Managing Employee Training Files - 21 CFR Part 820.25

R

rdawson_001

#1
Per the regulations:

Sec. 820.25 Personnel.
(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

(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.

My question is as follows:

Anyone have any experience on how to store CEO employee files that sits off-site at a corporate location? Should their file be in a separate visitor binder? Or should they have a permanent employee file as local personnel?
 
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Ninja

Looking for Reality
Trusted Information Resource
#3
Re: Managing Employee Training Files

Either would be fine.

Not sure what you mean by "CEO Employee Files"...I am assuming that it does NOT mean the training files for your CEO...but hey, you never know...

If your training records are electronic (spreadsheet or Dbase), it makes it quite easy to store them at any location you desire...and access from wherever you desire...
I would highly recommend storing training records in electronic format. There are things that can change frequently (adding to them) and adding a line on a database entry is much faster and easier than collating paper.

JMO
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Re: Managing Employee Training Files

The CEO is an employee. His/Her training should be documented just like anyone else in the same system. Unless your procedures states otherwise.

Is your CEO's training secret?

And I'm not so sure the FDA would really care much about the CEO's training unless this person is actively involved in the processes that realize the product. my last company was pretty small and the only training that anyone ever asked of our CEO was on the Management Review procedure... and that was a customer who then said "just kidding" but we produced it anyway.
 
S

sarahstec

#5
We had two employee files - one with all the training we did, which was on-site and auditable. The other was our HR file with our pay information, annual reviews, etc, which was not auditable (as it was confidential information). We had both on-site, but in separate locations - the HR file was in HR and the training file was with Quality/the department manager.

I'm also not sure what you mean by "CEO Employee File," but in case the CEO is confused about what the auditor is going to look at in their file, splitting it into two may be a solution.
 
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