Change  Management  within QMS

Agenda

Change management within the QMS provides a centralized approach and resource for managing and executing change within the QMS, and has proven workflow methodologies that can provide a venue for managing change. The approval phase ensures that the appropriate people in each step of the process approve the change. 

Change management involves the selection of strategic approaches to facilitate the transition of from a current state of operation to the new, desired state. More specifically, it involves a process approach and set of techniques to manage the change being introduced. The impetus of any organizational change initiative is to improve some aspect of operations or longer term outcomes. Change projects result in new policies, processes, protocols, or systems to which staff must become accustomed, and change management is used to facilitate the transition.

Change management is essential to sustaining a culture of Quality improvement (QI)  and also to  designing system and process changes that lead to operational improvements, and an organizational culture of quality is one in which concepts of quality are ingrained in organizational values, goals, practices, and processes. In the context of quality, change could be something as discrete as a revised contracts approval process resulting from a QI project, or it could be something as transformational as a complete shift to an organizational strategy and culture that embraces quality. In both cases, structural and process changes are introduced and change management is key to facilitate employee transition to the new state.

Module 1. What is Change Management

Module 2. The Change Management process

Module 3. Current Legislative Requirements

Module 4. Key Change Management Principles

Module 5. Change Control Challenges 

Module 6. Change Control within Pharma and Medical Device  industries

Learning Objectives

 “Change is the only constant in life” according to the Greek Philosopher Heraclitus.  As Quality practitioners we must make modifications and changes at all stages within the entire quality system life cycle so change control is an inevitability in our daily lives. Having a robust change control process can ensure you have the most cost effective use of resources with minimal disruption to services while implementing change. This course is an introduction to Quality Change Control. It focuses on key terms and definitions, regulatory requirements and best practice approaches to support the system. It provides the contextual background for you and employees to understand the importance of the Quality Change Control System.