CAPA (Corrective Action and Preventive Action) after Correction always?

[QAMTY]

Hello everybody

I want to ensure that after a Correction
a CA/PA must be implemented.

ON where document should I include this statement?

On the NCR, CA/PA, or in the Claim and complaint
procedure?

But still have doubt in this issue.

For example when a NC, appears
and disposition is "use it as is", then,this is fixed
but is not eliminated the root cause.
Then in this case a CA/PA is needed in my opinion.

But if disposition is Scrap, then this part/equipment
is replaced for a new one.

In here I suupose is not needed a CA/PA
is it correct my assumption?

Should I then, that CA/PA is needed only in
disposition like Use it as is, Rework, Repair
and not needed when disposition is Degrade and scrap?

Please help me in clarifying this.

Thanks

 

[samsung]

Re: CA/PA after Correction always?

But if disposition is Scrap, then this part/equipment
is replaced for a new one.

In here I suupose is not needed a CA/PA
is it correct my assumption?

Still you need to find out the root cause of the problem as to how & why it happened and take CA as appropriate. You take corrective actions on the root cause of the problem encountered, not on the nonconforming product which you have already decided to scrap.

Nonconformance and nonconforming product are two separate things although it's the former that results into the NC product.

 

[somashekar]

Re: CA/PA after Correction always?

Hello everybody

I want to ensure that after a Correction
a CA/PA must be implemented.

ON where document should I include this statement? <snip>

Hi, This is a very common place where clarity gets missed. You have to be very clear about what you will do to control a NC product as said in 8.3. This is to prevent the unintended use or delivery.
Having done this you will most probably get data about :
1. Non-conformity of product to requirements
2. Characteristics and trends of processes and products
You have to analyse this data and where you find that the NC data or the characteristics and trends show lack of suitable and effective realization processes against your set objectives as said in 8.4, then you have to take up corrective actions to detect the root cause and eliminate the detected cause of nonconformity so as to prevent further occurance, as said in 8.5.2. thereby able to meet your set objectives going forward.
Please note that :
Corrective actions shall be appropriate to the effects of the nonconformities encountered

Now to help you further:
If your yield target is 97% and you find 1% visual defects that you take a decision to use "as is" and you find another 1% scrap that you replace with good products, you have data to analyse and see that you are still meeting the target. See what you can do by any means to maintain or improve your performance, but if you happen to get 1% visual defects and 5% scrap than you may have to take up a formal CA/PA to find the root cause of the 5% scrap and then take actions to eliminate.

 

[Bev D]

succinctly: not all nonconformances (product or process) require Corrective action. In many cases correction is sufficient.

 

[QAMTY]

Thanks Bev D

So I think that it depends on the NC, ok?
We should define what applies for CAPA.

Doesn´t ISO states is a must
a CAPA after a correction?


THanks

 

[Bev D]

Doesn´t ISO states is a must
a CAPA after a correction?

NO it doesn't. Read it again.
try to find where YOU think it says to utilize Corrective Action whenever a correction occurs...

 

[tbsiva]

Hello Bev D - Can u tell us an example where you will only do only correction, but no CA/PA??

 

[atitheya]

.......

Doesn´t ISO states is a must
a CAPA after a correction?


THanks

Answer to this question is in ISO9001:2008 '8.5.2 c) evaluating the need for action to ensure that nonconformities do not recur.'

Take a corrective action, where required, for effectiveness and improvement of your system.

I am in agreement with Mr Somashekhar and will like to add that his post be read adding this clause.

 

[Bev D]

Hello Bev D - Can u tell us an example where you will only do only correction, but no CA/PA??

sure: most of our customer "complaints" are simply corrected, either we walk them thru a solution, replace their product or return and repair their product.

Most of our test and inspection failures are simply reworked. Any components removed are placed in MRB ("NCR") for disposition of the part.

We do not issue corrective actions for every nonconformance.

We DO trend and track our complaints, failures, NCR material etc. and we launch improvement projects (Corrective actions) for the highest impact Problems.

 

[ChrissieO]

sure: most of our customer "complaints" ar esimply corrected, either we walk them thru a solution, replace their product or return and repair their product.

Most of our test and inspection failures are simply reworked. Any components removed are placed in MRB ("NCR") for disposition of the part.

We do not issue corrective actions for every nonconformance.

We DO trend and track our complaints, failures, NCR material etc. and we launch improvement projects (Corrective actions) for the highest impact Problems.

IMHO you haven't addressed CA only applied the sticking plaster (bandaid). After this has been done you then need to look at route cause and implement your CA.

PA doesn't come into this scenario as something has already gone wrong. PA is applicable when controls/improvements have been identified before the non conformance.

Chrissie