Is 'Operator Error' as Root Cause ever acceptable?

I have conducted hundreds of medical device investigations for NCR's. As with any other conclusion, I would only used operator error if I had a demonstrable path to point to. I try to avoid at all costs using such a root cause code without exhausting all other avenues first (5 M's). In my experience, I have seen too often that Operator Error is used as a cruch for an incomplete investigation that is lacking of cohesive details. This is probably why your customer demanded more information, perhaps they did not feel such a RC was waranted without sufficient documented analysis of the processes and procedures.

I've been successful in the past in using "operator Error" only after i've provided objective evidence that there is a procedure/work instruction in place and training records showing the operator was aware of the requirement.

mrangel8103 said:

I've been successful in the past in using "operator Error" only after i've provided objective evidence that there is a procedure/work instruction in place and training records showing the operator was aware of the requirement.

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Welcome! Can you help us understand what you describe as "successful"? Was this in identifying better training, or different competencies, revised instructions?

mrangel8103 said:

I've been successful in the past in using "operator Error" only after i've provided objective evidence that there is a procedure/work instruction in place and training records showing the operator was aware of the requirement.

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mrangel,

Does this mean that none of the tasks in your production of service delivery processes are mistake-proofed?

John

If this is a repeat please forgive me.

The short answer is "NO"

What I have seen to be successful in responding to customer concerns is more like "the operator failed to Bla Bla Bla (Failed to do something or did some thing they were not supposed to).

The next step would be to address whatever that failure was.

Tom

mrangel8103 said:

I've been successful in the past in using "operator Error" only after i've provided objective evidence that there is a procedure/work instruction in place and training records showing the operator was aware of the requirement.

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Hello mrangel,

operator error could always be applicable in those circumstances. However, when it comes to writing the report, I would still need to thoroughly evaluate the instructions used to perform the process and describe them in detail. (Example -Do the instructions provide photos or easy to understand diagrams / Could they benifit from them?)
This additional detail in the report will help the MRB to objectively review evidence and determine the instructions were clear enough and not a factor in the operators mistake. A signed training record is only one part of that puzzle and not a very strong one by itself.

In my experience a training record alone cannot prove that an operator was properly trained and thus simply negligent while performing the procedure.

Most operators work in a very fast paced, dynamic environment with little time for stopping to learn new procedures. And procedures can change quite frequently for certain operations. It takes a companywide effort to provide a qualtiy training process and when there is successful process in place then op error should almost never happen. Just my .02

I would agree with Laura and Jim that "operator error" is not a root cause. If anything, it is a copout, an easy way out. Yes, people make mistakes and you can't mistake-proof or error-proof every conceivable possibility of failure, but you can work on improving processes, training, etc., to prevent this new occurrence from happening again (continuous improvement). Instead of just writing something off as operator error, you look at it as an opportunity to improve. A company I used to work for had a machine operator that was writing obscenities on the inside flaps of product. Not much you can do about that, is there? We didn't look at it that way and we developed a new screening process when hiring new employees (the operator got fired, of course). It turned out to be a great CI project.

Dvaniah,

This post goes back 14 years! If you go back and look over it from the beginning you may develop a different perspective. Lemme know if you actually do this.

Remember, never is a pretty powerful concept.