(1) Design and development of quality control procedures

 

1. Purpose                                

 

Through the control of the entire design and development process, ensure that the product design can meet the needs and expectations of customers and meet the requirements of relevant national laws, regulations and standards.

 

2) Procedure

 

l Design and development planning

 

The source of the design and development project and the basis for project establishment are the new product contract or technical agreement signed with the user; market information and new product requirements; the approved "design development review report" as the basis for project establishment and design and development planning.

 

l Design input

 

The "Design Plan Task Book" should specify the following:

 

a. Product name (model specifications), function description, main technical parameters and performance indicators (including the outline installation dimensions and main component structure requirements);

 

b. Applicable relevant standards, laws, regulations, special requirements of customers and social needs;

 

c. Relevant requirements of previous similar designs and other requirements necessary for design and development, such as safety, protection, environmental, and economic requirements;

 

l Design output (draft)

 

Prepare the corresponding preliminary design draft: including drawings and documents to guide production, inspection and other activities, such as final assembly drawings, assembly drawings, parts drawings, schematic drawings, standard parts, outsourced purchases and lists, and product inspection standards Ensure that major design features related to product production, acceptance, use, maintenance, and safety have been clarified or identified and meet design input requirements.

 

l Design review

 

The design review shall explain the suitability of design output, key points, areas of existing problems, and possible deficiencies; the content of the review includes compliance with standards, feasibility of processing, maintainability, testability, structural rationality, and aesthetics And environmental impacts, etc., make assessment conclusions, and take corresponding corrective or improvement measures.

 

l Trial production and design verification

 

Verify or calculate each technical parameter or performance index of the prototype, and take corresponding corrective or improvement measures for problems found in the design verification process.

 

l Design confirmation

 

Acceptance and evaluation of the prototype, and propose a process of satisfaction with the product's compliance with standards or contract requirements

 

Degree and appraisal of product suitability, according to the submitted "new product appraisal report", take corresponding corrective or improvement measures when necessary.

 

l Design draft (design finalization)

 

During the design review and design verification process, each designer must gradually improve the corresponding first draft of the design. After the design is confirmed (design finalized), all the design output files are organized into original drafts and sent to the archives for archiving.

 

l Design changes

 

Designers need to correctly evaluate the impact of design changes on the product's raw material use, production process, performance, safety, and reliability.

 

When design changes involve changes in main technical parameters and performance indicators, or related to personal safety and related regulatory requirements, the changes should be properly reviewed and verified before implementation.