I was wondering if anyone had a very basic manufacturing format for Design and Development. I am currently revising our process and I am struggling with the definitions of the terms and who should be responsible for each (inputs, outputs, etc.). I have read other posts but didn't really find the answer I was looking for. I would appreciate any help.

The basic format is defined in Section 7.3 Design and Development from 7.3.1 to 7.3.7

Everything necessary for D&D is performed within those requirements.

You're going to get a lot of answers but they are all going to boil down to meeting the requirements as provided.

The defining of responsibilities is up to you to suit your needs, use whatever job titles you want, there isn't any right or wrong. It's you system, use what you want and don't dwell on what others do or try to make others happy.

Quality system related terms are clearly defined in ISO 9000:2005


Where you at in Arkansas?

The problem I am having is deciding which process to list for each requirement. We have processes that could be inputs or outputs. And I was also not sure if we should be the ones to validate or should our customers?

Flippin actually. Home of Ranger Boats as most people know it.

What type of products do you manufacture?

You gotta understand that an output of one thing may very well be the input into another. What has to be done is the management of the linkage between them. You are not suffering under something unique.

You entire organization is nothing more than a single large process transforming inputs into outputs and containing multiple smaller processes doing exactly the same thing. Each "process" may have one or more inputs that must be converted into one or more outputs which may or may not need to be fed into another "process".

To easily understand what I am talking about just get a box of Jello (preferably cherry), look at the picture on the front...that is the desired output. Turn the box over and read the instructions. You will see the necessary inputs, the "product realization process", the monitoring and measuring requirements and the desired end result and hopefully customer satisfaction is the result.

What you guys do is not different than making that Jello, it's just a bit bigger with a few more extras.

We are an injection molding company with numerous different product lines.

Sorry I should have asked before what industry do you make parts for?

Electronics and medical mostly.