Re: Prepare for design input documents
hello,i am prepare for a product's quality documents.
i have no idea of the following item.is there anyone can help me?
"documents difining the design input requirements"
thank you!
Judy,
You should have a procedure (SOP) in place which follows the standard requirements, for example in mine in the Design & Development Inputs section states:
The design input requirements (listed below) must be clearly defined and documented to preclude the possibility of any deviations. The design input will include:
•Customer/Market requirements and specifications, and where applicable, information from similar designs.
•Tolerances as specified.
•Conformance to regulations and legislative requirements, which will be documented to the requirements of 93/42/EEC Council Directive and the relative product regulatory standards.
•Results of risk management analysis performed.
•Evidence of the product functional, performance, safety and reliability requirements according to intended use under normal conditions.
•Material specifications, cost, lead times, special tooling, manufacturing processes, installation and servicing.
•Relevant documentation, which will be verified by the Product & Design Manager and/or the Quality Assurance Manager.
i.e. it covers section 7.3.2
I hope this helps.
Steve