Regulatory and Statutory Compliance: Its Everybody’s Business (Presentation)

Diana Lough gave this presentation to Pikes Peak ASQ in September 2009.

Regulatory and Statutory Compliance: It’s Everyone’s Business

09 Sep 2009 ASQ Presentation by Diana Lough

TITLE: Regulatory and Statutory Compliance:It’s Everybody’s Business

Regulatory and statutory compliance has long played a part in business. Traditionally the emphasis has focused on the safety and efficacy for raw materials, components, sub-assemblies and finished products sold. It often included third-party testing resulting in a listing or mark on the product and for finished products and/or it may have required a registration or license with a government agency. Where there are regulatory and statutory requirements, compliance is mandatory and enforceable. Failure to comply can result in product confiscation, lost future sales, fines, and in severe cases, plant closures and legal prosecution. No matter the scale, failure to comply requires time and resources (and therefore money) to resolve the issue along with interruption to the business and failure to meet customer needs.

In today’s global marketplace, more governments are increasing “protection” for their citizens. More countries are following in the footsteps of Europe, Japan and Australia by requiring product registrations and in-country representation. Medical device exports have more stringent requirements.In some countries, medical and consumer product labeling and/or instructions for use must be translated in their official language.

And with the changing emphasis on the environment, the impact has broadened and more statutory requirements are coming into play. Local laws and ordinances may govern your organization’s waste stream, nuisance control and other negative impacts on the environment. Depending on the destination market for your product (national or international), there may be statutory laws regarding the product’s packaging (content and disposal) and the end of product life disposal. Legislation for banned chemicals is more commonplace, particularly in Europe and Canada. And transportation of goods even has country-specific restrictions.

So what business processes are impacted? New product development and design changes are still a primary focus. But regulatory and statutory requirements also impact marketing, sales, manufacturing, shipping and transportation, disposition of nonconforming material, facilities management, complaint handling, documentation, record keeping, and management. A brief overview of process controls for each of these will be covered.

The sky isn’t falling by any means. By ensuring your business processes are defined and implemented with adequate controls, your organization will maintain compliance and keep up with our changing world.