For pharmaceutical and chemical companies, the routine environmental monitoring program is a critical aspect for documenting the state of control of a manufacturing facility. Environmental monitoring should promptly identify potential routes of contamination, allowing for the implementation of corrections before product contamination occurs. The objective is to ensure product quality and safety in the current and upcoming production processes.
Life Sciences Quality Control & Assurance provides the capability to manage environmental monitoring programs by manually or automatically generating quality orders to examine the quality of environmental factors (e.g., air or water) in the facility upon completion of a specific manufacturing operation:
Manual quality orders with Reference type “Route operation control” can be created. Upon creation, it is possible to select the Controlled item corresponding to the item that the quality order should be generated against (e.g., water or air). The controlled item is different from the manufactured product (i.e., Item field) for the reference batch order/production order or its specific operation.
Automatic quality orders can be generated based on a quality association with the Reference type “Route operation control”.
Users should create a quality association (Life Sciences Quality Control & Assurance > Setup > Quality control > Quality associations) and select the “Route operation control” Reference type. When this type is selected, the Controlled item field becomes editable. For this type of quality associations the user needs to enter the following information:Item, i.e., the manufactured product whose batch order/production order triggers the quality order generation. However, the quality order is not created for this item since the Quality Control needs to be executed on the controlled item;
Controlled item, i.e., item for which the quality order should be generated in this scenario (e.g., water or air).
Other quality association parameters follow the standard Microsoft Dynamics 365 Finance & Supply Chain Management behavior.
Depending on the selected Event type and Execution in the Timing FastTab (e.g., after “Report as finished”), the system will automatically generate a quality order for the Controlled item whenever a selected route operation is executed during the manufacturing process of the Item.
Example
Quality association is set up as follows:
Site: 1
Reference type: Route operation control
Item code: Table
Item: FP001
Account code: Table
Account selection: Filling
Controlled item: Air
Event type: Report as finished
Execution: After
Test group: TG_AIR_001
Item sampling: IS-001
Whenever a production order for item “FP001” is started, and the “Filling” operation included in the production route is reported as finished, the system automatically generates a quality order for item “Air” with test group “TG_AIR_001” and item sampling “IS-001”.