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What should be Audited in a Product Audit

A

ajay.khosla

#11
#11
What do you do if you select a lot at the warehouse before shipping? For this you can separately perform dock audit. Just select a lot before shipping and check the product's critical parameters. You don't have to put all the parameters, just pick some important parameters which will affect the functioning of the product.
 
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Q

qusys

Trusted Information Resource
#12
#12
ajay.khosla said:
What do you do if you select a lot at the warehouse before shipping? For this you can separately perform dock audit. Just select a lot before shipping and check the product's critical parameters. You don't have to put all the parameters, just pick some important parameters which will affect the functioning of the product.
Click to expand...
Thks a lot.
I try to apply the clause of the standards that also deals with packeging and labelling.
In the production line I will check if control plan have all control and that the reaction mechanisms have been applied according to specs, for example.
However this is just done during process internal audit.
In my opinion in the semiconductor environment it is very difficult to perform product audit, in the sense that it is not beneficial to the organization.
There are a lot of functional tests before shipping and in case of problem the material is stopped before shipping and segregated.
In the production line there are many measurement ( for example measurement of thickness and critical dimension) and check steps ( for example control of defects) and in case of issue the lot is stopped for engineering decision based upon the statistical process control.
In semiconductor environment probably probably process audit and product audit can be combined, but the external auditors do not like this. They want to have them separated.
On the shipping process, it is easier because there is a check vs procedures for labelling , packaging before the delivery vs the external.But this dock audit can cover only a part of the product audit.
Thought on this? Any experience and example from semicondictor factories?
 
A

ajay.khosla

#13
#13
I dont know anything about semiconductor business.
But let me tell you what i would have done if i would have been there at your place.
First of all, i would have made a plan for SPC study differently like if i have 24 parts in my firm then i would have put 2 parts(like 11044 or say 11065)in each month and acording to the plan would have started doing SPC study.Now, the thing is this it will help you to make the process stable slowly and slowly.If only this will be done honestly,a stage will come where you will not need to stop the lot for engineering decision based upon the statistical process control.
Now.after this,i would have made formats for process audits for every part and would have started doing audits.
Now for the product audit in semiconductor industry,i would have made a combined format like product cum dock audit and would have put all the necessary things in the format which would affect the functionality of product and also, the packaging details.Now, i would have put only those parameters in this format which are very very necessary to be checked not all the product parameters coz you said its very difficult to check all the product parameters which are there in control plan in a semiconductor industry.
I hope this helps.
 
Q

qusys

Trusted Information Resource
#14
#14
ajay.khosla said:
I dont know anything about semiconductor business.
But let me tell you what i would have done if i would have been there at your place.
First of all, i would have made a plan for SPC study differently like if i have 24 parts in my firm then i would have put 2 parts(like 11044 or say 11065)in each month and acording to the plan would have started doing SPC study.Now, the thing is this it will help you to make the process stable slowly and slowly.If only this will be done honestly,a stage will come where you will not need to stop the lot for engineering decision based upon the statistical process control.
Now.after this,i would have made formats for process audits for every part and would have started doing audits.
Now for the product audit in semiconductor industry,i would have made a combined format like product cum dock audit and would have put all the necessary things in the format which would affect the functionality of product and also, the packaging details.Now, i would have put only those parameters in this format which are very very necessary to be checked not all the product parameters coz you said its very difficult to check all the product parameters which are there in control plan in a semiconductor industry.
I hope this helps.
Click to expand...
Understood your point.
Keep in mind that 100% of the material is probed with specific test program and in case of problem the affected material is stopped for quality decision.
Before probing , there are many parametric test that check for goodness of the material.
Said that, i think it is unusefull to perform product audit , for the production line, given that all is controlled by ad hoc program.
We do process audit checking for control plan and reaction mechanism for material in general, but we do not focus on specific lot ( in the backwards sense). :bigwave:
 
C

Citizen Kane

#15
#15
Hi !

For the product audit your refference that you must follow is the Control Plan - the processes in withc you add value on the line. WRH and/or shipping is not manadatory. We stop at packaging station (of course, including la labeling and final check)
 
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