A Day in the Life… of an FDA Audit

It’s the front desk on the line with those dreaded words, “There’s someone from the FDA here to see you”.

That dread should be a vestige of the early days of surprise visits. These days the FDA operates in a very professional manner, and unless something has been going very wrong, it will be a visit that was by appointment. You should have some notice.

But still …… everyone is a little nervous that their quality system might not stand up to a thorough audit.

Have your plan in place

You (or your QA leader) need to know the routine.

  1. Receive the Auditor
  2. Take them to your Planned Area
  3. Have your people ready to go and ready for introductions so the auditor can meet the players.
  4. Use this as a learning experience even if it’s not your first go round.

Once everyone is settled in the Auditor’s specialty and style will start to show. You can be certain of one thing – they will know at least something of what is going on in your company as they will have reviewed past audits if any or if you have any recent 510(k) filings.  

This will start them down the road to looking at everything from Design Controls to Manufacturing Systems to Sales Processes.

So what do you do?  

If you have your house in order this can be a time to shine and show off the understanding and diligence your company has with its Quality System.

Do remember the audit is a two way process. If they don’t already know you, the auditor will be learning your system. And as no two systems are identical, sometimes you will have to point out how your system handles a situation.

In return you have control to immediately resolve a point that, if not addressed, could result in an observation or even a warning in the Audit Summary.

Customer Complaints

Many Auditors start with Customer Complaints giving them the opportunity to work backward through your system. They will want to know:

  1. How do you receive and record Customer Complaints?
  2. Who is the responsible individual?
  3. What actions do you take for analysis?
  4. What corrective actions are performed if deemed necessary?
  5. How did you monitor the effectiveness of those corrective actions?

And that‘s just the start!

Manufacturing Process Questions

From there they can turn to how that product was manufactured. These questions will sound like this:

  1. Can you trace that device from the complaint through the process?
  2. What was the lot number?
  3. What was the production process?
  4. Were there work instructions?
  5. Were the individuals trained?
  6. Can you prove they were trained?
  7. Was the equipment calibrated?
  8. How frequently?
  9. Can you show them proof?
  10. Can you identify which components were used in what device?
  11. Can you trace the components back to the supplier?
  12. How were those parts inspected?
  13. What sampling method was used, and why?
  14. By the way how did you determine whether that supplier was qualified to produce the component?
  15. How and how often do you audit them?

Validations and Verifications

Speaking of manufacturing:

  1. Was your manufacturing process validated?
  2. Oh, that first validation is part of your design process – Can you explain that?
  3. OK you have the Design History File for the Device and you started with an Opportunity Analysis to see whether it would fit your portfolio or growth direction and when you determined it did what did you do?

What Do Auditors Want to See?

It’s always helpful to have a list of the kinds of things the auditor will be looking for and expecting in their review:

They will be happy to see Design Inputs and corresponding Design Outputs through the process. You’ll also want to show a good Development Plan showing responsibilities and timelines. Design Reviews conducted at appropriate project thresholds are important as well.

Project Updates and notes are there. Proper FMEA’s were performed and actions were taken, Risk Analysis was performed.

You have performed your Design Validation to confirm the design specification meets the user needs and intended use. Is the Design Verification in there?

There it is, showing through testing and evaluation the design meets the finalized Design Inputs. Looks like there were some design changes along the way – do you have an Engineering Change Order system in place and was it used?

Ah there are the Manufacturing Validations. All the IQ, OQ, PQs are there and everything was found capable – excellent.

One final check on the Design Transfer process and whether all appropriate sign-offs are there, and it’s time for Sales and Marketing to be looked at.

Tired yet?  You can’t stop now!

The Auditor starts on the Sales Process using the Customer Complaint as a basis. Can Customer Service tell them if there were other devices from that lot that were sent to other facilities, and how many to each and were there other complaints?

Remember we talked about traceability – it doesn’t stop in manufacturing. Was the failure that initiated the customer complaint serious enough to file an MDR (Medical Device Reporting), and if not why not?

Can they review the customer complaint? – certainly but remember they do not need to see the Customer Complaint Log. Have all relevant documentation ready to review but no more than requested.

How was the Customer Complaint handled internally and was a root cause analysis performed?

Was your Corrective and Preventive Action System in place and used well? Was the Corrective Action appropriate and followed up on for effectiveness?

Hey while we’re here do you have a Customer Feedback Procedure? You do – do you lead that back into your Corrective and Preventive Action process?

OK even your Auditor is tired now

Give them a quiet undisturbed place to prepare their documents for wrap up.

When they are ready gather together the appropriate staff. There should not be any surprises in the wrap up as you should have worked to resolve questions during the Audit.

Any Auditor worth their badge will have some comments even if they have no observations, and no system stops needing improvement. Take them as constructive, but if incorrect politely disagree and be prepared to provide evidence otherwise.

Again a good working relationship should have evolved over the period of the audit and it’s best to resolve easily disputed items before they leave.

So you are done! Well not really. Any action items need to be entered into your Corrective and Preventive Action system and you can be sure the Auditor will review what has been done on them next time they visit.

Managing the effects of being Audited

So how did you get to the point that an Audit is just part of the business and not a traumatic event?

Involve everyone in the company from the bottom up. Have shop floor workers, customer service reps, engineers, human resources, finance, and management be educated in the corrective action process and how to make suggestions by using that process as the mechanism for introduction into the system.

These ideas from the people involved directly in every process can be hugely valuable.

Make them responsible for knowing the quality process for their area, and holding them accountable to follow process.

Have cross functional internal audits – create audit guidelines and train smart detail oriented individuals from each specialty as internal auditors and let them audit areas outside their own area of expertise.

Be audit hungry – both internally and externally – make sure everyone that supplies to you has systems that can withstand scrutiny.

Welcome outside audits, even to the point of bringing in independent consultants to give an objective view. There is nothing better than cross pollinating systems to find weaknesses and strengths.  

Who the heck am I, and do I advocate a QA Monarchy?  I am a mechanical engineer by training and past Vice President of Operations for a medical device company. I do not advocate any individual function for single guidance but rather a system that utilizes effective processes of all kinds that allow everyone go home and sleep well at night not waiting for the inquisition.


RoyMellingRoy Melling – Partner

Roy joined Innovate in 2004, bringing with him a background in development of consumer electronics and health care products.

Whether bridging the gap between design and manufacturing or dealing with medical device compliance, Roy has extensive knowledge in the manufacturing end of product development, both domestically and overseas.

If you like, you can always connect with him directly on LinkedIn.

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