Announcement No.1 of 2014
Announcement of National Certification and Accreditation Administration of the People’s Republic of China (CNCA) on Issuing the Compulsory Certification Implementation Rules Factory Quality Assurance Capability Requirements
To further promote the scientific, standardized, and effective implementation of Compulsory Product Certification, in accordance with the Regulations of the People’s Republic of China on Certification and Accreditation, the Provisions on Administration of China Compulsory Certification (CCC), and the Circular of the CNCA on Clarifying the Adjustment Plan and Requirements for Documents Concerning Compulsory Certification Implementation Rules (CNCA Certification Document [2013] No. 39), CNCA has developed two general implementation rules for Compulsory Certification: Compulsory Certification Implementation Rules — Factory Quality Assurance Capability Requirements, which are used to regulate and guide production enterprises of products within the China Compulsory Certification (CCC) Catalogue to establish quality assurance capabilities ensuring that their products continuously meet the CCC requirements; Compulsory Certification Implementation Rules — General Requirements for Factory Inspection, which are used to regulate and guide the consistency of factory inspection activities carried out by designated Compulsory Certification Bodies. These implementation rules are hereby issued.
The two general implementation rules above are used in conjunction with specific certification implementation rules issued subsequently, and took effect on September 1, 2014.
Hereby announced.
Attachments:
1.Compulsory Certification Implementation Rules — Factory Quality Assurance Capability Requirements (No.CNCA-00C-005)
2.Compulsory Certification Implementation Rules — General Requirements for Factory Inspection (No.CNCA-00C-006)
CNCA
2nd January, 2014
Attachment 1
No.CNCA-00C-005
Compulsory Certification Implementation Rules
Factory Quality Assurance Capability Requirements
Published: 2014-01-02 Implemented: 2014-09-01
National Certification and Accreditation Administration of the People’s Republic of China
Contents
2.1 Person Responsible for Certification Technology 2
2.2 Certified Product Consistency (Product Consistency) 2
2.5 Periodic Confirmation Inspection of Critical Components 2
3.Factory Quality Assurance Capability Requirements 3
3.1 Responsibilities and Resources 3
3.3 Procurement and Control of Critical Components 6
3.4 Production Process Control 7
3.5 Routine Inspection and/or Confirmation Inspection 8
3.6 Inspection and Testing Instruments and Equipment 9
3.7 Control of Nonconforming Products 10
3.9 Control of Changes and Consistency of Certified Products 11
3.10 Product Protection and Delivery 12
3.11 CCC Certificate and Mark 12
In accordance with the Provisions on Administration of China Compulsory Certification (CCC), the production enterprise shall control the consistency of certified products, and its quality assurance capability shall continue to conform to the certification requirements. To regulate and guide production enterprises of products within the China Compulsory Certification (CCC) Catalogue to establish quality assurance capabilities ensuring that their products continue to conform to the CCC requirements, these implementation rules are formulated.
In the specific implementation of certification activities, factories shall aim to ensure the consistency between certified products in production and type testing samples. In accordance with the provisions of these Implementation Rules and the corresponding implementation rules or detailed rules for certification implementation, factories shall establish quality assurance capabilities complying with the requirements herein based on product characteristics and production and processing features.
Note: The “factory” mentioned in these implementation rules refers to the certification applicant, the manufacturer, and the production enterprise.
These implementation rules specify the basic requirements for factory quality assurance capability and serve as one of the bases for certification bodies to conduct factory inspections.
An internal staff of the manufacturer and/or production enterprise who is proficient in the requirements of the standards for certification, confirms and approves changes to certified products within the scope of responsibilities specified in the certification implementation rules or the detailed rules, and assumes corresponding responsibilities.
The manufactured certified products remain consistent with the type testing samples. Specific requirements for product consistency are specified in the certification implementation rules or the detailed rules.
It refers to the 100% inspection conducted on certified products usually at the final production stage to eliminate non-conforming products caused by occasional factors in the production process. Equivalent and rapid methods confirmed after verification are permitted for routine inspection.
Note: For certain products, routine inspection may be conducted by sampling in accordance with the requirements of the certification implementation rules or detailed rules.
A sampling inspection conducted to verify whether certified products continuously comply with the standards for certification.
A periodic sampling inspection conducted to verify whether the quality characteristics of critical components continuously comply with the standards for certification and/or technical requirements.
Note: Critical components refer to a general term for components, parts, raw materials and other items that play a critical role in enabling products to meet the requirements of standards for certification.
Inspections carried out to verify whether the intended functions of testing instruments and equipment meet specified requirements.
The factory is the main entity responsible for product quality. Its quality assurance capability shall continuously meet certification requirements, the manufactured products shall meet the standard requirements, and the certified products shall be consistent with the type testing samples. The factory shall accept and cooperate with the designated certification body in various factory on-site inspections, market inspections, and sampling tests conducted in accordance with these Rules and the relevant certification implementation rules or the detailed rules.
3.1.1 Responsibilities
The factory shall define the responsibilities, authorities, and interrelations of personnel involved in certification-related activities, and appoint a person responsible for certification quality within the management of the organization, who, regardless of other responsibilities, shall have the following responsibilities and authorities:
(a) Ensure that the requirements of this document are effectively established, implemented, and maintained in the factory;
(b) Ensure product consistency and product conformity to the standards;
(c) Ensure the proper use of CCC certificates and marks, and ensure the continuous validity of the certificate for products bearing the CCC mark.
The quality manager shall be fully competent to bear all the responsibilities. The quality manager may also serve as the technical manager for certification.
3.1.2 Resources
The factory shall be equipped with necessary production equipment and inspection or testing equipment for stable production of products conforming to the requirements of the standards for certification. It shall allocate corresponding human resources and ensure that personnel engaging in activities affecting certified product quality have the necessary competence. Suitable environments and facilities for production, inspection or testing, storage, and others shall be established and maintained.
For external resources used on a lease basis, the factory shall ensure the continuous availability and proper use of such resources. The factory shall keep records related to external resources, such as contracts, agreements, and usage records, etc.
3.2.1 The factory shall establish and maintain documented procedures to effectively control the documents, necessary external documents, and records as required by these Rules. Product design standards or specifications shall not be lower than the standards for certification for the product. For the main issues that may affect product consistency, the factory shall develop necessary design documents such as drawings, samples, critical component lists, process documents, and working instructions etc., and shall ensure the ongoing validity of these documents.
3.2.2 The factory shall ensure the adequacy and suitability of the documents , and ensure the use of their valid versions.
3.2.3 The factory shall ensure all records are clear, complete, and traceable, which shall serve as evidence that the products meet the specified requirements. The retention period for quality-related records shall meet the requirements of laws and regulations. Records generated since last inspection shall be available for the current inspection, and the minimum retention period shall be no less than 24 months.
3.2.4 The factory shall identify and retain important documents and quality information related to compulsory certification, such as type testing reports, factory inspection results, CCC certificate status information (valid, suspended, withdrawn, cancelled, etc.), certification modification approval information, testing reports of surveillance sampling, product quality complaints and their processing results, etc.
3.3.1 Control of Procurement
For outsourced critical components, the factory shall identify and specify their technical requirements in procurement documents. These technical requirements shall also ensure that the final product meets the certification requirements.
The factory shall establish and maintain a list of qualified critical component manufacturers or production enterprises and purchase critical components from them. The factory shall retain records of critical component procurement and usage, such as purchase orders, inbound and outbound slips, and ledgers, etc.
3.3.2 Quality Control of Critical Components
3.3.2.1 The factory shall establish and maintain documented procedures to complete verification and/or inspection of the technical requirements of purchased critical components upon incoming receipt and shall retain related records.
3.3.2.2 For the quality characteristics of outsourced critical components, the factory shall select appropriate control methods to ensure continuous compliance with the technical requirements of the critical components and the certification requirements of the final product, and shall retain related records. Appropriate control methods may include:
(a) Obtaining CCC certification or voluntary product certification results that are recognized for the final products’ compulsory certification; the factory shall ensure the validity of the certificate status.
(b) For critical components without relevant certificates, periodic confirmation inspection shall comply with the requirements of the certification implementation rules or detailed rules.
(c) The factory may develop its own control scheme, provided that the control effectiveness is not less than that required in 3.3.2.2(a) or (b).
3.3.2.3 When critical components are purchased from distributors or traders, the factory shall take appropriate measures to ensure the consistency of the outsourced critical components and their continued conformity to the specified technical requirements.
For critical components, parts, sub-assemblies, assemblies, semi-finished products, etc., produced by subcontractors, the factory shall control them as outsourced critical components to ensure that the subcontracted products continue to satisfy the specified requirements.
For self-produced critical components, control shall be exercised according to 3.4.
3.4.1 The factory shall identify processes that affect the quality of certified products (referred to as “critical processes”). The identified critical processes shall meet the specified requirements. Operators of critical processes shall possess the necessary competence. Control of critical processes shall ensure that certified products conforming to the standards and the consistency of the products. If a critical process cannot be carried out without documented provisions, corresponding working instructions shall be prepared to keep the production process under control.
3.4.2 When product production process requires specific environmental conditions, the factory shall ensure that the working environment meets the specified requirements.
3.4.3 When necessary, the factory shall monitor and measure appropriate process parameters.
3.4.4 The factory shall establish and maintain a maintenance system for production equipment to ensure that the equipment capability continues to satisfy production requirements.
3.4.5 When necessary, the factory shall inspect, monitor, and measure the product and its characteristics at appropriate stages of production as specified, to ensure product conformity to the standards and product consistency.
The factory shall establish and maintain documented procedures to control routine inspection and/or confirmation inspection of final products. The inspection procedures shall meet the specified requirements and include information about inspection frequency, items, content, methods, and assessment criteria, etc. The factory shall implement and retain related inspection records.
For inspections entrusted to external organizations, the factory shall ensure that the competence of such external organizations meets inspection requirements, and retain relevant competence evaluation results such as laboratory accreditation certificates, etc.
3.6.1 Basic requirements
The factory shall be equipped with sufficient inspection and testing instruments and equipment to ensure that the capability of instruments and equipment used in procurement, production & manufacturing, final inspection and other stages meets the inspection and testing requirements for mass production of certified products.
Inspection and testing personnel shall be competent to operate the instruments and equipment correctly, master the inspection and testing requirements, and carry out them effectively.
3.6.2 Calibration and verification
Inspection and testing instruments and equipment used to confirm that the manufactured certified products meet the specified requirements shall be calibrated or verified at specified intervals. Such intervals may be determined based on service frequency, previous calibration status, etc. For in-house calibration, the factory shall specify calibration methods, acceptance criteria, and calibration intervals, etc. Calibration or verification shall be traceable to national or international reference standards. The calibration or verification status of the instruments and equipment shall be readily identifiable by users and management personnel, and relevant records shall be kept by the factory.
Where calibration or verification is entrusted to external organizations, the factory shall ensure that the external organization’s capability meets the calibration or verification requirements and shall retain relevant capability evaluation results.
Note: For critical monitoring and measuring devices in production process control, the factory shall manage them according to the requirements of the certification implementation rules or detailed rules.
3.6.3 Functional check
When necessary, the factory shall perform functional checks on routine inspection equipment according to specified requirements. If functional check results fail to meet the requirements, the factory shall be able to trace back to products that are already tested. When necessary, these products shall be re-tested. The factory shall specify the actions to be taken by operators when equipment function failure is detected.
The factory shall retain records of functional check results and actions taken in the event of equipment function failure.
3.7.1 For nonconforming products identified during procurement, production & manufacturing, inspection, and other stages, the factory shall take measures such as identification, segregation, and disposition, etc. to avoid unintended use or delivery of nonconforming products. Reproduced or repaired products shall be re-inspected.
3.7.2 For nonconformity information of certified products, such as national or provincial product quality supervision spot checks, product recalls, customer complaints and claims, the factory shall analyze the causes of nonconformity and take appropriate corrective actions. For related certified products, the factory shall retain records of nonconformity information, cause analysis, disposition, and corrective actions.
3.7.3 When the factory learns about any major quality problem of its certified products (e.g., non-conformity found in national and provincial supervised random inspections, etc.), the factory shall notify the designated certification body without any delay.
The factory shall establish documented internal quality audit procedures to ensure the continued conformity of its quality assurance capability, product consistency, and product conformity to the standards. The factory shall take appropriate corrective and preventive actions against non-conformity identified during audits and retain records of internal quality audit results.
The factory shall establish and maintain documented procedures to control changes that may affect product consistency and product conformity to the standards (e.g., changes to processes, production conditions, critical components, and product structure, etc.). The procedures shall meet the specified requirements. Changes shall not be implemented without approval from the designated certification body or the technical manager for certification. The factory shall retain related records.
The factory shall control product consistency throughout applicable quality stages, including product design (design changes), processes and resources, procurement, production & manufacturing, inspection, product protection and delivery, so as to ensure products continuously conform to the requirements of the standards for certification.
Product protection during procurement, production & manufacturing, inspection, and other stages, such as identification, handling, packaging, storage, and preservation, shall comply with the specified requirements. When necessary, the factory shall control the product delivery process according to specified requirements.
The factory’s management and use of the CCC certificate and mark shall comply with the Provisions on Administration of China Compulsory Certification (CCC) and the Measures on the Administration of China Compulsory Certification Marks etc. The factory shall keep usage records for uniformly printed standard-size CCC marks and CCC marks affixed by means of printing, molding, or other methods. The CCC mark shall not be applied, nor shall the product be released, under the following circumstances:
(a) Products within the China Compulsory Certification (CCC) Catalogue but have not obtained certification;
(b) Products for which changes after certification require designated certification body’s approval but have not been approved;
(c) Products with a certificate expired;
(d) Products under certificates that have been suspended, withdrawn, or cancelled;
(e) Nonconforming products.