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Type and Control of Outsourced Processes - ISO 9001 Clause 4.1

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somashekar

Staff member
Super Moderator
#12
What is your interpretation and how to ensure compliance to the following paragraph in req 4.1 (provide a couple of examples please):

ISO 9001: 2008

"Where an organization chooses to outsource any process that affects product conformity, 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. Can you expand and interpret the underlined words in order to be in compliance. I am a bit confused with this statement. Appreciate your input.
Look at it this way ... Its not an off the shelf item and you want it done the way you have defined. You do not have all the resources and hence you look for an external source who can do it the way you want it. How do you monitor it ?
This includes proper evaluation and selection of the source, determine his capability to understand and execute your requirement, evidences that he is indeed following, monitoring and maintaining his processes to deliver what you have defined and desired for each batch / lot.
My example: Passivation of SS tubing : The external source has the capability and is in this business and caters to reputed industries., Is able to follow our referenced standard and get a process flow chart approved by us., Provides data of process time and bath concentration and water quality used for every lot., We visit and audit the process as defined and verify the records at his site periodically., We conduct passivation test on random sample from third party recognized lab per standard and have records of ongoing compliance.
Would this help you ....
List all your out sourced processes in your QMS documentation (ex. your purchasing procedure) and map the type and extent of control that you will want to exercise on each of them. The above example could help you.
 
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chayumi

#13
i think this means all services that are provided by a third party is considered an outsourced process. However, me too is quite confused now coz we have an outsourced process, our R&D group the R&D Manager and the specifically the process aerial spraying. However, they are from an affiliate of our company. We have the same Managing Director, the owner and the General Manager. The difference is only the name of the company. Should i consider this an outsourced process?
please help me.. am in process of my documentation and this has always be a finding to us in audits, the lack of criteria and control of outsourced processes.
 

harry

Super Moderator
#14
................We have the same Managing Director, the owner and the General Manager. The difference is only the name of the company. Should i consider this an outsourced process?...............
You can have the same owners, directors or even management team but as long as they are incorporated as a separate entity (company), that is outsourcing.
 
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chayumi

#15
Thanks harry... actually, that's how i explained to the Management Team. However, they insist not to consider an outsource for that reason. They wanted me to research about this. Anyway, I'll discuss with the team again about this input.

If the outsourced process that has to be evaluated is the R&D Manager and the services of the group, who shall be responsible of the evaluation? Our Production Team or our General Manager?

Thanks again...:)
 

harry

Super Moderator
#16
................They wanted me to research about this. Anyway, I'll discuss with the team again about this input. ..............
This is from TC 176/SC2:
An outsourced process can be performed by a supplier that is totally independent from the organization, or which is part of the same parent organization (e.g. a separate department or division that is not subject to the same quality management system). It may be provided within the physical premises or work environment of the organization, at an independent site, or in some other manner.
You may use this attachment to convince your management.
 

Attachments

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chayumi

#17
hello... can you give me an idea on who should set the criteria of an outsourced process? In our QMS, there is a Crop Protection Management but the Crop Protection Manager is an outsourced. He is employed from a separate entity, a sister company. He makes recommendations which shall be approved by the GM and be implemented by our Production team. Who shall establish the criteria then? our production or our Quality team? can anyone suggest me some examples of controls?
 

harry

Super Moderator
#18
hello... can you give me an idea on who should set the criteria of an outsourced process? In our QMS, there is a Crop Protection Management but the Crop Protection Manager is an outsourced. He is employed from a separate entity, a sister company. He makes recommendations which shall be approved by the GM and be implemented by our Production team. Who shall establish the criteria then? our production or our Quality team? can anyone suggest me some examples of controls?
Sorry, somehow we missed this. This situation is also addressed in the TC176 document.

2.3.2) There are two situations that frequently need to be considered when deciding the appropriate level of control of an outsourced process:

a) When an organization has the competence and ability to carry out a process, but chooses to outsource that process (for commercial or other reasons).

In this situation the process control criteria should already have been defined, and can be transposed into requirements for the supplier of the outsourced process, if necessary.

b) When the organization does not have the competence to carry out the process itself, and chooses to outsource it.

In this situation the organization has to ensure that the controls proposed by the supplier of the outsourced process are adequate. In some cases it may be necessary to involve external specialists in making this evaluation.
Item b) should answer your question.
 
I

ISO 9001 Guy

#19
As usual, a variety of means could achieve conformity. In process approach fashion, we would determine how/when/where this requirement applies to your processes. For example, let's consider a machine shop operating the following management system processes: Sales, Purchasing, Receiving, Production, and Shipping. Using the process approach, the outsource requirement would be addressed (and defined) in procedures dedicated to processes where it is encountered.
It could be that the requirement to employ outsourced processes is first encountered in the Sales process. When a Salesperson quotes an order requiring plating, a reasonable procedure might urge Sales personnel to acquire bids from qualified suppliers (which provides a segway to the Purchasing process).
Outsourced processes are often procured via an organization's purchasing function. So, we would expect to see in a Purchasing procedure what requirements pertain to suppliers of outsourced processes, what product requirements and acceptance crieria are needed/communicated, requirements for inspections/certificates of conformity, etc.
Often, the results of outsourced processing require verification in Receiving before product arriving from outsourced processing is accepted/used/released to the customer. So, a sensible Receiving procedure would naturally address how product arriving from outsourced processing is verified.
Product requiring outsourced processing first often has value added internally, then outsourced processing is required, while resulting product is then often returned to the organization for further processing before release to customers. The arrangements for product release to outsource suppliers is naturally addressed in a good Production procedure, as is the acceptance of product resulting from outsourced processing and authorization to use this product in Production (following successful incoming inspection).
Finally, the Shipping procedure would address how product is packaged and transported to suppliers of outsourced processing. In many manufacturing organizations, a Traveler or Router awaits product return from outsourced processing, which is different from the routine for releasing product to customers.

Again, this is how the "outsource control" requirement would be addressed in process approach fashion in a manufacturing company.
 

tony s

Information Seeker
Trusted Information Resource
#20
somashekar said:
List all your out sourced processes in your QMS documentation (ex. your purchasing procedure) and map the type and extent of control that you will want to exercise on each of them. The above example could help you.
Our auditor raised a nonconformity because we don't have this LIST.:frust:

Although controls are in place to make sure that providers of the outsourced processes deliver what we want from them, we did not mention them (i.e. controls) on our quality manual.

According to him ISO 9001 standard requires us to "document" the type and extent of control for the outsourced processes within our QMS documentation.

What's your take on this?:bigwave:

tony s
 
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