How do you handle change control, incidents, and deviations?

Question

Accepted Answer

I handle change control, incidents, and deviations by following a structured process and ensuring effective communication.

I establish a change control process to document and track any changes made to systems or processes.
I prioritize incidents based on their impact and urgency, and promptly address them to minimize disruption.
I investigate deviations from established procedures, identify root causes, and implement corrective actions.
I maintain clear communication channels with stakeholders to keep them informed about changes, incidents, and deviations.
I regularly review and update change control, incident, and deviation management procedures to improve efficiency and effectiveness.

Accepted Answer

Change Control: Within quality management systems and information technology systems, change control is a process—either formal or informal—used to ensure that changes to a product or system are introduced in a controlled and coordinated manner.

Incidence : Any unplanned or uncontrolled event in the form of non-compliance to the designed systems or procedures at any stage of testing, and storage of drug product due to system failure or equipment breakdown or manual error.

Deviation: A deviation is any unwanted event that differs from the approved processes, procedures, instructions, specifications, or established standards. Deviations can occur during the manufacturing, packing, sampling, and testing of drug products.

How do you handle change control, incidents, and deviations?

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