Is 'Operator Error' as Root Cause ever acceptable?

B

Bob Bonville

#91
Very interesting discussion going on here. I have dealt with this issue for many years, I mean a lot of them. The fact of the matter is that it has become a crutch for many of those assigned the responsibility of investigating these CARs. It is, and should continue to be a step along the way of determining the root cause but not a stand alone, because it can always have a reason why there was operator error. I will tell you another crutch in this area and that is "Trend Analysis". This is given in many cases when the investigator doesn't feel there is enough data to make an immediate decision as to root cause. Well, how much is enough? Again, used way too much in situations like this.
 
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Bob the QE

Quite Involved in Discussions
#92
I have and will continue to accept operator error as a resopnse if and only if the individual can provide the road map that lead them to this conclusion and that map has key factors identified and evidence of investigation. I can't accept it as being a scape goat or one answer fit's all. To many times I have found that if I do true verification of supplier corrective actions I find that these roads where not traveled due to other constraints (time, resources, etc..) if that is the case the CA answer is not helpfull in resolving the root cause. jmho
 
P

PobreGato

#93
Since many of us agree that a Corrective Action is sometimes not truely cost effective or sometimes just an exchange of paperwork to meet compliance, why can't we come up with some form of Notice of Defect (N.O.D) whereby the vendor acknowledges the defect but both parties agree that a full blown investigation and process change is not in the best financial interest of either company.

(How is that for a run on sentence? :))
Usually I mine this resource to gather insight rather than offer input (being long in tooth to manufacturing but new to Elsmar Cove and quality assurance).
In reference to post #80 Silentrunning, we actually use a “Notification of Discrepancy” that has two choices that can be checked. One requires a CA and the other that is simply a notification. We do track these just in case a supplier tends to be a “repeat” offender.
:agree1:
 
S

Sandra Gauvin

#94
Operator Error is one of the most over used root cause categories, usually because the corrective action is a no-brainer....retrain. When trending, if one of your largest root cause categories is Operator Error, an auditor may challenge your conclusion....or even worse....question the competence of your people. I experienced this during an FDA audit....if they see that you're constantly retraining your employees (especially the same ones) it will only lead to more questions. I would recommend taking the time to understand why an operator error occurred....was it because the SOP was poorly written or the training the person received lacking, etc.
 
D

Desara01

#95
Umang is spot-on! WTG:applause:

There may be isolated errors - but of course, we should be striving to design systems that do not allow errors to happen in the first place. While this is not always possible, it is certainly something to strive for. Retraining may or may not work; there is always the chance that an employee didn't understand or is not suited for the job. If retraining doesn't work, that's an indication that management has designed a system that will cause people to fail - whether it be that process, or the process for placing people into the jobs! (HR won't like that, I'm sure!)

Nothing frustrates me more than seeing a response to corrective actions "Spoke to operator" over and over again. Well a lot of "spokes" means something else is wrong and putting notes in people's files and belittling them will not solve the problem.

Mistake-proofing processes does not have to be expensive -

Those are the :2cents: from Penny :bigwave:
 

Bob the QE

Quite Involved in Discussions
#96
I have and have had several customers who will not accept "operator error" or "will retrain" as a response. There logic is simple and yet useful if you follow it to the root cause.
"operator error" - Why? Using the five why concept (more less than 5 is acceptable) as it drives towards the real cause of a problem. The biggest road block I find here is "we were short of time or people and they were filling in". Finding: Management commitment to resources to meet my (customer) requirements. I am not saying that there is not operator error associated to problems I am suggesting that it is a contributing cause not a root cause.
"will re-train" - Weren't they trained and found competent to do the job before they worked, processed or shipped my product? Finding; Training.
I am not saying these are never acceptable response but they should not be the first. There should be evidence that they problem had been evaluated, analyzed, communicated and corrected. Find that evidence and you will be doing customer, supplier and yourself a value added activity.

My opinion.
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#97
I think to first proclaim that operator error is never an acceptable response, every process should be able to be certified operator proof. Just go right down the process flow and show how it is impossible for an operator to influence each and every characteristic. Then, you are good. That likely means eliminating the operator altogether, perhaps an acceptable corrective action. :rolleyes:

No matter how well you write the work instructions, not matter how many times you validate the training, humans have the ability to be distracted or lose focus. When that occurs, errors can happen. This is partly the cause of 100% inspection not being 100% effective. Not every process can physically be poke-a-yoked to the true definition, anyway. A fully poke-a-yoked process is nice work if you can get it. (And be sure to check your poke-a-yokes to be sure that they are still working...oh, wait...can you do a poke-a-yoke to prevent someone from forgetting to check the poke-a-yokes? That will keep you awake tonight...) Saying that operator error is never a root cause is just as sloppy of an analysis as using operator error for every root cause.

Sorry for not trotting up the high road. Just keepin' it real. :cool:
 
B

Britman - 2012

#98
"Operator Error" - they happen, why were pencils marketed with an "eraser" on the end?

The computer still includes the Delete key - we all make "operator errors"

Within Quality we do aim to reduce instance of error, however in any process a human has at some point had an input!

Attached is a simple flow process chart to help expand on a "root cause", when the documented reason is "human error" within a system.

Not mine,but it may help.
 

Attachments

Mike S.

Happy to be Alive
Trusted Information Resource
#99
"Operator Error" - they happen, why were pencils marketed with an "eraser" on the end?

The computer still includes the Delete key - we all make "operator errors"

Within Quality we do aim to reduce instance of error, however in any process a human has at some point had an input!

Attached is a simple flow process chart to help expand on a "root cause", when the documented reason is "human error" within a system.

Not mine,but it may help.
Looks good, but...in the last series, if the person elected not to follow the rules how is he not responsible?
 
I have come to believe that everything boils down to operator error. "But...", you say "...it is the process that failed." Yes, but why did the process fail? "Because it was not robust enough." So, then why was it not robust enough? "Because this particular event was not forseen by the person who designed the process." So, it was the process engineer that made an error. "Well, the engineer could only make decisions based on the information available. This information was not available at that time." Ahh, I see. So who was supposed to provide the information? That person made an error in the data gathering......

We could go on and on...... No matter what "non-operator" thing you throw out, someone can always come back to show that someone was responsible for that thing, and we are back to operator error.
 
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