Change Assessment

The Change Assessment process (often referred to as Change Control or Change Management) is the formal evaluation undertaken by an organization to determine the impact of any proposed modification to its products, documentation, procedures, facilities, or quality systems.

A Change Assessment is the mandatory process of checking if a planned change is safe, effective, and compliant before it is implemented, ensuring the organization avoids unintended negative consequences.

Core Components of Change Assessment

The assessment activities are integral to maintaining a rigorous Quality Management System (QMS) and typically involve the following steps:

Identification and Documentation:

The change (such as a modification to a process, design, or material) must first be identified and formally documented.

Review and Approval:

The change must be formally reviewed and approved by authorized personnel before implementation. For changes to design documentation, the procedures require documentation, review, and approval before release.

Verification and Validation:

The core of the assessment is demonstrating that the change does not compromise safety or effectiveness. This often requires testing:

• For changes to design, production processes, or computer software, the manufacturer must establish and maintain procedures for validation or verification (where appropriate) of those changes prior to their implementation.
• For human cells, tissues, and cellular and tissue-based products (HCT/P), any change to a process must be verified or validated to ensure it does not create an adverse impact elsewhere in the operation.
• For suppliers changing equipment, programs, process parameters, or materials, the purchaser requires written notification to evaluate the impact of the change to the quality of the finished product/service before the supplier implements it.

Regulatory Triggers for Change Assessment

The rigor of the assessment dictates regulatory actions, particularly in the medical device industry:

Premarket Review (FDA): A new premarket notification (510(k)) is required if a device is significantly changed or modified in design, components, manufacturing method, or intended use, where the modification could significantly affect the safety or effectiveness of the device. It is also required for a major change or modification in the intended use.

Premarket Approval (PMA): For high-risk Class III devices that already have PMA approval, a PMA supplement must be submitted for any change or modification that affects the safety or effectiveness of the device.

EU MDR (European Union Medical Device Regulation): When changes are made to a device under the MDR framework, the modification must be assessed in terms of safety and performance, and checked to ensure the device's intended use remains unchanged. If the change affects the device's risk classification or intended purpose, a new conformity assessment may be required.Risk Management: If a change is being implemented, such as modifying a design or process, the risk management scope may be narrowed to focus specifically on analyzing that change. Verification steps for risk controls should be similar to those completed if a design change is implemented through the Change Control process

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