What is risk assessment all about?

Manufacturers of machinery and plants, as well as manufacturers of electrical equipment, must determine the hazards and risks posed by their products. This is a legal requirement, e.g. under the Machinery Directive, the new Machinery Regulation or the Low Voltage Directive.

The international standard EN ISO 12100 explains the procedure for risk analysis and risk evaluation.

The risk assessment enables designers to identify risks posed by a product, machine or electrical device.

The aim is to identify potential hazards at an early stage and take appropriate protective measures to ensure the safety of people, the environment and other objects.

Key facts on the risk assessment

Need for a risk assessment


  • Legal obligation (e.g. for CE marking in accordance with the Machinery Directive, Machinery Regulation or Low Voltage Directive)
  • Increased product safety and prevention of accidents
  • Minimisation of liability risks for manufacturers and operators
  • Avoidance of retrofit costs or recalls

Legal basis & standards


  • Machinery Directive 2006/42/EC or Machinery Regulation (EU) 2023/1230 and Low Voltage Directive 2014/35/EU
  • EN ISO 12100 – International standard for Safety of machinery – Risk assessment and risk reduction
  • Further specific standards depending on the hazard zone (e.g. electrical hazards, noise, etc.) and depending on the product area

Elements of a risk assessment


  • Determination of limits of the product
  • Identification of potential hazards
  • Estimation of the associated risk
  • Risk evaluation
  • Risk reduction

Responsibility for the risk assessment


  • Manufacturers: Before placing a product or machine on the market
  • Operators: In particular for machines, if these are built for their own production or if existing machines are converted

     

Is risk assessment voluntary or required by law?

  Machinery Directive and Machinery Regulation

It is often assumed that performing a risk assessment is voluntary. However, both the Machinery Directive 2006/42/EC and the new Machinery Regulation (EU) 2023/1230 clearly state in Annex I and Annex III that risk assessment is a mandatory requirement:

The manufacturer (...) shall ensure that a risk assessment is carried out, in order to determine the essential health and safety requirements which apply to the machinery (...)
 

  Low Voltage Directive

The Low Voltage Directive 2014/35/EU (LVD) imposes completely analogous obligations on manufacturers:

The manufacturer shall establish the technical documentation. (...) shall include an adequate analysis and assessment of the risk(s).
 

Risk assessment according to other directives

Numerous guidelines of the so-called New Legislative Framework require the performance of an appropriate risk analysis and assessment.

Details on the relevant legal provisions that require risk assessment or comparable requirements can be found in our technical article on the New Legislative Framework.

Risk assessment process

The most important steps in the risk assessment process are:

  1. Determining the limits of the product (intended use, spatial and temporal limits, etc.)
  2. Identifying potential hazards (mechanical, electrical, thermal, chemical, ergonomic hazards, etc.)
  3. Risk estimation (combination of severity of damage and probability of occurrence)
  4. Risk reduction through protective measures such as
    • fixed guards (e.g. fencing or enclosures)
    • movable interlocking guards (e.g. doors with safety switches)
    • sensitive protective devices (e.g. light curtains, safety mats)
    • safety devices for machine control (e.g. enabling device, step-by-step control)
    • Limiting devices (e.g. speed limit switches, emission monitoring devices
  5. Evaluation of residual risk (if risks cannot be completely eliminated, they must be documented)
  6. Preparation of technical documentation (necessary for CE marking and product liability)

Excerpt from the iterative process for risk reduction,
EN ISO 12100:2010, Figure 1

Design objectives

The risk reduction methods must be implemented by the designer in a specified order. This order is based on the so-called three-step iterative process for risk reduction from the EN ISO 12100 standard, which serves to systematically identify, evaluate and minimise hazards on a machine. The three steps in the iterative process are:

  1. Inherently safe design, e.g.
    • Consideration of geometric factors and physical aspects
    • Consideration of general technical knowledge
    • Selection of suitable technologies
  2. Safeguarding and/or implementation of complementary protective measures, e.g.
    • fixed guards (protective fences, covers, etc.)
    • movable guards (flaps, doors, etc.)
    • protective devices (safety light curtains, two-hand controls, etc.)
  3. Information for use, e.g.
    • Warning signs in the form of pictograms
    • Information in the operating instructions

This legally prescribed sequence from EN ISO 12100 can be found in modified terminology in both the Machinery Directive and the Machinery Regulation. For products according to the Low Voltage Directive, CENELEC Guide 32 provides relevant information.

At IBF, we support you with our software solutions and seminars in the correct implementation of the risk assessment in mechanical and plant engineering (Machinery Directive and Machinery Regulation) and for electrical equipment (Low Voltage Directive).
 

Software risk assessment

Safexpert is our tried-and-tested software for CE marking and risk assessment in accordance with Machinery Directive 2006/42/EC and Machinery Regulation (EU) 2023/1230 as well as Low Voltage Directive 2014/35/EU. Thanks to their modular structure, our software solutions are suitable for companies of all sizes – from one-person businesses to medium-sized companies and international corporations.

The tool provides step-by-step guidance through the entire risk assessment process:

  • Structured recording of all potential hazards for associated hazard zones in the phases of the machinery life
  • Risk matrix for easy evaluation of hazards according to probability of occurrence and severity of harm
  • Systematic documentation of solutions for risk reduction
  • Clear reports ...

Depending on the scope of your projects, Safexpert offers special modules that provide you and your team with significant support in creating a standard-compliant risk assessment in accordance with EN ISO 12100.

Picture advertisement seminar designing safe machines risk assessment in practice
Seminars and consulting on risk assessment

We hold our in-person seminars at various locations in Germany, Austria, and Switzerland, while events in English and French take place online.

In addition to “traditional” practical seminars on risk assessment and CE marking, some events are also dedicated to specific technical topics or legal issues. These events are currently held exclusively in German.

We would be happy to offer you a training concept tailored to your needs, directly at your company, also in English and, of course, worldwide!

Tip: For help with Safexpert and our CE marking services, please contact our international partners!

 

Tip: Free eBook
‘Risk assessment in practice’

WHAT needs to be done by WHOM and by WHEN in order to meet the legal requirements of the Machinery Directive 2006/42/EC and Machinery Regulation (EU) 2023/1230 as efficiently as possible. These are the key questions addressed in the eBook ‘Risk Assessment in Practice’. Where possible, legal details are not included.

 

Download

Common mistakes in practice

Risk assessments are performed too late

Risk assessments are performed by one person after the machine has been built, if at all. This procedure does not comply with legal requirements and usually costs a lot of money! Every person involved in the product development process is obliged to participate in the risk assessment as part of their work. Hazards are identified at an early stage and appropriate measures are determined immediately. Eliminating hazards during commissioning or during operation can be very expensive!

The CE coordinator does it (has to do it)

Everyone involved in the development processes relies on a possible CE representative or CE coordinator. This person can coordinate, organise or provide support, but should not be responsible for the operational implementation of risk assessments in projects!

Expensive safeguards instead of inherently safe designs

Cost-saving inherently safe designs are not used. Instead, expensive safeguards are installed that would not be necessary in this form for the identified hazards and the assessed risk. A qualitative risk assessment can help to avoid unnecessary safety measures!

References to residual risks instead of technical solutions

References to residual risks in the operating instructions are preferred to technical solutions. Numerous court rulings show that compliance with the legally required sequence is particularly important in order to avoid liability cases.

Support by IBF

CE Software Safexpert

CE software for systematic and professional safety engineering

Seminars

Practical seminars on aspects of risk assessment and ce marking

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