Working With Retains Tests

Retains Testing involves testing Samples from a specific production batch that were set aside and stored for later analysis. These Samples may be used to investigate future issues such as quality concerns, customer complaints, or regulatory questions. In some cases, such as under Food and Drug Administration Regulation 21 CFR 211.170 in the United States, setting aside samples for Retains Testing may be mandated by law.

If configured by an Admin, you can define and perform Retains Testing either as part of a predetermined schedule, or on an ad hoc basis.

Defining Retains Tests

A design data Admin can define Retains Tests to be performed by Analysts.

To define Retains Tests, perform the following additional steps during Spec Data creation:

  1. When viewing a Batch Release Spec Data in the Spec Data Builder, you can select Mark Retains to mark a sample as intended for Retains Testing. You can only mark one sample per Sample Definition as the Retains Sample. This establishes the Retains path, which can include any number of sample actions.
  2. If not already defined, you can enter the Retains Testing Frequency and Retains Testing Unit in the resulting prompt. These fields are used to populate the Next Retains Testing Date for Retains Samples. You can edit them later by selecting the Edit Spec Data pencil icon in the Spec Data Builder.

Performing Retains Testing

In order to begin a Retains Test:

  1. On the Release Lab Sample record details page for the sample to undergo retains testing, select Actions > Initiate Retains Testing.
  2. The resulting dialog includes the following fields:
    1. Scheduled
    2. Pulled Date: This field is required and autopopulates with the current date.
    3. Next Retains Pull Date: This field is required and autopopulates with the current date + the frequency selected. For example, A test with a Pulled Date of July 22, a Retains Testing Frequency of 1, and a Retains Testing Unit of months would have a Next Retains Pull Date of August 22. If either the Retains Testing Frequency or the Retains Testing Unit is blank, this field also remains blank.
    4. Override Next Retains Pull Date: This field defaults to False.
    5. Location
    6. Quantity Pulled
    7. Unit of Measure
    8. Comments: Depending on your configuration, this field may be required.
  3. Click Save.

About the Retain Inventory

The Retain Inventory and Retain Inventory Summary track the quantity of samples from a given batch that have been marked for Retains Testing as they move in and out of storage. These records are automatically created when a Lab Sample record is created or updated such that Retains Testing (retains_testing__v) = Yes. Each Retains Sample in a given batch has its own Retain Inventory.

They track the following fields:

  • Quantity Stored
  • Quantity Pulled
  • Quantity Remaining
  • Quantity Disposed

The below table explains how each of the fields is calculated:

Object Field How it is Populated How it is Updated
Inventory Quantity Stored Current value + Release Lab Sample.Quantity When the Quantity (amount__v) field is populated or updated on the Release Lab Sample (when updated, the calculation needs to adjusted based on the different between the previous and new value)
Inventory Quantity Pulled Current value + Retain Lab Sample.Quantity When the Quantity (amount__v) field is populated or updated on a Retain Lab Sample related Lab Sample (when updated, the calculation needs to adjust based on the difference between the previous and new value)
Inventory Quantity Pulled Current value - Retain Lab Sample.Quantity Stored When the Quantity Stored (quantity_stored__v) field is populated or updated on a Retain Lab Sample (when updated, the calculation needs to adjusted based on the different between the previous & new value)
Inventory Quantity Remaining Quantity Stored - Quantity Pulled - Quantity Disposed When any of the 3 field values are updated
Inventory Quantity Disposed Manual entry Manual entry
Inventory Summary Quantity Pulled Sum of Quantity Pulled across all related Inventory records When the Quantity Pulled is updated on any of the related Inventory records
Inventory Summary Quantity Stored Sum of Quantity Stored across all related Inventory records When the Quantity Stored is updated on any of the related Inventory records
Inventory Summary Quantity Remaining Sum of Quantity Remaining across all related Inventory records When any of the 3 field values are updated on any of the related Inventory records
Inventory Summary Quantity Disposed Sum of Quantity Disposed across all related Inventory records When the Quantity Disposed is updated on any of the related Inventory records