The Quality Risk Assessment SOP serves as a crucial document for organizations operating in regulated industries within Nigeria. It is designed to ensure compliance with NAFDAC requirements while incorporating international best practices in quality risk management. This document becomes essential when organizations need to systematically identify, assess, and control quality-related risks in their operations. The SOP includes detailed procedures for risk identification, analysis, evaluation, and control, along with specific documentation requirements and responsibilities. It is particularly relevant for organizations seeking to maintain compliance with Nigerian regulatory frameworks while implementing robust quality management systems. The document takes into account local regulatory requirements, international standards like ICH Q9, and industry best practices, making it suitable for both local Nigerian operations and international organizations operating within Nigeria.
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1. Purpose: Clear statement of the SOP's objective in establishing a systematic approach to quality risk assessment
2. Scope: Defines the boundaries of the SOP, including applicable processes, products, and departments
3. Definitions: Detailed definitions of technical terms, risk-related terminology, and abbreviations used in the document
4. Responsibilities: Defines roles and responsibilities of all personnel involved in risk assessment processes
5. Risk Assessment Procedure: Step-by-step methodology for identifying, analyzing, and evaluating risks
6. Risk Control: Procedures for risk reduction, mitigation strategies, and acceptance criteria
7. Documentation Requirements: Specifies required records, forms, and documentation procedures
8. Review and Monitoring: Procedures for periodic review of risk assessments and monitoring of control measures
9. Training Requirements: Specifies training needs for personnel involved in risk assessment activities
1. Risk Communication: Procedures for communicating risk-related information to stakeholders. Include when organization has multiple departments or external stakeholders
2. Change Management: Procedures for managing changes that affect risk assessments. Include for complex operations or when frequent process changes occur
3. Emergency Response: Procedures for handling urgent risk situations. Include for high-risk operations or when handling dangerous materials
4. Vendor Management: Risk assessment procedures for suppliers and contractors. Include when external vendors are critical to operations
5. Computer System Validation: Procedures for validating software used in risk assessment. Include when using specialized risk assessment software
1. Risk Assessment Matrix Template: Standard template for risk evaluation including severity, probability, and detectability scales
2. Risk Register Template: Template for documenting and tracking identified risks and their controls
3. FMEA Template: Failure Mode and Effects Analysis template for detailed risk analysis
4. Risk Assessment Report Template: Standard format for documenting complete risk assessment results
5. Review Checklist: Checklist for periodic review of risk assessments
6. Training Record Template: Template for documenting risk assessment training completion
7. Risk Control Plan Template: Template for documenting risk control measures and their implementation
Authors
Relevant legal definitions
Clauses
Relevant Industries
Pharmaceutical Manufacturing
Food and Beverage Production
Medical Device Manufacturing
Biotechnology
Chemical Manufacturing
Cosmetics Manufacturing
Healthcare Services
Contract Research Organizations
Clinical Research
Agricultural Products Processing
Relevant Teams
Quality Assurance
Quality Control
Regulatory Affairs
Operations
Production
Research & Development
Validation
Documentation
Compliance
Manufacturing
Laboratory Services
Process Engineering
Relevant Roles
Quality Assurance Manager
Quality Control Supervisor
Regulatory Affairs Director
Compliance Officer
Production Manager
Operations Director
Risk Management Specialist
Quality Systems Analyst
Validation Engineer
Quality Auditor
Manufacturing Manager
Laboratory Manager
Process Engineer
Documentation Specialist
Training Coordinator
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