Design and Development Changes: A Comprehensive Guide to Control and Implementation

Design and development changes occur throughout the entire cycle of design, development, production, and support. Design and development personnel should correctly identify and assess the impact of design changes on raw material usage, production processes, usability, safety, reliability, and other aspects of the product.\n\nDuring the design process, design personnel can directly modify (with signature) or recompile and issue the corresponding technical documents and materials on the technical files and materials.\n\nFor products that have already been produced, the relevant proposer should notify the technical department, and the relevant design personnel should fill out the change notice form with relevant information based on feasibility and necessity, which will be reviewed by the supervisor.\n\nThe execution of design and development changes should be carried out in accordance with the "Engineering Specifications and Change Control Specification" and the "Documented Information Control Specification".\n\nWhen changes involve major technical parameter changes or are related to personal safety and environmental protection legal requirements, appropriate verification and confirmation should be conducted, and they can only be implemented after approval by the general manager.\n\nRelated design personnel and departments:\n- QD8.3.2 Engineering Specifications and Change Control Specification\n- Change Notice Form 6\n- Documented Information\n - 6.1 QD7.5.1-2021 "Documented Information Control Specification"\n - 6.2 QD8.3.2-2021 "Engineering Specifications and Change Control Specification"\n - 6.3 Other records can be found in the attachment.\n\nModification Column:\nSerial Number Page Number Modification Content Modification Date Implementation Date Approval Prepared by: Reviewed by: Approved by: Date: Date: Date: Attachment: Design and Development Master Plan - Product + Process Design - 71 tables\nQR8.1-01 Operation Plan and Control Plan\nQR8.1-02 Quality Plan\nQR8.1-03 Confidential Inspection Record\nPhase One: Planning and Project Determination\nQR8.3-21 Engineering Specification Review Comments\nQR8.3-42 Workshop Layout Management Diagram Inspection Form\nQR8.3-62 Capacity Analysis Report\nQR8.3-01 Design and Development Master Plan\nQR8.3-22 Product Error-proofing Checklist\nQR8.3-43 Process Flowchart\nQR8.3-63 Initial Process Capability Study Report\nQR8.3-02 Product Development Project Proposal\nQR8.3-23 Manufacturability and Assemblability Design\nQR8.3-44 Product and Process Special Characteristics List\nQR8.3-64 Process Parameters Testing Record\nQR8.3-03 New Product Development Plan\nQR8.3-24 Mold Configuration Application Form\nQR8.3-45 Characteristic Matrix Chart\nQR8.3-65 Trial Production Validation Test Report\nQR8.3-04 Design Task Book\nQR8.3-25 Mold Design Task Book\nQR8.3-46 Trial Production Control Plan\nQR8.3-66 Production Control Plan\nQR8.3-05 APQP Team Members and Responsibilities Skills Table\nQR8.3-26 Mold Manufacturing Quotation\nQR8.3-47 Production Equipment List\nQR8.3-67 Parts Submission Guarantee Certificate\nQR8.3-06 Initial Material List\nQR8.3-27 Mold Supplier Evaluation Form\nQR8.3-48 Inspection Equipment List\nQR8.3-68 Product Quality Planning Summary and Approval\nQR8.3-07 PQP Planning Phase Review Report\nQR8.3-28 Mold Processing Contract\nQR8.3-49 Process Specification Review Report\nQR8.3-69 APQP Trial Production Phase Review Report\nPhase Two: Product Design and Development\nQR8.3-29 Mold Tracking Review Acceptance Record\nQR8.3-50 Process Operation Instructions\nPhase Five: Feedback, Evaluation, and Improvement\nQR8.3-08 Product Design and Development Input Review\nQR8.3-30 Prototype Sample Inspection Summary Report\nQR8.3-51 Measurement System Analysis Plan (Process Capability Study Cpk)\nQR8.3-09 DFMEA\nQR8.3-31 Design and Development Verification Record\nQR8.3-52 Initial Process Capability Study Plan (Quality, Cost, Capacity, etc. Data)\nQR8.3-10 Product Special Characteristics List\nQR8.3-32 Design and Development Confirmation Record\nQR8.3-53 Packaging Operation Instructions (Packaging Specifications)\nQR8.3-11 3D Drawing\nQR8.3-33 Design and Development Change Record\nQR8.3-54 OTS Sample Full-size Report\nQR10.2-01 8D Report\nQR8.3-12 Design and Development Review\nQR8.3-34 Feasibility Commitment by Team\nQR8.3-55 OTS Sample Material Test Results\nQR10.3-01 Continuous Improvement Plan\nQR10.2-02 Corrective and Preventive Measures Table\nQR8.3-13 Assembly Drawing, Part Drawing, Assembly Drawing\nQR8.3-35 Product Design and Development Output Review\nQR8.3-56 OTS Sample Performance Test Results\nQR9.1-02 Customer Satisfaction Survey Form\nQR8.3-14 Product Assurance Plan\nQR8.3-36 APQP Product Design Phase Review Report\nQR8.3-57 Process Design and Development Output Review\nQR9.1-04 Customer Satisfaction Statistical Analysis Report\nQR8.3-15 Design Verification Plan\nPhase Three: Process Design and Development\nQR8.3-58 APQP Design Phase Review Report\nQR6.2-03 Process Performance Indicator Statistics Table\nQR8.3-16 Sample Control Plan\nQR8.3-37 Product/Process Quality System Review\nPhase Four: Product and Process Confirmation\nQR8.3-70 Engineering Change Request Form\nQR8.3-17 New Equipment Tooling and Test Equipment Inspection Form\nQR8.3-38 Process Design and Development Input Review\nQR8.3-59 Trial Production Plan\nQR8.3-71 Engineering Change Notice\nQR8.3-18 New Equipment Tooling and Test Equipment Development Plan Progress Table\nQR8.3-39 PFMEA Form\nQR8.3-60 Trial Production Preparation Checklist (Confirm Equipment, Tooling, Personnel)\nQR8.3-72 Embedded Software Development Evaluation Form\nQR8.3-19 Product Safety Protection Form\nQR8.3-40 Product Characteristic Importance Level Classification Table\nQR8.3-61 Trial Production Summary Report\nQR8.3-20 Product Material Usage Specification Table (BOM)\nQR8.3-41 Workshop Layout Management Diagram\nQR7.1.5-06-10 Measurement Resource Analysis Report