compliance

In the ever-changing global economy there is a growing number of product regulatory compliance requirement standards being imposed on manufacturers. Before marketing their products to domestic and international customers a manufacturer must deal with regulatory issues that apply to the development of their products. This results in the manufacturer having to have a regulatory compliance function within his company’s organizational structure that is staffed by competent well-trained personnel. This includes a Compliance Specialist who will need to stay abreast of the steadily changing regulatory compliance requirements, technology advances, and new areas of product regulations. The primary areas where product regulatory compliance requirements are applied are EMC, Product Safety, Environmental Protection, and Energy Conservation. All of these requirements have a direct impact on a product’s development program that includes its quality and reliability attributes.

Being first to market is what enables a company to capture the rewards of an efficient product development program. Among the benefits of such a program is a greater return on investment (ROI), triumph over the competition and increased shareholder’s satisfaction. However, there are pressures such as a slow growth domestic economy, a growing global marketplace and a highly competitive market environment.

The REACH Era
The regulation referred to as REACH (Registration, Evaluation and Authorization of Chemicals), came into effect in European Union Member States in June of 2007. The intent of REACH is to regulate chemicals that can cause cancer and other diseases.

REACH applies to thousands of chemicals (substances) that are used or present in electrical equipment. REACH also applies to mixtures or solutions of substances (preparations), and end products (articles). Substances of Very High Concern (SVHCs), are the most hazardous and harmful substances and are highly regulated. Products containing SVHCs may not receive authorization if a safer alternative exists.

REACH affects all organizations that export, manufacture, or use chemicals. Early planning and good communications are urgently needed to avoid disruptions in the supply chain. Parts and equipment manufacturers will be affected by unexpected withdrawal of substances from their suppliers due to REACH.