The DREADED...."White Out"!!! *insert scary music*

G

gfreely

Hey all...

I ran into something the other day that I haven't seen in YEARS...I was randomly sampling our router packages and I found corrections with White Out in some of the process entries. I almost had kittens on the spot. :mad:

I brought it up to some management peoples and received various responses, from "That's not supposed to happen" to "So? It looks neater." It *almost* escalated beyond my control :argue: (I am still employed so it didn't go TOO far...:lol:)

I scoured 9001:2k and our QAM, searching for something to back me up so I can shout from the rooftops (or the top of a desk at least) that this CANNOT go on. I can just see the expression on our ISO auditor or a customer auditor's face when they see a huge splotch of correction fluid on one of our controlled documents!

Can anyone tell me where I might find this in writing? If it needs to be incorporated into our QS, then so be it...but I wanted to find backup to see if maybe the follks who wrote this system maybe just...forgot? :confused:

ANY help would be greatly appreciated!
 

Wes Bucey

Prophet of Profit
To my knowledge and experience, the primary proscription for white out or erasure is only in regulated industries (pharmaceuticals, for one.)

Individual organizations may have specific procedures or work instructions which describe how changes may be made, but none of the Standards like ISO 9001, or even ISO 13485 (to my own recollection) have such a clause against erasure or whiteout.

What they DO SAY is the organization must (shall) have a procedure for controlling a document against UNAUTHORIZED changes. The case you have described is not so much against the manner of erasure or whiteout, but the fact the identity of the person making a change was not disclosed, nor the reason (audit trail) for such change.

If the organization's procedures and work instructions are silent on WHO may make a change (need more than one approval?) and the manner of change (x-out, line out, erase, whiteout, reprint, etc.), then the procedure probably should be modified (approvals, etc.) and all pertinent personnel trained and evaluated on the revised procedure.

In point of fact, the auditor would only ask to see the procedure which governs document changes, not go ballistic.
 

GStough

Leader
Super Moderator
What I've learned in my 16+ years in an FDA-regulated industry (medical devices) is that when someone uses white-out on a record, an FDA investigator may take it to mean that someone was trying to cover up something (nonconforming measurements, etc.) or falsify a record.

This is a very good reason NOT to use white-out, IMO. :yes:
 

John Broomfield

Leader
Super Moderator
It is in ISO 9001, see the requirement in clause 4.2.4 for legible records (the original record cannot be read) :).

You may need to have the managers teach this discipline to everyone, below is a fair-use extract from clause 4.13.2.3 of ISO 17025:2005:

"When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside. All such alterations to records shall be signed or initialled by
the person making the correction. In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data." :read:

Hope this helps (I think the "when" instead of "if" is very helpful).
 

John Broomfield

Leader
Super Moderator
I am also worried about the extent of this problem. For someone to go buy some White Out (fairly rarely needed these days) may indicate a chronic nonconformity.
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
If you have white-out on a controlled document ( print, procedure, etc.), you have an uncontrolled change. It may not be spelled out in the standard as "do not use white out", but the uncontrolled change is worth a finding in an audit.

Now, as far as data on a controlled form, ISO9000:2000 may not be as straight forward. What everyone mentioned about the regulated industries is well known to those folks. But, outside of that it would be up to you to specify that in your procedures. But, also, be fair. If you have cramped forms with no place to strike out and rewrite data be ready to get a mess that would fail clause 4.2.4 for legible records.

Don't feel bad. In spite what you have in your procedures, I would have likely reacted the same way you did.:cool:
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
This sounds so familiar. In my career that has expanded 25 years, this was instilled into my head that the use of white-out is wrong.

Funny that you brought this question up, because it was identified in my AS9100 Stage 2 assessment. There is nothing specifically addressing the use of white out, but as someone said, the records must be legible. That is what the Assessor stood on. I didn't disagree.
 
C

Craig H.

There might be another concern here, but I could not find a reference to it. Years ago when I was a lab tech with my very own bound lab notebook (that I wish they had let me keep when I left...) I was told that there are times when those documents can be used for filing a patent, defending a patent, or defending an infringement claim (lawsuit). Therefore whiteout was not even allowed in the labs.
 
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Z

zancky

just a consideration.
I remember that a long time ago when designers were artists working on A0 film, it was too expensive to print again the drawing. The designer "white out" the dimension to be changed and overprint the new requirement reporting the change in the note of the drawing. That may be a reason for ISO 9k and TS not to mention "white out is not allowed". It make no sense now on the Pc era.
 
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