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  #1  
Old 20th March 2010, 09:56 AM
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Question Cl 8.5.2 Corrective Action - "Cause" vs. "Causes"

I was recently a Quality Manager for 8 years. About 8 months ago, I left the field and I am pursing another field (which I use my Quality background in more than one would ever realize!).

To shorten this question... My Mother works in a company and she was thrown into being the Quality Manager, and I try to answer and provide support to her questions as much as I can.

Recently she had an audit, where they listed a step in a procedure, but failed to describe how it was done. The auditor wrote up the minor. In doing that, the auditor said "When you write the noncompliance, do not just write one root cause. The new standard states that you must give me more than one "cause" for the noncompliance". That is when I did this I proceeded to tell my Mother that I believe that the ISO:9001:2008 standard was updated to say "causes" so that people will not only search for one "cause". If only one cause is found, which in this case it's simple oversight, why does she have to list several causes.

Because I've been out of the Quality business for a bit am I missing something? Or is their auditor correct in saying he will not accept just "one cause" to this noncompliance? I know that the standard says "Corrective actions shall be appropriate to the effects of the nonconformity encountered". That is what I told her to use back if they still made an issue.

Thank you for any help for this "rusty" QA mgr!

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Old 20th March 2010, 10:19 AM
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Re: Cl 8.5.2 Corrective Action - "Cause" vs. "Causes"

Quote:
In Reply to Parent Post by michelle8075 View Post

I was recently a Quality Manager for 8 years. About 8 months ago, I left the field and I am pursing another field (which I use my Quality background in more than one would ever realize!).

To shorten this question... My Mother works in a company and she was thrown into being the Quality Manager, and I try to answer and provide support to her questions as much as I can.

Recently she had an audit, where they listed a step in a procedure, but failed to describe how it was done. The auditor wrote up the minor. In doing that, the auditor said "When you write the noncompliance, do not just write one root cause. The new standard states that you must give me more than one "cause" for the noncompliance". That is when I did this I proceeded to tell my Mother that I believe that the ISO:9001:2008 standard was updated to say "causes" so that people will not only search for one "cause". If only one cause is found, which in this case it's simple oversight, why does she have to list several causes.

Because I've been out of the Quality business for a bit am I missing something? Or is their auditor correct in saying he will not accept just "one cause" to this noncompliance? I know that the standard says "Corrective actions shall be appropriate to the effects of the nonconformity encountered". That is what I told her to use back if they still made an issue.

Thank you for any help for this "rusty" QA mgr!
It's another case of an auditor not understanding the requirements. If your mother is confident that the cause of the problem has been identified and corrected, nothing more needs to be done.

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Old 20th March 2010, 10:49 AM
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Re: Cl 8.5.2 Corrective Action - "Cause" vs. "Causes"

Jim is right. The text of ISO 9001:2008 states causes (plural) to jive with nonconformities (also plural). But, in a corrective action exercise, the typical approach is to do root cause analysis towards the likely/probable cause. That is the one that needs addressing.

At the end of a root cause analysis, it is possible to end up with more than one probable cause for a failure. In that case, take corrective action on the most likely one, and, IF APPROPRIATE, deal with the other ones via a preventive action resolution. But that is not either required, nor the norm out there.

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Old 20th March 2010, 01:06 PM
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Re: Cl 8.5.2 Corrective Action - "Cause" vs. "Causes"

Jim and Sidney,
Thank you for your most helpful replies. I have printed this out for my Mother so she can read your replies.

Good to know that I'm not 100% rusty after all! I did not have the ISO-9001:2008 nor the sanctioned interpretations with me. She had some other OFI and findings that I said to. But I think I have given her enough information to use in the future.

Thanks again and enjoy your weekends!

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Old 20th March 2010, 02:22 PM
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Re: Cl 8.5.2 Corrective Action - "Cause" vs. "Causes"

The auditor is full of rubbish and I will say so out loud ... RUBBISH!, and your mother can say that I said so.

This is the type of requirement that goes with "all records must be in ink" and "all departments must have an objective"

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Old 20th March 2010, 03:36 PM
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Re: Cl 8.5.2 Corrective Action - "Cause" vs. "Causes"

Randy, I love it!

I did tell my Mother that the people on this site are fantastic and have way more experience in the Quality field than her auditor. I also said that I have always gotten top notch advice on here when I was in the QA field.

The auditor also tried to tell her that they had a problem with their "work environment clause" because he heard someone cough. It's cold and allergy season in these parts! What was somewhat funny to us was the fact that her company produces hazardous materials and they are so regulated by every other agency out there and have always passed with flying colors. So our joke was something like "Oh someone's coughing, guess the auditor wants more than the EPA!" LOL

But I will say, she's had the same auditor for a while, and there have been times where I armed her with rebuttals.... and also the auditor has provided some great feedback. Who knows what the auditor was thinking the other day. I'm clueless!

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Old 20th March 2010, 10:06 PM
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Re: Cl 8.5.2 Corrective Action - "Cause" vs. "Causes"

Here is some wonderful guidance for responding to audit nonconformances. It is from ANAB.

The audience is different, as it is guidance for a certification body in responding to nonconformances written against them by ANAB. It still fits registered companies responding to nonconformances written against them by their certification body, but it helps to pay attention to the labels of the parties involved. Some certification bodies have distributed this to their auditors as guidance.

Pay particular attention to 8.

"8. The root cause must focus on a single issue. a) If more than one root cause is identified, for instance training and inadequate work instructions, then two Corrective Action plans must be submitted."

http://www.anab.org/media/4600/hu137.pdf

I stress, this is guidance, not a requirement.
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Old 21st March 2010, 02:24 AM
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Re: Cl 8.5.2 Corrective Action - "Cause" vs. "Causes"

The reason ISO states "causes" not mean that "MUST" provide more than 1 cause, it means you can have more than one cause, not compulsory to have more than one causes.
No any NC be issued unless the auditor find out some another rootcause to be added in
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