Life Sciences Quality Control & Assurance allows authorized users to apply a statistical approach to quality inspections. Reduced test groups (that is, reduced testing policies) with predefined variables can be set up to determine if a quality order is subject to full testing or reduced testing.
Two different scenarios are covered within the system:
When full testing is required in a quality order, all tests must be executed (results must be inserted in the corresponding quality order lines).
When reduced testing is applied to the quality order, only mandatory tests must be executed, while other tests, that is, Reduced tests, can be skipped without generating a failure.
Setup
To set up reduced test groups, users must go to Life Sciences Quality Control & Assurance > Setup > Quality control > Reduced test group and define:
Approved status (optional) – The status of the vendor-item combination in the approved vendor list that determines the application of reduced test (for example, the reduced testing policy is applicable only to qualified vendors).
Batch period – After reaching this specified number of batches, full testing is required (for example, one full testing generated every 10 batches received).
Days – Maximum period between two full test quality orders (for example, on full testing generated every year).
Batch counter method – The criterion used to update the batch counter. The following values are available:
Vendor – The batch counter considers the combination vendor-item.
Manufacturer – The batch counter considers the combination manufacturer-item.
Both – The batch counter considers the combination of item-vendor-manufacturer.
None – Used for manufactured batches (that is, not purchased).
Excluded analysis types (optional) – The analysis types to be excluded (from a quantity standpoint) when the reduced test policy applies. For example, in case of reduced testing it is possible to skip the microbiological testing, therefore the sample quantity associated to the microbiological analysis type can be excluded).
Additionally, after setting up reduced test groups, users need to:
Define the test groups where reduced testing is applicable. This can be done by selecting a reduced test group from the Reduced test group dropdown menu in the Test groups form (Life Sciences Quality Control & Assurance > Setup > Quality control > Test groups), or it can be selected when creating a quality association in the Quality association form (Life Sciences Quality Control & Assurance > Setup > Quality control > Quality association).
Note
It is not possible to associate a Reduced test group with Batch counter method = None to a Purchase quality association.
Define which tests within the test group can be skipped during reduced testing by marking the Reduced test checkbox in the test group lines.
Example
Test group TG001-1 is set to perform a full testing every three batches; otherwise, reduced testing. The batch counter method is set to Manufacturer. The item sampling is configured to generate a sample composed of 100 g for microbiological testing and 100 g for chemical testing. In case of reduced testing the microbiological analysis type is excluded.
Four quality orders are created for four different batches:QO-000956 for batch BNG032 (Manufacturer MAN001): full testing (total quantity: 200)
QO-000957 for batch BNG033 (Manufacturer MAN001): reduced testing (total quantity: 100)
QO-000958 for batch BNG034 (Manufacturer MAN001): reduced testing (total quantity: 100)
QO-000959 for batch BNG035 (Manufacturer MAN001): full testing (total quantity: 200)
QO-000960 for batch BNG036 (Manufacturer MAN002): full testing (total quantity: 200)
Test group TG002-1 is set to perform a full testing every two days; otherwise, reduced testing. The item sampling is configured to generate a sample composed of 100 g for microbiological testing and 100 g for chemical testing. In case of reduced testing the microbiological analysis type is excluded.
Two quality orders are created on the 1st Oct. 2020:QO-000952: full testing (total quantity: 200)
QO-000953: reduced testing (total quantity: 100)
Two quality orders are created on the 2nd Oct. 2020:
QO-000954: reduced testing (total quantity: 100)
QO-000955: reduced testing (total quantity: 100)
Two quality orders are created on the 3rd Oct. 2020:
QO005: full testing (total quantity: 200)
QO006: reduced testing (total quantity: 100)
Batch information
In the Batch information form (Life Sciences Quality Control & Assurance > Tracking dimensions > Batches information), the system displays the following information:
Item number: item received/produced.
Vendor account: vendor from which the item has been purchased. Populated only for purchased batches if the Batch counter method is set to Vendor or Both.
Manufacturer: manufacturer of the purchased batch. Populated only for purchased batches if the Batch counter method is set to Manufacturer or Both.
Batch counter: number of batches received from the same site/item and eventually vendor/manufacturer (depending on the Batch counter method). The counter is increased only in case a quality order is generated for the received/produced batch. Every new full quality order generated the counter is reset to “1”.
Last batch fully tested and Test date: last batch number for which a full quality order was generated and date of the quality order creation.
The Batch information form is an inquiry; it is not possible to manually modify the status of the batch counter.
The batch counter takes in consideration the Approved status specified in the reduced test group. The Batch information form is not updated with a new line for a certain item until the status of the vendor from which the item is purchased meets the status specified in the Reduced test group defined. For example, if the Reduced test group is applicable for an Approved status = Qualified, if one or multiple batches are received from a vendor in status Under qualification, all quality orders are generated with full testing and the batch counter is not affected.
Additionally, users can open the batches form directly from the Batch information form (by clicking the Batches button) automatically filtered by the Vendor account/Manufacturer or combination of both of the selected line of the Batch information form.