Risk Analyses

Risk analysis is one of the most important steps in ensuring product safety.

Risk analysis identifies the hazards associated with a product, machine or device, evaluates their severity and likelihood, and defines the measures required to reduce risk. The analysis covers the entire product lifecycle, from transportation and installation through operation, maintenance and end-of-life disposal.

At Revismo, we treat risk analysis as an integral part of product development rather than simply a mandatory document. Conducting the analysis early helps support sound engineering decisions, reduce residual risks and ensure the product is suitable for its intended use while meeting safety requirements and applicable regulations.

Problems that can be avoided

Unidentified hazards
Inadequate safety measures
Accidents caused by foreseeable misuse
Insufficient warnings
Non-compliant products
Costly late-stage redesigns
Safety issues discovered during production
Incomplete CE documentation

Why choose Revismo for risk analysis?

A comprehensive approach to product safety

Our risk analyses are based on how the product, machine or device actually operates and is intended to be used. We evaluate risks throughout the entire lifecycle, from transportation and installation to operation, maintenance and disposal.

An engineering-driven methodology

Risk analysis is more than identifying hazards and completing checklists. Our engineers evaluate how the product’s design, control systems, operating methods and environmental conditions influence safety, allowing us to recommend the most effective engineering controls for reducing risk.

Practical risk reduction measures

The outcome is more than a list of identified risks. We provide practical recommendations to eliminate or reduce them. These may include design modifications, safety guards, protective functions, control system improvements, warnings or updates to the user manual.

Addressing risks early in development

Risks are most effectively reduced while the product is still being developed, when engineering decisions can still be changed. An early risk analysis helps prevent costly redesigns, inconsistencies in technical documentation and safety issues that might otherwise appear during production or operation.

Integrated with CE compliance and technical documentation

Risk analysis is an essential part of CE compliance and the technical documentation for many products. We identify the applicable requirements and prepare the analysis so it aligns with the rest of the technical file and the overall conformity assessment process.

Risk analysis workflow

1

Collecting project information

We begin by gathering the technical information required for the analysis. This may include engineering drawings, CAD models, photographs, operating cycle descriptions, automation concepts and information about the intended operating environment. Any missing details are clarified together with the client.

2

Defining product functions and use cases

We identify the product’s functions and analyse activities related to transportation, installation, operation, setup, cleaning, maintenance and troubleshooting. This helps determine where users or other people may be exposed to potential hazards.

3

Hazard identification

We identify mechanical, electrical, ergonomic and other potential hazards. Each hazard is linked to specific operating stages, use scenarios and reasonably foreseeable misuse.

4

Risk evaluation

Each identified hazard is evaluated based on the severity of its potential consequences and the likelihood of occurrence. This provides a structured basis for prioritising which risks require additional mitigation measures.

5

Defining risk reduction measures

We recommend technically justified measures to eliminate or reduce identified risks. Following recognised safety principles, we prioritise inherently safe design solutions, followed by protective measures and safety functions, with warnings, user instructions and administrative controls applied where necessary.

6

Residual risk evaluation and documentation

After risk reduction measures have been implemented, we evaluate any remaining residual risks and determine what safety information should be included on the product or in the user manual. All project data, risk evaluations, mitigation measures and conclusions are compiled into a clear technical document suitable for CE compliance and internal safety documentation.

Why risk analysis should never be overlooked

Risk analysis is one of the fundamental tools of product and machine safety. Its purpose is not only to document known hazards but also to systematically evaluate how a product may behave in different operating conditions and determine the engineering and organisational measures needed to reduce risk.

For many CE-marked products, risk analysis is an essential part of conformity assessment and the technical documentation. It demonstrates that potential hazards have been identified, appropriate safety measures have been implemented and users have been informed about any remaining residual risks. Without a comprehensive risk analysis, the product design, user manual and supporting technical documentation may fail to accurately reflect the actual safety risks.

The greatest value of risk analysis comes when it is carried out early in the product development process. Hazards identified at this stage can often be eliminated through improvements to the design, control system or operating concept before prototyping and manufacturing begin. Addressing the same issues later typically requires more engineering effort, higher costs and modifications to products that have already been built.

If anything is still unclear

A risk analysis is required both during the development of new products and for existing products or machinery that are modified, upgraded or reintroduced to the market. In addition, a risk analysis is a mandatory part of CE technical documentation.
The purpose of a risk analysis is to identify potential hazards associated with a product or machine, evaluate their severity and likelihood and define appropriate risk reduction measures. This helps ensure safe operation and compliance with applicable European Union requirements.
A risk analysis is a mandatory component of CE documentation. It demonstrates that product safety has been evaluated, risks have been reduced to an acceptable level and the product complies with applicable legislation and standards. Without a properly completed risk analysis, CE marking cannot be legitimately applied.

The time required to complete a risk analysis depends primarily on the complexity of the product, machine or system being analysed. For simpler equipment, hazards and mitigation measures can usually be assessed relatively quickly and the analysis is typically completed within 1–2 days.

For more complex machinery, production lines or IoT solutions, both the number of risk scenarios and the required level of detail increase significantly. In these cases, a risk analysis may take between 1 and 4 weeks, depending on the number of functions, integrated technologies and the required scope of documentation.

A risk analysis requires as much technical information as possible about the product or system being analysed. This typically includes 3D models, technical drawings, lists of functions, descriptions of operating cycles and use scenarios, automation logic, information about the operating environment and details of potential hazards. If some of the required information is unavailable, we work together with the client to identify and define the missing inputs.

Yes. Revismo performs risk analyses for both newly developed products and machinery or equipment already in operation. We assess both modern solutions and older machines where documentation may be incomplete, outdated or unavailable.

For existing machinery, a risk analysis helps identify deficiencies that may affect safety, reliability or compliance with current requirements. Where necessary, we provide recommendations for improvements that enhance safety and support the continued operation of the equipment.

Yes. Every risk analysis includes a clear list of recommended actions to reduce identified risks. These may include mechanical safeguarding, functional safety solutions, operating instructions, training requirements or technical modifications designed to improve the overall safety of the product or machine.

Identify risks before they become hazards

The earlier risks are identified, the easier and more cost-effective they are to reduce. Contact us to discuss your product’s safety, identify potential risks and define the next steps.

Risk analyses. Revismo

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