Ask ECRI: How to Conduct an Impact Analysis

​​A member recently asked for impact analysis resources to use when an organization is considering implementing new procedures, policies, or equipment to ensure that they consider how the change might affect the work of various departments. In our response, we provide an overview of how impact analyses, predictive systems, and failure mode and effects analysis (FMEA) can be useful in this endeavor, as well as provide multiple resources to help guide risk managers in conducting such analyses.

"Impact analysis" is a method used to assist with anticipated changes and is often used in business management. The method provides a broad understanding of the implications of a proposed change and helps a business make informed decisions about which proposals to approve. An impact analysis has three phases:

Predictive systems analyses and FMEA are also useful in evaluating processes, equipment, or techniques in advance of making changes and are often used in the healthcare industry. FMEA is a "bottom-up" approach, meaning that it starts at a task level of the product or process and works its way up to the effects to systems or subsystems. FMEA also analyzes interlinks among devices or systems. FMEA mandates a detailed examination of each potential device to consider how it...