Machinery Risk Assessments

Machinery Product Risk Assessments

Machinery Risk Assessments

A safety risk assessment is a legal requirement according Machinery Directive 2006/42/EC and has to be conducted by every manufacturer of a machine. According Annex I of the directive

The manufacturer of machinery or his authorised representative must ensure that a safety risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery.

‘Safety,’ is viewed as a proactive approach to provide protection from danger or to achieve a condition with as little risk as possible, or as low as reasonably practical (ALARP).

The machinery must then be designed and constructed taking into account the results of the safety risk assessment.

To do a product safety risk assessment, you need to understand what, in your product that, might cause harm to people and decide whether you are doing enough to prevent that harm. Once you have decided that, you need to identify and prioritise putting in place, appropriate and sensible control measures.

Start by:
• identifying what can harm people when operating, maintaining the equipment physical injury or damage to health
• identify the potential source of harm and the most appropriate way to apply the protective measures
• consider the performance of the function under specified conditions and for a given period of time without failing list foreseen and unforeseen misuse
• evaluating the risks and deciding on the appropriate controls, taking into account the controls you already have in place
• recording your risk assessment
• reviewing and updating your assessment

Your safety risk assessment should include consideration of what in your product might cause harm and how and, who might be affected. It should take into account any controls which are already in place and identify what, if any, further controls are required.

You should be able to show from your assessment that:
• a proper check was made
• all potential risks were considered
• all significant risks have been assessed and the protective measure adopted
• the precautions are reasonable
• the remaining risks are as low as reasonably practicably

In essence, making sure a risk has been reduced ALARP, is about weighing the risk against the sacrifice needed to further reduce it. The decision is weighted in favour of health and safety because the presumption is that the manufacturer should implement the risk reduction measure. To avoid having to make this sacrifice, the manufacturer must be able to show that it would be grossly disproportionate to the benefits of risk reduction that would be achieved. Thus, the process is not one of balancing the costs and benefits of measures but, rather, of adopting measures except where they are ruled out because they involve grossly disproportionate sacrifices.

Using “reasonably practicable” allows us to set goals for manufacturer, rather than being prescriptive. This flexibility is a great advantage. It allows manufacturers to choose the method that is best for them and so it supports innovation, but it has its drawbacks, too. Deciding whether a risk is ALARP can be challenging because it requires manufacturer to exercise judgement.

Risk Assessments should also be carried out to satisfy the requirements of legislation but above all to ensure the Health & Safety of the operators.

It is recommended that all manufacturers conduct an initial product risk assessment using ISO 12100 at the design stage to eliminate expensive changes in production.

Risk assessments should always be carried out by a person who is experienced and competent to do so. This is usually the designer as he knows the product better than anybody, but this means sometimes they require additional help, remember competence does not mean you have to know everything, competence also means knowing when you know enough or when you should call in further expert help.

BS EN ISO 12100 Safety of machinery

General principles for design

Risk assessment and risk reduction
What is it?

BS EN ISO 12100:2010 sets the international standard for machinery safety. It gives you the tools to design and develop reliable equipment that remains fit for purpose throughout its lifecycle. BS EN ISO 12100 outlines the general principles of machinery safety and risk assessment and management. This framework helps you identify and eliminate hazards at different stages of the machinery’s lifecycle and avoid costly accidents.
How does it work?

BS EN ISO 12100 is a guidance document to establish the safety of machinery. Understand the terminology, principles and processes of risk assessment and management. BS EN ISO 12100 gives you the tools to design and develop safe machinery – hazard checklists and machine schematics make the standards easy to use and relevant to your needs, and guidance on risk reporting will help you achieve internationally recognized BS EN ISO 12100 safety standards.

It should be noted that the EU Machinery Directive and the corresponding UK Supply of Machinery (Safety) Regulations stipulate that the machine manufacturer or his representative must ensure that a risk assessment is carried out. In addition, the Technical File must contain a copy of the risk assessment. It is therefore essential that the risk assessment process is both carried out and documented adequately. The risk assessment can also assist in preparing the instructions for the machine, as the Machinery Directive requires that information about the residual risks must be included in the instructions.

Risk Assessment Methodology

There are 8 steps to carrying out a good risk assessment template;
1. Identify the type of hazards
2. Identify those at risk origin/potential consequences
3. Identify existing control measures
4. Evaluate the risk
5. Decide/Implement control measures
6. Re-assessment after, Implement control measures ensuring ALARP is achieved
7. Record assessment in technical file
8. Inform “all potential risks should be clearly stated in the operating manual”

HOW WE CAN HELP:

The CE Marking Authority has over 40 years experience with machinery requirements and can assist manufacturers, importers, and users of machinery and their components by offering a range of services to meet your needs. Here are some of the services on offer:

• Conduct risk assessment to ensure all risks are ALARP ensuring the controls with the product are safe
• Perform assessment reports detailing assessments to harmonised European standards
• Technical file review
• Consultancy advice on related Directives (Pressure, LVD, EMC & RoHS)