z作为一名优秀的翻译请使用正确且正式的英语表达翻译以下公司文件内容并按照原文格式排版。目的： 为了确保产品安全相关的产品和制造过程进行有效控制。 适用范围： 适用于企业产品安全相关的过程控制。 职责： 31技术部门负责本规范的归口管理负责与产品安全相关的产品和制造过程要求的总识别、控制。 32各部门负责职责范围内的与产品安全相关要求的识别控制管理。 产品安全控制流程图见附件 工作流程 识别产品安全

To ensure effective control over product safety and related manufacturing processes.

Scope: Applicable to process control related to product safety within the company.

Responsibilities: 3.1 The Technical Department is responsible for the centralized management of this specification and for identifying and controlling the requirements of product safety and related manufacturing processes. 3.2 Each department is responsible for identifying and controlling the requirements related to product safety within their respective scope of responsibility.

Process Flowchart for Product Safety Control, see attachment.

Workflow:

• Identify legal and regulatory standards requirements for product safety. The Technical Department is responsible for collecting relevant legal and regulatory standards for product safety, including requirements and regulations issued by government authorities, and completing the "Product Safety Requirement Identification and Control Evaluation Checklist."
• Notify customers of the above requirements. For identified legal and regulatory requirements related to product safety, the Technical Department informs the sales department personnel to notify customers, ensuring customer understanding and timely compliance.
• Special approval for Design Failure Mode and Effects Analysis (DFMEA). The Technical Department conducts DFMEA analysis for relevant product safety characteristics and grants special approval.
• Identify product safety characteristics. The Technical Department organizes relevant departments such as quality, sales, procurement, and production to comprehensively identify product safety requirements and complete the "Product Safety Requirement Identification and Control Evaluation Checklist."
• Identify and control safety-related characteristics from a product and manufacturing perspective. During design and development, identify and determine the safety characteristics of the product considering production and manufacturing, and incorporate them into relevant control plans, FMEA, and work instructions for control.
• Special approval for control plans and Process Failure Mode and Effects Analysis (PFMEA). After the development and review of control plans, FMEA, and work instructions are completed, they are implemented after obtaining relevant leadership approval according to the process.
• Develop reaction plans. In control plans, establish reaction plans for possible errors or variations.
• Define responsibilities, escalation processes, and information flow, including customer notifications, involving top management. For product safety requirements, clarify the departments and individuals responsible for implementation, ensure effective communication of information, and ultimately communicate with top management and customers, completing the "Product Safety Requirement Identification and Control Evaluation Checklist."
• Training for personnel involved in product safety-related products and manufacturing processes as determined by the company or customers. The responsible person for human resources is responsible for developing and implementing training programs.
• Approval of changes to products or processes, including evaluation of potential impacts on product safety resulting from changes to processes and products. Refer to the identified sources of product safety requirements and complete the "Product Safety Requirement Identification and Control Evaluation Checklist."
• Transfer of product safety requirements throughout the entire supply chain, including customer-specified sources. Implement according to the "Product Safety Requirement Identification and Control Evaluation Checklist," involving the procurement department and incorporating them into procurement requirements.
• Traceability of products throughout the entire supply chain by manufacturing batch. Control according to the "Identification and Control Specification for Traceability by Labeling."
• Lessons learned from the introduction of new products. Consider safety requirements based on the experience of safety requirements for existing and similar products for each new product development, aiming to improve work efficiency.

Related Documents: 6.1 QD8.1.1-2021 "Project Management and APQP Control Specification" 6.2 QD8.3.1-2021 "Design and Development Control Specification"

Related Records: 7.1 QR4.4-03 "Product Safety Requirement Identification and Control Evaluation Checklist"

Attachment: Product Safety Control Flowchart

Process Document Information Operating Department a. Identify legal and regulatory product safety requirements "Product Safety Requirement Identification and Control Evaluation Checklist" Technical Department b. Notify customers of the above requirements Notify customers Technical and Sales Departments c. Identify customer requirements "Product Safety Requirement Identification and Control Evaluation Checklist" Technical and Sales Departments d. Special approval for DFMEA "DFMEA" Technical Department e. Identify product safety characteristics "Product Safety Requirement Identification and Control Evaluation Checklist" Technical Department f. Control safety-related characteristics "Work Instructions" Technical and Production Departments g. Special approval for control plans and PFMEA "Production Control Plan" "PFMEA" Technical Department h. Define reaction plans "Control Plan" Technical Department i. Define responsibilities, escalation processes, and information flow "Product Safety Requirement Identification and Control Evaluation Checklist" Technical Department, Human Resources Department j. Product safety training "Training Records" Technical Department k. Evaluation of potential impacts of changes "Product Safety Requirement Identification and Control Evaluation Checklist" Technical and Quality Departments l. Customer-specified sources Evidence of customer-specified sources Technical and Sales Departments m. Supply chain traceability "Labeling Traceability Control Specification" Technical Department n. Lessons learned from new product introductions "Feasibility Analysis for New Product Development" Technical Departmen