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By now, we should all be familiar with the European Union's RoHS Directive (Restriction of the use of certain Hazardous Substances in electrical and electronic equipment). Companies that anticipate selling their products within the EU are expected to comply with the member state laws that implement the directive by taking all reasonable steps and exercising all due diligence to ensure their products comply.
"Reasonable steps" is pretty straightforward. But what exactly is due diligence? According to the U.K. National Weights & Measures Laboratory (NWML), due diligence is simple: have systems and procedures in place that are effective and that provide proof of compliance.
The operative word here is "proof". The U.K., as an example, defines proving compliance as follows: "A producer shall, at the request of the enforcement authority, submit within 28 days of the date of the request, technical documents or other information showing that electrical and electronic equipment placed on the market complies with the requirements of the regulations."
(See related RoHS enforcement article: RoHS police are busy at work.)
In addition, up to four years after a product is placed on the market, there must be sufficient proof available to indicate the product did not contain materials that exceeded the permitted levels. Ignorance of the law, poor command of a language or lack of common sense will not be acceptable excuses for non-compliance.
Your organization may have developed a Quality Management System, which is ISO certified. The problem is that ISO certification does not address the specificity of the EU RoHS requirements. As it relates to RoHS, is your system adequate? Is it being used and can you prove it?
Having a system in place that no one follows is an exercise in futility and is just as bad as having no system at all. In order to be confident that the system works, periodic or even constant monitoring is required. In creating an efficient working system you must consider all aspects of your business from the design stage through production; from product delivery to product repair.
Design Chain Associates recommends that a comprehensive quality system, if not already in place, be established and implemented. A vital component of this quality system is the audit process. An audit process will serve as an excellent tool to be used by your company as it endeavors to meet the objectives of the RoHS requirements.
The purpose of an audit is to provide a checklist by which a company's ability to comply with the requirements of RoHS regulations is assessed. A controlled system, which focuses heavily on prevention and detection of errors early in the product development process can greatly reduce, if not eliminate altogether, the
risk of producing non- compliant products.
Using an audit program such as the one developed by Design Chain Associates will identify gaps within the production process and allow for appropriate safeguards to be implemented and corrective actions to be taken. The entire quality system must be reviewed or internally audited on a regular basis to ensure that corrective actions occur and remain effective.
Click the link for the DCA sample audit scoring table..
As the product manufacturer, you must be able to demonstrate your ability to consistently ship compliant product. Your existing quality system must be enhanced by incorporating RoHS requirements into the review process. Your training objectives must be updated to include RoHS training, which is both adequately detailed and well documented. It cannot be emphasized enough that such a training program is vital to your success. An effective audit will contain a thorough review of the training program. Although these steps provide a general overview of the scope of a RoHS audit, much more depth and detail is required.
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