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However, many products are exempted from the provisions of the RoHS Directive, including medical devices, military equipment, some fluorescent lamps, and batteries (at this time, batteries have now been listed under the EU’s 1991 Battery Directive, 91/157/EEC). For the six listed substances (cadmium excepted), the maximum concentrations are 0.1%, or 100 ppm by weight of the homogeneous product; the allowable limit for cadmium is limited to 0.01%, or 10 ppm. The manufacturer must be careful of the above limits as they do not apply to the entire finished product but instead to any single homogeneous material which could be physically separated. For example, a product containing a lead flywheel used to provide easier knob rotation could be considered non-compliant if the flywheel could be physically separated from the product, even if the lead content of the flywheel was less than 0.1% of the total product weight. RoHS Regulations in Other Countries The concern over environmentally hazardous materials is spreading throughout the world, with a number of the Pacific Rim countries (including China and Japan) beginning work on their own versions of RoHS regulations. China RoHS regulations are slightly different from those in the EU. Instead of having a general classification with a lengthy list of exemptions, China will generate a list of included products. This list will be embedded in the totality of Electronic Information Products (or EIPs) to which the regulations will apply. And, of course, there is a different marking requirement for products complying with China RoHS. Japan, on the other hand, has its own marking requirement, but is relying on its recycling laws to drive manufacturing to a lead-free process. Another problem to be faced by manufacturers is the changing regulatory environment from country to country. For example, while medical equipment is presently exempted from the EU’s RoHS regulations, that is not the case in China. Also, substances which are not presently covered may find themselves on the hazardous materials list in the future. Closer to home, a majority of the states within the U.S. are also working on their versions of RoHS regulations. For example, California is preparing to adopt a subset of the EU’s statutes. As presently written, it will only cover TV displays larger than 40” and will not exclude PBB and PBDE (California’s requirements can be found in SB20/50 – the Electronic Waste Recycling Act of 2003, or EWRA). Enforcement Efforts The ability to ship non-compliant products to the global marketplace without incurring monetary penalties is rapidly shrinking. Companies shipping products with substances banned under the EU’s RoHS regulations after 1 July 2006 can face monetary fines or prosecution by the EU. The avoidance of financial penalties is not the only concern – the negative publicity which can be generated by RoHS-compliant competitors can significantly impact sales. As a further incentive to induce compliance, managers and CEOs must be aware that the possibility of prosecution may extend up the managerial ladder, should it be shown that failure to comply was due to neglect, or consent, of any manager. It is important to note that RoHS compliance extends past the producer’s manufacturing operations, and includes subunits in any system that ships to an EU location. Unfortunately, imposition of RoHS penalties is spotty at best, which tends to actually penalize those manufacturers that work to maintain compliance because of increased production costs when compared to the scofflaws. As yet, no policing authority has been emplaced to assure RoHS compliance, and even the much more mature CE testing is not strictly enforced. For example, non-conformance rates to CE testing in Germany is reportedly as high as 50%, and still exceeds 30% even in UK. Typically, non-compliant products are either unmarked or, if CE marked, do not possess the required backup documentation. The Burden on Manufacturers The imposition of regulations necessary to meeting the EU’s RoHS requirements can impose an almost onerous burden on manufacturing processes and quite probably increase product costs. But one of the benefits of RoHS compliance is that the produced units are safer to handle and create less health and environmental risk when disposed of at the end of their life cycle. For these underlying reasons of variability in “green” restrictions, a manufacturer must view RoHS compliance as a continuing effort, not a one-time occurrence. The effort required for companies to achieve RoHS certification can basically be divided into three major areas, as follows: production processing, incoming inspection, and the implementation of accurate database/recordkeeping procedures. To convert a company’s production processes to comply with RoHS requirements can take years of constant work by a dedicated committee. As RoHS compliance affects almost all areas of the manufacturing entity, it is necessary to include managers from the engineering department, the quality control department, the purchasing department, and the sales department. In other words, the effort must be an all-encompassing, organization-wide activity that is embraced by executives and managers in all of the participating areas. Further, the RoHS compliance committee must be chaired by an executive who is sufficiently senior within the organization to ensure that the recommendations and procedures will be carried out. One major challenge to converting to an RoHS-compliant facility (particularly if you are converting only a portion of your product line) is to adequately manage the inventory control function. The question arises both as to part identification of the end product as well as purchased parts and materials. (For example, is it necessary to change all part numbers, or just those which are part of the RoHS product line?) Procedures must be created to assure that received material is not incorrectly apportioned, and to ensure that the received parts and material inventory stayed “clean” during the transition. Ultimately, the sets of internal regulations and procedures which comprise our own company’s RoHS compliance program encompass a multi-faceted protocol that exceeds industry standards. For example, one of the major changes to our production process has been the incorporation of a lead-free soldering protocol. The implementation of a new solder technique can be a difficult and time consuming process, as many different solder alloy formulations and PCB materials needed to be evaluated. This effort will require months of material research combined with an interactive process profile evaluation. The resulting lead-free soldering process requires a higher soldering temperature, and printed circuit boards need be reconfigured to assure resistance to the stresses generated by exposure to the environment. Also, the possibility of tin whisker growth must also be accounted for in the design of printed circuit board trace spaings. Manufacturers should expect an investment of considerable capital and time when implementing a new lead-free soldering process, and it would be prudent to do this early in the conformity cycle to assure that it will be in-house and under control when it becomes time to switch over. Meeting Due Diligence Hurdles In actuality, the RoHS Directive requires only due diligence on the part of equipment manufacturers, and does not specify the minimum actions that are required to provide a reasonable defense against charges of non-compliance. The major question which could cause stress should the company be subject to legal proceedings over RoHS compliance is exactly what is meant by “due diligence,” and how a manufacturer can prove that they meet this standard. Simply doing nothing, or asserting lack of awareness of the requirements or lack of intent to contravene such requirements, is not a sufficient defense. Instead, manufacturers must ensure that the compliance system that they have established works, and that they posses sufficient documentation to prove that it does. It is clear that the courts will insist that positive action be taken, and that all reasonable steps are also taken to assure compliance. Such steps might include periodic audits of the compliance checks, and a genuine commitment on the part of the company’s executives and managers that the system is followed. It may also be necessary to set up incoming inspection protocols than include hand inspection and 100% x-ray (XRF) scanning of all RoHS required material or chemical analysis. This scanning process will help discover any potential distributor mix-ups (accidents can happen), and will provide a secondary verification of the manufacturer’s certifications. Don Kennedy, the Chief Engineer at Pulizzi Engineering, Inc., a division of Eaton Corporation, notes that “many certifications for components and materials are very general, aren’t based on actual lot test results, aren’t traceable to specific manufacturing or material lots, and are therefore not reliable. We’ve found that XRF scanning of receiving inspection samples has been much more effective in preventing non-conforming materials from making their way into our products.” In one manufacturing environment, the results of the XRF scanning were surprising. At least 25% of the RoHS certifications which accompanied the incoming parts were invalid because the parts failed this critical inspection step. The suppliers claimed to have documented compliance from their vendors, and suggested that the inspection process was at fault. To back up the in-house quality control department, the manufacturer committed money for a number of independent inspections by outside labs, which did indeed verify the internal scans. Based on this experience, it’s easy to see why a company’s purchasing department needs to be represented on the RoHS conformity committee, as questions can arise over whether to reject all or partial amounts of the incoming material, or possibly to accept the entire lot. It is necessary to be flexible and interactive with suppliers to help them transition to the RoHS restrictions and compliance processes. Incoming material that is destined for RoHS-compliant products should be so marked and kept separate until pulled for the RoHS-dedicated assembly line. This physical separation prevents components from entering and contaminating the lead free circuit board manufacturing process. Then, the assembled product should be subjected to a thorough final RoHS compliance check before being marked as “RoHS Certified” and shipped to the customer. To conform to the RoHS regulations, the “Certificates of Compliance” (verifiable, written statements of assurance that any material or components do not contain any amounts of the proscribed elements above the allowable limits) must be retained for a minimum of four years. As the RoHS limitations apply to the total amount of these materials, statistics on the cumulative amounts must be generated and maintained, since it is not the percentage of hazardous material related to the total product weight but the percentage of these materials in any physically separable element of the shippable unit. These records must be readily accessible so that it is easy to provide the totals for each end item. Additionally, the recordkeeping database must include a sufficiently robust inventory control protocol to keep non-compliant components from accidentally entering a product which will be RoHS-certified. This may require a complete rework of a company’s part numbering/inventory system to assure that RoHS-compliant elements do not possess the same part numbers as previously purchased non-compliant parts. Conclusion Conformity with the RoHS Directive is difficult and more costly than “non-green” manufacturing protocols, but is rewarded not only by benefits to the planet, but the ability to trumpet ones “green” product as against the negative publicity which could be generated by your RoHS-compliant competitors. The investment is huge, both in financial and human terms, but if you plan on staying in business during this movement to more environmentally friendly products and manufacturing, it is going to be necessary to actively and diligently pursue these RoHS conformance issues and regulations. n Roger Edelson is a senior technical staff writer with Pulizzi Engineering, Inc., a division of Eaton Corporation, and can be reached at rogharv@comcast.net. © Copyright 2007 Conformity |