Detail of CNCA-00C-006-2014

Introduction of CNCA-00C-006-2014

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.

Contents of CNCA-00C-006-2014

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