Risk Assessment
European directives place great emphasis on operational diligence (due diligence) and its close link with risk analysis. This approach is particularly relevant across several regulatory fields, including product safety, environmental protection, data protection, and corporate social responsibility.
Risk assessment for products represents a fundamental element to ensure that only safe and efficient goods are placed on the market. Through systematic identification and continuous monitoring of hazards, companies can prevent incidents, improve the quality of their products, and ensure compliance with regulatory requirements. Proper risk management therefore becomes a strategic tool that protects not only consumers but also a company’s reputation and long-term sustainability.
In the context of product design and commercialization, risk assessment is an essential step in the product’s life cycle, requiring careful consideration of the specific characteristics, intended use, and foreseeable use of the product.
1.
Intended Use
Intended use defines a product’s functions, conditions, and users: if the product is used as intended, the risks must be minimized and kept at an acceptable level.
It is also necessary to consider foreseeable misuse and adopt technical and informative preventive measures (protections, limits, warnings), properly documented in the assessment.
Intended Functionality
Every product is designed to perform specific functions; when used correctly, risks should be minimized or reduced to an acceptable level.
Foreseeable or Improper Use
Incidents often occur when a product is used in ways not intended by the manufacturer. It is therefore important to assess and prevent foreseeable misuse.
2.
Risk Assessment Process Steps
The risk assessment process is a structured and traceable cycle: it begins with hazard identification and proceeds to probability and severity analysis (e.g., matrix, FMEA), where criticality levels are prioritized to identify mitigation measures across design, materials, controls, and user information.
The cycle continues with implementation, monitoring, and periodic reviews throughout the product’s life cycle, with updates and improvements based on new data.
Hazard Identification
The first step involves identifying all potential hazards that a product may present. This includes:
- Risks related to the materials used.
- Design or assembly defects.
- Possible misuse of the product by consumers.
- Environmental impacts during the product’s life cycle.
Risk Analysis
Once identified, risks are analyzed in terms of:
- Probability of occurrence.
- Severity of consequences for the user and the environment. Tools such as the risk matrix and FMEA (Failure Mode and Effects Analysis) are used to classify and quantify criticalities.
Evaluation and Prioritization
After analyzing the risks, they are evaluated against specific criteria and prioritized:
- High-impact, high-probability risks require immediate action.
- Minor risks can be monitored or managed with medium- to long-term solutions. This step is crucial to allocate resources effectively and in a targeted manner.
Implementation of Mitigation Measures
For each identified risk, mitigation strategies are developed, which may include:
- Design modifications to the product.
- Use of safer materials.
- Introduction of stricter quality-control systems.
- Clear information and warnings for correct product use.
Monitoring and Review
Risk assessment for products is not a one-off activity. It is necessary to:
- Continuously monitor the product throughout its life cycle.
- Conduct periodic reviews to update safety measures based on new evidence and regulations.
- Gather user feedback to identify any critical issues not detected during the initial analysis.
Customized Risk Assessment for Your Product
We analyze hazards, probability, and severity, define technical and documentary measures, and align the product with EU requirements — reducing non-compliance risks and time to market.