ISO 9000 & AUDITS WORLD CONFERENCE

Integrating Visual Risk Management Throughout the Quality Management System

Presenter:   Daniel William Burgess FRQA, Chief Compliance Officer, Pharm-Olam, Houston, TX, USA

Keywords: Risk Management, Risk Communication, Integration of Risk Management, Living Processes

Industry: Healthcare

Level: Advanced

ABSTRACT

Risk management is misunderstood to mean the task of risk assessment rather than a system of connected risks and controls. Risk management must include the actions taken to control risk. Control over risk is, coincidentally, the primary goal of a quality management system.

Therefore, Risk management must be integrated throughout processes and projects, not as an afterthought/ add on. Risk based procedures defining their measures of effectiveness are an example of how to gain control over risk at the system level. Providing visibility of effective control and risk communication is the primary goal of risk management. The bowtie method of risk assessment allows strategic thinking and visual demonstration of risk exposure. Visually demonstrating control over identified risks is the clearest way to provide evidence of a risk-based quality management system.