Safety and Recall (GPSR) SOP

This detailed SOP provides safety managers, compliance officers, and recall coordinators with a comprehensive framework for managing Safety and Recall (GPSR) procedures effectively.
Key features include:
– Subprocesses and Process Flow: Divided into four essential subprocesses—Risk Monitoring and Documentation, Notification and Communication, Product Recall Execution, and Evaluation and Process Improvement. Each subprocess is meticulously designed to ensure timely and effective management of product safety issues and recalls.
– Risk Management: Identifies critical risks such as delayed risk identification, ineffective communication, and incomplete product retrieval. Mitigation strategies include continuous risk monitoring, robust communication protocols, and structured recall execution plans.
– Compliance and Regulatory Requirements: Ensures adherence to GPSR and GDPR by outlining strict timelines for notifying EU authorities, securing sensitive data, and maintaining detailed compliance records.
– Key Performance Indicators (KPIs) and Controls: Defines KPIs such as risk identification timeliness, product recall completeness, and customer satisfaction. Controls include comprehensive communication protocols, structured recall procedures, and regular compliance reviews to ensure effectiveness and alignment with regulations.
– RACI Framework: Clearly delineates roles and responsibilities for Safety Managers, Compliance Officers, Recall Coordinators, and Quality Improvement Specialists. This ensures accountability and collaboration throughout the safety and recall lifecycle.
– Systems Requirements: Specifies tools such as Risk Management Platforms, Product Recall Management Systems, and Communication Repositories to facilitate streamlined execution, compliance, and documentation.
– Appendices: Offers practical resources, including risk monitoring checklists, notification templates, recall execution guidelines, and evaluation methodologies, to support consistent and efficient implementation.