Fronius品质验厂审核内容

Fronius验厂品质方面主要审核内容： / Main aspects Performance

1. 不合格品 / Nonconforming material

2. 产品检验 / Inspection of parts

3. 供应商管理 / Supplier management

4. 工艺管理 / Process suitability

5. 可持续性改进 / Continuous

6. 研发 / Research & Development

7. 其它 / Miscellaneous

1、Fronius验厂 - 不合格品 / Nonconforming material

1.1 明确的不合格产品标识要求 /Clear requirements for the identification of nonconforming product

1.2 储存不合格品（隔离储存，电脑锁，分开存放合格产品和有缺陷产品）/Storage of nonconforming product (Quarantine store; IT-storage; separation between acceptable and nonconformance products) ?

1.3 在生产过程中是否分别记录在公司批准的格式文件中？（人员的资质，需求，可接受的返工，返修产品的流程） /Are discrepancies documented on company-approved forms during the manufacturing process?, (Qualification of personnel;Requirements, Acceptance procedure for reworked/repaired products)

1.4 特殊发放 (通知Fronius) /Special release (Information to Fronius)

1.5 客户索赔的需求/流程（如何处理从客户那里追回的产品） /Requirements/Process for customer claims (Handling of returned products from customer)

2、Fronius验厂之产品检验 / Inspection of parts

2.1 检测指导书，样品计划， 目视检测，安全可靠测试，包装说明等 /Inspection instruction, sample plans, visual inspection, safetycritical tests, Packing instructions

2.2 检验标识 （检验状态）Inspection identification (Status of the performed inspection)

2.3 对于各个批次的产品的可追溯性的检测和实验记录（包括文件储存，详细的文档，可追溯的批次/批号/序列号和检测记录） /
How is the traceability of inspection and test records maintained for all lots/batch (file storage; detailed documentation;
Traceability to Charge/Lot/Serial Number and Inspection records)

2.4 测量工具和仪器的流程管理（文件） / Procedure for the Tool and Gage Control?

3、Fronius验厂之供应商管理 / Supplier management

3.1 供应商的认可和发布Supplier Qualification and Supplier Release

3.2 供应商索赔流程Claim process to the supplier

3.3 关于进一步的送货确认供应商的阻止和发放 Supplier blocked and release of the supplier for further deliveries

3.4 收货检验（根据目前制定的A，B，C等级制度）Procedure for the receiving inspection (in coordination of the current customer rating A,B, C)

3.5 风险管理的流程文件，特别是核心产品（单一资源；核心设备）
Procedure for the risk management for eg Key Products (Single source; Bottleneck machine)

4、Fronius验厂之工艺管理 / Process suitability

4.1 材料或零件生产的流程文件 (供应指导书，作业指导书)
Process documentation for parts or materials that are manufactured (Process instructions, Work instructions)

4.2 工艺的发布 - 参照相应的技术资料（图纸和或工艺规范）执行过程能力 Release of process - reference the appropriate technical data
(drawings and/or process specifications) to perform process capability?

4.3 员工资质培训流程 /Procedure of the employees qualification

4.4 过程监控程序（如测量，监控，责任，过程的稳定性）Procedure for process monitoring (eg measuring; monitoring;responsibilities; process stability);

4.5 工艺流程控制 （责任，工艺改进）Procedure for the process control (Responsibilities; Process improvement)

5、Fronius验厂之可持续性改进 / Continuous Improvement

5.1 可持续性改进流程（整合相关的员工，责任，文件和资质） /Continuous improvement process (responsibility, documentation,
qualification and integration of employees)

5.2 鉴别可持续性改进的流程（从失败的结果，评审，交货期，客户投诉索赔） /Procedure for the identification of continuous improvements (from failure re-porting, audits, delivery dates, customer claims)

5.3 可持续性改进的报告（根源问题剖析，职责责任）/Reporting of the continuous improvements (root cause analysis, responsibility)

5.4 及时实现可持续和有效改善 /Timely realization of continous improvements and effectivity

6、Fronius验厂评估之研发 / Research & Development

6.1客户需求customer requirements

     - 需求 (在项目开展前的客户需求，批准的工艺流程）- Requirements(what is requested from the customer before project start,approval process)

     - 客户澄清（书面文件）- Clarifications with customer (in writing, documentation)

6.2 衍生的技术参数derivation of technical parameter s

     - 技术规格（开发，批准，客户澄清）- technical specifications (development, approval,clarifications with customer

     - 应用的标准，认证，法律规定- application of standards,certifications,legal requirements

     - 可行性检查- feasibility check

6.3 R&D 流程 R&D process

     - 阶段和关口（过程描述和标准/样品）- phases and gates (process description and criteria / samples

     - 过错预防和分析，产品失效模式分析，经验教训- fault prevention and analysis, FMEA,lessons learned

     - 项目管理- project management

6.4 R&D Know How

     - 能力和资格- capabilities and qualification

     - 经验/同类产品参考- experience / references similar products

     - 工具和方法（CAD, 仿真测试）- tools and methods (CAD, simulation,testing, ...)

6.5 核查和验证研发成果/产品 verification and validation of R&D results / products

     - 测试（内部/外部测试）- testing (internal/external)scope of testing

     - 与第三方的合作- experience and cooperation with 3 rd party testing

     - 客户的批准（样品，报告）- approval by customer (sampling, reports, ...)

     - 文档（内容，归属，储存）- documentation (content,submission, storage)

6.6 产品更改 product changes

     - 更改流程- change process

     - 沟通，内部/客户批准，旧版PCN- communication and internal / customer approval, PCN part history

     - 文档（内容，归属，储存）- documentation (content,submission, storage)

     - 验证 / 确认- verification / validation

7、其它 / Miscellaneous

7.1 处理，存储和包装ESD（散）/Are stored parts appropriately segregated and protected (eg. are materials protected in accordance to ESD requirements)?

7.2 风险管理（核心机器，刀具磨损，核心员工）/Does the company have a procedure for risk management(eg. second source; bottleneck ofa machine)?

7.3 内部评审 (流程审核，产品审核) /Internal audits (process audits,product audits)

7.4 SOS (安全，整洁，清洁) /Safety, tidiness and cleanliness

7.5 流程中的质量管理体系/Quality system in process

7.6 沟通 (内部， 直接客户；供货情况；会面情况) Communication (internal, direction customer; Availability; Meeting architecture)

7.7 产品更改 product changes

     - 工艺修改- change process

     - 沟通和内部/客户的批准，PCN 零件的历史 - communication and internal / customer approval, PCN part history

     - 文档（内容，归属，储存）- documentation (content,submission, storage)

     - 验证 / 确认- verification / validation

点击查看：Fronius验厂风险管理评估 及 Fronius验厂物流管理审核要求