FDA Audit Procedure - SOP - Small Medical Device Company

[Microbe]

Hi,

It's been a long time since I posted, for which I can only say sorry!

I work for a small medical device company based in the UK. We have quality systems geared towards the EU, but are now in the process of adapting them to the FDA's requirements. It has been suggested that we generate an FDA audit procedure so that everyone is aware of what is expected of them prior to an audit. Does anyone have an SOP that they would be willing to share with me?

Many thanks

Microbe

 

[howste]

Re: FDA Audit - SOP

What would be the content of the procedure? How to pass an audit? I would think that an "awareness training session" for all employess might be more appropriate. The purpose would be just to let them know what to expect during the audit, and to answer any questions they may have.

 

[MIREGMGR]

Re: FDA Audit - SOP

Does anyone have an SOP that they would be willing to share with me?

This FDA QSIT explanatory document is not a procedure per se, but it might meet your need for a means of educating your people as to what the FDA expects:

Moderator note: THe QSIT link originally posted here expired - see the new link in post #11 below...

 

[RickRay]

Re: FDA Audit - SOP

Yes instead of a procedure perhaps a yearly training session to keep everyone sharp and focused. Here are a few things to think about to get things started:
- Examine the credentials of the inspector (identification). Look but don’t photocopy.
- Contact the RA/QA Manager to alert them to the inspector’s presence.
- Set the proper tone. Be available, professional, polite and cooperative.
- Provide the inspector with a place to work. Keep the room free of clutter. If there are any cabinets or drawers in the room, keep them locked.
- Have records and source documents available. Provide only requested records.
- Confirm with the inspector his/her preference for handling issues and queries.
- Provide the appropriate pager number and paging instructions in case he/she needs to reach you prior to the agreed meeting time. Remember to track all requests from the inspector and make photocopies, if appropriate.
- Do not volunteer information; just answer all questions briefly, honestly and accurately.
- Know what you are talking about before you say anything and can back it up with documentation. If you are not sure how to answer a question or do not feel comfortable answering a question, do not be afraid to say “I will have to get back to you on that.” Then seek advice on how to answer the question.
- Escort the inspector at all times during the audit.
- Limit your hospitality. The inspector may interpret your actions differently than you intended them.
- Appoint someone to document the information from the Exit Interview. This person should not be distracted by participating in the discussion. Remember tape recorders are not permitted.
- Be diplomatic when pointing out any observation that has been corrected since the beginning of the audit. Being argumentative will not be constructive and could make things worse.
- If any observation noted deals with not meeting FDA regulations, carefully point out that the regulations are subject to interpretation.
- If it is clear that corrective action is necessary on an observation, and it is clear what the action to be taken is, indicate that you plan to take appropriate corrective measures on that observation immediately.
- Do not commit yourself to a future action that you do not intend to make or cannot undertake.

 

[spursqa - 2009]

Re: FDA Audit - SOP

Hi,

Thanks This is helpful to me too.

Does anyone have an example of an FDA building Inspection SOp, or know what should be in it?

Many thanks

 

[Shamann2]

Re: FDA Audit Procedure - SOP

I recently worked for a tiny medical device company that was going to have an announced FDA inspection. Because only one other person in the company had ever experienced an FDA inspection, I wrote a procedure with step by step instructions for the receptionist and others in the organization. We had training and even did a dry run of the "inspector" coming through the door. I'm so glad we did the practice run because our poor receptionist was so flustered when I came throught the door and announced that I was with the FDA that she stammered and mixed everything up. We ended up doing the dry run 3 times.

When the inspector finally showed up, people knew what they needed to do, how to find the documents that would probably be requested, and how to answer questions.

I'll see if I can find a copy of the procedure I wrote and I'll post it here.

Sue

 

[Ajit Basrur]

Re: FDA Audit Procedure - SOP

Hi,

It's been a long time since I posted, for which I can only say sorry!

I work for a small medical device company based in the UK. We have quality systems geared towards the EU, but are now in the process of adapting them to the FDA's requirements. It has been suggested that we generate an FDA audit procedure so that everyone is aware of what is expected of them prior to an audit. Does anyone have an SOP that they would be willing to share with me?

Many thanks

Microbe

Firstly, welcome back

Currently, I am writing a procedure on "Handling Regulatory Inspections". If you dont mind the wait, I can share. My procedure should be ready by the end of Aug 09 - what is your timeline ?

 

[Marc]

Re: FDA Audit Procedure - SOP

I'll see if I can find a copy of the procedure I wrote and I'll post it here.

Sue

I'm sure many people will appreciate your sharing!

 

[zolakeene]

Re: FDA Audit Procedure - SOP

Hi Sue

did you post the procedure?
thanks

 

[shamann221 - 2010]

Unfortunately, the company I wrote it for would not release it to me and I don't have a copy. Sorry I can't provide it. I have it on my "to do" list to write it again but since I now work for a big company, there is no need for it at work and I haven't gotten to it.