What is the recommendation for appropriate documentation and methodology for performing and recording the product's conformity to the relevant requirements and adequate analysis and assessment of the risk(s)?
Assuming this is referring to EN50581 & due diligence requirements, the idea is to do two risk assessments.
Risk Assessment 1: Materials
Do you have high-risk materials or low-risk materials? An example of low risk material is stainless steel. There’s no coating, no lead, mercury cadmium, or hexachrome. Therefore stainless steel is risk-free.
A power supply, with 150 components from 150 suppliers? That’s a very complex component that takes up one part number on your BOM and is very high risk because of all the different exemption dates for ceramic capacitors and leaded solder, etc.
Risk Assessment 2: Suppliers
Where are your suppliers located? Maybe they are in Asia, Mexico or India. You don’t have access to them, you don’t do audits to ensure they’re in compliance, and you are taking their word that they are in compliance, even if the documentation you receive from them is out of date, or flaky at best.
Based on those two risk assessments, you will know if you’re allowed to accept a declaration of conformity from them, or require a test data sheet from an accredited laboratory that their product indeed meets the RoHS directive.
TÜV Rheinland is able to come on-site and do a RoHS2 ready-audit, which typically takes around one day. We will go through the different departments in your organization to find out if you’re doing everything necessary to meet REACH, WEEE, and RoHS2 requirements. To give you an example of how to put together a risk assessment, follow EN50419 and create your technical construction file.
Please visit our website for more information on REACH compliance.
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