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Different types of Design and Development - AS9100C Clause 7.3

R

Rockanna

#1
I need help. We have different types of design and development at our facility. We have simple designs with not much information given to start the project and the very detailed scopes of work.
1. How do we write a procedure for AS9100C to capture simple versus detail?
2. Is there an information available as what is considered a modification to an existing product? Once the design project is completed and you are asked to change a component within the first design, is it a change or a new design?

I appreciate any help you can provide on this subject. We have a very short time to create a document for compliance to AS9100C. Of course, the PE group I am working with is hesitant to do anything more than they need to.
 
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howste

Thaumaturge
Super Moderator
#2
I need help. We have different types of design and development at our facility. We have simple designs with not much information given to start the project and the very detailed scopes of work.
1. How do we write a procedure for AS9100C to capture simple versus detail?
Although a documented procedure is not required in AS9100 for design, most design-responsible organizations probably should have one. Since the design and development requirements in AS9100 don't change by product, the basics need to be considered for any product being developed. Because sometimes the "inputs" are clearly specified and sometimes they're not, I'd suggest that the procedure include how to come up with the product information that is not specified by the customer (see 7.2.1, 7.3.2). The rest of the process should be very similar.
2. Is there an information available as what is considered a modification to an existing product? Once the design project is completed and you are asked to change a component within the first design, is it a change or a new design?
Does it matter if it's a new design or a modification? If you look at clause 7.3.7, a design change requires inputs, outputs, review, verification, and validation just like a new design would. The main point to consider is this: if the design affects product in the field or components already developed, then they would also need to be considered.
I appreciate any help you can provide on this subject. We have a very short time to create a document for compliance to AS9100C. Of course, the PE group I am working with is hesitant to do anything more than they need to.
As mentioned above AS9100 doesn't specifically require a documented design procedure, but you probably need one anyway (see 4.2.1d). They absolutely shouldn't do anything they don't need to do. The design procedure should address all of the things necessary to ensure a robust product that meets customer needs with minimal risks, while also meeting AS9100 requirements.
 

Big Jim

Super Moderator
#3
Your company gets to define where modification of an old design ends and new design begins. The pertinent portions of the standard are 7.3.2 c "These inputs shall include . . . where applicable, information derived from previous designs . . . " and 7.3.7 already quoted by Howste.

As for how to handle designs of different complexity, no two projects are really alike, so you are doing it anyway. My main suggestion is to use a good design checklist to help guide you through it. Don't forget that of the seven topics in element 7.3, five of them require keeping records, and for that matter, you will probably have records for the other two anyway. A design checklist provides guidance on keeping those records and provides a place to either keep them or reference them.
 
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