The Risk Assessment

The risk assessment is one of the first and perhaps the most important step in any product compliance. It is often overlooked with a tendency to immediately apply standards. This can be a costly misstep as it results in applying the wrong standards and over testing. Often technical justification and analysis can substitute for testing.

It is best to carry out the risk assessment early in the design phase or when sourcing as the identification of the hazards can help in the application of the applicable regulations that best address those hazards.

The manufacturer, importer or distributor must ensure that a risk assessment of the product is carried out to determine the health and safety requirements which apply to the product.  It must then be designed and constructed considering the results of the risk assessment. By the iterative process of risk assessment and risk reduction referred to above, the supplier shall:

• Determine the limits of the product, which include the intended use and any reasonably foreseeable misuse thereof.
• Identify the hazards that can be generated by the product and the associated hazardous situations.
• Estimate the risks, considering the severity of the possible injury or damage to health and the probability of its occurrence.
• Evaluate the risks, with a view to determining whether risk reduction is required.
• Eliminate the hazards or reduce the risks associated with these hazards by application of protective measures.

The risk assessment usually begins with identification of hazards and giving them a weighting based on frequency of exposure, probability of occurrence and the level of hazard. Sometimes the risk assessment can be based on simple checklists and experience but increasingly calculation of the risk level is required. Once the risks are identified and quantified measures to address them are employed to change the design and incorporate safety features. Labelling and warning signs are not in themselves sufficient to address the risks and in most cases the product must be made inherently safe even in those cases where the misuse of the product is unintentional.

Standards and codes of practice can assist in the risk assessment and ultimately form part of the compliance plan. Verification of the required safety, the applied safety features and performance is usually done by testing, inspection and analysis based on standards.
Elimination or reduction of the risks identified to acceptable levels is often best achieved through design.  It can be by using components and sub-systems that are in themselves designed and approved to comply with the essential protection requirements and installing them in accordance with the suppliers’ guidelines. Testing and analysis during the design and development phase can also identify risks and provide an opportunity to validate risk reduction measures. The application standards act to both quantify the risks and where met provide a presumption of conformity. The activities undertaken during the risk assessment are to be included in the technical file and made available on request to the relevant authorities.

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