One-Time parts separate from QMS?

[Russ]

We have an ISO9000 certification. We do quite a few one part job shop things here along with our regular production. Is there any reason why we could not separate those small 1-2 part lots into a streamlined "One-Off" process?

 

[Reg Morrison]

Actually you have a certification to ISO 9001 (not ISO 9000).

It is a mistake to think parts should be run outwith of a QMS. The key is to have agile, lean, cost effective processes WITHIN the QMS to run the low quantity orders.

Quality processes have to be scalable and adaptable to the needs of the customer and product.

 

[somashekar]

We have an ISO9000 certification. We do quite a few one part job shop things here along with our regular production. Is there any reason why we could not separate those small 1-2 part lots into a streamlined "One-Off" process?

You do quite a few one part job as you say.
So I am sure you have a system in place just as much necessary for one-off.
The process is no different but for the scale of system operations.
By separating., tell us what differently you wish to do, which seems to bother you .....
There is no reason why you could not separate those small 1-2 part lots into a streamlined "One-Off" process, as long as you aim and meet the customer requirement and assure quality. This one-off process will simply be within your QMS operation.

 

[Russ]

Actually you have a certification to ISO 9001 (not ISO 9000).

It is a mistake to think parts should be run outwith of a QMS. The key is to have agile, lean, cost effective processes WITHIN the QMS to run the low quantity orders.

Quality processes have to be scalable and adaptable to the needs of the customer and product.

Not wanting to run these outside the system just unsure how to streamline and wondering if anyone else has done this and maybe an example. I know it has to be simple or it will never work here but will be ignored.

 

[John Broomfield]

Not wanting to run these outside the system just unsure how to streamline and wondering if anyone else has done this and maybe an example. I know it has to be simple or it will never work here but will be ignored.

Russ,

You choose how to define the scope of your management system; what services and products to include and exclude.

You can eliminate this service from the scope of your certification.

The bigger question is assuming that quality services and products cost more than the alternative.

John

 

[somashekar]

You can eliminate this service from the scope of your certification.

John.
There is nothing to say that the one-part job is not in the scope of the certified QMS.
The questions seems simple and straight.
Can they implement two processes, one that covers small 1-2 parts and other perhaps the volume parts. Perhaps the OP is running into difficulty in certain processes of their QMS that they have more aligned with volume parts.
Touching the scope here perhaps is deviating.

 

[John Broomfield]

Somashekar,

Deviating from what?

The scopes of the management system and its certification are determined by the organization provided the certification scope is no larger than the scope of the management system.

And, I agree, that the management system's processes and controls should be tailored according to the needs of the customer as a result of planning (7.1).

For some reason the latter seems not to be happening.

Perhaps Russ will advise.

John

 

[Ninja]

Not wanting to run these outside the system just unsure how to streamline and wondering if anyone else has done this and maybe an example. I know it has to be simple or it will never work here but will be ignored.

Hi Russ,

As John mentioned, you CAN run these outside of the QMS...but I'm not sure why you would do so.

Run them outside of SPC, CpK and other things built for an ongoing production line, sure. But there is no reason to run outside of your QMS.

Example: If the one-off part ships and the customer complains about it...how would you handle the complaint? The customer feedback would go right into your QMS processes wouldn't it?

It is easy enough to document that jobs meeting {X criteria} will be handled "this way", totally within your QMS.
Not knowing what you're doing, so drawing from my own one-off things instead, it could be a single document defining how job-shop items are handled. It does not have to be a whole suite of procedures.

Picture a single document stating that
"Short run fabrication as defined by the Production controller {or equivalent} shall be handled as follows: ...."
(and remember that it is always best to have a positive record that 'this job' was defined as short-run....a $10 Rubber Stamp "Short-Run" and an initial on the job ticket would get it done)
It doesn't need to be complicated.

 

[Jen Kirley]

Not wanting to run these outside the system just unsure how to streamline and wondering if anyone else has done this and maybe an example. I know it has to be simple or it will never work here but will be ignored.

Job shops need the QMS to cover the "onesies and twosies" at least as much as places who make thousands of assembly line products because there is no room for error.

But process realization does not need to be difficult. A work order/traveler can start with a template and be filled out to contain all of the specific criteria for receipt inspection, set up, first article and final inspection criteria, and even special shipping instructions. The work order/traveler can have blanks for responsible persons to sign completion and acceptance, plus which instruments were used to measure or test the produced items. The work order/traveler can then be filed by customer name along with the PO, raw material invoices, CofAs, prints etc. plus whatever other communication took place, to refer to later as needed. As always, if there are changes to the criteria in the work order/traveler I would expect them to be approved by a person with defined authority.

A central list of approved suppliers and customer satisfaction data should still be used, and corrective actions, if any, should refer to the customer name/work order number from an index, etc. for tractability's sake.

In this way you can avoid making a bunch of, or long and complicated procedures and test/inspection methods. Filing can be largely centralized. All of the standard and customer requirements can be met and you can pull out these files for auditors who ask about purchasing information, inspection criteria and results, etc.

I hope this helps!

 

[Russ]

Hi Russ,

As John mentioned, you CAN run these outside of the QMS...but I'm not sure why you would do so.

Run them outside of SPC, CpK and other things built for an ongoing production line, sure. But there is no reason to run outside of your QMS.

Example: If the one-off part ships and the customer complains about it...how would you handle the complaint? The customer feedback would go right into your QMS processes wouldn't it?

It is easy enough to document that jobs meeting {X criteria} will be handled "this way", totally within your QMS.
Not knowing what you're doing, so drawing from my own one-off things instead, it could be a single document defining how job-shop items are handled. It does not have to be a whole suite of procedures.

Picture a single document stating that
"Short run fabrication as defined by the Production controller {or equivalent} shall be handled as follows: ...."
(and remember that it is always best to have a positive record that 'this job' was defined as short-run....a $10 Rubber Stamp "Short-Run" and an initial on the job ticket would get it done)
It doesn't need to be complicated.

Thanks! I was kinda thinking along those lines so I believe I will do just that. I want to keep them in the QMS, now I just have to come to an agreement here on the content.

Thanks to all for your input, it really helped me think it through!!!!