FDA Inspection (Audit) Readiness Procedure

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RunningMommaCT

#1
My company is 1.5 years old and we just registered or product with FDA. Now that we are on the Agency's radar, I think we need to be "audit ready." I am about to train the front room, back room and was wondering if other organizations have a formal Audit Readiness or Audit Preparation procedure. Yes/No? If yes, are you willing to share a redacted procedure?

Thank you!
 
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Tyler C

#2
Re: Audit Readiness Procedure

I am not familiar with FDA regulations, so I am basing this response from my experience in ISO (so bear with me if I am way off here).

The company I work for does not have an Audit Readiness procedure. Don't train your people how to act during an audit, instead train them on the requirements of the FDA regulations. If people are acting within these requirements, you should always be audit ready. Which, in my opinion, is the right/best thing to do anyway.

On a side note, take the statement "Don't train your people how to act during an audit..." with a grain of salt. You should train your people how to act during an audit, but not with the intent of passing the audit if/when it happens, instead do so with the intent of helping the audit go smoother. Train on things such as, if someone doesn't understand a question, ask the auditor to repeat the question in an understandable way, or what to do if someone doesn't know an answer (pointing to the appropriate person is better than "I don't know" or guessing), etc.

When you are informed that an audit will be conducted, it shouldn't be scramble mode to get things ready. Things should already be compliant and ready for the audit. That, in my opinion, is the point of standardization. This shouldn't require a procedure.

I hope I'm not too far off base here, and I hope this helps.
 

yodon

Staff member
Super Moderator
#3
Re: Audit Readiness Procedure

Agree with Tyler C (not off base) and would add as one of the "how to act" points, just answer the question. Auditors / inspectors will let folks talk all they want - which usually leads to trouble. I was in one once where a guy was asked a question about a particular product, correctly answered the question, and then said "but on this other product..." I'd like to say hilarity ensued but, not exactly.

I presume you're already doing internal audits. Certainly not the same as an FDA inspection but it does help people get comfortable answering questions. A mock audit / inspection can be quite helpful (and enlightening).
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Re: Audit Readiness Procedure

My company is 1.5 years old and we just registered or product with FDA. Now that we are on the Agency's radar, I think we need to be "audit ready."
You probably will benefit from reviewing this Inspection Readiness Checklist.

Good luck.

PS. The FDA normally refers to this as an inspection, rather than an audit.
 

Attachments

Mark Meer

Trusted Information Resource
#5
I'd suggest making yourself a checklist against the applicable FDA requirements, and doing a mock audit yourself beforehand. Be as strict in your interpretation of the requirements as possible (because, worst case, that's what an FDA auditor will do).

Where conformance to a requirement requires a degree of explanation, consider updating the system to make evidence of conformance as clear as possible.

As far as training other personnel, I agree with all advice given thus far.
...again, make sure that specific requirements are met (see, for example, 21 CFR 820.25 - if medical devices are your product), and ensure that personnel can respond to such questions regarding their roles & responsibilities, and how they impact the system and product.

Good luck!
MM
 
T

Tyler C

#6
Great additions everyone. I'm not in a position that I have to deal with the FDA, but I've learned from this thread as well. This is why I love the Cove!
 

Ronen E

Problem Solver
Staff member
Moderator
#7
If I had to give just one advice in that context, that would be:

Sunscreen. Wear sunscreen.

Just joking... It would be:

Focus your resources on your org being compliant with the regulations rather than on your org surviving an audit while it's not compliant.

It usually works wonders. Not only on audit day.
 

somashekar

Staff member
Super Moderator
#8
My company is 1.5 years old and we just registered or product with FDA. Now that we are on the Agency's radar, I think we need to be "audit ready." I am about to train the front room, back room and was wondering if other organizations have a formal Audit Readiness or Audit Preparation procedure. Yes/No? If yes, are you willing to share a redacted procedure?

Thank you!
You have very good inputs. Look into specifics in the 21 CFR 820 and ensure that your processes map them... Some examples.

(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.
(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.
(h) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may
affect the quality of a finished device.
(3) Adjustment. Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments.
§820.184 Device history record.
Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.

.
..
... There could be more. Read the 21CFR820 in detail and map activities to requirement.
 

JeantheBigone

Quite Involved in Discussions
#9
I'd like to chime in here with an analogy for the difference between an inspection and an audit - and for that matter a certification. I heard this years ago from a seasoned consultant and once he said this, it really helped me.

If you get stopped by a cop with a radar gun, that is like an inspection. No good can come out of this situation. In the best case, nothing changes, the worst case is you lose your license.

Now let's say that same cop is the examiner sitting next to you at your driving exam. This is like a certification. The best possible outcome is you get a drivers license. In the worst case, you're no worse off than before (well, unless you really blow it I suppose).

Now let's let that same cop be the person who gives driving lessons. This is comparable to an audit. The off-duty cop makes you aware of where you have room for improvement, but there are no material consequences.
 
R

RunningMommaCT

#10
All good tips. I will train everyone but was really trying to gauge if others formalized their "what to do when the FDA walks in the front door" into an SOP or WI.

Have a great day!
 
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