4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer

May 24, 2016

first time

As an engineer, there’s not a lot that makes me nervous. Going through an FDA / ISO audit? That makes the top of the list in my book.Not too long ago, I was the lead engineer for a medical device development project.  

The company was going through an audit, but I assumed I’d be “safe” and wouldn’t need to be involved.  

I was wrong about that.  They had selected my project as one to audit, in order to show we were following our design and development process.  

It was my very first time ever being audited and I’d had zero practice/preparation for it.  

Although the auditor was really friendly, I still found my hands shaking as I started opening up my design history file (DHF) and handing her documents.  

The worst part was the silence.  

She’d sit there silently reading our corporate policy and making checkmarks as she found the items in the DHF.  

With her pen hovering over the paper, she’d look up and ask a seemingly simple question – and then stare at me for several seconds after I had answered.  

I’d find myself wanting to fill that silence with more, whether she’d asked for it or not.

If you’re involved in the design or manufacturing of medical devices, you might have a similar story.

In fact, if you start googling for information about FDA / ISO audits, you’re going to find a bunch of these stories – and information on how to prepare for them.  

Everyone gives the very helpful advice of practice.  It’s great advice, but it never seems quite adequate for me.  

Here’s what I really wish someone would have told me in advance.


1. Be ready for the silent stare.

They always tell you that you should be brief when answering questions.  

That you should only give the exact information that is asked for.  That more often than not, it means answering with a yes or no response.  

What I wish they had told me was what to do after I answered the question.  

After answering the auditors question, silently count to 10.  

No one likes awkward silence.  You know this.  Auditors know this.  

Auditors use this to their advantage.  They’re counting on you wanting to fill the silence.  

If you silently count to 10 after answering, chances are that you’ve adequately answered the question and the auditor is going to move on to the next question.  

If the auditor hasn’t said anything by the time you reach 10, do it again.


2. Don’t assume.

While everyone tells you just to answer the question asked, during the audit that can be hard to do.  

It’s human nature to want to be helpful and provide additional information and clarification.  

So when the auditor asks “Do you have a policy for this?” you’re going to want to answer “Yes, here’s what we do.”

Listen to the question and answer what was asked.

If the auditor asks a question that starts with “do you have…”, they are asking a yes or no question.  

If they want information on what you do or how you do it, they’ll follow-up with additional questions.


3. It’s okay to refer to the company policies.

Very few people have 100% perfect recall.  

Add in stress and our memories are even less perfect.  That’s okay!  

Auditors don’t expect you to have everything memorized.  They don’t award extra points for it.  

When an auditor asks you how you do something, you can refer them to the appropriate policy.

In fact, it’s better to say “when I do X, Y, Z...I refer to SOP-123 and follow the procedure listed there”, then it is to say “I think I’m supposed to do abc, but I’m not really sure”.  

That’s why the policies are written and readily available.  Just make sure you know which policy to consult…


4. Take advantage of internal audits. 

You can be involved in the required internal audits and use those as practice.  

Ask the internal auditor to provide feedback on the things you did well and what you need to improve on.  

It’s a lot less intimidating to be in an audit with your co-workers. Once you’ve been through it a few times internally, it’s a lot less scary.

At the end of the day, no matter how many times you practice, it’s likely still going to cause your heart to race when you get pulled into an audit.  

That’s okay!  

Take a few deep breaths and remember these keys to success.  I bet you’ll find out, like I did, that it’s not nearly as scary as that first time.

how to respond to FDA 483 observations and warning letters PDF download


Jesseca Lyons is a Senior Medical Device Guru at Greenlight Guru and a Mechanical Engineer by trade who loves working with cross functional teams, including both engineering and non-engineering disciplines. She’s spent most of her career gathering and defining requirements for new product design and development in the...

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