Incomplete forms and records missing date or a name

[Haddad9921]

Hi,
I have a question about incomplete forms and records. I am talking about forms and records missing date for example or a name. Is that considered to be a nonconforming situation under 4.2.3, 4.2.4 or any other clause(s) of ISO 9001-2008?
Thank you

 

[Marc]

It depends upon the specific scenario. Have a read through How to deal with incomplete forms and see if your question is answered there. If not, come back to this discussion thread and ask a more detailed question.

The bottom line is that all forms must be completely completed unless otherwise stated in your internal documentation. This should be part of the instruction and/or training employees responsible for using and completing the form receive.

 

[insect warfare]

Hi,
I have a question about incomplete forms and records. I am talking about forms and records missing date for example or a name. Is that considered to be a nonconforming situation under 4.2.3, 4.2.4 or any other clause(s) of ISO 9001-2008?
Thank you

If you're referring to records, 4.2.4 is the relevant clause. But nowhere does it explicitly state that incomplete fields on forms and such are by and large a nonconforming situation. It merely states that "records shall remain legible, readily identifiable and retrievable".

The classification of nonconforming will most likely come down to the degree in which the missing information will have a negative impact on business performance. More serious infractions or omissions should always be given the higher priority for correction or corrective action. If the missing information is important to your business, common sense dictates that it is probably a NC in one way or another.

Brian

 

[Marc]

I respectfully disagree. Even in ISO 9001 (which is no more than "Basic Business Practices 101") incomplete forms (which become records) are going to be problematic.

You are correct in saying ISO 9001 does not explicitly require that forms be completed - But just consider the aspects of responsibilities (e.g.: no name entered).

Relating non-completed forms to "business performance" is not appropriate in my opinion.

A "Form" with omissions is no less than an "in-complete" record.

 

[Helmut Jilling]

<snip> forms and records missing date for example or a name. Is that considered to be a nonconforming situation under 4.2.3, 4.2.4 or any other clause(s) of ISO 9001-2008?

A nonconformance is a situation where someone is not doing what is expected. Lots of companies have forms where not all fields are not filled out. Is it right? Is it wrong? We could debate for a long time.

Some information is clearly necessary, depending on the form. As an auditor, if it appears there is meaningful information missing, it would be an audit trail. It frequently leads to a nonconformance against records. If non-meaningful info is missing, I would probably just move on to more meaningful discussions, or perhaps suggest they modify the form.

 

[Marc]

A nonconformance is a situation where someone is not doing what is expected required. <snip>

Fixed that for you.

 

[insect warfare]

I respectfully disagree. Even in ISO 9001 (which is no more than "Basic Business Practices 101") incomplete forms (which become records) are going to be problematic.

You are correct in saying ISO 9001 does not explicitly require that forms be completed - But just consider the aspects of responsibilities (e.g.: no name entered).

Relating non-completed forms to "business performance" is not appropriate in my opinion.

A "Form" with omissions is no less than an "in-complete" record.

Marc, I was thinking in broader terms of "information", not just the completeness of paper forms, but also the use of electronic data (which too qualifies as "records") as an input for decision-making. If negative trends begin to manifest themselves, a lack of meaningful information may lead to missed opportunities, so I believe (in this context) it is appropriate to relate to the business performance angle.

For example, if a large company experiences a sudden increase in product failures but (because of poor IT planning) their shop floor control data does not provide traceability to specific users, an opportunity was missed either to re-align the under-performing individuals to the related objectives or to re-assign them to less critical tasks, thereby allowing those persons to continue to operate undetected. This can significantly affect business performance in a negative way, if not corrected in a timely manner.

I do think that Helmut summed the "paper form" thing up with:

A nonconformance is a situation where someone is not doing what is expected. Lots of companies have forms where not all fields are not filled out. Is it right? Is it wrong? We could debate for a long time.

Some information is clearly necessary, depending on the form. As an auditor, if it appears there is meaningful information missing, it would be an audit trail. It frequently leads to a nonconformance against records. If non-meaningful info is missing, I would probably just move on to more meaningful discussions, or perhaps suggest they modify the form.

Brian