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New Product Risk Assessment

New Product Risk Assessment Template for Austria

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Key Requirements PROMPT example:

New Product Risk Assessment

"I need a New Product Risk Assessment for our new smart home security system launching in Austria in March 2025, with particular focus on data privacy risks and electromagnetic compatibility compliance."

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Document background
The New Product Risk Assessment is a critical document required before introducing new products to the Austrian market, designed to identify and evaluate potential risks associated with product design, manufacturing, and usage. This assessment is mandated under Austrian law, particularly the Product Safety Act (Produktsicherheitsgesetz), and must comply with relevant EU directives and standards. The document includes comprehensive analysis of potential hazards, risk evaluation matrices, compliance verification with applicable standards, and detailed risk mitigation strategies. It serves as essential documentation for product safety compliance, liability protection, and market authorization purposes. The assessment should be conducted during the product development phase and updated as necessary based on new information or product modifications.
Suggested Sections

1. 1. Executive Summary: Brief overview of the assessment findings, key risks identified, and main recommendations

2. 2. Product Information: Detailed description of the product, including specifications, intended use, target market, and technical characteristics

3. 3. Assessment Methodology: Description of the risk assessment approach, standards applied, and evaluation criteria used

4. 4. Regulatory Framework: Overview of applicable regulations, standards, and compliance requirements in Austria and the EU

5. 5. Hazard Identification: Comprehensive list and analysis of potential hazards associated with the product

6. 6. Risk Analysis: Detailed assessment of identified risks, including probability and severity evaluations

7. 7. Risk Evaluation: Analysis of risk levels and their acceptability according to defined criteria

8. 8. Risk Control Measures: Proposed measures to eliminate or minimize identified risks

9. 9. Conclusions and Recommendations: Summary of findings and specific recommendations for risk mitigation

Optional Sections

1. Chemical Safety Assessment: Detailed analysis of chemical risks when the product contains or involves chemical substances

2. Environmental Impact Analysis: Assessment of environmental risks when the product may have significant environmental implications

3. Electromagnetic Compatibility Assessment: For electronic products, analysis of EMC-related risks

4. Supply Chain Risk Analysis: Assessment of risks related to the supply chain when complex manufacturing or distribution is involved

5. Child Safety Assessment: Additional safety considerations when the product may be accessible to children

6. Professional Use Considerations: Specific risk assessment for products intended for professional/industrial use

7. Post-Market Surveillance Plan: When ongoing monitoring of product safety is required

Suggested Schedules

1. Appendix A: Technical Specifications: Detailed technical documentation including drawings, specifications, and materials

2. Appendix B: Test Reports: Results and certificates from safety testing and performance evaluations

3. Appendix C: Risk Assessment Matrices: Detailed risk scoring matrices and evaluation criteria

4. Appendix D: Compliance Checklist: Checklist of all applicable regulatory requirements and compliance status

5. Appendix E: Photo Documentation: Photographs and visual documentation of the product and its components

6. Appendix F: Safety Data Sheets: Material safety data sheets for any chemical components or materials

7. Appendix G: User Instructions Review: Analysis of user manual, warnings, and instructions for adequacy

Authors

Alex Denne

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

Linkedin in social icon imageX social icon image
alex.den.21@genieai.co
Relevant legal definitions
Acceptable Risk
Assessment Date
Authorized Representative
Compliance Requirements
Control Measure
Corrective Action
End User
Essential Requirements
Foreseeable Misuse
Harm
Hazard
Hazard Identification
Intended Use
Life Cycle
Manufacturer
Mitigation Measure
Notified Body
Product
Product Category
Product Safety
Protective Measure
Reasonably Foreseeable Use
Residual Risk
Risk
Risk Analysis
Risk Assessment
Risk Category
Risk Control
Risk Evaluation
Risk Level
Risk Management
Risk Matrix
Safety Factor
Severity
State of the Art
Technical Documentation
Technical File
User Group
Validation
Verification
Clauses
Product Identification
Scope of Assessment
Regulatory Compliance
Risk Assessment Methodology
Hazard Identification
Safety Requirements
Technical Specifications
Testing Procedures
Risk Analysis
Risk Evaluation
Risk Control Measures
Product Documentation
Quality Control
Safety Standards
Conformity Assessment
Market Surveillance
Emergency Procedures
Liability Provisions
Certification Requirements
User Safety
Environmental Impact
Manufacturing Controls
Post-Market Monitoring
Product Modifications
Documentation Requirements
Verification Procedures
Validation Requirements
Relevant Industries

Manufacturing

Consumer Electronics

Medical Devices

Chemical Industry

Automotive

Consumer Goods

Industrial Equipment

Food and Beverage

Pharmaceuticals

Telecommunications

Construction Materials

Toys and Children's Products

Relevant Teams

Product Development

Quality Assurance

Regulatory Affairs

Legal

Research and Development

Manufacturing

Safety and Compliance

Technical Operations

Risk Management

Product Management

Relevant Roles

Product Safety Manager

Quality Assurance Director

Risk Assessment Specialist

Compliance Officer

Product Development Manager

Technical Director

Safety Engineer

Regulatory Affairs Manager

Quality Control Supervisor

Product Manager

Manufacturing Manager

Research and Development Director

Legal Counsel

Operations Manager

Chief Technical Officer

Industries
Product Safety Act 2004 (Produktsicherheitsgesetz): The main Austrian legislation governing product safety requirements, conformity assessment procedures, and market surveillance obligations
General Product Safety Directive 2001/95/EC: EU directive implemented in Austrian law that establishes general safety requirements for consumer products and related risk assessment procedures
Austrian Consumer Protection Act (Konsumentenschutzgesetz): Governs consumer rights and business obligations regarding product safety, information requirements, and liability
Risk Assessment Guidelines EN ISO 14971: European standard for risk management systems and risk assessment methodologies, particularly important for product safety evaluation
Austrian Standards Act (Normengesetz): Establishes the framework for technical standards and conformity assessment in Austria
Product Liability Act (Produkthaftungsgesetz): Defines liability requirements and obligations related to product defects and safety issues
Trade Regulation Act (Gewerbeordnung): Contains specific requirements for business operations and product-related services in Austria
RAPEX Guidelines: EU guidelines for risk assessment that must be considered when evaluating product safety and reporting serious risks
Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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