Classification of Findings in Audits to the new standard

#21
I agree with Wes. To do any thing else other than to properly document the investigation of the finding(s) sets the system up to fail. No matter what you call them, they are still nonconformances and shouild be adressed using the basic corrective action methodology.
 
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Wes Bucey

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#22
Sam said:
I agree with Wes. To do any thing else other than to properly document the investigation of the finding(s) sets the system up to fail. No matter what you call them, they are still nonconformances and shouild be adressed using the basic corrective action methodology.
You may be outnumbered at work, Dawn, but as Sam says here, creating a process to make an action without a real understanding of the cause of the event is just setting the system up to fail.

To do what you suggest (discipline) implies your entire system of recruiting, training and assigning employees to tasks is fundamentally flawed and by disciplining "omissions" without finding and curing the root cause, the bad habit of incorrectly completing a form is reinforced and becomes a "process."

As the Quality professional, your task is to help the "powers that be" learn the benefit of doing things in the most efficient and effective manner possible.

For your own sake, think through the ramifications of doing things as you suggest because you are "outnumbered." An impaired organization cannot be an effective competitor, because its cost of doing business with a flawed system is more than a savvy customer will be willing to pay.
 

RoxaneB

Super Moderator
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#23
Wes Bucey said:
You may be outnumbered at work, Dawn, but as Sam says here, creating a process to make an action without a real understanding of the cause of the event is just setting the system up to fail.
Overall, I agree. But I also know that here on the Cove, we keep saying it's "our" system and to make it work for "us".

Wes Bucey said:
To do what you suggest (discipline) implies your entire system of recruiting, training and assigning employees to tasks is fundamentally flawed and by disciplining "omissions" without finding and curing the root cause, the bad habit of incorrectly completing a form is reinforced and becomes a "process."

As the Quality professional, your task is to help the "powers that be" learn the benefit of doing things in the most efficient and effective manner possible.
Personally, I don't believe that doing root cause analysis on why Mr. X forgot to sign Line 9 of Form ABC is effective. What I see as being effective, however, is a Preventive Action issued upon the analysis that Mr. X has failed to sign Line 9 of Form ABC n times this year and to indicate what the impact was/potentially could have been.

Sometimes, it may be a case of Mr. X forgetting and doing a root cause analysis on "forgetting" does not inspire people to believe in the system. In fact, these "exercises in paperwork" cause dissention, groan, eye rolling and an overall disrepect for the system and its processes.

We are to treat problems in a suitable manner. Mr. X didn't sign Line 9. Okay...Mr. X corrects and signs Line 9. Abnormality has been treated.

Analysis of data (annually, semi-annually, quarterly...whatever works for you) discovers that Mr. X was issued a number of abnormalities that exceeds our allowable trigger where he failed to sign Line 9. Trend. Now, we can look at root cause. We have data supporting an adverse trend which Management will most likely wish to correct. They don't want to spend their time doing root cause on what is perceived to be a one-of item.

In theory, yes, root cause on everything. Personally, I'd love it if that were reality. Unfortunately, we have Customer requirements to meet, product to make, employees to keep safe, an environment to protect, suppliers to pay and shareholders to keep happy. We don't have that much time for paperwork, so we develop, implement, maintain (and improve) a system that works for us.

It may not work for everyone. It may not work for Dawn's organization. But it working for us. :)
 
J

Jonell

#24
Perhaps it's more of a training issue

How about if I throw another wrench into the works? My thought process is that if during an audit, I come across and employee who is not following documented procedures, I ask the person how they were trained. Then I go back and look at the training records for that procedure. If I find that that there is no training record for the person on that procedure, then my nonconformance states that. If I find that there is a training record, then the issue is given to their supervisor to deal with.

Let me give you an example. 2 people are running an operation. They do not inspect their parts all day, even though the work instruction at the operation clearly states that product is to be inspected every hour. Investigation of the training log shows that only 1 of the 2 was ever trained to do this job. Is this a case of not following the documented procedure (work instruction), or is a training issue. Let's make it even more messy. Let's say that the next day, the one that is "trained" stops the press because the product won't fit the gage. Investigation shows that the individual was trying to put the part on the wrong gage. Hmmm, makes one wonder just how effective the training was?

Jonell
 
D
#25
Thanks - I have a form I created to resolve the issues - havent tried it yet. Roxanne, can i get a look at yours? :nopity:

(By the way - I have that same quote on the bottom of my emails)
 

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