ISO 9001 Certification Nonconformance Root Cause Help!

[earthboundmisfit82]

Re: ISO Certification Nonconformance Root Cause Help!

Our auditor takes corrective actions very seriously. For each nonconformance he was us to do a full "investigation" if you will. He said he would not accept our CARs without a full detailed root cause analysis. As a whole, we have an effective QMS with well-written procedures and work instructions. How we as a company failed to include any mention of purchased NCM in our procedure is truly beyond me.

 

[Jim Wynne]

Re: ISO Certification Nonconformance Root Cause Help!

I've never posted before so thanks everyone in advance for the help!

We recently had our stage 2 audit. We only had 3 minor nonconformances. I have no problems with corrective actions for two of them. However, I'm struggling to come up with a root cause for the one NC. Here's the nonconformance: "Although, there are processes in place, there is no evidence of procedural requirements for controlling nonconforming purchased product". I know exactly why this was written up. I had completely forgotten to include purchased product in my NCM procedure. I don't know how I missed it! At any rate, what in the world would the root cause for something like this be? The truth is, I simply forgot. However, I don't think our auditor will go for that.
Any insight???

It's always helpful to include the complete nonconformity statement, including the auditor's reference to the relevant requirement(s) in the standard. There is no requirement to specifically address the handling of nonconforming purchased product. 7.4.3 establishes requirements for verification of purchased product but doesn't mention nonconforming product, and 8.3 is about control of nonconforming product but doesn't address purchased product specifically. If you have a documented procedure (and process) that addresses the requirements in 8.3, and you handle nonconforming purchased material in accordance with it, there is no nonconformity that I can see.

Of course, there may be things that we can't see, such as a process for handling returns to suppliers, asking for corrective action, etc. that the auditor saw in place but saw no documented requirements for them. It could be that the auditor cited (or had in mind) 4.2.1(d) where ..."documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes..." are required. In order for this to result in a nonconformity, there would have to be evidence that your company determined that documentation for control of nonconforming purchased product was necessary but it didn't exist.

In any event, because you acknowledge that the omission was unintentional, the best thing to do is correct the situation and notify the CB of how it was corrected. As others have already suggested, root cause analysis shouldn't be required or considered helpful.

 

[Jim Wynne]

Re: ISO Certification Nonconformance Root Cause Help!

Our auditor takes corrective actions very seriously. For each nonconformance he was us to do a full "investigation" if you will. He said he would not accept our CARs without a full detailed root cause analysis. As a whole, we have an effective QMS with well-written procedures and work instructions. How we as a company failed to include any mention of purchased NCM in our procedure is truly beyond me.

If your auditor (and by that I assume you mean your CB) won't accept a simple, straightforward explanation, you should consider getting a different auditor or CB. The idea of corrective action is (a) correct the immediate problem and (b) prevent similar occurrences in the future. In order for there to be recurrence of this problem, you would have to start the registration process over again from scratch, so taking measures to prevent recurrence, or doing a big investigation is just a waste of everyone's time. Never allow an auditor to waste your time.

 

[qusys]

Re: ISO Certification Nonconformance Root Cause Help!

Our auditor takes corrective actions very seriously. For each nonconformance he was us to do a full "investigation" if you will. He said he would not accept our CARs without a full detailed root cause analysis. As a whole, we have an effective QMS with well-written procedures and work instructions. How we as a company failed to include any mention of purchased NCM in our procedure is truly beyond me.

I advice you to put in place a process to fix root cause, not for pleasing the registrar auditor, but to gain benefit from your organization.
Said that, you could think about Ishikawa diagram (cause and effect analysis) to do in multi-disciplinary approach.
I have understood that the auditor did not have problem in understanding that there is a process in place when you do a non conforming in purchased product, but probably your organization underestimeed this in the mandatory procedure.
My question for you is this and you can reflect with your organization: is there in place a process approach in managing non conforming product? is there a process owner for this? If so, why wasn't it possible to reveal the fault in the procedure? Was the procedure prepared by yourself only?
I think that you can contain making the updating of this procedure, but corrective action should be more in depth based upon a clear examination from your organization.hope this helps

 

[AndyN]

Re: ISO Certification Nonconformance Root Cause Help!

Thanks, Jim - your answers are the most appropriate, well reasoned and practical advise, given the reported situation! Thanks for the clarity.

 

[earthboundmisfit82]

Re: ISO Certification Nonconformance Root Cause Help!

Thanks to everyone who answered.
Everyone has excellent answers and I appreciate the insight.

 

[Groo3]

Re: ISO Certification Nonconformance Root Cause Help!

I think Jim Wynne explains it nicely...

For the corrective action piece, it can be helpful if you have more than one internal expert to help in the review and approval of the procedures. Thankfully, for my site, we have several individuals, each with at least 8 + years of experience with ISO requirements (a couple of us each have 15 + years experience with ISO QMS standards). When I need a hand with some major procedures, or re-writes to some key documents, I always ask one or more of these individuals to serve as a reviewer / approver. There is no guarantee that 100% of the time, they will all do an effective job in reviewing the documents I send them, but with a couple others looking to make sure our documents say what they should, it's a very rare day when requirements get overlooked. Two heads are sometimes better than one.

As for the root cause analysis, I think of the Blues Brothers movie where Jake Blues is confronted for missing his wedding and his fiance wants to know the "root" cause "... I ran out of gas. I, I had a flat tire. I didn't have enough money for cab fare. My tux didn't come back from the cleaners. An old friend came in from out of town. Someone stole my car. There was an earthquake. A terrible flood. Locusts. IT WASN'T MY FAULT, I SWEAR TO GOD."
Root cause = my bad, sorry.

 

[Bill Pflanz]

Re: ISO Certification Nonconformance Root Cause Help!

Our auditor takes corrective actions very seriously. For each nonconformance he was us to do a full "investigation" if you will. He said he would not accept our CARs without a full detailed root cause analysis. As a whole, we have an effective QMS with well-written procedures and work instructions.

It looks like you have received the appropriate advice for responding to the nonconformance. There is no need for a full investigation but sometimes you find auditors who have their own interpretation of CAR. If the auditor insists on more than we have recommended you may have to go directly to the registar to resolve it. Let us know if the auditor objects and we can help you again.

Bill Pflanz

 

[qusys]

Re: ISO Certification Nonconformance Root Cause Help!

It looks like you have received the appropriate advice for responding to the nonconformance. There is no need for a full investigation but sometimes you find auditors who have their own interpretation of CAR. If the auditor insists on more than we have recommended you may have to go directly to the registar to resolve it. Let us know if the auditor objects and we can help you again.

Bill Pflanz

Agree. I tried to give some help. It could be beneficial to know the clause vs which the non conformity was raised up.

 

[harry]

This kind of issue should had been discovered during the stage 1 audit (adequacy check). If the CB can overlook, why not you? After all, they are the expert and you are the novice. I had seen it happening before and a correction is acceptable.