产品质量不合格调查 Investigation into Non Conforming Product Quality

gaowenhua

产品质量不合格调查是企业质量管理体系中的核心环节，旨在系统性地识别、分析和解决产品在生产、检验或使用过程中出现的不符合规定要求的问题。
其目标不仅是纠正当前的缺陷，更重要的是找出根本原因并实施有效的预防措施，防止问题重复发生，从而提升产品质量、客户满意度和企业信誉.



The investigation of product quality non-compliance is a core component of the enterprise quality management system, aimed at systematically identifying, analyzing, and resolving issues that arise during the production, inspection, or use of products that do not meet regulatory requirements.Its goal is not only to correct current defects, but more importantly, to identify the root cause and implement effective preventive measures to prevent the recurrence of problems, thereby improving product quality, customer satisfaction, and corporate reputation

gaowenhua

什么是“产品质量不合格”？

指产品在以下任一方面未满足既定标准：

• 客户要求（合同、技术协议、样品）
• 内部标准（图纸、规格书、作业指导书）
• 国家/行业标准（如GB、ISO、IEC）
• 法律法规（如安全认证、环保指令）
  

常见类型：尺寸超差、功能失效、外观缺陷（划伤、色差）、材料错误、包装破损、标识错误等。

What is' unqualified product quality '?
Refers to a product that fails to meet established standards in any of the following aspects:

Customer requirements (contract, technical agreement, sample)
Internal standards (drawings, specifications, work instructions)
National/industry standards (such as GB, ISO, IEC)
Laws and regulations (such as safety certification, environmental directives)
Common types: size deviation, functional failure, appearance defects (scratches, color difference), material errors, packaging damage, labeling errors, etc.

gaowenhua

调查流程（基于CAPA或8D框架）阶段1：发现与初步响应

• 发现途径：

  • 来料检验（IQC）
  • 过程检验（IPQC）
  • 成品检验（OQC）
  • 客户投诉/退货
  • 市场反馈/售后维修
    

• 立即行动（遏制措施）：

  • 标识：对不合格品贴上“不合格”标签。
  • 隔离：转移到专用不合格品区，防止混用或误发。
  • 暂停：暂停相关批次的出货或生产流转。
  • 报告：填写《不合格品报告单》并通知质量部门。
    
  
  

✅ 工具：《不合格品隔离记录表》

---

阶段2：问题描述（清晰、量化）

使用 5W2H 方法准确描述问题：

维度示例
What什么产品？什么缺陷？（如：型号X的充电器外壳有裂纹）
Where在哪个环节发现？（如：OQC终检、客户产线）
When何时发现？生产日期/批次号？
Who谁发现的？涉及哪些人员？
How如何发现的？（目视、测试仪报警）
How many数量多少？不良率？（如：抽检200件，发现8件，不良率4%）

📌 输出：一份清晰、客观的《不合格问题描述报告》

---

阶段3：根本原因分析（Root Cause Analysis）

这是调查的核心，避免“治标不治本”。

推荐分析工具：1. 5Why 分析法（连续追问“为什么”）

→ 根本原因：模具开发流程缺失模流分析环节。

2. 鱼骨图（因果图）

从 人、机、料、法、环、测 六个维度系统分析：

• 人（Man）：操作失误、培训不足
• 机（Machine）：设备老化、参数漂移
• 料（Material）：原材料批次差异、供应商变更
• 法（Method）：工艺参数错误、SOP不清晰
• 环（Environment）：温湿度超标、静电干扰
• 测（Measurement）：检测设备不准、方法错误
  

3. 流程图分析

绘制生产流程，定位问题发生在哪个工序。

---

阶段4：制定并实施纠正与预防措施（CAPA）措施类型内容示例
短期措施（纠正）控制当前风险- 对在库品全检或返工<br>- 通知客户并协商处理方案
长期措施（预防）消除根本原因- 更新模具设计规范，强制要求模流分析<br>- 修订《模具开发流程》<br>- 对设计人员进行培训

📌 输出：《纠正与预防措施报告》（CAPA Report）

---

阶段5：效果验证与标准化

• 验证有效性：

  • 跟踪后续3~5个生产批次，确认不良率是否降至目标水平。
  • 现场检查新措施执行情况。
    

• 标准化：

  • 将有效措施写入SOP、FMEA、控制计划等文件。
  • 更新相关培训教材。
  • 在QMS系统中归档。
    
  
  

---

阶段6：总结与关闭

• 完成调查报告，提交管理层审批。
• 召开总结会议，分享经验教训。
• 在质量管理系统中正式关闭该不合格项。
• 必要时对团队进行表彰（如8D中的D8）。
  

Investigation process (based on CAPA or 8D framework)
Stage 1: Discovery and Initial Response
Discovery pathway:
Incoming Quality Control (IQC)
Process Inspection (IPQC)
Finished product inspection (OQC)
Customer complaints/returns
Market feedback/after-sales maintenance
Immediate action (containment measures):
Identification: Attach a "non-conforming" label to non-conforming products.
Isolation: Transfer to a dedicated non-conforming product area to prevent mixing or misplacement.
Pause: Suspend the shipment or production flow of relevant batches.
Report: Fill out the "Nonconforming Product Report Form" and notify the Quality Department


Stage 2: Problem Description (Clear, Quantitative)
Accurately describe the problem using the 5W2H method:


Dimension Example
What product? What defect? (For example, the charger housing of model X has cracks)
Where was it discovered at which stage?
When was it discovered? Production date/batch number?
Who discovered it? Which personnel are involved?
How was it discovered? (Visual inspection, tester alarm)
How many? How many? Poor rate?
📌  Output: A clear and objective Non conformance Problem Description Report
Stage 3: Root Cause Analysis
This is the core of the investigation, avoiding 'treating symptoms without addressing the root cause'.
Recommended analysis tools:
1. 5Why analysis method (continuous questioning of "why")
Root cause: Lack of mold flow analysis in the mold development process.
2. Fishbone diagram (causal diagram)
Man: operational errors, insufficient training
Machine: Equipment aging, parameter drift
Material: Differences in raw material batches, changes in suppliers
Method: Process parameter errors, unclear SOP
Environment: Excessive temperature and humidity, static interference
Measurement: Inaccurate detection equipment and incorrect methods
3. Process diagram analysis
Draw the production process and locate the process where the problem occurs.


Stage 4: Develop and implement Corrective and Preventive Actions (CAPA)
Example of measure type content
Short term measures (correction) to control current risks - full inspection or rework of inventory items<br>- notify customers and negotiate a solution
Long term measures (prevention) to eliminate root causes - update mold design specifications and mandate mold flow analysis - revise the "Mold Development Process" - train designers
📌  Output: Corrective and Preventive Action Report (CAPA Report)


Stage 5: Effectiveness Verification and Standardization
Validity verification:
Track the follow-up 3-5 production batches to confirm whether the defect rate has dropped to the target level.
On site inspection of the implementation of new measures.
Standardization:
Write effective measures into SOP, FMEA, control plan and other documents.
Archive in QMS system.
Stage 6: Summary and Closure
Complete the investigation report and submit it for management approval.
Hold a summary meeting to share experiences and lessons learned.

gaowenhua

• 跨部门协作：质量、生产、技术、采购、工程等部门必须共同参与。
• 数据驱动：基于事实和数据做判断，避免主观猜测。
• 客户沟通：若涉及客户，需及时通报调查进展和处理方案。
• 记录完整：所有证据、分析过程、决策依据均需可追溯。
• 防止复发：将措施制度化，避免“头痛医头，脚痛医脚”。
  

Cross departmental collaboration: Quality, production, technology, procurement, engineering, and other departments must participate together.
Data driven: Making judgments based on facts and data, avoiding subjective speculation.
Customer communication: If it involves customers, it is necessary to promptly report the progress of the investigation and the handling plan.
Complete record: All evidence, analysis process, and decision-making basis must be traceable.
Preventing recurrence: Institutionalize measures to avoid "treating the head for the headache and treating the foot for the foot".