生产工厂质量部门架构调整 Reorganization of the Quality Department in the Product

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Quality Assurance (QA)
Customer Quality: Coordinate with customers, handle complaints, 8D reports, customer audits, PPAP submissions.
System and Compliance: Maintain QMS system (ISO/IATF, etc.), organize internal audits and management reviews to ensure regulatory compliance.
Process Quality (PQ)
Process Quality: Responsible for process capability (CPK) and SPC monitoring of critical processes PFMEA、 Control Plan (CP).
Equipment and fixtures: Ensure equipment accuracy (MSA), effective error prevention devices (Poka York), and participate in equipment acceptance.
Project quality: Participate in the introduction of new products (NPI), lead the quality monitoring of trial production, and ensure smooth mass production.
Quality Control (QC)
Incoming Quality Control (IQC): Inspect raw materials and purchased parts to ensure compliance with standards.
Process Inspection (IPQC): Conduct inspections during the production process to monitor process parameters and product characteristics.
Final inspection (FQC/OQC): Conduct a full inspection or random inspection of the finished product to ensure its factory quality.
Supplier Quality Engineer (SQE)
Manage supplier quality performance, drive supplier improvement, and handle incoming material defects

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架构调整的关键策略1. 质量前移（Quality Gate Forward）

• 做法：将质量工程师（如PQE、CQE）派驻到研发、工艺、生产部门。
• 目的：在设计和工艺阶段就识别风险，避免问题流入生产。
  

2. 建立跨职能质量团队

• 做法：针对重大质量问题（如客户投诉、高不良率），组建由质量、生产、工程、采购组成的快速响应小组（RRT）。
• 目的：打破部门墙，快速协同解决。
  

3. 数据驱动决策

• 做法：建立质量数据看板，实时监控关键指标（如FPY、PPM、OEE、CAPA关闭率）。
• 工具：利用QMS、MES系统实现数据自动采集和分析。
  

4. 分层审核（Layered Process Audit, LPA）

• 做法：不同层级的管理者（班组长、主管、经理）定期对关键过程进行审核。
• 目的：确保标准作业执行到位，及时发现偏差。
  

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Key strategies for architecture adjustment
1. Quality Gate Forward
Method: Deploy quality engineers (such as PQE, CQE) to the R&D, process, and production departments.
Purpose: Identify risks during the design and manufacturing stages to prevent problems from flowing into production.
2. Establish a cross functional quality team
Method: For major quality issues such as customer complaints and high defect rates, establish a Rapid Response Team (RRT) composed of quality, production, engineering, and procurement.
Purpose: To break down departmental barriers and quickly collaborate to solve problems.
3. Data driven decision-making
Method: Establish a quality data dashboard and monitor key indicators in real-time (such as FPY, PPM, OEE, CAPA closure rate).
Tools: Utilize QMS and MES systems to achieve automatic data collection and analysis.
4. Layered Process Audit (LPA)
Method: Managers at different levels (team leaders, supervisors, managers) regularly review key processes.
Purpose: To ensure the proper execution of standard operations and timely detection of deviations.

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调整实施步骤

• 诊断现状：评估现有架构的优缺点，识别痛点。
• 明确目标：设定可量化的调整目标（如“6个月内客户投诉下降30%”）。
• 设计新架构：绘制组织架构图，定义岗位职责（RACI矩阵）。
• 沟通与共识：与工厂管理层、相关部门负责人充分沟通，获得支持。
• 人员配置与培训：
  • 评估现有人员能力，决定留任、转岗或招聘。
  • 对新角色进行培训（如FMEA、SPC、8D、QMS系统操作）。
    
• 试点运行：在一条产线或一个产品系列试点新架构。
• 全面推广：总结试点经验，优化后全厂推广。
• 持续监控：定期回顾KPI，持续优化架构和流程。
  

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Adjust the implementation steps
Diagnosis status: Evaluate the advantages and disadvantages of the existing architecture and identify pain points.
Clear goal: Set quantifiable adjustment targets (such as "30% reduction in customer complaints within 6 months").
Design a new architecture: Draw an organizational chart and define job responsibilities (RACI matrix).
Communication and Consensus: Fully communicate with the factory management and relevant department heads to obtain support.
Personnel configuration and training:
Assess the capabilities of existing personnel and decide whether to retain, transfer, or recruit.
Train new roles (such as FMEA, SPC, 8D, QMS system operation).
Pilot operation: piloting a new architecture on a production line or product line.
Comprehensive promotion: Summarize the pilot experience, optimize and promote it throughout the factory.
Continuous monitoring: Regularly review KPIs and continuously optimize architecture and processes.

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成功要素与风险防范

成功要素

风险防范

高层领导的坚定支持

员工抵触 → 加强沟通，说明调整对个人发展的益处。

清晰的职责划分（RACI）

职责重叠或真空 → 通过RACI矩阵明确“谁负责、谁批准、咨询谁、告知谁”。

与生产运营深度融合

质量与生产对立 → 建立共同KPI（如一次通过率），促进协作。

数据透明与实时反馈

信息孤岛 → 推动系统集成，实现数据共享。

持续的培训与能力建设

技能不足 → 制定培训计划，引入外部专家。

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Success factors and risk prevention
Risk prevention of success factors
Strong support from senior leaders and employee resistance → Strengthen communication to demonstrate the benefits of adjustments for personal development.
Clear division of responsibilities (RACI): Overlapping or vacuum of responsibilities → Clearly define "who is responsible, who approves, who consults, and who informs" through the RACI matrix.
Deeply integrate quality and production opposition with production and operation → establish common KPIs (such as first pass rate) to promote collaboration.
Data transparency and real-time feedback information island → Promote system integration and achieve data sharing.
Lack of continuous training and capacity building skills → Develop training plans and introduce external experts.

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生产工厂质量部门的架构调整，核心是从“被动检验”向“主动预防和过程保证”转变。一个高效的现代质量架构应具备：

✅ 前瞻性：质量前移，预防为主。
✅ 协同性：打破部门墙，跨职能合作。
✅ 数据化：用数据说话，驱动决策。
✅ 敏捷性：快速响应内外部问题。

通过科学的调整，质量部门可以真正成为工厂的“价值创造中心”和“客户信任的守护者”，而不仅仅是“成本中心”或“拦路虎”。

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The core of the restructuring of the quality department in the production factory is to shift from "passive inspection" to "active prevention and process assurance". An efficient modern quality architecture should have:

✅  Forward looking: Quality moving forward, prevention oriented.

✅  Collaboration: Break down departmental barriers and collaborate across functions.

✅  Dataization: Speak with data and drive decision-making.

✅  Agility: Quickly respond to internal and external issues.

Through scientific adjustment, the quality department can truly become the "value creation center" and "guardian of customer trust" of the factory, rather than just a "cost center" or "roadblock".