posted 24 July 2001 04:33 PM               

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).

posted 24 July 2001 08:34 PM               

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.

posted 25 July 2001 10:42 AM               

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.

posted 25 July 2001 02:11 PM               

quote:

---

Originally posted by druid:
Tom,
Your situation is the one I'm in. I'm not beating myself up, the registrar is beating me up. So what were the registrars "words"? I know what I did and have read tons of info on mental slips, but nopbody has discussed a way to prevent them. As far as getting a second expert, our lil ol tiny low budget company has no spare change for such a luxery...

---

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).]

posted 25 July 2001 03:21 PM               

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

posted 25 July 2001 07:24 PM            

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.

posted 26 July 2001 07:43 AM               

I agree, that "human error" could be used (misused) to label every non-conformance. However, its judicious use (when all other avenues have been explored) should not be dismissed. I believe that there are times when human error is the root cause - regardless of how good the QMS is, how tight the procedures, how well the people are trained. Human beings are prone to flaws.

JMHO...

Cheers!!!

posted 26 July 2001 09:42 AM            

I must disagree. I may be wrong but I can't think of a situation that cannot be described in some way other than "human error". How do you provide corrective action for "human error".

In an audit situation, I would want something more specific. Sure it was a human error, but of what type.

i.e. "author failed to include step. error not caught at document review."

Surely this is a human error, but it says what type, and gives something tangable to create a corrective action against.

IMHO this is what the auditor is looking for.

James

------------------
Low tech is better than no tech.

posted 26 July 2001 01:23 PM               

I certainly agree with you... in my experience, by and large, most non-conformances can be tied to a root cause that is, typically, process or training oriented.

However - let me hypothesize the following very abreviated scenario: Employee comes into work hung over from a night of heavy duty partying. He doesn't tell anyone he is hung-over. The supervisor and co-workers can't tell he's hung-over, so no one knows this guy is not functioning at his best. John Q. Worker works in... oh... let's say Packing & Shipping and is in charge of putting the literature in the box with the widget, closing and sealing the box and putting the shipping label on it. He packs an order for 10 widgets and gets the literature in 8 of the 10 boxes. Boxes ship to I.M.D. Customer, Inc. A few days later the QA Manager of I.M.D. Customer, Inc. calls up and wants a corrective action report written because 2 of the 10 widgets didn't contain literature. Procedures are clear and well defined and John Q. Worker has not messed this up before and is more than adequately trained in the procedures. What would the root cause be? What would the corrective action be?

Just some food for thought... Anyone care to take a stab at this?

Cheers!!!

posted 27 July 2001 09:29 AM            

The human error involved here is not following the procedure as written. In my mind this becomes a training issue. The issue may be one of procedural training, and/or disciplinary training. Exactly how this is handled internally depends. If this is a good employee, I'd just walk back and talk to him. If the employee is a "chronic party animal", it may require a more formal censure.

I would write it up as:

Root Cause: Failure to Procedure as written

Corrective Action: Retrained personnel in proper use of procedure and need to follow procedures as written.

James

posted 30 July 2001 02:58 PM               

I'll buy that root cause & corrective action. Seems to handle the situation and deal with the problem, yet doesn't rely on "human error" as the root cause. Unfortunately, the situation is somewhat factual, the name was changed to protect the innocent(?), but the guy turned into a chronic party hampster.

Cheers!!

posted 30 July 2001 08:09 PM               

This will leave Mr Hangover free to test matches or something.

posted 31 July 2001 05:26 PM            

Human error is inescapable it's true, but I have found that when dealing with CAR's human error is the stert of the cause investigation, not the end.

Lets look at Michael T's scenerio using the 5 why's. Customer receives boxes missing liturature.
Why -
Because the operator didn't put it in the box.
Why -
Because He did not follow the procedure
Why -
(this ones tricky. Hung over? - Not a good reason)
Because he was overconfident, or he was not impressed with the importance of following procedures, or poor attitude
Why -
Either too long on the job, or boss is not pushing compliance.
Why - (you fill in the blank)

I think you'll agree that there are a lot of points to work on here, - Training, motivation, ergonomics, etc. - without needing to resort to human error as a root cause.

James

posted 01 August 2001 12:54 PM               

energy

posted 01 August 2001 09:05 PM            

Fortunately I think most folks in our business also see this, and just need to get something to complete the paper trail.

We get it done, and move on to something important.

Hope I didn't ruffle too many feathers. I can get pretty nitpicky myself sometimes.

cheers

James

posted 20 August 2001 08:37 AM               

Am I missing something here, or my partying last night may be affecting my reasoning? The intent of the scenario escapes me. How can one answer, like the previous ones, a question when only he knows he was partying? It appears that nobody but him knew and you. If you know he's hung over (reeking of booze) and not functioning properly, the CA/PA is pretty easy. It becomes a disciplinary issue. If your preventive action doesn't prevent future behavior, then you can use the oldest excuse in the book. "He don't work here anymore". If you are suggesting that no one knew, the whole issue of his night before doesn't even come into play, when trying to determine why he messed up. Only he knows that is human error caused by over indulgence. Do you think it may affect his conscience? I doubt it. I'm confused.

posted 20 August 2001 01:23 PM               

quote:

---

Originally posted by energy:
Mike T.,

Am I missing something here, or my partying last night may be affecting my reasoning? The intent of the scenario escapes me. How can one answer, like the previous ones, a question when only he knows he was partying? It appears that nobody but him knew and you. If you know he's hung over (reeking of booze) and not functioning properly, the CA/PA is pretty easy. It becomes a disciplinary issue. If your preventive action doesn't prevent future behavior, then you can use the oldest excuse in the book. "He don't work here anymore". If you are suggesting that no one knew, the whole issue of his night before doesn't even come into play, when trying to determine why he messed up. Only he knows that is human error caused by over indulgence. Do you think it may affect his conscience? I doubt it. I'm confused.

energy

---

Hi Energy...

Sorry to confuse you... The situation I described was somewhat hypothetical (real person - different circumstances and after several incidents it was discovered that the individual did have a problem with late night partying). While I don't like to rely on the term "human error" as a root cause, I was trying to convey the idea that sometimes a root cause can only be attributable to human error given the information provided at the time. Since no one knew that our party-guy was hating life because he lost a battle with a bottle of Tequila - and he didn't have a past history of coming to work hung-over, I could see no other root cause than human error.

I suppose I could have given the hypothetical without the reference to the hang-over -- and, hind-sight being 20/20, I suppose I should have.

I have a question though (a couple, actually)... What if our fun loving friend came clean to his supervisor (Jimminey Cricket was harping on Mr. Party pretty heavy that morning) and he confessed that he was hung-over -- what do you tell your customer in the CAR? Let's say the root cause is determined to be a hang-over and corrective action was "employee disciplined" which would probably constitute a good butt-chewing and the P/A would be "don't do that again, young man", do you share that with I.M.D. Customer? Would you (as a customer) be willing to accept that root cause & C/A?

Cheers!!

Mike

posted 20 August 2001 03:26 PM               

In that case I WOULD offer him up to the Customer as the cause due to an employee's inability to function because of problems of a personal nature. Management has counselled the individual and offered assistance to this, otherwise, responsible person. The employee has been warned that these kind of mistakes are unacceptable with severe consequences if it continues" or something like that. Of course, maybe it's just me, I would tell the employee that he would remain anonymous to the customer, but that my answer would contain this type of information because we mean it.
Also, I'm in favor of human, operator or worker error as a cause only when there is no other answer. That's why I've posted on this subject several times. Most Customers have HR dept's in their facilities and deal with the same issues. I think they would appreciate the candor, particularly if you haven't showered them with this type of response before. But, as you can tell by some of the responses, the only people who don't make mistakes are the people who review the Supplier's CA/PA.

I just have to add this: I love the example tomvehoski posted on 7/25/01 so much that I printed it for future reference. Specifically the Long Term CA/PA. It says the same thing but far more eloquently than I can. And I thought I could really toss the manure. Great Post!

energy

posted 20 August 2001 03:40 PM               

Great hypothisis, I really have never thought about employee disciplinary (sp) action as the possible reason for a corrective action.

Although I am not against it, would this really be the root cause?

I don't have a real opinion yet, just looking for further input.

Have a good day!

posted 20 August 2001 03:51 PM               

Good day to you. The root cause would be a violation of company rules involving employee behavior. I know that here it's a violation to come to work under the influence of drugs and alcohol with immediate testing if it's suspected. I wouldn't go into the actual details with the customer other than counseling and assistance has been offered. They should interpret that as a confidential matter that needs no further explanation. I'm just saying what I would do, like everybody else. We never know what the Customer will say regarding an answer like that. I just have more faith in mankind. Yea, I'm a softy!
Nice to hear from you again.

posted 21 August 2001 09:31 AM               

I agree, I like tomvehoski's example, especially, "Further preventive actions to eliminate the cause of potential future occurrences would not be commensurate with the minimal risk involved." Too many times I've seen customers request a Corrective Action on something that is, by-and-large, inconsequential, simply (I believe) to flex their muscles.

I would be somewhat leery about "offering him up" as the root cause. As Sam pointed out - there could be reprocussions with that approach, and I don't like to air out dirty laundry in public - so to speak. If the problem were significant and termination was the result, I would (and have) offered that as a corrective action.

Thanks for the feedback!

Cheers!!

Mike

posted 21 August 2001 09:35 AM               

In this HYPOTHETICAL situation, the problem has been detected. The only solutions are to fire Mr. Party or offer him counseling and retain him under certain conditions. Do you then want to make up something (a fabrication, if you will) to please the Customer? The employee has full anonymity and his rights are not violated. If an employee went haywire and threw your order in the trash can, you wouldn't tell that to a Customer when he complains that his order is late? As a business owner you also know that a lot of stuff goes on over the telephone that never makes it to paper. How would you deal with your partying employee that caused you to disappoint a Customer? My guess, you would discuss this guy over the phone or dinner.

posted 21 August 2001 10:29 AM               

Good call!

posted 21 August 2001 12:09 PM               

Again, I'm making some critical leaps with the scenario and am 'presuming' that this IS an isolated incident (not just for this individual but overall). Also am presuming that this isn't a 0ne-time order and lets say customer gets 10 boxes a week...and has for at least a year.

Frist, my questions to the customer:
Have you had a problem with this issue in the past we do not know about?

Check the #'s and lay it out.
Let's say they've received 10 bx a week for a year (520). If these are the only 2 that have ever been missed we're looking at less than .4% failure of a non-critical process.

The instructions are (presumed) necessary but easy to fix (Customer can make copies, Fed ex them some, etc...) and does not affect the functionality of the widget!

To me the significant aspect is 'what componenet of the system' lead to the failure?

I would try to bring the customer around to my perspective (gently...we don't want to lose his business), and while we believe this is an isolated incident (but have never collected data to know for sure), convey that we would be willing to add a temporary 100% inspection of this process on site and would welcome same data collection at their point and compare data in ? weeks (negotiate). Try to get the customer to agree that if there isn't a repeat in that time frame, we'll add a 'spot-check' inspection (say once a month by each shift supervisor or leadman) and compare data again in 6 months.

To me, if I can disuade the customer alltogether I would...but still do a no-notice sampling just to rebuild the confidence level in my process.

posted 21 August 2001 04:01 PM               

quote:

---

Originally posted by energy:
When the Customer Representative tells me that it is unacceptable, I will offer to meet him over many cocktails and resolve it. Just as long as we didn't have to go to work the next day. Smile!

energy

---

Thanks for the laugh, Energy! You have a wicked sense of humor...

posted 21 August 2001 05:07 PM               

How dare you!

Our Energy has no sense of humor at all!!!!!