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Does ISO/TS 16949:2009 require us to perform Final/Pre-dispatch Inspection?

A

AMIT BALLAL

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#1
#1
Hi,
I have a doubt, while SPC is in place with QMS- do we still need to perform Final/Pre-dispatch ispection ?
Is it required by ISO/TS 16949:2009 to perform final/Pre-dispatch ispection, while you are also performing SPC?

If it is mandatory in TS, can we reduce Sampling frequency as we are performing SPC?


Thanks,
Amit

100% inspection will guarantee trouble.!!!
-Dr.W.Edward Deming
 
Last edited:
QMS for Medical Device Companies
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Q

qusys

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#2
#2
AMIT BALLAL said:
Hi,
I have a doubt, while SPC is in place with QMS- do we still need to perform Final/Pre-dispatch ispection ?
Is it required by ISO/TS 16949:2009 to perform final/Pre-dispatch ispection, while you are also performing SPC?

If it is mandatory in TS, can we reduce Sampling frequency as we are performing SPC?


Thanks,
Amit

100% inspection will guarantee trouble.!!!
-Dr.W.Edward Deming
Click to expand...
TS does not oblige you to do it.
You should start from your process flow then proceed with FMEA and control plan . Final dispatch is however independent from SPC.
 
Ron Rompen

Ron Rompen

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#4
#4
Just to echo what everyone else has said, TS does not specify frequency of inspection, or at which stage you have to perform it. This is driven (mostly) by your own knowledge and understanding of your processes, and (in part) by your customers requirements.

Your inspection steps should be detailed in your Process Flow, PFMEA and Control Plan as a part of your PPAP submission. Any change to that (particularly a reduction or elimination of inspection, for whatever reason) needs to be discussed with and approved by your customer. Got caught on this during an audit a few years ago, and it still burns :)
 
A

AMIT BALLAL

Trusted Information Resource
#6
#6
Thank you all.....

I got answer to my question. as mentioned by Mr.Ron.

It depends on "What mention in our Control plans/PFD/FMEA- about at which stage we'll perform which inspection- with approval of customer."

:thanx:
 
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