The word “holistic” very much embodies the approach needed today to maintain quality control in complex manufacturing, while simultaneously advancing business innovation and competitive domination. At the root of this monumental challenge lie two distinct groups – quality management and product development – both of which operate within distinct environments in manufacturing organizations.

For the sake of quality, this distinction must now disperse and make way for symbiotic and standardized behavior between the two teams so the company can embrace, rather than deflect, the ever-tightening demands of regulatory and consumer scrutiny and make way for continued innovation. This coming together and streamlining of once-disparate business functions will give the organization the strength and focus it needs to thrive in this new world of micro-oversight and competitive shrewdness. For our purposes, this new model of enabling both quality and innovation simultaneously will henceforth be referred to as “standardized innovation.”

The fundamental enabler that lies at the very core of standardized innovation is enterprise-level centralization. With such macro-level harmonization comes significant business enhancements such as higher-quality production, more robust R&D, increased operational efficiency, reduced costs, faster time to market and compliance with all necessary external requirements – both governmental and consumer-driven.

Compliance Pressures
In the wake of major product recalls, tarnished brand images and faltering corporate bellwethers, we see perhaps stricter governmental and consumer-driven pressures than ever before to ensure quality production and adequate product safety. On the regulatory side, there are countless agencies attempting to enforce quality control. A few examples of the U.S. agency-enforced quality control initiatives include:

• The FDA’s Good Manufacturing Practice (GMP) requirements set forth by the Food, Drug and Cosmetic (FD&C) Act “…requires that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of finished medical devices intended for commercial distribution in the United States.” With this act comes substantial safety, quality and environmental requirements and mandates at every stage of the product lifecycle.
• The EPA's Metal Products and Machinery rule “establishes national technology-based limits on pollutants in wastewater discharges from facilities that manufacture, rebuild or maintain metal parts, products or machines.” These limits protect the environment but also challenge a business's operational efficiencies.
  
• OSHA’s strict regulatory enforcement places mandates on machine safety, personal protective equipment, safety warning labels, electrical equipment and more.

While each of these regulatory policies are certainly designed to protect the public and the environment from any undue harm, they can also consume a manufacturer’s precious limited resources, potentially leading to production delays, missed market opportunities, inflated costs, regulatory violations, brand pressures and so on.

A centralized, enterprise-wide quality control and regulatory compliance mechanism would help to solve many of these business challenges – ensuring the valuable resources are spent on innovation rather than regulatory compliance.

All large manufacturers around the world face these quality and compliance issues every day, and many have already sought and deployed centralized software systems to help streamline processes, ensure compliance and drive quality. However, there are also a significant number of complex manufacturers across the globe that rely on home-grown, paper-based or disparate and departmentalized point solutions to serve their needs.

These solutions have obvious limits on capability, scalability and effectiveness. As an organization grows, either organically or through mergers, so does its need for an enterprise-wide quality management solution that can scale along with it and continue to meet its requirements.