Managing Change for Continuous Improvement in a Regulated Industry

Managing Change for Continuous Improvement in a Regulated Industry

Marcos Batan
Carestream Health Inc.

The lack of an effective process for controlling change will lead to a chaotic manufacturing environment. Unexplained failures, increased variability, excessive waste and non-conforming product are common results of that scenario. For a medical device manufacturer, effective change control is not optional. It is a requirement under the title 21, part 820.70 of the Code of Federal Regulations. It is also essential for sound traceability of the product affected by the change and its recall if needed. The traditional interpretation of that requirement led to efforts to limit changes. However, in an ever changing business environment where continuous improvement is imperative, that approach can result in declining financial results and loss of competitiveness. Instead, a fully functional change management program, with focus on the life cycle of the change, may provide the framework for the regulatory control without stopping beneficial changes. In this presentation, I will discuss strategies for companies to create competitive advantage through continuous improvement in a regulated environment where changes have to be documented and controlled.