Product Safety Control Procedure: Ensuring Effective Management of Safety Requirements

To ensure effective control over product safety and related manufacturing processes.\n\nScope: Applicable to process control related to product safety within the company.\n\nResponsibilities:\n3.1 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.\n3.2 Each department is responsible for identifying and controlling the requirements related to product safety within their respective scope of responsibility.\n\nProcess Flowchart for Product Safety Control, see attachment.\n\nWorkflow:\n- Identify legal and regulatory standards requirements for product safety.\nThe 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."\n- Notify customers of the above requirements.\nFor 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.\n- Special approval for Design Failure Mode and Effects Analysis (DFMEA).\nThe Technical Department conducts DFMEA analysis for relevant product safety characteristics and grants special approval.\n- Identify product safety characteristics.\nThe 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."\n- Identify and control safety-related characteristics from a product and manufacturing perspective.\nDuring 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.\n- Special approval for control plans and Process Failure Mode and Effects Analysis (PFMEA).\nAfter 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.\n- Develop reaction plans.\nIn control plans, establish reaction plans for possible errors or variations.\n- Define responsibilities, escalation processes, and information flow, including customer notifications, involving top management.\nFor 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."\n- Training for personnel involved in product safety-related products and manufacturing processes as determined by the company or customers.\nThe responsible person for human resources is responsible for developing and implementing training programs.\n- Approval of changes to products or processes, including evaluation of potential impacts on product safety resulting from changes to processes and products.\nRefer to the identified sources of product safety requirements and complete the "Product Safety Requirement Identification and Control Evaluation Checklist."\n- Transfer of product safety requirements throughout the entire supply chain, including customer-specified sources.\nImplement according to the "Product Safety Requirement Identification and Control Evaluation Checklist," involving the procurement department and incorporating them into procurement requirements.\n- Traceability of products throughout the entire supply chain by manufacturing batch.\nControl according to the "Identification and Control Specification for Traceability by Labeling."\n- Lessons learned from the introduction of new products.\nConsider safety requirements based on the experience of safety requirements for existing and similar products for each new product development, aiming to improve work efficiency.\n\nRelated Documents:\n6.1 QD8.1.1-2021 "Project Management and APQP Control Specification"\n6.2 QD8.3.1-2021 "Design and Development Control Specification"\n\nRelated Records:\n7.1 QR4.4-03 "Product Safety Requirement Identification and Control Evaluation Checklist"\n\nAttachment: Product Safety Control Flowchart\n\nProcess Document Information Operating Department\na. Identify legal and regulatory product safety requirements "Product Safety Requirement Identification and Control Evaluation Checklist" Technical Department\nb. Notify customers of the above requirements Notify customers Technical and Sales Departments\nc. Identify customer requirements "Product Safety Requirement Identification and Control Evaluation Checklist" Technical and Sales Departments\nd. Special approval for DFMEA "DFMEA" Technical Department\ne. Identify product safety characteristics "Product Safety Requirement Identification and Control Evaluation Checklist" Technical Department\nf. Control safety-related characteristics "Work Instructions" Technical and Production Departments\ng. Special approval for control plans and PFMEA "Production Control Plan" "PFMEA" Technical Department\nh. Define reaction plans "Control Plan" Technical Department\ni. Define responsibilities, escalation processes, and information flow "Product Safety Requirement Identification and Control Evaluation Checklist" Technical Department, Human Resources Department\nj. Product safety training "Training Records" Technical Department\nk. Evaluation of potential impacts of changes "Product Safety Requirement Identification and Control Evaluation Checklist" Technical and Quality Departments\nl. Customer-specified sources Evidence of customer-specified sources Technical and Sales Departments\nm. Supply chain traceability "Labeling Traceability Control Specification" Technical Department\nn. Lessons learned from new product introductions "Feasibility Analysis for New Product Development" Technical Department