Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Revising a drawing to eliminate a nonconformance

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by RPNYVB, Feb 15, 2020.

  1. RPNYVB

    RPNYVB Member

    Joined:
    Feb 15, 2020
    Messages:
    21
    Likes Received:
    1
    Trophy Points:
    2
    This is my first post (in any forum not related to cars/trucks). I'm a quality engineer by day, and an issue has come up at work that I'd sure be interested in hearing outside opinions on.

    When a nonconformance exists on a production part, we all know a nonconformance record should be created to control the nonconforming material. If the nonconformance is considered to be acceptable as is, a Use-As-Is disposition is proposed. In some instances, however, at my place of employment, instead of proposing a use-as-is disposition, the nonconforming part waits while a drawing change is processed to make the engineering definition match (or at least tolerate) the nonconforming characteristic. Then the nonconformance record is closed, cancelled, or dispositioned as "rework."

    I am opposed to this method, and I think it is not in accordance with the intent of the QMS; however, I cannot find anything that specifically states it can't be done. My take is that the part should be held to the released engineering at the time of its manufacture. Thoughts?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,771
    Likes Received:
    1,905
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Welcome! I've faced this exact situation all too frequently. Engineering put dimensions on drawings which cannot always be capably manufactured. I see no reason not to do what's being implemented, as long as the drawing change is made formally (ECO/ECN) and the disposition should be recorded, "use-as-is" with a reference to the ECO/ECN number.
     
  3. RPNYVB

    RPNYVB Member

    Joined:
    Feb 15, 2020
    Messages:
    21
    Likes Received:
    1
    Trophy Points:
    2
    Thanks for the response. I would be in favor of a Use-As-Is disposition, as a Use-As-Is disposition basically translates to "the part is nonconforming, but the proposal is to use it in its current configuration anyway." My gripe is that after the engineering definition is revised, the part in question is then considered conforming and the disposition becomes "rework," rework means actions were performed to the part to make it conform to the engineering definition (which is not exactly what happened). I see no provisions for doing this in our QMS procedures for processing nonconforming material - the procedure has options and potential paths for how to disposition nonconforming material, not one of which is to wait and revise the engineering definition so that it tolerates the nonconformance.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,771
    Likes Received:
    1,905
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    I believe you're "overthinking" this. If, some time down the road, someone asks "what happened?", you can recreate the history and show the spec was changed, such that the disposition is correct. It's time-based so your "gripe" isn't based on the reality of what happened at the time.
     
  5. RPNYVB

    RPNYVB Member

    Joined:
    Feb 15, 2020
    Messages:
    21
    Likes Received:
    1
    Trophy Points:
    2
    I appreciate your opinion/input on the matter, and I understand what you're saying as far as the paper trail telling an accurate configuration tale. It still seems to me that drawing change effectivity should only apply to parts not yet built. Applying drawing changes to parts already built seems crooked (it alters defect metrics, for one thing). But, the fact that I can't find anything that specifically forbids it should be an indicator to me that it isn't as offensive as I think.
     
  6. RPNYVB

    RPNYVB Member

    Joined:
    Feb 15, 2020
    Messages:
    21
    Likes Received:
    1
    Trophy Points:
    2
    Another follow on thought to this... the organization has certain obligations related to nonconforming product, such as notifying the customer of delivered nonconforming product, or if not yet delivered, to seek customer approval. The organization may be side-stepping some of these requirements/obligations by revising the engineering definition instead of treating the product as nonconforming.
     
  7. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    468
    Likes Received:
    319
    Trophy Points:
    62
    Location:
    Upper Midwest- USA
    Good day RPNYVB;
    A few questions if I may..
    1- is your organization design responsible (or does your organization simply mfg to the customer provided drawings?)
    2- what is the contract with the customer ? (Is there an agreed upon print? ; Is the specification in question on a control plan or other method sent to/“contracted” with the customer? )
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,771
    Likes Received:
    1,905
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    If this were so, there'd be no need to revise the drawing! What you are struggling with is that someone has an ineffective Product Design Process. Changes for such reasons are an indicator that the NPD process doesn't prove the manufacturing capability, until after release.
     
  9. RPNYVB

    RPNYVB Member

    Joined:
    Feb 15, 2020
    Messages:
    21
    Likes Received:
    1
    Trophy Points:
    2
    1 - The design is the organization's, not provided by the customer. The organization is the prime contractor and does have design authority. There are policies and procedures related to drawing changes, although I don't believe the procedure is so detailed as to specify whether the change can affect parts already built or not. Sorry for the vague terms, I have some (likely irrational) concern about being too specific on a public forum.
    2 - The contract calls out the engineering drawing #s, but there are provisions for drawing revisions during production. There is a process for processing drawing changes, and (eventhough I'm not directly involved in this part), the customer is somehow involved in concurring with those changes.
     
  10. RPNYVB

    RPNYVB Member

    Joined:
    Feb 15, 2020
    Messages:
    21
    Likes Received:
    1
    Trophy Points:
    2
    To give an example, let's say 100 parts are made with 10 holes slightly oversized. Everyone agrees that the holes can still be used in their current condition (no technical concern). The quality org, however, doesn't want the 100 x 10 defects to hurt their metrics, so they let the parts sit on a shelf while the engineering dept. processes a design change to open the tolerance to tolerate these 100 parts. The nonconformance record is then changed to show the parts meet design, and some additional processing steps/approvals are avoided. The engineering dept. owes the quality manager a favor now, but in the meantime it seems the fidelity of the process has been jeopardized.

    And as Andy mentioned, it does seem like there is an issue with Product Design Verification (I am not as familiar with that section of ISO 9001). I'll have to revisit that section before commenting much more on it, but I recall reading the product verification section and thinking that it didn't jive with the backwards design change trick I've been describing.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,771
    Likes Received:
    1,905
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    You've got an issue with the wrong people owning the "metrics" it seems. If there's a defect which is resolved by a design change, that's not a Quality "hit". Quality, as a function, don't usually own metrics relating to defects. If they do, you might want to revisit peoples' understanding of the various functions and their metrics. Start with the basic principles of "O.T.I.S" - "On Time, In Spec". Manufacturing made it out of spec. because the Design Spec was too high for the process capability. Not a "Quality" issue at all.
     
    John C. Abnet likes this.
  12. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    468
    Likes Received:
    319
    Trophy Points:
    62
    Location:
    Upper Midwest- USA
    Good day @RPNYVB ;
    Based on what I understand, it sounds as if resident expert @Andy Nichols 's council is spot on specific to your current situation. I do, however, agree with your concerns. Specifically, as stated by @Andy Nichols , the seemingly poor job done during NPD (new product development) in ensuring a capable process. This is "quality 101" and can/will surely lead to real or potential problems in the future (as you clearly seem to be aware).

    Beyond the inherent risks to your organization, there is a risk (if an astute auditor) of a QMS non-conformance specific to 8.3.5-b , whereas, "the organization shall ensure that design and development outputs are adequate for the subsequent processes..."
    In other-words, the product design and development "...shall ensure..." = DFM- Design For Manufacture. (i.e. do product design engineers have the necessary information as to process capability, and are they considering that when the design?)

    If your organization was NOT design responsible, then the responsibility would be part of 8.2.3.1 (Review of requirements (i.e 'feasibility" review).
    Since your organization IS design responsible, then the aforementioned 8.3.5-b applies.

    Hope this helps.

    Be well.
     
    tony s and Andy Nichols like this.
  13. RPNYVB

    RPNYVB Member

    Joined:
    Feb 15, 2020
    Messages:
    21
    Likes Received:
    1
    Trophy Points:
    2
    Ah, yes, I see what you're saying. The ding would be against Manufacturing, not the Quality dept. I'm clearly not involved in that part of the process!
     
  14. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    724
    Likes Received:
    356
    Trophy Points:
    62
    You’re way overthinking it and over complicating it. If the parts can be used as is, then are they really “defective?” Bring them in with a pencil and work on real issues.
     
  15. RPNYVB

    RPNYVB Member

    Joined:
    Feb 15, 2020
    Messages:
    21
    Likes Received:
    1
    Trophy Points:
    2
    Yes, they are defective if they do not match the engineering definition.
     
    Andy Nichols likes this.
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,771
    Likes Received:
    1,905
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    One company I am very familiar with had exactly this issue and in pure admin terms was costing them US$8M annually. That was a conservative estimate, BTW. Now, what were your saying about real issues?
     
  17. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    724
    Likes Received:
    356
    Trophy Points:
    62
    So you're saying making quick work of "use as is" parts by revising the print was costing them $8m? Obviously there's a lot more to that story. If it doesn't affect the part, it doesn't affect the part, and some drawing isn't going to change that.
     
  18. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,771
    Likes Received:
    1,905
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    The parts were rejected. Not to print. So, from the moment the QC dude picks up a pencil (or whatever) to record a non-conformity, the "$ clock" starts ticking... With the number of parts being made and rejected each year - subsequently dispostioned as "use-as-is" - the cost associated with processing these rejects was $1000 each. Made worse, by the downtime due to parts shortages etc. It was actually higher, since the build process was stop/start and final product failures were created as a result. The actual cost was closer to US$14M
     
  19. RPNYVB

    RPNYVB Member

    Joined:
    Feb 15, 2020
    Messages:
    21
    Likes Received:
    1
    Trophy Points:
    2
    "Defect" is not a term I commonly use, and when I do, I translate it as "nonconformance to engineering requirement." I revisited ISO9000 today, and was surprised at how ISO9000 defines "defect." I wish their definition were more clear, as they describe "defect" generically as a nonconformance that impacts "use." In my world, a part either meets the requirements or it doesn't. Some group of people somewhere decided what was important enough to be a requirement and what wasn't. Whose responsibility is it now to determine what nonconformances are defects and what aren't? And why does it matter? So, if we're using the ISO9000 definition of "defect," I'm not sure I stand by my earlier statement. I'll stick with using the term "nonconformance" in the future, as the term "defect" seems obscure to me.
     
  20. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    724
    Likes Received:
    356
    Trophy Points:
    62
    I don't really get your point. If you have a "defective" part (defective because it doesn't match the print) but the "defect" will have no adverse affect on the part/final assembly, and it is "fixed" by modifying the print so this and subsequent parts will be in conformance, do you not reduce future costs by not constantly dealing with the issue.
     

Share This Page