Is Management Representative a loose cannon or am I unnecessarily concerned?

M

mischele68

#1
Hello everybody :bigwave:. I've been viewing posts here on the Cove for a while now, but have not yet seen any posts related to the situation I currently find myself in. I have been employed at an AS9100-approved manufacturing facility for quite a few years; my responsibilities have included Document Control and Internal Auditing functions for the majority of that time. Over the years, I have seen several Quality Managers / Management Representatives come and go. Each one had a different mindset about this, that or the other regarding the QMS and made changes based on that mindset. (Resulting in total :confused: for me!) Our most recent representative appears to have placed the responsibility for supporting external audits squarely on himself, i.e. SME's are not interviewed by the customers, he is providing all answers to questions, etc. Today I discovered that during the course of our last customer audit, a spreadsheet with links to objective evidence that it was felt the auditor may be looking for was created. Not a problem, I thought it was a novel idea. What I have taken issue to, perhaps incorrectly, is the fact that during the creation of this spreadsheet, controlled documents were copied from the master file location to a secondary location instead of linking them directly from the master. Nothing is marked as reference material as far as I can tell...my question to you who are CB auditors is: can the duplicate copies of QMS documents (which may or may not be updated in case of revision) be considered an noncompliance (Control of Documents) should they be discovered in a future registrar audit? Sadly, as far as I can determine, we are one of those companies whose management views the QMS as a necessary evil instead of good business practice (No management review in almost 3 yrs). :frust:
 
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C

Chance

#2
can the duplicate copies of QMS documents (which may or may not be updated in case of revision) be considered an noncompliance (Control of Documents) should they be discovered in a future registrar audit? Sadly, as far as I can determine, we are one of those companies whose management views the QMS as a necessary evil instead of good business practice (No management review in almost 3 yrs). :frust:
I am not a CB auditor. If the duplicate copies violate your control of documents procedure, for sure that is a finding.:2cents:
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Welcome to the Cove! :bigwave:

Normally I am a purist, and if it was me I would be hyperlinking to the controlled document.

But wait! The audit is a snapshot in time, and that includes a snapshot of documentation that was in place at the time of the audit. If hyperlinks are used, would they lead to the current revision whenever they are clicked on? Although these will be presumed to be "official" versions while viewed, after the audit they are a kind of record of what was covered at the time... so long as they are valid when presented, that is.

Then there is the documents' purpose. Yes, uncontrolled copies are a general no-no, but these are not going to be used for doing production work, true? The spirit, if not clearly the letter of the control requirement is based on using the correct work instruction.

I would have maked them "for reference only" or some such, just to be safe. But my organization's documents say in every footer: "Not Controlled unless viewed on-line" and that's what we tell everyone: operators, managers, auditors, etc.

I welcome other people's input - I am also not a CB.
 
M

mischele68

#4
Jennifer / Chance - thanks for your responses.

Jennifer- like you, I too tend to be a purist and want everyone to follow procedures/requirements to the letter. :whip:

Our internal QMS documents all say "Reference Only When Printed". I agree with your comment regarding the snapshot in time and in theory, no, the copied files should not be used for production; however, the properties of the folder in which the copies reside is open to viewing by anyone in the facility...but then again, the PROPER location to view CURRENT QMS docs is included in our procedure, has been communicated company-wide time and again, and the procedure says nothing about having multiple copies in different locations...
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Jennifer / Chance - thanks for your responses.

Jennifer- like you, I too tend to be a purist and want everyone to follow procedures/requirements to the letter. :whip:

Our internal QMS documents all say "Reference Only When Printed". I agree with your comment regarding the snapshot in time and in theory, no, the copied files should not be used for production; however, the properties of the folder in which the copies reside is open to viewing by anyone in the facility...but then again, the PROPER location to view CURRENT QMS docs is included in our procedure, has been communicated company-wide time and again, and the procedure says nothing about having multiple copies in different locations...
There is always the chance that personnel will copy a process document somewhere, or print it out. Hey, I also have printed copies of some of these documents. I am held responsible to make sure they are always current to the job at hand. We all are. And our document control procedure is silent about all of this EXCEPT the obligatory "The only controlled copy is the one viewed online via the XYZ system."

So based on what I have seen I do not think your QM is a loose cannon in this matter.
:2cents:
 

Jim Wynne

Staff member
Admin
#6
Jennifer / Chance - thanks for your responses.

Jennifer- like you, I too tend to be a purist and want everyone to follow procedures/requirements to the letter. :whip:

Our internal QMS documents all say "Reference Only When Printed". I agree with your comment regarding the snapshot in time and in theory, no, the copied files should not be used for production; however, the properties of the folder in which the copies reside is open to viewing by anyone in the facility...but then again, the PROPER location to view CURRENT QMS docs is included in our procedure, has been communicated company-wide time and again, and the procedure says nothing about having multiple copies in different locations...
I'm not a CB auditor either, but I think you might be looking at this from a strict compliance perspective and might need to view it in a more pragmatic way. Jennifer makes an excellent point regarding why linking to the current controlled copy would be a bad idea. If your document control system doesn't allow for what the MR did, the requirements should probably be changed so as to not handcuff people who are trying be sensible.

It's common practice in paper-based systems to attach copies of controlled documents to audit reports; no one, including CB auditors, should expect those documents to be replaced with current versions when they've been superseded. It shouldn't be any different for electronic systems.
 
M

mischele68

#7
I'm not a CB auditor either, but I think you might be looking at this from a strict compliance perspective
Absolutely - that was the mindset / example set by the previous QM/MR; this new MR seems to have a completely different view of things, something I have not quite adjusted to.

It's common practice in paper-based systems to attach copies of controlled documents to audit reports; no one, including CB auditors, should expect those documents to be replaced with current versions when they've been superseded. It shouldn't be any different for electronic systems.
I see your point as I have done this very same thing in my audits in years past.
 
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