Operational Risk Solution
Quality Risk Management Enables Operational Excellence and Enterprise Sustainability
Recalls happen. It’s a fact of life and business and there is no surefire way to prevent them. But in reality, there are no new events, companies need to be able to plan for adverse events and mitigate the impact.
Depending on the size, scope and issues pertaining to a recall, it is often forgivable by everyone from consumers to partners. But what happens when one recall turns into five? And the items being recalled aren’t household products or electronics, but medicines and medical devices that consumers rely on for their health?
What happens when quality control spins out of control?
The core challenge of achieving quality is fundamentally a knowledge management and continuous improvement problem. The enterprise market has recently seen the emergence of Quality Risk Management as an enterprise software category aimed at fundamentally changing how manufacturers go about designing and manufacturing their products from a quality perspective.
Quality Risk Management is unique because it is characteristic driven, strongly dependent on knowledge management, and emphatically cross-functional in its need for communication and linking.
Fundamentally, QRM centers around one central concept: characterizing products and process such that critical characteristics that impact quality are identified and controlled across the entire product and process lifecycle. QFDs, FMEAs, Design Verification, Design of Experiments (DOE) all, ultimately, do one thing: identify characteristics and controls. To avoid repeat issues and failures, you must: 1) find the right characteristics and controls; and 2) manage them so we apply the best practices we discover on similar future and current programs.
This paper outlines the core principles of Quality Risk Management and provides a roadmap for improving continuous improvement in your organization.