Make sure you don't have any CAR that says "operator error"!!

Make sure you don't have any CAR that says "operator error"!!

If I have a CAR where the cause is ascribed to operator error, I will have ascertained that it's the actual cause (people do make mistakes, you know), and any auditor who wants to arbitrarily exclude operator error as a legitimate cause will be "managed." :D

If I have a CAR where the cause is ascribed to operator error, I will have ascertained that it's the actual cause (people do make mistakes, you know), and any auditor who wants to arbitrarily exclude operator error as a legitimate cause will be "managed." :D

How many auditors are you allowed to "manage" before you become "managed"? :lol:

Generally, "Operator error" is a red flag to me. I have dealt with an organization that kept meticulous records of operator errorsssss, trainingssss, and retrainingssss...Five years worth of data....85 to 90% of their CARs pointed to operator error.

Generally, "Operator error" is a red flag to me. I have dealt with an organization that kept meticulous records of operator errorsssss, trainingssss, and retrainingssss...Five years worth of data....85 to 90% of their CARs pointed to operator error.

We got into a pattern of routinely listing "operator error"
as the cause on our process deviations (medical device industry),
now some of our customers are insisting that we dig deeper
in our root cause efforts, as this seems to be a hot button item
with the FDA.

How many auditors are you allowed to "manage" before you become "managed"? :lol:

Generally, "Operator error" is a red flag to me. I have dealt with an organization that kept meticulous records of operator errorsssss, trainingssss, and retrainingssss...Five years worth of data....85 to 90% of their CARs pointed to operator error.

Operator errors.....:D

See attached.

Stijloor.

How many auditors are you allowed to "manage" before you become "managed"? :lol:

Generally, "Operator error" is a red flag to me. I have dealt with an organization that kept meticulous records of operator errorsssss, trainingssss, and retrainingssss...Five years worth of data....85 to 90% of their CARs pointed to operator error.

This is substantially different from your original statement, which was,
Make sure you don't have any CAR that says "operator error"!! (Emphasis added)

I agree that a pattern of ascribing failure to operator error is not a good thing and should be looked into.

This is substantially different from your original statement, which was,
(Emphasis added)

I agree that a pattern of ascribing failure to operator error is not a good thing and should be looked into.

I don't feel there is a substantial difference between the two posts.

Can you share one "real" and not a fictional case that you observed personally and felt comfortable with "operator error" excuse?

I personally would not write a CAR for ONE operator error and more than one error shows a deeper systemic deficiency or problem.

I personally would not write a CAR for ONE operator error and more than one error shows a deeper systemic deficiency or problem.

I would hope not...The proper thing to do would be to issue a non-conformity for the non-fulfillment of a requirement. The CAR would come into play in fixing the NC.

As an auditor I don't issue CAR's (I understand fully how organizations use this term so please no lecture or enlightenment)


How many non-fulfillments of a requirement does it take for something to be non-conforming?

1?

5?

10?

I kinda confused now.:confused:

NOTE:

This thread was split from the following thread on a 9001 audit:

Tips on Technical Things the Auditors might ask during an Audit (http://elsmar.com/Forums/showthread.php?p=241098#post241098)

This is a thoroughly good subject that should have it's own thread.:)

Generally, "Operator error" is a red flag to me. I have dealt with an organization that kept meticulous records of operator errorsssss, trainingssss, and retrainingssss...Five years worth of data....85 to 90% of their CARs pointed to operator error.Good grief. :rolleyes:

Operator error = S*it happens

(Let he among you.... cast the 1st stone:lol:)

Operator error = S*it happens

(Let he among you.... cast the 1st stone:lol:) Well, yes and no. The amount of 'Operator Error' allowable (for lack of a better word) depends upon the processes and product. E.g.: Manufacturer of Medical Implant Device (such as a Heart Pacemaker) vs. Injection Molding rubber ducks for kids to use in the bath tub vs. Wafer Fab in an IC manufacturing plant.

Differences in product and processes is an important consideration when we discuss many topics in the forum. Operator Error is one of them.

Consider: Is 'Operator Error' as Root Cause ever acceptable? (http://elsmar.com/Forums/showthread.php?t=3176)

Some other discussions on operator error (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=operator+error).

I don't feel there is a substantial difference between the two posts.

Can you share one "real" fictional case that you observed personally and felt comfortable with "operator error" excuse?

I personally would not write a CAR for ONE operator error and more than one error shows a deeper systemic deficiency or problem.

The basic question is, "Is operator error always preventable?" The obvious answer is "no." Sometimes CARs must be opened due to customer concerns, so we can't always opt to forgo the CA process. Having an arbitrary rule proscribing operator error as a legitimate cause is counterproductive.

Friends,

While I agree that "operator error" is in many cases not a true root cause, let's keep in mind that most problems occur because of the action and inaction of people. And these folks my friends are often found in the higher ranks of the organization.

When a true, in-depth root cause analysis is conducted, are we ready and prepared to deal with the folks in the higher echelons?

"Fear" as pointed out by Dr. W. Edwards Deming is still rampant in most organizations. Speak the truth, be it about a root cause or other, and your future with the organization may be in serious jeopardy.

That's why most root causes are "safe" causes, possibly somewhat close to the truth, but still not pointing to what the heck is really going on.

As far as customer complaints is concerned, most problem solving efforts I have witnessed are more geared towards pleasing the person that initiated it. Again, no meat, no teeth.

Just my 2 euro cents....:(

Stijloor.

In my view there are many companies operating (Isolated cases! Ha ha …) with out mistake proof method / systems and many operations are forced on operator’s pure skill and efficiency.

In such cases if an error occurred due to an operator, we can say that it is not operator mistake and it is management who doesn't provide necessary resources to avoid the route cause problem. But the fact is many business can't afford to invest a lot to save operator NC's. May be the business could accept a level of defects. Still the operators are pushed to do write job without error.

In such case the operator mistake (each NC) is to be covered by education / training.

Sridhar

Operator error in 1987 with BGen Wesley Clark as a passenger

http://elsmar.com/Forums/showpost.php?p=217672&postcount=5