Laboratory Concepts: Batch Management (Quality Management)

Content

Fundamental Concepts

Top

Batch Test Setup

Laboratory Concept

LabVantage Concept

Example

Product

A Product within LabVantage represents a raw material, an intermediate product or a finished product.

Product details include information about its suppliers/manufacturers and the test plan for quality measurement.

I make pencils using Batches of graphite purchased from three suppliers. Before I actually manufacture the pencils, I want to test some of these Batches from each supplier to ensure that the scratch hardness meets my standards.

The first thing I must do is to classify each type of pencil. I do this by creating a Product to classify the "Raw Material" used for each hardness grade, e.g., "HB", "2H", and so on throughout the hardness scale.

Batch

A Batch represents a specific quantity of a product that is intended to have uniform quality, within specified limits and is produced using a single manufacturing cycle.

For the Batch of "HB" graphite, I create the Raw Materials Batch "B-001" and associate it with the Raw Materials Product "HB".

Specify test plan or sampling plan to measure the product quality

A Product Variant defines supplier/manufacturer and specific testing strategy for a product.

The latter specifies a State, Product Variant Ruleand a Sampling Plan.

In order to specify the testing strategy (in the Product Variant Rule) for each vendor, I create three Product Variants.

All three Product Variants will apply to the same Sampling Plan (HB-220-SP) and the same Product (HB), but each applies to a different supplier:

•	"Full Testing" applies to "Global Mineral", since only 50% of their graphite meets my standards.
•	"Reduced Testing" applies to "National Mineral", since their success rate is 75%.
•	"SkipLotTesting" applies to "Local Mineral", with a success rate of 100%.

During testing, the Product reports the state of the Product Variant for each supplier.

A Product Variant Rule determines the level of testing that is conducted for a Batch that is at a given "state".

For example, a state indicating poor quality would require full testing, while a state indicating better quality would require partial testing.

Test results can also drive rules governing transition from one state to another.

The testing strategy is defined and driven by these "states", which characterize the test results:

•	"Preferred" defines a testing strategy for when I usually expect the required quality.
•	"Qualified" defines a testing strategy for when I sometimes expect the required quality.
•	"Unqualified" defines a testing strategy for when I seldom expect the required quality.

To define these testing strategies, I create three "Product Variant Rules":

•	"FullTesting" will test every Batch, regardless of state.
•	"Reduced Testing" will test every Batch if the state is "Unqualified", every 10th Batch if "Qualified", every 1000th Batch if "Preferred".
•	"SkipLotTesting" will test every Batch if the state is "Unqualified" or "Qualified", only one Batch per month if the state is "Preferred". However, if any test fails, the state transitions to "Qualified".

For each level of testing defined by the "Product Variant Rule", a Sampling Plan defines:

•	The number of Batch Samples created.
•	The Tests and Specifications associated with the Samples.

Other options can be specified, such as the "source" (location from which the Sample is taken in the Batch) and "stages" (points in the lab process where the Sample is taken).

In order to define how the Batches will actually be created, I create Sampling Plan "HB-220-SP". The Sampling Plan states:

•	Create 30 "Raw Material" Samples from the top of the Batch, associate the "scratch hardness" Test and "scratch hardness" Specification with them, and conduct a "Full" level of testing on them.
•	Create 20 "Raw Material" Samples from the middle of the Batch, associate the "scratch hardness" Test with them, and conduct a "Reduced" level of testing on them.
•	Do not create any Samples from the bottom of the Batch. Samples will be taken only from the first Batch of each month ("SkipLot" level of testing), when they will be tested against the "scratch hardness" Test and "scratch hardness" Specification.

Batch Test Execution

Laboratory Concept	LabVantage Concept
Register incoming raw material or finished product batches	Batch Creation is the process of creating a Batch record in the LabVantage database. During batch creation, the number of samples and the tests required for the Batch are automatically determined by the system based on the Product definition.
Print labels for test samples	Labels can be generated for the test samples using barcode printing software.
Physical receipt of raw material batches at the facility	Batches can be marked as received through the user interface.
Draw test samples from Batch & deliver to laboratory	Batch Test Samples can be marked as received through the user interface.
Assign resources to tests	An Analyst, Department or Instrument can be assigned to the test associated with the Sample.
Record test results	Results can be entered either manually or directly from an Instrument.
Review test results and Approve batch	When the testing is finished, the results for the test samples can be Reviewed and a batch can beReleased. Batch Release can be configured on a product by product basis to either be automated if the system detects that all samples of a batch pass the specifications, or set to always require a manual review.
Track batch genealogy	Genealogy Viewer allows to graphically view the entire Genealogy of a Batch. The viewer helps find a particular batch of Consumables or ingredients used for the manufacture of different batches of finished product.