Human error?

Depending on the amount of business this customer provides I too might quite likely do exactly what they ask.

 

Ahhh. The old "no such thing as human error" discussion again.

Personally, I think human error can absolutely be a root cause. I think in the quality field the taboo of not having human error has arisen from it being overused as a reason. Far easier to say "human error" than do any sort of diligence work.

The point is - I think - to REALLY LOOK at the system to ensure human error cannot occur.

So in James case, one could suggest change the box shape so mis packing cannot happen (poka-yoke it). But that would then raise the NEXT question ... how much COST would it add for him to stock and use custom boxes? I'm venting a bit, but it's aggravating to have an SQ demand you spare no expense to go from 2 ppm down to 1 ppm, and not want to talk about a price increase.

Rant over. Here's a possible solution: Since these parts are visually so close in appearance that the mixing is an issue, change the process such that you cannot do this operation without running 2 or 3 different parts in between to purge the line. (It's an old bearing manufacturing trick. If you run bearing A and bearing B is VERY CLOSE in size, you don't want to pollute the B run with stray, leftover A components. So instead of running B, you run C which is VERY different.)

 

No. We have had the same issue over the years with our biggest customers. Like clockwork, they issue the "intergalactic multilevel 25D" or whatever they are calling it these days. There is no affordable solution and it is such a minor occurrence that we come up with some "BS" to get the "paperwork" done and move on to bigger issues. It actually isn't the end of the world.

 

You forgot having to key in the intergalactic multilevel 25D into their "portal" that has an interface so poor and clunky, it takes an afternoon.

 

Is it documented that training of said W.I.'s and S.O.P's was taught, understood and finally quizzed to each individual?
Maybe WI's & SOP's shouldnt be used as "Reference"......

 

Just to add my own $0.02 to this discussion. Some time ago I posed the same question (on a different forum) and someone was kind enough to share a Human Error Root Cause Analysis (HERCA) document with me. I am attaching a copy to this post - hopefully some will find it useful.

 

Hi
I m new here
So I have a query hope u guys will help, what happened our accounts department done a blunder in appraisal system in distribution of salaries at the time of dispersal so we took a deviation but when it comes to check effectiveness of the CAPA I think it would be checked at the time of next appraisal so by saying that this is a non compliance once in a year type. Should I wait for next year to close the CAPA as there is no specific time is given nor in ISO 9001 neither in ICH or FDA guideline regarding this

 

Thank you andy for your kind words, hope I will hear such an experience words from you in future

 

Hi Bev, thanks for your reply but let me give you the brief of that incident, company planned to disperse bonus as they do regularly but at that time the company usually make an excel sheet where they keep all employees data and salary previous structure so, at that time they revised the salary structure and in some employee case they did a goof in adding bonus by which their annual CTC gets affected and because of this reason some of them get lower amount and some of them got higher then the decided one, so we did a root cause analysis and found that the excel which is made and approved by management were not checked by accounts and that was the reason why this deviation occured.

Hope this will help you

 

All your questions are valid Bev but the lack of rechecking and communication gap between accounts and management was the severe cause that created that scenario where questions can be raised, I want your expert solution in that

 

That was harsh but i will take it as positive to learn for sure, Thanks Andy.