Document Control for ISO- Labeling DWG's as Uncontrolled Documents

The QMS at my company is moving towards ISO certification compliance. Our Engineering Department is now placing "UNCONTROLLED DOCUMENT" on all of it's drawings, and it is stated on every copy we print (as well as the digital versions we have access to). This is a new thing, as we have never had "UNCONTROLLED DOCUMENT" on any of our prints before. We do not have SWI's in place to guide production (at the moment) and are relying on the DWG's to guide production. The documents are, in fact, controlled documents with revision records, approvals, release dates, etc., and the hardcopies of the documents are controlled on the plant floor by: 1) our system of distribution, 2) audits against Master Lists to verify latest REV's, and 3) regulations against marking on the printed DWG's. Engineering Dept. insists that 'once the DWG's are printed, they are uncontrolled.' I do not agree as the system controls the placement, and updating, of the hardcopies.

Is Engineering correct?

Can we use the DWG's labeled "UNCONTROLLED DOCUMENT" to guide production/assembly processes and still be in compliance with ISO requirements?

 

I will greatly appreciate input on the situation.

 

I think verifying the revision of the uncontrolled drawing to the Master List is acceptable. Then you only have to control the Master List.

You will have to specify how often to compare, such as daily, each use, etc.

Good luck getting ISO certified.

 

Prints when they are used in production are difficult to control. What you want is a master file which contains the controlled copy of the print. This is updated as print revisions change and such. Then you use copies of those prints in production. That print is uncontrollable. Too difficult to track and ensure you can get every one. Supplement with a procedure to address possible revisions during production and you should be set.

 

But hardly anybody verifies cash is correct and the customer loses when counterfeit cash is discovered.

 

Plus, they couldn't recall 100% of the money if they had a revision change.

 

In many cases what happens is s that print is copied and placed with the order paperwork which travels around the shop. Thus, Jane doesn't have to constantly get the print -- it's right there with her other paperwork. That copy is uncontrolled but is only temporary during production of the order. It's then taken out of circulation.

 

Dear I Feel Only we have 01 Master Copy i.e. in your System Data Base & rest all copies taken from it is controlled while ensuring person who takes it and its revesion. for example if there is provision to take older revisions of document it can lead to NC and it has to be ensured that the print comming out of the data base will only be of the latest revesion then by default it is controlled not uncontrolled as system of controlling document is ok

 

Hello all this is my first time responding to something posted here. Everyone has been a great wealth of knowledge to me so thank you.

So the drawing (uncontrolled copy) has been issued to (Job-M123, for P/N 123-45-678 Rev B this was released on 04/01/2017)by production control or document control. The parts are manufactured by Jimmy Bob and signed off as complete. The parts and paperwork are then moved to inspection. Inspector Rufus Teebone verifies that the latest revision of the part matches the paperwork and parts. The drawing sent along with the packet shows what revision was used to manufacture the widget. Upon completion the “uncontrolled drawing” can be destroyed or placed in the file with the other paperwork to show what was used to manufacture the widget.

I have seen this done in a few companies I have worked at.

 

Bank notes are not really controlled. They are just issued and all revisions are acceptable.

 

Good day Joey E Hoyt;
First things first. Welcome to this site and let me congratulate you on your profile photo and your beautiful family. It helps me (all) keep things in perspective.

Back to your original question, as I fear "we" have drifted slightly.

As you can see by the most relevant clauses of ISO 9001:2015 (7.5.2; 7.5.3; 8.5.6), the standard relies on terms such as "available", "identification", "control", etc...

As with most management system standards, ISO 9001:2015 does not generally state how a requirement is to be met. When provided a blank canvas (i.e. the lack of "how" requirements), you and your organization have the ability to "paint" a process that not only meets the requirements of the standard, but also (most importantly) serves your organization and ensures conforming product/outputs.

Organizations I have worked with have used the "uncontrolled if printed" flag successfully, with the intent of ensuring that those documents are not used beyond the immediate intended readability, reference, etc... Pragmatism leads me to firmly believe that printing controlled information for brief/immediate use/reference is a necessary evil and I am, therefore, an advocate of some type of "uncontrolled if printed" method for certain information.

A good rule of thumb for identifying the need for a "controlled document" is what I call the WRONG or GONE principal.
In other words, if the information being WRONG or GONE, can it lead to a nonconformance?
If the answer is yes, then this "document" (information) is CTQ and controls should be put in place commensurate with that risk.

Hope this helps.

 

While labeling all drawings as "Uncontrolled Document" goes against all I was taught, I'm in what seems like an unusual position. Rarely does a customer provide drawings, and many of them have wrong or missing information needed to make the item correctly. Often, they simply drop off a sample, and we make the drawing. I discussed this with our CB auditor and was advised that we can make approvals on drawings we generate, even though the design is not ours. It is routine that drawings on the production floor have hand-written changes with out initials and date.

So having all drawings labeled as "Uncontrolled" is looking pretty good to me right now, especially since the GM is usually the person making the notes/changes on the drawings, after speaking with the customer (probably not recorded in an e-mail).

Any ideas on this?

Thanks.

 

Thank you all for the input. Obviously this is not a simple issue to address, and the answer is not black and white. I also note that ISO auditors can vary from of one to another on what they view as acceptable. Our engineering department is in another state [from the manufacturing plant], and does not have their system documented (yet). I work at our two manufacturing plants, mostly, and our Quality Manager and I are closing in on having one of the two plants "compliant", albeit virtually, at the moment before moving to our corporate office to battle our engineering department into compliance. We have submitted multiple gap analysis to upper management identifying non compliant, and missing, procnotes but have not gotten encouraging results to this point. We are still pushing our ME for manufacturing process controls at the plants in fact, so we are far from ready for an external audit. As a trained ISO internal auditor who has never worked within a mature system, I am still learning daily. I know our process should control or inputs to the point where or outputs meet customer and engineering criteria/expectations. Our DWG's are located at each department, in hardcopy form, within binders. One set at each location. Our engineering places only the newest revision in a folder on or server for office personnel to access (we have no electronic system for line workers to access). Quality department (i.e. me) replaces DWG's in these binders with the latest revision each time one is released. Line workers reference these hardcopies during production for specifications. We have policies against marking on these DWG's and against copying them so that only the newest revision is accessible (ideally). Our plants are only 70-80 workers, so I am fairly confident that we would be able to find instances of these policies were they being violated. So, I still feel like they are controlled and therefore acceptable to guide production. The "uncontrolled document" stamps on them (these notations are also on the Inventor and AutoCAD versions used by engineering) contradict the control system we are pushing to implement. So, I still am not sure if I am correct in my assumption. We use "uncontrolled document" and "for reference only" stamps on external documents such as owner's manual pages, or welding inspection criteria, or 5S documents which we print and place at work stations for the workers to reference (these documents are not typically replaced with newer versions should ones exist). My thought is if we have uncontrolled on everything, as an internal auditor, then the auditor in me must view these as being uncontrolled and therefore violating ISO 9001:2015 clauses 7.5.3, 8.5, 8.6, and other clauses (e.g. 7.1.2 [training]) which fail as major noon conformance. However, I am 9001:2008 trained, so could be mistaken on the 2015 clauses' intentions. Strictly ISO pass fail is what I am seeking guidance on, not best practices. Thank everyone again, and I will watch for input.