Is special CA (Corrective Action) verification step necessary?

[psquared]

When a nonconforming condition is caught by an in process inspection designed to catch the specific nonconformity, is it necessary to add a separate verification step (to the process) in order be sure the condition is now corrected and in conformance?

I think the standard answer may be yes but lean thinkers ask why a lot. So WHY? I don’t see how it adds value- but it adds cost. Our system keeps the CA open until verified but generates an additional discrepancy report if the CA was ineffective. When inspection steps are in place, we would like to close out the discrepancy when the assignees claim the situation has been corrected.

An ISO consultant was assertive in getting us to add this step and all I see is waste. NCs are wasteful enough w/out additional NVA steps.

Thanks for your help, I don't post often but get lots of advice from the forum.

 

[Sidney Vianna]

Re: Is special CA verification step necessary

Since you placed this thread under the ISO 9001 forum, from a "standards" perspective, the answer is a no-brainer since the ISO 9001 document requires

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

From a common sense perspective, doesn't it make sense to assure that the previously non-conforming product is now within the specification?

Just like the original product realization process allowed a non-conforming product to be generated, so can the rework and repair processes.

 

[psquared]

Re: Is special CA verification step necessary

Thanks for the quick reply,

But if the inspection step that caught the non conformance is still in place, won't the same inspection step verify effectiveness. Can we state that as our verification process? Note: I am not talking about a system NC or something of grater scope than a mfg. process defect caught at the verification step.

 

[Sidney Vianna]

Re: Is special CA verification step necessary

But if the inspection step that caught the non conformance is still in place, won't the same inspection step verify effectiveness?

It should, in most cases. Unless the product was repaired, which might require a different verification criteria.

Can we state that as our verification process?

I don't see why not.

 

[Helmut Jilling]

...So WHY? I don’t see how it adds value- but it adds cost.

Our system keeps the CA open until verified but generates an additional discrepancy report if the CA was ineffective. When inspection steps are in place, we would like to close out the discrepancy when the assignees claim the situation has been corrected.

I think that is the root of your confusion. If you do a formal CA, the verification step is designed to stay open until demonstrated and verified to be effective, then it is closed. You are opening a second document if the first one was not effective. You are doing extra paperwork because you are using the CA process incorrectly.

 

[Bev D]

Helmut has it exactly: the original inspection step and CA from can - and should - be used for the verification. There is no need for a separate step or form.

to address the question about waste: all inspections are waste but the idea is to find the causes of the defects or nonconformities and eliminate or significantly reduce their occurence in order to eliminate the inspection or move to a reduced sample plan...

 

[Coury Ferguson]

Re: Is special CA verification step necessary

Thanks for the quick reply,

But if the inspection step that caught the non conformance is still in place, won't the same inspection step verify effectiveness. Can we state that as our verification process? Note: I am not talking about a system NC or something of grater scope than a mfg. process defect caught at the verification step.

Look at it from the Process view. Is there something deeper that may have caused the nonconformity in the process. The verification of the CA would include looking anywhere else in any processes. Is that not what the verification aspect is all about prevention and improvements?

I guess I am a little upset here. The verification process is one of the most important parts of an effective CAPA program.

 

[Jen Kirley]

I think Coury has raised a valid point. While the same inspection would indicate there are no more defects, the inspection doesn't tell you why no more defects occurred. Depending on the process/process step's complexity, particularly if not every part had the same defect, I would consider looking at the actual corrected process function to verify it is indeed preventing the defect.

I hope this makes sense.

 

[Bev D]

well it all depends on what the OP means by the initials "CA" What Helmut posted speaks to the correction (rework or repair) of a single defective part. This was my interpretation as well. If the situation being described is only correction of defective material then a resubmittal thru the initial inspection step is sufficient to ensure that the defect was indeed corrected and the part is now conforming.

If a corrective action was issued with the intent of determining cause and preventing future defective product for that defect type, then yes a separate verifiaction action is required to determine if the corrective action was effective: was it implemented as intended and did it work? this is indeed a different step/process than merely allowing parts to move thru the inspection step and not get rejected

 

[Sidney Vianna]

all inspections are waste but the idea is to find the causes of the defects or nonconformities and eliminate or significantly reduce their occurence in order to eliminate the inspection or move to a reduced sample plan...

The second part of this sentence negates the first one. I don't think that all inspections are wasted efforts. In addition to identify failure modes, inspections should provide confidence in the product integrity. I agree that the ultimate goal is to eliminate inspection through making the product realization processes very robust. But until we reach a process maturity high enough to forgo inspection, we should use inspection as a value added activity to confirm the process improvements in eliminating defects.

Concerning this thread: Between the editing done by the OP to the original post and the editing done to the title of the thread, by a moderator, I am not sure what we are aiming at, anymore.