质量问题发现和解决 Discovery and resolution of quality issues

gaowenhua

质量问题的“发现”机制

要解决问题，首先要能及时、全面地发现问题。以下是常见的质量问题发现途径：

发现渠道说明工具/方法
1. 来料检验（IQC）发现供应商原材料/零部件不合格抽样检验（AQL）、尺寸测量、功能测试
2. 过程检验（IPQC）生产过程中发现工艺偏差或半成品缺陷首件检验（FAI）、巡检、SPC监控
3. 成品检验（OQC）出货前发现整机或成品不符合标准全检或抽检、老化测试、包装检查
4. 客户投诉与退货市场端反馈使用问题，最具警示性CRM系统、8D报告、失效分析（FA）
5. 内部审核与飞检主动排查流程漏洞质量体系审核、飞行检查
6. 员工自检与互检一线员工在操作中发现问题5S管理、防错（Poka-Yoke）报警
7. 数据监控系统通过MES、QMS系统自动预警SPC控制图、不良率趋势分析

✅ 最佳实践：建立“全员质量意识”，鼓励员工上报质量问题（如“质量异常报告单”）。

The 'discovery' mechanism for quality issues
To solve problems, the first step is to be able to identify them in a timely and comprehensive manner. The following are common ways to discover quality issues:


Discovery Channel Description Tools/Methods
1. During incoming inspection (IQC), it was found that the supplier's raw materials/components were found to be non compliant. Sampling inspection (AQL), dimension measurement, and functional testing were conducted
2. Process Inspection (IPQC): First Article Inspection (FAI), patrol inspection, and SPC monitoring of process deviations or semi-finished product defects discovered during the production process
3. Finished product inspection (OQC): If the whole machine or finished product does not meet the standards before shipment, full inspection or random inspection, aging testing, and packaging inspection are required
4. Customer complaints and feedback on usage issues from the market side, including the most warning CRM system, 8D report, and Failure Analysis (FA)
5. Internal audit and proactive investigation of process vulnerabilities, quality system audit, and flight inspection
6. Employee self inspection and mutual inspection. Frontline employees discover problems during operation, 5S management, error prevention (Poka York) alarm
7. The data monitoring system automatically alerts SPC control charts and defect rate trend analysis through MES and QMS systems
✅  Best practice: Establish a 'quality awareness' among all employees and encourage them to report quality issues (such as' quality anomaly reports').

gaowenhua

质量问题的“解决”流程（8D / CAPA 框架）
推荐使用 8D问题解决法（8 Disciplines），广泛应用于汽车、电子、医疗等行业。

🔹 D1：成立团队（Team）
组建跨部门小组：质量、生产、技术、工程、采购等。
指定负责人（D lead）。
🔹 D2：问题描述（Describe the Problem）
使用 5W2H 方法清晰描述问题：
What：什么产品？什么缺陷？
Where：在哪个工序/客户处发现？
When：何时发现？批次号？
Who：谁发现的？
How：如何发现的？（测试失败、客户投诉）
How many：数量多少？不良率？
🔹 D3：实施遏制措施（Interim Containment Action）
目的：立即控制影响，防止问题扩大。
隔离在库品、暂停出货
对已发货产品进行风险评估
向客户提供临时解决方案（如补货、换货）
通知相关方（客户、销售、生产）
🔹 D4：根本原因分析（Root Cause Analysis）
这是最关键的一步，避免“治标不治本”。
5Why 分析法
鱼骨图（因果图）        从人、机、料、法、环、测六个维度系统分析
FMEA        检查设计或过程失效模式是否被识别
流程图分析        定位问题发生在哪个工序
🔹 D5：选择并验证纠正措施（Choose & Verify Permanent Correction）
确保措施能彻底消除根本原因
🔹 D6：实施永久纠正措施（Implement Permanent Correction）
更新文件：SOP、FMEA、控制计划
培训相关人员
监控执行情况
🔹 D7：防止再发（Prevent Recurrence
更新设计规范、工艺标准
优化供应商管理流程
纳入新员工培训内容
🔹 D8：团队表彰与总结（Congratulate the Team）
向管理层和客户汇报结果
关闭问题项




The "Solution" Process for Quality Issues (8D/CAPA Framework)
Recommend using the 8D problem-solving method (8 Disciplines), which is widely used in industries such as automotive, electronics, and healthcare.

🔹  D1: Establish a Team
Establish cross departmental teams: Quality, Production, Technology, Engineering, Procurement, etc.
Designated leader (D lead).
🔹  D2: Describe the Problem
Use the 5W2H method to clearly describe the problem:
What: What product? What defect?
Where: Found at which process/customer?
When: When was it discovered? Batch number?
Who: Who discovered it?
How: How was it discovered? (Test failure, customer complaint)
How many: How many? Poor rate?
🔹  D3: Implement Interim Containment Action
Purpose: To immediately control the impact and prevent the problem from escalating.
Quarantine inventory and suspend shipment
Conduct risk assessment on shipped products
Provide temporary solutions to customers (such as restocking, exchanging)
Notify relevant parties (customers, sales, production)
🔹  D4: Root Cause Analysis
This is the most crucial step to avoid treating the symptoms without addressing the root cause.
5Why analysis method
Fishbone diagram (causal diagram) systematically analyzes from six dimensions: human, machine, material, method, environment, and measurement
FMEA checks if design or process failure modes have been identified
Process diagram analysis identifies which process the problem occurred in
🔹  D5: Choose&Verify Permanent Correction
Ensure that measures can completely eliminate the root cause
🔹  D6: Implement Permanent Correction
Updated documents: SOP, FMEA, Control Plan
Training related personnel
Monitor the execution status
🔹  D7: Prevent Recurrence
Update design specifications and process standards
Optimize the supplier management process
Include new employee training content
🔹  D8: Congratulate the Team
Report the results to management and clients
Close the problem item

gaowenhua

质量问题的“解决”流程（8D / CAPA 框架）
推荐使用 8D问题解决法（8 Disciplines），广泛应用于汽车、电子、医疗等行业。

🔹 D1：成立团队（Team）
组建跨部门小组：质量、生产、技术、工程、采购等。
指定负责人（D lead）。
🔹 D2：问题描述（Describe the Problem）
使用 5W2H 方法清晰描述问题：
What：什么产品？什么缺陷？
Where：在哪个工序/客户处发现？
When：何时发现？批次号？
Who：谁发现的？
How：如何发现的？（测试失败、客户投诉）
How many：数量多少？不良率？
🔹 D3：实施遏制措施（Interim Containment Action）
目的：立即控制影响，防止问题扩大。
隔离在库品、暂停出货
对已发货产品进行风险评估
向客户提供临时解决方案（如补货、换货）
通知相关方（客户、销售、生产）
🔹 D4：根本原因分析（Root Cause Analysis）
这是最关键的一步，避免“治标不治本”。
5Why 分析法
鱼骨图（因果图）        从人、机、料、法、环、测六个维度系统分析
FMEA        检查设计或过程失效模式是否被识别
流程图分析        定位问题发生在哪个工序
🔹 D5：选择并验证纠正措施（Choose & Verify Permanent Correction）
确保措施能彻底消除根本原因
🔹 D6：实施永久纠正措施（Implement Permanent Correction）
更新文件：SOP、FMEA、控制计划
培训相关人员
监控执行情况
🔹 D7：防止再发（Prevent Recurrence
更新设计规范、工艺标准
优化供应商管理流程
纳入新员工培训内容
🔹 D8：团队表彰与总结（Congratulate the Team）
向管理层和客户汇报结果
关闭问题项




The "Solution" Process for Quality Issues (8D/CAPA Framework)
Recommend using the 8D problem-solving method (8 Disciplines), which is widely used in industries such as automotive, electronics, and healthcare.

🔹  D1: Establish a Team
Establish cross departmental teams: Quality, Production, Technology, Engineering, Procurement, etc.
Designated leader (D lead).
🔹  D2: Describe the Problem
Use the 5W2H method to clearly describe the problem:
What: What product? What defect?
Where: Found at which process/customer?
When: When was it discovered? Batch number?
Who: Who discovered it?
How: How was it discovered? (Test failure, customer complaint)
How many: How many? Poor rate?
🔹  D3: Implement Interim Containment Action
Purpose: To immediately control the impact and prevent the problem from escalating.
Quarantine inventory and suspend shipment
Conduct risk assessment on shipped products
Provide temporary solutions to customers (such as restocking, exchanging)
Notify relevant parties (customers, sales, production)
🔹  D4: Root Cause Analysis
This is the most crucial step to avoid treating the symptoms without addressing the root cause.
5Why analysis method
Fishbone diagram (causal diagram) systematically analyzes from six dimensions: human, machine, material, method, environment, and measurement
FMEA checks if design or process failure modes have been identified
Process diagram analysis identifies which process the problem occurred in
🔹  D5: Choose&Verify Permanent Correction
Ensure that measures can completely eliminate the root cause
🔹  D6: Implement Permanent Correction
Updated documents: SOP, FMEA, Control Plan
Training related personnel
Monitor the execution status
🔹  D7: Prevent Recurrence
Update design specifications and process standards
Optimize the supplier management process
Include new employee training content
🔹  D8: Congratulate the Team
Report the results to management and clients
Close the problem item

whping

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