The Quality Risk Assessment SOP serves as a foundational document for organizations operating in regulated industries within the Philippines. It is specifically designed to meet the requirements of the Philippine FDA while incorporating international best practices. This SOP should be implemented when organizations need to establish or update their quality risk management processes, particularly in response to regulatory requirements, operational changes, or quality improvement initiatives. The document provides detailed procedures for risk identification, analysis, and control, ensuring compliance with Philippine GMP guidelines and international standards. It includes specific templates, tools, and methodologies for conducting risk assessments, making it essential for organizations seeking to maintain regulatory compliance and operational excellence in quality management.
Your data doesn't train Genie's AI
You keep IP ownership of your information
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
OR
Let Ƶ's market-leading legal AI identify missing terms, unusual language, compliance issues and more - in just seconds.
1. Purpose: Defines the objective of the SOP in establishing a systematic approach to quality risk assessment
2. Scope: Specifies what operations, products, processes and departments are covered by this SOP
3. References: Lists all relevant regulations, guidelines and related internal procedures
4. Definitions: Defines key terms used in the SOP including risk-related terminology
5. Responsibilities: Outlines roles and responsibilities of different personnel involved in risk assessment
6. Risk Assessment Process: Details the systematic process for identifying, analyzing and evaluating risks
7. Risk Control: Describes methods for risk reduction, mitigation and acceptance criteria
8. Documentation Requirements: Specifies how risk assessments should be documented and maintained
9. Review and Monitoring: Establishes the frequency and process for reviewing risk assessments
10. Training Requirements: Specifies training requirements for personnel involved in risk assessment
1. Risk Communication: Section detailing how risk-related information should be communicated to stakeholders - include when communication is a critical aspect of operations
2. Emergency Response: Section for handling urgent risk situations - include for high-risk operations or when dealing with hazardous materials
3. Vendor Risk Assessment: Section specific to assessing supplier-related risks - include when supplier quality has significant impact
4. Computer System Validation: Section for risk assessment of computerized systems - include when using electronic quality management systems
5. Environmental Risk Considerations: Section for environmental impact assessment - include when operations have significant environmental aspects
1. Risk Assessment Matrix: Template for risk evaluation showing severity, probability and detectability scales
2. Risk Assessment Form Template: Standardized form for documenting risk assessments
3. Risk Register Template: Template for maintaining a log of identified risks and their status
4. Risk Control Plan Template: Template for documenting risk control measures and their implementation
5. FMEA Template: Failure Mode and Effects Analysis template for detailed risk analysis
6. Risk Assessment Examples: Sample completed risk assessments for reference
7. Risk Assessment Checklist: Checklist for ensuring completeness of risk assessment process
Relevant legal definitions
Clauses
Relevant Industries
Pharmaceuticals
Healthcare
Medical Devices
Biotechnology
Food and Beverages
Cosmetics
Contract Manufacturing
Clinical Research
Chemical Manufacturing
Healthcare Technology
Relevant Teams
Quality Assurance
Regulatory Affairs
Production
Research and Development
Manufacturing
Validation
Compliance
Technical Operations
Quality Control
Process Excellence
Relevant Roles
Quality Assurance Manager
Quality Control Supervisor
Regulatory Affairs Director
Production Manager
Validation Specialist
Quality Systems Specialist
Risk Management Coordinator
Compliance Officer
Operations Director
Quality Auditor
Technical Operations Manager
Product Development Manager
Manufacturing Engineer
Quality Management Representative
GMP Compliance Specialist
Find the exact document you need
Risk Assessment Summary
A comprehensive risk evaluation and analysis document compliant with Philippine regulations, assessing organizational risks and providing mitigation strategies.
Download
Manual Handling Risk Assessment Form
A structured risk assessment form for manual handling operations, compliant with Philippine OSHS and DOLE regulations, designed to identify and control workplace manual handling risks.
Download
Hospital Compliance Risk Assessment
A regulatory compliance and risk assessment document for hospitals in the Philippines, aligned with DOH and PhilHealth requirements.
Download
Bia Risk Assessment
A comprehensive risk assessment document that evaluates business impacts and risks under Philippine law, providing structured analysis and mitigation strategies.
Download
Employee Risk Assessment
A mandatory workplace safety assessment document under Philippine labor laws that identifies and evaluates occupational hazards and establishes control measures.
Download
Risk Assessment For Welding Works
A Philippine-compliant risk assessment document for welding operations, aligned with RA 11058 and DOLE requirements, detailing hazards, controls, and safety protocols.
Download
Museum Risk Assessment
A comprehensive museum risk assessment document aligned with Philippine cultural heritage regulations and safety standards.
Download
Local Risk Assessment
A mandatory risk evaluation and management document under Philippine regulations that identifies, analyzes, and provides mitigation strategies for operational and environmental hazards.
Download
Risk Assessment For Churches
A Philippine-compliant risk assessment framework for churches, addressing operational, safety, and structural risks while meeting local regulatory requirements.
Download
Abrasive Wheels Risk Assessment
A risk assessment document for abrasive wheel operations, compliant with Philippine DOLE regulations and safety standards.
Download
Hazard And Risk Assessment Form
A Philippine-compliant workplace safety assessment tool for identifying hazards, evaluating risks, and establishing control measures under DOLE regulations.
Download
Risk Assessment Policy
A Risk Assessment Policy document compliant with Philippine regulations, establishing procedures for systematic risk identification, evaluation, and management.
Download
Liquidity Risk Assessment
A regulatory-compliant assessment of a financial institution's liquidity risk profile and management framework under Philippine banking laws and BSP requirements.
Download
Mobile Catering Risk Assessment
A risk assessment template for mobile catering operations in the Philippines, ensuring compliance with food safety regulations while addressing operational and environmental hazards.
Download
Information Technology Risk Assessment
A Philippine law-governed agreement for conducting IT risk assessments, ensuring compliance with local data privacy and cybersecurity regulations while following international security standards.
Download
Information Security Risk Assessment Report
A detailed assessment of an organization's information security risks and recommended controls, compliant with Philippine data protection and cybersecurity regulations.
Download
Emergency Response Risk Assessment
A Philippine-compliant Emergency Response Risk Assessment document analyzing potential hazards and response capabilities while meeting local regulatory requirements.
Download
Continuous Risk Assessment
A comprehensive continuous risk assessment framework aligned with Philippine regulations, providing systematic guidelines for ongoing risk identification, assessment, and management.
Download
Client Risk Assessment Questionnaire
A Philippine-compliant risk assessment tool for financial institutions to evaluate client risk profiles and ensure regulatory compliance with BSP and SEC requirements.
Download
Business Risk Assessment
A comprehensive business risk assessment document that evaluates potential business risks and mitigation strategies in compliance with Philippine regulatory requirements.
Download
Risk Management Audit Report
A formal evaluation of an organization's risk management framework and controls under Philippine regulations, providing findings and recommendations for improvement.
Download
Risk Assessment Science Experiment
A Philippine-compliant risk assessment framework for scientific experiments, incorporating local regulatory requirements and safety protocols.
Download
Risk Maturity Assessment Report
A comprehensive evaluation of an organization's risk management capabilities and frameworks, aligned with Philippine regulatory requirements and industry best practices.
Download
Risk Assessment Matrix Oil And Gas
A risk assessment matrix for oil and gas operations in the Philippines, ensuring compliance with local regulations while following industry best practices.
Download
Quality Risk Assessment SOP
A comprehensive SOP for quality risk assessment that complies with Philippine FDA regulations and international standards, providing systematic risk management guidelines for regulated industries.
Download
Risk Assessment Plan For (Construction)
A legally compliant construction risk assessment plan under Philippine regulations that outlines procedures for identifying, evaluating, and controlling construction-related hazards.
Download
Rapid Risk Assessment
A structured risk evaluation document compliant with Philippine regulations that identifies, assesses, and provides mitigation strategies for potential hazards and risks.
Download
Home Risk Assessment
A Philippine-law governed agreement for professional home risk assessment services, detailing assessment scope, methodologies, and obligations of all parties.
Download
Government Risk Assessment
A comprehensive risk assessment framework for Philippine government agencies, aligned with national regulatory requirements and public sector governance standards.
Download
Building Risk Assessment
A detailed evaluation of building-related risks and safety compliance measures under Philippine regulations, providing risk analysis and mitigation recommendations.
Download
Risk Self Assessment
A comprehensive risk evaluation document compliant with Philippine regulations, used for identifying and managing organizational risks.
Download
Risk And Control Assessment
A structured evaluation of organizational risks and controls compliant with Philippine regulatory requirements and corporate governance standards.
Download
Program Risk Assessment
A comprehensive risk assessment document for program implementation that complies with Philippine regulatory requirements and risk management frameworks.
Download
Dance Risk Assessment
A Philippine-compliant risk assessment document for dance activities, outlining safety measures and emergency protocols under local regulations.
Download
Smoking Risk Assessment
A structured evaluation of smoking-related workplace risks and control measures, compliant with Philippine tobacco control and safety regulations.
Download
Plant And Equipment Risk Management Form
A Philippine-compliant risk management form for assessing and controlling hazards associated with industrial plant and equipment operations.
Download
Patient Manual Handling Risk Assessment
A Philippine-compliant risk assessment document for evaluating and managing patient manual handling risks in healthcare settings, aligned with DOLE regulations.
Download
Machine Guarding Risk Assessment
A technical assessment document for evaluating machinery safety and guarding measures in compliance with Philippine DOLE regulations and safety standards.
Download
IT Security Assessment Report
A technical evaluation document assessing an organization's IT security posture and compliance with Philippine cybersecurity and data protection regulations.
Download
Field Level Hazard Assessment
A workplace safety assessment document required under Philippine law for identifying and controlling field-level hazards before commencing work activities.
Download
ұԾ’s Security Promise
Genie is the safest place to draft. Here’s how we prioritise your privacy and security.
Your documents are private:
We do not train on your data; ұԾ’s AI improves independently
All data stored on Genie is private to your organisation
Your documents are protected:
Your documents are protected by ultra-secure 256-bit encryption
We are ISO27001 certified, so your data is secure
Organizational security:
You retain IP ownership of your documents and their information
You have full control over your data and who gets to see it
.png)