Frequently Asked Questions: Change Control
What is change control?
Change control is a process used to manage changes to a product, organizational structure, process, equipment, input or methodology so that changes are introduced and controlled in a coordinated manner. The goals of change control procedures are to ensure thorough evaluation and documentation of the change’s necessity, impacts and implementation so that there is minimal disruption to services and a cost-effective use of resources.
Why is change control important to quality management?
The goal of a quality management system is to ensure the ongoing quality and safety of your products and services. Any changes that occur in the process of creating these products and services must be thoroughly evaluated and documented to ensure their integrity and to meet regulatory requirements that hold organizations to these standards.
What regulations require implementing change control?
Both the International Organization for Standardization (ISO), GMP, and the U.S. Food and Drug Administration (FDA) discuss methods for managing change control in their regulatory requirements.
ISO 9001 and ISO 13485 require an organization to have plans in place to manage the change process, review the consequences of unintended changes and prevent or mitigate any adverse effects. GMP guidelines state, “Significant amendments to the manufacturing process, including any change in equipment or materials, which may affect product quality and/or the reproducibility of the process should be validated.”
FDA 21 CFR Parts 210, 211 and 820 all require manufacturers to establish and maintain procedures for the identification, documentation, validation, verification, review, and approval of design and manufacturing changes. In addition, any changes to documents require review and approval by a qualified monitor, and communication of changes to stakeholders in a timely manner.
How is change control different from project management?
While the goals of change control and project management differ, the basic approach to each is very similar – initiate, analyze, plan, execute, close. Change control, however, looks to manage the process of change and predict how it may affect already established systems. Project management is tasked with ushering a team or product from Point A to Point B until the project’s goal is completed.
How can QT9 QMS help me with change control?
QT9 incorporates a robust change control application into its eQMS. The module is able to integrate with related applications, such as corrective actions, deviations, and document control.
QT9 QMS is a total quality solution available at an accessible price point, with 25-plus standard modules that help simplify and centralize quality and compliance. Plus QT9 offers full customer support, an ERP integration and a Business Intelligence tool to help visualize and make informed decisions in real time.
