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RCA for every nonconformity? (10.2)

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by FlightlessWaterfowl, Nov 3, 2017.

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  1. FlightlessWaterfowl

    FlightlessWaterfowl New Member

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    Newby here, hello!

    I work in a large organization that is transitioning to 2015. We are currently stuck in a mode of assuming that any nonconformance to a documented process must go through thorough root cause analysis and corrective action (which dilutes the attention we can pay to high risk problems). While 10.2.1(b) indicates that we explicitly have the ability to evaluate the need for action based on the root cause, I have seen in this forum (and among my more experienced quality peers) that it is possible to stop and think about whether a nonconformity is a "big deal" or not before descending down the path of a full root cause analysis. I am having trouble aligning this common sense approach with 10.2.1(b)(2) which states that we must "determine the cause" of the nonconformity in order to determine whether corrective action is required. It seems like this requires a full RCA for all nonconformities, but we can decide whether or not to implement corrective actions. This doesn't align with the many threads that say a full RCA may not be needed if the problem is not systemic.
     
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  2. Golfman25

    Golfman25 Well-Known Member

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    You're reading too much into it. You don't necessarily have to do a full RCA to determine the cause. Some causes can be "obvious." Also, when you get to the end of 10.2.1 it says "corrective actions shall be appropriate to the effects of the NC encountered." Every problem isn't a nail and thus every solution isn't a hammer. You analysis should look something like this:

    1) Problem or NC
    2) One off or systematic
    3) If it is a one off, fix it and move on. If it is systematic, then mover towards a full RCA.

    The worst thing you can do to your system is require a full RCA and 8D Corrective action process for every issue. It drives people crazy. Focus on the real stuff. Good luck.
     
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  3. normzone

    normzone Well-Known Member

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    Here's how my current informal triage tree works for such matters - bear in mind that it's an ever-evolving point of view ....


    Is action necessary?


    If no action is necessary, then there is no need for either cause analysis nor corrective action


    When a root cause has been determined, and if appropriate, correction made, would a corrective action result in a change to the process?


    If there is no process change it is unlikely the corrective action would be effective.


    Ineffective corrective actions discourage support for the system.


    Risk management – if it’s not important enough to change the process, it’s not that serious a risk.


    Training may be conducted if appropriate, but if the system remains the same, the potential for recurrence does not significantly change.
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Furthermore, ISO 9001 allows for correction. As someone says in the Forrest Gump movie; "Stuff Happens", so you should allow yourself to deal with simple corrections.
     
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  5. tony s

    tony s Well-Known Member

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    Nice topic! This may not directly hitting the subject but let me share this interpretation where I subscribe to:
    upload_2017-11-4_11-4-58.png
     
  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Since there is an expectation that all processes take a risk-based approach, we are invited to not take a sledgehammer to all problems when a flyswatter would do.

    That said, we are asked to determine the cause of the problem and address it to prevent recurrence. We might want to avoid the "death by a thousand cuts" phenomenon that prompted Juran to claim cost of poor quality was equal to up to 10 to 30 percent of sales. That involves more than material costs; it includes administration and lost opportunity to do something more productive. So we could just "fix it" if we are sure the issue is not larger than it seems.
     
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  7. FlightlessWaterfowl

    FlightlessWaterfowl New Member

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    Thank you for your help!
     
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  8. tony s

    tony s Well-Known Member

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    Nice topic FlightlessWaterfowl.:)

    This also prompted me to ask our esteemed members: DOES A COMPLAINT FROM A CUSTOMER AUTOMATICALLY WARRANT A CORRECTIVE ACTION?
     
  9. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Chances are good they will tell you it does. o_O
     
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  10. Golfman25

    Golfman25 Well-Known Member

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    I would say nothing is automatic. However depending on the complaint, I would say the lean is toward a CA. In our case product complaints usually do. Other complaints, like "you didn't get back to me soon enough" even though they emailed at 5:00 on a holiday -- we won't.
     
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  11. RoxaneB

    RoxaneB Moderator Staff Member

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    In my opinion, nope. As Golfman pointed out, it really depends on the nature of the complaint. I've seen complaints where the customer simply wanted their money refunded - if the cost of the refund was less than what it would cost to investigate or below a $-trigger point that we had established, we "corrected" the situation by providing the refund and did not do RCA or corrective action. We did log/track all complaints, however, to re-evaluate our trigger points on a regular basis.
     
  12. The PPAP Assassin

    The PPAP Assassin Active Member

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    Here's a question related to this:

    -ISO tells us we need to review the effectiveness of corrective actions taken. I set goals for myself and inform others that I need to collect objective evidence a few times over a span of a month or 2 in order to "close it out".
    ...So what is happening is I end up with a collection of open CAR folders that I am sitting on, waiting to follow up and collect evidence on..

    My question is, for CAR's where a lot of time has passed and there is no way to collect evidence other than observing that it has not reoccurred, is it okay to make a statement of "there has been no further re-occurrences since this CAR has been issued". Is that enough?
     
  13. RoxaneB

    RoxaneB Moderator Staff Member

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    How about I try to answer your question with a question...why do YOU need to be the one to close them out?
     
  14. The PPAP Assassin

    The PPAP Assassin Active Member

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    Well... "because I am the quality assurance guy and that's my job" See the quotes? lol
     
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  15. The PPAP Assassin

    The PPAP Assassin Active Member

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    I see your point though... hmmm

    I could be getting the managers/ sups responsible to collect evidence. That could really streamline things.
     
  16. RoxaneB

    RoxaneB Moderator Staff Member

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    Air quotes are not always our friend. ;)

    I'd challenge that "responsibility" and counter with "quality assurance is responsible for designing, developing, and implementing a sustainable CA process that adds value to the organization." Saying that you're the one responsible to close them out, is akin to saying the police are responsible if I'm caught speeding. It's their law (okay, it's really the government's, but I'm trying to make a point here) but because I didn't follow it, they should be the ones to get the ticket. Sounds kind of silly right? But by having you tasked with closing someone else's CAR, you're now the police.

    I tend to look at QA's role from the perspective of getting the system out there and educating the USERS on how to gain value from it, including being "responsible adults" (ahem...see the quotes? *lol*) and closing them as/when appropriate.
     
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  17. RoxaneB

    RoxaneB Moderator Staff Member

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    Exactly! It's not YOUR system...it's the ORGANIZATION'S system. Q.A. should, in my opinion, ensure the system is efficient and that the users are using effectively (and appropriately).
     
  18. The PPAP Assassin

    The PPAP Assassin Active Member

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    Excellent advice!
    Right after this I am marching into their offices! Maybe I'll have a clipboard in my arm with some important looking documents on it so it looks like I mean business!

    Or, maybe I need to work on the "approach" first...haha

    People here love doing more work, so this should be a breeze!

    :D

    Thanks!!
     
  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Maybe they should see it's their cr*ppy process which caused the customer complaint and that you, unlike their parents before them, are NOT going around cleaning up after them. It sucks to get the reality check late in life, but that's what an effective management system does.
     
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  20. RoxaneB

    RoxaneB Moderator Staff Member

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    What's that phrase? "If it was easy, everyone would be doing it."

    If anything, you're making it easier for them, because - in theory - they should know enough about their own process outputs (i.e., monitoring them) to know how they're doing in regards to closing that corrective action. Waiting for your stamp of approval could be considered a bottleneck in the process because they need to wait for you, the Grand Poobah of Corrective Action, to deem it as closed. You're giving them the responsibility and the authority to control their own activities within the parameters of corrective action.

    From my own experience, our departments would have monthly department reviews and "CARs" were on the agenda. They reviewed open ones and the department manager determined, based on the results of the "review period", if the CAR could be closed or if it would remain open. They also reviewed new CARs. I would do periodic spot checks just to see how well they were adhering to our CAR process and, when it was time to look at corrective action during an audit, we would look at their reponses in more detail.

    Granted, this approach works best for a mature system. If your QMS is relatively young and people are still trying to figure it out, having QA as the responsible is a good initial way to go, with a plan to migrate the responsibility of CAR closure to the appropriate level at a later date.

    ...but good luck with that march! *lol*
     
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