Quality associations define:
When a quality order must be automatically generated.
The sampling plan and test specifications to be applied.
Life Sciences Quality Control & Assurance introduces additional functionalities related to quality associations.
Quality association based on vendor status or manufacturer
For quality associations of type Purchase, different inspections on incoming materials can be applied depending on the vendor status and/or the manufacturer of the received item.
Steps
To set up quality associations by vendor status/manufacturer, users must:
Go to Life Sciences Quality Control & Assurance > Setup > Quality Control > Quality associations.
Create a new quality association with the Purchase = Reference type.
Select a status from the Vendor status dropdown menu.
Select a value in the Manufacturer code field:
All – The quality association is valid for all manufacturers (including batches and sub-batches with blank Manufacturer).
Table – The quality association is valid only for the manufacturer selected in the Manufacturer field.
Quality associations based on customer
For quality associations of type Production or Route operation, different inspections may be carried out on manufactured products based on the receiving customer. This applies to make-to-order batches, which are produced for individual customers and may require unique manufacturing processes and quality controls tailored to each customer’s needs.
Steps
To set up quality associations by customer, users must:
Go to Life Sciences Quality Control & Assurance > Setup > Quality Control > Quality associations.
Create a new quality association with Reference type = Production or Route operation.
Enable the Enable customer condition parameter.
Select a value in the Customer code field:
Group – The quality association is valid for the group of customers selected in the Customer selection field.
Table – The quality association is valid only for the customer selected in the Customer selection field.
When a batch order is created from a sales order or project (Reference type = Sales order), the Customer account in the All production orders table is automatically filled from the related sales order. If there’s no link to a sales order, you can select the Customer account manually. Quality orders are then generated according to the quality association that matches the defined Customer account, allowing for customer-specific properties such as tests, specifications, and sampling plans.
Quality associations based on intended use
The quality controls and acceptance criteria used for lot release might differ based on the batch’s intended use (for example, commercial, clinical). For example, the release of a commercial batch usually requires more testing, and it might have more restrictive acceptance criteria than a batch that will be used for R&D purposes.
Steps
For this reason, Life Sciences Quality Control & Assurance allows for the definition of different quality controls based on the Use code field in the Quality associations form. To set up quality associations by use code, users must:
Go to Life Sciences Quality Control & Assurance > Setup > Quality Control > Quality associations.
Create a new quality association with Reference type = Purchase, Route operation, or Production.
Select a value in the Use code valid for field:
All – The quality association is valid for all use codes (including batches and sub-batches with blank Use code).
Table – The quality association is valid only for the use code selected in the Use code field.
Quality order generation upon production order “Start”
For quality associations of type Production, in addition to standard document types for quality order generation, Life Sciences Quality Control & Assurance allows users to trigger the quality order generation when starting a production order.
This can be configured as follows:
Document type must be set to Start.
Execution must be set to After.
Quality order generation upon production order “Report as finished – End job”
For quality associations with the Reference type set to Production, the standard Report as finished event type triggers the quality order generation upon the posting of the Report as finished journals. For the same batch order, it is possible to create multiple Report as finished journals (for example, in case of partial production). In this case, the system creates a quality order for every Report as finished journal that is posted.
Life Sciences Quality Control & Assurance allows users to select the Report as finished – End job event type. This event type triggers the quality order generation only when updating the batch order status to Reported as finished (that is, when the End job checkbox is enabled). In this scenario, the Execution field is greyed out.
Example
Quality order generated per batch
Item: “FP001”
Batch order quantity: “10”
The user registers the first “5” units in batch number “BN001” and five sub-batches. The End job parameter is set to “No” because the production is not yet completed. No quality order is generated when the journal is posted.
The user registers the remaining “5” units in batch number “BN001” and five sub-batches. The End job parameter is set to “Yes” because the production is now completed. The system generates a quality order for batch “BN001”. The Total sub batches field in the quality order is “10”.
The outcome described in the example above is applicable to the report as finished process via client and via mobile device (that is, Work creation processes are Advanced report as finished and put away and Advanced report as finished).
Allow next operations before quality order completion
Upon execution of specific manufacturing processes, the completion of in-process Quality Control may or may not be required to be allowed to proceed with the following operation. Life Sciences Quality Control & Assurance provides the capability to define if the quality order completion is critical/non-critical for the manufacturing process.
For quality associations of type Route operation and Production, authorized users can enable the Allow next parameter to let the manufacturing process proceed even if there are still open or failed relevant quality orders.
For quality associations, type Route operation or Production the Allow next parameter can be configured:
When the Allow next parameter is disabled, the batch order is stopped while Quality Control is in progress or in case of Quality Control failure.
When the Allow next parameter is enabled, the system allows production to proceed even if Quality Control is still pending or failed.
Note
Quality orders are automatically created before/after the route operation is reported as finished. In case of the Allow next parameter is disabled, and a quality order in status open/fail exists for the route, the system does not allow users to report as finished the following route operation or the batch order/production order.
To use Allow next, enable the Enable allow next parameter in Life Sciences Quality Control & Assurance parameters (Life Sciences Quality Control & Assurance > Setup > Life Sciences Quality Control & Assurance parameters). Once enabled, the feature works as described above. However, because it is deprecated starting in version 10.0.48, we recommend leaving Enable allow next disabled and using Microsoft Event blocking functionality instead.
The Event blocking field is available in Quality associations (Life Sciences Quality Control & Assurance > Setup > Quality controls > Quality associations) and determines which process step is blocked when related quality orders remain open. For example, for a Production quality association, setting Event blocking to End prevents users from ending a production order while associated quality orders are still open. If this control is not needed, set Event blocking to None.
“Route operation control” quality associations
Life Sciences adds the Route operation control Reference type, which can be used to support the environmental monitoring program.
Quality associations of type Route operation control trigger the quality order upon the report as finished of the selected operation (similarly to the Route operation quality associations).
“Project” quality associations
Quality associations of type Project can be set up to define the material, the stability/environmental control schedule (that is, test group with a defined quality schedule), and the item sampling to be applied for stability study and environmental control inspections.
Example
The quality association is set up as follows:
Site: “1”
Reference type: Project
Item code: “Table”
Item: “FP001”
Account code: Table/Group/All
Account code:
Select the sub-project for which the quality association is applicable, if the Account code is Table.
Select the main project for which the quality association is applicable, if the Account code is Group.
Disabled, if the Account code is All.
Test group: “TG_STAB_001”
Item sampling: “IS-002”
Whenever planned quality orders are generated from a stability or environmental control project for item “FP001”, the system automatically generates quality orders with test group “TG_STAB_001” and item sampling “IS-002”. The number of quality orders and the tests included in their lines may vary based on the test group quality schedule.
Use current test group version
When configuring test group specifications, you can select Use current test group version. With this enabled, the system will always reference the latest active version for that specific test group. As a result, if a new test group version becomes available but hasn’t been updated in the quality association, the system considers the newest active version for the test group.