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Auditor threatening Formal NC and CA for not enough PA
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Auditor threatening Formal NC and CA for not enough PA
Auditor threatening Formal NC and CA for not enough PA
Auditor threatening Formal NC and CA for not enough PA
Auditor threatening Formal NC and CA for not enough PA
Auditor threatening Formal NC and CA for not enough PA
Auditor threatening Formal NC and CA for not enough PA
Auditor threatening Formal NC and CA for not enough PA
Auditor threatening Formal NC and CA for not enough PA
Auditor threatening Formal NC and CA for not enough PA
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Some Related Topic Tags
audit nonconformances and findings, audits and auditing, preventive action (pa)
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  Post Number #17  
Old 4th April 2014, 10:52 AM
Helmut Jilling

 
 
Total Posts: 4,366
Re: Auditor threatening Formal NC and CA for not enough PA

Quote:
In Reply to Parent Post by mguilbert View Post

On a side note, the TC has felt PA to be so important the current draft of 9001 does not even contain PA.
I think it would be more accurate to say that Preventive Action has expanded into a broader concept of Risk Analysis, which is all over the CD1 draft. The PA form appears to be gone. But the concept of being Preventive, rather than reactive is greatly expanded. That is always a good thing.
Thank You to Helmut Jilling for your informative Post and/or Attachment!

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  Post Number #18  
Old 4th April 2014, 11:00 AM
Bev D's Avatar
Bev D

 
 
Total Posts: 3,547
Re: Auditor threatening Formal NC and CA for not enough PA

I would agree. The idea that one treats "Preventive Actions" just like Corrective Actions was well intended but horribly misguided. there are really more PAs than CAs in any company. And many - though not all - are actually covered in the standards in other areas. consider that Design reviews, verification and validation are part of preventive actions.
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  Post Number #19  
Old 4th April 2014, 11:00 AM
mguilbert's Avatar
mguilbert

 
 
Total Posts: 347
Re: Auditor threatening Formal NC and CA for not enough PA

Quote:
In Reply to Parent Post by Helmut Jilling View Post

That is a little bit of a stretch....you are saying they put a section in the standard ...just in case maybe you might want to kind of use it some day...? You're better than that....

But, it is moot....because ISO has thrown in the towel...It looks like PA will go away in the 2015 version... probably because so few people did them right anyway.

In it's place they will take it up a notch to "Risk Assessment" which could be a good thing if people figure out how to do that!
Based on what I have heard about "risk based thinking" in 2015, it is not a documented procedure at this time. IMHO if you do not do good job of Risk Assessment you wont be in business long.
  Post Number #20  
Old 4th April 2014, 11:56 AM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,937
Re: Auditor threatening Formal NC and CA for not enough PA

Quote:
In Reply to Parent Post by Helmut Jilling View Post

...why do we make this so complicated?
The APPLICATION of preventive action in the real world has been fraught with controversy. The Should the TC 176 Re-word the Requirements for Preventive Action? thread that I created discusses at length the challenges for the PRAGMATIC application of preventive actions.

In usual fashion, Jim Wynne summed up pretty well in post #60 of that thread:
Quote:
As most here know, there is much about the ISO view of corrective and preventive action that doesn't make much sense to me. I won't rehash my misgivings again in this thread, but it seems to me that when there's such a perception of widespread misunderstanding, something's wrong with the standard, and not the implementation of it.

While they will never admit to it, a few highly influential members of the ISO TC 176 SC2 peruse this very Forum, constantly. I would not be surprised if some of the discussions we endured here in the last 12 years had not highly influenced the direction that they took the ISO 9001:2015 towards, dropping requirements for "formal" preventive actions, in favor of "risk based thinking", with all the challenges to make that an auditable and/or verifiable requirement.
I am concerned that, without serious thought about how this "risk-based thinking" is written and codified in ISO 9001:2015, the challenges we've had so far with preventive actions will be miniscule, compared to auditing risk-based thinking....
Thank You to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #21  
Old 4th April 2014, 01:34 PM
ABRSPLY

 
 
Total Posts: 9
BIG Smile Re: Auditor threatening Formal NC and CA for not enough PA

Thank you all for your input. We do cover all of this in our management meetings, as well as having regular employees meetings. I will transfer that information to a form to keep him happy. Overall, I am happy with our auditor. I just think some of this stuff (adding these to a preventive action form, etc.) do not add any value.
I am not the type that just wants to generate paper that does not actually mean anything. Training and communication are way more important, especially in a company with only 12 people.
Again, thanks for the help.
  Post Number #22  
Old 4th April 2014, 02:04 PM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,473
Lightbulb Re: Auditor threatening Formal NC and CA for not enough PA

Good to know we've been able to help. I would still ask you to look closely at your auditor's performance, however. You may be happy with them, but let's look at the collective effort expended here (given freely of course) as an indication of a "wild goose chase" that - without the immediacy of the internet - you might have had to expend a significant amount of time/money with bringing in a consultant, or researching yourself. All for what? As a small company you probable can't afford to do this again, and I wonder if your auditor has a clue the "carnage" they leave behind when they offer such comments.

At the very least, you should sit them down, next visit, and explain you won't tolerate such ill-considered statements again.

My professional concerns is that, unchecked, the auditor is going around all of their other clients making such facile comments - and think what that's causing...
Thanks to AndyN for your informative Post and/or Attachment!
  Post Number #23  
Old 5th May 2014, 05:22 AM
JaneB's Avatar
JaneB

 
 
Total Posts: 3,518
Re: Auditor threatening Formal NC and CA for not enough PA

Agree with Andy. If an auditor needs it 'transferred to a form' to keep him happy - information that is already generated and used in your company in a different format, what on earth does that say about your auditor. I wouldn't do it - it's changing your system to fulfil a personal preference of your auditor, and that is always a bad idea.
Thank You to JaneB for your informative Post and/or Attachment!
  Post Number #24  
Old 6th May 2014, 12:16 AM
Eloy Gomez

 
 
Total Posts: 182
Re: Auditor threatening Formal NC and CA for not enough PA

Thanks Randy. You are right.
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