8.3 Design and Development of Services

I would like to give my take on the design and development of services in the standard and invite some feedback.
My take on this clause is that if you are already delivering a service and you have a detailed process map of the steps, controls records etc. you have demonstrated that you have designed the process to meet the customers needs. If this is the only service process you intend to deliver - you could based on the context of the organisation claim design clause as a exclusion. However if you feel based on your business strategy that you are likely to expand the business into other service areas - then it would a good idea to develop a procedure/process, (or be able to demonstrate via records of a new service introduced in the passed), as to how the development of the new service is project managed, validated via auditing and then formally integrated into the documented QMS would cover you for this requirement.
At least that is my interpretation of the requirements to comply with this clause, feed back on my thoughts are very welcome!

 

Slight change to the OP....

Manufacturing - metal fabrication - currently we exclude D&D, as corporate owns the documents/specs or, if not corporate, the customer provides them. We essentially take these drawings and break them down to form individual plates.

Working on my GAP analysis from 2008 to 2015 and I have a concern with excluding the Design and Development section: if we use existing drawings and assembly but change the type/grade of material or substitute customer requested material (they request specific pipe, but we can make it cheaper by rolling & welding equal quality plate). IMO these "modifications" negate the "design and development" exclusion.

Comments, interpretations, ...

 

It would seem to me if you change the material called out you should have an approved change request.

 

When you say corporate owns the docs/specs, do you mean you are in a company that has a corporate section that does design? On the material substitution, so far any time we've needed to do that it has been at the approval of the design authority. We've never substituted materials without their approval, and to me that's their design acceptance not ours.

 

Materials and component specification and also the designed operating range form a major part of the Design & development process. Any change to either material spec or the operating range is a violation of the D&D output and hence customer's specific requirement. Equivalent materials or components could be used but only with approval of the customer.
Also, when the D&D is for an in-house product, the company can go ahead with replacing originals with alternative materials & components. Such a product can be sold to customers but would clearly carry a specify caution that the machine, assembly/ sub-assembly or component is under performance validation. In such a case, there needs to be available
a. A clear control plan with max permissible performance limits & repair/replacement limits
b. A list of risk exposures & mitigation plan
c. Period of such validation
d. Acceptance/rejection criteria - a measure of success or failure of the validation process
e. Continuation plan or alternate plan in the event of success or failure respectively

 

ISO Guru,
Your understanding is perfect.

 

Yes, separate corporate engineering group. Some prints have not changed since the 50's!

Customer requested one of our standard catalog products but with a higher-temperature rated pipe. Someone here decided we could roll plate (of at least equal temperature rating) in lieu of the $$$/ft pipe. No risk to the customer nor compromise of the products' function.

Thanks everyone, just another thing to add to my GAP analysis and let Top Management know that these types of actions violate our D&D exclusion.

 

Hehe, you could ask who is the design authority. Seems odd they don't see it as them, but who else would it be? Of course I may be missing things.