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Foqus, Inc. has established and implemented the procedures and work instructions for the control and verification of the design of the product-service in order to ensure that the specified requirements are met.
The design process is used at Foqus, Inc. to develop and implement new product-services/processes and to control improvement or modification of an existing product-service/process.
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The design process is followed by a completion of multiple on-line documents. All the design phases are described in detail in QP-004.
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4.2 Design and Development Planning
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The design plan is developed for new product-service design and for a change to an existing product-service. The design plan describes each activity required and who is responsible for ensuring these activities are implemented. These activities are assigned to qualified personnel and appropriate resources are provided. The design plan is updated as each stage of design is completed or changed. The level of detail of the design plan is directly related to the complexity of the project. At minimum it identifies the responsible personnel assigned to the project and the estimated time line for completion of tasks. (See QP-004)
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4.3 Organizational and Technical Interfaces
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The organizational and technical interfaces between different groups which input into the design process are defined in design plan (See QP-004) so that the necessary information is documented, distributed and regularly reviewed with the appropriate personnel.
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| 4.4 Design Input |
The design-input requirements relating to the product-service are identified and documented. These include applicable statutory and regulatory requirements. Any conflicting requirements are identified and reviewed with those imposing the requirements prior to project approval.
Design input takes into consideration the results of any contract-review activities (See QP-004).
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| 4.5 Design Output |
The design-output is verified and documented and expressed in terms of design-input requirements in project documentation.
Design-output as a minimum:
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meets the design-input requirements
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| b) |
contains acceptance criteria;
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| c) |
identifies those characteristics of the design that are crucial to the proper functioning and performance of the product-service
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Personnel identified in the design plan review design-output documents.
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| 4.6 Design Review |
A final review is conducted as defined in QP-004. The participants at design review include representatives of all functions concerned with the design being reviewed, as well as other specialist personnel, as required. Records of design documentation and reviews are maintained as described in QP-016.
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| 4.7 Design Verification |
Design verification is performed to ensure that the design output meets the design-input requirements. The design verification measures are recorded. Records of design verification are maintained as part of project documentation and as described in QP-016.
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| 4.8 Design Validaation |
Design validation is performed when user requirements are specified. The financial results and customer satisfaction are monitored to ensure that the design was effective.
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| 4.9 Design Changes |
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All design changes and modifications are identified, documented, reviewed, and approved by authorized personnel before their implementation (See QP-004).
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