Ensuring RoHS 2 success with agility
Lisa Ann Cairns, Ph.D. , Senior Market Analyst, Smith & Associates
RoHS 2 is the second phase of the European Union's (EU) Restriction on Hazardous Substances (RoHS). After having a decade to understand and implement the requirements of RoHS, manufacturers must now comply with RoHS 2, which primarily extends the product classes, restrictions, and traceability requirements of the original directive. RoHS 2 extensions pertain to product classes (a subset of medical electronics, and industrial monitoring and control instruments), declarations of conformity, technical documents and archiving, Conformit?? Europ??enne (CE) mandatory product marking, product identification, traceability, and compliance demonstration through testing or assessment, as well as the phase-out of exemptions from the original RoHS legislation.
With these extensions to RoHS, more companies along the semiconductor and electronics supply chain that supply products to the EU must meet the RoHS 2 requirements. Furthermore, because of the requirement for the CE marking, there are additional responsibilities for manufacturers, importers, distributors, and authorized representatives to ensure and verify conformity to RoHS 2 by maintaining records for products, components, and sub-components, and ??? in the event that conformity to RoHS 2 is not met ??? it is the responsibility of the party with that information to report the incident.
Traceability and testing by certified partners
Given the explicit and detailed requirements of RoHS 2, agile and knowledgeable distributors are the in-demand partners. When looking for such a leading partner, it is important to ensure that they are industry accredited and certified to provide the quality management (QM), component and material testing laboratory facilities, and full traceability and flow-down reporting necessary to meet RoHS and CE requirements.
Among the internationally-recognized industry standards for accrediting testing laboratories is the ISO/IEC 17025 quality standard. The ISO/IEC 17025 accreditation is both a management and a technical facility quality standard. Labs certified to this standard are those whose testing is performed by industry-recognized professionals and whose facility itself meets various equipment, facility management, and testing methods for the products that are handled.
Facilities and businesses who have received ISO/IEC 17025 accreditation, as well as ISO 9001, Quality Management Systems, are those that have and are continuously able to demonstrate that both their operations and procedures (O&P) and their QM processes meet rigorous requirements and are adopted and well-established throughout their organization. This type of detailed O&P is the cornerstone to ensuring proper CE and RoHS 2 compliance.
Quality at the core
Certainly RoHS 2 has increased the requirements and QM O&P for many businesses, but, in the global semiconductor supply chain, quality is all the more essential to general corporate strategies. RoHS 2 has increased the detailed list of what we are to recognize as and how we are to understand industry standards, at least for the EU presently, but this is certain to widen in geographical scope. Industry standards inform our understanding of recognized guidelines for processes and procedures, technical knowledge, and laboratory capabilities. While we continue to smooth the learning curve to ensure complete RoHS 2 compliance, understanding how to evaluate partners who can facilitate these transitions and remove any questions or burdens associated with compliance is truly a value add to business strategies today.
Solid State Technology | Volume 56 | Issue 3 | May 2013