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

[QATN11]

During an audit, two versions of the same form are found. All questions and content are identical; however, the format is different. Is this a non-compliance? major? minor? observation? The issue resulted from a form format that existed prior to addition of revision number and date was added was used and completed; therefore, a controlled record was created. The annotated form questions and content are identical to the form without date/version footer.

Auditor stated this was a major noncompliance. Counter argument was content should have priority over format and this should not be a major NC ("a pervasive and systemic error" auditor's wording), but rather an observation, or minor(isolated) NC.

I would appreciate feedback.

 

[harry]

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

1. Is this an internal audit or a third party audit.

2. Were there evidence that there were other forms of a similar nature to conclude that this is a 'systemic' issue?

3. Generally, an internal audit is for improvement purpose. An NC is an NC and it is quite meaningless to classify it as major or minor. Carry out the necessary investigation and take appropriate action such as correction for isolated events and corrective action for recurring events and improved from there.

4. Assuming this to be a systemic issue and hence evidence of weaknesses in your Document Control, third party auditors will usually consider the possible damage it can create. I don't think a 'format' issue will result in a major for most auditors that I know

5. However, I do know of a few dinosaur auditors over here who were from the 'write what you do and do what you write' era that will jump on you for this one.

 

[Peter West]

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

Hi QATN11

At first reading i thought a major nonconformance was way over the top. If it was one document used by one person amidst 100 documents used by 100 people its a minor at best.

Harry has made some good points, but what really stood out was if the issue was systemic (indicating that the process for controlling documents had repeatedly failed). Were there any other identified issues relating to document control? How do you communcate changes to documents and ensure only the most up-to-date templates are available? We use our company intranet so that if this arises the primary cause is down to the individual (training tells them to refer to intranet too).

If it is a 1-off (1 person from a big group, 1 time, 1 office) then I would consider it barely grades as a minor. If there are more instances (more than one person doing this, more than one document, a failure in training) then a major should be expected IF the outcome would have a serious impact on the service/product delivered or if it would be picked up by a systems audit or management review etc.

I would rate at minor from info i have at the moment, with a subsequent major if clear close out and root cause resolution was not evident.

Good luck

 

[Marc]

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

<snip> The issue resulted from a form format that existed prior to addition of revision number and date was added was used and completed; therefore, a controlled record was created. The annotated form questions and content are identical to the form without date/version footer.<snip>

Did this happen because you had printed paper forms that you were using to "use up" the old paper forms after you switched to the new form with the date and version in the footer?

I bring this up because many times a company will have paper forms which they make minor (inconsequential) change(s) to, but have a lot of the older format forms already in stock. Rather than throw them away, they use them until they are gone. If so, as long as everyone knows this is happening it shouldn't be a problem.

 

[AndyN]

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

If a CB auditor found this, then they clearly need to get a life! A major? Not in this life... What they SHOULD have done is investigated some more and determined what happened to have the situation, to at least be helpful.

If it were an internal audit, then firstly, there's no point in grading the thing. It doesn't read like a major, and management are going to shrug their shoulders in confusion/apathy/indifference...

Too many auditors get excited over documents! Who cares, really? The same data was recorded? Was the data any good? What happened as a result of duplication? Did it affect anything which was delivered to the customer? Risk, anyone?

IMHO, this type of finding is what constantly undermines the credibility of audits (and auditors) as a management tool...

 

[QATN11]

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

1. 3rd Party
2. No other evidence of a systemic issue. Auditor stated his only choices were "systemic" or "Isolated". 2 records of the odd form were used and conclusion was 2 indicated "systemic". Our rebuttal, was the occurrence was "isolated" since the 2 records were used at the same time and not spaced over a period of time.
3. Data was good and no risk was exposed. Form was purely an informational survey and not product/performance related.

 

[Stijloor]

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

Who is the Registrar?

 

[Sidney Vianna]

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

During an audit, two versions of the same form are found. All questions and content are identical; however, the format is different. Is this a non-compliance? major? minor? observation? The issue resulted from a form format that existed prior to addition of revision number and date was added was used and completed; therefore, a controlled record was created. The annotated form questions and content are identical to the form without date/version footer.

Auditor stated this was a major noncompliance. Counter argument was content should have priority over format and this should not be a major NC ("a pervasive and systemic error" auditor's wording), but rather an observation, or minor(isolated) NC.

I would appreciate feedback.

I am clearly on your side on this issue. The proper categorization for this finding would be an observation. If all the important data was captured on the form, making it a valid record, the format is secondary. The fact that the auditor considers this a major nonconformity makes me wonder about his/her ability to appropriately assess evidence against criteria.

Without a doubt this nonconformity MUST be appealed. Not only the categorization of a major, but also the categorization as a nonconformity itself.

If possible, keep us posted.

 

[AndyN]

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...

 

[db]

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

I will take a different approach.

My first thought was the timeline. The question is what format was in play when the forms were filled out. Format 1 might have been the proper format when one was filled out, then later format 2 was issued and the second one was done on that. In that scenario, all would be normal.

However.....

If you are allowing two separate formats to be used in your organization, you are openening yourselves up for some real trouble. If folks know multiple formats are acceptable, the document control system can become casual. Format, revision level, document identification could all be compromised. You could very easily lose total control of your doc control. That is why I don't allow docuemnts (or gages) "for reference only". When we start allowing exceptions and multiple rules (including formats), then folks can get confused and the entire system could end up with the perception of being meaningless.