Product Compliance Assessment (GPSR) SOP

This detailed SOP provides product safety professionals, compliance officers, and quality assurance teams with a structured framework for conducting Product Compliance Assessment (GPSR) in accordance with the EU General Product Safety Regulation.
Key features include:
– Subprocesses and Process Flow: Details four essential subprocesses—Risk Identification and Evaluation, Compliance Verification, Reporting and Documentation, and Continuous Monitoring and Feedback. Each subprocess is supported by structured actions, decision points, and templates to ensure thorough assessment, compliance, and ongoing safety standards adherence.
– Risk Management: Identifies key risks, such as inaccurate hazard identification, non-compliance with GPSR, and stakeholder disengagement, with mitigation strategies leveraging methods like FMEA and HAZOP, structured stakeholder engagement, and robust documentation protocols to ensure integrity and compliance.
– Compliance and Regulatory Adherence: Addresses compliance with GPSR and other applicable standards through systematic risk assessment, compliance testing, documentation, and stakeholder reviews, ensuring alignment with legal and safety requirements.
– Key Performance Indicators (KPIs) and Controls: Defines essential KPIs, including risk assessment accuracy and compliance rates, with associated controls like standardised risk management protocols, detailed compliance documentation, and regular assessments for performance monitoring.
– RACI Framework: Clearly delineates roles and responsibilities for Risk Managers, Compliance Officers, Documentation Specialists, and Stakeholders, ensuring accountability and collaboration throughout the compliance process.
– Systems Requirements: Specifies tools such as Risk Management Software Platforms, Compliance Verification Tools, and Feedback Collection Systems to support a streamlined and transparent compliance assessment lifecycle.
– Appendices: Provides practical resources, including checklists, compliance templates, scoring methodologies, case studies, and real-life scenarios to guide users through each stage of compliance assessment effectively.