The first element is Quality Governance. This is the body that provides:
- the Vision—the aspirational view of the future, and how Quality Management is integral to the business strategy;
- the Leadership—the top business unit and functional heads who motivate, align, plan and engage the organization toward its quality goals;
- the Standards—the policies and standards that are endorsed by Leadership that establish the quality requirements—the “what” is required?
- the Oversight—the communication channels and forums that provide to Leadership the direct visibility of product quality and compliance risks and trends—in order to make effective data-driven decisions.
- establishes the Document Architecture—the hierarchy of the official, approved written instructions and executable records;
- implements the Procedures—the processes—or the “How” to apply—the requirements of the Standards to your operation;
- maintains Control—quality is about controlling variation, and the Pharmaceutical Quality System establishes your intentional and consistent ways of working to control variables—including the human variable—to operate in a state of control.
- includes the Records that captures the product history and the manufacturing and environmental information that surrounds it.
- Execution—the daily management of the quality processes described in procedures to ensure it works and is being followed;
- Maintenance—to ensure that the quality process remains current with regulatory requirements and industry practices; and remains applicable to your changing business;
- Performance—the measurement of how well the process is working and being managed, as well as the problems and opportunities the process is detecting;
- Escalation—the identification of unacceptable conditions or events that puts the patient and the business at risk—and taking the immediate actions necessary to mitigate the risk, and making recommendations for permanently solving the problem.
John Snyder & Company, Inc.
Also, find me on LinkedIn for peer-reviewed articles on Quality Management System Topics.
The QA Pharm