How do you assess change control?

Question

Accepted Answer

Assessing change control involves evaluating processes to ensure compliance and effectiveness in managing changes.

Evaluate the change request: Ensure it is well-documented and justified, e.g., a new software implementation.
Assess impact: Analyze how the change affects existing processes, e.g., a new procedure may require retraining staff.
Review approval process: Ensure changes are reviewed and approved by relevant stakeholders, e.g., quality assurance and regulatory teams.
Monitor implementation: Track the change to ensure it is executed as planned, e.g., conducting audits post-implementation.
Document outcomes: Record the results of the change to inform future decisions, e.g., lessons learned from a product recall.

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