1. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
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.

Document Control NCR's

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by k_richer, Jan 30, 2018.

  1. k_richer

    k_richer Member

    Joined:
    Nov 14, 2016
    Messages:
    22
    Likes Received:
    3
    Trophy Points:
    2
    Hi,
    I have a question on how to handle this document control issues.

    We have document control issues.
    I've done training, we have procedures, we've had countless NCR's, I've literally audited people's computers, and I don't know how to handle this anymore. It is quite honestly, one of the most frustrating things since it seems so damn simple.
    During my first production internal audit of the year I found that when the designers send down a new drawing (model) to our programmers, they didn't get rid of the older version of the model.
    This is standard procedure, if you check other job files, it is not this way, they are organized properly and consistently, but alas the one I was auditing, this was what I found.

    What is insanely frustrating is that everyone should know what document control is.

    The designers especially should know what document control is.

    We had one of our NCR's from our recent transition audit for document control.

    I just don't know what the next step is.

    How do I do an NCR and close it properly when the root cause literally seems like "this person is lazy".
     
  2. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    459
    Likes Received:
    144
    Trophy Points:
    42
    Why do they have to "get rid of" the the old model? Why can't they just continue to update the rev level? So you have filename rev a, filename rev b, filename rev c, etc.
     
    Jennifer Kirley likes this.
  3. hogheavenfarm

    hogheavenfarm Well-Known Member

    Joined:
    Jul 30, 2015
    Messages:
    203
    Likes Received:
    138
    Trophy Points:
    42
    We keep all the old revisions, but they are placed in a folder named "revised-obsolete", and only the most current revision is 'outside' that folder. Production can access the job folder and immediately on 'top' is the current drawing, all others are in the revised folder. For other control, engineering sends the latest version directly to the CNC machines for use, eliminating the need for production to access the folders at all.
     
  4. k_richer

    k_richer Member

    Joined:
    Nov 14, 2016
    Messages:
    22
    Likes Received:
    3
    Trophy Points:
    2
    They are usually engineering changes.
     
  5. k_richer

    k_richer Member

    Joined:
    Nov 14, 2016
    Messages:
    22
    Likes Received:
    3
    Trophy Points:
    2
    This is how they are supposed to do it as well.
    They have obsolete folders for them to go in to.
    My question is how to enforce it more. Obviously more audits is one example, but it literally happens in all departments for everything.
     
  6. hogheavenfarm

    hogheavenfarm Well-Known Member

    Joined:
    Jul 30, 2015
    Messages:
    203
    Likes Received:
    138
    Trophy Points:
    42
    ideally, one controlled version is kept on the server and is called up by anyone that needs it. In practice, top management keeps "local copies" on their machines for convenience. It is these copies that become outdated and uncontrolled. Getting TM to play by the rules has always been a big challenge. I set it up correctly and let the outside audits pick it up, that's the only way I can apply any 'enforcement'.
     
  7. normzone

    normzone Well-Known Member

    Joined:
    Aug 3, 2015
    Messages:
    137
    Likes Received:
    74
    Trophy Points:
    27
    I know it's of no consolation for you, but this is the most common and easiest to find nonconformance for auditors, especially in challenged environments.

    It doesn't help that what you're describing is essentially a glorified "honor system" - unless there's some cool software tool that the outfit is using to control this, you are reliant upon humans, and you know how that goes.
     
    Jennifer Kirley likes this.
  8. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    459
    Likes Received:
    144
    Trophy Points:
    42
    So.

    Are they not controlled by the rev. level? If you have rev. A,B,C,D etc. in your folder, why can't they just use the latest rev? That way I have a running rev. history and don't have to cut and paste a bunch of files, which can lead to errors of moving the wrong file to the wrong place. Have you had major problems with using the wrong rev level file?
     
  9. Maikgom

    Maikgom New Member

    Joined:
    Jan 30, 2018
    Messages:
    1
    Likes Received:
    0
    Trophy Points:
    1
    Golfman25

    We need a little more information to be able to understand this situation better,

    You said,

    1) "the designers send down a new drawing (model) to our programmers", How is this accomplished? Is there a process or work instruction to do this?
    2) "programmers didn't get rid of the older version of the model", Do they know? IS there a W.I for this? Have they been trained on it? What is their special need or barrier ? Dig Deeper...! 5 why it to death!
    3) " This is standard procedure", Is this your assumption? or Is there really a standard work document for this?
    4) "everyone should know what document control is", Agreed. How was this accomplished in your organization?
    4) " We had one of our NCR's from our recent transition audit for document control." What was this NC on? Same issue? What was stated as the RC and CA on the NC response?
    5) "root cause literally seems like "this person is lazy". partially perhaps..., Certainly that doesn't help any, but remember , its never the individual's fault, but rather the system is weak (gaps) or broken.

    As an Internal Auditor, work to understand the process, identify where its failing, and document the specific NC against a clear demonstrated failure against your policy, procedure , WI or activity of your QMS.

    Hope this helps...
     
  10. johnnymo77

    johnnymo77 Member

    Joined:
    Sep 1, 2015
    Messages:
    37
    Likes Received:
    10
    Trophy Points:
    7
    Location:
    Stevensville Michigan
    This should be showing up on the Management Review.

    What does management say about recurring Internal Audit NCRs?

    I think an NCR about ineffective Management Review may be needed.

    I had a Manager put items like this on the department's personnel goals and annual reviews to drive compliance.

    Good luck!
     
  11. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    459
    Likes Received:
    144
    Trophy Points:
    42
    Actually I think the first question is what's the risk of not getting rid of the old file? Have there been any issues using the wrong files? If there haven't been issues and it's low risk, then we have the situation of an overly burdensome procedure causing needless nonconformances.
     
  12. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    654
    Likes Received:
    424
    Trophy Points:
    62
    Location:
    Laguna Philippines
    Maybe you can include such responsibilities as part of the performance criteria your organization will evaluate during the appraisal period for the designers. If they're not performing as per the criteria, then they will get a low appraisal score. Low appraisal score could mean low or no income raise, lose the opportunity to be a regular employee or lose the job.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,070
    Likes Received:
    1,076
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    I'm wondering what the procedure is. In my experience, it's not laziness, it's a poor procedure...
     
    John C. Abnet and Candi1024 like this.
  14. PDCA Unicorn

    PDCA Unicorn New Member

    Joined:
    Feb 2, 2018
    Messages:
    3
    Likes Received:
    2
    Trophy Points:
    2
    Location:
    Minnesota
    Your root cause needs to be something you can control. You cannot control "This person is lazy", take a step back and look at the answer you came up with before you settled on "lazy". Your process is the issue and really should be thoroughly reviewed by the management team.

    We were having some of the same issues because our documentation system is a series of word and excel docs. People would change original docs and not go to the next revision, they would keep local copies and not delete them when new revisions came out, it was mind boggling to me. What we ended up doing is putting controls on local copies - if someone wants a document on their desktop for easier access, it has to be a shortcut to the original. They cannot copy and save to the desktop because that document is then considered out of control. That way if a new revision is created and the original doc is placed into the obsolete folder the local links stop working. We also locked all but a few people out of the system so changes couldn't randomly be made. You can give read only access to certain users. People who felt a work instruction or process needed to be changed can print the document, write their recommended changes and turn the document in with a Document Change Request form. That way - everyone still has input into the QMS.

    With your corrective action process, you need to have something to measure to make sure that your changes are working. This could be done by routine audits of peoples' computers: Check for local files instead of shortcuts during these audits. Ensure people are held accountable for following these processes. Document your actions and your attempts to change the situation, ensure your management team is on board and helping to flow change appropriately.
     
    John C. Abnet likes this.
  15. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    662
    Likes Received:
    479
    Trophy Points:
    62
    Location:
    USA
    As an ex-document control admin my heart goes out to people with document control issues. The process is a mix of man, method (procedure) and machine (technology) is difficult to control. The more we rely on man and method, the more likely we are to fail to maintain revision control.

    It does not help if there is no visibility of the process or repeat NCRs for it. This sort of thing should be included in the management system performance review, but the unhappy fact is few managers think it is important enough. Additionally, people who mismanage the revision control don't appear to have suffered any consequence, either directly from lack of change control or indirectly from the management.

    This is one of those areas in which error proofing wins out over behavior. Some kind of software application is usually the best solution.

    Sorry I can't give you any brilliant solutions.
     
    John C. Abnet likes this.
  16. Bhuwan Sharma

    Bhuwan Sharma New Member

    Joined:
    Feb 3, 2018
    Messages:
    4
    Likes Received:
    2
    Trophy Points:
    1
    I can suggest you to check following things and act accordingly:

    1) If SOP/WI is available for that, then check it proper training and its significance explained to all concern and make it documented.

    2) Is SOP/WI is good effective one and cover all the aspects?

    3) If after training also, the concern person is taking the document control casually then it should be reported to the management and concern department manager.The same should be reflected in his/her appraisal and increment.

    4) Make a frequent and surprise audit system in more problematic area and share the reports to the management.

    I do believe if these points are acted upon you will get a good relief on this issue.

    Please share your thoughts on the same.
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,070
    Likes Received:
    1,076
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Internal audits should NEVER be "surprise". Also, tying compliance to procedures to performance and pay is both bad and, what's more, against Deming's principles. It's 19 century management style at its worst.
     
    Candi1024 and Jennifer Kirley like this.
  18. Bhuwan Sharma

    Bhuwan Sharma New Member

    Joined:
    Feb 3, 2018
    Messages:
    4
    Likes Received:
    2
    Trophy Points:
    1
    Thanks for your thoughts..

    Then we expect to know from you that in this case how you will effectively manage?
     
  19. PDCA Unicorn

    PDCA Unicorn New Member

    Joined:
    Feb 2, 2018
    Messages:
    3
    Likes Received:
    2
    Trophy Points:
    2
    Location:
    Minnesota
    You change your process so the only choice is compliance. Software and automation is going to be the easiest method in this particular case.
    Your first customers are your employees, roping in pay to compliance will get you bad reviews.
     
  20. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,070
    Likes Received:
    1,076
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    I'd prefer that the organization do a root cause analysis, rather than me "tell them" something. We are in the Quality profession, so we should use the diagnostic tools at our disposal...
     

Share This Page