In Part 2, the quality function was indicated to be in the best position to make the defense of the relevance, but all too often it has problems of its own and should be the focus of serious organization development.
But there nothing like a data-rich source of information to know how effective the quality system is. Otherwise one is flying blind.
Obstacle 3: There is an Inadequate Management Review of the Quality Management System Performance
- Performance metrics are procedurally established.
- System owners present objective metrics; functional areas own the performance.
- Functional leadership and empowered decision makers are present and active.
The QA Pharm
John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.