Risk assessment

Risk Assessment is one of the fundamental activities that a manufacturer (but not only) is required to conduct in order to comply with its legal obligations to ensure the safety and health of people when using products.

An objective of the risk assessment is to eliminate the risks to the greatest extent possible and, if this is not possible, to reduce them to the minimum extent possible based on the knowledge gained through technological advancement. In particular, it entails all prevention and protection measures for the elimination or reduction of risks.

There are several product directives that require a thorough Risk Assessment to be carried out, and these include:

• directive 94/9/EC ATEX – Potentially Explosive Atmosphere
• directive 2014/68/EU PED – Pressure Equipment
• directive 2014/30/EC – Electromagnetic Compatibility
• directive 2014/35/EU – Low Voltage
• directive 2006/42/EC – Machinery

Each directive identifies specific EHSRs (Essential Health and Safety Requirements) in accordance with its objectives. Below we take as an example the Machinery Directive 2006/42/EC and its indications for products such as machines, partly completed machinery, installations and devices.

MACHINERY DIRECTIVE AND RISK ASSESSMENT

Even within the machinery sector, safety primarily stems from the comprehension and awareness of the implications of risk, hazard, and their consequences, namely, injury.

It is said that “there is no human activity devoid of risk in an absolute sense”, but what exactly is risk? And what distinguishes it from hazard?

Let's start with these concepts to understand what the Machinery Directive 2006/42/EC indicates.

What is hazard

Let's examine the concept of hazard:

Thus, hazard is a potential source of injury , meaning a harmful way of being of a substance, machine, work situation, or behaviour that can lead to an adverse event.

Hazard is often qualified by defining its origin (e.g. a hazard of a mechanical or electrical nature, etc.) or the nature of the potential harm (e.g. a danger of cutting, fire, crushing, shearing, etc.).

Hazard implies an objective, de facto condition, a property from which potential injury may result.

What is risk

Let's examine the concept of risk:

So the risk concerns the probability that something adverse will happen when dealing with hazardous situations (or with something dangerous), related to the severity of the event itself. We speak of residual risk when referring to the risk that remains after protective measures have been taken to reduce the risk as much as possible.

If hazard is the source of the possible injury, the risk can be identified through the following formula

R = H x I

where the risk R is the combination of the probability P that a hazard will actually cause injury and the severity I of the Injury is associated with the hazardous event.

The risk value also indicates the urgency of intervention: immediately or through planning, depending on the circumstances.

What is injury

If risk is the probability that a person is exposed to hazard that can cause an injury, injury is the consequence (physical/health injury).

A numerical estimate is also attributed to the injury in descending order from most severe to least severe, allowing for the classification of severity.

What the Machinery Directive says

The Machinery Directive 2006/42/C E explicitly mentions that a risk assessment must be kept in the technical file:

To understand it better, the concept of Risk assessment is summarised in this short story:

BEGINNING OF THE STORY

END OF THE STORY

WHAT SHOULD THE MANUFACTURER DO?

The risk communication system is a risk itself, which is why the manufacturer must follow standards to “do things properly”.

In this case the reference standard is UNI EN ISO 12100:2010 – General design principles – Risk assessment and risk reduction or which, through the specification of principles for risk assessment and risk reduction, defines the specifications for achieving safety in machinery design.

According to the standard, you should:

• identify the machine hazards
• estimate and assess the risks during the life cycle phases of the machine
• eliminate hazards or achieve sufficient risk reduction.

The saying “prevention is better than cure” is also favoured by legislation: risk assessment is primarily about prevention, i.e., activities carried out to lower the risk probability, and secondly, about protection, i.e., activities that protect against the resulting injury:

• Prevention is the set of operations carried out to reduce the likelihood of a particular harmful event occurring (the presence of risk is avoided)
• Protection is the set of operations carried out to reduce the severity associated with a particular harmful event (protection against present risk).

When drafting the Risk Assessment document, it is important to evaluate multiple factors , including:

• the likelihood that a injuries may occur
• the actual exposure of the person
• which conditions that raise the risk.

The main risk factors