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GoodDog.Net 9/19/2K

Design Control

Our network of technical resources utilizes the eight key elements of ISO 9001 Design Control as a guideline to successfully ensure customers design intent is met!

• DESIGN INPUT
• DESIGN PLANNING
• DESIGN REVIEW
• TECHNICAL RESOURCE ORGANIZATION
• DESIGN VERIFICATION
• DESIGN OUTPUT
• DESIGN CHANGES
• PRODUCT VALIDATION

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Design Input

All design input such as performance requirements (Product Specification), project scheduling and cost are maintained and documented in a product brief. All changes must be approved by the customer when the initially-stated design intent is affected.

The product brief is also used as a checklist for all formal design reviews and in the preparation production scale up.

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Design Planning

Design activities are identified, scheduled, and assigned resource requirements. For each assignment, design requirements and the source of design input and output are identified. Verification activities including reviews and document and drawing release dates are scheduled. The design plan specifies dates and resource requirements to completion of activities.

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Design Review

Design reviews are conducted at predetermined design stages and are scheduled in the design project plan. The purpose of design reviews is to audit and assess how well the design meets design intent. Another important function is to trace progress of design verification and validation activities. The product brief is used as one of the checklists for this evaluation.

The final design review is for the costumer to approve the design and authorize its release to trial production and validation.

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Technical Resources Organization

Our network is responsible for obtaining, documenting, transmitting, and regularly reviewing the necessary design input information. We also coordinate the product design-related activities of the suppliers and vendors.

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Design Verification

At agreed upon stages of the design, scheduled into the project plan, design verification shall be performed and results recorded. Design verification may include comparison to existing product designs, analytical system analysis and/or building and testing prototypes. Prototype testing should be planned and documented in prototype phase of the project. Prototype testing focuses on process capability and verification that the design satisfies the expected user needs and requirements with regard to special characteristics and performance, including product life, reliability, and durability.

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Design Output

All design output is documented and reviewed by the customer to verify that it meets, if not exceeds the design intent.

Primary design output consists of documents that define the product, instruct how to manufacture and related costs of resources and capitol equipment. These documents may include drawings, specifications, procedures, workmanship standards, acceptance criteria, etc. Characteristics that are crucial to the safe and proper functioning of the product, as well as customer-specified special characteristics, are identified also.

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Design Changes

As a new product design project evolves, preliminary studies, additional input, design reviews, and prototype testing, may identify the need for design changes. Required or desirable design changes are reviewed with and authorized by the customer. All design changes are reviewed with the customer prior to release of the design. Design changes are not implemented without written approval from Customer.

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Product Validation

The purpose of product validation is to demonstrate that the design conforms to customer defined needs and requirements and performs satisfactorily under real or simulated conditions of intended and unintended use. Validation follows successful design verification and includes:

- inspection and testing of finished products from the production trial run;

- confirmation of production processes and readiness for mass production;

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