Glossary

Risk assessment

The procedure by which a manufacturer identifies, evaluates and reduces the hazards of a machine. It stands at the beginning of the design, not at the end: only the risk assessment decides which protective measures are solved by design, which are safeguarded technically and which go into the instructions. Without it there is no valid declaration of conformity.

Also
Risk analysis · Hazard analysis · Risk assessment to EN ISO 12100
Also known as
  • Risk analysis
  • Hazard analysis
  • Risk assessment to EN ISO 12100
01

Who prepares it and why

The risk assessment is a duty of the manufacturer of a machine. EU machinery law requires the manufacturer to identify the hazards arising from the machine, estimate the risks and design and build the machine taking the results into account. EN ISO 12100 describes the method.

It is a design tool, not a closing document. If it is written only when the machine is finished, all that remains are guard fences and warning signs – the weakest means.

02

The procedure

The standard divides the procedure into fixed steps that are repeated until the risk has been adequately reduced.

  • Determine the limits of the machine: intended use, reasonably foreseeable misuse, limits in space and time.
  • Identify hazards – for all life phases from transport and assembly through operation, cleaning and fault-finding to dismantling.
  • Estimate the risk: severity of harm and probability of occurrence.
  • Evaluate the risk: is reduction required?
  • Reduce the risk and check again whether the measure has created new hazards.
03

What risk is made up of

Risk is the combination of the severity of possible harm and the probability of its occurrence. That probability in turn is made up of three elements: how often and for how long persons are exposed to the hazard, how likely the hazardous event is, and whether the harm can still be avoided or limited.

With manually guided devices the first point weighs heavily: the operator is permanently within the range of movement of the load.

04

The three steps of risk reduction

The order of protective measures is prescribed. First, inherently safe design: eliminate or reduce hazards, for example by positive locking instead of a friction grip, or by limiting forces and speeds. Then safeguarding and complementary protective measures: load holding on loss of energy, interlocks, guards. Finally, information for use: notices on the machine and in the instructions about the remaining residual risks.

A later step must not replace an earlier one that would have been possible.

05

Not to be confused: the workplace risk assessment

The machinery risk assessment looks at the machine and is the manufacturer’s business. The workplace risk assessment – Gefährdungsbeurteilung in German law – looks at the workplace and is the employer’s business. It builds on the manufacturer’s information but reaches its own conclusions: installation site, parts handled, qualification of the operators, interaction with other work equipment.

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Overview

Machinery risk assessment and workplace assessment compared

Aspect Machinery risk assessment Workplace risk assessment
Responsible manufacturer employer
Legal basis EU machinery law national occupational safety law
Subject the machine over all life phases the workplace and the activity
Timing during design before use, kept up to date
Outcome protective measures, residual risks in the instructions protective measures, inspection intervals, instruction
Frequently asked questions

Frequently asked questions about Risk assessment

Does the manufacturer have to hand over the risk assessment?

No. It is part of the technical file and is presented only to market surveillance authorities on request. The operator receives the operating instructions, which describe the residual risks and the protective measures needed.

When does a risk assessment have to be repeated?

Whenever the machine is changed in a way that can create new hazards or increase risks – a different gripper, a higher capacity or a modified control system, for example. Depending on the result, this may be a substantial modification.

What role does foreseeable misuse play?

It is expressly part of the assessment. The manufacturer must also consider behaviour that is not intended but readily predictable – lifting heavier parts, for instance, or bypassing an inconvenient safeguard.

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