Document vs. Record - What's the Difference under TS 16949?

[dbzman]

Under 4.2.3 Control of documents - records are said to be a special type of document.
I'm in the habit of keeping two control listings. One for records and one for document (intructions, SOPs, etc).
Under this definition if a document has data entered on it then it becomes a record.
Would it be better to just have one listing or is there another way to control records? Am I making this too complicated?

[Ken K]

The way we separate the two is if we update or change a document it would require a revision change because it's controlled.

But, we also use various files and logs which are updated as part of normal operations without necessitating a revision change.

Both are considered part of our quality system.

[db]

if we update or change a document it would require a revision change because it's controlled.

Very good Ken! And if we change a record it is called an update, but the revision level doesn't change. Or does it? If I update a record, then the last entry could be considered the rev level, although it would not show on the master list, which gets back to your statement.

As my mind is, this may sound too simplistic:

If you change the info on a procedure, instruction, or form, there is a need for a revision.

A record is just that, a record. Do we revise records? I would not think so, revising records could lead to what has been going on recently in many corporations, If we don't like the results let's change the records.

If there is a record that is disfavorable it needs to be acted upon with some type of preventive or corrective action.

Just a thought!

ASD...

[durnan]

Originally Posted by dbzman

Under 4.2.3 Control of documents - records are said to be a special type of document.
I'm in the habit of keeping two control listings. One for records and one for document (intructions, SOPs, etc).
Under this definition if a document has data entered on it then it becomes a record.
Would it be better to just have one listing or is there another way to control records? Am I making this too complicated?

Document is the form in a blank state then it changes to a record when it is filled in.
the document would prob be stored on the hard drive on pc then when it is turned into a record prob filed away. Hope this helps.

[dbzman]

Hello everyone!


I am coming in on this discussion a little late but it looks like the question is “what is the difference between a document and a record”.
I look at this in a slightly bent way.

The way that I look at records vs. documents is this:

1. If I wanted to see how a job/activity was performed I would look at a record.
2. If I want to look at how a job/activity is to be performed I would look at a document.

Once data is placed on a document it becomes a record.

You would revise a document but not a record. You may update the information on a record (with signatures and dates) but not the revision.

Maybe I just oversimplify but that is my take on the difference.

[Helmut Jilling]

Originally Posted by dbzman

Under 4.2.3 Control of documents - records are said to be a special type of document.
I'm in the habit of keeping two control listings. One for records and one for document (intructions, SOPs, etc).
Under this definition if a document has data entered on it then it becomes a record.
Would it be better to just have one listing or is there another way to control records? Am I making this too complicated?

Whatever works best for you. Although, under the general principle of less is better, if you can comfortably do it on 1 log, so much the better. I have seen some companies do that by adding some columns for Retention Times and Storage and Disposal requirements to the right hand side of the log.

The main thing is control the stuff so the information is accurate, and it is available if some needs to read it. If you achieve that aim, you have met the ISO intent pretty well.