Change is an inherent part of the lifecycle of a medical device. It can affect all aspects of Current Good Manufacturing Practice (CGMP), from research and development to production and supply. Change management is a concept that ensures change is implemented in compliance with quality and regulatory requirements. It is the most critical element in a quality management system — inadequate change management creates a risk of non-compliance.
6 Steps to Effective Change Management
Effective change management serves to maintain validated processes and qualified facilities through a series of stages. Following is a breakdown of the actions taken at each stage.
Change management begins with a change proposal, which defines a problem and proposes a solution. The change manager evaluates the proposal and rejects it if it does not meet business objectives. If approved, the proposal leads to the creation of a change order, which details the scope of the required change.
A change control committee consisting of personnel from areas such as quality assurance, manufacturing, regulatory affairs, engineering and sales evaluate the change order and classify the change as minor or major, based on the effects it may impart.
3. Risk Assessment
Classification triggers the need for an assessment of the risks associated with the change order. A risk mitigation strategy is drawn up to reduce any potential risks to the lowest practicable level.
After risk analysis and reduction, the change control committee approves or rejects the change order. If approved, an implementation plan is used to ensure processes, systems, personnel and management are sufficiently prepared for change implementation.
As change takes place, quality assurance and other designated personnel monitor and evaluate the progress toward achievement of all business objectives. The results of their activities provide an audit trail that can be used to demonstrate compliance and inform future change management.
6. Post-Implementation Review
On completion of the change, a post-implementation review is carried out to confirm the change has met its objectives. It also ensure any hazards inadvertently introduced during implementation have been identified and addressed. The results are reported to management for evaluation and then presented as a completed change for stakeholder agreement. If the results are satisfactory, the change is closed and documented.
Effective change management is crucial to maintaining efficient medical device manufacturing. It ensures only necessary changes are implemented and guarantees these changes are evaluated for their effect on quality and compliance.