Functional Risk Assessment

Functional Risk Assessment Template for Switzerland

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Key Requirements PROMPT example:

"I need a Functional Risk Assessment for our new pharmaceutical manufacturing facility in Basel, scheduled to begin operations in March 2025, with particular focus on chemical handling processes and compliance with Swiss GMP requirements."

Document background

The Functional Risk Assessment is a critical document required under Swiss workplace safety regulations to systematically evaluate and address operational risks within organizations. It serves as both a compliance tool and a practical guide for risk management, aligning with Swiss federal laws including the Labor Law (ArG) and Accident Insurance Act (UVG). This document becomes necessary when implementing new processes, modifying existing operations, or as part of regular safety reviews mandated by Swiss regulations. It includes detailed analysis of operational hazards, probability assessments, impact evaluations, and control measures, while considering Swiss-specific legal requirements and industry standards. The assessment helps organizations demonstrate due diligence in risk management while providing a structured approach to maintaining workplace safety and operational efficiency within the Swiss regulatory framework.

Suggested Sections

1. Document Control: Version history, approval status, and document management information

2. Executive Summary: Overview of key findings and critical risks identified

3. Introduction: Purpose, scope, and objectives of the risk assessment

4. Assessment Methodology: Description of the risk assessment approach, scoring criteria, and evaluation methods used

5. System/Process Description: Detailed description of the system, process, or activity being assessed

6. Risk Identification: Comprehensive list of identified risks and their sources

7. Risk Analysis: Detailed analysis of each identified risk, including likelihood and impact assessment

8. Risk Evaluation: Evaluation of risk levels against acceptance criteria

9. Current Control Measures: Description of existing control measures and their effectiveness

10. Risk Treatment Plan: Proposed measures for risk mitigation and implementation timeline

11. Monitoring and Review: Process for ongoing monitoring and periodic review of risks

12. Roles and Responsibilities: Definition of key stakeholders and their responsibilities in risk management

Optional Sections

1. Cost-Benefit Analysis: Financial assessment of proposed risk mitigation measures, used when significant investments are required

2. Environmental Impact Assessment: Analysis of environmental risks and impacts, required when environmental factors are significant

3. Emergency Response Procedures: Detailed emergency protocols, included when dealing with high-risk operations

4. Training Requirements: Specific training needs identified during risk assessment, included when new procedures or equipment are introduced

5. Compliance Matrix: Mapping of assessment against specific regulatory requirements, used for highly regulated industries

6. Stakeholder Consultation: Documentation of consultation process with affected parties, included when multiple parties are impacted

Suggested Schedules

1. Risk Assessment Matrix: Detailed risk scoring matrix and evaluation criteria

2. Risk Register: Complete listing of all identified risks and their characteristics

3. Control Measure Checklist: Detailed checklist of all control measures and their implementation status

4. Action Plan Timeline: Detailed timeline for implementing risk treatment measures

5. Technical Data Sheets: Technical specifications and safety data relevant to the assessment

6. Assessment Tools and Templates: Copies of tools and templates used in the risk assessment process

7. Relevant Certificates and Permits: Copies of relevant safety certificates and operational permits

8. Incident History Log: Historical record of relevant incidents and their outcomes

Authors

Alex Denne

Head of Growth (Open Source Law) @ ��Ƶ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

Relevant legal definitions

Clauses

Relevant Industries

Manufacturing

Chemical Industry

Pharmaceutical

Construction

Healthcare

Transportation

Energy

Financial Services

Technology

Food Processing

Mining

Logistics

Research and Development

Biotechnology

Aerospace

Relevant Teams

Operations

Health and Safety

Quality Assurance

Risk Management

Compliance

Production

Maintenance

Environmental Health

Project Management

Technical Operations

Process Engineering

Facility Management

Legal

Human Resources

Senior Management

Relevant Roles

Risk Manager

Safety Coordinator

Operations Director

Compliance Officer

Quality Assurance Manager

Process Engineer

Facility Manager

Environmental Health and Safety Specialist

Production Manager

Project Manager

Technical Director

Maintenance Supervisor

Chief Operating Officer

Plant Manager

Workplace Safety Officer

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Authors

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