Attachment 2
No.CNCA-00C-006
Compulsory Certification Implementation Rules
General Requirements for Factory Inspection
Published: 2014-01-02 Implemented:2014-09-01
National Certification and Accreditation Administration of
the People’s Republic of China
Contents
3. Principles of Factory Inspection Activities 2
4. Factory Inspection Requirements 3
4.1 Factory Professional Category 3
4.2 Basic Requirements for Factory Inspection Implementation 3
5. Determination of Site Boundaries for Factory Inspection 4
6. Determination of Factory Inspection Method, Content, and Inspection Team 4
7. Risk Control for Manufacturing Enterprise Relocation 5
8. Disposal Upon Receiving Information about Non-conforming Certified Products 5
9. Factory Inspection for Certificate Restoration 5
10. Special Requirements for Affixing CCC Marks 6
10.1 Requirements for Affixing CCC Marks during Production 6
10.2 Requirements for Entrusting Interested Parties to Print or Mold CCC marks 6
11. Factory Inspection Conclusion Assessment 7
11.1 Factory Inspection Conclusions and Classification of Non-conformities 7
11.2 Criteria for Factory Inspection Conclusion Assessment 8
11.3 Notification of Factory Inspection Conclusion 10
In accordance with the requirements of the Provisions on Administration of China Compulsory Certification (CCC), during factory inspection activities, the designated certification body shall inspect the production enterprise’s quality assurance capability, the consistency between the manufactured products and the type testing samples, and other related aspects. To regulate the factory inspection activities of compulsory certification, guide the consistency of the implementation of factory inspection by designated certification bodies, and guarantee the pertinence and effectiveness of factory inspection activities, these Implementation Rules are formulated.
The designated certification body shall, based on these Implementation Rules and the requirements of the corresponding compulsory certification implementation rules, and taking into account factors such as product characteristics, production process features, production enterprise classification management, and inspector usage management, develop a factory inspection implementation plan that suits its own characteristics, based on risk assessment.
These implementation rules apply to the organizational management and implementation of factory inspection activities, and assessment of factory inspection conclusions carried out by designated certification bodies.
The terms and definitions established in the Compulsory Certification Implementation Rules — Factory Quality Assurance Capability Requirements (hereinafter referred to as “Factory Quality Assurance Capability Requirements”), and the following terms and definitions apply to these implementation rules.
It refers to an evaluation activity conducted on the factory’s quality assurance capability, product consistency, and conformity of the product to the standards. The scope of factory inspection includes product scope and site boundaries.
Note: The product scope refers to the certified products. Site boundaries refer to the sites, departments, activities, and processes related to product certification quality. When the manufacturing of certified products involves multiple sites, the factory inspection site boundaries shall at least include the locations where routine inspection, product nameplate affixing, and CCC mark affixing are carried out. When necessary, further inspection (i.e., extended inspection) shall be conducted at other sites (such as critical processes).
It refers to a test conducted by the production enterprise personnel, in which the inspection team selects certified products at the production enterprise on site and selects test items according to the standards for certification to evaluate the consistency of the certified product and its conformity to the standards.
(a) Objectivity, impartiality, openness, confidentiality;
(b) Focus on product consistency and product conformity to standards;
(c) Obtain the true status of the certified product and the factory;
(d) Select representative inspection samples;
(e) Reach a factory inspection conclusion based on risk assessment.
The certification body shall, based on the Factory Quality Assurance Capability Requirements and combined with the characteristics of the product and the industry, specify and publish the factory inspection requirements. The factory inspection requirements shall at least include the applicable content of the Factory Quality Assurance Capability Requirements and shall be consistent in the following aspects:
Factory professional categories are classified based on the same product category, the same series of standards for certification, the same or similar critical production processes that affect the quality of certified products, and special circumstances that may be considered.
When the same factory covers different factory professional categories, factory inspections shall be conducted separately. In principle, product consistency inspection, designated tests, sampling tests, and confirming inspection shall cover different professional categories of the factory.
For products certified by different certification bodies under the same group of certification implementation rules, the requirements for the critical components list, periodic confirmation inspection of critical components, routine inspection, and confirmation inspection shall be kept consistent.
Before certification approval, the certification body shall negotiate with the factory to determine the site boundaries for factory inspection. Special attention shall be given to sites, departments, activities, and processes related to product certification quality that are outside the actual address of the production enterprise.
After certification approval, the certification body shall ensure the completeness and accuracy of the site boundaries for factory inspection to provide the necessary conditions for selecting representative inspection samples.
The certification body shall determine the implementation method and content of the factory inspection based on its specific purpose, such as announced or unannounced factory inspection, obtaining samples from the factory, market or place of use, sampling or purchasing samples, as well as the factory inspection clauses, the inspection focus of each clause, product consistency inspection, designated tests, surveillance sampling, etc.
The certification body shall determine the inspection team members with appropriate competence based on the specific purpose, method, and content of the factory inspection, and shall provide them with complete, accurate, and up-to-date information and materials necessary for the factory inspection.
For announced factory inspections, the certification body shall agree with the production enterprise on the factory inspection time, confirm the factory inspection scope, and the inspection plan before the on-site inspection.
For production enterprise relocation, the certification body shall take appropriate and necessary measures to control the following potential risks:
(a) Risks caused by changes in production conditions, personnel competence, production processes, etc.;
(b) Risks that products manufactured at the new production site are released from factory or sold without certification.
Upon receiving the information on non-conforming certified products, the certification body shall, as appropriate, conduct a special inspection or investigation, focusing on analyzing the causes of nonconformity and the degree of impact on the certified product, and take corresponding actions.
For certificates suspended due to quality reasons, during the factory inspection for certificate restoration, the certification body shall:
(a) Pay attention to whether the factory’s analysis of the reasons for the suspension is comprehensive and sufficient;
(b) Pay attention to whether the measures taken by the factory meet legal and regulatory requirements such as product recall, and whether the correction and corrective actions are appropriate and effective to prevent recurrence of the same or similar problems;
(c) Pay attention to whether any related products were released from factory, sold, or imported during the certificate suspension period.
For products that require CCC marks to be affixed during production (e.g., motor vehicle tires, wires and cables), the certification body shall pay attention to and control the following potential risks and take appropriate and necessary measures to prevent unintended use or delivery:
(a) Products with undetermined status from the time of CCC mark affixing to routine inspection;
(b) Nonconforming products that have already been affixed with CCC marks.
For factories that entrust interested parties to print or mold CCC marks (e.g., motor vehicle lighting manufacturers entrusting lens producers to mold CCC marks onto the lens surface), the certification body shall focus on the following risks and take appropriate and necessary measures to keep the risks under control:
(a) Whether the activities of the interested party in affixing CCC marks are controlled and conform to specified requirements;
(b) Unintended use or delivery of nonconforming products affixed with CCC marks;
(c) Whether conforming products affixed with CCC marks are only delivered to the production enterprise;
(d) Whether the products on which CCC marks are printed or molded by the interested party fall within the scope of the CCC Catalogue.
Factory inspection conclusions are typically classified into four types: “Factory Inspection Passed,” “Documentation Verification Passed,” “On-Site Verification Passed,” and “Factory Inspection Failed.” “Documentation Verification Passed” means that there are non-conformities the factory takes corrective actions within the specified time limit, and the certification body confirms effectiveness through documentation verification, after which the factory inspection is considered passed. “On-Site Verification Passed” means that there are non-conformities, the factory takes corrective actions within the specified time limit, and the certification body confirms effectiveness through on-site verification, after which the factory inspection is considered passed.
Non-conformities in factory inspection are classified into minor non-conformities and major non-conformities: a minor non-conformity refers to a non-conformity that may have a minor impact on product certification quality. A major non-conformity refers to serious quality defects occurred in the production and manufacturing or inspection of certified products, as well as substantial discrepancies in product structure, critical components and other aspects against the certification approval results.
11.2.1 Factory Inspection Passed
No non-conformity.
11.2.2 Documentation Verification Passed
It shall be deemed as a minor non-conformity; or any circumstances other than "On-Site Verification Passed" and "Factory Inspection Failed".
11.2.3 On-Site Verification Passed
There are non-conformities, but they do not seriously affect product consistency or product conformity to the standards. Examples include:
(a) Although there are multiple minor non-conformities constituting systematic non-conformities, they do not seriously affect product consistency or product conformity to the standards;
(b) Although there are non-conformities in major quality links of product realization such as resources, critical component quality control, production process control, inspection, etc., they do not seriously affect product consistency or product conformity to the standards;
(c) Other non-conformities that are difficult to verify through documentary evidence of corrective actions but do not seriously affect product consistency or product conformity to the standards.
11.2.4 Factory Inspection Failed
There are multiple minor non-conformities or individual major non-conformities constituting systematic non-conformities that directly jeopardize product consistency or product conformity to the standards, for example:
(a) Designated test results are non-conforming (in principle);
(b) Critical resources do not meet the requirements, making it difficult to ensure product consistency or product conformity to the standards;
(c) There are serious problems with product consistency that will cause the product to fail to meet standard requirements, such as changes in product structure or critical components that do not meet the specified requirements;
(d) Certified products have defects that may lead to quality and safety accidents;
(e) The control of changes and consistency of certified products has not been effectively implemented, resulting in product inconsistency and systemic failure of quality assurance capability;
(f) During the certificate suspension period, the factory has not taken corrective actions, or still fails to meet requirements after corrective actions;
(g) Illegal use of CCC marks or certificates;
Primary instances of illegal use include: forging, altering, renting, lending, misusing, buying, trading, transferring CCC marks or certificates, and fraudulent use of CCC marks; continuing to use CCC marks or certificates after knowing that the certificate has been withdrawn or suspended; intentionally affixing CCC marks on products that have not obtained CCC certificates; other intentional illegal use of CCC marks or certificates.
(h) The factory obtains the CCC certificate through improper means such as fraud, bribery, etc.;
(i) Other major non-conformities that directly jeopardize product consistency or product conformity to the standards.
For factory inspection conclusions assessed as “Documentation Verification Passed” or “On-Site Verification Passed,” the certification body shall notify the production enterprise of the verification results without delay.
When the factory inspection conclusion is modified after reassessment by the certification body, the production enterprise shall be notified of the updated result without delay.