標準編號:	CNCA-00C-006-2014
中文名稱:	強制性產品認證實施規則工廠檢查通用要求
英文名稱:	Implementation Rules for Compulsory Product Certification - General Requirements for Factory Inspection
行業分類:	CN
發布日期:	2014-01-02
實施日期:	2014-9-1
標準狀態:	valid
翻譯語言:	英文
文件格式:	PDF
中文字符數:	10000 字
翻譯價格(元):	1000.0
交付時間:	付款后 1 個工作日

0. Introduction According to the requirements of "Regulations on Compulsory Product Certification", manufacturers shall control the consistency of their certified products, and their quality assurance capacity shall persistently meet the certification requirements. The Rules is formulated with a view to standardizing and guiding manufacturers producing products within the Catalogue of Products Subject to China Compulsory Certification (hereinafter referred to as CCC certification) to establish the quality assurance capacity required to ensure products being persistently in conformity with CCC certification. During the specific implementation of certification, the factory shall establish the quality assurance capacity required by the Rules according to the requirements of the Rules and corresponding product certification implementation rules/regulations and in terms of product features and their characteristics in manufacturing and processing for the purpose of ensuring the consistency of certified products they produced and the type test samples. Notes: The factories in the Rules involve certification clients, producers and manufacturers. 1 Application Scope The Rules specifies the basic requirements of factory quality assurance capacity and is one of the criterion for implementing factory inspection by certification authorities. 2 Terms and Definitions 2.1 Certification Technology Director a person who belongs to the producer and/or manufacturer, masters the requirements of certification standards, confirms and approves the change(s) of the certified product according to the responsibility scope specified in product certification implementation rules/regulations, and undertakes the corresponding responsibilities 2.2 Consistency of Certified Products (Product Consistency) the certified products produced shall be consistent with the type test samples. The specific requirements for product consistency are specified in the product certification implementation rules/regulations 2.3 Routine Inspection to eliminate nonconforming products caused by accidental factors in production, 100% inspection will usually be carried out on to-be-certified products during the final production stage. Routine inspection is allowed to be carried out with the proven equivalent and fast methods Note: As for special products, sampling inspection may be adopted as routine inspection according to the requirements of product certification implementation rules/regulations. 2.4 Verification Inspection the sampling inspection carried out to verify whether certified products meet the certification standards persistently 2.5 Periodical Verification Inspection for Key Components the periodical sampling inspection carried out to verify whether the quality characteristics of key components persistently meet the certification standards and/or technical requirements Note: “Key component” is a general term of parts and components, accessories, raw materials, etc., which play a key role for products meeting the requirements of certification standards. 2.6 Function Inspection a inspection check carried out to determine whether the intended functions of the inspection and test instruments/equipment meet the specified requirements 3 Factory Quality Assurance Capacity Requirements The factory is the responsibility subject for product quality, its quality assurance capacity shall persistently meet the certification requirements, the products it produced shall meet the standard requirements, and it shall ensure that the certified products are consistent with the type test samples. The factory shall receive and cooperate in all factory on-site inspections, market inspections and sampling tastings conducted by the certification authority according to the Rules and relevant product certification implementation rules/regulations. 3.1 Responsibilities and Resources 3.1.1 Responsibilities The factory shall specify responsibilities, authorities and interrelationship for personnel at all levels concerned to certification requirements and shall also appoint a quality director from its management level; regardless of responsibilities of the appointed person in other aspects, he/she shall be provided with the following responsibilities and authorities: (a) Ensuring that the requirements of this document are established, implemented and maintained effectively in the factory; (b) Ensuring the product consistency and the conformity of products with the standards; (c) Using the CCC certificate and mark correctly and ensuring that the certificates for CCC marked products are continuously valid. The quality director shall be competent for the work and may also act as the certification technology director. 3.1.2 Resource The factory shall be equipped with necessary production facilities and inspection and test instruments/equipment so as to stably produce products which meet the requirements of certification standards; shall allocate corresponding human resource and ensure that the staff engaged in such work having influence on product certification quality possess necessary ability; and shall establish and maintain requisite environment and facilities suitable for the production, inspection and test, storage, etc., of products. As for external resources which shall be used by leasing, the factory shall ensure their continuous availability and correct application, and shall also keep the records of relevant external resources, such as the contract agreement and service record. 3.2 Documentation and Records 3.2.1 The factory shall establish and maintain documented procedures to ensure effective control of the files required by this document, necessary external files and records. The product design standards or specifications shall not be inferior to the requirements of the certification standards for the product. As for the main contents which may affect the product consistency, the factory shall have necessary drawings, templates, list of key components, process documents, operation instructions and other design documents, and ensure continuous effectiveness of the documents. 3.2.2 The factory shall ensure the sufficiency and suitability of the documents and use the valid versions of the documents. 3.2.3 The factory shall ensure the records to be clear, complete and traceable, so as to serve as the evidence for product meeting the specified requirements. The retention period of quality-related records shall meet the requirements of the laws and regulations to ensure the previous post-inspection record can be obtained in this inspection, and shall be at least 24 months. 3.2.4 The factory shall identify and keep the important documents and quality information related to product certification, such as the type test report, factory inspection results, status information (valid, suspended, withdrawn, cancelled, etc.) of CCC certificate, approval of certification change, supervised sampling inspection reports, product quality complaints and handling results, etc. 3.3 Control of Procurement and Key Components 3.3.1 Control of procurement The factory shall identify and define the technical requirements of procured key components in the procurement document, and these technical requirements shall also ensure that the final products meet the certification requirements. The factory shall establish and keep the list of the qualified producers/manufacturers of key components, and make procurement from them; the factory shall keep the procurement and application records, etc., of key components, such as the procurement list, ex-warehousing/warehousing list, accounts, etc. 3.3.2 Quality control of key components 3.3.2.1 The factory shall establish and maintain documented procedures, verify and/or inspect whether the technical requirements of key components are fulfilled during procurement (entering the factory) and keep related records. 3.3.2.2 As for the quality characteristics of the procured key components, the factory shall select suitable control modes to ensure their continuous conformity with the technical requirements of key components and to ensure that the final products meet the certification requirements, and shall also keep related records. Suitable control modes may include: (a) As for CCC certificate or the voluntary product certification results which may be recognized by the compulsory certification of final products, the factory shall ensure the validity of the certificates. (b) As for the key components without relevant certificates, their periodical verification inspection shall meet the requirements of product certification implementation rules/regulations. (c) As for the control scheme formulated by factory, its control effect shall not be inferior to the requirements in Article 3.3.2.2 (a) or (b). 3.3.2.3 When procuring key components from dealers and traders, the factory shall take adequate measures to ensure the consistency of procured key components as well as their continuous conformity with the technical requirements. As for the key parts, components, subassemblies, assemblies and semifinished products entrusted to subcontractors for producing, the factory shall control them as procured key components, so as to ensure the subcontracted products continuously meeting the specified requirements. Self-produced key components shall be controlled according to Article 3.4. 3.4 Production Process Control 3.4.1 The factory shall identify the process which may affect the quality of certified products (referred to as critical process) and the identified critical process shall meet the relevant requirements. The operators of critical process shall possess appropriate capacity; the critical process shall be so controlled as to ensure the conformity of the certified product with the standards as well as the product consistency; where the quality of certified products cannot be guaranteed if no document is provided for the critical process, then corresponding operation instructions shall be prepared to control the production process. 3.4.2 If there is any requirement for the environment conditions during production, the factory shall ensure the working environment meeting the specified requirements. 3.4.3 If necessary, the factory shall monitor and measure the appropriate process parameters. 3.4.4 The factory shall establish and maintain a maintenance system for production equipment to ensure that the capacity of the equipment continuously meets the production requirements. 3.4.5 If necessary, the factory shall inspect, monitor and measure the products and their characteristics at the proper stage of the production according to the specified requirements, so as to ensure the conformity of products with the standards as well as the product consistency. 3.5 Routine Inspection and/or Verification Inspection The factory shall establish and maintain documented procedures to control the routine inspection and/or verification inspection on final products; the inspection procedures, which shall include the inspection frequency, items, contents, procedures, judgment, etc., shall meet the relevant requirements. The factory shall carry out inspections and keep relevant records. As for the inspection entrusted to an external organization, the factory shall ensure its capacity meets the inspection requirements and shall keep the evaluation results of relevant capacity, such as the laboratory accreditation certificate. 3.6 Inspection and Test Instruments/Equipment 3.6.1 Basic requirements The factory shall be equipped with sufficient inspection and test instruments/equipment to ensure that the capacity of instruments/equipment used in such links as procurement, manufacture, and final inspection/test can meet the inspection and test requirements during the batch production of certified products. Inspectors/testers shall be able to correctly use instruments/equipment, master the inspection and test requirements, and apply them effectively. 3.6.2 Calibration and verification The inspection and test instruments/equipment used to determine that the produced certified products meet the relevant requirements shall be calibrated or verified per specified period, and this period may be set according to their use frequency, previous calibration condition, etc. As for instruments/equipment need internal calibration, the factory shall specify their calibration methods, acceptance criteria and calibration period, etc. Calibration or verification shall be traced back to national or international benchmark. The calibration or verification state of instruments and equipment shall be easy to be identified by the user and manager. The factory shall keep the calibration or verification records of instruments and equipment. As for the calibration or verification entrusted to an external organization, the factory shall ensure the capacity of this organization meeting the requirements of calibration or verification and shall keep the relevant capacity evaluation results. Note: As for critical monitoring and measuring devices in the production process control, the factory shall manage them according to the requirements of product certification implementation rules/regulations. 3.6.3 Functional check If necessary, the factory shall carry out function check on the routine inspection equipment according to the specified requirements. If the result of function check fails to meet the requirements, the products detected shall be traceable; if necessary, these products shall be re-detected. The factory shall specify the measures that shall be taken by the operators upon finding the function failure of instruments and equipment. The factory shall keep the records for function check results and those for measures taken when the instruments and equipment are in failure. 3.7 Control of Nonconforming Products 3.7.1 As for nonconforming products found in such links as procurement, manufacture and inspection, the factory shall take measures, like marking, isolating and disposing, to avoid unintended use or delivery of nonconforming products. The reworked or repaired products shall be reinspected. 3.7.2 As for any external information concerning the nonconformity of certified products, like supervision and random inspection at national and provincial levels, product recall and customer complaints, the factory shall analyze the reason for the nonconformity and take appropriate corrective measures. The factory shall keep the records of nonconformity, cause analysis, disposal and corrective measures, etc., of the certified products.

0.Introduction 1.Scope 2.Terms and Definitions 3.Criteria of Factory Inspection Activities 4.Factory Inspection Requirements 5.Determining Basic Requirements for Factory Inspection 6.Determining the Mode, Contents and Inspection Team of Factory Inspection 7.Risk Control for Manufacturer Relocation 8.Disposal after Finding the Nonconformity of Certified Products 9.Factory Inspection for Certificate Recovery 10.Special Requirements for Adding CCC Mark 11.Judgment for Factory Inspection Conclusion

2014年第1號 國家認監委關于發布工廠質量保證能力要求 等強制性產品認證實施規則的公告 為進一步促進強制性產品認證實施科學、規范、有效，根據《中華人民共和國認證認可條例》和《強制性產品認證管理規定》以及《國家認監委關于明確強制性產品認證實施規則類文件調整方案及要求的通知》（國認證〔2013〕39號），我委制定了兩個強制性產品認證通用實施規則：《強制性產品認證實施規則工廠質量保證能力要求》，用于規范指導強制性產品認證目錄內產品生產企業建立確保產品持續符合CCC認證要求的質量保證能力；《強制性產品認證實施規則工廠檢查通用要求》，用于規范指導強制性產品認證指定認證機構工廠檢查工作實施的一致性，現予以發布。 上述兩個通用實施規則與后續發布的具體產品認證實施規則配套使用，于2014年9月1日起實施。 特此公告。 附件：1.《強制性產品認證實施規則工廠質量保證能力要 求》（編號：CNCA-00C-005） 2.《強制性產品認證實施規則工廠檢查通用要求》 （編號：CNCA-00C-006） 國家認監委 2014年1月2日 附件1 編號：CNCA-00C-005 強制性產品認證實施規則 工廠質量保證能力要求 2014-01-02發布 2014-09-01實施 中國國家認證認可監督管理委員會發布 目 錄 0.引言························································5 1.適用范圍····················································5 2.術語和定義··················································5 2.1認證技術負責人············································5 2.2認證產品一致性（產品一致性）·······························5 2.3例行檢驗··················································6 2.4確認檢驗···················································6 2.5關鍵件定期確認檢驗········································6 2.6功能檢查···················································6 3.工廠質量保證能力要求········································6 3.1職責和資源·················································7 3.2文件和記錄·················································8 3.3采購和關鍵件控制···········································8 3.4生產過程控制···············································9 3.5例行檢驗和/或確認檢驗·····································10 3.6檢驗試驗儀器設備··········································10 3.7不合格品的控制···········································12 3.8內部質量審核·············································12 3.9認證產品的變更及一致性控制·······························12 3.10產品防護與交付··········································13 3.11CCC證書和標志···········································13 0.引言 按照《強制性產品認證管理規定》的要求，生產企業應控制獲證產品一致性，其質量保證能力應持續符合認證要求。為規范指導強制性產品認證（以下簡稱CCC認證）目錄內產品生產企業建立確保產品持續符合CCC認證要求的質量保證能力，制定本實施規則。 在認證工作具體實施中，工廠應以保證生產的認證產品與型式試驗樣品的一致性為目標，根據本實施規則及相應產品認證實施規則/細則的要求，針對產品特性和生產加工特點，建立符合本實施規則要求的質量保證能力。 注：本實施規則中的工廠涉及認證委托人、生產者、生產企業。 1.適用范圍 本實施規則規定了工廠質量保證能力的基本要求，同時也是認證機構實施工廠檢查的依據之一。 2.術語和定義 2.1認證技術負責人 屬于生產者和/或生產企業內部人員，掌握認證依據標準要求，依據產品認證實施規則/細則規定的職責范圍，對認證產品變更進行確認批準并承擔相應責任的人。 2.2認證產品一致性（產品一致性） 生產的認證產品與型式試驗樣品保持一致，產品一致性的具體要求由產品認證實施規則/細則規定。 2.3例行檢驗 為剔除生產過程中偶然性因素造成的不合格品，通常在生產的最終階段，對認證產品進行的100%檢驗。例行檢驗允許用經驗證后確定的等效、快速的方法進行。 注：對于特殊產品，例行檢驗可以按照產品認證實施規則/細則的要求，實施抽樣檢驗。 2.4確認檢驗 為驗證認證產品是否持續符合認證依據標準所進行的抽樣檢驗。 2.5關鍵件定期確認檢驗 為驗證關鍵件的質量特性是否持續符合認證依據標準和/或技術要求所進行的定期抽樣檢驗。 注：關鍵件是對產品滿足認證依據標準要求起關鍵作用的元器件、零部件、原材料等的統稱。 2.6功能檢查 為判斷檢驗試驗儀器設備的預期功能是否滿足規定要求所進行的檢查。 3.工廠質量保證能力要求 工廠是產品質量的責任主體，其質量保證能力應持續符合認證要求，生產的產品應符合標準要求，并保證認證產品與型式試驗樣品一致。工廠應接受并配合認證機構依據本實施規則及相關產品認證實施規則/細則所實施的各類工廠現場檢查、市場檢查、抽樣檢測。 3.1職責和資源 3.1.1職責 工廠應規定與認證要求有關的各類人員職責、權限及相互關系，并在本組織管理層中指定質量負責人，無論該成員在其它方面的職責如何，應使其具有以下方面的職責和權限： (a)確保本文件的要求在工廠得到有效地建立、實施和保持； (b)確保產品一致性以及產品與標準的符合性； (c)正確使用CCC證書和標志，確保加施CCC標志產品的證書狀態持續有效。 質量負責人應具有充分的能力勝任本職工作，質量負責人可同時擔任認證技術負責人。 3.1.2資源 工廠應配備必須的生產設備、檢驗試驗儀器設備以滿足穩定生產符合認證依據標準要求產品的需要；應配備相應的人力資源，確保從事對產品認證質量有影響的工作人員具備必要的能力；應建立并保持適宜的產品生產、檢驗試驗、儲存等必備的環境和設施。 對于需以租賃方式使用的外部資源，工廠應確保外部資源的持續可獲得性和正確使用；工廠應保存與外部資源相關的記錄，如合同協議、使用記錄等。 3.2文件和記錄 3.2.1工廠應建立并保持文件化的程序，確保對本文件要求的文件、必要的外來文件和記錄進行有效控制。產品設計標準或規范應不低于該產品的認證依據標準要求。對可能影響產品一致性的主要內容，工廠應有必要的圖紙、樣板、關鍵件清單、工藝文件、作業指導書等設計文件，并確保文件的持續有效性。 3.2.2工廠應確保文件的充分性、適宜性及使用文件的有效版本。 3.2.3工廠應確保記錄的清晰、完整、可追溯，以作為產品符合規定要求的證據。與質量相關的記錄保存期應滿足法律法規的要求，確保在本次檢查中能夠獲得前次檢查后的記錄，且至少不低于24個月。 3.2.4工廠應識別并保存與產品認證相關的重要文件和質量信息，如型式試驗報告、工廠檢查結果、CCC證書狀態信息（有效、暫停、撤銷、注銷等）、認證變更批準信息、監督抽樣檢測報告、產品質量投訴及處理結果等。 3.3采購與關鍵件控制 3.3.1采購控制 對于采購的關鍵件，工廠應識別并在采購文件中明確其技術要求，該技術要求還應確保最終產品滿足認證要求。 工廠應建立、保持關鍵件合格生產者/生產企業名錄并從中采購關鍵件，工廠應保存關鍵件采購、使用等記錄，如進貨單、出入庫單、臺帳等。 3.3.2關鍵件的質量控制 3.2.2.1工廠應建立并保持文件化的程序，在進貨（入廠）時完成對采購關鍵件的技術要求進行驗證和/或檢驗并保存相關記錄。 3.3.2.2對于采購關鍵件的質量特性，工廠應選擇適當的控制方式以確保持續滿足關鍵件的技術要求，以及最終產品滿足認證要求，并保存相關記錄。適當的控制方式可包括： (a)獲得CCC證書或可為最終產品強制性認證承認的自愿性產品認證結果，工廠應確保其證書狀態的有效。 (b)沒有獲得相關證書的關鍵件，其定期確認檢驗應符合產品認證實施規則/細則的要求。 (c)工廠自身制定控制方案，其控制效果不低于3.3.2.2(a)或(b)的要求。 3.3.2.3當從經銷商、貿易商采購關鍵件時，工廠應采取適當措施以確保采購關鍵件的一致性并持續滿足其技術要求。 對于委托分包方生產的關鍵部件、組件、分總成、總成、半成品等，工廠應按采購關鍵件進行控制，以確保所分包的產品持續滿足規定要求。 對于自產的關鍵件，按3.4進行控制。 3.4生產過程控制 3.4.1工廠應對影響認證產品質量的工序（簡稱關鍵工序）進行識別，所識別的關鍵工序應符合規定要求。關鍵工序操作人員應具備相應的能力；關鍵工序的控制應確保認證產品與標準的符合性、產品一致性；如果關鍵工序沒有文件規定就不能保證認證產品質量時，則應制定相應的作業指導書，使生產過程受控。 3.4.2產品生產過程如對環境條件有要求,工廠應保證工作環境滿足規定要求。 3.4.3必要時，工廠應對適宜的過程參數進行監視、測量。 3.4.4工廠應建立并保持對生產設備的維護保養制度，以確保設備的能力持續滿足生產要求。 3.4.5必要時，工廠應按規定要求在生產的適當階段對產品及其特性進行檢查、監視、測量，以確保產品與標準的符合性及產品一致性。 3.5例行檢驗和/或確認檢驗 工廠應建立并保持文件化的程序，對最終產品的例行檢驗和/或確認檢驗進行控制；檢驗程序應符合規定要求，程序的內容應包括檢驗頻次、項目、內容、方法、判定等。工廠應實施并保存相關檢驗記錄。 對于委托外部機構進行的檢驗，工廠應確保外部機構的能力滿足檢驗要求，并保存相關能力的評價結果，如實驗室認可證明等。 3.6檢驗試驗儀器設備 3.6.1基本要求 工廠應配備足夠的檢驗試驗儀器設備，確保在采購、生產制造、最終檢驗試驗等環節中使用的儀器設備能力滿足認證產品批量生產時的檢驗試驗要求。 檢驗試驗人員應能正確使用儀器設備，掌握檢驗試驗要求并有效實施。 3.6.2校準、檢定 用于確定所生產的認證產品符合規定要求的檢驗試驗儀器設備應按規定的周期進行校準或檢定，校準或檢定周期可按儀器設備的使用頻率、前次校準情況等設定；對內部校準的，工廠應規定校準方法、驗收準則和校準周期等；校準或檢定應溯源至國家或國際基準。儀器設備的校準或檢定狀態應能被使用及管理人員方便識別。工廠應保存儀器設備的校準或檢定記錄。 對于委托外部機構進行的校準或檢定活動，工廠應確保外部機構的能力滿足校準或檢定要求，并保存相關能力評價結果。 注：對于生產過程控制中的關鍵監視測量裝置，工廠應根據產品認證實施規則/細則的要求進行管理。 3.6.3功能檢查 必要時，工廠應按規定要求對例行檢驗設備實施功能檢查。當發現功能檢查結果不能滿足要求時，應能追溯至已檢測過的產品；必要時，應對這些產品重新檢測。工廠應規定操作人員在發現儀器設備功能失效時需采取的措施。 工廠應保存功能檢查結果及儀器設備功能失效時所采取措施的記錄。 3.7不合格品的控制 3.7.1對于采購、生產制造、檢驗等環節中發現的不合格品，工廠應采取標識、隔離、處置等措施，避免不合格品的非預期使用或交付。返工或返修后的產品應重新檢驗。 3.7.2對于國家級和省級監督抽查、產品召回、顧客投訴及抱怨等來自外部的認證產品不合格信息，工廠應分析不合格產生的原因，并采取適當的糾正措施。工廠應保存認證產品的不合格信息、原因分析、處置及糾正措施等記錄。 3.7.3工廠獲知其認證產品存在重大質量問題時（如國家級和省級監督抽查不合格等），應及時通知認證機構。 3.8內部質量審核 工廠應建立文件化的內部質量審核程序，確保工廠質量保證能力的持續符合性、產品一致性以及產品與標準的符合性。對審核中發現的問題，工廠應采取適當的糾正措施、預防措施。工廠應保存內部質量審核結果。 3.9認證產品的變更及一致性控制 工廠應建立并保持文件化的程序，對可能影響產品一致性及產品與標準的符合性的變更（如工藝、生產條件、關鍵件和產品結構等）進行控制，程序應符合規定要求。變更應得到認證機構或認證技術負責人批準后方可實施，工廠應保存相關記錄。 工廠應從產品設計（設計變更）、工藝和資源、采購、生產制造、檢驗、產品防護與交付等適用的質量環節，對產品一致性進行控制，以確保產品持續符合認證依據標準要求。 3.10產品防護與交付 工廠在采購、生產制造、檢驗等環節所進行的產品防護，如標識、搬運、包裝、貯存、保護等應符合規定要求。必要時，工廠應按規定要求對產品的交付過程進行控制。 3.11CCC證書和標志 工廠對CCC證書和標志的管理及使用應符合《強制性產品認證管理規定》、《強制性產品認證標志管理辦法》等規定。對于統一印制的標準規格CCC標志或采用印刷、模壓等方式加施的CCC標志，工廠應保存使用記錄。對于下列產品，不得加施CCC標志或放行： (a)未獲認證的強制性產品認證目錄內產品； (b)獲證后的變更需經認證機構確認，但未經確認的產品； (c)超過認證有效期的產品； (d)已暫停、撤銷、注銷的證書所列產品； (e)不合格產品。 附件2 編號：CNCA-00C-006 強制性產品認證實施規則 工廠檢查通用要求 2014-01-02發布 2014-09-01實施 中國國家認證認可監督管理委員會發布 目 錄 0.引言······················································16 1.范圍·······················································16 2.術語和定義·················································16 2.1工廠檢查·················································16 2.2指定試驗··················································17 3.工廠檢查活動的準則·········································17 4.工廠檢查要求···············································17 4.1工廠專業類別·············································17 4.2工廠檢查實施的基本要求.···································18 5.確定工廠檢查的基本要求·····································18 6.確定工廠檢查的方式、內容和檢查組····························18 7.生產企業搬遷的風險控制·····································19 8.獲知認證產品不合格信息后的處置·····························19 9.證書恢復的工廠檢查·········································19 10.CCC標志加施的特殊要求····································19 10.1需在生產過程中加施CCC標志的要求························20 10.2委托相關方印刷、模壓CCC標志的要求························20 11.工廠檢查結論判定·········································20 11.1工廠檢查結論和不符合項分類······························20 11.2工廠檢查結論判定條件····································21 11.3工廠檢查的結論告知······································23 0.引言 按照《強制性產品認證管理規定》的要求，在工廠檢查活動中，指定認證機構應對產品生產企業的質量保證能力、生產產品與型式試驗樣品的一致性等情況進行檢查。為規范強制性產品認證工廠檢查活動,指導指定認證機構工廠檢查工作實施的一致性,保證工廠檢查活動的針對性和有效性，制定本實施規則。 指定認證機構應根據本實施規則及相應產品認證實施規則的要求，針對產品自身特性和生產加工特點、生產企業分類管理、檢查員使用管理等因素，在風險評估的基礎上，建立與機構自身特點相適應的工廠檢查實施方案。 1.范圍 本實施規則適用于指定認證機構工廠檢查活動的組織管理、實施、工廠檢查結論判定等活動。 2.術語和定義 《強制性產品認證實施規則工廠質量保證能力要求》（簡稱工廠質量保證能力要求）中確立的以及下列術語和定義適用于本實施規則。 2.1工廠檢查 對工廠質量保證能力、產品一致性和產品與標準的符合性所進行的評價活動。工廠檢查范圍包括產品范圍和場所界限。 注：產品范圍指認證產品。場所界限指與產品認證質量相關的場所、部門、活動和過程；當認證產品的制造涉及多個場所時，工廠檢查的場所界限應至少包括例行檢驗、加施產品銘牌和CCC標志環節所在場所，必要時還應到其余場所（如關鍵工序）進一步檢查，即延伸檢查。 2.2指定試驗 為評價認證產品的一致性、產品與標準的符合性，檢查組在生產企業現場抽取認證產品并根據認證依據標準選定項目，由生產企業人員所進行的試驗。 3.工廠檢查活動的準則 (a)客觀、公正、公開、保密； (b)以產品一致性、產品與標準的符合性為關注焦點； (c)獲取認證產品及工廠的真實狀況； (d)選取具有代表性的檢查樣本； (e)得出基于風險評估的工廠檢查結論判定。 4.工廠檢查要求 認證機構應依據工廠質量保證能力要求并結合產品及行業特點，明確并公布工廠檢查要求。工廠檢查要求應至少包含工廠質量保證能力要求中的適用內容，并在以下方面保持一致： 4.1工廠專業類別 工廠專業類別按相同的產品大類、相同的認證依據標準系列、相同或相似的影響認證產品質量的關鍵生產工藝、可考慮的特殊情況等進行劃分。 同一工廠涵蓋不同工廠專業類別時，工廠檢查應分別實施。原則上，產品一致性檢查、指定試驗、抽樣檢驗和確認檢驗應覆蓋不同的工廠專業類別。 4.2工廠檢查實施的基本要求 對于同一認證規則下不同認證機構實施認證的產品，關鍵件清單、關鍵件定期確認檢驗、例行檢驗、確認檢驗的要求應保持一致。 5.確定工廠檢查的場所界限 在認證批準前，認證機構應與工廠協商確定工廠檢查的場所界限，對于生產企業實際地址以外的與產品認證質量相關的場所、部門、活動和過程，應特別關注。 在認證批準后，認證機構應確保工廠檢查場所界限的完整性、準確性，為選取具有代表性的檢查樣本提供必要條件。 6.確定工廠檢查的方式、內容和檢查組 認證機構應根據工廠檢查的具體目的確定其實施方式和內容，如預先通知或不通知的工廠檢查、從工廠/市場/使用場所獲取樣品、抽樣或買樣，以及工廠檢查的條款、各條款的檢查重點、產品一致性檢查、指定試驗、監督抽樣等。 認證機構應根據工廠檢查的具體目的、方式和內容，確定具備相應能力的檢查組成員，并為其提供完整、準確、實時更新的工廠檢查所需資料和信息。 對于預先通知的工廠檢查，認證機構應在現場檢查前與生產企業約定工廠檢查時間、確認工廠檢查范圍和計劃安排。 7.生產企業搬遷的風險控制 對于生產企業搬遷，認證機構應采取適當和必要的措施控制可能存在的如下風險： (a)由于生產條件、人員能力、生產工藝等變化所導致的風險； (b)工廠在新生產場所生產的產品，未經認證即出廠、銷售的風險。 8.獲知認證產品不合格信息后的處置 在獲知認證產品不合格信息后，認證機構應視情況實施特殊檢查或調查；重點分析導致不合格的原因及對認證產品的影響程度，并采取相應的處置措施。 9.證書恢復的工廠檢查 對于因質量原因所暫停的證書，在證書恢復的工廠檢查時，認證機構應： (a)關注工廠對證書暫停的原因分析是否全面、充分； (b)關注工廠采取的措施是否滿足產品召回等法律法規要求，糾正和糾正措施是否適當、有效，以避免同類問題的再次發生； (c)關注在證書暫停期間，是否有相關產品出廠、銷售、進口。 10.CCC標志加施的特殊要求 10.1需在生產過程中加施CCC標志的要求 對于需在生產過程中加施CCC標志的，如機動車輛輪胎、電線電纜等，認證機構應重點關注并控制下列可能存在的風險，采取適當和必要的措施以避免其非預期使用或交付： (a)從加施CCC標志至例行檢驗之間的，狀態未定產品； (b)已加施CCC標志的不合格品。 10.2委托相關方印刷、模壓CCC標志的要求 對于工廠委托相關方印刷、模壓CCC標志的，如機動車燈具生產企業委托配光鏡生產者將CCC標志模壓在配光鏡表面等，認證機構應重點關注以下方面的風險，采取適當和必要的措施使風險可控： (a)相關方加施CCC標志的活動是否受控并符合規定要求； (b)加施CCC標志的不合格品的非預期使用或交付； (c)加施CCC標志的合格品是否僅用于向生產企業交付； (d)相關方所印刷、模壓CCC標志的產品是否在強制性產品認證目錄內。 11.工廠檢查結論判定 11.1工廠檢查結論和不符合項分類 工廠檢查結論通常分為“工廠檢查通過”、“書面驗證通過”、“現場驗證通過”、“工廠檢查不通過”四種。其中，“書面驗證通過”指存在不符合項，工廠在規定的期限內采取糾正措施，報認證機構書面驗證有效后，工廠檢查通過；“現場驗證通過”指存在不符合項，工廠在規定的期限內采取糾正措施，認證機構現場驗證有效后，工廠檢查通過。 工廠檢查不符合項分為一般不符合項和嚴重不符合項兩類。其中，一般不符合項指可能對產品認證質量產生輕微影響的不符合項；嚴重不符合項指認證產品在生產制造或檢驗過程中產生嚴重的質量問題，以及產品結構、關鍵件等與認證批準結果不一致且較為嚴重的不符合項。 11.2工廠檢查結論判定條件 11.2.1工廠檢查通過 無不符合項。 11.2.2書面驗證通過 屬于一般不符合項；或者“現場驗證通過”和“工廠檢查不通過”以外的情況。 11.2.3現場驗證通過 存在不符合項，但沒有對產品一致性或產品與標準的符合性產生嚴重影響，具體例如： (a)雖有構成系統性不符合的較多一般不符合項，但未對產品一致性或產品與標準的符合性產生嚴重影響的； (b)雖有在資源、關鍵件質量控制、生產過程控制、檢驗等產品實現的主要質量環節存在不符合項，但未對產品一致性或產品與標準的符合性產生嚴重影響的； (c)其他難以通過糾正措施的證明性材料進行書面驗證，但未對產品一致性或產品與標準的符合性產生嚴重影響的。 11.2.4工廠檢查不通過 有構成系統不符合的較多一般不符合項或個別嚴重不符合項，且直接危及產品一致性或產品與標準的符合性時，具體例如： (a)指定試驗結果不合格（原則上）； (b)關鍵資源不滿足要求，難以保證產品一致性或產品與標準的符合性的； (c)產品一致性存在問題且較為嚴重，將導致產品不符合標準要求，如產品結構、關鍵件變更不符合規定要求的； (d)認證產品存在缺陷，可能導致質量安全事故的； (e)認證產品的變更及一致性控制未有效實施，造成產品不一致且質量保證能力系統性失效的； (f)認證證書暫停期間，工廠未采取整改措施或者整改后仍不合格的； (g)非法使用CCC標志或證書； 非法使用CCC標志或證書的主要情況有：偽造、變造、出租、出借、冒用、買賣、轉讓CCC標志或證書，以及盜用CCC標志；在獲知證書被撤銷或暫停后，繼續使用CCC標志或證書；在未獲得CCC證書的產品上，故意加施CCC標志；其它故意非法使用CCC標志或證書的情況。 (h)工廠以欺騙、賄賂等不正當手段獲得認證證書的; (i)其它直接危及產品一致性或產品與標準的符合性的嚴重不符合項。 11.3工廠檢查的結論告知 對于工廠檢查結論判定為“書面驗證通過”或“現場驗證通過”的，認證機構應將驗證結果及時告知生產企業。 當經過認證機構評定后的工廠檢查結論發生變化時，認證機構應及時告知生產企業。