This information is provided to aid businesses that have limited or no experience with using change control to facilitate management oversight of operational functions such as:

• Documentation management.
• Manufacturing process and product design.
• Implementation and modification of engineered systems.

Changes to SOPs, batch records and other manufacturing documents may be requested and implemented with a documentation management change control system. Changes to manufacturing processes, materials or product specifications may require the use of a design change control system. An engineering change control system may be required for changes to engineered systems such as facilities, manufacturing equipment, process control software, and utility systems.

The level of control imposed by a change control system may vary in accordance with the impact and criticality of the change. Highly critical changes may demand a greater level of management oversight due to the impact on:

• Quality of finished products.
• Validated state of manufacturing systems.
• Compliance with regulatory requirements.
• Training qualification of personnel.

A less critical change may have no impact other than to correct a deficiency such as a typographical error in an SOP. Often times, more than one type of change control must be utilized for a single change. For example, new material specifications will require a design change control that declares the suitability of the new material as well as a documentation change control for revising the SOPs and batch records that reference the material.

Among the benefits of the change control management tool are:

• Formal review and pre-approval by management for requested changes.
• Formal review and post-approval by management for implemented changes.
• Creation of historical records for documenting changes.
• Risk assessment of the impact of proposed changes on personnel training, documentation, validation studies, and product quality.
• Prevention of unexpected deviations as a result of uncontrolled modifications to manufacturing processes, materials and equipment.

Historical records of change controls are often used for troubleshooting process deviations and for regulatory audit purposes. Change control is also a necessary tool for effective project management as a means of:

• Fostering communication.
• Preventing project scope creep.
• Maintaining timelines, budgets and resource allocations.