Can we use a black pen to sign documents, fill out forms, etc?

[ScottK]

In the Pharma world, using blue or black pens are the industry standard. I don't recall any standard about which type of pen you should use. I concur other folks mentioned that it should be part of the Good Documentation Practices training for employee training. I prefer using blue pen for documentaion. For example, my signature on the scanned copy is very distinct.

In my experience you can use either. My current company only uses black for quality records.
One important aspect of inks is the type of ink... no "eraseable" pen and we stay away from gel ink/"Rollerball" pens because the ink runs easily if you spill something on it. We got dinged on a customer audit because of a smeared signature due to a cleaning agent spill.

 

[db]

Considering this the the ISO 9001 forum, anything could work. ISO 9001 does not sspecify, or even hint, as to the color. Pencil would even be okay. However, you might have a customer requirement, and that would be different. But as far as ISO 9001, there is no color requirement.

 

[Ramrethan]

Hello friends
On a recent audit that was carried out by one of our costumer,
There was a discussion with in our management can we use a black pen?!
can someone could refer me Where can I find reference the Regulation on this subject?
and in the same subject is the any regulation on draw a single line through mistakes?

I would be inclined to think that a black pen is acceptable...

 

[Wes Bucey]

Hello friends
On a recent audit that was carried out by one of our costumer,
There was a discussion with in our management can we use a black pen?!
can someone could refer me Where can I find reference the Regulation on this subject?
and in the same subject is the any regulation on draw a single line through mistakes?

Considering this the the ISO 9001 forum, anything could work. ISO 9001 does not sspecify, or even hint, as to the color. Pencil would even be okay. However, you might have a customer requirement, and that would be different. But as far as ISO 9001, there is no color requirement.

I tend to agree with db - unless a customer's CONTRACT specifically states the color of ink on documents for that customer (and ONLY that customer), the Standard is absolutely silent on ink color, type of pen or pencil, handwritten, typed, stamped, location on document or any other stricture. Any auditor (internal, second party, or third party) who says otherwise is engaging in mission creep (extending the parameters of a Standard according to a personal interpretation or bias.)

We here in the Cove have a mantra for all of these Mission Creep creeps:
"Show me the shall!"

 

[JaneB]

You can use purple, green or whatever colour you want.

Provided that a certain colour/way of setting things out isn't a contractual requirements.

And I applaud you, by the way, for asking the question. Because far too many people simply go along with things believing that 'this is how it must be' or 'this is what I was told' and never raise the why? question.




This whole thing about 'blue is not acceptable' reminds me of the old story about the pot roast.

 

[The Specialist]

JaneB,

I read your link article. Interesting!

Does rather beg the question though (as the grandmother was too 'poor' to buy a bigger pot)... Why not just buy a smaller joint?!

 

[JaneB]

Does rather beg the question though (as the grandmother was too 'poor' to buy a bigger pot)... Why not just buy a smaller joint?!

Hey, I dunno, it didn't happen in my family!