How do you manage and document changes to processes, equipment, or materials?

Auditee: Managing and documenting changes to processes, equipment, or materials is a crucial aspect of ensuring product quality, regulatory compliance, and continuous improvement. Our change control process is designed to systematically evaluate, implement, and document changes while maintaining the integrity of our operations.

Change Initiation: Changes can be initiated for various reasons, such as process improvements, equipment upgrades, regulatory updates, or quality enhancements. When a change is proposed, the following steps are followed:

Change Proposal: The change is formally proposed, outlining the nature of the change, its purpose, potential impact, and anticipated benefits.
Impact Assessment: A cross-functional team assesses the impact of the

change on product quality, regulatory compliance, safety, and other relevant aspects.

Risk Assessment: A risk assessment is conducted to identify potential risks associated with the change. This helps determine the level of scrutiny and testing required.

Change Approval: The change proposal, along with the impact and risk assessments, is reviewed and approved by relevant stakeholders, including quality assurance, regulatory affairs, and operations.

Change Implementation: Once the change is approved, it is implemented with meticulous attention to detail:

Documentation Update: The affected documentation, such as standard operating procedures (SOPs), batch records, and specifications, is updated to reflect the approved change.
Training: Personnel affected by the change undergo training to ensure they understand the updated processes, equipment usage, or material handling.
Validation: Changes that impact critical processes or equipment are subject to validation protocols to ensure that they function as intended and continue to meet specifications.

Change Documentation: Detailed documentation is maintained throughout the change control process:

Change Request Form: The change request form captures all relevant information about the proposed change, including its rationale, scope, and anticipated impact.
Change History: A history of changes, including their approval and implementation dates, is recorded for each relevant document or process.
Verification and Testing: For changes requiring validation or testing, detailed records of these activities are maintained, along with results and any corrective actions taken.
Approval Signatures: All documents related to the change are reviewed, approved, and signed off by designated personnel.

Through our rigorous change control process, we ensure that changes are thoroughly evaluated, documented, and implemented in a manner that upholds product quality, regulatory compliance, and the overall success of our operations.