Design and development planning in AS9100 standard
Design and development planning in AS9100 standard
Clause 7.3.1
The organization shall plan and control the design and development of product. During the design and development planning, the organization shall determine
a) the design and development stages,
- in respect of organization, task sequence, mandatory steps, significant stages and method of configuration control,
b) the review, verification and validation that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.
Where appropriate, due to complexity, the organization shall give consideration to the following activities:
- structuring the design effort into significant elements;
- for each element, analyzing the tasks and the necessary resources for its design and development. This analysis shall consider an identified responsible person, design content, input data, planning constraints, and performance conditions. The input data specific to each element shall be reviewed to ensure consistency with requirements.
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
The organization shall manage the interfaces between all groups involved with software development to ensure effective communication and clear assignment of responsibility.
Planning output shall be updated, as appropriate, as the design and development progresses.
The different design and development tasks to be carried out shall be defined according to specified safety or functional objectives of the product in accordance with customer and/or regulatory authority requirements.
Development planning shall address at a minimum the following items:
a. The definition of the project, including a statement of its objectives and reference to any related customer or organization projects and requirements.
b. The definition of input and output products of the project as a whole.
c. The organization of the project resources, including the team structure, responsibilities, use of subcontractors, and material resources to be used.
d. Identification of standards, rules, practices, conventions, tools, and techniques for development; configuration controls placed on tools; configuration management practices; method of controlling nonconforming products; methods of controlling software used to support development; procedures for archiving, backup, and recovery, including contingency planning; and methods of control for virus protection.
e. Planning such as quality, risk management, configuration management, integration, test, installation, migration, training, maintenance, and reuse.
f. Reliability, maintainability, and safety.
g. Schedules including the phases of the project; the work to be performed, the associated resources and timing; the associated dependencies; the milestones.
h. Software process improvement.
The organization shall have a documented process in place for evaluating and approving use of non-developmental software (e.g., COTS, re-engineered, reused/previously developed).
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