According to the FDA, you are required to have controls in place that address design changes. The verbiage in 820.30(i) states that “each manufacturer shall establish and maintain procedures for the identification, documentation, validation or – where appropriate – verification, review and approval of design changes before their implementation.” The purpose of documenting Design Change is to ensure that all changes and documentation are carefully controlled in order to prevent implementation of inappropriate changes to an established design.
There are two aspects of design change that need to be considered: document/process control and design change control. The first one is easy to address – all documents related to a design (design documents, drawings and other items of design input or output which directly correlate to the design) need to have a way to track their status and revision history. Process changes alter the process control methods (documents), but are not intended to alter the design. The second concept is more complex, as this includes control of deficiencies and their corrective actions as well as tracking their resolution. Simply put, design change is an alteration of the device’s basic design. Changes to a design are usually initiated due to a field or quality problem.
The main objectives with design change documentation is to prove that corrective actions have been tracked to completion, changes are put in place to fix a problem while not creating new issues, and appropriate documents get updated/revised. It is important for the procedures involved in design change to include a requirement to re-verify and re-validate the design. While all changes to a device are considered design changes, not all changes require design control (validation and/or verification). Should you decide that design control is not necessary, you are still required to document this decision and why it was determined these tests were not needed to be conducted prior to approving and implementing the change(s).
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