Subject: SAP-Quality-Management
In today’s complex supply chains, ensuring product authenticity, safety, and regulatory compliance is paramount. Serialization and Track and Trace technologies have become essential tools within SAP Quality Management (SAP QM) to enhance product quality assurance and visibility throughout the product lifecycle. These capabilities not only help prevent counterfeit goods but also support efficient recalls, improve transparency, and strengthen customer trust.
Serialization refers to the process of assigning unique identifiers, or serial numbers, to individual products or batches. Each serialized unit can be tracked independently, allowing for granular quality control and traceability.
Within SAP, serialization can be managed through integration with modules like SAP Advanced Track and Trace for Pharmaceuticals (ATTP) or embedded serial number management in SAP S/4HANA. Serialization data is linked with quality management records to provide a detailed history of inspection, testing, and handling.
Track and Trace is the capability to record and monitor the movement and status of serialized products throughout the supply chain—from raw material procurement, production, quality inspection, packaging, distribution, to end customer delivery.
SAP Track and Trace solutions capture data at every stage, enabling real-time visibility into the product journey and supporting compliance with global regulations such as the EU Falsified Medicines Directive (FMD) or the US Drug Supply Chain Security Act (DSCSA).
Enhanced Product Authenticity
Serialization combats counterfeiting by enabling verification of product authenticity at any supply chain point.
Improved Recall Management
In case of quality issues or safety concerns, serialized track and trace data allow companies to quickly identify and isolate affected products, minimizing impact.
Regulatory Compliance
Many industries (pharmaceuticals, medical devices, food & beverage) require serialization and track and trace to meet legal standards.
Data-Driven Quality Insights
Linking serialized data with quality inspection results helps identify quality trends linked to specific batches, production lines, or suppliers.
Customer Transparency and Trust
Providing end customers with verifiable product information boosts brand reputation and consumer confidence.
Integration with Serial Number Management
SAP QM links quality inspection lots, results recording, and quality notifications to serialized units, ensuring every product’s quality status is traceable.
Quality Notifications Linked to Serialized Products
Quality issues can be reported against specific serial numbers, enabling precise corrective actions.
Batch and Serial Number Traceability
SAP QM enables tracking from raw materials to finished goods, maintaining full traceability for audits and investigations.
Reporting and Analytics
Comprehensive reports on quality trends by serial number or batch help pinpoint recurring issues and improve processes.
Compliance Support
SAP supports compliance with serialization regulations by facilitating data exchange with regulatory authorities and supply chain partners.
A pharmaceutical company uses SAP ATTP integrated with SAP QM to manage serialization. Each drug package is assigned a unique serial number and scanned at every production and distribution point. Quality inspections are logged against these serial numbers.
When a packaging defect is detected in a batch, quality notifications are raised referencing the affected serial numbers. The company quickly identifies affected units and initiates a targeted recall, ensuring patient safety and compliance.
Plan Serialization Strategy Early
Define how serialization aligns with quality processes and supply chain requirements.
Ensure Data Accuracy and Consistency
Use automated scanning and data capture to minimize manual errors.
Train Users and Partners
Equip internal teams and supply chain partners with knowledge and tools for effective serialization handling.
Leverage SAP Analytics
Utilize SAP BW or embedded analytics for deep insights into serialized quality data.
Maintain Regulatory Readiness
Keep serialization and trace data ready for audits and regulatory reporting.
Serialization and Track and Trace capabilities are indispensable for modern quality management in SAP environments. By uniquely identifying and monitoring products throughout their lifecycle, organizations can enhance quality control, streamline recalls, comply with regulations, and build customer trust. SAP QM, combined with advanced serialization and track and trace solutions, empowers companies to meet these challenges efficiently and effectively.