The Use Of White-Out on Quality and Other Records

[Marc]

After the November debacle at a client's registration audit where I 'vigorously' protested a 'finding' for the use of white-out on one gal's schedule (this was not even the master record, it was a paper sheet the gal used as her own reminder -- and I won't go into the registrar practically demanding that this 'personal' schedule be classified as a quality record despite the fact that the master is a computer file....), I saw this discussion and felt it to be something everyone should be aware of in the 'interpretations' category of ISO 9001:2000.

Here goes:

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<jennejohnn@uwstout.edu>
Date: Wed, 4 Jul 2001 10:24:07 -0500
Subject: Re: Use of White-Out on Q-Records /Robison/Madden

From: Lori Madden <lmadden@semproducts.com>

Regarding Jim Robison's email about using white-out:

It is the auditor's responsibility to determine if the organization is compliant or non-compliant. Period. In my humble opinion, unless the standard states that white-out is not permitted, the auditor has no basis on which to justify writing a finding. True, it isn't the best practice to use white-out (we do not allow it and say so), but if it hasn't prevented the organization's ability to prove they have a suitable and effective QMS, and if it hasn't caused any reason for customer dissatisfaction, leave it.

The standard does say (and I'm speaking of ISO 9000), "Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate with the risks encountered." What are the magnitude and risks of using white-out? Sometimes the only corrective action is to do nothing. (If the customer requires that white-out not be used, this should be clearly documented and adhered to. In this case, I would have written a finding also.)

A related issue is the use of pencil. In my document control and record control procedures, it says the use of pencil is not allowed. This may sound petty, but it was brought about because supervisors were signing final approval in pencil and signatures were 'mysteriously' getting erased. We had a stack of batches that had been released without approval, or so it appeared. Our corrective action was to eliminate the use of pencil. I do

write nonconformances if this is not followed. But we have it documented, and our employees also know why it is important.

An auditor who truly is auditing for the benefit of the company will suggest that white-out is not a good idea, followed by examples of why. But write a finding? That's almost as bad as my auditor writing a finding because the page number on the bottom of one of our work instructions had been slightly cut off during copying. I believe a good auditor will also give the auditee the benefit of the doubt. Some issues are a matter of interpretation.

A QMS should work for the organization, not the other way around.

Lori

> From: "JIM ROBISON" <jimrobison@msn.com>
>
> I am an experienced ISO consultant and audit for a nationally
recognized
> third party. A client of mine that makes commercial plastic parts,
> recently had a finding from their Registrar on using white-out to make
> minor corrections on their data entry forms, or a few of their quality
> records. The client does NOT have any customer/contractual (or
> regulatory) requirements for not using white-out. The client's procedure
> on records, clearly states that "Due to the nature of the business, that
> white-out is permitted to make corrections on q-records". The client's
> Registrar wrote that "the use of white-out prevents seeing the previous
> entry", which by the way ... was an error that was corrected, by the
> person recording the data as they do their job.
>
> With all due respect to the Registrar, I say the Registrar is incorrect
> & this is personal auditor opinion. I say my client should "appeal" the
> finding, as they feel it does not add value to "scratch through, initial
> & date the correction" as they could do... but they really do not want
> change their process of using white-out, as it makes it neater when they
> run a copy & submit a record to their customers.
>
> Also, recall that it is clearly stated in their current procedure that
> users "ARE ALLOWED" to use white-out to make corrections to data entry
> errors...
>
> In my experience as an Auditor & consultant, I believe that white out
> can be used, provided: 1) No customer or regulatory requirement exists,
> and 2) If their procedure says "it is a permitted practice", meaning it
> is documented in their procedure.
>
> I would appreciate your comments as to the use of "White-Out" & how my
> client should respond to this finding. I say it is an incorrect write-up
> and they should appeal.
>
> Does anybody know of an official ISO document/requirement or know of a
> "sanctioned statement, like in QS-9000" on the use of white-out?
>
> Any thoughts and/or suggestions?
>

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<jennejohnn@uwstout.edu>
Date: Wed, 4 Jul 2001 10:25:54 -0500
Subject: Re: Use of White-Out on Q-Records /Robison/Solomon

From: Solomon, Jason <Jason.Solomon@EAE.Siemens.com>

I work for a sizable electronics firm, and we have used "white-out" since initial certification two years ago. Our registrar, who is quite picky, has never had an issue with our use of this universal document bandage.

I say, appeal the finding.

Jason S. Solomon

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<jennejohnn@uwstout.edu>
Date: Wed, 4 Jul 2001 10:28:05 -0500
Subject: Re: Use of White-Out on Q-Records /Robison/Bradley

From: Mark Bradley <mbradley@Ameriqual.com>

The registrar is correct.

It doesn't matter what is written in their procedures, this is a given rule that has been around for ages in quality. If you allow white-out or use of pencils, then data can not only be corrected, but changed to the producers advantage. In other words, out-of-spec results can be changed to in-spec

results. In order to prevent this, it has always been a rule that if a correction must be made to a quality record, the previous value is crossed out, with the new value written in and initialed by the person correcting the record.

Mark A. Bradley

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<jennejohnn@uwstout.edu>
Date: Wed, 4 Jul 2001 10:30:48 -0500
Subject: Re: Use of White-Out on Q-Records /Robison/Bogoe

From: Søren Bogø <sb@sbconsult.net>

Use of white-out = loss of credibility - what was originally recorded? Consider these questions: when and by whom was it corrected and what was the justification to alter it ?

Reference to absence of contractual requirement not to use white-out is merely disregarding what quality records are about, and a misconception of what should be achieved by ISO.

just my 0.02$

Soren Bogoe

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<jennejohnn@uwstout.edu>
Date: Wed, 4 Jul 2001 10:33:30 -0500
Subject: Re: Use of White-Out on Q-Records /Robison/Miller

From: Ray Miller <millerlb@dol.net>

Hmmm... I have never heard of a quality procedure that permitted the use of white-out on a quality record. The practice of casting a line through the incorrect entry, initialing and dating the correction has substantial weight in common practice, even if it is not written in the stone of ISO-9xxx or QS-9001.

A substantial part of the problem with the white-out practice is, I believe, that you now make it impossible to objectively answer the 3 questions, How wrong? How long? Who if anyone was impacted by the error?

If a quantity was transposed, for example 14 is written as 41, and it is caught right away and corrected, there is no impact. If on the other hand, the entry has already gone on into inventory and invoicing, correcting the paper copy without a corresponding transaction in the system will result in potentially serious customer service impact down the road.

I think if the procedure is tightened up to say that white- out is permitted to make corrections -- as long as the record being corrected has never left the hands of the originator or been entered into the computer -- then you would be on firmer ground. I also feel that "Due to the nature of the business" is far too ambiguous. I suggest firming up the language to give reasoning that fits the real world, such as "to ensure that records fax well when we need to send them to customers, white-out is permitted on paper records when ..."

Your problem with the auditor is not that he noticed a problem, but rather that he seems to have asserted what your customer's solution must be. This has often been a topic of debate on this list - the role of the auditor is limited to observing problems, and the job of determining the solution is strictly within the client's domain. As long as the auditor suggests a --potential-- solution that would satisfy him, fine, it's when the auditor says --this is the only solution-- then he puts himself into his client's box, which is wrong.

--Ray

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<jennejohnn@uwstout.edu>
Date: Wed, 4 Jul 2001 10:36:07 -0500
Subject: Re: Use of White-Out on Q-Records /Robison/Mackenzie

From: James Mackenzie <qualimedd@hotmail.com>

I work in a regulated industry ( Medical devices) where whiteout is effectively banned - as are pencils!

The auditor could raise an NCR by quoting from ISO 9001 1994 4.16

All quality records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss.

Retrievable suggests that whiteout conceals the original quality record.

Best Regards,

Jim Mackenzie

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<jennejohnn@uwstout.edu>
Date: Wed, 4 Jul 2001 10:37:30 -0500
Subject: Re: Use of White-Out on Q-Records /Robison/VanDorp

From: "Darryl VanDorp" <dvandorp@westlandfasteners.com>

Ok,

In a similar vein but not specifically "white-out" we had a pile of "Costing Plans" which we use during our Contract review phase where the individual had taken a bunch of blank forms and signed and dated them, in order to save time he then proceeded to photocopy them ( with signature and date) before filling them out.

I made the observation that the intention of the form was to have an original signature vs. a photocopied one. Is this something a registrar would have issues with or am i being too picky?

-Darryl

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<jennejohnn@uwstout.edu>
Date: Wed, 4 Jul 2001 10:39:21 -0500
Subject: Re: Use of White-Out on Q-Records /Robison/Monnich

From: Herbert Monnich <canink@hal-pc.org>

The registrars auditor needs to have some training. The supplier (the company registered) is the organization that establishes the processes for their organization under ISO 9001 (either 94 or 2000). A customer may request that a particular process be used or a regulatory body may require the use of a process but these are separate from ISO 9001.

Herbert Monnich

[Alf Gulford]

For whatever it's worth, and to add emphasis to some information above:

A few years ago the consultants we use for FDA/QSR matters found us using pencil, white-out and 'scribbles.' I don't recall if they had a regulation to cite but told us if we want to stay out of trouble with the FDA that there are recognized quality record standards we have to observe; a) use ink only, b) no white-out/correction tape/etc., and c) use a single strike-thru, leaving the original entry legible. It makes good sense, especially if the number under the white-out is an out-of-spec condition. You may know it's legitimate but an FDA investigator would have a tough time accepting it. Anyway, our procedures now reflect this and internal auditors watch for it.

Alf

For those of you who may still have copies of MIL-Q-9858 or MIL-I-45208, you may find a "white out" (erasures)prohibition and "ink" requirement. For as long as I can remember, a long time, white-out was forbidden. In-house Gov't Inspectors would chastize you if they saw white-out on your desk or work station. Personally, for the reasons mentioned, (hiding original error or whatever)a line should be drawn through it with initials and a date. I will check those ancient specs (home).

energy

[This message has been edited by energy (edited 05 July 2001).]

[Marc]

I don't think there's any arguement that in MIL or FDA or Aerospace manufacturing white-out is considered no less than fraud. But - how about companies that injection mold GI Joe parts where there's no traceability requirement or anything else 'critical'. The question is: Does ISO 9001 - anywhere - state that white-out is not allowed? We know it does not. Which leaves us with: Interpretation.

Note that I did not post this because I think white-out is a good idea. Typically I do not. But I do not believe ISO 9001 forbids it. I think that is an interpretation.

[Graeme]

Agreeing with Marc, there are rules that prohibit white-out, opaque white tape, typewriter correction tape, pencils and erasures - but ISO 9000 is NOT one of them.

Control of records is required and must be documented, and a reasonable part of that procedure would cover the handling of misteaks in entering data on a form. What is allowed or not should be determined by an evaluation of the criticality of the data by the company.

I don't think white-out is a good idea. On the other hand, the spaces on most printed forms are already too small for the data, let alone crossing it out, putting in a correction and initialling the whole mess!

A lot of people use electronic forms and records now. (There are probaly a few people reading this thread who have never seen white-out!) If you discover a data error before you commit the record you can just backspace over it, type in the correct value, and proceed ... will the next step be auditors telling us to remove the BS and DEL functions from computers? I don't think so.

We are all human beings, and are somewhat less than perfect. We have to deal with that imperfection. But the means of dealing with it should reasonable, and should be proportional to the actual risk of ocurrence from a qualified worker, and the probability of damage ocurring, and the probable consequences of the damage.

[JRKH]

To change electronic records one must have access to the system. White out is available to everyone.

I think this issue really is one of control. If the item is whited out without explanation, it is not controlled. However it may be possible to attach in notes etc, that such and such cell was changed/corrected due to blah blah blah, and signed off by the responsible party.
This method might also overcome the "crowded document" problem mentioned in an earlier post.

James

The Registrar is full of it!
The comments above about electronic documents are right on the money. The statement not everyone has access to an electronic form but everyone does have access to white out is weak. If they need to input data in the first place then they obviously have access to the form. If your company has "rogue data changers" running around randomly changing forms with no apparent reasoning, you have problems beyond ISO registration. 1994 4.16 and 2000 4.2.4 mention nothing about being able to see the data in the original form, input errors and tronsposing errors are a fact of life in almost any system. When we design spreadsheets we usually have a check cell which confirms our data. If we follow through with the registrars train of thought, we would have to freeze and save the screen as an "original" version and then identify the change and place an electronic signature on any subsequent versions, right? Call the home office and tell them to send another auditor with a brain or you are going to seek another registrar.
Don't be sheep.

Carl-

My 2 cents boils down to 2 points...

1. White out, as a rule, should not be used and probably isn't a "best practice" for making corrections. I've always used and instructed others to use the single strike-thru, new info next to, initial method. (Left over from my defense contractor days) It minimizes any hint of impropriety.

2. However, since there are no specific requirements for prohibiting white out in ISO 9000:2000, the registrar is out of line. Auditors should not be writing findings based on a best practice. Findings should be written against the requirement. If they wanted to identify this as an area of improvement, I would accept this. But not a nonconformance.



[This message has been edited by J.R. Strickland (edited 06 July 2001).]