Many manufacturers are prepping their product development and other departments to meet requirements for regulatory compliance. But cutting-edge companies are going beyond short-term compliance. They are starting to rethink their processes for products under development. Instead of coming at compliance as an after-the-fact checkbox item, these manufacturers are reengineering their business processes and systems to make compliance an integral part of the early design stage.
In phase two, companies address compliance just as they would any other design requirement--for example, design for cost or for manufacturability. Part of the impetus is to establish formal and traceable business processes to avoid missteps that could lead to regulatory fines, product shutdowns, or PR meltdowns reminiscent of what Mattel experienced when it recalled lead-containing toys built by some of its Chinese suppliers. Perhaps the more compelling argument for a design-for-compliance strategy is that addressing the requirements early in the design phase is far more cost-effective and efficient than being forced to make changes closer to production.
Source: Managing Automation, http://www.managingautomation.com