Change controls or deviations investigation procedures and it's risk assessment with escalations

Question

Accepted Answer

Change controls and deviations investigation procedures involve risk assessment and escalations.

Establish clear change control procedures to document and track any changes made to processes or systems.
Implement a deviations investigation procedure to identify, assess, and address any deviations from standard practices.
Conduct risk assessments to evaluate the potential impact of changes or deviations on operations and quality.
Escalate significant changes or deviations to higher management for review and approval.
Ensure thorough documentation of all changes, deviations, risk assessments, and escalations for future reference.

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