产品出问题解决 Solution to product issues

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生产的产品出现问题，不能简单归咎于某一个部门。产品质量是“全流程、全链条、全员参与”的结果，问题的根源可能出现在从市场调研到售后服务的任何一个环节。

然而，生产部门往往是问题的“暴露点”或“最后一道防线”，但这并不意味着它就是“唯一”或“主要”责任部门。

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Typical Scenarios and Responsibility Attribution
The main responsible departments for the possible root causes of the problem phenomenon (from a system perspective)
Batch size out of tolerance process parameter setting error, equipment not calibrated, tool wear not replaced Engineering Department (Process), Equipment Department, Production Department
Unqualified material performance, poor incoming materials from suppliers, loose or missed IQC inspection standards, procurement department, quality department (IQC)
Functional failure (design flaw): The design did not consider the actual usage environment, and there was insufficient simulation verification in the R&D and technical departments
Improper protection, unreasonable tooling design, and incorrect handling methods during surface scratching operations in the production and engineering departments
Customer complaint: "Easy to damage" packaging design is unreasonable, transportation method is inappropriate. R&D department (packaging design), logistics department

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The problems with the products produced cannot be simply attributed to any one department. Product quality is the result of "full process, full chain, and full participation of all personnel", and the root cause of problems may occur in any link from market research to after-sales service.

However, the production department is often the "exposure point" or "last line of defense" of problems, but this does not mean that it is the "only" or "main" responsible department.

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产品质量问题的“全链条”责任分析

环节

可能的问题

涉及部门

1. 市场与需求

客户需求理解错误，导致产品设计偏离实际

市场部、销售部

2. 设计与研发

设计缺陷、材料选型不当、公差不合理、未进行DFMEA（设计失效分析）

研发部、技术部、设计部

3. 采购与供应链

采购的原材料/零部件质量不合格、供应商管理不善、来料检验（IQC）失效

采购部、供应链部、品质部（IQC）

4. 工艺与工程

工艺流程设计不合理、作业指导书（SOP）不清晰、工装夹具设计缺陷、未进行PFMEA（过程失效分析）

工艺部、工程部、技术部

5. 生产制造

操作员未按SOP操作、设备维护不到位、过程监控缺失、环境控制不当（如洁净度、温湿度）、自检互检失效

生产部、设备部、车间

6. 质量控制

过程检验（IPQC）漏检、最终检验（FQC/OQC）标准执行不严、测量设备未校准、数据记录不真实

品质部（QA/QC）

7. 仓储与物流

储存条件不当（如潮湿、高温）、运输过程中损坏、标识错误导致混料

仓储部、物流部

8. 销售与服务

客户使用不当、安装错误、售后维护不到位

销售部、售后服务部

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Analysis of the "full chain" responsibility for product quality issues
Possible issues in the process may involve departments
1. Misunderstanding of market and customer needs leads to product design deviating from actual market and sales departments
2. Design and R&D design defects, improper material selection, unreasonable tolerances, failure to conduct DFMEA (Design Failure Analysis) R&D department, technical department, design department
3. Poor quality of raw materials/components, poor supplier management, and ineffective incoming inspection (IQC) in procurement and supply chain procurement. Purchasing department, supply chain department, and quality department (IQC)
4. Unreasonable design of process and engineering process flow, unclear operation instructions (SOP), defects in fixture design, failure to conduct PFMEA (Process Failure Analysis) in the process department, engineering department, and technical department
5. Production and manufacturing operators did not operate according to SOP, equipment maintenance was not in place, process monitoring was missing, environmental control was improper (such as cleanliness, temperature and humidity), self inspection and mutual inspection failed in the production department, equipment department, and workshop
6. Quality Control Process Inspection (IPQC) omissions, lax implementation of Final Inspection (FQC/OQC) standards, uncalibrated measuring equipment, and inaccurate data recording. Quality Department (QA/QC)
7. Improper storage and logistics conditions (such as humidity, high temperature), damage during transportation, and labeling errors leading to mixed material storage and logistics departments
8. Improper use, installation errors, and inadequate after-sales maintenance by sales and service customers. Sales and after-sales service departments

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如何正确应对产品问题？—— 用“系统思维”代替“追责思维”✅ 正确做法：启动“根本原因分析”（RCA）

• 组建跨部门团队：

  • 成员应包括：品质部（主导）、生产部、技术/工程部、采购部、研发部等。
  • 避免“生产背锅”，确保视角全面。
    

• 使用系统性分析工具：

  • 5Why分析法：连续追问“为什么”，直到找到根本原因。
    • 例：产品开裂 → 为什么？材料脆 → 为什么？供应商换了批次 → 为什么？采购未通知变更 → 为什么？变更流程未规定通知生产/品质？
      
  • 鱼骨图（因果图）：从“人、机、料、法、环、测”六个方面系统分析。
  • FMEA（失效模式与影响分析）：回顾设计和过程FMEA，看是否已识别该风险。
    

• 区分“直接原因”与“根本原因”

  • 直接原因（表象）：如“操作员A未拧紧螺丝”。
  • 根本原因（系统性）：如“SOP未明确扭矩要求”、“未配备扭矩扳手”、“培训不到位”、“无防错设计”。
    

• 制定纠正与预防措施（CAPA）

  • 纠正（短期）：隔离不良品，返工或报废。
  • 纠正措施（消除根本原因）：修订SOP、增加防错装置、加强培训、优化供应商管理流程。
  • 预防措施：在其他类似产品或流程中排查同类风险。
    
  
  

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How to deal with product issues correctly? ——Replace 'accountability thinking' with 'systems thinking'
✅  Correct approach: Initiate Root Cause Analysis (RCA)
Building a cross departmental team:
The members should include: Quality Department (lead), Production Department, Technical/Engineering Department, Procurement Department, R&D Department, etc.
Avoid 'production backfiring' and ensure a comprehensive perspective.
Using systematic analysis tools:
5Why analysis method: Continuously ask "why" until the root cause is found.
Example: Product cracking → Why? Why is the material brittle? Why did the supplier change the batch? Procurement not notified of changes → Why? Is the change process not specified for notifying production/quality?
Fishbone diagram (causal diagram): a systematic analysis from six aspects: human, machine, material, method, environment, and measurement.
FMEA (Failure Mode and Effects Analysis): Review the design and process FMEA to see if the risk has been identified.
Distinguish between "direct cause" and "root cause"
Direct cause (appearance): such as "Operator A did not tighten the screws".
Root cause (systemic): such as "SOP does not specify torque requirements", "lack of torque wrench", "inadequate training", "no error prevention design".
Develop Corrective and Preventive Action (CAPA)
Correction (short-term): Isolate defective products, rework or scrap.
Corrective measures (eliminating root causes): Revise SOP, add error prevention devices, strengthen training, optimize supplier management processes.
Preventive measures: Investigate similar risks in other similar products or processes.

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典型场景与责任归属

问题现象

可能的根本原因

主要责任部门（系统视角）

批量尺寸超差

工艺参数设置错误、设备未校准、刀具磨损未更换

工程部（工艺）、设备部、生产部

材料性能不合格

供应商来料不良、IQC检验标准过松或漏检

采购部、品质部（IQC）

功能性故障（设计缺陷）

设计未考虑实际使用环境、仿真验证不足

研发部、技术部

表面划伤

操作过程中防护不当、工装设计不合理、搬运方式错误

生产部、工程部

客户投诉“易损坏”

包装设计不合理、运输方式不当

研发部（包装设计）、物流部

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关键结论

• 生产部门是“执行者”，但不是“唯一责任人”。如果SOP本身有问题，或来料不合格，生产很难“制造出好产品”。
• 品质部是“监督者”，但不是“挡箭牌”。品质不能“检验出质量”，质量是设计和生产出来的。
• 管理层是“系统构建者”。流程、制度、资源、文化由管理层决定，问题背后往往有管理责任。
• “谁发现，谁负责改进”比“谁造成，谁挨罚”更重要。建立“无责备文化”（Blame-Free Culture），鼓励员工主动报告问题，才能真正实现持续改进。
  

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Key conclusions
The production department is the 'executor', but not the 'sole responsible person'. If there are problems with the SOP itself or if the incoming materials are not qualified, it is difficult to "manufacture good products" in production.
The quality department is a 'supervisor', but not a 'shield'. Quality cannot be 'inspected', quality is designed and produced.
The management is the 'system builder'. Processes, systems, resources, and culture are determined by management, and there is often management responsibility behind issues.
Whoever discovers it is responsible for improvement "is more important than" whoever causes it is punished ". Establishing a 'Blame Free Culture' that encourages employees to proactively report issues is essential for achieving continuous improvement.