Printed Documents are considered Uncontrolled

[Stijloor]

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 states "This document is valid for 24 hours from the date printed. It is the users responsibility to ensure they have the current revision of this document." Then there is a printed date and time.
He asked if we print copies everyday. I said no because the revision is still valid. 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. But all of this has made me question my controls and maybe looking into a way where the auditor will not question it again.
I work in a small company where the manufacturing line doesn't have access to the computer to get the current Rev. We have trained our supervisors to make sure their employees have the current rev. Plus as part of my procedure for revising a document is to send an email informing all of the new revision. So far it is a good system in my opinion.
Any ideas or suggestions from anyone would be appreciated.

Lisa,

Don't worry about it. You have a process that works. It has been verified. The audit evidence is there. Don't let the auditor and his/her opinion be a cause of concern on your part.

Keep up the great work!

Stijloor.

 

[Big Jim]

Re: Any printed documents are considered Uncontrolled

no it was not an NC - It was an "observation not affecting the outcome of the audit" in our registrar's terminology. Something that will be an NC next time if they find it again in the same area.

Something isn't quite right here. It is either a nonconformance or it isn't. There is no such thing as an observation that if uncorrected becomes a nonconformance.

There is a name for this. It is called "soft grading" and is frowned upon by certification bodies and their accreditation bodies.

 

[Cheryl Lourdes]

Hi,

Am using this template for my firm.

 

[JoCam]

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 states "This document is valid for 24 hours from the date printed. It is the users responsibility to ensure they have the current revision of this document." Then there is a printed date and time.

Hi LisaB,

That is the exact same system I have always used, and all auditors have been happy and failed to find any issues.

 

[ScottK]

Re: Any printed documents are considered Uncontrolled

Something isn't quite right here. It is either a nonconformance or it isn't. There is no such thing as an observation that if uncorrected becomes a nonconformance.

There is a name for this. It is called "soft grading" and is frowned upon by certification bodies and their accreditation bodies.

You're judging without all the facts and taking the worst case scenario, I think... as if it was a critical process and nonconforming product was being made.

It was one document in one location in a non critical process.
The auditor found this one instance. He looked for more around the facility and found no others. Thus is wasn't worth an NC, especially since we fixed it within 5 minutes - removed the offending piece of paper and counseled the operator.

I would have made the same call.

 

[ScottK]

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 states "This document is valid for 24 hours from the date printed. It is the users responsibility to ensure they have the current revision of this document." Then there is a printed date and time.
He asked if we print copies everyday. I said no because the revision is still valid. 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. But all of this has made me question my controls and maybe looking into a way where the auditor will not question it again.
I work in a small company where the manufacturing line doesn't have access to the computer to get the current Rev. We have trained our supervisors to make sure their employees have the current rev. Plus as part of my procedure for revising a document is to send an email informing all of the new revision. So far it is a good system in my opinion.
Any ideas or suggestions from anyone would be appreciated.

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.

 

[Big Jim]

Re: Any printed documents are considered Uncontrolled

You're judging without all the facts and taking the worst case scenario, I think... as if it was a critical process and nonconforming product was being made.

It was one document in one location in a non critical process.
The auditor found this one instance. He looked for more around the facility and found no others. Thus is wasn't worth an NC, especially since we fixed it within 5 minutes - removed the offending piece of paper and counseled the operator.

I would have made the same call.

That certainly isn't auditing with "rigor" and has been a big issue with certification bodies. Next time you find a nonconformance you don't want to write up, call your CB and ask them if they want you to "soft grade".

When you do this, you diminish the reputation off all auditors as well as for the entire ISO QMS scheem.

 

[ScottK]

Re: Any printed documents are considered Uncontrolled

That certainly isn't auditing with "rigor" and has been a big issue with certification bodies. Next time you find a nonconformance you don't want to write up, call your CB and ask them if they want you to "soft grade".

When you do this, you diminish the reputation off all auditors as well as for the entire ISO QMS scheem.

That's only slightly insulting.
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.
I forgot to mention that we answer "observations" with CAPA's as if they were NC's.

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.

But I'll pass on your sentiments to my Registrar/Notified Body and see what they have to say.

 

[Big Jim]

Re: Any printed documents are considered Uncontrolled

That's only slightly insulting.
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.
I forgot to mention that we answer "observations" with CAPA's as if they were NC's.

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.

But I'll pass on your sentiments to my Registrar/Notified Body and see what they have to say.

I'm only passing on what the registrar I mostly deal with brings up with every training session. They do it because ANAB pushes it.

 

[ScottK]

Re: Any printed documents are considered Uncontrolled

I'm only passing on what the registrar I mostly deal with brings up with every training session. They do it because ANAB pushes it.

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.