FDA Audit Risk Assessment

Answer 10 questions across 7 areas to see where your quality system may carry FDA audit risk.

This assessment covers:

Quality Management System 3 questions

CAPA & Deviation Management 1 question

Documentation & Data Integrity 1 question

Complaints & Vigilance Reporting 1 question

Supplier & Vendor Management 1 question

Training & Personnel 1 question

FDA Inspection History 2 questions

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 current are your SOPs? SOPs are outdated or do not reflect current practice Some SOPs are current, but review is inconsistent Most SOPs are current and reviewed on a defined schedule All SOPs are current, reviewed on schedule, and consistently followed

Question 2 of 10

How robust is your Change Control process? Changes are made informally with no documented process A change control process exists but is not consistently followed Change control is documented and generally followed Change control is documented, consistently followed, and includes risk assessment

Question 3 of 10

What is the status of your internal audit program? No internal audit program is in place Internal audits occur but are irregular or incomplete Internal audits occur on a regular schedule Internal audits occur on a regular schedule with documented follow up and closure

Question 4 of 10

How are CAPAs and deviations identified, investigated, and closed? CAPAs and deviations are not consistently identified or tracked CAPAs and deviations are tracked, but investigation and closure are inconsistent CAPAs and deviations are tracked with defined investigation steps CAPAs and deviations are tracked, investigated, and closed within defined timeframes

Question 5 of 10

How are records and documents controlled and maintained? Records and documents are not consistently controlled Some records and documents are controlled, but practice is inconsistent Records and documents are controlled under a defined process Records and documents are controlled under a defined process with regular verification

Question 6 of 10

What is the status of your MDR / Vigilance reporting process? No defined process for MDR or vigilance reporting A process exists, but timeliness or completeness is inconsistent A defined process is followed for most reportable events A defined process is followed consistently and meets reporting timeframes

Question 7 of 10

How are critical suppliers qualified and monitored? Critical suppliers are not formally qualified Critical suppliers are qualified, but ongoing monitoring is limited Critical suppliers are qualified and monitored on a defined schedule Critical suppliers are qualified, monitored on a defined schedule, and reassessed as needed

Question 8 of 10

How is personnel training managed and documented? Training is not consistently documented Training is documented, but records are incomplete Training is documented and tracked for most personnel Training is documented, tracked, and verified for all relevant personnel

Question 9 of 10

What is the outcome of your most recent FDA inspection? The most recent inspection resulted in significant observations The most recent inspection resulted in several observations The most recent inspection resulted in minor observations The most recent inspection resulted in no observations

Question 10 of 10

Have 483 observations from prior inspections been addressed? Prior observations have not been addressed Some prior observations have been addressed Most prior observations have been addressed and verified All prior observations have been addressed and verified as closed

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Your results

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%