Re: Clause 7.3.3 Design and Development outputs - How Should I audit it?
I just created an 8-hour training course on Design and Development (7.3) and here's a piece of it on this subject. My friends here and others helped in the effort.
Outputs must meet the requirements of 7.2.1 a, b, c and d.
Examples of “7.2.1d - “characteristics of the product that are essential for its safe and proper use” are some wonderful things our legal system has brought us such as warning labels that are typically common sense like the shelf on step ladders that have the notice that says “Do not step here”. Other greats are the warning labels on lawn mowers telling you not to put your fingers under the deck while the mower is running; and the safety instruction on steam irons that tell you to “remove clothing before ironing”, whatever that means.
Some examples of design outputs are:
* Schematics
* Drawings
* Proposals, or statements of work (SOW’s) – as in the service
* Organizations
* Formulas
* Prototypes or models (an example of a design output, but not a traditional record)
Outputs should also include information that can allow verification and validation to planned requirements. Additional examples of the output of design and development may also be:
* Data demonstrating the comparison of process inputs to process outputs,
* Product specifications, including acceptance criteria,
* Process specifications,
* Material specifications,
* Testing specifications,
* Training requirements,
* User and consumer information,
* Purchase requirements,
* Reports of qualification tests.