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Struggling with Writing Effective Root Cause Statements

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Little Mary

#1
Recently went through audit to recertify to ISO 9001:2008/AS9100 Rev B. We struggle with writing effective root cause statements. Our first nonconformance was for NOT having an established system for flowing down customer requirements to purchasing and then on to supplier. We are a very small company and this information has always been communicated by email as well as noted on our production schedules. We thought the root cause of our NCR was that neither the customer service nor purchasing procedure gave guidelines on HOW to flow down the information. We stated that and we added purchasing to our work traveler and we added this step to our procedures. Our auditor told us that our root cause statements for all our NCRs were 'weak' and unacceptable. Auditor asked "WHY wasn't this information on our procedures." I am seriously at a loss for the next step in the WHY process. We have struggled with root cause statements for almost 4 years of ISO/AS certification. Why don't the registrars 'train' us in this mindset?:(
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Root Cause Statement

Welcome to the Cove! :bigwave:

Your registrars did not train you in root cause statements because they cannot do so and remain objective - they could be accused of consulting.

When I ask for root cause analysis and definition, I ask for the root cause AND an explanation of why the problem had not been noticed. This tends to go past the "Why don't you have it" and into the "Why didn't you develop it" question.

But you aren't off the hook. You have a quality management system that should have customer specific requirements, if any, as specifics in what needs to be done. I have seen laymen struggle for years to promulgate robust processes; they usually need some help from internal consultants such as the internal audit team and/or QA personnel. Has that ever happened?

I have also seen this effort require a number of iterations to get settled into what works best for all concerned.

Now for more bad news. Performing root cause analysis can be so challenging and subjective that it's difficult to tell if one is ever looking at the best one's people can do. Getting good root cause statements is one of my biggest challenges - and I work in a mature system. You are not alone.

But since your registrar has made note of the need, you can't just let it go by. Check out the related threads at the bottom of this screen, and also search the Cove's Post Attachments via the green Post Attachments List button in the header graphic. There are some presentations in there, and also discussions because this is a common subject.
 
#3
Some guidance on answering nonconformances can be found among the ANAB "Heads Up" documents.

http://www.anab.org/documents/heads-up.aspx

Find # 137.

Be aware that the intended audience is slightly different, but still very useful. Heads Up 137 is intended to provide guidance to certification bodies in responding to nonconformances written against them by ANAB. The information is still extremely useful.

The certification bodies are getting tougher on accepting poorly written nonconformances. That is because the accreditation bodies are getting tougher too. On the positive side, organizations like yours are getting better at determining effective resolutions. Better resolutions result in a smoother running quality management system.
 
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Bill Pflanz

#4
I freely admit that I do not do ISO work anymore, but do the auditors really expect a root cause on every nonconformance? I can understand requiring a corrective action on the immediate problem and certainly some type of review of whether it is a recurring problem. If it is a recurring problem than a root cause analysis would be needed to determine if there is a system problem.

Bill Pflanz
 
L

Little Mary

#6
Thank you so much for sending this link. It breaks down the steps in clear statements. I appreciate your help.
 
L

Little Mary

#7
Thank you so much for providing this link. It is helping to shape my mindset toward root cause analysis.
 

Marc

Captain Nice
Staff member
Admin
#8
I freely admit that I do not do ISO work anymore, but do the auditors really expect a root cause on every nonconformance? I can understand requiring a corrective action on the immediate problem and certainly some type of review of whether it is a recurring problem. If it is a recurring problem than a root cause analysis would be needed to determine if there is a system problem.
I'm in your camp. There is no way a company can do an exhaustive Root Cause Analysis for every nonconformance, and where a root cause analysis is not done, but the corrective action prevents a recurrence, I would say sufficient action has been taken. When I used to do implementations and this came up I took the position you describe.

I will add that in addition to a recurring problem there is also the severity of the effect of the nonconformance with respect to safety, monetary and some other aspects which may cause a full blown root cause analysis to be done on a single event nonconformance
 
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JaneB

#9
There is no way a company can do an exhaustive Root Cause Analysis for every nonconformance, and where a root cause analysis is not done, but the corrective action prevents a recurrence, I would say sufficient action has been taken. When I used to do implementations and this came up I took the position you describe.

I will add that in addition to a recurring problem there is also the severity of the effect of the nonconformance with respect to safety, monetary and some other aspects which may cause a full blown root cause analysis to be done on a single event nonconformance
Yes, very true. All excellent points, Marc.
 
L

Little Mary

#10
Thanks to Big Jim~This ANAB document has helped tremendously today to identify a root cause and write a clear concise root cause statement. Knowing what is expected of the auditors really helped to crystallize my perspective of the problem. Seems I had been overthinking it and making it more complicated than it was. Thanks so much for the tip!
 
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