Application of Quality Risk Management to Non-Production Processes in the Pharmaceutical Quality System

Since the publication of ICH Q9, Quality Risk Management, in 2005, there has been much written about its application to the production process, to product development, and to validation. Relatively little has been published about its application to some of the production supporting processes that are an important part of the pharmaceutical quality system. Annex 2 of ICH Q9 discusses the application of quality risk management to some of these supporting processes: change management/change control, quality defects, auditing/inspection, documentation, training, calibration/preventive maintenance and periodic review. In this course, we will present models of various supporting processes that integrate quality risk management into their design. This use of quality risk management should result in more effective and more efficient processes.

The real benefits from quality risk management arise when it is embedded in all processes, routine activities and the culture of the company. It is a way of thinking. We start toward achieving this goal by redesigning our processes and their accompanying procedures to contain risk analysis as a formal and integral part of the process. In the analysis of risk, we will consider severity, the consequences if a failure occurs, and the probability of failure.

Another neglected aspect of quality risk management that will be discussed briefly in the course is biases/errors made in the estimation of severity and especially the probability of a failure. The course will focus on how to recognize these biases and on how to reduce their influence so that more accurate estimations of severity and probability are obtained. Thus, better decisions can be made.

Who Should Attend

Quality and production managers will benefit from taking this course.

Prerequisites

Students should read ICH Q9 before the course.