Had a third party audit yesterday.
They guy was great - knows the stuff inside out, has been doing it for a long time, was friendly and offered a lot of good advice.

He had a few observations one of which I felt is good to bring up here...

How careful are you about using the word "training" in CAPAs?
He picked one CAPA where the preventive action was to 'retrain' the operator.
So he asked for the training record. Which we didn't have.
Now, I have a very good training system set up but I don't want to bog it down with little stuff - it's meant for tracking formal training, not reminders from the supervisor.
So I stated that in the context of the CAPA "retrain" was really just used by the person who wrote in place of "counseled".
Fine - we'll "retrain" our managers and supervisors to use the word "counseling" in situations likes this so we don't have to put this little stuff in the formal training system, good observation and thanks.

Then he started going on about some Deming lectures he attended in the 70's and that people generally know what they should be doing and how to do it so it's almost always the system's fault that these mistakes happen - either the instructions weren't clear or managemet did not provide time or resources to get the job done right, whatever. So counseling should not be the action to prevent recurrence.
I maintained that this was a one time occurrence. If it was a repeated error then perhaps the system should be redesigned. But the fact is, people make mistakes or get careless once in a while no matter how good the system is.

Why is carelessness such a bad word these days?

Had a third party audit yesterday.
They guy was great - knows the stuff inside out, has been doing it for a long time, was friendly and offered a lot of good advice.

He had a few observations one of which I felt is good to bring up here...

How careful are you about using the word "training" in CAPAs?
He picked one CAPA where the preventive action was to 'retrain' the operator.
So he asked for the training record. Which we didn't have.
Now, I have a very good training system set up but I don't want to bog it down with little stuff - it's meant for tracking formal training, not reminders from the supervisor.
So I stated that in the context of the CAPA "retrain" was really just used by the person who wrote in place of "counciled".
Fine - we'll "retrain" our managers and supervisors to use the word "counciling" in situations likes this so we don't have to put this little stuff in the formal training system, good observation and thanks.

Then he started going on about some Deming lectures he attended in the 70's and that people generally know what they should be doing and how to do it so it's almost always the system's fault that these mistakes happen - either the instructions weren't clear or managemet did not provide time or resources to get the job done right, whatever. So councliling should not be the action to prevent recurrence.
I maintained that this was a one time occurrence. If it was a repeated error then perhaps the system should be redesigned. But the fact is, people make mistakes or get careless once in a while no matter how good the system is.

Why is carelessness such a bad word these days?

Unless the auditor can demonstrate a systemic issue, he should keep his opinions to himself beyond the strictly conversational level. That said, I do think that there should be a record if retraining or counseling is considered necessary. This is important not only for QMS reasons--if the problem continues and some form of discipline becomes necessary, you need to have a trail.

Unless the auditor can demonstrate a systemic issue, he should keep his opinions to himself beyond the strictly conversational level. That said, I do think that there should be a record if retraining or counseling is considered necessary. This is important not only for QMS reasons--if the problem continues and some form of discipline becomes necessary, you need to have a trail.

yes. Good point.
Generally we'll have the counseled person initial the CAPA sheet. Something we need to get better at though.

In our training program, we have a training code set aside for "retraining" due to a CAR. We document that in our training records and keep a copy of the syllabus.

I do believe that most of recurrent issues are due to management involvement, or lack thereof.:mad:

I agree this fellow might well be right about the Deming thing but he should be sending his opinions where they belong. I dare say he could not have seen enough to know if what he was looking at was truly a systeming or management issue.

All in all the issue at hand is how the corrective action was managed; how you can show it was done, and how you know if it was effective, and what happened then. The choice between training or counselign belongs to you unless it's evident the same type of corrective action is being done over and over with no remedy.

you can also review the discussion in http://elsmar.com/Forums/showthread.php?t=3176
(Is 'Operator Error' as Root Cause ever acceptable?)
for more on your exact situation...

If we indeed need to re-train, we have a document that becomes a record of training and signed by the trainees. The top of the page has a space for the training topic, instructor, date, place. This then becomes a record of the training. However, we find that some people have short memories and have to look for better means to prevent the issues.

All in all the issue at hand is how the corrective action was managed; how you can show it was done, and how you know if it was effective, and what happened then. The choice between training or counselign belongs to you unless it's evident the same type of corrective action is being done over and over with no remedy.

Yes - exactly. Recording or not recording individual retraining or counseling depends on what your system processes say you do about that. What matters for the CAPA is if that retraining or counseling was actually effective in eliminating reoccurrence, not only for that individual but for preventing the same from happening for anyone else who would be doing that task.

...Then he started going on about some Deming lectures he attended in the 70's and that people generally know what they should be doing and how to do it so it's almost always the system's fault that these mistakes happen - either the instructions weren't clear or managemet did not provide time or resources to get the job done right, whatever. So counseling should not be the action to prevent recurrence.
I maintained that this was a one time occurrence. If it was a repeated error then perhaps the system should be redesigned. But the fact is, people make mistakes or get careless once in a while no matter how good the system is....



The good Dr. Deming notwithstanding, I agree with your view. One off minor events do not mean the system must be changed. I do agree that operator errors frequently result from system issues. Deming said 80% or so were system related. My audits tend to bear out something in that 80-85% range. But not always.

I think your view and approach is largely correct.

I'm thinking you shot yourself in the foot, by making it a CAPA topic. If you'd simply made it a correction, because it only happened the one time, the comments from the auditor wouldn't have been made. By making it a CAPA issue, you've escalated it to a systemmic issue, hence his comments.

There should always been 'room' in any system for correction and tracking to see if there are trends in correction, which indicate a corrective action is required.

:2cents:

I'm thinking you shot yourself in the foot, by making it a CAPA topic. If you'd simply made it a correction, because it only happened the one time, the comments from the auditor wouldn't have been made. By making it a CAPA issue, you've escalated it to a systemmic issue, hence his comments.

There should always been 'room' in any system for correction and tracking to see if there are trends in correction, which indicate a corrective action is required.

:2cents:

perfect! that's exactly it...

If we indeed need to re-train, we have a document that becomes a record of training and signed by the trainees. The top of the page has a space for the training topic, instructor, date, place. This then becomes a record of the training. However, we find that some people have short memories and have to look for better means to prevent the issues.
Before re-training, shouldn't someone assess the effectiveness, sufficiency, and adequecy of the training program?

Before re-training, shouldn't someone assess the effectiveness, sufficiency, and adequecy of the training program?

Hello michellemmm,

To answer your question; considering the scope of the proposed training, "sufficiency" and "adequacy" could be determined prior to the training. "Effectiveness" is usually assessed after the training has been delivered. I usually assess knowledge retention at the end of the program, the ability to effectively apply what's been learned, some time afterwards.

Stijloor.

Hello michellemmm,

To answer your question; considering the scope of the proposed training, "sufficiency" and "adequacy" could be determined prior to the training. "Effectiveness" is usually assessed after the training has been delivered. I usually assess knowledge retention at the end of the program, the ability to effectively apply what's been learned, some time afterwards.

Stijloor.

Thank You, Stijloor.

How do you accurately predict "sufficiency" and "adequacy" of training program?

Are you saying your training program is perfect?

What about continual improvement of the training process?

I personally believe every process needs to be verified and validated...including training process. PDCA applies to training process.

Thank You, Stijloor.

How do you accurately predict "sufficiency" and "adequacy" of training program?

Are you saying your training program is perfect?

What about continual improvement of the training process?

I personally believe every process needs to be verified and validated...including training process. PDCA applies to training process.

Hello Michellemmm,

Thank you for your response and questions.

I was not commenting on a training process as a whole, but merely in the context of a simple (training) response to Corrective Action/Preventive Action. I do not disagree with continual improvement, verification, validation, PDCA, etc. of training. Again, that was not the intent of my response.

And no, my training is not perfect. I have been in this (training) business more than 35 years, and I am still learning....:)

Hope this clarifies.

Stijloor.

I'm thinking you shot yourself in the foot, by making it a CAPA topic. If you'd simply made it a correction, because it only happened the one time, the comments from the auditor wouldn't have been made. By making it a CAPA issue, you've escalated it to a systemmic issue, hence his comments.

There should always been 'room' in any system for correction and tracking to see if there are trends in correction, which indicate a corrective action is required.

:2cents:

Just by making it a CAPA doesn't make it systemic. It was a noted nonconformance. If he searched deeper he wouldn't have found another.

However - I appreciate your point. But understand that our CAPA system is fairly new so we are trying to get some data into it. Discression is being taught as a result of this observation.
It was just auditor luck that the guy picked this one.