Module 17 2024

05/12/2024

• Establish Robust Quality Management Systems (QMS) : Implementing a comprehensive QMS helps maintain consistent product quality and regulatory compliance. This system should include detailed procedures for handling unannounced audits. • Conduct Regular Internal Audits: Regular internal audits can help identify and address potential issues before an unannounced audit occurs. It can be particularly beneficial to view your processes through the lens of a regulatory inspector. • Train Employees : Ensure that all employees are aware of the possibility of unannounced audits and know their roles during such events. Regular training sessions can help keep everyone prepared. How can Manufacturers prepare for Unannounced Audits.

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How can Manufacturers prepare for Unannounced Audits

• Maintain up-to-date Documentation: Keep all necessary documentation, such as design control records, material specifications, and batch release records, up to date and easily accessible. • Supplier Preparedness : Inform your suppliers about the possibility of unannounced audits and include this requirement in your quality agreements as a mandatory responsibility of the supplier. Ensure they are also prepared to provide necessary documentation and access. • Communication Plan : Establish a communication plan to quickly notify key personnel when auditors arrive. Assign a point person responsible for coordinating the audit process and ensuring auditors have what they need. Also, ensure deputies are in place for all relevant personnel. • Keep the Notified Body Informed: Ensure the Notified Body is aware of factory closures, holiday shutdowns, etc., including critical suppliers/subcontractors.

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