by Stanley H. Salot, Jr.
The Restriction of Hazardous Substances (RoHS) update, known as RoHS2, was adopted by the European Council in May, thus marking the beginning of the directive’s transition from testing products for compliance to a process-based management system and third-party conformity assessment. RoHS2 doesn’t eliminate the use of testing, but it puts added emphasis on process control verification to ensure compliance.
These new European Union (EU) member-state regulations are set to take effect January 2013. Category 8 medical devices will become subject to the new rules in 2014, in-vitro diagnostic medical devices must comply by 2016, category 9 monitoring and control instruments will be brought into scope in 2014, and industrial monitoring and control instruments will become subject to the changes in 2017. Category 11, “All EEE Not Covered by Any Other Category” is required to come into scope in 2019. Active implantable medical devices remain exempt from RoHS2.
The new RoHS scope
The types of restricted substances and their limits remain the same in RoHS2 as in the original RoHS directive, but it’s important to consider the recitals in the introductory part of the directive. In the future, manufacturers will need to consider the potential inclusion of phthalate plasticizers (DEHP, BBP, DBP) and brominated flame retardant (HBCDD). Other hazardous substances, including nanomaterials, should also be considered in future revisions to RoHS. The definition of electrical and electronic equipment (EEE) remains the same as in the original RoHS directive, i.e., dependent on electricity or electric fields to work properly.
RoHS2 includes the first legal definition of homogeneous materials: “Material of uniform composition throughout or a material consisting of a combination of materials that cannot be mechanically disjointed into different materials.”
The most-asked question about the original RoHS has related to its scope: “Dependent on electric current or electromagnetic fields for its primary function.” In RoHS2, the related scope is, “Dependent on electric current or electromagnetic fields to fulfill at least one intended function.”
An example of how this scope applies would be a teddy bear that talks when you do something to it. “Talking” is an intended function of the teddy bear. In RoHS1, this would be out of scope, but with RoHS2, it’s in scope.
RoHS2 exemptions policy
Exemptions in RoHS2 are handled differently than they are with RoHS1. Article 2, paragraph 4 includes a list of permanent exemptions (e.g., military equipment). Exemptions in Annex III and Annex IV have a maximum validity period of up to five years for categories 1–7, 10, and 11; categories 8 and 9 are given seven years. The burden of proof is placed on industry through the use of applications for exemptions to be granted, renewed, or deleted. Information for how to apply for exemptions is included in Annex VI(a). If you are applying for an exemption renewal, you must submit the required documentation at least 18 months prior to the exemption’s expiration. The commission must decide at least six months before the expiration date. If a renewal application is rejected or a deletion request is accepted, the exemption will expire 12–18 months after the date of the decision.
RoHS2 CE marking requirements
To begin implementing the RoHS2 process management system, a manufacturer is required to create and maintain product technical files and the management controls necessary to control the production process. These requirements are detailed in Module A of Annex II of 768/2008/EC—Conformity Assessment Procedures. The technical documentation must include a general description of the product; a bill of materials; and examinations performed including but not limited to materials assessments, declarations from suppliers, and test reports.
The manufacturer must now provide a CE declaration of conformity (DoC) and maintain the associated technical documents and DoC records for at least 10 years after the EEE product is put on the market. Products shall have the CE Mark, type, batch, or serial number; manufacturer name or trade mark; and contact address. If the product is too small, the mark shall be placed on the packaging or documentation accompanying the product.
RoHS2 requires manufacturers to take immediate action for any noncompliant products shipped. This includes market withdrawal or product recall—if appropriate—and immediate notification of member states where the products were sold of the details of the noncompliance and corrective action measures taken. They must also keep distributors informed of nonconformities and product recalls. Manufacturers are also required to provide member states, upon their request, all information and documentation necessary to demonstrate conformity in a language that can be easily understood by the authority and to cooperate with requests for any action to ensure compliance. Distributors must now operate with “due care,” as RoHS also holds them liable for ensuring that their products are compliant with the directive. They should understand and ensure that products include the CE Mark; their manufacturers’ name and contact address; their importers’ name and contact address; and the type, batch, or serial number. If a distributer has reason to believe that a product is not RoHS2 compliant, it cannot sell it and must inform the manufacturer, importer, and member state regulators.
Like the manufacturer, the distributor must ensure that immediate action for noncompliant product is taken. This may include market withdrawal or product recall. Distributers must also immediately inform member states where they sold the noncompliant products and provide details about the noncompliance and corrective measures taken. They must provide member states, upon request, with all information and documentation necessary to demonstrate product conformity and cooperate with actions to ensure compliance if requested. All of these requirements will affect products resold after January 2013. RoHS2 doesn’t have a phase-in period for stock bought before January 2013.
Process conformity assessment—technical documentation
Module A of Annex II of 768/2008/EC requires technical documentation of the manufacturer’s internal production controls. This includes specifying the requirements for product design and manufacturing, enabling assessment of RoHS2 conformity for the product during the production process, and conducting a documented risk assessment. The technical documentation shall include a general description of the product, bill(s) of material, examinations performed (i.e., materials assessment, declarations from suppliers, etc.), and test reports.
The technical file must have a product risk assessment that includes a robust risk modeling to show an eliminated risk of noncompliance, a product risk assessment used to determine the level of internal production control required for the product, and—if the technical file doesn’t require test reports for certain parts—an explanation of why test reports aren’t applicable. The internal production controls must also manage ongoing compliance risks.
Internal production control for RoHS2
A product risk assessment is used to determine the level of internal production control required for a product. A review of the product design and supply chain may reveal higher levels of risk in certain areas of the process. The internal production control includes supplier management and sets the criteria by which suppliers are required to demonstrate compliance. Forms of demonstrated compliance can be self declaration, test reports, and trusted foundries that are subjected to regular and documented quality assurance checks with significant sampling or testing reports. Internal production control can also include screening with XRF-type equipment and/or independent testing.
Quality assurance checks on significant samples of test reports can also be used as the foundation for using self declaration for materials from low-risk suppliers. Process verifications must ensure that relevant part numbers are checked when changes to product design or production processes are changed. It’s also critical to ensure that the test reports used are signed and dated and that the measurement data confirms compliance for all substances of all homogenous materials in the parts. Reports must also be provided by an accredited or approval laboratory in a language that is understandable to the reader.
Where technical files don’t require test reports for certain parts, an explanation is required attesting to the reason(s) that test reports aren’t applicable. For compliance management, a risk assessment should be used to set the internal production control criteria to identify which suppliers are required to provide self declarations and which suppliers must also provide test reports.
In conclusion, RoHS2 requires a systematic approach to gathering and analyzing declarations and test reports from suppliers.
Re-thinking your product compliance management
Business penalties for noncompliance to RoHS2 are much higher than with the original RoHS. Manufacturers, importers, and distributors must take immediate action in the case of a noncompliance, including product withdrawal or recall, and member states must be notified upon identification of noncompliance.
Increased burden of proof
RoHS2 places considerably more burden of proof on industry. Technical files must include test reports wherever applicable and risk assessments must be used to set the criteria for what a supplier must provide to demonstrate compliance. A systematic approach for gathering and analyzing declarations and test reports from all suppliers must be demonstrable.
The path forward is set, are you ready?
It’s not surprising to see that RoHS2 embraces a process management approach for demonstrating compliance. Before RoHS, industry around the world understood that testing for compliance wouldn’t be viable. Even today, five years after RoHS went into effect, test results of products purchased from retailers and distributors in the EU are still indicating a 10 to 30 percent failure rate for RoHS compliance. Supply chain management remains a critical aspect of compliance for product manufacturers. Increasing volumes of reclaimed components from product returns and recycling programs make it more difficult than ever to ensure that the components buyers purchase from unfranchised distributors comply with requirements. Created in 2005, the third-party IECQ QC 080000 HSPM certification program has helped more than 3,134 organizations worldwide be well prepared for the release of RoHS2. Virtually everything required for placing the CE Mark on a product is included in the IECQ QC 080000 specification, which was created from the U.S. standard EIA/ECCB 954.
About the author
Stanley H. Salot Jr. is president and CEO of BQPM. He is an acknowledged expert in business and quality process management and is active in U.S. and international industry standards bodies. He also serves as president and CEO of ECC Corp., which serves as the U.S. representative for the U.S. national committee of the International Electro-Technical Commission Quality Assessment System for Electronic Components (USNC/IECQ). Salot served as the chairman of the working group that authored and implemented EIA/ECCB 954 and international specification QC 080000 IECQ HSPM for hazardous substance process management for the electronics and electrical industries.
Salot has served as chairman of the users advisory group for the USNC/IECQ. He is an active member of the American Society for Quality and has held senior component engineering, technical, quality assurance management, and executive business development positions with California Computer, Anderson Jacobson, Systems Industries, Altos Computers, Logitech Inc., the National Standard Authority of Ireland, and Hitachi Micro Systems Inc. He also served 10 years in the U.S. Army, the last five of which were in the Army Signal Corp.