Regulatory and statutory compliance has long been involved in business. Traditionally, the emphasis has focused on the safety and efficacy for raw materials, components, sub-assemblies and finished products sold. It is often accompanied by testing a third party resulting in a listing or logo on the product and finished products and / or it could have required registration or licensing of government. Since there are rules and provisions, compliance is mandatory and enforceable. Failure to comply can result in confiscation of goods, lost future sales, fines, and in severe cases, plant closures and prosecuted. The same extent that non-compliance requires time and resources (and the money) to resolve the issue of disruption of operations and failure to meet customer needs.
In the global market today, more governments are increasing “protection” for their citizens. More countries are to follow in the footsteps of Europe, Japan and Australia by requiring product registration and country representation. Medical devices have stringent export requirements.In some countries, medical and consumer product labeling and / or instructions for use and must be translated in the official language of.
And with the changing emphasis on the environment, the impact has broadened and more provisions come into play. Laws and provisions, may manage waste your organization, nuisance control and other negative effects on the environment. After a destination market for the product (national or international), it can be statutory law on the packaging of the product (content and disposal) and end of life product disposal. Legislation for a banned substance is common, especially in Europe and Canada. And the transport of goods has even country-specific restrictions.
So what business processes are affected? New product development and design changes are still primarily focused. But the rules and provisions also affect the marketing, sales, manufacturing, shipping and logistics, disposal of substandard materials, facilities, complaint handling data, registration, and management. A brief overview of the process control for each of these will be discussed.
The sky is not falling in some way. By ensuring your business processes are defined and implemented with adequate controls, your business will maintain compliance and keep up with our rapidly changing world.