Around we go!
Now it sounds as if Design control is applicable to the scope. The problem will be in capturing what the customer wants.
With the latter it is easier - once you understand the differences in this type of machine and how it interacts with your product you can put together a specification for the product to design against. With the first example the spec is more difficult to define. How do you define "easy to remove?"
Sounds like a typical iterative design process. The verification activity will be any evaluation you carry out in house to test the "new" product against the original specification. The validation will probably be a trial run at your customer's premises.
If this is something your customer pays for (even if it is amortised in the cost of product you supply) then my opinion is that it should not be excluded from your scope. There are plenty of others who may disagree.
Now it sounds as if Design control is applicable to the scope. The problem will be in capturing what the customer wants.
Colleen said:
Customer requirements are changing. Examples of what the requirements are: The client says" we want your casing to be easily removable from the sausage we make" or "we want your casing to work on our type of filling machinery".
Colleen said:
So we experiment with our original technology (adding components, changing technological conditions (time, etc) or adjusting our old existing machinery. And we make a sample product. If the customer is satisfied then we describe the technological process for the "new" type of casing (keeping the "old" for other types of casing as needed). After that we go ahead with a full production.
Colleen said:
So this new exerimental production line of casing is done in parallel with what we have done according to the original technology. Perhaps we could exclude this new line from the scope of the quality system if it indeed requires D&D??

