Human error?

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

 

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.

 

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.

 

"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.

 

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.

 

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

 

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.

 

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.

 

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.

 

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.

 

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.

 

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?