Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008

[antoine.dias]

Re: Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 D

To control outsourced activities we implemented the following as in attached word doc.

On a case by case we add specific items for the outsourced activities under consideration.
It's a 2 year old file but I have saved it today in the new Word version.

Best regards,

Antoine

 

[abd_sg]

Re: Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 D

Hi,

2008 version still for discussion,any way for outsourcing PDCA still the best techniques including its First Article,Top Defects and frequent visits to suppliers for monitoring purposes.Control for materials consigned or turnkey,machine overall effectiveness(output,cycle time and downtime) must be monitored by customers including Handling issues.

"learning after failing"

 

[B Krause]

Re: Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 D

Hello All,

Interesting discussion. I believe the controls implemented are risk based and start with the contractural agreement and/or statement of work with the supplier. This document MUST clearly define the expectations and if the supplier is not ISO certified, then the specific requirements need to be defined and agreed in the signed contract or SOW. Once the requirements are clearly defined, your supplier quality program can take over and audit the supplier against the contract or SOW.

This has worked in our organization with mixed results, all depending on how well thought-out the contract or statement of work is for the supplier quality program to perform their audits effectively.

 

[Obi-wan Kenobi]

Re: Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 D

Hi All,

Outsourcing controls?
Well, as per ISO 9001:200x which had emphasized on the Process Approach, would it be considered to think about process management involving the outsourcing activities such as how do the outsources activities impacting to the organization in terms of positive and negative. From these assessment, the types of controls can be introduced as per the levels of the impact, so that the system will be robust enough to deliver quality products and services. Such assessment can be considered is the business risk management, process and product risk management, or financial risk management.

I hope this could enlighten us... Cheers!

'May The Force Be With You'

OB1

 

[Karen Whitehead]

Re: Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 D

Well, tommorrow I'm going to get the 2008 revision to the standard since obviously I am being audited to that version even though I contracted under the 2001 version. However, I need to know the definition of "outsourced process." I will determine, in accordance with any new requirements, what controls I must have on an outsourced process, BUT I need to first know what is considered outsourced. My definition of outsourcing is "an arrangement in which one company provides services for another company that could also be or usually have been provided in house." My situation: I purchase a metal housing from a supplier. I receive the housing , inspect it, and send it out to a firm to annodize. I don't have the capability to annodize and of course I have never performed that process inhouse. Have I outsourced a process, or have I simply purchased a service?

Kindly give me your thoughts.
Thanks

 

[Sidney Vianna]

Re: Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 D

even though I contracted under the 2001 version.SNIP SNIPKindly give me your thoughts.

2001 version? You probably mean 2000....

Concerning outsourced processes....what about the TC176 assistance: Guidance on Outsourced Processes. All your questions answered...

 

[howste]

Re: Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 D

My definition of outsourcing is "an arrangement in which one company provides services for another company that could also be or usually have been provided in house."

Sounds pretty good. It's actually defined in Note 2 of ISO 9001:2008 under 4.1:

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.

My situation: I purchase a metal housing from a supplier. I receive the housing , inspect it, and send it out to a firm to annodize. I don't have the capability to annodize and of course I have never performed that process inhouse. Have I outsourced a process, or have I simply purchased a service?

You have outsourced a process. It may have been done (and controlled) through your purchasing process.

 

[Karen Whitehead]

Re: Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 D

Yes, I do mean 2000. Sorry. I have just read ISO/TC 176/SC . . and guidance on "what is an outsourced process." As now defined 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. Since my annodization is one activity in a set of activities in the product realization process, I assume that I have not outsourced a PROCESS?? Sorry to be so muddy on this, but it seems that there ought to be a definite line here on what is a purchase of a service or product versus what is a subcontracted or outsourced process. My auditor gave the example of "painting" or "plating." I assume these are similar to "annodizing." It looks like it could get even muddier on "purchased machined parts." I would like for you to give me your opinion, right or wrong, a to whether my annodizing process is an outsourced "process."
Thanks

 

[AndyN]

Re: Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 D

Karen:

If you send parts out to a supplier - for anodizing - that's an outsourced process. Your organization doesn't do the process itself, so it can only be 'outsourced'.......I think you're over thinking this!

 

[Sidney Vianna]

Re: Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 D

I would like for you to give me your opinion, right or wrong, a to whether my annodizing process is an outsourced "process."

You have outsourced a process.

If you send parts out to a supplier - for anodizing - that's an outsourced process. I think you're over thinking this!

I agree with Steve and Andy. And, depending on the type of anodizing you need, part of the control to be exercised here could include requirements for process validation.