Is a stamp necessary to control a paper document?

cubix rube

Involved In Discussions
#1
I really feel like an idiot, even ASKING such a question! The company I've come to work for recently is migrating from 9000 to 13485, and I've been very busy putting all of the various modifications to the QMS necessary to succeed. We're hand picking a few products to which we want to apply the full 13485 documentation requirements, so we have some records to audit, and I'm reading through our manual and procedures to ensure nothing gets missed.

Our Q Manual says, in several places, that "customer drawings are controlled..." Yet, when I go into a customer quote file, where their drawings are stapled to quotes, notes, and other assorted job sepcific docs, not one drawing that I can find is actually stamped "controlled". We've been ISO 9000 certified for something like 10 years, so I'm sure doc control has been audited many many times.

Can something as simple as a storage location specify control, even if it's not necessarily worded that way in our procedures or Q Manual?

For the record, we do NOT scan them and file them into a secured area on the server, either, so it's not like we maintain controlled electronic copies, instead, nor do we have a separate file area just for drawings. They're ONLY found in these quote files, and NOT stamped...

Should I schedule the next three weeks to go through every file cabinet and stamp drawings??!! This just seems weird, to me.
 
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#2
Re: Is a stamp necessary to control a paper doc?

Cubix - "document controlled", stamps and similar practices are a somewhat outmoded form of indicating control. Often, it's done purely to placate external auditors. Control doesn't come from such devices, more it comes from a robust system of review, approvals, distribution and change methodology, than stamping, per se. It's certainly not foolish to ask, but it is an unnecessary step, given that there are better ways to achieve control.

If you want a job, go ahead and stamp them...
 

Wes Bucey

Quite Involved in Discussions
#3
Re: Is a stamp necessary to control a paper doc?

Over the years, we adhered to every Standard that even remotely impinged on our business (QS9000, ISO 9100, ISO 13485, FDA, FAA, etc.) and we never had such a stamp. As Andy says, it's about managing and keeping track. Of course, to some folks with such a stamp, the temptation is to be like a five-year-old with a hammer - the kid thinks everything is a nail; the guy with the stamp thinks every document, even used gum wrappers, needs to be stamped, "CONTROLLED!" to grow his little empire.
 
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Sidney Vianna

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Staff member
Admin
#4
Can something as simple as a storage location specify control, even if it's not necessarily worded that way in our procedures or Q Manual?
Stamps ARE ABSOLUTELY not necessary. Since document control is one of those QMS facets that require a documented procedure, according to both the ISO 9001 and 13485 Standards, you should ensure that the organization follows the practices described in the procedure.

In my experience, stamping of documents is an archaic practice, and, for the most part, non-value added. Most organizations are being forced to work leaner. Document control, in many cases, is done very inefficiently, wastefully and unnecessary bureaucracy.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
The only reason I can think of stamps is if there's a question of the document's authenticity. Birth records tend to only be accepted for legal purposes when they have the embossed stamp/whatever of their origin. Paper money has its watermark. It's about risk and the practicality of using a stamp to alleviate it.
 

cubix rube

Involved In Discussions
#8
Well well well...Now I feel kind of silly for the OPPOSITE reason!

We actually do have a very good system of distribution and control. Just no stamps. For the last 6 years, I was at a company that got certified back in the 90's, and they still followed their same systems, including stamping EVERY controlled document, faithfully. I really don't get out much.

Thank you all once again for your sound advice!
 
D

dswit

#9
I've worked at many companies that insisted on using stamps, even though the distribution, storage and archive systems were very well documented and followed. This is a very archaic control method that has primarily lasted this long because 'that's they way it's always been done'.

A few years back working for a large pharma company, we went through cLEAN process and discovered during value stream mapping that 90% of what we were doing wasn't a regulatory requirement, but requirements we had imposed upon ourselves to mitigate any and all risk.

As professionals, we should challenge ourselves and our systems in looking for ways to streamline our processes without introducing unnecessary risk. It is possible, we just have to think outside the box.

I vote NO STAMPS!
 

Stijloor

Staff member
Super Moderator
#10
I've worked at many companies that insisted on using stamps, even though the distribution, storage and archive systems were very well documented and followed. This is a very archaic control method that has primarily lasted this long because 'that's they way it's always been done'.

A few years back working for a large pharma company, we went through cLEAN process and discovered during value stream mapping that 90% of what we were doing wasn't a regulatory requirement, but requirements we had imposed upon ourselves to mitigate any and all risk.

As professionals, we should challenge ourselves and our systems in looking for ways to streamline our processes without introducing unnecessary risk. It is possible, we just have to think outside the box.

I vote NO STAMPS!
Old habits die hard....:mg:

Stijloor.
 
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