Paperwork not Properly Filled Out and Signed Off

M

MBraun76

#1
Hello everyone,

I just performed an internal audit where I found paperwork which was either not filled out in its entirety or not properly signed off. Is there anything in ISO 9001 that states forms need to be filled out in their entirety and/or all signature fields must be filled out or "N/A"? Or is this an internal process which we need to develop?

I would like to write it up as a non-conformance so we can address the issue but I have nothing to use as a reference. Sadly our own processes need some updating on many subjects including this.
 
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J

Jason PCSwitches

#2
Re: Paperwork not properly filled out/signed off

You need to examine your internal document/records control procedure to determine what is acceptable to the organization. ISO only stipulates that these documents must exist and be maintained. The manner of accomplishing conformity is entirely up to your organization.

If nothing is specific, use practical thinking and determine if it should be specified. This may not be a non-conformance, perhaps an opportunity for improvement.
 
A

arios

#3
Re: Paperwork not properly filled out/signed off

This is an interesting scenario, although it would be convenient to see it on a case-by-case basis.

For instance, if the missing signature was an evidence decision-approval for product release, or process deviation, or procedure update, or evidence of training, then I woud consider raising the issue as a non-conformance. You can support the non-conformance stating what is the SOP requirement regarding the needed signature.

As for missing spaces it all depends on their purpose. If the space had not use at all and was obviously not applicable, then an opportunity for improvement is appropriate, if on the other hand the missing data was intended to provide a decision making result, then an NC is more appropriate.

At the end, auditing is not exact science, you as an auditor need to make a decision based on the facts, amount of evidence, impact, implications, previous similiar findings, severity, etc.
 
#4
Re: Paperwork not properly filled out/signed off

Filling out paperwork, and signatures are part of a control system. The real question is: Does there have to be this level of control? If the absense of a signature, or the loss of recorded data could adversly affect the planning, control or operation of the process, then missing information could have serious negative impact.

However, there is a greater danger. Even if the signatures, or loss of recorded data does not adversly affect the process or the product ~ in this case~, are you setting yourself up for issues in cases where it would make a difference. When we start telling folks it is okay to deviate in a certain instance, or area, we add confusion to the process.
 

somashekar

Staff member
Super Moderator
#5
Hello everyone,

I just performed an internal audit where I found paperwork which was either not filled out in its entirety or not properly signed off. Is there anything in ISO 9001 that states forms need to be filled out in their entirety and/or all signature fields must be filled out or "N/A"? Or is this an internal process which we need to develop?

I would like to write it up as a non-conformance so we can address the issue but I have nothing to use as a reference. Sadly our own processes need some updating on many subjects including this.
Yes, you need to develop this internal process that fits your use.
Go ahead and write up a NC,
Sadly our own processes need some updating on many subjects including this.
you also have a solution written down as quoted.
But remember to see one aspect...
Is it systamatic across and several documents are incomplete and unsigned ? Then your own process needs a updating as you mention. If not them just get them corrected and get moving further.
 

BradM

Staff member
Admin
#6
Maybe a little different flavor here...:D

Paperwork not filled out.... not good to me.

If I am a customer and see any not completed documentation, I wonder "was that important? Did they skip over that part for a reason?"

Sometimes I ask. They respond "Oh... that is for blah, blah, blah and is not needed". I think "Ok, then revise the form; or mark N/A". But don't leave it blank.

So either the information is needed, and needs to be completed. Or that information is not necessary anymore, and the form needs to be revised. Make the forms more useful; it saves times, and increases the chance for it to be completed properly.

So you're auditing the process and their process procedures have requirements for Approval Here, or assure that X is not there, or something like that. If that part of the form is not complete, then they cannot provide evidence that was done. So to me, that is more the deficiency, that they cannot provide the evidence of completion of their own process documents. Again... either the information is needed and should be documented. Or, it's no longer needed, and they need to revise the forms.

Like the others mentioned, I would add a documentation section somewhere stating how forms and documents are to be completed, to not use pencil, don't scribble, don't use pink ink:D, etc.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
I just performed an internal audit where I found paperwork which was either not filled out in its entirety or not properly signed off. Is there anything in ISO 9001 that states forms need to be filled out in their entirety and/or all signature fields must be filled out or "N/A"? Or is this an internal process which we need to develop?
Paragraph 7.5.3 of ISO 9001 stipulates that product status, related to the monitoring and inspection, must be identified. If your process relies on data, signatures, etc. to indicate completion AND approval of specific operations in the product realization cycle, the missing items (might) violate that requirement of the ISO 9001 standard.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
I have questions:
  • What is the paperwork? Is it inspection records of nuclear piping system welds? A purchase order for toilet paper? Something in between?
  • What information is being left off - is it incomplete paperwork or is it just some blanks for data that aren't available or aren't needed? How can you tell?
  • Where is the use of this paperwork called out? Do the instructions clearly state what is to be filled out?
There are times when the lack of data on forms can invite the auditor to inquire about the details, based on the need to determine a process's effectiveness and the fulfillment of standard elements wherever a requirement for records is called out. This seems like such a time.

Back in the dark days when I was inspecting piping welding repairs, we were required to ensure every blank on an inspection record was filled with something to help ensure nothing else was entered after the inspection was over. But not all paperwork carries this level of requirement. It depends on the data, its importance, the likelihood and need to avoid "tampering" and other considerations the organization finds important.

I hope this helps!
 
J

Jason PCSwitches

#9
we were required to ensure every blank on an inspection record was filled with something to help ensure nothing else was entered after the inspection was over. But not all paperwork carries this level of requirement. It depends on the data, its importance, the likelihood and need to avoid "tampering" and other considerations the organization finds important.

These exceptions should be outlined in the organizations documents control procedures. This will prevent any confusion when an auditor notes a blank space on a document or record.
 
D

dbzman

#10
When we create paperwork we are inferring that this document is needed for some reason. We put the document into use and expect it to perform some function. This function could be to convey information or to record some decision or action. Since it has been created and is intended to be used it would be an issue with a customer if it was not used properly.

If the signoff is used to show completion and/or compliance then the absence of the signature could adversely affect customer satisfaction and therefore would be a non-conformance.
 
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