A Systems Engineering

Approach to Risk Management 9/30/2015 | 8:45AM

Michael Robkin, MBA

President

Anakena Solutions, Inc.

© 2015 Association for the Advancement of Medical Instrumentation www.aami.org

Systems Engineering

Systems Engineering is a cross industry, inter-disciplinary, 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