D
druid
The procedure has been audited several times by various auditers (customer and 3rd party).
Before you beat yourself up - remember:
"To err is human, To forgive divine, and an auditor usually hits on the one screw-up in the 50 (otherwise perfect) samples EVERY TIME!"
Seriously, you didn't give much detail. Some questions that come quickly to mind are:
* If it was a core ISO requirement where was the Mgmt Rep?
* How are your internal auditors used?
* Is it an internal procedure?
* What type of review/approval process do you have?
* What contingency plan if you are gone for indefinate period of time?
Well, questions lead to more questions which is not what you asked for, so I'll try to be more helpful. On the surface...I would recommend root cause as "Training/Awareness Situation". Plain simple honesty, we all know that even experts aren't perfect (at least...you are not going to be 100% perfect all the time!). The big question that comes up (and in MHO you should prepare an answer for) - Are there other areas with single 'experts' that significant or even critical processes/procedure requirements overlooked? If this can happen in one place, it can happen in others.
Hence, I would also suggest a revisit of the decision to have only 'one expert', common business practice is to at least someone else (maybe with some cross-training) with some knowledge to assist with review (process & procedural).
Hope it helped some...Eileen
"To err is human, To forgive divine, and an auditor usually hits on the one screw-up in the 50 (otherwise perfect) samples EVERY TIME!"
Seriously, you didn't give much detail. Some questions that come quickly to mind are:
* If it was a core ISO requirement where was the Mgmt Rep?
* How are your internal auditors used?
* Is it an internal procedure?
* What type of review/approval process do you have?
* What contingency plan if you are gone for indefinate period of time?
Well, questions lead to more questions which is not what you asked for, so I'll try to be more helpful. On the surface...I would recommend root cause as "Training/Awareness Situation". Plain simple honesty, we all know that even experts aren't perfect (at least...you are not going to be 100% perfect all the time!). The big question that comes up (and in MHO you should prepare an answer for) - Are there other areas with single 'experts' that significant or even critical processes/procedure requirements overlooked? If this can happen in one place, it can happen in others.
Hence, I would also suggest a revisit of the decision to have only 'one expert', common business practice is to at least someone else (maybe with some cross-training) with some knowledge to assist with review (process & procedural).
Hope it helped some...Eileen
Have you read through https://Elsmar.com/ubb/Forum31/HTML/000023.html
and
https://Elsmar.com/ubb/Forum31/HTML/000033.html ?
Note: This is an edit on 10/1/2001:
I can't re-lookup and change every old link to posts in the old forums. Most of them *should* still be there. If you want to find the post in the New forums, if the link to the thread in the old forums works (most of them should...), look at the thread (topic) title and what forum it is in. Then back here in the New forums - go to that forum and look for the thread topic title - OR - do a Search for the key words from Title (Note - you can search entire threads or just the 'subject' or 'title' - if you look in the Forums search page you'll see the options.
and
https://Elsmar.com/ubb/Forum31/HTML/000033.html ?
Note: This is an edit on 10/1/2001:
I can't re-lookup and change every old link to posts in the old forums. Most of them *should* still be there. If you want to find the post in the New forums, if the link to the thread in the old forums works (most of them should...), look at the thread (topic) title and what forum it is in. Then back here in the New forums - go to that forum and look for the thread topic title - OR - do a Search for the key words from Title (Note - you can search entire threads or just the 'subject' or 'title' - if you look in the Forums search page you'll see the options.
D
David Mullins
Q. If you honestly believe auditors find the only nonconformance in a big pile of perfect, you are:
a. Statistically incorrect;
b. Deluded;
c. A Production/Manufacturing Manager; or
d. Ready for retirement or consulting (sorry Marc).
druid - we all forget little things occasionally, so fix it and move on - beating yourself up borders on paranoia.
------------------
a. Statistically incorrect;
b. Deluded;
c. A Production/Manufacturing Manager; or
d. Ready for retirement or consulting (sorry Marc).
druid - we all forget little things occasionally, so fix it and move on - beating yourself up borders on paranoia.
------------------
D
druid
OK gang,
I wrote the procedure and I overlooked something (specific requirement, item, a reference, etc.), I am the most expert person in the company regarding the method concerened, so anyone reviewing the procedure probably would not catch the oversight. Months later an auditor notices and I have to provide a root cause corrective preventive action. I know it was just an oversight (mental slip. Is my correction then "I'm an incompetant moron and better find a new job"? I've asked myself why not five six or eight times now, but hundreds! and I can't come up with a root cause prevention...
I wrote the procedure and I overlooked something (specific requirement, item, a reference, etc.), I am the most expert person in the company regarding the method concerened, so anyone reviewing the procedure probably would not catch the oversight. Months later an auditor notices and I have to provide a root cause corrective preventive action. I know it was just an oversight (mental slip. Is my correction then "I'm an incompetant moron and better find a new job"? I've asked myself why not five six or eight times now, but hundreds! and I can't come up with a root cause prevention...
A
Al Dyer
Just one question before I respond and put my foot in my mouth,
Are you already registered to a quality system. If so the problem should have been caught during the registrars desk audit.
Are you already registered to a quality system. If so the problem should have been caught during the registrars desk audit.
T
tomvehoski
I once did the same thing for a client - I forgot to put in one of the minor "shalls" in a procedure. The registration auditor did not catch it at the desk audit (I'm not sure he even did the desk audit), but did pick up on it during the registration and wrote a minor NC. I fully admit it was my mistake.
We completed the corrective action by adding one sentence to the procedure and releasing the revision - about 5 minutes of work. For the NC root cause, we put "Human error - consultant forgot to type in sentence. Desk audit reviews also missed." or something similar. The auditor would not accept human error as a valid root cause analysis. He insisted that I "misinterpreted" the standard and would not close it until I put his wording into the root cause. He said he would NEVER accept human error as a root cause - it has to be lack of training or something. Apparently he is perfect, but it was not worth arguing about, so I wrote it in his words and moved on with life. Of course I would never recommend him to another client.
[This message has been edited by tomvehoski (edited 25 July 2001).]
We completed the corrective action by adding one sentence to the procedure and releasing the revision - about 5 minutes of work. For the NC root cause, we put "Human error - consultant forgot to type in sentence. Desk audit reviews also missed." or something similar. The auditor would not accept human error as a valid root cause analysis. He insisted that I "misinterpreted" the standard and would not close it until I put his wording into the root cause. He said he would NEVER accept human error as a root cause - it has to be lack of training or something. Apparently he is perfect, but it was not worth arguing about, so I wrote it in his words and moved on with life. Of course I would never recommend him to another client.
[This message has been edited by tomvehoski (edited 25 July 2001).]
T
tomvehoski
The auditor insisted I misintrepreted the standard, so I gave in and used that wording. This was about a year ago so I don't remember exactly what the issue was or what my response was. I personally believe that human error is an acceptable RC for minor issues. Am I supposed to say my 5th grade spelling teacher did not verify my spelling competence properly for every mis-spelled word I put in an e-mail? It is not worth the argument though if he won't accept "human error".
For your problem I might try something like:
Root Cause
Document author/reviewer missed error in document. Additional reviewers also missed. Human error (optional).
Short Term C.A.
Updated and re-issued document per document control procedures.
Long Term C.A. / P.A.
None. Error was minor in nature and did not affect safety, quality of products, services or processes. Current review system is sufficient to catch the vast majority of errors. The rest of the quality system has been audited and found to conform to requirements of ISO 9001. Further preventive actions to eliminate the cause of potential future occurrences would not be commensurate with the minimal risk involved.
Verification
Verified that revised documents were issued to all holders and obsolete copies were destroyed. Obsolete master has been stamped as such and filed in the obsolete file. Master list updated. Issue considered closed.
The biggest thing is probably the "commesurate with the risks encountered". If a mental slip caused a safety condition, bad part, etc., I would attempt to find a PA. For a document error it is not a big deal.
Tom
[This message has been edited by tomvehoski (edited 25 July 2001).]
[This message has been edited by tomvehoski (edited 25 July 2001).]
M
Michael T
Greetings all...
If I remember correctly, the issue of human error as an unacceptable root cause was discussed a while back ago. I don't recall the outcome of the discussion and can't seem to find it.
Anyway - pardon my naiveté - however, if after all other potential root causes have been exhausted (e.g. training is adequate, procedures are adequate, etc., etc.) why can't human error be an acceptable root cause for a MINOR non-conformance?
Sorry - I just don't grok (grok = understand, for those non-Robert Heinlein fans).
Thanks!!!
Mike
If I remember correctly, the issue of human error as an unacceptable root cause was discussed a while back ago. I don't recall the outcome of the discussion and can't seem to find it.
Anyway - pardon my naiveté - however, if after all other potential root causes have been exhausted (e.g. training is adequate, procedures are adequate, etc., etc.) why can't human error be an acceptable root cause for a MINOR non-conformance?
Sorry - I just don't grok (grok = understand, for those non-Robert Heinlein fans).
Thanks!!!
Mike
J
JRKH
Michael,
No expert here but I suspect that "human error" is not accepted because it tis too broad, and vague. Most mistakes could be classified as human error.
The purpose of the QMS is to provide safeguards against this. Training, document review, audits etc.
In Druid's case, perhaps when a procedure is written that is so well known by one person, perhaps someone else should not only proof read the but actually perform the procedure under the guidance of the author. This should reveal the ommission very quickly.
James
No expert here but I suspect that "human error" is not accepted because it tis too broad, and vague. Most mistakes could be classified as human error.
The purpose of the QMS is to provide safeguards against this. Training, document review, audits etc.
In Druid's case, perhaps when a procedure is written that is so well known by one person, perhaps someone else should not only proof read the but actually perform the procedure under the guidance of the author. This should reveal the ommission very quickly.
James
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