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  1. James Doherty

    James Doherty Member

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    Seeking your professional experience and personal opinions.

    Our QMS (AS9100D + ISO9001:2015 certified) appears robust, well planned and executed. Unfortunately we did have a failure and shipped the wrong product (one size too small, part number suffix is different)– product was labeled correctly, but the outer box was not. I want to make sure we take all steps to further mitigate the likelihood this happens again. If we already have daily quality audits and performance tracking, regular training, process flows, an SOP and WIs - which were existing at the time this issue occurred (they cannot be used as evidence for prevention because ultimately they failed to prevent in this case) - what can I do further?


    How do you handle, a root cause analysis that boils down to human error? We have a redundant system in place and it is clear that instructions were not properly followed as the packing slip was initialed next to the part number verifying a check.


    Given our current and available resource allocation and the cost of efficiency for accuracy, I feel we have no other options at our disposal.

    Feedback warmly welcomed!

    Thanks,
    James
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Did you adopt the (automotive tools) of process flow>process fmea>control plan?
     
  3. Golfman25

    Golfman25 Well-Known Member

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    Been there done that. What I do is calculate the number of shipments between "issues." It helps keep it in perspective. We can go 17,000+ shipments and 2+ years. Hard to justify any more automation, etc. I then move on to more important things.

    Depending on you're results you can see how much of a problem it is and what resources you want to put to it. Good luck.
     
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  4. RoxaneB

    RoxaneB Moderator Staff Member

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    Building upon Golfman's points, as time goes on, are there patterns with these types of occurrences?

    • Same part/box combination - could be a process design/material issue
    • Same person - could be an HR issue
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm always a bit skeptical about human error as being a reason to suggest the preventive measures, above, failed. Experience shows they weren't as preventive as they should have been and as a result, they allowed the error to be processed. Point in case: Work instructions are frequently written by people who a) don't do the work, b) have different qualifications/competencies than the folks doing the work, c) are presented in a format which isn't helpful to the users, and d) don't highlight all potential situations which can be encountered when processing (they are "one-size-fits-all" and we know what that means...) It follows therefore, that any training on those instructions is going to be less than effective, even if the training is stellar in its own right (which is also highly dubious). Hence my earlier question about the use of a framework of process control/risk management, around which can be set the various documents listed.
     
  6. James Doherty

    James Doherty Member

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    Thank you so much for the questions!

    We utilize a bar-code scanning system for creation of labels and we do have visual aids for teammates to distinguish between part families. These particular parts are so close in size that they are not visually distinguishable without measurement - e.g. would be packing size 11 shoes in a size 12 labeled box. There where six parts to be scanned in and instead of scanning each part, which would have detected the incorrect part, we believe the teammate scanned one part six times (five of the six parts were correct).

    One teammate pulls the items from the warehouse against the pick ticket and another packages the item from the warehouse against the pick ticket.

    Technical error: Human error (possibly due to Fatigue, Pressure, Stress identified in the "Dirty Dozen" of human mistakes - "ALC-107: Dirty Dozen - Human Error In Aircraft Maintenance") - Wrong part number ("5000-275" for customer ABC on P.O.123 which should have been "5000-281") was pulled from warehouse stock according to pick ticket. Order required 6 boxes and the teammate pulled boxes from the location where 5000 series are warehoused and pulled one box incorrectly. Part number was not verified according to pick ticket and was identified on the Label affixed to outside packaging (box only, not actual parts which were labeled correctly). Order required 6 boxes and the teammate did not verify all box parts numbers and lot numbers matched the call-out on the pick ticket.

    Detection error: Human error (possibly due to Fatigue, Pressure, Stress identified in the "Dirty Dozen" of human mistakes - "ALC-107: Dirty Dozen - Human Error In Aircraft Maintenance") - Teammates did not verify all box parts numbers and lot numbers matched the call-out on the pick ticket.

    System error: N/A as the system was circumvented.

    We have documented SOP and WI which describe the process flow, responsibilities and areas of attention trained too and available for reference.
    We have annual FOD training and Dirty Dozen training – revised annually based from previous year(s) OFI/NCR related incidents.
    We monitor teammate and department accuracy daily, provide weekly updates and report on monthly. KPIs are derived annually and are utilized in employee incentive programs.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    As Deming said; "A bad system will beat a good person every time." Something in all those items detailed allowed the error to present itself. It wasn't of itself an error proof (poke yoke) process/activity. James, since you cite aircraft industry error categories etc. have you familiarity with performing a Process Failure Modes, Effects and Criticality Analysis, with the people involved in packing etc?
     
  8. RoxaneB

    RoxaneB Moderator Staff Member

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    Okay, I'll bite...Why did the employee/teammates not verify all box parts numbers and lot numbers matched the call-out on the pick ticket?

    Similar to Andy, I'm hesitant to attribute "human error" as the cause, because fundamentally, everything is "human error" (e.g., a human designed the process, a human programmed the software, a human built the scan-gun, a human picked up the box).

    That said, after double-digit years in a manufacturing environment, I made the switch over into healthcare (i.e., the provision of care in people's homes), and I've come to appreciate the role "human error" can play in the perfect storm resulting in a nonconformance...but I still push teams to look beyond the people side as the sole cause.
     
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  9. Miner

    Miner Moderator Staff Member

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    Can you pack at the operation rather than picking from the warehouse?
     
  10. James Doherty

    James Doherty Member

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    "Can you pack at the operation rather than picking from the warehouse?"

    I am not sure what this is asking, I apologize. Our stock is warehoused and we pull stock based off of orders and pack for shipment.
     
  11. James Doherty

    James Doherty Member

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    Hello RoxaneB,
    Thanks for the bite -
    I too loath going to human error as a root cause, and I concur, everything then could be attributed to human error.
    As yo the why question, unfortunately the shipping teammate is no longer with the company to ask the question, but based on feedback from the department in general, we came to the conclusion that it is reasonable to assign "Fatigue, Pressure, Stress" as catalysts for the error.
    Ultimately the System Error was that the system was bypassed by not scanning each item independently - e.g. would be buy several different boxes of cereal and the cashier just scanning one box for the total quantity to be purchased.
     
  12. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It's been accepted that fatigue, pressure and stress can contribute to human error. That could be the reason 7.1.4 (work environment in 9001) now includes those notes.

    And so, what are you going to do about it?
     
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  13. Golfman25

    Golfman25 Well-Known Member

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    I would go back and determine how much of a problem it really is? Once a week or once a year?
     
  14. James Doherty

    James Doherty Member

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    We have made over 500 shipments in the coarse of 4 years this is the first (reported) error with regards to mislabeling. My customer is also requesting an RCA and CA beyond the processes we already have in place.
     
  15. Richard Billings

    Richard Billings Active Member

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    I wouldn't do a root-cause for a human error issue. I would correct the issue (talk to the operator about it, maybe a bit of instruction) and watch for any repeats. If repeats are significant I would than do a root-cause.
     
  16. James Doherty

    James Doherty Member

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    We do perform annual training on the "Dirty Dozen" of human mistakes ("ALC-107: Dirty Dozen - Human Error In Aircraft Maintenance") which include what they are, what to watch out for in yourself and others, and that is not just "OK" but encouraged to inform you management when this may be an issue so it can be proactively responded to.

    The teammate who packed this particular shipment is no long with the company to try and ascertain more detail. I greatly appreciate suggestions.
     
  17. Bev D

    Bev D Moderator Staff Member

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    But is it really OK to inform their manager? I've seen so much lip service in this area (the operations management says it's OK when you are around and then when you leave it's all pressure to make the build plan, push push push, and don't anyone dare complain)
    and what will the manager do? if management lets the environmental conditions get to be fatiguing, pressured and stressful - what confidence can you have that they will correct it once it's pointed out? Isn't it their job to prevent it? Where are the known effective processes and mistake proofing tools that prevent these kinds of human error? any well trained industrial engineer or someone well trained in TPS could put these things in place quickly to solve this and other fatigue/pressure/stress enabled errors. when will we hold managers as accountable as our operators?
     
  18. James Doherty

    James Doherty Member

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    Bev, I feel what you are saying and I too have experience "lip service" from management, but if we cannot trust all teammates to do their job - hourly/salary/management - then we have an issue with our hiring and retention processes - 360 review and employee feedback. In this our case, once a inform has been made, the responsible management is accountable for the solution. Until they are made aware of "environmental conditions get to be fatiguing, pressured and stressful" how can they react to it?

    Manager are held equally responsible for there teams KPIs, which in this case is Shipping accuracy and their bonus compensation is also impacted; so their isn't a separation accountability.
     
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  19. Golfman25

    Golfman25 Well-Known Member

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    One time in 4 years, 500 shipments, and the employee has left the company -- you're chasing a ghost.

    I know your customer wants the RCA and CA, but that is probably because it's the typical knee jerk reaction to an issue. IMO, your system seems to be working fine, given it's human limitations. I am certain you have bigger issues to focus on. Good luck.
     
  20. James Doherty

    James Doherty Member

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    I would agree... "you're chasing a ghost," but the are a big customer and IMHO have designed themselves into a QMS hole requiring supplies provide very specific 8D regardless of the non-conformance. I am just trying have all my bases covered.

    Would you opinion be different if it was a teammate who was still with the company?
     

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