文件编号：QMDT-QA-WI053
產品安全及環境符合性保證 版本/版次：A/0
第 1 页 共 8 页 工作指引
品質管理部-QA
编制人/日期
文文件件分分发发控控制制标标识识
Joe Law/Nov 28,2009
审核人/日期 批准人/日期
文件修订记录
序修改 修改人
号 页码 /日期
修改内容摘要
版本
审核人 生效日期
/版次
文件编号：QMDT-QA-WI053
產品安全及環境符合性保證 版本/版次：A/0
第 2 页 共 8 页 工作指引
品質管理部-QA
1.0 制定程序,保證本公司生產的產品能夠符合所有國際標准/法例及客戶要求.
To assure that all of products can comply with all international standards/regulation and the customer’s requirements. 2.0 公司/方針:
根據客戶要求或某些國際法令強制性要求, 本公司產品能夠符合以下國際標准/法例及客戶要求:
Company’s policy
According to customer’s requirement and international regulation, our products can comply with the following requirements. 1. ASTM F963-07 2. EN71-Part 1, 2, 3, 6, 9 3. EN62115 4. EMC/FCC 5. ISO 8124
6. Canada Hazardous Product Act (Toys) 7. Japan ST
8. 94/27/EC (Nickle Release) 9. 2002/61/EC(AZO DYE) 10. 2005/84/EC(Phthalates) 11. 91/338/EEC(Cadmium Content) 12. 94/62/EC(Packaging Directive) 13. 2002/95/EC (RoHS) 14. 2002/96/EC (WEEE) 15. 67/548/EEC 16. REACH (1907/2006)
17. CONEG 包裝物料重金屬要求 18. 2006/66/EC Directory for Batteries
19. 2005/32/EC用能產品指令 2005/32/EC energy product order 20. PROP 65 (CALIFORNIA) for lead content in wire 21. 某些客戶特別要求,如Mattel QSOP, Hasbro SRS.
文件编号：QMDT-QA-WI053
產品安全及環境符合性保證 版本/版次：A/0
第 3 页 共 8 页 工作指引
品質管理部-QA
Customer’s special requirement, for instance, Mattel QSOP, Hasbro SRS. 22. 其它產品安全或環境要求
Other safety and environment requirement if applicant.
3.0 程序 procedure
3.1 QA部負責獲得所有最新產品安全及環境要求的國際標准/歐盟法令及其它客戶要
求, 在咨詢其它專業機構(例如公證行)及接受相關培訓,充分了解具體要求及運作之後,第一時間將相關要求報告管理層,知會各有關部門(報價部、采購部、工程部、PMC/PPC、生產部、QA/QC等),必要時制定詳細的內部工作指引或(及)舉行培訓講座.
QA is responsible to acquire updated standards and regulations. After consulting other professional organization (e. g: the 3rd party lab), accepting the related training and sufficiently knowing about the concrete requirement and operation, QA should firstly report the requirement to management, and circulate to related dept. (Declare Dept., Eng Dept. PMC/PPC, Production dept. QA/QC, etc.) If necessary, QA should set up the detailed internal Working Instruction and/or hold a training accordingly.
3.2 PMC收到訂單後需注意某些特別要求並知會所有相關部門.
PMC should pay attention to some special requirement and notify all related department after receipt the orders from customers.
3.3 工程部發放工程決定時注明產品需要符合的特別要求.
The Eng dept. should indicate the special requirement that product should comply with
when releasing EDM.
3.4 采購部將相關要求以書面形式通知所有供應商及制造商並根據工程資料訂購符
合要求的物料. 此外，采購部應要求供應商提供相關測試報告或(和)符合性保證書。應包括但不限於以下項目：
3.4 The purchasing dept. should give a written notice about the requirement to all suppliers and
manufacturers, and order the material in compliance as per Eng’s information. Otherwise,
文件编号：QMDT-QA-WI053
產品安全及環境符合性保證 版本/版次：A/0
第 4 页 共 8 页 工作指引
品質管理部-QA
suppliers are required to provided related test report or guarantee letter. Contain the following programs but not limited:
3.4.1 所有塑膠原料供應商需提供EN71-3重金屬，RoHS及2005/84/EC
Non-phthalates PVC保證書(附表QMDT-QA-WI053-R-01)及MSDS(物料安全數據表)。PVC原料供應商必須提供Non-phthalates測試報告。
All raw plastic material supplier must provide the declaration letters of EN-71-3 heavy element, RoHS and 2005/84/EC Non-phthalates PVC and MSDS (material safety data table). PVC material supplier must provide the Non-phthalates test report.
3.4.2 所有色粉供應商需提供EN71-3, ASTM F963, RoHS及2005/84/EC
non-phthalates PVC保證書(附表QMDT-QA-WI053-R-01)。必須提供EN71-3及RoHS測試報告。
All pigment suppliers need provide the declaration letters of the EN71-3, ASTM F963, RoHS and 2005/84/EC non-phthalates PVC , EN71-3 and RoHS test report.
3.4.3 所有油漆/開油水及所有用於產品表面塗層以及用於清潔產品的化學品供
應商需提供EN71-3, ASTM F963, QSOP 3600, SRS012, RoHS及2005/84/EC non-phthalates PVC保證書(附表QMDT-QA-WI053-R-01)、測試報告及MSDS。帶有表面塗層的外購件供應商需提供重金屬ASTM F963,EN71-3及2005/84/EC Non-phthalates PVC保證書(附表QMDT-QA-WI053-R-01)及測試報告。
All suppliers of paints/thinner and all chemistry used in surface coating and cleaning solvent must provide declaration letter of EN71-3, ASTM F963, QSOP 3600, SRS012, RoHS and 2005/84/EC non-phthalates PVC , as well as test report and MSDS. The purchased part (with surface coating) supplier must provide declaration letter of ASTM F963, EN71-3 and 2005/84/EC Non-phthalates PVC, also test report.
文件编号：QMDT-QA-WI053
產品安全及環境符合性保證 版本/版次：A/0
第 5 页 共 8 页 工作指引
品質管理部-QA
3.4.4 根據訂單要求，所有適用的電子物料、輔料(包括紅膠，黑膠，洗機水等)
及用於產品的熱熔膠、黃膠供應商需提供RoHS保證書(附件RoHS-F-01)及測試報告。
According to the specification in the order, all supplier for applicable electric
material, supplemented materials (including red glue，black epoxy glue, cleaning solvent) and hot melt glue, yellow glue must provide the declaration letter of RoHS and test report.
3.4.5 所有外購用於產品的軟膠部件(例如PVC, EVA, Kraton, PE, PU, 橡膠等)及
用於產品的熱熔膠、黃膠等供應商需提供EN71-3、2005/84/EC non-phthalates PVC、SRS 046、QSOP 3610保證書(附件QMDT-QA-WI053-R-01)及2005/84/EC non-phthalates測試報告。
All suppliers of soft plastic materials (e.g. PVC, EVA, Kraton, PE, Pu and rubber, etc.), hot melt glue, and yellow glue must provide the declaration letter of EN71-3, 2005/84/EC non- phthalates PVC, SRS 046, QSOP 3610, and the report of 2005/84/EC non- phthalates.
3.4.6 所有布料、紡織品、皮革供應商需提供EN71-3及AZO DYE保證書(附件
QMDT-QA-WI053-R-01)。
All suppliers for the cloth, fabric and leather must provide the declaration letter of EN71-3 and AZO DYE.
3.4.7 所有包裝物料(包括用作包裝物料的膠水，熱熔膠，扎線，膠紙,清潔劑等)
供應商需提供94/62/EC及CONEG保證書(附件QMDT-QA-WI053-R-01). All suppliers for package materials (including glue, hot melt glue, strap, tape, cleaning solvent) must provide the declaration letter and of 94/62/Ec and CONEG .
3.4.8 所有化學品供應商需提供REACH保證書(附件QMDT-QA-WI053-R-01)及
MSDS.
文件编号：QMDT-QA-WI053
產品安全及環境符合性保證 版本/版次：A/0
第 6 页 共 8 页 工作指引
品質管理部-QA
All chemistry supplier must provide declaration letter of REACH and MSDS.
3.4.9 電池(跟產品走貨的電池)供應商需提供2006/66/EC保證書(附件
QMDT-QA-WI053-R-01)及測試報告。
The battery (shipped with product) supplier must provide 2006/66/EC declaration and test report.
3.4.10 走歐洲的用能產品(例如交流變壓器)供應商需提供2005/32/EC保證書(附件
QMDT-QA-WI053-R-01)及測試報告。
For the energy product to EU (e.g. AC adaptor), the supplier should provide 2005/32/EC declaration and test report.
3.4.11 根據產品特性(例如要求有關供應商提供EN71-9保證書(附件
QMDT-QA-WI053-R-01)。
According to product characteristic, related suppliers are required to provide EN71-9 guarantee if applicant.
3.4.12 某些特定的測試報告，如TRA, 化妝品等。
Some special test report, e.g. TRA, cosmetic.
3.4.13 所有供應商需每年經評估合格(附件FR-PMC-02~04). All suppliers must be evaluated yearly.
3.5 生產部使用正確物料, 按工程資料及QA/QC制定的內部工作指引進行生產,保證
產品符合要求.
The production dept. should use the proper materials, and put in process as per the Eng
information and internal Working Instruction set up by QA/QC to make sure product can comply with requirement.
3.6 QA/QC對內部各部門運作進行定期Audit及檢討.
QA/QC should audit and review the operation of internal dept periodically. 附件QMDT-QA-WI052-R-02: 產品安全及環境符合性內部檢查日程表.
Appendix QMDT-QA-WI052-R-02: Inspection schedule about the safety and environment
文件编号：QMDT-QA-WI053
產品安全及環境符合性保證 版本/版次：A/0
第 7 页 共 8 页 工作指引
品質管理部-QA
compliance on the product. 3.7 各種物料風險評估及測試計劃 Material 物料名稱 Sourcing 來源 purchasing Self-prepare Powder Parts with coatings purchasing Purchasing Subcontracted EL Purchasing Subcontracted EL Risk Level 風險等級 High High High High Low High High Low Test Request 測試要求 PH/HE HE HE HE HE PH PH PH Test Frequency 測試頻率 Lot by lot Lot by lot Lot by lot Lot by lot Weekly 2 weeks Black part: lot by lot Others: weekly 3 months Accessible:lot by lot In accessible:Per RoHS test plan Lot by lot Per year Weekly Monthly NA Per RoHS procedure Remark 備注 Request DoC/Test Report/MSDS Request DoC/Test Report/MSDS Request DoC Request DoC Request DoC and Test Report Paint PVC and soft parts Metal part Purchasing High HE Die cast regrind material Fabric Pigment Plastic raw material Elec. material EL Purchasing Purchasing Purchasing High Low Low Low HE Azo Dye HE HE Heavy Element/ Phthalates RoHS Request DoC Request DoC/MSDS/ Test Report Request DoC/Test Report Purchasing M
文件编号：QMDT-QA-WI053
產品安全及環境符合性保證 版本/版次：A/0
第 8 页 共 8 页 工作指引
品質管理部-QA
