Process and Part Qualifications - Automotive Industry and Consumer Electronics

[QE]

Dear Coves

I am a QE in medical device manufacturing and wonder what would be the approach of validations in automotive industry and consumer electronics.

I am familiar to the part qualifications - PPAP in the Automotive Industry and
For process qualification - IQ, OQ and PQs in medical device.

Kindly advise what will be the approaches in the auto industry for product and process validations ?

QE.

 

[Stijloor]

Can someone help?

Thank you!!

Stijloor.

 

[Marc]

A quick "Bump" - If anyone here can help with this one, my Thanks in advance!

 

[howste]

Dear Coves

I am a QE in medical device manufacturing and wonder what would be the approach of validations in automotive industry and consumer electronics.

I am familiar to the part qualifications - PPAP in the Automotive Industry and
For process qualification - IQ, OQ and PQs in medical device.

Kindly advise what will be the approaches in the auto industry for product and process validations ?

QE.

If I understand your question correctly, the typical process would be the PPAP process. You say that you're familiar with the PPAP process already though. Are you asking about something different?

 

[Marc]

<snip> Kindly advise what will be the approaches in the auto industry for product and process validations?

Are you familiar with the APQP (Advanced Product Quality Planning) Process?

 

[QE]

Marc and Howste, Thanks for replies.

Howste: PPAP - is for Production Part Approval Process which helps communicating the expectations in the supply chain.
Marc: Yes, I am familiar to the APQP process.

The 4th phase/Step of the APQP process talks about the Product and Process Qualification. In medical devices the Qualification efforts are based on Risk of a non-conformity to a patient (i.e Severity). So to elobrate, a product non-conformace which can compromise theraphy ability (identified in your Dfmea) of a device will be a high severity. In that case the qualification will have higher efforts to acheive a high level of surety that those defects can be prevented from shipments ?

How would this be done for a Consumer Electronics Product, in other words what are the decession makers for qualifications in a product and process ? what will be the sample size for different qualification efforts ?

QE

 

[Marc]

<snip> I am a QE in medical device manufacturing and wonder what would be the approach of validations in automotive industry and consumer electronics.

I am familiar to the part qualifications - PPAP in the Automotive Industry and
For process qualification - IQ, OQ and PQs in medical device.

Kindly advise what will be the approaches in the auto industry for product and process validations?

Consumer electronics are typically not "critical" devices where human life is involved. Requirements for Risk Analysis for Medical Devices and automobiles is much higher than for consumer electronics.

That said, product and process validations for each are different, especially with regard to regulations for each. I personally don't know much about consumer electronics. I know automotive. As to medical devices, it's not my field so what I know I have learned here in the forum.

<snip> Kindly advise what will be the approaches in the auto industry for product and process validations?

APQP requirements.

 

[QE]

Marc, How would the validations be performed in Automotive ? what would be the method of identifying the important requirement out of multiple requirements ?

 

[howste]

Howste: PPAP - is for Production Part Approval Process which helps communicating the expectations in the supply chain.

The PPAP submission is how suppliers demonstrate to customers that their processes are capable of producing the desired product.

 

[QE]

Sure, Thanks for claryfying the true meaning. Once the parts are qualified then the assembley of those parts is done at the customer site. What validations are performed at that level ? - QE