Sampling Plans

•	Whether or not to include Stages (with or without Samples) in a Batch.
•	Sample Template used for creating Samples in the Batches.
•	Count Rule that defines the number of Samples created in the Batch.
•	Tests and Specifications associated with the Samples in the Batch.

Typically, you would have a Sampling Plan for each Product. Sampling Plans are versioned.

The Sampling Plan page contains three significant tabs that are described in the following sections below:

•	Process Stage defines a stage in the manufacturing process at which something is done to a Batch.
•	Level Samples chooses which sourced Samples (and how many) for each supported Level.
•	Tests and Specs chooses Tests and Specifications to associate with each sourced Sample.

 

Define a Stage to include in a Batch.

Clicking the "Add" button in the Process Stage tab gives you the following options:

Process Stage Options	Choose...
Stage	What will be done to the batch in the Stage. Choose any of the Common Process Stages (defined as a Reference Type) or enter your own.
Count	The number of times to repeat the Stage.
Template	The Batch Stage Template to be used. Batch Stage Templates allow you to define an Approval process for Stages. Depending on your decision in BatchSamplePolicy these approvals will be required before a Batch can be released.

You can define multiple Stages in each Sampling Plan.

 

For a combination of Stage, Level and Source Label (a Reference type), "Level Samples" defines:

•	Sample Template to use.
•	Number of Samples to create.
•	Whether or not the Sample is associated with a Stage.

Samples are created for all combinations of Stage, Level and Source Labels. Values shown in boxes indicate choices you can select from a dropdown:

NOTE:

The actual values in your configuration for Level, Stage, Source Label and Template will differ, as these are the OOB values.

Level		Stage		Source Label		Template		Count
Full Reduced Skip		Mixing Grinding		Top Middle Bottom Composite		Environment Finished Intermediate QC Raw Material Research Stability		See below.

Field	Description
Level	Defines how the Sampling Plan is to be executed. It controls the number of Samples and the required testing on the samples. This is taken from the ProdVariantRuleLevel Reference Type (e.g., Full, Reduced, Skip Lot).
Stage	Whether or not the Sample is associated with a Stage. The Process Stages you define in the Process Stage tab will be available here. Note: Leaving Stage blank creates a sample not associated with a Stage.
Source Label	Location or area from which the Sample is collected. This is taken from the SourceLabel Reference Type (e.g., Top, Middle, Bottom, Composite).
Template Id	Sample Template.
Count	Number of Samples to insert (of the specific Sample Source). As an alternative, you can predefine Range Rules (see Count Rules). Count rules are entered through a Count Rule Dialog: There are four ways the Count can be entered: Option Description Example Number Numeric value. 2 Groovy Groovy expression using columns from Batch, Product, Address, and LV_ProdVariant SDCs. (Batch.size>50)?10:2 Note:Batch size does not have a unit. Range Expression indicating a range of values. Ranges can be reused multiple times, e.g., Standard AQL limits. Number of Samples is 15 if Batch size = 30, Number of Samples is 45 if Batch size >30, otherwise 5. Count Rule Count Rule predefined in Lab Admin → Process → Count Rule. MyCountRule An SDI in the LV_CountRuleSDC normalizes Ranges and Groovy expressions. The "Return Value" button opens a new dialog containing a radio button to choose which one of the four modes you will use. A dynamic area is reformatted based on the choice. There is also a Return Value button to close the window and return the count to the Level Sample Grid.
Department	Default Department to set as the Security Department of the created Batch Samples. This field is defined by the DefaultDepartmentId column of the s_spdetail table. The Department is copied to the SecurityDepartment column of the created Samples.

 

After setting up "Level Samples" and saving, a Tests and Specs detail lets you associate Tests ("Add Test Method") and Specifications ("Add Spec") with the Sampling Plan.

The header transforms rows in "Level Samples" to color-coded columns. Associate Tests and Specifications with a Level by checking the relevant box. In the example below:

•	At "Full" Level Spec "AAA" is associated with the Stage "Mixing", Source "Top" and Stage "Grinding", Source "Middle". At Reduced Level Spec "AAA" is associated with Stage "Grinding" Source "Composite".
•	"Test Method" is associated, in "Full" Level with the Stage "Mixing", Source "Top" and in "Reduced" Level with Stage "Grinding" Source "Composite".

NOTE:

To handle Skip Lots, Level=Skip and Count=0. Accordingly, if one of the Levels defines a Skip Lot, there will not be a corresponding column in the detail, since a Skip Lot has no Samples.

This grid is rendered by the spdetailitem Element (Level colors can be configured there).