你是一名优秀的翻译请用比较正式的英语表达翻译以下公司的文件并按照原文格式排版。45外协加工过程控制 451外协加工供应商如选择必须在合格供应商范围内进行。 452外协加工应规定质量要求、验收标准和方法、交货日期、交货地点、加工价格等要求应遵守采购技术规范书、采购协议等。 453品质部应对外协产品的加工质量过程必要时进行监督和控制与协力厂一同跟踪并填写《外协产品质量跟踪记录》已示对产品质量控制与品质
4.5 Outsourcing Process Control 4.5.1 If an outsourcing supplier is selected, it must be within the range of qualified suppliers. 4.5.2 The outsourcing should specify the quality requirements, acceptance criteria and methods, delivery date, delivery location, processing price, etc., and should comply with the procurement technical specifications and procurement agreements. 4.5.3 The Quality Department should supervise and control the processing quality of outsourced products if necessary, track and fill in the "Outsourced Product Quality Tracking Record" together with the cooperating factory, demonstrating the control of product quality and responsibility for quality traceability. 4.5.4 After the outsourced processed products enter the company, the Quality Department should conduct inspections according to the requirements specified in the drawings, and the entry procedures can only be completed after consulting relevant documents. 4.6 Purchase Data Management 4.6.1 The purchase documents mainly include the technical requirements of the purchased products, including the purchase plan and delivery schedule. The documents should reflect compliance with the product acceptance criteria. 4.6.2 When settling with the company, suppliers must return various technical information provided by the company to the procurement department, which will be kept by the relevant departments. 5. Monitoring of Suppliers 5.1 Compliance with regulations 5.2 Approval of customer-approved sources of supply 5.3 Quality of purchased products 5.4 Monitoring of suppliers, when necessary, the procurement department will organize personnel from the engineering department, quality department, etc. to visit the supplier's site to audit and guide their production and process control. 5.5 Control measures for external suppliers and their results, please refer to the "Control Measures for External Provision" table. 6. Relevant Documented Information 6.1 QD8.4.1 "Supplier Management Specification" 6.2 QD8.6.1 "Product and Service Release Control Specification" 6.3 QD8.7.1 "Nonconformity Control Specification" 6.4 QR8.4-12 "List of External Provision Process Products and Services" 6.5 QR8.4-13 "Procurement Technical Specifications" 6.6 QR8.4-14 "Purchase Plan" 6.7 QR8.4-15 "Purchase Requisition" 6.8 QR8.4-16 "Purchase Order" 6.9 QR8.4-17 "Supplier Quality System Development Plan" 6.10 QR8.4-18 "Control Measures for External Provision" 6.11 QR8.4-19 "Outsourced Product Quality Tracking Record" 6.20 QR8.5.4-05 "Goods In and Out Ledger"
Attachment 1: Control Flow Chart for External Provision Process Products and Services:
- Flow
- Related Forms
- Responsibility Unit
Flow: Proposal of outsourcing process product and service requirements Related form: Internal requisition form Responsibility unit: Requisition department
Flow: Supplier capability investigation form Related form: Administrative department procurement/quality department Responsibility unit: Administrative department procurement/quality department
Flow: Preparation of relevant documents Related forms: Supplier evaluation form, qualified supplier list, purchase plan or requisition form Responsibility unit: Procurement department
Flow: Inquiry and quotation Decision on supplier Purchase order Responsibility unit: Procurement department
Flow: Purchase Purchase technical specifications Purchase order Processing requirements, technical drawings Responsibility unit: Procurement department
Flow: Follow-up and expedite Follow-up by phone or written notification Responsibility unit: Procurement department
Flow: Arrival Supplier delivery note Incoming inspection report Responsibility unit: Quality department
Flow: Incoming acceptance Responsibility unit: Quality department/procurement department
Flow: Nonconforming Responsibility unit: Procurement/related departments
Flow: Acceptance Return Responsibility unit: Procurement
Flow: Acceptance with concession Responsibility unit: Quality department/procurement
Flow: Receipt Manufacturing process monitoring and control specifications Purpose: To monitor the manufacturing process of the quality management system and measure it when applicable to ensure that the process achieves the planned results. When the planned results are not achieved, appropriate corrective and preventive measures should be taken to ensure product conformity. Scope: Applicable to monitoring and measuring control of all manufacturing processes in the company's quality management system. Responsibilities:
- The general manager is responsible for the centralized management of manufacturing process monitoring and measurement activities.
- Relevant departments are responsible for monitoring and measuring the manufacturing process.
- Necessary improvement measures should be taken by relevant departments based on the monitoring and measuring results of the manufacturing process. Workflow and content:
- Relevant departments should use appropriate methods to monitor and measure the processes under their responsibility, and confirm the ability of the processes to achieve the planned results through measurement when necessary. When the planned results are not achieved, appropriate corrective and preventive measures should be taken to ensure product conformity.
- Depending on the characteristics of the process, monitoring methods applicable to the manufacturing process should be given priority, such as process research, internal audit of manufacturing, routine supervision, inspections by department heads, regular reviews, performance evaluations, statistical summary of process measurement indicators, statistical techniques, etc. If necessary, measurement tools can be used to determine values. Workflow:
- Approval of monitoring specifications and plans
- Process research
- Process capability maintenance
- Process event recording
- Monitoring of product process parameters
- Response plan Related departments: Production, Technology, Quality Responsibility unit: General Manager, Technology Department, Production Department, Quality Department Work content:
- Develop "Manufacturing Process Monitoring and Control Specification", "Process Capability Research Plan", "Manufacturing Process Capability Analysis Ppk, Cpk, Cmk", "Production Service Process Control Specification", "Facility Control Specification", "Production Tooling Management Specification", "Preventive Predictive Maintenance Specification", etc.
- Develop "Production Control Plan", "Process Flowchart", "Routine Inspection Specification", "Sampling Inspection Specification", "Zero Defect Management Plan - Acceptance Criteria", etc.
- Record important process events, especially tooling replacement, machine repairs, production stoppages due to faults, etc.
- Determine manufacturing process parameters and product characteristics, establish "Process Parameter Specification", "In-Process Monitoring Specification", and conduct process monitoring for operation preparation verification, key processes, and special processes.
- Control the flow of products, conduct 100% inspection, perform root cause analysis, and implement corrective measures. Forms used:
- "Initial Process Capability Research Plan"
- "Initial Process Capability Analysis Report"
- "Equipment Preventive Predictive Maintenance Plan"
- "Equipment Repair Maintenance Record"
- "X-R Control Chart"
- "Process Monitoring and Measurement Record"
- "Job Completion Acceptance Record"
- "Operation Preparation Verification Record"
- "Process Monitoring Record"
- "Nonconforming Product Handling Form"
- "Product Inspection Record"
- "Corrective Measures Form
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