Technical Risk Assessment

Technical Risk Assessment Template for Switzerland

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Key Requirements PROMPT example:

"I need a Technical Risk Assessment for our new pharmaceutical manufacturing facility in Basel, Switzerland, with particular focus on automated production lines and compliance with GMP requirements, to be completed by March 2025."

Document background

A Technical Risk Assessment is a crucial document required by Swiss regulations for organizations operating technical systems, processes, or facilities that could pose potential risks to safety, environment, or operations. This document is typically required when implementing new technical systems, making significant modifications to existing systems, or as part of regular safety reviews mandated by Swiss authorities. The assessment must comply with Swiss federal laws including the THG, UVG, and relevant cantonal regulations, while also considering international standards. The document provides a structured analysis of technical risks, their potential impacts, and detailed mitigation strategies, serving as both a compliance document and a practical tool for risk management. It's particularly important in regulated industries and helps organizations demonstrate due diligence in risk management to authorities, insurers, and stakeholders.

Suggested Sections

1. Executive Summary: High-level overview of the assessment's key findings, major risks identified, and critical recommendations

2. 1. Introduction: Purpose of the assessment, scope, methodology used, and assessment context

3. 2. System Description: Detailed description of the technical system, process, or facility being assessed, including operational parameters and boundaries

4. 3. Regulatory Framework: Overview of applicable Swiss regulations, standards, and compliance requirements

5. 4. Risk Assessment Methodology: Detailed explanation of risk assessment approach, criteria for risk evaluation, and assessment tools used

6. 5. Risk Identification: Comprehensive list and description of identified risks, including potential hazards and their sources

7. 6. Risk Analysis: Detailed analysis of each identified risk, including likelihood and consequence assessments

8. 7. Risk Evaluation: Evaluation of analyzed risks against established criteria, risk prioritization, and risk level determination

9. 8. Risk Treatment Recommendations: Specific measures and controls recommended to address identified risks

10. 9. Implementation Plan: Proposed timeline and approach for implementing risk treatment measures

11. 10. Monitoring and Review: Procedures for ongoing monitoring of risks and periodic review of assessment

Optional Sections

1. Cost-Benefit Analysis: Detailed analysis of the costs associated with recommended risk treatments versus potential benefits, used when significant investment decisions are required

2. Environmental Impact Assessment: Assessment of environmental risks and impacts, included when the technical system has potential environmental implications

3. Data Protection Impact Assessment: Evaluation of data protection risks, included when the technical system processes personal data

4. Business Continuity Considerations: Analysis of business continuity implications, included for critical systems or processes

5. Security Assessment: Detailed security risk analysis, included when cybersecurity or physical security is a significant concern

6. Stakeholder Analysis: Analysis of stakeholder interests and impacts, included for projects with significant external stakeholder involvement

Suggested Schedules

1. Appendix A: Risk Assessment Matrices: Detailed risk matrices showing likelihood and consequence ratings for all identified risks

2. Appendix B: Technical Specifications: Detailed technical specifications of systems, equipment, or processes assessed

3. Appendix C: Testing and Validation Results: Results of any testing or validation procedures conducted during the assessment

4. Appendix D: Compliance Checklist: Detailed checklist showing compliance status with relevant Swiss regulations and standards

5. Appendix E: Risk Register: Comprehensive register of all identified risks, including tracking information

6. Appendix F: Assessment Tools and Methods: Detailed description of tools, methods, and calculations used in the assessment

7. Appendix G: Photo Documentation: Photographic evidence and documentation of physical inspections

8. Appendix H: Interview Protocols: Records of interviews and consultations conducted during the assessment

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

Pharmaceutical

Chemical Industry

Energy and Utilities

Transportation and Logistics

Healthcare

Information Technology

Construction

Mining and Resources

Food Processing

Aerospace

Telecommunications

Industrial Automation

Research and Development

Environmental Services

Relevant Teams

Risk Management

Technical Operations

Health and Safety

Compliance

Quality Assurance

Engineering

Operations

Maintenance

Project Management

Environmental Management

Legal

Internal Audit

Research and Development

Relevant Roles

Risk Manager

Technical Director

Safety Officer

Compliance Manager

Operations Manager

Chief Technical Officer

Quality Assurance Manager

Environmental Health and Safety Manager

Process Engineer

Facility Manager

Maintenance Manager

Project Manager

Chief Risk Officer

Industrial Safety Specialist

Technical Safety Expert

Regulatory Affairs Manager

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Authors

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