Today process industries like Pharmaceuticals & Specialty Chemicals are facing some tough challenges. Regulatory bodies like FDA are putting more pressure to have complete tracking and tracing of an order. The absence of this capability results in a time consuming investigation and root cause analysis for quality deviations and it becomes extremely difficult to track orders back to raw materials and respective vendors in case of customer complaints or product recalls, thus resulting in a higher cost of quality and compliance.
To address these challenges SAP Labs & Cognizant came together under the SAP Co-Innovation Lab initiative to build a solution based on SAP MII (Manufacturing Intelligence & Integration) 12.1.
The Order Trace solution simulates the Enterprise to shop floor integration using the following software components:
- Plant Floor – Matrikon OPC Simulator
- Manufacturing Execution – Performix xMES 7.6
- Manufacturing Integration – SAP MII 12.1
- Enterprise planning – SAP ECC 6.0
The solution uses the SAP MII platform and leverages its powerful analytics capability combined with the integration capability to help today’s manufacturers realize their operational excellence dream.
The solution enables production personnel, particularly Quality Managers, to easily track and trace a process order across its four aspects of execution – Input Raw Material, Finished Good, Labor Usage and Equipment Usage thus providing them with a platform for continuous improvement and collaboration.
It enables the users to look at key Quality Metrics like CAPA completions, Deviated Process Orders, SPC analysis for CTQ(Critical to Quality) parameters and top vendors by aggregating the data from the shop floor and the enterprise systems. These metrics in turn help the users in taking the right decisions and help the organization in the quest for achieving operational excellence.
The need for tracking and tracing arises when the User identifies a deviation with an order/batch. The solution enables the user to analyze the deviations and identify the root cause.
The root cause can be analyzed across
- Finished Good: Track any Quality deviations with the Finished Good.
- Equipment Usage: Track Process related deviations with the Equipments used in the order execution
- Labor :Track Labor deviations from Quality Certifications perspective (Skilled vs. non-skilled)
- Raw materials: Track Quality Deviations with the raw material and drill down to the supplier of the deviated batch of raw material used
- Enables the users to drill down into process order execution details
- Showcases the traceability of a process order from Finished Goods to its input materials and their corresponding vendors/suppliers
- Complete tracking of Labor and Equipment Usage during order execution
- Performance Management and Decision Support through reports and analytics
- Integration of Shop Floor and enterprise systems
The solution is slated to benefit the business in the following manner:
- Increased consumer safety and satisfaction
- Compliance to Quality/Regulatory standards
- Mitigate risk of product recall
- Lower the cost of quality
It brings the following benefits to the operations:
- “Built-In” product traceability into the manufacturing process
- Increase responsiveness to non conformance incidents
- Traceability from Finished Good to the raw materials used
- Ensuring fast response to customer queries and satisfying regulatory authorities
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