Systems Engineering Systems Engineering is a cross industry, interdisciplinary, universal and all-inclusive methodology meant to provide technical and managerial discipline to a project wherever and whenever it is found lacking. The methodology intends to strongly persuade and bring about a determined plan of action for establishing accountability, order, logic and coordination wherever and whenever it is needed throughout an entire project life cycle. Resulting in the project’s end product/system/service successfully meeting the customers’ expectations and fulfilling formalized need statements.
You’re Already Doing Systems Engineering • GMP and QSR are based on (+/- 90’s) Systems Engineering practices. • But the Silo-ing of Risk Management and the assumption that quality and safety can be “tested in” has made RM and 14971 compliance appear to be barrier and a cost. However…..
Quality is Free - Philip Crosby
Source: Nancy Levenson
More than Just Engineering • Systems Thinking: Include the entire system in your problem => Ask the right question • Systems Analysis: Breakdown the problem into its components => Find the simplest correct answer • Systems Engineering: Manage complexity through processes and feedback => Deliver the right solution.
Healthcare Lacks Systems Thinking FDA regulation does not match the scope of Healthcare Systems’ definition of hazards, risks, and quality.
Two Medical Devices:
Pulse Oximeter
Monitor Standardized Interface
What is the System?
Now What? One size of does not fit all - Healthcare has unique Systems Engineering needs.
Summary Systems Engineering is holistic realization of multiple engineering and management disciplines. It adds value to existing standards and techniques. With SE: • Risk Management > 14971 • Quality Management > 13485 • Safety and Effectiveness > 60601