Auditor found Form with Identical Contents but different Format - is this an NC?

Sidney Vianna

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Staff member
Admin
#11
Re: Audit found Form with Identical Contents but different Format - is this an NC?

If you are allowing two separate formats to be used in your organization, you are openening yourselves up for some real trouble.
How so?

In the early days of word processing software, people would change fonts in forms just because they like to experience/play or just because they could.

Some sophisticated forms provide acceptance criteria, but, for the most part, the intent of a form is to capture data/results of an activity. If different formats of a form (for example, what Marc said about exhausting previous versions of a form, before using a new one) capture all the required data, I don't see how critical the issue would be. As Andy mentioned, the concept of identifying a potential nonconformity, categorizing and reporting it, should go through a brief and mental risk assessment. I see very little risk in two operators using two dissimilar forms, once again, if they capture all the necessary data and results. After all, the content, not the format, is important.

I also second Andy's comment about auditors focusing excessively on documents and records. Unfortunately, auditors tend to go to their comfort zones during an audit, zooming into less subjective issues. To this date, document control is one of the most written up sections of the QMS standards. Why is that? Simply because it is very easy to audit for, the number of opportunities for problems is high and auditors like "black and white" scenarios because there is very little arguing if the master list calls for Rev. E as the current one for a document and the technician is using Rev. C, it is a clear failure.

Auditors tend to shy away from process and areas that they are not comfortable with, especially top management.

If a form is revision controlled, everybody should be using the proper version, but categorizing a finding as a nonconformity, especially a major one, should take into account risks and impacts of the evidence at hand. In this particular case, based on the information we have at hand, I would be hard pressed to consider the situation a detriment to the QMS.
 
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Elsmar Forum Sponsor
#12
Re: Audit found Form with Identical Contents but different Format - is this an NC?

Okay, I understand your point, and perhaps the issue is just one of semantics. Formatting may be as simple as header or footer, or font. But it could also involve number of decimal places and measurement units. But regardless, I look at how the forms are viewed by the folks using them. The greater differences (even if it is just font size), they may see the two forms as being different. And if we allow what they view as different forms to be used, it could open the door for the use of unapproved forms.

Employees may think that if those two are okay, a third (unapproved) must also be okay. I have seen this happen in real life. A company had a form that was used in various departments. In all there were three different versions of the same form (all contained the same data fields, but different layouts). The employees started creating their own forms, thinking that any form would do... after all these three forms all were identified as the same form, but were clearly different. They felt the document control rules were developed just to make someone happy, but not really important.
 

Randy

Super Moderator
#13
Re: Audit found Form with Identical Contents but different Format - is this an NC?

Fix it and move on

If you find more stuff like it then you probably have a document control issue.

Flip a coin, choose the one you want or like and make it happen.
 

Wes Bucey

Quite Involved in Discussions
#14
Re: Audit found Form with Identical Contents but different Format - is this an NC?

I find myself in the "investigate further before ANY report" category.

I suspect we are looking at different versions of the same form, since all the factors are the same, just in different order.

The question is:
Do the folks actually using (filling in the data on) these forms [when they are blank] realize they are the same EXCEPT for layout, font, etc.?

If yes, they are not confused (the only issue - is ANYBODY going to be confused later when viewing data on different forms?)

Sidney's advice is sound, here - protest!

I also would merely add that folks seeking to eradicate reams of blank forms when a new layout comes out consider adding a "saving clause" to the change notice to the effect:
"To avoid confusion, data added to existing stocks of blank forms during the 30 days AFTER [date of version] shall be either marked "CONFORMS TO VERSION ___" in large contrasting colors or transcribed on to new version blanks. After the 30 day transition period, all previous versions of blank forms shall be removed from use. Any inadvertent exceptions completed after that date will be transcribed on to the most current version when and if discovered."


As I see it, many auditors, whether in house, internal auditors or 2nd or 3rd party auditors, are trained and constrained to accept written documentation, not anecdotal "talk," regardless of who is doing the talking. This is not an issue of mission creep on the part of the auditor, but a case of limited foresight on the part of the folks who issued the version change of forms. They simply forgot to consider not only the initial users of the form (the folks who add data), but also any future folks who might be confused (as the auditor probably was) when viewing the form.

:topic:
I like to believe that everyone is a genius, easily able to infer the big picture from a smattering of fragments, but my business partners were more probably more correct when they said, "Think of everybody as Lois Lane. How dumb was she that in 50 years she didn't recognize that Superman was Clark Kent without glasses?"
 
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Jim Wynne

Staff member
Admin
#15
Re: Audit found Form with Identical Contents but different Format - is this an NC?

This is a non-issue, and it's the auditor that's the problem. Nonetheless, I discovered a long time ago that it generally doesn't pay to control forms. You don't have to-- All you have to do is control the information that's reported and specify that the reporting may be in any format so long as all of the required information is present. You may then provide a form that may be used.
 
J
#16
Re: Audit found Form with Identical Contents but different Format - is this an NC?

Totally agreed, Sidney! Further more, when considered within the context of the total number of forms etc. this cannot be considered anything but a "found it, fix it" type of finding!

I'd also recommend that this 'major' (yeah, right!) be appealed directly with the technical staff at the CB. Based on what they reply with, you might wish to seek at least a different auditor...
Normally in such cases I suggest that fighting it might take more energy than just fixing it...But I agree with Andy here that an appeal can and should be made for the purpose of "auditor training" (if the CB sides with you, they get to retrain their auditor...) and "CB evaluation" (in case they side with the auditor and you consider finding another CB).

Peace
James
 
Z

zancky

#17
Re: Audit found Form with Identical Contents but different Format - is this an NC?

my modest comment:
it may depend in the firm business, some fields stress over documents control (eg. pharma, medical etc).

the second comment is depends on the nature of the form: a Certificate of conformance, or a certificate of calibration of a laboratory for an external customer with wrong revision may be a big issue; if the wrong form was used to buy paper for the printer, well I do not spend a lot of time.

Every document may have got a risk analysis therefore we pay more attention to the most critical ones. Forms that have no impact on quality and they looks like the updated version are not a proof of systematic mistake
 
C

Chance

#18
Re: Audit found Form with Identical Contents but different Format - is this an NC?

Is filing for an appeal not expensive?
 
#19
Re: Audit found Form with Identical Contents but different Format - is this an NC?

Normally in such cases I suggest that fighting it might take more energy than just fixing it...But I agree with Andy here that an appeal can and should be made for the purpose of "auditor training" (if the CB sides with you, they get to retrain their auditor...) and "CB evaluation" (in case they side with the auditor and you consider finding another CB).

Peace
James
Maybe James, but I'd suggest that the effort would be expended if a raw material supplier had sent in something outside of spec., and that they'd told you they were correct (!) - the reject/supplier CAR process would be used.

We need to stop 'rolling over' on this type of thing!
 

QATN11

Involved In Discussions
#20
Re: Audit found Form with Identical Contents but different Format - is this an NC?

No, plans are in process. Auditor has submitted his findings and did change from "pervasive" to 'isolated", but this will also be challenged. Waiting on reviewer's comments.
 
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