防火阻燃材料產(chǎn)品工廠質(zhì)量保證能力要求

1、防火阻燃材料產(chǎn)品工廠質(zhì)量保證能力要求Quality assurance capacity requirements from factory of products with Fireproof retardant material為保證產(chǎn)品與已獲型式試驗合格的樣品的一致性，工廠應滿足本文件規(guī)定的產(chǎn)品質(zhì)量保證能力要求。In order to ensure the products to be in consistency of the qualified samples having been tested, factories should meet the requirements of

2、product quality guarantee capacity hereinafter.職責和資源Responsibilities and Resources職責Responsibilities工廠應規(guī)定與質(zhì)量活動有關的各類人員職責及相互關系，且工廠應在組織內(nèi)指定一名質(zhì)量負責人，無論該成員在其他方面的職責如何，應具有以下方面的職責和權限：Factories should stipulate all staff responsibility and mutual relationships related to product quality, and also designate a q

3、uality assurance manager within the organization, who shall have the responsibility and authority of the following aspects whatever duty in others:負責建立滿足本文件要求的質(zhì)量體系，并確保其實施和保持；a) To ensure the QMS are established, implemented and maintained in Consistent with this document.b) 確保加貼標志的產(chǎn)品符合產(chǎn)品標準的要求；b) To

4、ensure labeling products conform to product standards requirements;c) 建立文件化的程序，確保標志的妥善保管和使用；c) To establish a documented procedure to ensure properly keep and use of LOGO;d) 建立文件化的程序，確保不合格品和獲證產(chǎn)品變更后未經(jīng)認證機構確認，不加貼標志。質(zhì)量負責人應具有充分的能力勝任本職工作。d) To establish a documented procedure to ensure no labeling logo on

5、 non-conforming products and once certified product without renewed certification by authorized agency.Quality director should have the ability to fully competent for the job.1.2資源Resources工廠應配備必須的生產(chǎn)設備和檢驗設備以滿足穩(wěn)定生產(chǎn)符合規(guī)則的產(chǎn)品要求；應配備 相應的人力資源，確保從事對產(chǎn)品質(zhì)量有影響工作的人員具備必要的能力；建立并保持適 宜產(chǎn)品生產(chǎn)、檢驗、試驗、儲存等必備的環(huán)境。Factories sh

6、ould be equipped with necessary production equipment and testing equipment to meet product requirements of steady production in line with rules ; Also Should be armed with corresponding human resources to ensure that personnel engaged in product quality activities possess the necessary ability; Also

7、 should establish and maintain the production, inspection, testing, storage and other necessary conditions of appropriate production.對國家安全法規(guī)、衛(wèi)生法規(guī)、環(huán)保法規(guī)等明確規(guī)定應加以勞動、安全防護措施的生產(chǎn)崗位、儲存部位和檢驗崗位，工廠必須建立這些崗位的安全操作規(guī)定、管理要求等文件，崗位人員必須獲取國家頒發(fā)的資格證書。工廠的產(chǎn)能規(guī)模應符合國家有關產(chǎn)業(yè)政策要求。As clearly regulated in national security, health, e

8、nvironmental protection rules that positions of production, storage and inspection shall additionally take some measures in labor, safety and protection, factory must document safety operation regulation, management and others .Furthermore, personnel must obtain the qualification certificate issued

9、by our country.The factory's production capacity size shall comply with the requirements of relevant national industrial policy.2. 文件和記錄2. Documents and Records2.1工廠應建立、保持文件化的質(zhì)量計劃或類似文件，以及為確保產(chǎn)品質(zhì)量的相關過程 有效運作和控制需要的文件。質(zhì)量計劃應包括產(chǎn)品設計目標、實現(xiàn)過程、檢測及有關資源 的規(guī)定，以及產(chǎn)品獲證后對獲證產(chǎn)品的變更（標準、工藝、關鍵件等）、標志的使用管理等 的規(guī)定。2.1 The fac

10、tory shall establish and maintain a documented quality plan or similar document, as well as the required file of the effective operation and control related to the process of ensuring product quality. Quality plan should include product design goals, implementation process, testing, and regulations

11、on resources, as well as provisions of the use and management of change products (standard, process, key-module, etc.) and LOGO.產(chǎn)品設計標準或規(guī)范應是質(zhì)量計劃的一個內(nèi)容，其要求應不低于有關該產(chǎn)品的國家標準要求。Product design standards or specifications should be one of the contents of quality plan, which require no lower than the relative

12、national standard requirements.2.2工廠應建立并保持文件化的程序以對本文件要求的文件和資料進行有效的控制。這些控制應確保：2.2 The factory shall establish and maintain documented procedures to effectively control of required files and materials. These controls should ensure that:a) 文件發(fā)布前和更改應由授權人批準，以確保其適宜性；a) In order to ensure its suitability,

13、the file should be approved by the authorizer prior to its release and alteration.b) 文件的更改和修訂狀態(tài)得到識別，防止作廢文件的非預期使用；b) Identify the alteration and revision of file to prevent unintended use of invalid files.c) 確保在使用處可獲得相應文件的有效版本。c) While needed ,ensure to obtain corresponding effective document version

14、.2.3工廠應建立并保持質(zhì)量記錄的標識、儲存、保管和處理的文件化程序，質(zhì)量記錄 應清晰、完整以作為產(chǎn)品符合規(guī)定要求的證據(jù)。質(zhì)量記錄應有適當?shù)谋４嫫谙蕖?.3 The factory shall establish and maintain quality record identification, storage; safekeeping and handling of documented procedures, and quality records shall be clear and complete as evidence of a product conform to speci

15、fication.Quality records shall have proper expiration.3. 米購和進貨檢驗3. The Purchasing and Incoming Inspection(IQC)3.1供應商的控制3.1 The Supplier's Control工廠應制定對關鍵元器件和材料的供應商的選擇、評定和日常管理的程序，以確保供 應商具有保證生產(chǎn)關鍵元器件和材料滿足要求的能力。工廠應保存對供應商的選擇評價和日常管理記錄。Factories should establish procedures towards the choose, evaluatio

16、n and daily management of supplier upon key components and materials, to ensure that the supplier has the required capability of ensuring key components and materials to meet the requirements.Factories should save the selection, evaluation and daily management of supplier.3.2關鍵元器件和材料的檢驗/驗證3.2 Key Co

17、mponents and Materials ' Inspection/Verification工廠應建立并保持對供應商提供的關鍵元器件和材料的檢驗或驗證的程序及定期確認 檢驗的程序，以確保關鍵元器件和材料滿足型式認可所規(guī)定的要求。Plant shall establish and maintain inspection or verification process and regular Verification test procedure of key components and materials provided by the supplier, to ensure th

18、at the key components and materials in accordance with approval regulations.關鍵元器件和材料的檢驗可由工廠進行，也可以由供應商完成。當由供應商檢驗時，工廠應對供應商提出明確的檢驗要求。The key components and materials inspection can be conducted by the factory, also be done by the supplier. When the supplier did, factory shall specify inspection to supp

19、lier.工廠應保存關鍵件檢驗或驗證記錄、確認檢驗記錄及供應商提供的合格證明及有關檢 驗數(shù)據(jù)等。Factories should preserve key components inspection or verification records, confirmation inspection records and qualification as well related inspection data, and etc from supplier.工廠應采用對人身安全、環(huán)境無危害的原料、半成品、元器件等。因工藝技術要求、 配方要求等不可避免的原因而使用可能導致對人身或環(huán)境安全有危害作用

20、的原料、半成品、 元器件等時，必須具備有關安全生產(chǎn)部門或環(huán)境保護部門、衛(wèi)生防疫部門的許可。Factory should adopt raw materials, semi-finished products, components harmless to the personal safety and environmental. While harmful raw materials, semi-finished products, components for personal or environmental safety generated owing to such inevitab

21、le reasons technological requirement and formulation requirement, the factory must have license of the safety production department or the environmental protection department and the health and epidemic prevention department.4. 生產(chǎn)過程控制和過程檢驗4. The Production Process Control and Process Inspection4.1工廠

22、應對關鍵生產(chǎn)工序進行識別，關鍵工序操作人員應具備相應的能力，如果該工 序沒有文件規(guī)定就不能保證產(chǎn)品質(zhì)量時，則應制定相應的工藝作業(yè)指導書，使生產(chǎn)過程受 控。4.1 The key production processes should be identified by the factory and the key process operators shall have the corresponding ability. The factory shall make the corresponding technological instruction to make the product

23、ion process controlled if the process does not file regulation.4.2產(chǎn)品生產(chǎn)過程中如對環(huán)境條件有要求，工廠應保證工作環(huán)境滿足規(guī)定的要求。4.2 If environmental conditions are required in products production process, the factory shall ensure the work environment meet the prescribed requirements .4.3可行時，工廠應對適宜的過程參數(shù)和產(chǎn)品特性進行監(jiān)控。4.3 When feasib

24、le, the factory monitor process parameters and product characteristics properly.4.4工廠應建立并保持對生產(chǎn)設備進行維護保養(yǎng)的制度。4.4 The factory shall establish and keep to maintenance system of production equipment.4.5工廠應在生產(chǎn)的適當階段對產(chǎn)品進行檢驗，以確保產(chǎn)品及零部件與樣品一致。4.5 The factory should inspect products in the appropriate stages of p

25、roduction, to ensure that the products and components are consistent with the sample.4.6產(chǎn)品生產(chǎn)過程有可能產(chǎn)生影響人身安全和環(huán)境保護要求的，應采取切實有效的預防、防護措施，具備安全管理手段，應獲得政府許可或通過第三方評估。4.6 While harmful substance for personal or environmental safety generated in products production process, the factory should take concrete and e

26、ffective prevention and protection measures, equipped with safety management methods, also obtain the permission of the government or pass the assessment of a third party.5. 例行檢驗和確認檢驗5. Routine Inspection and Confirmation Inspection工廠應制定并保持文件化的例行檢驗和確認檢驗程序，以驗證產(chǎn)品滿足規(guī)定的要求。 檢驗程序中應包括檢驗項目、內(nèi)容、方法、判定等。并應保存檢驗記

27、錄。具體的例行檢驗 和確認檢驗要求應按相應產(chǎn)品的實施規(guī)則的要求執(zhí)行。Factories should establish and maintain documented routine inspection and verification test procedures, to verify that products meet the requirements of regulations. Inspection items shall be included the inspection procedures, contents, methods, assessmentand etc.

28、and inspection records shall also be saved. Specific routine inspection and confirmation inspection shall be executed according to the implementation requirements of the corresponding product.例行檢驗是在生產(chǎn)的最終階段對生產(chǎn)線上的產(chǎn)品進行的100%僉驗，通常檢驗后，除包裝和加貼標簽外，不再進一步加工。Routine inspection is to fully inspect production of

29、the production line in the final stage of the production, and generally , no further processing after inspection in addition to the packaging and labeling.確認檢驗是為驗證產(chǎn)品持續(xù)符合標準要求進行的抽樣檢驗。Verification test is a sampling inspection to verify the product continual conforming to the standards requirements.6.

30、檢驗試驗儀器設備6. Inspection Test Equipment用于檢驗和試驗的設備應定期校準和檢查，并滿足檢驗試驗能力。檢驗和試驗的儀器設備應有操作規(guī)程，檢驗人員應能按操作規(guī)程要求，準確地使用儀 器設備。Inspection and testing equipment should be calibrated and check regularly to have the inspection & experiment performance.Inspection and testing equipment should be equipped with operationa

31、l procedures, and inspection personnel should abide by operation procedures to set up the equipment correctly6.1校準和檢定6.1 The Calibration and Verification用于確定所生產(chǎn)的產(chǎn)品符合規(guī)定要求的檢驗試驗設備應按規(guī)定的周期進行校準或檢定。 校準或檢定應溯源至國家或國際基準。對自行校準的，則應規(guī)定校準方法、驗收準則和校 準周期等。設備的校準狀態(tài)應能被使用及管理人員方便識別。應保存設備的校準記錄。Inspection and testing equipme

32、nt, used to determine the products meet the provisions, calibration and verification shall do in a regular way .Calibration and verification shall be traced back to the national or international benchmarks. For self-calibration, specified calibration methods, acceptance criteria, and the calibration

33、 cycle should be set. Equipment calibration status should be recognized by the user manager.Calibration records shall be preserved.6.2運行檢查6.2 Operational Check對用于例行檢驗和確認檢驗的設備除應進行日常操作檢查外，還應進行運行檢查。當 發(fā)現(xiàn)運行檢查結果不能滿足規(guī)定要求時，應能追溯至已檢測過的產(chǎn)品。必要時，應對這些產(chǎn)品重新進行檢測。應規(guī)定操作人員在發(fā)現(xiàn)設備功能失效時需采取的措施。運行檢查結果及采取的調(diào)整等措施應記錄。For routine

34、inspection and confirmation equipment, except daily operation inspection, also operational check must. When found running status cannot meet the specified requirements, should be able to back to having tested products. When necessary, retest these products. Failure of the equipment, measures should

35、be taken.Running status and adjustment measures shall be recorded7. 不合格品的控制7. Control of Nonconforming Product工廠應建立不合格品控制程序，內(nèi)容應包括不合格品的標識方法、隔離和處置及采取 的糾正、預防措施。經(jīng)返修、返工后的產(chǎn)品應重新檢測。對重要部件或組件的返修應作相 應的記錄，應保存對不合格品的處置記錄。The factory shall establish nonconforming product control procedures, which should include th

36、e nonconforming product identification methods, isolation and disposal and some measures to correct and prevent. Retest the products after repair and rework. Repair record of the important parts or components should be preserved and the disposal of non-conforming product record shall be kept.8. 內(nèi)部質(zhì)量

37、審核8. Internal Quality Audits工廠應建立文件化的內(nèi)部質(zhì)量審核程序，確保質(zhì)量體系的有效性和型式認可產(chǎn)品的一 致性，并記錄內(nèi)部審核結果。對工廠的投訴尤其是對產(chǎn)品不符合標準要求的投訴，應保存記錄，并應作為內(nèi)部質(zhì)量 審核的信息輸入。對審核中發(fā)現(xiàn)的問題，應采取糾正和預防措施，并進行記錄。The factory shall establish a documented internal quality audit procedures to ensure the effectiveness of the quality system and the consistency of the type approva