Howdy everyone. I have a question related to the Design and Development portion of ISO. Our customers are responsible for the design of product, however we do offer input as recommendations. As far as I can tell, the Design and Development portion doesn't apply to us. I've included the text that I am thinking of using for the Design and Development portion of our quality manual. Does anyone see a problem with this?

"7.3 Design and Development

ATS’ customers are responsible for the control and verification of the design of their products. ATS will fully support its customers through the broad range of technical capabilities and services provided. This includes early involvement with Design for Manufaturability / Test / Reliability / Serviceability / Unit Cost (DFX) projects and other pertinent recommendations as part of the new product introductions."

Since we are not directly responsible for the design, will this cover us?

I think so, especially if you have some supporting documents to show it actually works that way.

Anybody else?

Richard,

This might be enough foundation for exemption from ISO 9001:2000 requirements. If not for 9k2k you could have registered under 9002:1994.

Now you have to decide whether you would like to set up additional requirements for your people regarding design recommendations they give to your customers. If so, you better describe these activities in more details. This may be done through work instructions or the like.

Regards,

Anton

Richard, I posted some information that came from one of my registrar contacts in the thread "Design? Yes and NO". You might want to read it. As Anton said, your verbiage might not be sufficient. If your work impacts the design, then you could be design responsible, from an ISO 9001 standpoint.

Hey Richard. Welcome and good post. In my elementary mind, this is black and white------if you don’t paint yourself in a corner by giving too much information. If you are working jointly with your customers on firming up new projects, like during an APQP type process, but they are the group that issues drawings and other written requirements, and your company name is NOT on any of it (e.g. title blocks, letterheads), you can write exclusion. At the end of the day, who ultimately controls the design effort ? The customer, of course. Nothing says you can’t work “intimately” with your customers on projects. If we all did more of that, our PPM’s would be a heckuva lot lower anyway. Now, about your statement for the quality manual. I applaud the effort yet see that you are trying to cover something up. It lends to a lot of suspicion. I would simply say that you are not design responsible and let the customers’ documentation support it at audit time---not the verbiage in the QM. Hope this helps and good luck ! :thedeal:

I would also recommend adding a section to the front of your manual that lists all of the exclusions. I usually call a section in the front "Scope". If I am claiming any exclusions, I put in a table showing the section/paragraph number with an explanation. I also put the explanation under the section number in the body of the manual - 7.3 in this case. If I am not claiming any exclusions, I state "all requirements of ISO 9001:2000 apply to ..." It seems to make it easier for outsiders to figure out what applies at a glance.

Tom

Thank you for the information and assistance everyone. I have reworded the portion of the manual to the following:

"This does not apply as ATS’ customers are responsible for the control and verification of the design of their product and therefore this portion is excluded."

I am also adding an exclusion claim at the beginning of the manual.

My next question is that if we provide guidelines in the manufacturing, are we still excluded since the responsibility falls on the customer?

To give some background, we are a circuitboard manufacturer. The guidelines we provide are meant to indicate issues that relate to good PCB design (such as shape, edge clearance, etc). These reflect the ability of the design to be manufactured and the board working. We do have documentation that shows this, as well as other documentation to cover design. Since these are manufacturablity guidelines and the documentation supports this, can we still have exclusion in our manual? (sorry if this is confusing, but I promise that I am more confused :confused: )

Richard Olson said:


My next question is that if we provide guidelines in the manufacturing, are we still excluded since the responsibility falls on the customer?



Yes
:cool:

Richard,

I believe your activities would fall under the contract/order review (7.2.1, 7.2.2) portion of the standard. You are more or less required to do this by 7.2.1.b - "requirements not stated by the customer but necessary for the intended use..." If you know it will not work, you are obligated to inform the customer before you accept the order. If you are told to build it anyway, it is not your problem any more. I used to run into this all the time when we designed circuit boards with traces so close to mounting holes that the screw head broke the trace or cause a short when assembled. The supplier did not know how they were being mounted - the design was our responsiblity. If you document it in contract review it can also protect you against warranty claims for bad design - our production manager was constantly trying to return boards we broke for credit, even though the problem originated from engineering and the supplier did everything they were supposed to.

Tom

Regarding Design and Development exclusion. Is this normally referenced on the Certificate itself or just in the Quality Manual? I have seen the exclusion stated on a DNV certificate but not on others. If your scope of registration is stated as " The Manufacture of ........." do you have to spell out any exclusion you are stating on the Certificate as well?

Almost all organizations have design and development activities!
If we consider service organizations, I still haven’t found one case in which we can exclude D&D.
Why?
Considering for example an automaker. The design department work is to execute information (ISO 9001 - 7.3) so that the plant can produce cars (ISO 9001 - 7.5).
In a bank, if we consider the production (ISO 9001 - 7.5) all the normal activities of the bank, the know how that the bank produced in order to perform those normal activities is nothing more than D&D, and should be considered under ISO 9001- 7.3.
In other words, procedures and specifications made by the service organization are the result of D&D and should be treated as that.
Using this “technique” while making those specifications, risk analysis can be made for each activity and preventive actions can be made (some kind of project FMEA), in order to prevent nonconformance’s.
So why still try to exclude D&D, when it can be the perfect tool to change the system from corrective to preventive?

Hi
Sorry if i bring up back this subject but i'm confused about one point.
I find out one old manual copy in my personal archive, from my surfing on the net:tg: which is have this exclusion:
" ZYW inc. provides a service (maintenance of one plant and its operations) and don't have a D&D ressource capability. the design of plant is approved by the owner and any significant change required the approval of the owner.
the ZYW can contact the component's suppliers of the owner's designer about some changes. Section 7.3 is in this case excluded , expet sub section 7.3.7.
ZYW can also initiate a design change request. ZYW is responsible of: the administration and control of approved design changes including test and inspections, of the recording of these and the updating of design documentation "

My query is how can this Cie assume to not have any responsability if they cover all the relating activities????

As i can see, the owner approve but this is the ZWb which issue the change? and also they dealing directly with the supplier.

In my modest brain, if the owner gave the agreement to this ZYW Cie, the one is expert in their activity, maybe more than the owner and as well as there is kind of "confidence" on their experience on this scope. the owner can be convinced and approve one design change which can later issue a defect. The Design change Request can be proposed to the Client's approval just because the support the cost, isn't it ?


Can someone clarify that to me :confused:

:thanx:

Hi
no feedback :confused: