Key takeaways:
The article discusses the steps of risk assessment in accordance with EN ISO 12100 and the risk reduction methods used in the design and operation of machinery, including in the CE context.
- EN ISO 12100 describes a systematic risk analysis process: hazard identification, risk estimation and evaluation, and risk reduction.
- The standard is harmonized with the Machinery Directive 2006/42/EC and supports a consistent approach to machinery safety.
- The scope covers the machine’s entire life cycle: design, manufacture, use, modifications, and decommissioning.
- The risk assessment process begins by defining the machine’s limits (intended use, operating conditions, users).
- Risk reduction includes design solutions, technical measures (guards, interlocks, emergency stop), and procedures and PPE, with a requirement for documentation.
Machine safety is a critical aspect of any industrial operation, where risks associated with machine use can lead to serious consequences for both employees and the business itself. Risk assessment according to EN ISO 12100 is the primary tool for evaluating and minimizing risks related to the use of machinery. This standard provides guidance for machine designers, manufacturers, and users, ensuring a consistent approach to safety-related issues. In this article, we take a detailed look at the risk assessment process under EN ISO 12100, its importance, and its practical applications across different industries.
Fundamentals of risk assessment according to EN ISO 12100
Definition of risk assessment
Risk assessment according to EN ISO 12100 is a systematic process of identifying hazards, estimating risk, and taking measures to reduce it to an acceptable level. This process includes analyzing potential sources of hazards and assessing their consequences and likelihood of occurrence. EN ISO 12100 is one of the most important harmonized standards under the Machinery Directive 2006/42/EC.
Key elements of EN ISO 12100
EN ISO 12100 defines the basic terminology, principles, and methodology for achieving safety at the machine design stage. The key elements of this standard include:
- Machine safety terminology.
- Principles for designing safe machinery.
- Methods for hazard identification and risk assessment.
- Guidance on documenting and verifying the risk assessment.
Scope of the standard and its application
EN ISO 12100 applies throughout the entire life cycle of a machine, from design and manufacturing to use and decommissioning. It covers both new and modernized machinery, providing a consistent approach to risk assessment and risk reduction.
Risk assessment according to EN ISO 12100: the risk assessment process
Step 1: Define the limits of the machine
The first step in the risk assessment process according to EN ISO 12100 is to define the limits of the machine, including its intended use, operating conditions, and users. It is important to consider all aspects that may affect safety, such as:
- Foreseeable operating conditions.
- User requirements.
- Environmental conditions.
Step 2: Hazard identification
The next step is hazard identification according to ISO 12100 related to the use of the machine. This process includes analyzing all potential sources of hazards, including mechanical, electrical, ergonomic, and work-environment-related hazards.
Step 3: Risk estimation
Risk estimation involves assessing the likelihood of a specific hazardous event occurring and its potential consequences. This is a key stage that makes it possible to determine which hazards require further action. For more detail, see risk estimation according to ISO 12100.
Step 4: Risk evaluation
Based on the results of risk estimation, risk evaluation is carried out to determine whether additional protective measures are necessary. The goal is to reduce risk to an acceptable level.
Risk reduction according to EN ISO 12100
Methods of risk reduction
Risk can be reduced by applying various methods, such as:
- Using inherently safe design solutions.
- Implementing technical protective measures.
- Developing and implementing operating procedures and instructions for use.
Protective measures applied by the designer
Machine designers should aim to eliminate hazards as early as the design stage by taking ergonomic principles into account and using appropriate technologies and materials. Under EN ISO 12100, designers are required to document all activities related to risk assessment and risk reduction.
Technical protective measures
Technical protective measures, such as guards, interlocks, and emergency stop systems, are key elements in ensuring machine safety. Their proper design and implementation can significantly reduce the risks associated with machine use.
Practical application of the standard across different industries
In industrial automation, risk assessment according to EN ISO 12100 is essential for ensuring the safe and efficient operation of automated systems. This process includes assessing risks associated with industrial robots, conveying systems, and other automation equipment.
Design office and machine design
Design offices use EN ISO 12100 to design machines that meet the highest safety standards. Risk analysis is an integral part of the design process, making it possible to identify and eliminate potential hazards at an early stage.
CE certification of machinery and adaptation to minimum requirements
CE certification of machinery requires a detailed risk analysis in accordance with EN ISO 12100. This process ensures that machines meet the minimum requirements of EU directives such as the Machinery Directive 2006/42/EC, which is essential for CE marking.
Use of risk analysis in safety audits
The role of safety audits
A safety audit is a process for assessing whether machines comply with applicable standards and regulations. Risk analysis in accordance with EN ISO 12100 is a key part of the audit, enabling the identification and elimination of potential hazards.
Implementing EN ISO 12100 in audits
As part of safety audits, EN ISO 12100 is used to assess risk and define the necessary corrective actions. Industries where audits are particularly important include the food, chemical, and automotive sector.
Project management and engineering outsourcing
Risk management in project management
In project management, risk analysis in accordance with EN ISO 12100 is a key part of risk management. This process includes identifying potential hazards at different stages of the project and implementing measures to minimize them. It is also an excellent tool that complements overall project risk analysis.
Engineering outsourcing and risk analysis
Engineering outsourcing is becoming an increasingly popular solution in the engineering sector. Outsourcing companies that provide design and risk analysis services use EN ISO 12100 to ensure that projects comply with the highest safety standards.
Strength calculations (FEA) and their role in risk analysis
Introduction to strength calculations (FEA)
Strength calculations, also known as FEA (Finite Element Analysis), are a key tool in risk assessment. FEA makes it possible to analyze the structural strength of machines and components, helping to identify potential failure points and hazards.
The importance of FEA in risk assessment and risk reduction
FEA plays a key role in the risk analysis process under EN ISO 12100, enabling accurate modeling and simulation of machine behavior under different loads. This makes it possible to effectively predict and minimize the risk of failure and the related hazards.
Risk evaluation methods
In the risk analysis process under EN ISO 12100, one of the key stages is risk evaluation, which makes it possible to assess whether the level of risk is acceptable and whether additional risk reduction measures are required. One popular risk evaluation method is the Risk Score method. It involves assigning numerical values to different aspects of risk, such as:
- Severity of harm (Severity) – assesses the potential impact of the hazard on human health and life.
- Probability of occurrence (Probability) – assesses how often a given hazard may occur.
- Detectability (Detectability) – assesses how easily the hazard can be detected before it causes harm.
These values are then multiplied to produce the so-called risk score, which makes it possible to compare different hazards and set priorities for actions aimed at reducing risk. This method is particularly useful in project management and as part of safety audits, enabling a systematic and objective approach to risk evaluation.
Example of applying the Risk Score method:
Assume that a machine used in a production process may cause cutting injuries to the operator. To assess the risk associated with this hazard, we apply the Risk Score method.
- Severity: If a cutting injury could result in serious harm, we assign a value of 4 (on a scale from 1 to 5, where 1 means minor injury and 5 means fatal injury).
- Probability: If such injuries occur relatively often, we assign a value of 3 (on a scale from 1 to 5, where 1 means very low probability and 5 means very high probability).
- Detectability: If the hazard is difficult to detect and may only be noticed after an injury has occurred, we assign a value of 2 (on a scale from 1 to 5, where 1 means very easy to detect and 5 means very difficult).
We calculate the risk score:
Risk Score = Severity × Probability × Detectability
Risk Score = 4 × 3 × 2 = 24
Based on the result of 24, we can conclude that the risk is significant and requires appropriate protective measures, such as machine guards, operator training, and regular safety audits.
Summary and conclusions
Key conclusions from risk analysis according to EN ISO 12100
Risk analysis according to EN ISO 12100 is an essential tool for ensuring machine safety throughout the machine lifecycle. This process enables the systematic identification of hazards according to ISO 12100, risk assessment, and implementation of measures aimed at reducing risk.
The importance of the standard for machine safety
EN ISO 12100 provides the foundation for designers, manufacturers, and users of machines and production lines, ensuring a consistent approach to safety-related issues. It makes it possible to design machines that meet the highest safety standards and comply with legal requirements.
Recommendations for companies
Companies should regularly carry out risk assessment according to ISO 12100 and implement appropriate protective measures. It is also important that employees are properly trained and aware of the hazards associated with machine use. This makes it possible to ensure safe working conditions and minimize the risk of accidents and failures.
Risk analysis in accordance with EN ISO 12100
It is a systematic process of identifying hazards, estimating risk, and selecting measures to reduce risk to an acceptable level. It includes assessing the consequences and likelihood of hazardous events.
The standard is intended for machine designers, manufacturers, and users. It provides a consistent approach to safety at the design stage and throughout the machine’s entire lifecycle.
The process includes defining the machine’s limits, identifying hazards, estimating risk, and evaluating it. On this basis, a decision is made on whether additional protective measures are needed.
Inherently safe design solutions, technical protective measures (e.g. guards, interlocks, emergency stop), and operating procedures and instructions are used. Personal protective equipment (PPE) may also be required as a supplementary measure.
Yes, detailed risk assessment in accordance with EN ISO 12100 is required for CE certification of machinery. It helps demonstrate compliance with the requirements of the Machinery Directive 2006/42/EC.