Design and development outputs in AS9100 standard
Design and development outputs in AS9100 standard
Clause 7.3.3
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.
Design and development outputs shall
a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production and for service provision,
c) contain or reference product acceptance criteria,
d) specify the characteristics of the product that are essential for its safe and proper use, and
e) identify key characteristics, when applicable, in accordance with design or contract requirements.
All pertinent data required to allow the product to be identified, manufactured, inspected, used and maintained shall be defined by the organization; for example:
- drawings, part lists, specifications;
- a listing of those drawings, part lists, and specifications necessary to define the configuration and the design features of the product;
- information on material, processes, type of manufacturing and assembly of the product necessary to ensure the conformity of the product.
For software, design and development includes all activity from planning to product delivery.
For software, the required output from the design and development activities shall be defined and documented. The following are examples of documentation that should be reviewed for correctness, completeness, and consistency with the requirements:
a. Architectural design.
b. Detailed design.
c. Source code.
d. User guides.
e. Software version description.
f. Updated risk assessment.
g. Assurance and safety assessments.
h. Integration and test procedures.
i. Make-buy/trade studies.
j. Final test plans.
k. Coding standards and conventions.
l. External interface control documents.
m. Test tool configuration, test data, test scripts and test drivers/stubs.
There shall be evidence that design and development outputs have been coordinated with the customer as required by contract.
For software, key characteristics may include but not be limited to stability of requirements, stability of code size, defect levels, defect containment, cyclomatic complexity, memory and timing utilization or other product and process characteristics that have the potential to adversely impact development costs and schedules, specified performance, maintainability, safety, reliability or other customer expectations.
The organization shall determine the software key characteristics that are appropriate for the software product and process.
Appropriate measures of the key characteristic shall be established and used to manage or track the characteristic during the life cycle.
Levels or thresholds shall be established and action taken to mitigate adverse trends of the selected key characteristics.
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