Printed Documents are considered Uncontrolled

[Big Jim]

Re: Any printed documents are considered Uncontrolled

Curious - are you aerospace? Sidney Vianna posted a thread a couple of years ago about AS9100 registrars being told to stop soft grading.
Ok - I can understand that since lives are at stake in much of that industry.
But for General industry ISO9001? It's harsh.
Anyway, this is off topic - I'd be happy to start a new thread on soft grading if you'd like to bring others into the debate.

I would not mind having another thread, but it really isn't much different than what Sidney already covered in AS9100. That part of auditing is the same for either AS9100 or ISO 9001.

 

[JaneB]

Re: Any printed documents are considered Uncontrolled

I don't feel that my reputation as quality professional and auditor has been diminished by my registrar issuing an "observation" rather than a "nonconformance" for something like this.
If that error was indicative of the rest of the facility and repeated in other areas, or a repeated finding from prior audits, I would accept it as a nonconformance, maybe even a major if it was rampant - but he looked and was unable to find other instances....

Come on. Based on your rationale every company would fail every audit if an auditor wanted it to because you'd write up the most minor infraction as an NC.
So instead of "soft grading" they would be ignoring, or there would be a lot more companies losing certification.
I'd rather be soft graded and have a very minor deficiency pointed out than have it ignored and then blow up into something big later.

Yeah - good call. I agree, and hardly see a single instance as a prime example of 'softgrading'. Come on, Jim, let's get a bit of proportion happening, rather than shouting softgrade on this very thin basis.

 

[JaneB]

Re: Any printed documents are considered Uncontrolled

I think I am understanding my auditor now. He voiced he did not like my controls in my footer.

It's entirely irrelevant what your auditor 'likes' or 'does not like'. His / her job is to establish conformance etc, not to bring in his personal likes or dislikes.

When he asked how I had to show him every document so he could compare it to my documentation control list. When he found all was current he couldn't say anything and there wasn't even a concern on his report.

Fine - he did (at least one part of) his job: tested your system to see if it held up. It did. This is normal and OK.

But all of this has made me question my controls and maybe looking into a way where the auditor will not question it again.

Please don't go down that path. You'll go nuts trying to get a system that your auditor 'will not question'. It's their job to question and test it. It isn't their job to design it, to say how it 'should' be or what they 'like' to see. And if you get any auditor talking in those terms, take it up with their manager because it is NOT OK.

Design the system for you, not your auditor, ever. If an audit causes you to question part of your system, that may be a good thing. You may question it and decide to change it, or to leave it the same. But have good reason for doing so.

And it is not ever a good thing to change it because of what an auditor 'likes' or 'doesn't like'. Ever.

 

[John Martinez]

Re: Any printed documents are considered Uncontrolled

And it is not ever a good thing to change it because of what an auditor 'likes' or 'doesn't like'. Ever.

As a third party auditor, let me repeat...EVER! While your auditor may offer opportunities to improve your system, it is up to YOUR ORGANIZATION to decide if you will implement or not.

 

[Helmut Jilling]

Re: Any printed documents are considered Uncontrolled

I think that's perfectly fine.
Heck - we don't even embed time/date stamps in our hard copies and not a single auditor - customer, regulatory, or certification - has taken issue.

I'm also in a fairly small manufacturing company and the machine operators do not have direct access to a computer. However they are all trained to go to the supervisor's office and open document control directory on a couple of shared computers if they need to look at a work instruction or procedure.
In fact, when I give training I encourage them to just scan through the document control directory and look at anything they want. Read the quality manual, the employee handbook, org chart, whatever.

The original post described a method that can work pretty well. You seem to take it a bit further, and verge into territory that can fail easily. People simply do not go and check a document everytime they want to use it. Nor is it good to expect them to do that. Surely, you can develop a more robust method of doc control than that?

 

[Helmut Jilling]

Can you have in your document control procedure a statement saying the "any printed documents are considered Uncontrolled; use only current version on local electronic file location"?
Use that statement for documents that do not have it written in the footer or stamp such? Will that satify the requirement for ISO 9001:2008 clause 4.2.3 (c) - to ensure that relevant versions of applicable documents are available at points of use?

The standard requires that documents be controlled. Your procedure seems to say that printed documents are not controlled. That would typically be a nonconformance. If peopel are not supposed to use them, then don't put them out there to be used. There are easier, more effective ways to ensure information and documents are in control.

 

[Big Jim]

The standard requires that documents be controlled. Your procedure seems to say that printed documents are not controlled. That would typically be a nonconformance. If peopel are not supposed to use them, then don't put them out there to be used. There are easier, more effective ways to ensure information and documents are in control.

Well said. Finding an uncontrolled document in use would be a nonconformance.

I have seen a clever approach for this. The footer gave the time and date that the document was printed and stated that it was uncontrolled 24 hours after printing. I'm not sure that I would do it that way, but it was an interesting approach.

 

[ScottK]

Re: Any printed documents are considered Uncontrolled

The original post described a method that can work pretty well. You seem to take it a bit further, and verge into territory that can fail easily. People simply do not go and check a document everytime they want to use it. Nor is it good to expect them to do that. Surely, you can develop a more robust method of doc control than that?

That's a harsh judgment to make without seeing the system in action or even reviewing the document control procedure and training process and a very pessimistic view, Helmut.

People here simply do go and check documents when needed and are made aware when revisions occure thanks to a very robust triaining system.
We train them that way and empower them to do it.

My philosophy is about empowering people and not assuming that they are lazy and won't make the effort.

 

[Helmut Jilling]

Re: Any printed documents are considered Uncontrolled

That's a harsh judgment to make without seeing the system in action or even reviewing the document control procedure and training process and a very pessimistic view, Helmut.

People here simply do go and check documents when needed and are made aware when revisions occure thanks to a very robust triaining system.
We train them that way and empower them to do it.

My philosophy is about empowering people and not assuming that they are lazy and won't make the effort.

Sorry, did not mean to sound harsh. Of course I did not see your systme, my comments were directed toward your explanation.

However, I think we are not saying the same thing.

Your earlier post seemed to suggest that people would check a document everytime they want to use it. That is how I took it and is what I responded to when I said "People simply do not go and check a document everytime they want to use it."

Now you state that they "go and check documents when needed..." Well, that is a significant difference in degree. I argued that expecting them to check every time was impractical and probably would not work. If they can check "if needed," I suspect people usually will assume their document is current and will not check frequently unless there is some catalyst that prompts them to. I know I would not want to check every time either. (It would be interesting to count how many times someone actually verifies.)

Thus, my comment that there are more robust methods to ensure that current documents are in fact in place, and not require or depend on doc users to become doc control people. I don't think that is a particularly robust approach, and might not meet ISO requirements to ensure that docuemnts used are in control.

In any case, no offense intended, not sharing my observations.

 

[ScottK]

Re: Any printed documents are considered Uncontrolled

Sorry, did not mean to sound harsh. Of course I did not see your systme, my comments were directed toward your explanation.

However, I think we are not saying the same thing.

Your earlier post seemed to suggest that people would check a document everytime they want to use it. That is how I took it and is what I responded to when I said "People simply do not go and check a document everytime they want to use it."

Now you state that they "go and check documents when needed..." Well, that is a significant difference in degree. I argued that expecting them to check every time was impractical and probably would not work. If they can check "if needed," I suspect people usually will assume their document is current and will not check frequently unless there is some catalyst that prompts them to. I know I would not want to check every time either. (It would be interesting to count how many times someone actually verifies.)

Thus, my comment that there are more robust methods to ensure that current documents are in fact in place, and not require or depend on doc users to become doc control people. I don't think that is a particularly robust approach, and might not meet ISO requirements to ensure that docuemnts used are in control.

In any case, no offense intended, not sharing my observations.

I see - I read it as having to check documents every time they do a job. Our training is such that they shouldn't have to reference the documents often, but when they do feel the need for clarification or refresher they are empowered to do so at will.
The documents are in a controlled directory in un-editable format where only the most current rev lives. So the users don't have to worry about rev level. If the system works they'll only see current revs.

I've gotten loads of compliments on the system from custemers and have had it rated "benchmark" by two large medical device customers. So I must be doing something right.