Root Cause - Analysis and Defining - A/R against 8.2.2 Internal Audit

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lgoeke

I just completed our 9001:2000 renewal audit yesterday. The auditor wrote a A/R against 8.2.2 Internal Audit. The nonconformance was, no records requirement was listed in a document procedure. This is true and the corrective action is simple. However I am having a really hard time with the root cause.

The documented procedure in question has actually never been revised. It has been in place since the initial certification, long before my time here at the company. This is actually the second renewal audit the company has been through.

Does anyone have any suggestions for a root cause? I would really appreciate any help.
 
T

Ted Schmitt

Re: Root Cause-Analysis and Defining

I just completed our 9001:2000 renewal audit yesterday. The auditor wrote a A/R against 8.2.2 Internal Audit. The nonconformance was, no records requirement was listed in a document procedure. This is true and the corrective action is simple. However I am having a really hard time with the root cause.

The documented procedure in question has actually never been revised. It has been in place since the initial certification, long before my time here at the company. This is actually the second renewal audit the company has been through.

Does anyone have any suggestions for a root cause? I would really appreciate any help.

Either I am not understanding this right (or it´s just my opinion as an auditor), but I would not register this as an NC. What does it actually add to your QMS? To me it´s just a simple "oops, #*$&# I forgot to include it in the procedure".....

As for the root cause... Lack of attention by the author of the procedure in including all requirements of 8.2.2 in the procedure.
 

Stijloor

Leader
Super Moderator
Re: Root Cause-Analysis and Defining

I just completed our 9001:2000 renewal audit yesterday. The auditor wrote a A/R against 8.2.2 Internal Audit. The nonconformance was, no records requirement was listed in a document procedure. This is true and the corrective action is simple. However I am having a really hard time with the root cause.

The documented procedure in question has actually never been revised. It has been in place since the initial certification, long before my time here at the company. This is actually the second renewal audit the company has been through.

Does anyone have any suggestions for a root cause? I would really appreciate any help.

Don't get nightmares about this. Sometimes it is not even worth "searching" for the rootcause especially if the nonconformity is not systemic. It could be a simple oversight. Fix it and let it be.

Now, having said this, be aware that organizations do not always have defined/established criteria for reviewing NC's and deciding what course of action to take. So as a result, any NC, no matter how insignificant, is always treated/processed in the same manner. Could result in overkill and $$$ wasted.

Do you have criteria for NC review? It would help.

Stijloor.
 
L

lgoeke

Re: Root Cause-Analysis and Defining

We do not have a set criteria. Ours are all processed the same way.
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
I just completed our 9001:2000 renewal audit yesterday. The auditor wrote a A/R against 8.2.2 Internal Audit. The nonconformance was, no records requirement was listed in a document procedure. This is true and the corrective action is simple. However I am having a really hard time with the root cause.

The documented procedure in question has actually never been revised. It has been in place since the initial certification, long before my time here at the company. This is actually the second renewal audit the company has been through.

Does anyone have any suggestions for a root cause? I would really appreciate any help.

Why wasn't the records listed in a document?

Answer: Because there wasn't a document requiring them

Why wasn't there a document?

Answer: Because I didn't know it was required

Why didn't you know it was required?

Answer: Because I wasn't aware of the requirements.

Why weren't you aware of the requirements?

Answer: Because I lack proper training

Why did you lack proper training?

Answer: There was no training


Take it from here. Do you get what I am trying to say?

Use the simplest method to determine Root Cause, which would be the 5 Why's technique.
 
J

JaneB

The documented procedure in question has actually never been revised. It has been in place since the initial certification, long before my time here at the company. This is actually the second renewal audit the company has been through.

Does anyone have any suggestions for a root cause? I would really appreciate any help.

I tend to agree it sounds like a bit of an 'oops' rather than a serious NC. (But then, I wasn't the auditor.) I'm also having to guess that the 'lack of a records requirement' is related to records arising from internal audit - ie, that your procedure doesn't define what records should be kept/how?

Some of your answers are focused on 'you' whereas you say this situation predated your joining - the failure isn't in you, it's the system.

1.Sounds like the system doesn't include built-in review of procedures - any document that's still in place from 'long before' your time should have been reviewed. Any procedure should be reviewed at intervals, say mininum of annually (possibly 18 months in a smallish system).

2. Also sounds like the system lacks identification of records from internal audit in its records management procedures (to meet 4.2.4)

3. Lack of training?
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
Some of your answers are focused on 'you' whereas you say this situation predated your joining - the failure isn't in you, it's the system.

I was presenting a demonstration on the 5 Why's technique to the OP as an example of a 5 Why Analysis. These were my statements using what information I had from the OP.

Maybe the OP can perform it in the same way and there might be something different than what I would call Root Cause.

But using this technique it would reflect that the Training System/Process is the Root Cause.
 
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M

munagada

I see the root cause may be related to either Method or Man.

If it is method, you may not be having a PROPER document template with Record reference, so that you never forget to fill the Record reference coulumn.

If is is related to man, no wonder, it may be oversight, lack of interest or enthusiasm, lack of PROPER training.

Regards,
M Rama Krishna
 

AndyN

Moved On
It's simply not required to do a root cause analysis on every non-conformance!:nope:

Just go and fix it - it was a simple oversight - and the CB auditors were culpable too, if it's been missing that long!:yes:

Making up root causes just to satisfy an auditor doesn't make sense to me. And simply stating that something didn't get done is due to a lack of training is just inappropriate - 'jumping to conclusions' - not root cause!!

You are allowed to correct things, especially when the reason is right under your nose!:cool:

It might be worth taking a look, to confirm, that there aren't any other records missing, but don't make a witch hunt out of it!
 

Caster

An Early Cover
Trusted Information Resource
It's simply not required to do a root cause analysis on every non-conformance! Just go and fix it - it was a simple oversight It might be worth taking a look, to confirm, that there aren't any other records missing, but don't make a witch hunt out of it!

Thanks Andy, that was my thought as well, root cause it as error, just fix it and also do a quick check for 3 to 5 other required records to apply the lesson learned system wide and call it done.
 
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