7.5.2 Validation of Processes for Production and Service Provision - Distributor

D

Daniel Nguyen

Hi,

Any comments and/or guidance would be appreciated.

I have two questions:

1. Are counterfeit detection services for electronic components (e.g. de-cap, x-ray, xrf, electrical testing, scanning electron microscope, etc) considered "special processes"?

2. How do I validate these processes?

My organization, a distributor of EEE parts, outsources these processes to approved vendors or to customer approved special process vendors. Once the service (tests) are completed, product is shipped back to my organization with certificate of conformance (cofc) and/or test report. The product is verified by reviewing the cofc and/or test report and by performing final inspection.
 
John Broomfield

John Broomfield

Leader
Super Moderator
Daniel Nguyen said:
Hi,

Any comments and/or guidance would be appreciated.

I have two questions:

1. Are counterfeit detection services for electronic components (e.g. de-cap, x-ray, xrf, electrical testing, scanning electron microscope, etc) considered "special processes"?

2. How do I validate these processes?

My organization, a distributor of EEE parts, outsources these processes to approved vendors or to customer approved special process vendors. Once the service (tests) are completed, product is shipped back to my organization with certificate of conformance (cofc) and/or test report. The product is verified by reviewing the cofc and/or test report and by performing final inspection.
Click to expand...

Daniel,

If, to validate these processes, you have to destroy their products this fact indicates that clause 7.5.2 applies to them.

Genuine items will comprise attributes at are unique to these items but only destructive analysis or testing may determine their characteristics.

Your suppliers of these nondestructive counterfeit detection services should be accredited and have the records to show their processes are validated.

It may be time to upgrade your selection criteria and your purchase orders for such services.

John
 
somashekar

somashekar

Leader
Admin
Daniel Nguyen said:
Hi,

Any comments and/or guidance would be appreciated.

I have two questions:

1. Are counterfeit detection services for electronic components (e.g. de-cap, x-ray, xrf, electrical testing, scanning electron microscope, etc) considered "special processes"?

2. How do I validate these processes?

My organization, a distributor of EEE parts, outsources these processes to approved vendors or to customer approved special process vendors. Once the service (tests) are completed, product is shipped back to my organization with certificate of conformance (cofc) and/or test report. The product is verified by reviewing the cofc and/or test report and by performing final inspection.
Click to expand...
Do not think of the 'Special' word.
Do these equipment measure something ?
Calibrate them
Do these give output based on inputs into its library and does it require someone to be qualified to operate it, and use judgement to decide ?
Validate them including the personnel qualification.
When you outsource, the same applies., even if it happens to be customer approved vendor.
Reviewing and deciding based on cofc and test reports forms just one element of the controls you exercise. Ongoing assurance is not in control.
 
B

Big Jim

Admin
Considering that AS9120A, the standard specifically intended for aerospace distributors, automatically excludes 7.5.2, I would guess that either it is not, or that it falls under "value added services under the customer's guidance".

Either way though, if you are not doing destructive testing as part of value added, then it probably is not under 7.5.2.

Truly though, this is a question for your certification body.
 
D

dsanabria

Quite Involved in Discussions
Big Jim said:
Considering that AS9120A, the standard specifically intended for aerospace distributors, automatically excludes 7.5.2, I would guess that either it is not, or that it falls under "value added services under the customer's guidance".

Either way though, if you are not doing destructive testing as part of value added, then it probably is not under 7.5.2.

Truly though, this is a question for your certification body.
Click to expand...

To add to Big Jim statement - if you are using AS9120 for distributor and you are distributing electronic product - you should consider distributing AS5553 or AS6081.

7.5.2 "Special Process" is excluded from this standard but the customer through the Purchase Order may require additional testing - as long as you do not change the "Form, Fit and Function" of the product.
 
D

Daniel Nguyen

Hi,
Thank you John Broomfield, Somashekar, Big Jim and dsanabria, for your comments and guidance. Much appreciated.

After reviewing these comments, we decided to include 7.5.2 in our quality management system. My organization?s QMS is certified to AS9120A and is currently enhancing its QMS to include the requirements of AS9100C; with intentions of certification to AS9100C by June 2014. We are also interested in AS6081.

Once again, thank you for the comments and letting me be part of a great community.
 
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