Quality Systems, Management Controls, and the Missing 'M' System: Why Quality Systems Don't Work and the Solution to the Ultimate Root Cause - (PPT)

摘要

Does the phrase Quality Management mean the management of quality, or the quality of management? Is a Quality System really a Quality System or is it a Business Operations System? The most recent guidelines on quality systems from FDA and ICH will surprise you. What they do and don't focus on redefines quality and quality systems in a way that will most likely be viewed as a quantum leap forward in the achievement of operational excellence. Quality has always been about management but quality professionals typically haven't made that explicitly clear. The profession's customary use of language and the way the quality function is typically positioned within the organization have substantially compromised the level of business performance that could otherwise be achieved. This session will provide an overview and analysis of these two new groundbreaking guidelines and a discussion of what we have discovered through recent management assessments of top biopharmaceutical companies and the development of performance optimization plans. The results will surprise you too.