Outsourced special processes - How to control outsourced special processes

F

Fitz11

Morning Everyone,
My facilities to not perform on site any Special processes, but we do out source material which goes through a special and then to our customer.
Question 1
Do I (my facilities) have special processes?
Question 2
If yes, how do I deem to control it, when we are not the experts on that process?
 

Crusader

Trusted Information Resource
You do not have special processes as you stated. You outsource as you stated. We do the same. We control by receiving inspection, if possible. Also, the outsource processes can be controlled by the supplier evaluation process - going through first article approval process before placing regular orders. We also request certificates of conformance from the supplier to cover ourselves. Hope that sheds some light..:) This simple process passed the registrar audit. Control plans state the special process too. Our special processes are mainly cosmetic though. Yours may be more critical?
 
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pilchard

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7.5.2 Validation of processes for production and service operation

1) The organization shall validate any processes for production and service provision where the resulting output cannot be verify by subsequent monitoring or measurement.
2) Validation shall demonstrate the ability of these processes to achieve planned results.
3) The organization shall establish arrangements for these processes including as applicable:
a) defined criteria for review and approval of the processes
b) approval of equipment and qualification of personnel
c) use of specified methods and procedures
d) requirements for records
e) re-validation
;)
 

pilchard

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7.4.3 Verification of purchased product

1) The organization shall established and implement the inspection or their activities necessary for ensuring that purchased product meets specified purchase requirement
:(
 
M

morgand - 2006

Out sourcing

Is the process that you out source something that is single/sole source or something that the performer of the service is certified or authorized in? You can justitify sole source fairly easy. If its something that a certification or authorization is associated with, ask your contract folks to contact them and get a copy of the certification/authorization. Otherwise, your management has established requirments in contracts with these folks. These requirements are also part of your control.
 

pmwong

Involved - Posts
Control Of Outsource Special Process

These are some example of the activities for Outsource Special Process

1) Evaluate The Facilities that we are to Outsource To
2) Provide sufficient informations to the contractor that you are to
outsourced such as print, acceptance criteria, working instructions, etc.
3) Provide adequate training, if necessary e.g. what type of test need to be
done, etc, etc.
4) Any other control or informations deemed necessary for the outsourced items.

Hope this can provide you with some ideas
Thanks
 
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