The Application of HACCP in Clinical Engineering

Hazard Analysis and Critical Control Points, HACCP is a well-established risk management method that has been effectively applied in a number of process settings, including medical device manufacturing. Less common is the application of HACCP to operational processes, such as clinical engineering, including overall management, generic activities, and device specific activities. The advantage of HACCP is that it provides an organized and consistent framework for identifying risks and determining where, how and who will address them. In addition, it provides for monitoring of risk control and it engages the workforce, thus providing "buy-in" of both concept and execution.