Bolton Consultancy Ltd

Risk Assessment

A methodology for risk assessment is included in the RAPEX guidlines to support a consistent approach and facilitate quantification of risk.  The method is primarily intended to be applied by conformance authorities but the concepts should be applied by manufacturers and suppliers taking a risk based approach.   Bolton Consultancy Ltd has experience in assessing product risk and provides detailed Risk Assessment Reports based on the latest RAPEX methodology.

Taking A Risk Based Approach

To assure that your products conform to the GPSR it is advisable to establish a product risk assessment process within your organisation.  This need not be complex, excessively time consuming or difficult.   The key element is a regular risk review involving Hazard Identification, Risk Evaluation, Mitigation, and Record Keeping along the following lines.

Hazard Identification

Carefully examine potential hazards; anything which might cause harm to people.   Take into account who is using the product, their likely behaviour, the environment in which it is used, and anyone who might be affected by its use.  Consider the intended use and try to forsee it being used by unintended people or in unintended ways.   Consider the materials used, how it is constructed, and what could fail, go wrong, break, come off etc.   Build up a picture (hazard scenario) of the events or steps that need to occur in order for the hazard to be released.

Risk Evaluation

For each hazard you identify determine:

From this you now need to decide if any hazards present an unacceptable risk and if so take action to mitigate that risk.


A range of mitigation actions can be applied depending on the level of risk and range from a redesign of the product to user instructions, labelling and warnings. If significant risk is identified in a product that has already been sold it may be necessary to instigate its recall.

Record Keeping

A record of the analysis and mitigation actions should be kept and signed off at a reasonably senior level of authority.

Legislation, Standards and Guidelines

Of course many potential hazards, consequences and risks are generic to product types and use and have been recognised in various types of Legislation and Standards along with their acceptability and mitigation (such as labelling requirements). GPSR helps us here by offering an assumption of confromity when the product complies with appropriate standard and gives a list of the types in order of priority.

So the assessment should be guided by the requirements of any applicable legislation/standard, ensure that all areas are covered (as more than one can apply at once) and confirm that no other hazards remain.

Bolton Consultancy Ltd can provide assistance in adopting a risk based approach and provides training in product risk assessment, based on the latest RAPEX methodology.