Request: Bare Bones ISO9k2k DESIGN procedure and Forms - Metal Stamping (small)

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tomvehoski

Claes,

Most of my clients have a very straighforward design process, so we use a basic design plan form that records all of the inputs, outputs, reviews and so on. I also have some that do the full project management Gantt charting and so on. It all depends on the product being designed.

Where I would resist including design is the once a year type deal where someone drops by your welding shop and says I need a hook to pick up this part with a crane. Welder fabs a hook, they pick up the part to test it, it works and customer leaves with his hook in an hour. Technically this is design with inputs (pick this up), outputs (here is your hook), review, veriifcation and validation (picked it up, did not break). The missing link is documentation. I've seen this type design in a lot of small shops. I don't see much value in adding a procedure and documentation for it if it only happens very infrequently.

Tom
 
B

Bob_M

tomvehoski said:

Claes,

Most of my clients have a very straighforward design process, so we use a basic design plan form that records all of the inputs, outputs, reviews and so on. I also have some that do the full project management Gantt charting and so on. It all depends on the product being designed.

Where I would resist including design is the once a year type deal where someone drops by your welding shop and says I need a hook to pick up this part with a crane. Welder fabs a hook, they pick up the part to test it, it works and customer leaves with his hook in an hour. Technically this is design with inputs (pick this up), outputs (here is your hook), review, veriifcation and validation (picked it up, did not break). The missing link is documentation. I've seen this type design in a lot of small shops. I don't see much value in adding a procedure and documentation for it if it only happens very infrequently.

Tom

Can you provide a sample of the very straightforward design process form?

We NORMALLY don't need the who Gantt chart and so on system (which is what we have - its overkill like I stated).

We don't do the one time design so that wouldn't be a problem here.

Past example of a "design" that I wish we had documented (for future reference). It was worked on just prior to creating our current documentation (we basically had none, but I still have most of the legal pads and notes I kept).

Customer asked us to take an exisiting roof gas exhaust assembly (ancient design - semi owned by us) and MODIFY it to meet a new/different application.

Customer provided basic input. I provided internal input and design/production needs. Sample/sketches were supplied to customer (several times). Final design approved by CUSTOMER and TESTED by customer.

I consider this a BIG design project (from our perspective). But it was minor in customer's eyes.

Customer provided input, we made some internal sheet metal design changes and new subcomponent. Customer approved FINAL assembled product. We approved subcomponents for fit and function. So WE designed this product internally.

This is NOT a normal thing for us. We may NEVER do something that major again for our current product lines.

Our standard "design" changes are material changes, fit and function, etc that are not REQUIRED by customer and/or no prints ever existed (mainly sheet metal parts).

So yes, I feel we need a design program to assist in TRACKING the changes made. But I want a simple and straightfoward paperwork trail that I MUST follow per an updated procedure.

Does that help or make it worse?

Yeah almost time to go home!
 
T

tomvehoski

Bob,

I e-mailed you a sample since I'm not set up for attachments here (and not sure if you are).

Tom
 
B

Bob_M

tomvehoski said:

Bob,

I e-mailed you a sample since I'm not set up for attachments here (and not sure if you are).

Tom

Thanks for the sample. It should get me going in the right direction.

It looks simple and straightforward. We currently have a form for EACH step and several checklist forms. Talk about overkill for a small company that barely designs anything.

Obviously each company would need to tweak it based on their system.

Thanks
Bob_M
 
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M Greenaway

Tom

You are utterly wrong in what you say - you cannot, according to ISO9001, scope out of your certified system any activity you do which affects you ability to satisfy customers, whether the process is in the same building, across the road or in another country. Any certification body that grants a certificate under these circumstances is commiting gross mis-conduct.

Also the ISO9001 certificate applies to the QMS and the processes involved, it is not product specific, so to say that you are approved for the manufacture of blue paint is again misleading and incorrect.

But perhaps more importantly why would you not want to control a certain process, why scope it out ??
 
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Craig H.

Hi, all

I'm kind of late coming to this thread, but we do very little design and successfully completed our transition from ISO 9002:1994 to ISO 9001:2000. We did not exclude design. Instead, we have a 1-page procedure that states who has design input and final approval. Paper trail is provided by internal memos.

Its simple. Works for us.

Craig
 
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M Greenaway

Well done Craig.

Its not difficult to do is it !

Why make such a fuss to try and exclude design from your system (not that in reality you ever could).

Is it fear of designers, or the design process, or a feeling of inadequacy against these highly educated individuals ???

The design clauses are perhaps some of the loosest clauses you can find. You do not audit the technicality of the design itself, simply the management and control of the design process - its a piece of pizz.

Most external auditors swallow any old b@llocks from the design staff anyway so dont sweat over it.
 
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