batch from a particular vendor is controlled by the vendor's history in providing a quality product. The optimization strategy is put into effect if (and only if) the vendor is of sufficient quality.

To address these issues, three SDCs are used: Sampling Plan, Product Variant, and Product Variant Rule. These are described in the following sections.

 

Consider a Sampling Plan as a "super template". It can create multiple Samples from different Sources. It is not uncommon for a Batch's Samples to be taken from different Sources of the Batch. For example, one Sample could be taken from the top of a drum, one Sample from the bottom, and one additional composite. The Sampling Plan indicates how many Samples to take, and which Sample Template to use for each.

The number of Samples required is not always one sample from each source. The number of Samples may be specified using a Count Rule. Count Rules let you specify the number of Samples using four strategies:

•	Specifying the literal number of Samples for the specific Source (as in the example above).
•	Using a range expression based on the unitless Batch size (entered during Batch creation).
•	Specifying a Groovy expression to return the Batch size.
•	Referencing a normalized Count Rule. The Count Rule may exist independently for use by multiple Sampling Plans.

The Sampling Plan defines the Tests and Specifications required for each of the differently Sourced Samples.

The real power of the Sampling Plan is that it can be executed in multiple modes called "Levels". Levels let us use the Sampling Plan in either a Full, Reduced or Skip mode. For example:

•	In Full mode, all Tests are required on all Samples.
•	In Reduced mode, only a subset of the Tests are required.
•	In Skip mode, the Count Rule is set to require zero Samples, i.e., there are no Samples in the Batch.

 

Product Variants define the different organizations that supply and manufacture a particular Product. For each organization, a Product Variant is defined as a child to the Product. In fact, the structure is quite flexible in that one may consider additional organizations that may apply. For a Raw Material Product, you can track the shipper of the Product. For a Finished Goods Product, you can track a manufacturing site that manufactures the Product.

When it comes to specifying the manufacturer of a Raw Material, often all possible manufactures are NOT enumerated. Possibly, when the Batch is created, a different new organization manufactures the Raw Material. In this case, the Product's definition includes a Product Variant that does not define a manufacturing organization, and this is taken as a wild card.

Specifically what is tracked includes the status of this organization (or organization combination) as it pertains to the qualification of testing on its Batches. The Product Variant chooses which Sampling Plan ("super template") to use for the vendor associated with this Product. However, the typical case is that the Sampling Plan is the same regardless of the Product's Product Variant. Nevertheless, this flexibility is provided.

Also tracked are the rules honored by the particular Product Variant. These rules are defined in Product Variant Rules. One of the rules that is used is whether or not the system chooses to optimize its testing based on a Skip Lot strategy or a Reduced Testing Strategy. In both cases, it is the Product Variant that passes its determined level to the Sampling Plan to ultimately get the desired Samples and Tests.

 

Product Variant Rules basically define a state chart for the various states that an individual Product Variant may be in. For example, all new Product Variants may need to start with a particular initial State. This typically may be "UnQualified". While "UnQualified", full testing on all Samples may be needed for at least 3 Batches during the first 6 months this Organization supplies the batch.

A Product Variant Rule also defines rules for governing State transitions. These rules are usually based on the outcome of the prior Batch testing that has occurred. For example, while in the "UnQualified" state, the corresponding Product Variant would transition to a "Qualified" state if 3 successful batches within 6 months have passed. As another example, once in a "Qualified" state, it would take 12 months with no failures to transition to a "Preferred" State. Only while the Product Variant is in a "Preferred" State would the Skip Lot or Reduced Testing strategies be employed.

Lastly, the Product Variant Rule defines the Level to use while in the various States. In our example, when in the "UnQualified", or "Qualified" states, you would expect "Full" testing all the time. But in the "Preferred" state, you would use either "Skip" or "Reduced" testing. Please note that even "Preferred" Product Variants may occasionally require "Full" testing, depending on when the last Batch occurred and whether or not it was successful.

It should be noted that the actual terminology can be modified from the above. LabVantage uses configurable ReferenceTypes to enumerate the different Source values (Top, Bottom, Composite), Product Variant States (UnQualified, Qualified, Preferred), and the Levels (Full, Skip, Reduced)

 

Here is a high-level view of how all of this works:

1.		When the Batch is created, the user must choose a Product. Also chosen are the Organizations that supplied and/or manufactured the Product. By default, the user will choose only those Organizations that are associated with the Product (but the user may elect to choose any other Organization). The system then locates a single Product Variant.
2.		Each Product Variant has a State, a Product Variant Rule and a Sampling Plan. The Product Variant Rule is then used to determine, for this State, what Level should be used for this Batch. That Level is then passed to the Sampling Plan.
3.		The Sampling Plan then creates the required Samples from the required Sources, and associates the required Tests based on the Level that was passed.
4.		The Batch and its Samples are then created.

After a Batch is created, the Batch may require that it be Received. This is different than Sample Receipt in the lab. Batch Receipt applies to Raw Materials, indicating that the Batch is received at the loading dock. Samples are then sent to and Received in the lab. When the Samples are Received, the Batch Status will automatically transition to Active. It stays as "Active" until testing is finished. When testing is finished, the Batch status automatically transitions to "PendingRelease".

During the Release process, a Batch Disposition is determined. This causes the system to reevaluate the Product Variant's state, to determine if it must transition to a new State or not based on the current Batch's disposition, and the recent history of the Batches for this Product Variant. These transitions may or may not require Approval. Typically, if the Product Variant is transitioning from "Preferred" back to "Qualified", you would want this transition without Approval (to remove the risk that the next batch require "Full" testing). On the other hand, you may want the transition from "Qualified" to "Preferred" to always require a human review.

 

Details concerning all referenced items are in the following documents:

•	Batch Life Cycle
•	Batch Operations
•	Sampling Plans
•	Product Variants
•	Product Variant Rules
•	Count Rules
•	Products
•	Sampling Plan Policy
•	Batch Sample Policy