FDA Audit Risk Assessment 2

Answer 10 questions across 9 areas to see where your quality system may carry FDA audit risk.

This assessment covers:

Quality Management System 2 questions

Design Controls & Risk Management 1 question

CAPA & Deviation Management 1 question

Documentation & Data Integrity 1 question

Complaints & Vigilance Reporting 1 question

Supplier & Vendor Management 1 question

Facilities & Equipment Management 1 question

Training & Personnel 1 question

FDA Inspection History 1 question

10 questions · about 5 minutes

This tool is for internal planning purposes only and does not constitute legal or regulatory advice. Review your results with your regulatory affairs team.

Question 1 of 10

How well controlled is your document change history? Document changes are not tracked, or version histories are incomplete Document changes are tracked, but the audit trail is inconsistent Document changes are tracked with a consistent audit trail Document changes are tracked with a complete, independently verified audit trail

Question 2 of 10

What is the status of your design control and risk management process? Design controls and risk management activities are not formally documented Design controls and risk management exist but are not consistently applied across projects Design controls and risk management are documented and applied under a defined process Design controls and risk management are documented, applied consistently, and reviewed for effectiveness

Question 3 of 10

How is CAPA effectiveness verified after a corrective action is closed? CAPA effectiveness is not formally verified after closure CAPA effectiveness is checked informally, without a defined method or timeframe CAPA effectiveness is verified using a defined method within a set timeframe CAPA effectiveness is verified using a defined method and timeframe, with documented follow-up review

Question 4 of 10

How are audit trails and data integrity controls maintained for quality records? Audit trails and data integrity controls are not formally maintained Some audit trail and data integrity controls exist, but coverage is inconsistent Audit trails and data integrity controls are maintained under a defined process Audit trails and data integrity controls are maintained under a defined process with periodic verification

Question 5 of 10

How are customer complaints trended and reviewed for CAPA triggers? Complaints are not trended or reviewed for CAPA triggers Complaints are reviewed individually, but trending across complaints is inconsistent Complaints are trended on a defined schedule to identify CAPA triggers Complaints are trended on a defined schedule, with documented CAPA trigger criteria and follow-through

Question 6 of 10

How are supplier nonconformances tracked and resolved? Supplier nonconformances are not formally tracked Supplier nonconformances are tracked, but resolution and follow-up are inconsistent Supplier nonconformances are tracked and resolved under a defined process Supplier nonconformances are tracked, resolved under a defined process, and factored into supplier requalification

Question 7 of 10

How is equipment calibration and maintenance managed? Equipment calibration and maintenance are not consistently scheduled or documented Equipment calibration and maintenance occur, but scheduling or documentation is inconsistent Equipment calibration and maintenance occur on a defined schedule with documentation Equipment calibration and maintenance occur on a defined schedule with documentation and out-of-tolerance follow-up

Question 8 of 10

How is training effectiveness verified, beyond tracking completion? Training effectiveness is not verified beyond attendance or completion records Training effectiveness is checked informally for some roles Training effectiveness is verified using a defined method for relevant roles Training effectiveness is verified using a defined method for all relevant roles, with retraining triggered by gaps

Question 9 of 10

How often does management review occur, and are its outputs tracked? Management review does not occur on a regular basis Management review occurs, but outputs and action items are not consistently tracked Management review occurs on a defined schedule with tracked outputs Management review occurs on a defined schedule with tracked outputs and verified closure of action items

Question 10 of 10

How prepared is your organization for an unannounced FDA inspection? No mock audits or inspection-readiness practices are in place Inspection readiness is addressed informally, without a defined mock audit process Mock audits or inspection-readiness reviews occur on a defined schedule Mock audits or inspection-readiness reviews occur on a defined schedule with documented roles and follow-up

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Results by area

Priority areas

Responses that may carry elevated risk and are worth a closer look.

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Risk scale

Low 0–20%

Moderate 21–45%

High 46–70%

Critical 71–100%