Change in Direction - Management decides to Outsource Manufacturing Operations

[rkasparek]

Lets say that you've got an ISO compliant, but not yet registered system for a company that assembles parts they have manufactured by outside parties. They have been performing incoming receiving inspection per their procedures etc. and everything has been clicking along.

Management decides to outsource the entire manufacturing end of things and will simply order 'kits' to assemble, relying totally on the final inspection of the outsourced supply company. The kits will arrive with final inspection information, and will be assembled and tested. The outsourced function will track traceability, etc.

How would you handle the rewrite of the manual/system?

 

[Randy]

Re: change in direction

Simple, document it as it is planned to be done.

 

[AndyN]

Re: change in direction

Lets say that you've got an ISO compliant, but not yet registered system for a company that assembles parts they have manufactured by outside parties. They have been performing incoming receiving inspection per their procedures etc. and everything has been clicking along.

Management decides to outsource the entire manufacturing end of things and will simply order 'kits' to assemble, relying totally on the final inspection of the outsourced supply company. The kits will arrive with final inspection information, and will be assembled and tested. The outsourced function will track traceability, etc.

How would you handle the rewrite of the manual/system?

Do you have an approach documented under 'quality planning'? If the organization is complaint to ISO 9001, it will have some sort of quality planning process in place (under 7.1) which should be followed. This would be linked from/to a record of Management Review, when the decision to change the process (improve) would have been identified...etc.

Not just documentation, you see! It's a systematic approach...

 

[rkasparek]

Re: change in direction

Do you have an approach documented under 'quality planning'? If the organization is complaint to ISO 9001, it will have some sort of quality planning process in place (under 7.1) which should be followed. This would be linked from/to a record of Management Review, when the decision to change the process (improve) would have been identified...etc.

Not just documentation, you see! It's a systematic approach...

I understand that part - what I'm questioning is how would you re-document the system given that we draw up the engineering, and outsource the manufacturing and inspection?

 

[harry]

.......................... How would you handle the rewrite of the manual/system?

Do you really need to? Have not seen your documents and am not sure if you had anything written that commit you to what you are asking.

I observed that most people tend to favor procedures that are not unduly restrictive and putting details if any or needed into work instructions, etc. In a case similar to yours, you can have the required controls and other details incorporated into your contract or agreement for the out-sourced process.

 

[AndyN]

Re: change in direction

I understand that part - what I'm questioning is how would you re-document the system given that we draw up the engineering, and outsource the manufacturing and inspection?

We can't really tell you, since we don't know what your current QMS says! You could draw up a Quality Plan

 

[Jason PCSwitches]

Re: change in direction

I understand that part - what I'm questioning is how would you re-document the system given that we draw up the engineering, and outsource the manufacturing and inspection?

Also, review the general requirements section 4.1 (notes 1-3). Start there and you can guide yourself thru the process. After you review this, come back with your thoughts.

 

[somashekar]

Lets say that you've got an ISO compliant, but not yet registered system for a company that assembles parts they have manufactured by outside parties. They have been performing incoming receiving inspection per their procedures etc. and everything has been clicking along.

Management decides to outsource the entire manufacturing end of things and will simply order 'kits' to assemble, relying totally on the final inspection of the outsourced supply company. The kits will arrive with final inspection information, and will be assembled and tested. The outsourced function will track traceability, etc.

How would you handle the rewrite of the manual/system?

You just bring in this outsourcing activity also into the manual / system (include it if you have other out sourced processes listed OR document this outsourced process. If you have any other QMS documents pertaining to the outsourced process, use it as a part of your control exercised over the outsourced process.

 

[rkasparek]

You just bring in this outsourcing activity also into the manual / system (include it if you have other out sourced processes listed OR document this outsourced process. If you have any other QMS documents pertaining to the outsourced process, use it as a part of your control exercised over the outsourced process.

Thats sort of where I was heading... sometimes its just good to get confirmation that you're not daft!