Customer, Supplier and Internal Audits
Mock Audit and Mock Inspection
A mock inspection lets your team practice the real thing under realistic pressure. QMSAdvisor's FDA Inspection Simulator puts an advisor in the investigator's seat, runs document requests on a clock, scores interviews and closes with practice observations, so you find the weak spots while they're still yours to fix.
At a Glance
- Conducted by
- A QMSAdvisor advisor playing the investigator
- Scope
- Selected Compliance Program 7382.850 areas
- Output
- Practice observations and a simulated NAI, VAI or OAI outcome
- Status
- A practice exercise only; nothing it produces is an FDA document
What It Is
A mock inspection, or mock audit, is a rehearsal. Someone experienced plays the investigator or auditor, your team hosts as if it were real, and you learn how your records, your retrieval and your people hold up under questioning.
The FDA Inspection Simulator structures that rehearsal around how FDA now inspects. Sessions are scoped by Compliance Program 7382.850 areas. Document requests come with response clocks, and your back room produces documents from your library. Interviews are scored for answer discipline. Observations stay hidden until closeout, when they're revealed as practice observations along with a simulated NAI, VAI or OAI outcome.
It is always a practice exercise. Nothing it produces is an FDA document, an FDA finding or a prediction of what FDA will decide. What it gives you is a realistic view of where you stand and a list of things to fix, which convert directly into findings in your action plan.
Who Conducts It
A QMSAdvisor advisor plays the investigator, choosing requests and following up the way an investigator would. Your team plays itself: host, scribe, back room and subject-matter experts.
For certification, MDSAP or notified body preparation, an advisor can run a mock audit against that audit's criteria instead of the FDA compliance program.
What Triggers It
- An FDA inspection you expect, such as a PMA pre-approval inspection
- Your first inspection under the QMSR and Compliance Program 7382.850
- New hosts, back room staff or subject-matter experts who have never faced an investigator
- Remediation after a Form 483 or warning letter, ahead of a compliance follow-up
- Upcoming certification, MDSAP or notified body audits
What They Look At
Request Response
How quickly and accurately the back room finds, checks and delivers what was asked for, measured against the request clock.
Answer Discipline
Whether people answer the question asked, stay within what they know, avoid speculation and point to records.
Front Room Control
How the host manages the flow, clarifies requests and keeps the scribe log complete.
Record Quality
What the documents themselves show once they're produced, including gaps you didn't know about.
Risk File Walkthrough
Whether your team can start from risk management documentation and follow it into the QMS areas, the way CP 7382.850 inspections do.
Closeout Handling
How leadership receives practice observations and responds at the closing meeting.
How to Prepare
- 01
Choose the Scope
Pick the CP 7382.850 areas to cover, or go broad if you expect a baseline inspection.
- 02
Load the Library
Upload the documents you already have, so the back room produces from the same records it would use for FDA.
- 03
Assign Real Roles
Use the people who would really host, scribe, run the back room and answer questions.
- 04
Don't Over-Rehearse
Let the exercise surface weaknesses. Coaching people on expected questions beforehand defeats the purpose.
- 05
Plan the Fixes
Set aside time after the session to turn practice observations into owned actions.
Common Pitfalls
- Running a friendly walkthrough instead of a realistic exercise, so nothing useful is found.
- Using stand-ins for the people who would face the real investigator.
- Treating practice observations as a scorecard rather than a to-do list.
- Running one mock and assuming the team is ready, with no repeat after fixes.
- Reading the simulated outcome as a prediction of what FDA will decide.
How QMSAdvisor Helps
- The FDA Inspection Simulator, run by an advisor playing the investigator and scoped by CP 7382.850 areas.
- Document request clocks and a back room that produces from your own document library.
- Interview scoring for answer discipline, with practice observations revealed at closeout and a simulated NAI, VAI or OAI outcome.
- Practice observations that convert into findings in your action plan, with owners, due dates and evidence requirements.
- Repeat sessions after fixes, so you can see whether the changes held.
Mock FDA Inspection
A practice FDA inspection in our Inspection Simulator, with an advisor playing the investigator.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
PMA Pre-Approval Inspection Preparation
Getting Class III manufacturers ready for the facility inspection that accompanies PMA review.
Form 483 Response and Remediation
A structured, evidence-backed response to each Form 483 observation, and the remediation behind it.
Standards and Regulations Involved
Questions About the Mock Audit and Mock Inspection
Is the simulated outcome what FDA would decide?
No. The simulated NAI, VAI or OAI outcome is a practice result to help you prioritize. FDA decides classifications based on its own inspection, and nothing from the simulator is an FDA document.
Who should take part?
The people who would take part in a real inspection: the host, scribe, back room team and subject-matter experts. Using stand-ins hides exactly the gaps you need to find.
How is a mock inspection different from an internal audit?
An internal audit checks whether the system meets requirements. A mock inspection tests how your team performs under inspection conditions: retrieval, answer discipline, front room control and how records look to an outsider. They find different things, and both are worth doing.
Can a session focus on one area?
Yes. Sessions are scoped by CP 7382.850 areas, so you can rehearse a single area, such as complaints and MDR in a for-cause style scenario, or cover the system broadly.
What happens after the session?
Practice observations are revealed at closeout and convert into findings in your action plan. Fixes are then tracked with owners, due dates and evidence like any other finding.
Related Audits and Inspections
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
FDA Non-Baseline Surveillance Inspection
A focused FDA surveillance inspection that goes deep on selected QMS areas under Compliance Program 7382.850.
FDA For-Cause Inspection
An FDA inspection prompted by specific information, such as complaints, MDRs or recalls, and focused on it.
Internal Audit
Audits your own team runs of your quality system, now open to FDA inspection under the QMSR.
Request an Assessment
Prepare for Your Mock Audit and Mock Inspection With an Advisor
Tell us what's coming and when, and an advisor will scope readiness work around it. Please don't send confidential documents yet: secure upload is set up after onboarding.
