AS9100C Clause 7.3 Design & Development - Designing a System and Procedures

[rreinholt]

I have been tasked to get our company AS9100C certified ASAP. I have encountered an issue with our design and development procedure as we need it to incorporate our process for Models/Mock-Ups, Prototype, and final flight ready products. My management wants a system that allows minimal documentation/verification (purchasing, mfg, Test, etc.) for the Models/Mock-Ups & Prototypes but also a full design inputs, validation and verification process for the flight products.
Can I have a system that incorporates two flows for what seems to an outsider as the same design process and still adhere to the spirit of AS9100?

[Big Jim]

When you get right down to it, every design project is different. Depending on the nature of the company and its products, the variability can be slight or great. Just make your system flexible enough to accommodate what you are trying to do.

You may find it useful to develop a design checklist, and for that matter to even have more than one, depending on the complexity of design.

Most important of all though is that there are five topics in design and development that require records, so make sure that those five topics always have records.

You can easily find those five topics. As you look through element 7.3, look for (4.2.4).

[Jeff Frost]

The first part of the process of developing an AS9100C Design and Development compliant system is to gather all current documents and forms that your organization is now using. Review them and then develop a flow chart of the process. You may find that the system is somewhat disjointed but because of customer requirements may already meet many of the AS9100 requirements.

As part of your comparison of the current system to the AS9100C requirements make sure you review the terms and definitions in Section 3 of the standard. Your organization will be held to these terms and definitions during the registration audit. Here are some examples:

3.3, Critical items is referenced in 7.3.3.e, Design and Development Outputs

3.4, Key Characteristics is referenced in 7.3.3.e, Design and Development Outputs

Also your control of design and development changes referenced in Clause 7.3.7 must also include configuration management per Clause 7.1.3. You may also find it helpful to obtain ISO 10007, QMS-Guidelines for Configuration Management.