SCOTTS验厂资料.docx

1、SCOTTS验厂资料TYPE: AssessmentTITLE: Supplier Quality Risk Assessment RatingDOCUMENT NUMBER: AUDIT00007ECROSS REFERENCE(S): NoneSCOPE / PURPOSE: Guideline to assess supplier quality risk.REVIEW DUE DATE: Oct-10Supplier Quality Risk Assessment Rating document begins on page 2.AUTHORS: Chad Wills, Christo

2、phe Galy, Kevin Ballard, John Foster, Tom QuickTHE SCOTTS COMPANY & SUBSIDIARIESSUPPLIER QUALITY RISK ASSESSMENT RATINGCompany: Hangzhou Tonny Electric and Tools Co., Ltd. Annual spend or annual volume:100,000 pcs for the Spreaders and 3,000,000 pcs for the OEM parts Location:Hangzhou, China Quality

3、 contact:Whang Hong Wu Number of workers at site: 250 Date:16 Sep 2009 Auditor:CurrentAssessmentQuality Systems Assessment=Rate each of the following categories using the following criteria. Overall scoring is described at end of assessment.A Wouldnt suggest any improvements.B System exists, minor i

4、mprovements suggested.C Major improvements necessary. Complete breakdown or lack of system. No evidence of conformance.Note * denotes critical category1. Quality Management System 我们是否有质量体系 ？ Is the company registered with a recognized quality standard, i.e. ISO 9001?o Why important: Likely to have

5、necessary quality systems in place, documentation, records, and audited on some frequency. Are there quality objectives/metrics set? o Why important: Drive actions for improvement. A B CComments: Yes, we have ISO9001:2000 certificate. We got it in 2003. Yes, we have the quality objects which is the

6、quality degree over 95% and the customers satisfy degree Over 98%.2. Design Process 设计体系 Are customer critical-to-quality attributes are defined? 客人的重要要求是否明确o Why important: ensures that customer expectations are understood and defined. Are specifications determined by fit for use limits? 客人的重要要求是否验

7、证o Why important: Specifications are meaningful to the customer and not arbitrary. Is failure mode analysis (i.e. FMEA) conducted? 设计不成功的分析是否进行o Why important: identifies potential risk with design and challenges team to change design or build necessary controls into process to prevent failures. Is

8、there a documented process for the qualification of new/changed manufacturing process and/or product? 技术上的更改是否以文件来明确o Why important: Ensure that new or changed products or processes meet the expectations defined. Is the capability of the new product or process is assessed? What is the minimum accept

9、able value?o Why important: Ensures that product is capable of meeting expectations. 新的产品或工艺是否要进行验证。 A B CComments: 1. Yes, the critical dimensions and points are defined in our quality checking list. 2. Yes, the specifications on the drawings or fot the products will be de determined by fit for the

10、 use limites. 3. Yes, we will conduct the failure mode analysis for the production and document it toAvoid future mistakes again. 4. Yes, our R&D will issue the documents for any of the product size, process, specification , material changes. 5. Yes, we will perform the new product testing , accessi

11、ng prior the produciton on the capability,function , processing and etc. 3. Management of Change Process * 生产过程中的控制 Is there a process for approving changes to product and/or process? 是否有程序规定产品或工艺的更改o Why important: Ensures that changes are made correctly, in a controlled fashion and communicated wi

12、thin organization. Uncontrolled documents can cause wrong information to be used in production. Is there a document control process to ensure only controlled copies of documents are available and accessible to associates? 是否有文件规定只有受控的文件才可以用。o Why important: Uncontrolled documents can cause wrong inf

13、ormation to be used in production. Is customer approval requested for changes that could impact the final product? 客人同意过的更改是否可以马上进行o Why important: Prevent product performance issues due to unforeseen causes. Written procedure to dispose of obsolete documents, plates, tooling, etc. How is it dispose

14、d?o Why important: Prevents inadvertent use of earlier revision of materials or documents.是否有书面的文件规定如何处理旧的文件， 材料或模具。A B CComments: 1. Yes. Our R&D will issue the approval document or ENC for the changes to product or process. 2. Yes, We have a document controlled process. The couments will be stampl

15、ed with “ control “ Stamp and thre is a special person controls the documents. 3. We will perfrom the testing for any changes request from the customer to see if it correct and capability. Only after the testing is fine, then we will start for the final product. 4. For documents, we will stampe “ us

16、eless “ chop on the document For the materials, we will store it in the disposal area marked with “ disposal ” label on it. For the tooling, we will store it in the disposal area marked with “ disposal ” label on it. 4. Training for Associates 培训 Is a documented training matrix completed and maintai

17、ned for each job classification that lists required competencies and applicable procedures?是否有培训要求和培训记录对各个岗位o Why important: Ensures that all required tasks to perform a function are defined. Does someone signoff that the individual is competent to perform the role? 是否有验证上岗的人符合条件o Why important: Ens

18、ures that only trained and competent individuals are performing the task.A B CComments: 1. Yes, no matter of new workers or QC in our factory will be trained before they go for the job.2. The necessary testing or examination will be performed after the training to make sure that they are qualified.3

19、. The time to time training are performed too in our factory. 5. Identification and Tracibility * 识别和跟踪 Finished product can be traced from the warehouse through manufacturing to raw material lots. 成品可以从原材料， 到生产， 到成品进行跟踪。o Why important: Necessary to determine the root cause of a quality issue in or

20、der to implement a corrective action to prevent reoccurrence. Is all product is labeled with product identification, unique lot number or batch number? 所有的产品是否分类， 附上标签o Why important: Required to meet business/operational needs for tracibility. Are quality assurance records archived? 产品的合格报告是否有o Why

21、 important: Required to meet business/operational needs and legal record retention requirements. Is batch size meaningful and representative of size of blender or premix batch, raw material lot, etc.? What determines batch or lot size? 每批的材料是否分开放，没有混放o Why important: Batch size should be based to mi

22、nimize amount of material on hold if non-conforming material is found. Should be tracible to raw materials used. Is there a finished product retain sample program kept in a stable environment? How long are samples retained? 成品是否有封样 ？ 此样品我们保存多长时间 ？ o Why important: Required to meet business/operation

23、al needs and legal record retention requirements. A B CComments: 1. Yes, we have the record for the back traced. From the incoming material, production process, finished Goods, warehouse and shipment. 2. Yes, the all products is labeled with the description, number, date , p.o. number and etc.3. For

24、 the all goods in our factory will be performed finished goods checking before it goes into the warehouse. We have the final inspection reports for all batches of the orders. 4. We performe the early in material the early using policy for the batch size mateirals and there is a using record for the

25、material. 5. Yes, we will keep the samples in our QC room for 12 monthes6. Incoming Inspection/Supplier Controls * 进料检验， 合格供货商 Are raw material, packaging component specifications current and accessible to associates? Are there any materials not covered by specifications? Why? 原材料的要求采购人员是否有 ？o Why i

26、mportant: Ensures that only current revisions are on file to allow proper verification of materials using COA or testing. Are Certificates of Analysis (COA) reviewed against specification and signed off as to whether accepted or rejected? How long are COAs retained on file for reference? Data entere

27、d electronically is best practice.外来的质保单我们是否进行验证。质保单有效期多长 （我回答一份质保单对一批货）o Why important: Ensures that only raw materials that meet specification are used in production and helps prevent out of spec finished product. Necessary to determine the root cause of a quality issue in order to implement a cor

28、rective action to prevent reoccurrence. Are Raw materials requiring testing (not covered by COA) identified and tested to specifications? How long are records of acceptance or rejection retained? 原材料是否进行检验 ？ 检验报告保存多长时间我回答 12 个月o Why important: : Ensures that only raw materials that meet specificatio

29、n are used in production and helps prevent out of spec finished product. Necessary to determine the root cause of a quality issue in order to implement a corrective action to prevent reoccurrence. Test procedures are documented and in accordance with industry standard or Scotts corporate method. 是否有

30、检验程序确认检验符合要求o Why important: Ensure proper test methods are used to compare vs. specifications. Is there an approval process for suppliers? For FIFRA sites, do not use material from supplier other than is on CSF until written approval is received from Scotts that also indicates that CSF has been upd

31、ated. 是否有合格供应商程序o Why important: Ensure that only Scotts approved suppliers are used and not used until CSF is updated if applicable.A B CComments: 1. In our factory the associates ( purchasers ) are available with the control documents for the material specifications and etc. 2. COA is requested for some materials. We will review the all COA and some times will perform the Retesting by the 3rd party. Usually we perform one COA for one batch. 3. Yes all raw material will be testing and checked by our QC. Usually we perform 100% testing for All batches. 4. Yes we have testing