Having complete documentation does not automatically mean a product is safe. The general product safety framework requires that a product be safe under normal and foreseeable conditions of use , and that this be demonstrated through a structured risk assessment.
Components of risk assessment
STEP 1
Describe the product:Function, materials, components, packaging, target user group, and age range.
STEP 2
Identify the hazards:Mechanical, chemical, electrical, thermal, fire, suffocation, radiation, and ergonomic hazards.
STEP 3
Create scenarios:Normal use and foreseeable misuse scenarios; including access by children.
STEP 4
Rate the risk:An assessment of the severity of the harm and the probability of it occurring.
STEP 5
Take action:Eliminate through design, take preventive measures, or inform through warning, respectively.
STEP 6
Document and monitor:Record the results in a technical file and continuously update it with field data.
New dimensions brought by modern products
Connected products: In internet-connected products, a cybersecurity vulnerability can transform into a physical security risk.
Product changes: Products whose behavior changes due to software updates deviate from the assumptions made during the initial evaluation.
Learning systems: Risk is not constant in products whose behavior evolves with use.
Distance selling: The obligation to provide complete product information before purchase in online sales.
Marketplace responsibility: The obligations of online platforms regarding the security of products sold through them.
The system's contribution
When risk assessments are kept as a text document, they are often forgotten when the product changes and have to be rewritten from scratch for similar products. However, when they are kept in a structured system, templates can be used at the product family level , field complaint data can be directly linked to the risk record, and relevant hazard items can be marked when a component changes.