At the end of this blog I provide information for obtaining your free survey to use at your company to facilitate a discussion on the health of your Quality Management System.
- Vision—the aspirational view of the future, and how Quality Management is integral to the business strategy for operational performance and continuous product availability to patients;
- Leadership—the top business unit and functional heads who motivate, align, plan, and engage the organization toward its quality goals;
- Standards—endorse the policies and norms, which establish the quality requirements—the interpretation of laws and regulations to your operation—the “what” is required;
- Oversight—the communication channels and forums that give Leadership visibility to product quality and compliance risks and trends—in order to make effective data-driven decisions—and provide Leadership the means to exercise management responsibility.
- Management System—the totality of policies, standards, processes that directs and controls activities with regard to quality;
- Processes—to ensure consistency and intentional ways of working when applying the standards to your operation—and to control variables, including the human variable;
- State of Control—quality is about controlling variation, and the Pharmaceutical Quality System provide the capability of self-detecting and self-correcting problems and give us a clear picture of our current state of control.
- Continuous Improvement—knowing the top regulatory compliance risks at any give time and having project teams directed toward resolving them with verifiably effective solutions.
- Execution—they manage the daily operation of the quality processes described in procedures and ensure procedures are effective;
- Maintenance—they ensure that the quality process remains current with regulatory requirements and industry practices; and remain applicable to your changing business;
- Performance—they measure how well the process is working and identify problems with the process, and problems that the process detects—and always seeking ways to meet the requirements in the most efficient way.
- Escalation—they identify unacceptable conditions or events that puts the patient and the business at risk—and take the immediate actions necessary to mitigate the risk, and make recommendations for permanently solving the problem.
The QA Pharm
The QA Pharm is a publication of John Snyder & Company, Inc.
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.
Contact us at firstname.lastname@example.org.