We currently have a ISO 9001:1994 design system that has a lot of influence from QS (control plans and similar).

Our registrar recommended that we do not try to exclude design when we upgrade (October 2003) to ISO9k2k.

We are a very small metal stamping, sheet metal spot welding, and smaller hand assembly shop.

We typically do not design parts for customer or create new (finished) products from scratch to sell to customers. We occasionally "assist" our customers and provide input/suggestions.

Our design is mostly limited to new product introduction (unfortunately rather rare and infrequent), and minor design changes to sheet metal or in-process parts.

Few internal design changes would not be customer driven. Mostly sheet metal parts that have no offical "drawings" or requirements.

I'm really just looking for help/examples of a bare bones Design/Product introduction program that fits ISO and our needs. I can/probably will just go thru everything we have and TRY to simplify it to fit ISO and our needs, but examples will really help me out. (Our current system/forms are overkill to the extent that don't get used properly/fully. Too many, too much info to fill out repeatedly on multiple forms).

Note: We don't supply the Big 3, we're not in any of those Tiers, but we do have some QS customers.

Any tips/suggestions appreciated.
Thanks
Bob_M

Hi Bob,

Why did your registrar recommend not excluding design? Very curious.

I am in a similar business as yours and we have absolutely no intention of dealing with the design requirements of 9K2K.

We are a small sheet metal job shop, we manufacturing to customer design. Sure, we suggest design improvements, and occasionally redesign a part for better manufacturability, but that's about it. I'm sure you are doing similar.

Pin down your registrar, ask them why they recommend it. Don't waste your time on something you have no need for.

JMHO,
CarolX

CarolX said:

Hi Bob,

Why did your registrar recommend not excluding design? Very curious.

I am in a similar business as yours and we have absolutely no intention of dealing with the design requirements of 9K2K.

We are a small sheet metal job shop, we manufacturing to customer design. Sure, we suggest design improvements, and occasionally redesign a part for better manufacturability, but that's about it. I'm sure you are doing similar.

Pin down your registrar, ask them why they recommend it. Don't waste your time on something you have no need for.

JMHO,
CarolX

If it matters we use BSI...
We are currently 9001:1994
I don't know exactly why we went for the design element for the 1994 standard, but at the time I was the company's "Product Engineer" and I'm assuming that's what the last QA guy recommended.

When I mentioned excluding design to our auditor in March (1994 surveillance audit), he stated something to the fact that registrars are getting questioned more and more about companies that exclude design especially ones that previously were certified with design.

*shrug*

We probably could attempt to exclude. I'm not that worried about updating the process, but it would be mostly a waste of time. I still have not sat down with the boss (owner/president) and really discussed the topic yet.

And I'm not the best person to try and "argue" my way into getting an exclusion OKed by registrar.

I know I was not given the best reasons, but we really should have SOME kind of product introduction/design process for our own use (not just ISO).

Like I said our CURRENT process is OVERKILL and VERY QS driven. Those forms are only useful for PPAPs in our eyes.

Many companies wanted design under ISO 9001: 1994 because they felt that ISO 9002 was not as good as ISO 9001. I belive that is one of the major reasons they dropped 9002 - to stop companies from inventing design processes that did not really exist.

If it is just a waste of time and money don't do it. The registrar cannot force you to include design. Even if you have 100 product designers on staff you can exclude the design portion - as long as you don't try to state in your scope that you design.

In addition to saving the cost of setting up a procedure that won't be used, you should be able to have your audit days reduced.

Tom

Tom

I think you are quite wrong.

You cannot scope out of your QMS any process that affects your ability to satisfy your customers.

In a nutshell if you design you must meet the design related requirements of ISO9001:2000, if you dont then obviously you dont have to. You should state the scope of your QMS in your quality manual, but it must include everything you do.

The question here is does the company actually design. I would say that if you own the design then yes you do design, if you just have input into the design owned by others than you dont design.

M Greenaway said:

The question here is does the company actually design. I would say that if you own the design then yes you do design, if you just have input into the design owned by others than you dont design.

Martin,

Exactly. I am assuming that Bob is in the same business as my company. We do sheet metal fabrication. We make parts to customer prints, sketches or whatever documentation the customer give us (yes, we have done the old napkin drawings before). We may have input to the design, but no authority over the design.

Bob,

Talk to your registrar, in particular, the account manager you deal with. I am sure they will find that design should not have been included in the 1994 version, and should not be included now. If they still insist, ask for further clarification. No need to aurgue....but do ask WHY!

Good Luck,
CarolX

M Greenaway said:

Tom

I think you are quite wrong.

You cannot scope out of your QMS any process that affects your ability to satisfy your customers.

In a nutshell if you design you must meet the design related requirements of ISO9001:2000, if you dont then obviously you dont have to. You should state the scope of your QMS in your quality manual, but it must include everything you do.

The question here is does the company actually design. I would say that if you own the design then yes you do design, if you just have input into the design owned by others than you dont design.

M Greenway: I suppose in some ways we "own" the design of some of our products, and we technically can update/modify them if we wanted/needed to.

On a regular basis we DO NOT design.


-----------
tomvehoski:
Many companies wanted design under ISO 9001: 1994 because they felt that ISO 9002 was not as good as ISO 9001. I belive that is one of the major reasons they dropped 9002 - to stop companies from inventing design processes that did not really exist.

If it is just a waste of time and money don't do it. The registrar cannot force you to include design. Even if you have 100 product designers on staff you can exclude the design portion - as long as you don't try to state in your scope that you design.

In addition to saving the cost of setting up a procedure that won't be used, you should be able to have your audit days reduced.


Tom: That MAY have been why we used 9001... I honestly don't know. It doesn't really matter.

As far as reducing number of days...
We're currently only 1 day during surveillance, and 2 days during update... Can't get much shorter than that...

I think we SHOULD have a BAREBONES design program and thats what I'm looking for examples of. Barebones that work and have passed ISO and fit our needed.

Yes I know, only we can design that best, but examples are helpful :cool:

This is a good topic...

Ok, let's try this angle: In my opinion many registered companies really walked the line between the old 9001 and 9002.

I often point at ISO9001:2000, clause 4.2.1, note 2:

The extent of the quality management system documentation can differ from one organization to another due to

a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.

Assume that the design and development process is extremely straightforward... May it prove easier to describe the process than to defend an exclusion?

/Claes

Added later: Whups... Lots of posts poured in while I was writing this.

Bob

Even if you only design once a year you should meet the ISO9001:2000 requirements for this design process.

Note that you dont necessarily need a documented procedure, but I would imagine that in a scenario where the process is only done on rare occasions a procedure might be useful.

Just make sure it covers the basic steps in the ISO9001 requirements, i.e.:-

- Design Planning

- Identification of Design Inputs

- Design Outputs

- Design Review

- Design Verification and Validation

The nature of how you tackle these requirements would be very much based on the products you make, the markets you serve and perhaps safety/regulatory compliance.

To argue the Design scope statement,

I agree that if design is a major portion of the business and jobs are sold as "design and build", then it should be included.

Also consider, if a company has a design center and a manufacturing center in different buildings, the manufacturing center alone can be certified. The auditor can't say "you have a design component across the street, so they have to be included in the audit". You can treat design as outsourced if necessary. What difference does it make if the design center is in the same building as the manufacturing? Perhaps the design center operates as a separate profit center and has its own QMS. If you don't define a design process as part of your QMS, you can't be audited to it.

If I set up my system to say that my QMS includes production, purchasing, shipping/receiving, and so on without engineering - the auditor can't require me to include it because he runs across an engineer in the hallway. Same with manufacturing processes. I can be certified to make blue paint, but not red paint. As long as my scope of accreditation says "manufacture of blue paint", the auditor can't audit my red paint line. If my scope is “manufacture of paint”, all productions lines are open for audit.

I just went through an audit with an IT company. They have four basic processes - commercial software development, custom software development, IT staffing and are a testing location for Microsoft, among others. Software development was the important part of the business, so we built the system on that. We included staffing since it was also a big part and was not that much more difficult to include. We left out the testing center since it was very minor and ISO would not have helped. Their audit scope said nothing about testing. No problems with the audit.

Also had a QS client get a major because the auditor found a job that did not fit the "prototype stamping" scope they had defined. Client did not want that in the scope anyway since it was basically a favor to a customer to modify some parts. We fought it and had the NC removed.

This has strayed from the original questions, but my main point is don’t let auditors tell you what must be included in your system. They should be auditing to your system, not their interpretation of how things should be set up.



Tom

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

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!

Bob,

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

Tom

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

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 ??

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

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.