Outsourcing Special Processes such as Plating, Painting, NDT as related to AS9100

[Lorgeo]

Hello All,
Our Internal Auditor and the registrars auditor are at odds as to what constitutes Outsourcing.

One is saying that special processes such as plating, painting, NDT etc are NOT considered Outsourced because our company does not have the ability to do such things in-house.

The other is saying that regardless of in-house ability, any work done for us by another company is considered outsourcing.

Any input would be greatly appreciated. Thanks!

 

[Joy]

Re: Outsourcing as related to AS9100

In addition to that,any process related to your QMS done by a branch of your company but not covered under the scope of QMS would be considered as outsourced process.

Even if you hire someone (not your employee) to conduct your internal audits,may be considered as outsourced process.
Please see the note in clause 4.1 of AS9100:2009

Note:2 An outsourced process is a process that the organisation needs for its quality management system and which the organisation chooses to have performed by an external party.

Good luck

 

[alspread]

Re: Outsourcing as related to AS9100

By that definition, anything you purchased would have to be considered outsourced.

Buying a service (i.e. coating, heat treat, etc.) is not an outsourced process.

As Joy mentioned, an outsourced process is a process the organization needs for the QMS (i.e. auditing, calibration, design, etc.)

Good luck

 

[Marc]

Re: Outsourcing as related to AS9100

<snip> Buying a service (i.e. coating, heat treat, etc.) is not an outsourced process. <snip>

I disagree, but I'm open to being proven incorrect.

 

[Lorgeo]

Re: Outsourcing as related to AS9100

"Buying a service (i.e. coating, heat treat, etc.) is not an outsourced process."

I'm not sure I understand why buying a service would not be considered an outsourced process. As9100 Sect 4.1 States " Where an organization chooses to outsource any process that affects product conformity........"
Wouldn't a process such as affect product conformity?

 

[Marc]

Re: Outsourcing as related to AS9100

I suggest a read through:

Outsourced Processes

Special Processes

Also see: Validation Of Outsourced Special Processes under AS9100

 

[andygr]

From the rev C standard
"Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

From this guidance I would look at the process of having the special process performed from out side of your orginization as it being outsourced. You could have the process performed internaly but you have made the determination based on various analysis that it is best done by an external source.

Special process by there very nature can not be verifed based on their product output alone and so require more attention to controles of the process performed. As part of your quality management system you have to define how you will determine that they are capable and compliant. You still must define and perform the proper controles since you are also providing to the location performing the process what is acceptable as an output.

 

[alspread]

So what is section 7.5.2 Validation of Processes for Production and Service Provision for then?

Buying a special processes (or any service to meet product requirements) is a production process used to make conforming product. These processes are controlled by specification with clear requirements from their own specifications or drawing.

As such it is control by purchasing and verification of purchased product (service).

Buying service to help take care of Quality (or Business) Management System is not controlled by any other specification or drawing and therefore must be controlled within the organizations Quality (Business) Management System. By whatever means that organization wishes to develop as long as it is compliant to the standard.

I think the notes in 4.1 are clear when describing outsourced processes as a process needed for the quality management system and it further emphasizes the 4 major sections of the standard.

NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.

NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.

 

[samsung]

One is saying that special processes such as plating, painting, NDT etc are NOT considered Outsourced because our company does not have the ability to do such things in-house.

The other is saying that regardless of in-house ability, any work done for us by another company is considered outsourcing.

These are certainly outsourced processes whether or not the organization has the ability to do those activities. See the attached Guidance document.

 

[JaxQC]

Thank you samsung for tracking down the guidance doc.