你是公司的一名译者请你用准确忠实的英语翻译以下内容并且按照原文格式和断句进行排版。设计开发更改 1、设计开发的更改发生在设计开发生产和保障的整个周期中设计开发人员应正确识别和评估设计变更对产品的原材料使用生产过程使用性能安全性可靠性等方面带来的影响 2、在设计过程中的产品设计人员可在技术文件和资料上直接进行修改需签名或重新编制并发放相应的技术文件和资料 3、已经生产过的产品由相关建议人通知给技术部

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.

During 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.

For 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.

The 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".

When 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.

Related design personnel and departments:

• QD8.3.2 Engineering Specifications and Change Control Specification
• Change Notice Form 6
• Documented Information 6.1 QD7.5.1-2021 "Documented Information Control Specification"
• 6.2 QD8.3.2-2021 "Engineering Specifications and Change Control Specification"
• 6.3 Other records can be found in the attachment.

Modification Column: Serial 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 QR8.1-01 Operation Plan and Control Plan QR8.1-02 Quality Plan QR8.1-03 Confidential Inspection Record Phase One: Planning and Project Determination QR8.3-21 Engineering Specification Review Comments QR8.3-42 Workshop Layout Management Diagram Inspection Form QR8.3-62 Capacity Analysis Report QR8.3-01 Design and Development Master Plan QR8.3-22 Product Error-proofing Checklist QR8.3-43 Process Flowchart QR8.3-63 Initial Process Capability Study Report QR8.3-02 Product Development Project Proposal QR8.3-23 Manufacturability and Assemblability Design QR8.3-44 Product and Process Special Characteristics List QR8.3-64 Process Parameters Testing Record QR8.3-03 New Product Development Plan QR8.3-24 Mold Configuration Application Form QR8.3-45 Characteristic Matrix Chart QR8.3-65 Trial Production Validation Test Report QR8.3-04 Design Task Book QR8.3-25 Mold Design Task Book QR8.3-46 Trial Production Control Plan QR8.3-66 Production Control Plan QR8.3-05 APQP Team Members and Responsibilities Skills Table QR8.3-26 Mold Manufacturing Quotation QR8.3-47 Production Equipment List QR8.3-67 Parts Submission Guarantee Certificate QR8.3-06 Initial Material List QR8.3-27 Mold Supplier Evaluation Form QR8.3-48 Inspection Equipment List QR8.3-68 Product Quality Planning Summary and Approval QR8.3-07 PQP Planning Phase Review Report QR8.3-28 Mold Processing Contract QR8.3-49 Process Specification Review Report QR8.3-69 APQP Trial Production Phase Review Report Phase Two: Product Design and Development QR8.3-29 Mold Tracking Review Acceptance Record QR8.3-50 Process Operation Instructions Phase Five: Feedback, Evaluation, and Improvement QR8.3-08 Product Design and Development Input Review QR8.3-30 Prototype Sample Inspection Summary Report QR8.3-51 Measurement System Analysis Plan (Process Capability Study Cpk) QR8.3-09 DFMEA QR8.3-31 Design and Development Verification Record QR8.3-52 Initial Process Capability Study Plan (Quality, Cost, Capacity, etc. Data) QR8.3-10 Product Special Characteristics List QR8.3-32 Design and Development Confirmation Record QR8.3-53 Packaging Operation Instructions (Packaging Specifications) QR8.3-11 3D Drawing QR8.3-33 Design and Development Change Record QR8.3-54 OTS Sample Full-size Report QR10.2-01 8D Report QR8.3-12 Design and Development Review QR8.3-34 Feasibility Commitment by Team QR8.3-55 OTS Sample Material Test Results QR10.3-01 Continuous Improvement Plan QR10.2-02 Corrective and Preventive Measures Table QR8.3-13 Assembly Drawing, Part Drawing, Assembly Drawing QR8.3-35 Product Design and Development Output Review QR8.3-56 OTS Sample Performance Test Results QR9.1-02 Customer Satisfaction Survey Form QR8.3-14 Product Assurance Plan QR8.3-36 APQP Product Design Phase Review Report QR8.3-57 Process Design and Development Output Review QR9.1-04 Customer Satisfaction Statistical Analysis Report QR8.3-15 Design Verification Plan Phase Three: Process Design and Development QR8.3-58 APQP Design Phase Review Report QR6.2-03 Process Performance Indicator Statistics Table QR8.3-16 Sample Control Plan QR8.3-37 Product/Process Quality System Review Phase Four: Product and Process Confirmation QR8.3-70 Engineering Change Request Form QR8.3-17 New Equipment Tooling and Test Equipment Inspection Form QR8.3-38 Process Design and Development Input Review QR8.3-59 Trial Production Plan QR8.3-71 Engineering Change Notice QR8.3-18 New Equipment Tooling and Test Equipment Development Plan Progress Table QR8.3-39 PFMEA Form QR8.3-60 Trial Production Preparation Checklist (Confirm Equipment, Tooling, Personnel) QR8.3-72 Embedded Software Development Evaluation Form QR8.3-19 Product Safety Protection Form QR8.3-40 Product Characteristic Importance Level Classification Table QR8.3-61 Trial Production Summary Report QR8.3-20 Product Material Usage Specification Table (BOM) QR8.3-41 Workshop Layout Management Diagram QR7.1.5-06-10 Measurement Resource Analysis Repor