Developing an Optimized Risk Assessment Portfolio-- The Quality Risk Management Master Plan.

STRATEGIC planning; MANUFACTURING industries; PHARMACEUTICAL technology; MEDICAL equipment contamination; RISK assessment; HUMAN services programs; MEDICAL equipment safety measures; PRODUCT design; QUALITY assurance; GROUP decision making; PHARMACEUTICAL industry; RISK management in business; PATIENT safety; PREVENTION

The article focuses on the evolution of Quality Risk Management (QRM) in the pharmaceutical and biopharmaceutical industries. It discusses the importance of strategic planning, outlines the components of a QRM Master Plan, and emphasizes the need for a flexible and proactive approach in developing a living risk assessment library to better manage risks throughout the product lifecycle.