Correction fluid found on documents that are reviewed

gpalow

Starting to get Involved
#1
While reviewing records, I found that someone used correction fluid and made changes to important documents. Those responsible now understand the proper correction of records but this should really be documented somewhere. Are there any rules or steps needed to document these findings? Although I want to prevent recurrence, I want to make sure we have steps in place for such incidents.
 
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Ninja

Looking for Reality
Trusted Information Resource
#2
Howdy gpalow,

Can you give some perspective?

You are an employee?​
You are a CB auditor?​
You are the QM?​
These documents were modified after distribution, or production records?​
By whom, why...and to what extent?​
Way easier to give an opinion if there is some more fact to opine over...
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
I want to prevent recurrence,
Many companies long ago banned correction fluid on company property as strictly as smoking bans. However, as @Ninja says - More information from you is needed with regard to your specific case/scenario.
 

gpalow

Starting to get Involved
#6
Howdy gpalow,

Can you give some perspective?

You are an employee?​
You are a CB auditor?​
You are the QM?​
These documents were modified after distribution, or production records?​
By whom, why...and to what extent?​
Way easier to give an opinion if there is some more fact to opine over...
I guess more insight would be helpful. I am the QM(new to the role). The documents I found were batch records. We have eliminated all correction fluid from the department, however, it keeps making its way back! I can say it does not happen very often but I wasn't sure if I should document that correction fluid was used and if so, how?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#7
....it keeps making its way back....
I assume batch records are important records in your company (they are in most companies). Make/write a policy and train employees on it. Include some type of serious demerit (or whatever) for using it (or even for having correction fluid at all).

Back in my day, in DoD work, it was pretty close to a fireable offense to have, much less use, correction fluid, anywhere there were records being made or kept.
 

yodon

Staff member
Super Moderator
#8
We have eliminated all correction fluid from the department, however, it keeps making its way back!
That statement is as worrisome as any! Maybe more so. Clearly, the "root cause" has not been eliminated by just purging existing bottles. Training as @Marc suggests is probably in order. Everyone needs to understand the ramifications of their actions.

It's probably worth some time investigating. Maybe it's as simple as not knowing; but there could also be additional, underlying reasons. If it were me, I'd absolutely open a CAPA and work it from there. Should those records be audited / inspected, you should expect a finding. You probably need to see how widespread the problem is and take actions to correct these nonconformities (which they are).
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
As an aside: I worked with a small company (14 people) back around 1999 or maybe a bit earlier. They essentially have a quite prosperous business (over 40years old) in which they blended chemicals for metal cleaning. They made their money buy buying LOTS of chemicals in bulk. Anyway, when I first started working with them they had one computer which was only used for - No kidding - Printing labels for automotive customers. The company's founders were 2 guys and by the time I was involved one was deceased and within a few years the other also passed on (if I remember correctly). It was a family business and one of the younger guys, probably a son or grandson, really changed things.

All their batch records and - Well, everything was paper in the place. I'm trying to remember - I think his name was Mike. Anyway - He decided to bring the business into the world of computers. He hired a local guy who was really good. He set up a server, wrote some software and databases for them, and within maybe 4 or 5 years everything was done via a computer station.

I write this as an example of a small company transitioning to the digital world. In this day and age batch records should be electronic. I realize the world is not at a place where everything can be electronic mainly because of cost factors, but the world really is moving to the "paperless world" we've been hearing about for years.

That statement is as worrisome as any!
That was my first thought. <shivers thinking about it>

Back in my DoD days we even had random "walk-throughs" that included desk checks (including drawers). The walk-throughs had several purposes - It wasn't correction fluid focused - By it was one of their checks (much was security and fraud related).

EDIT ADD: Consequences of records being altered

ValuJet Flight 592 - Wikipedia

And all these years later: https://www.cnn.com/2018/04/06/us/valujet-fugitive-reward/index.html
 
Last edited:
#10
I would open a CAPA and say something to the effect "we found correction fluid being used. we do not want that at this facility. we will inform purchasing that none is to be bought. GDP SOP will be updated to say no correction fluid. All employees will be trained on new GDP SOP. Any correction fluid found will be disposed of." Maybe write and exception deviation for the use of the correction fluid tracing to the CAPA or just note the CAPA directly where the correction fluid was used. -Matt
 
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