Can NonConformance (NC) be raised against Effectiveness? (Ineffectiveness)

[Bill Pflanz]

Re: Can NonConformance (NC) be raised against Effectiveness?

It appears to me that a finding concerning effectiveness is a weak effort on the part of the auditor. If no nonconformances are found then, based on the sample taken, the system would not be ineffective. If nonconformances are found, then the auditors should make the nonconformances the findings not ineffectiveness. Then management can not only take corrective action but also the review the system for effectiveness. If an auditor cannot find any nonconformances but does not feel comfortable that the system is effective or has the potential to be ineffective that is an opinion and should be written as an observation.

Bill Pflanz

 

[Randy]

Re: Can NonConformance (NC) be raised against Effectiveness?

I violently agree with Randy on this!

Oh Cliff, my kind of dude...violent

 

[Geoff Withnell]

Re: Can NonConformance (NC) be raised against Effectiveness?

Even in this example, you would probably want to tread lightly. Here's a real-life situation:

An organization has been led to believe that every instance of nonconforming product requires a corrective action. Dutifully they have issued corrective actions against each nonconforming batch of product. The CARs have been closed as the nonconforming product has been reworked and various fixes applied to the production process.

The real problem is that the underlying process isn't/has never been stable and no one really knows why. It's a hard problem.

I would propose that an NC would not be appropriate in this situation.

I would beg to differ, and NC would be very appropriate in this situation. The point to corrective action is to correct the root cause of the nonconformance. In the example you describe, the root cause of the nonconformance is the instability of the process, and until someone knows why it is unstable, and fixes the problem, the CA should remain open. Another option is to document that this process produces Defect X at Y percentage, and subprocess Z has been put in place to prevent defect delivery to the customer; and correction has been deemed uneconomic or beyond the state of the art. At which point you stop doing CAs unless the defect rate exceeds Y%.
Short of officially deciding that the nonconformance is beyond hope, which should be an extremely rare occurance, the CAs should not be closed "as the nonconforming product has been reworked and various fixes applied to the production process." but when the fixes have been shown to be effective, which apparently has never happened, so the first CA should still be open.

BTW, "hard problems" are why I oppose set time frames for all CAs (often 6 months) to be closed. Time lines for closure should be both flexible depending on complexity of the issue and changeble, depending on the complexity of the solution. Infrequent but serious nonconformances may need a year or more for validation of the solution. Complex solutions requireing capital investment make take years to implement.

Geoff Withnell

 

[AndyN]

Re: Can NonConformance (NC) be raised against Effectiveness?

Geoff:
There's no indication of what's been found to be causing the ineffectiveness, so how can CA be initiated?

 

[Geoff Withnell]

Re: Can NonConformance (NC) be raised against Effectiveness?

Geoff:
There's no indication of what's been found to be causing the ineffectiveness, so how can CA be initiated?

Cause is something found during the CA process. It is often unknown until investigation is done. Corrective action is not just the fixing of the nonconformance, but the elimination of the root cause.

Geoff Withnell

 

[AndyN]

Re: Can NonConformance (NC) be raised against Effectiveness?

Cause is something found during the CA process. It is often unknown until investigation is done. Corrective action is not just the fixing of the nonconformance, but the elimination of the root cause.

Geoff Withnell

True, Geoff, but without clear qualitative and quantitative audit evidence, corrective action (or even simple correction) can't/won't happen. This is at the 'root' (no pun intended) of why so many people don't take audit findings seriously - there's little or nothing substantial to get them excited about doing anything!
For any (internal) auditor to simply say, "the process is ineffective" is unhelpful and inappropriate. The external auditors should do it even less! As Randy said earlier, it's just an opinion and is bogus, too!

 

[Geoff Withnell]

Re: Can NonConformance (NC) be raised against Effectiveness?

True, Geoff, but without clear qualitative and quantitative audit evidence, corrective action (or even simple correction) can't/won't happen. This is at the 'root' (no pun intended) of why so many people don't take audit findings seriously - there's little or nothing substantial to get them excited about doing anything!
For any (internal) auditor to simply say, "the process is ineffective" is unhelpful and inappropriate. The external auditors should do it even less! As Randy said earlier, it's just an opinion and is bogus, too!

I was responding to CliffK's example, with repetitive "fixes". A string of CAs against a process, with nonconformances continuing after they have been closed, would certainly in my mind constitute more than sufficient evidence of the CA system being ineffective. The desired "effect" of the CA system is the elimination or reduction of the occurance of nonconformances. Since that effect has not been achieved, the system is "ineffective". What more evidence would you want?

Geoff Withnell

 

[CliffK]

Re: Can NonConformance (NC) be raised against Effectiveness?

I was responding to CliffK's example, with repetitive "fixes". A string of CAs against a process, with nonconformances continuing after they have been closed, would certainly in my mind constitute more than sufficient evidence of the CA system being ineffective. The desired "effect" of the CA system is the elimination or reduction of the occurance of nonconformances. Since that effect has not been achieved, the system is "ineffective". What more evidence would you want?

Geoff Withnell

Perhaps I could have been more clear. The nonconformances did not continue after the CA's were closed. They reappeared, sometimes after as long as six or eight weeks after, to all evidence, they had been resolved.

Of course we all know that to demonstrate the cause of a condition, you should be able to turn the condition on and off by adding and removing your cause. In this case, though, the lab can't duplicate the problem and the organization certainly isn't going to experiment on a production batch.

What I don't see is how an NC against the corrective action program is going to lead to improvement. What would you expect the organization to do?

 

[pinpin - 2009]

Re: Can NonConformance (NC) be raised against Effectiveness?

I wouldnt raise an NC on effectiveness.

If the company has an objective which is being measured against and the company failed to meet that objective then yes it is ineffective, but if this is reviewed at management level and actions are proposed to correct this then the system is working.

If there are no actions to improve, or no review then it is this part of the system that is failing and warrants the NC.

I say you need to audit the system, not the outcome - does the company have a system of objectives, review and actions ?

I would like to say a million thanks to all of you here!

IMO I agree that auditor should not raise NC against effectiveness in the manner I quoted. Sorry that I cannot provide you with exact wordings here to prevent hurting the auditor or being sued...will I be sued? I am worry....

I will try to provide the NCs quoted provided I will not have problem...any suggestion?

Throughout ISO/TS clauses, I could not identify any requriements that enable auditor to raise NC as such. I only find requirements such as:
1) 5.6.1: to review the qms ...to ensure it is.... and effective,
2) 6.3.1: evaluate and monitor effectiveness of existing operations
3) 8.1 c and 8.5.1: to continually improve the effectiveness of the qms
4) 8.2.2 b: is effectively implemented and maintained
5) 8.2.2.2: audit each manufacturiing process to determine its effectiveness

I think auditor should not raise NC in this manner " the corrective action taken is not effective" (of course with the case particulars mentioned specifically in the NC Report). Why? Because ISO/TS Standard does not provide specific clauses that afford auditor the right to do so. Auditor can only raise NC against ineffectiveness of actions taken under Clause 8.5.2 "corrective action shall be appropriate to the effects of the nonconformities encountered". This is similar to 8.5.3's preventive action. Am I not right?

 

[M Greenaway]

Re: Can NonConformance (NC) be raised against Effectiveness?

Having read the posts so far my opinion is hardening even more that the word 'effective' should not be used in an audit NC.

If CA is not working, rather than say the CA is ineffective its more like that there was no CA, that is a better sounding NC - I would tread very carefully here also though as unless the auditor intimately knows the process how can he determine that the root cause originally CA'd is the root cause of the new occurrence ? Also as audits generally do not use any statistical sampling methodology, claiming ineffectiveness on the basis of one or two samples seen during audit could be wildly inaccurate.