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

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Joey E Hoyt, Jul 27, 2017.

  1. Joey E Hoyt

    Joey E Hoyt New Member

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    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?
     
  2. Joey E Hoyt

    Joey E Hoyt New Member

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    I will greatly appreciate input on the situation.
     
  3. johnnymo77

    johnnymo77 Member

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    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.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    "Uncontrolled" on everything is a cop-out. What it means is they can't be bothered to - or don't understand - how to control documents. Now, it may also be that the procedure written in the name of controlling documents and drawings/specs is also burdensome, hence the cop-out!

    Share your (sanitized) procedure here and we can take supporting you from that point...
     
    Pancho likes this.
  5. Golfman25

    Golfman25 Well-Known Member

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    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.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why? Bank notes are controlled documents and there's millions of those...
     
  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I see a lot of "Uncontrolled when printed" on documents. It won't help. What matters is that the content is accurate and current.
     
    Andy Nichols likes this.
  8. RoxaneB

    RoxaneB Moderator Staff Member

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    Jane works at Station A where she makes widgets. The widgets she makes are based on customer-approved drawings, created by her company's Engineering department. During a normal work day, she can make up to five different designs requiring five different drawings. The drawings she needs are located in a centralized location on the shop floor. Jane needs to stop her machine and safely lock it out, before walking over to that centralized location to pick up the drawing that she needs for the next round of widgets to be made. Then she walks back and safely restarts her machine. A few hours later she has to repeat this process. Frustrated at what she believes in an inefficient process, Jane uses part of her lunch break one day to make copies of the drawings she needs. She is pleased at the decreased downtime at her station and thrilled with her increased productivity, using these copies of the drawings now available beside her. Two weeks later, Customer 123 calls the organization, furious that the shipment of widgets they received today do not meet their specs that were revised the previous week. Quality investigates and is unclear how this mix-up could have happened as the centralized location with the controlled engineering drawings has the updated version. They speak with Jane who admits that she thought she was helping the process by making a copy of the drawings she needed and no one told her there was a change.

    At the end of the day, controlled hard copies are all well and good, but it's human nature to be lazy. If people can find a way to work around your organization's process for controlling the hard copies of the documents, they will. Why? Because they do not believe that the system helps them. How does your system of distribution, audits against Master Lists and rules about no marking of the drawings help your shop floor employees do their job?

    I agree with Andy that slapping Uncontrolled on everything is the easy out, but I think they're also recognizing how the drawings will end up being used. What they haven't done is provide a solution that ensures people have easy access to the right information at the right time.
     
    John C. Abnet and yodon like this.
  9. johnnymo77

    johnnymo77 Member

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    But hardly anybody verifies cash is correct and the customer loses when counterfeit cash is discovered.
     
  10. Golfman25

    Golfman25 Well-Known Member

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    Plus, they couldn't recall 100% of the money if they had a revision change.
     
  11. Golfman25

    Golfman25 Well-Known Member

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    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.
     
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  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    How do these points relate to document controls? What has verification got to do with it? Who counterfeits QMS documents?

    Given the volume and those who want to keep some as collectors - which no-one wants to do with QMS documents.

    For the most part, people make too much of "document control". The fact remains that bank notes ARE controlled documents, yet they don't require the types of bureaucratic controls put in place for a (very small) number of boring QMS documents! Discover effective document control methods before creating and sustaining a monster...
     
  13. RoxaneB

    RoxaneB Moderator Staff Member

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    While I do not necessarily disagree, that was not included in the Original Poster's scenario. Then again, we don't know what the "system of distribution" is that the OP mentioned.
     
    Andy Nichols likes this.
  14. Manish Rawat

    Manish Rawat New Member

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    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
     
  15. Zebra418

    Zebra418 Member

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    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.
     
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  16. johnnymo77

    johnnymo77 Member

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

    Andy Nichols Moderator Staff Member

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    Oh no they aren't! In fact, if you look at the way the UK change their bank notes, they frequently change designs - to reduce counterfeiting - and when I visit I often have old versions which are NOT accepted by stores. I'm not sure what country you live in, but your statement isn't universally true.
     
    johnnymo77 likes this.
  18. John C. Abnet

    John C. Abnet Well-Known Member

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    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.
     
  19. SpinDr99

    SpinDr99 Member

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    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.
     
  20. Joey E Hoyt

    Joey E Hoyt New Member

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    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.
     

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