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Audit Readiness Tips

Know the key areas FDA will be looking at:

• Complaints
• Recalls & Field Corrective Actions (FCAs)
• CAPAs
• MDRs

Know the QSIT areas FDA will be looking at:

• Management Controls
• CAPA
• Design Control
• Production Process Control
• Supplier Management
• Training

Have an FDA Inspection Plan

• Back room
• Scribes & Runners
• Facilitators
• Subject Matter Experts for each QSR area
• All of the above should be trained and rehearsed

Have an FDA Inspection Plan

• Back room
• Scribes & Runners
• Facilitators
• Subject Matter Experts for each QSR area
• All of the above should be trained and rehearsed

Have a brief but strong opening presentation

• Products, facility, organizational charts
• Make a copy for the FDA auditors in advance

Have the support of Senior Management during the Inspection

• Attendance at opening and closing meeting
• Open door to be interviewed during the inspection
• Commitments at the closing meeting
• Have a "strategy team" to monitor the inspection and jump in as needed

Have a planned presentation on the workings of the Quality System

• Formal presentation
• Handouts for the FDA auditors

Have a "story board" with facts and data for all QSR areas and FCAs

• Show before and after complaint rates

Work with the Facilitator and FDA to make the inspection go smoothly and quickly

• Check-in with the FDA asking if they are getting everything they need for the inspection