The process whereby you determine how unsafe a non-compliant product is risk assessment (RA). Producers apply it during the design and manufacturing of a product and, subsequently, if a later version of the product is found non-compliant with the safety requirements. Market surveillance authorities also carry out risk assessments as part of their activities. RA is applied as follows:
• First a compliance assessment is performed to check if the product complies with the safety requirements. Normally this is done by testing the product according to a (harmonised) standard.
• If the product does not comply, a RA is undertaken to find the risk level presented by the product.
• If the risk level is unacceptable, it is necessary take action to lower or remove the risk. This is called risk management.
PROSAFE has been studying the application of RA since the first EMARS Joint Action in 2006. This has been undertaken by an expert group that studied RA methods and their application, at the same time supporting the product-targeted actions and activities with advice on RA for their particular products.
PROSAFE’s RA is based on the method from the RAPEX Guidelines 2010/15/EC, which is used for justification of RAPEX notifications. This method is commonly recognised as one of the “best practice” methods for assessing the risk for consumer products and it is the method that is used for justification of RAPEX notifications. Risk is severity multiplied by probability. This method measures the severity level on a 4-level scale and it estimates the probability using injury scenarios that establish a sequence of events that describes how the product hazard can cause an injury to the consumer. (The method presumes that all unsafe products can cause injuries. Harms to animals, property, environment, etc. are not considered.)
Below are a number of links to further information and guidance material:
• PROSAFE e-learning module on risk assessment. (Please register to access the module.)
• The Book “Best practices in Market Surveillance”, chapter 10.
• The PROSAFE guideline “ Tips & tricks in risk assessment”.
• Risk Assessment Templates for:
• CO Alarms: ;
• Smoke Alarms: ;
• Baby bath tubs: ;
• Cords & Drawstrings: ;
• Cots: ;
• High chairs: ;
• Telescopic Ladders: ;
• Robotic Lawn Mowers: ;
• Ride-on Lawn Mowers: ;
• Rotary Push Lawn Mowers: ;
• Toy kick scooters: ;
• Sports kick scooters: ;
• Toys for children under 36 months: ;
• Toys for children above 36 months: ;
• Wheeled child conveyances: ;
• A Guide on how to use the templates.
If you need the data files for the RAG webtool , please contact PROSAFE.