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Where in ISO 9001 is White Out on Forms and Records Prohibited?

MichaelDRoach

CAAA Business Management Systems Specialist
#1
Where within the standard can I find the requirement that tells us not to use whiteout to obliterate information? I do realize that all information is transparent, but it was asked of me and I can for the life of me recall where this is located within the standard.

Sorry all, I found what I was needing in other threads. Please ignore this thread and let it die.
 
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PaulJSmith

#2
Because it's not. The Standard only requires that they "remain legible, readily identifiable and retrievable."

...and, welcome to The Cove, Michael.
 

Marc

Captain Nice
Staff member
Admin
#3
<snip> Sorry all, I found what I was needing in other threads. Please ignore this thread and let it die.
It is rare that we delete or close a thread if it has even one answer. It is the nature of a forum. I know there are forums which automatically close a thread to new replies to "old" threads as well. We have never taken that approach here. Someone else may be looking for the same information you were but not find it in other threads here. Searching through threads is different for everyone. Some can find things easier than others. I am glad you found the answer.

In this case, Paul provided the answer, however it may be that others may want to add to it. Maybe not since it is relatively straight foreword, but we'll leave the thread open just in case. Over the years we have had some good discussions here about using whiteout in various scenarios.
 
#4
Now I'm curious. OP wrote
In Reply to Parent Post by MichaelDRoach

<snip> Sorry all, I found what I was needing in other threads. Please ignore this thread and let it die.
So, was the question answered because OP is in an industry like pharma where whiteout or erasure is a no no, regardless of ISO Standards?

Is OP in an R&D environment where whiteout can endanger patent application?

None of the above and OP's organization is in an environment where erasures and whiteouts have sufficient OTHER safeguards to avoid repeating errors which may not be discovered because of erasure/whiteout?

Just to throw a monkey wrench in the discussion:
It is true none of the Standards listed in this particular forum, especially ISO 9001, speak to the issue, but there is an ISO Standard which does:
ISO/ IEC 17025:2005 The clause of the standard says:

"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."
Ref: Clause 4.13.2.3, ISO/ IEC 17025​

There are myriad reasons why this would be a good practice for EVERY organization to follow, but it would be "mission creep" to declare it mandatory unless the organization is constrained to do so by being under a specific governmental regulation, customer requirement, or voluntary submission to a Standard such as the one cited above. In any case, I would like to see [but it's only my bias] that the correction be dated as well.
 
T

t.PoN

#5
Personally, I don't think ISO 9001 prohibit the use of white out on forms.

However, Some says that ISO 9001, clause 4.2.3 state
"Records are a special type of document"

and ISO 9001 clause 4.2.3.c require you to ensure that changes and the current revision status of documents are identified.

based on that, some org prohibit the use of white out and correction fluid because you can't identify the changes you made to the documents/records


my opinion: ISO 9001, clause 4.2.3 state
Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
however, i think its a good practice to not use the correction fluid and cross out the mistakes instead
 

Mike S.

An Early 'Cover'
Trusted
#7
You can't "identify" a change, nor would the original value be "legible", if the original entry is obliterated -- via whiteout or whatever.

Context would mean a lot. In the "old days" when typing (on a typewriter) was ubiquitous, if a word on a memo was whited out to correct a misspelling, I'd consider it no big deal. Data records are a different story. The only place I ever saw that obliterated original entries on data records before a change was made was doing it to "fudge" data. :nope: I still get the willies when I think about it...
 

John Broomfield

Staff member
Super Moderator
#8
ISO 17025 is more specific than ISO 9001 on this.

For the control of technical records, clause 4.13.2.3 specifies:

"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 initialed by the person making the correction."

But under ISO 9001 alone, a record obliterated by white-out was made illegible and is a nonconformity to clause 4.2.4:

"Failure to maintain the legibility of records"

...so the original record and the reasons for change are known to the people using the record.

Just as ISO 17025 restricts this requirement to technical records, such as test results, under ISO 9001 we should consider the impact of bad decisions due to corrected or altered records before reporting this nonconformity for corrective action.
 

Marc

Captain Nice
Staff member
Admin
#9
We have to remember in all of this that ISO 9001 is essentially just a "base", in a way, which gives basic minimum requirements for a quality management system. The standards for regulated industries such as ISO 13485, and to some degree ISO 17025, are more specific. More than that, and I will include ISO 14001, require many more requirements which add on to the "base" of the standard and at least one of which (local, state, government, customer specific requirements, etc.) often "are in addition to" the requirement(s) of the standard(s).

The answer to this thread topic - "Where in ISO 9001 is White Out on Forms and Records Prohibited?" is it isn't specifically called out. The aspect of clause 4.2.4 ("Failure to maintain the legibility of records") is subject to interpretation. The form/record may be legible even though something on it has been covered by white out and over written.

As has been discussed here in other threads, white out should always be a No No. Proper is single strike through and initial any change. White out is, as Mike S said, a relic of typewriter days.

Also see:

The Use Of White-Out on Quality and Other Records

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

PaulJSmith

#10
Maybe I'm just a little dull, but could someone please explain to me how I could possibly use whiteout in a way that the initial entry would still "remain legible"?
It cannot. However, that's not the intent, I believe, of the "legibility" directive in 9001. That standard refers to Documents and Records as a whole. If I were to use white out (which I don't) to cover a mistake on an otherwise legible document or record and rewrite it in a legible manner, that document or record remains legible.

Is it a good idea? Absolutely not, in my opinion.
Is it a violation of 9001? No, I don't believe it is.
 
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