Nonconformance on the Corrective Action Process - Audit Finding

[Pam11]

I really need help.

We just went through a ISO/TS 16949:2009 audit (external). We have been written a nonconformance on how are corrective actions have been answered. Exact wording of the auditor below:

Nonconformity: The process to ensure that a corrective action reports are completed to address systemic issues was found to be ineffective.

Requirement: The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. This should include determining the cause, implementing action needed, recording the results and reviewing the effectiveness of the corrective action taken.

Now my confusion, is I know what the problem is and how to answer the corrective actions in future. But I don't know how to answer this nonconformance to the auditor. I must submit action plan by end of next week and than solid proof that implementation and verification by end of Jan.

Can some one please help me how to tackle this nonconformances. I have some ideas but am not sure.
Thanks
Pam

 

[AndyN]

Re: Nonconformance on the Corrective Action Process.

I really need help.

We just went through a ISO/TS 16949:2009 audit (external). We have been written a nonconformance on how are corrective actions have been answered. Exact wording of the auditor below:

Nonconformity: The process to ensure that a corrective action reports are completed to address systemic issues was found to be ineffective.

Requirement: The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. This should include determining the cause, implementing action needed, recording the results and reviewing the effectiveness of the corrective action taken.

Now my confusion, is I know what the problem is and how to answer the corrective actions in future. But I don't know how to answer this nonconformance to the auditor. I must submit action plan by end of next week and than solid proof that implementation and verification by end of Jan.

Can some one please help me how to tackle this nonconformances. I have some ideas but am not sure.
Thanks
Pam

Welcome to the Cove! How's "Winterpeg"?

Firstly, what was the evidence? I don;t see any mention of any evidence here, and without such evidence, there's no no-conformity! If this was all the auditor wrote, you should first seek the evidence (unless you actually saw what they reported on). It's actually a requirement of the TS rules that they provide such details.

Secondly, your auditor should have left you with half a clue as to how to respond. Each CB has their own requirements, so check with your agreement/contract - it should be spelled out. If not, call your representative and ask them. Next time, please don't let the auditor leave without a) giving you evidence in their report, and b) what their required actions are!

 

[qusys]

I really need help.

We just went through a ISO/TS 16949:2009 audit (external). We have been written a nonconformance on how are corrective actions have been answered. Exact wording of the auditor below:

Nonconformity: The process to ensure that a corrective action reports are completed to address systemic issues was found to be ineffective.

Requirement: The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. This should include determining the cause, implementing action needed, recording the results and reviewing the effectiveness of the corrective action taken.

Now my confusion, is I know what the problem is and how to answer the corrective actions in future. But I don't know how to answer this nonconformance to the auditor. I must submit action plan by end of next week and than solid proof that implementation and verification by end of Jan.

Can some one please help me how to tackle this nonconformances. I have some ideas but am not sure.
Thanks
Pam

Hi Pam,
welcome on the forum!
Agree with AndyN.
This non conformity looks too "academic" and it is not supported by the evidence that violeted the clause concerning with the corrective actions.
We needs more details about the dynamic of the audit, the evidences showed and what the auditor elicited as proof of the non conformity.
Did he/she refer to the cloure of the non conformities coming from the internal audit or what else? Did he/she find something about the non conformities in your production line that were not dealt in compliance with your documented procedure of corrective actions? Where did the auditor catch the evidence of the non conformity?
However, I would also like to propose an interpretation of mine about the statement of the non conformity: the auditor refers to a process of the corrective action. It seems to me that it is not properly correct, just because corrective action mgmt could not be seen as a process but more like an activity spread across all over the organization that is regulated by a documented procedure.
If you provide more details, we could better understand and probably have a larger overview of the happened facts.
Good week end for Thanksgiving day!!!

 

[Pam11]

Re: Nonconformance on the Corrective Action Process.

Winterpeg is good it is +6 today...

Yes she did leave Evidence:
Evidence: Sampled corrective action report showed poor root cause anaylsis and systemic corrective actions were not defined and implemented. Example -XXX 7D#XXXX. Also this is example of company accepting corrective action responses from cina which are not addressing the true root cause and using this response to communicate correctve action to the final custmer.

Only Clue she left was I better see sold proof that you guys are doing your corrective actions that resolve he systemic issue.
Where did the system fail.

 

[qusys]

Re: Nonconformance on the Corrective Action Process.

Winterpeg is good it is +6 today...

Yes she did leave Evidence:
Evidence: Sampled corrective action report showed poor root cause anaylsis and systemic corrective actions were not defined and implemented. Example -XXX 7D#XXXX. Also this is example of company accepting corrective action responses from cina which are not addressing the true root cause and using this response to communicate correctve action to the final custmer.

Only Clue she left was I better see sold proof that you guys are doing your corrective actions that resolve he systemic issue.
Where did the system fail.

Thanks for replying.
I would interpret that this document is corrective action requeste versus a supplier of yours, correct?
If so, do you use to trasmit an 8D report to your supplier in case of non conformity provoked by it? If you use a problem solving method also for this kind of issue, the supplier will be facilitate to provide a more systematic response. This is also included in the supplier development to be compliant with ISO TS.
What kind of acitivity do you have in place to examine and eventually accept the supplier's actions for a non conformity? Do you have a multidisciplinary team with competences and skills to evaluate it or the responsibility resides on an unique person? In brief, how do you ensure the "quality" of the response?
Probably , this is a guess of mine, the auditor saw a root cause but the corrective action was not in line with the most probable cause identified.
Pleas, let us know if this assumptions are correct.

 

[Big Jim]

The ANAB Head's Up 137 (can be found on the ANAB site) provides wonderful guidance on how to answer audit nonconformances. Be aware that it is addressed to certification bodies, but as long as you are aware that the audience is slightly different you should have little trouble applying it to yourself.

So let's quickly walk through this.

You nonconformance is that you have an ineffective corrective action program, at least in practice.

There are three main things you need to do to properly address it.

Correction
Root Cause Analysis
Corrective Action

Each are different and cannot repeat themselves in your response. Be careful that your corrective action is not a repeat of the correction and be careful that your root cause analysis is not a repeat of the nonconformance statement.

Correction = action to overcome a nonconformance (as defined in ISO 9000)

Corrective Action = action to overcome the CAUSE of a nonconformance (as defined in ISO 9000.

Correction also often includes containment (often the two terms are interchanged).

So what have you done to contain the situation? Did you go back and redo the nonconformance responses that triggered the issue?

Have you determined why you did a poor job of handling nonconformance responses? Did you dig deep enough the truly get to the root of it? Perhaps the cause was inadequate knowledge of how to create robust responses.

If inadequate knowledge was the root cause, what will you do to overcome the inadequate knowledge? Take a class? Study ANAB's Heads Up 137? Reviewed the requirements of element 8.2.3 more deeply to understand the need for robust responses?

I hope you see the pattern. The exact responses depend on what you really did (or will do).

1) You contained or will contain (with an action plan) the problem.

2) You determined the true root cause, not a superficial or contributing cause, but the root cause.

3) You have or will overcome (with an action plan) the cause so that it will not recur.

 

[AndyN]

Re: Nonconformance on the Corrective Action Process.

Winterpeg is good it is +6 today...

Yes she did leave Evidence:
Evidence: Sampled corrective action report showed poor root cause anaylsis and systemic corrective actions were not defined and implemented. Example -XXX 7D#XXXX. Also this is example of company accepting corrective action responses from cina which are not addressing the true root cause and using this response to communicate correctve action to the final custmer.

Only Clue she left was I better see solid proof that you guys are doing your corrective actions that resolve the systemic issue.
Where did the system fail.

On the basis on ONE corrective action, they are writing you up for a SYSTEM problem? I sincerely hope not! I still don;t see the evidence that the action was ineffective! All I read is that (apparently) the actions weren't defined or implemented - if I were your management I'd be totally confused...

The comment is less than helpful and I'd suggest that you complain to your CB about the lack of clear direction as to expectations for resolution, even if you did have a real NC to deal with...

I'd suggest you take it up with your CB's management...

 

[Big Jim]

Re: Nonconformance on the Corrective Action Process.

On the basis on ONE corrective action, they are writing you up for a SYSTEM problem? I sincerely hope not! I still don;t see the evidence that the action was ineffective! All I read is that (apparently) the actions weren't defined or implemented - if I were your management I'd be totally confused...

The comment is less than helpful and I'd suggest that you complain to your CB about the lack of clear direction as to expectations for resolution, even if you did have a real NC to deal with...

I'd suggest you take it up with your CB's management...

Andy,

I disagree. It is clearly written that their execution is weak so that problems are not fully resolved. It doesn't look like she will get far on an appeal, and that isn't what she is looking for. She is looking for help on responding to this particular nonconformance. It looks like she know what she needs to do in the future.

Do you have any advice on how to respond to this one? That is what she is after.

 

[AndyN]

Re: Nonconformance on the Corrective Action Process.

Andy,

I disagree. It is clearly written that their execution is weak so that problems are not fully resolved. It doesn't look like she will get far on an appeal, and that isn't what whe is looking for. She is looking for help on responding to this particular nonconformance. It looks like she know what she needs to do in the future.

Do you have any advice on how to respond to this one? That is what she is after.

Are you saying, Jim, that as a practicing CB auditor you find ONE example and write non-conformity reports without any evidence? 'Poor' is a subjective assessment... I see NOTHING reported (if the OP has been accurate with the report) on what portions of the 7D were 'poor' - at least the report should contain some paraphrasing of what was recorded. How you can come to a conclusion on how to help the OP fix this, without knowing the whole story baffles me.

 

[Big Jim]

Re: Nonconformance on the Corrective Action Process.

Are you saying, Jim, that as a practicing CB auditor you find ONE example and write non-conformity reports without any evidence? 'Poor' is a subjective assessment... I see NOTHING reported (if the OP has been accurate with the report) on what portions of the 7D were 'poor' - at least the report should contain some paraphrasing of what was recorded. How you can come to a conclusion on how to help the OP fix this, without knowing the whole story baffles me.

Post #4 from the OP, Pam, says that objective evidence was provided.

I would agree that there is probably more than the few words she reported, but she seems to be aware of it. She certainly knows more about the responses that the auditor found than has been relayed to us.

But that isn't the point. She asked for help on how to respond although she already knows what had to change in the company's practice.

If you want to review the totality of the NCR, then ask Pam to provide everything, so you will be better informed in providing advice that goes beyond what she is seeking.

I'm not opposed to that approach, but it is more than she asked for.