Thoughts on issuing a CAR for Operator Error

Jim Wynne

Leader
Admin
Re: Can you give some tips Before the ISO 9001 audit ?

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
 

michellemmm

Quest For Quality
Re: Can you give some tips Before the ISO 9001 audit ?

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.
 

Doug Tropf

Quite Involved in Discussions
Re: Can you give some tips Before the ISO 9001 audit ?

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.
 

Stijloor

Leader
Super Moderator
Re: Can you give some tips Before the ISO 9001 audit ?

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.
 

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Jim Wynne

Leader
Admin
Re: Can you give some tips Before the ISO 9001 audit ?

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.
 

michellemmm

Quest For Quality
Re: Can you give some tips Before the ISO 9001 audit ?

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.
 
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Randy

Super Moderator
Re: Can you give some tips Before the ISO 9001 audit ?

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:
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Re: Can you give some tips Before the ISO 9001 audit ?

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:
 
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