CCC factory inspection introduction

CCC factory inspection require understanding points

Section 1 Responsibilities and Resources

1.1 Duties
The factory shall stipulate the duties and relationships of various personnel related to the quality activities, and the factory shall appoint a quality person in the organization, regardless of the other duties of the member, shall have the following responsibilities and permissions:
a) Responsible for establishing a quality system that meets the requirements of this document and ensuring its implementation and maintenance.
b) Ensure that products bearing the compulsory certification mark meet the requirements of the certification standards.
c) Establish a file program to ensure the proper storage and use of the certification mark.
d) Establish a file program to ensure that non-conforming products and certified products are not confirmed by the certification body after the change, and no compulsory certification mark is attached.

The person in charge of quality should have sufficient ability to do his job.

Understanding points:
● Factory, the material basis owned by the manufacturer or commissioned by the manufacturer for production and assembly activities, including personnel, sites, facilities and equipment;
● Personnel that affect the quality of the certified product include at least: the person in charge of quality, the management personnel at all levels related to the quality activity, the designer (if any), the purchasing personnel, the personnel who evaluate the supplier, and operate according to the manufacturing process. Personnel, inspection/test personnel, equipment maintenance personnel, metrology personnel (if any), internal auditors (regardless of other duties), personnel engaged in packaging, handling and storage. All types of personnel should have corresponding responsibilities, and the interface of each responsibilities should be clear and clear;
● The designated quality manager should be, in principle, a member of the top management, or at least a person who can communicate directly with the top management. The factory may assign an agent of the quality person in charge to perform the corresponding duties when the person in charge of quality is absent;
● The person in charge of quality (regardless of other responsibilities) should be given the responsibilities and permissions to cover 1.1 a) to d). He/she should have corresponding quality control work experience or experience, and be authorized accordingly, have the ability to coordinate and handle matters related to the quality of certified products, familiar with the relevant certification implementation rules and the certification body’s management requirements for mandatory certification marks.

Review points:
● Whether the responsibilities and interrelationships of various types of personnel related to quality activities have been specified, and the sufficiency, suitability and coordination of the regulations;
● Whether the factory has designated the person in charge of quality, whether it has been given the duties and permissions specified in 1.1 a) ～ d);
● Through the review of relevant processes and activities, determine whether the quality person in charge has sufficient ability to do his or her job;
● Assess the performance of various personnel’s responsibilities by reviewing related processes and activities.

1.2 Resources
The factory shall be equipped with the necessary production equipment and inspection equipment to meet the requirements of stable production of products that meet the compulsory certification standards; it shall be equipped with the corresponding human resources to ensure that the personnel engaged in the work of the product quality have the necessary capabilities; establish and maintain suitable products Necessary environment for production, inspection, testing, storage, etc.

Understanding points:
● This clause is a general requirement for plant resources, including production equipment, inspection equipment, human resources and work environment;
● The human resources should be equipped to meet the requirements of quality activities for personnel;
● The factory should have sufficient production and inspection equipment, and its technical performance, precision, and operating status can provide guarantees for the certified products to meet the compulsory certification standards;
● The working environment refers to the environment required to ensure that the certified products meet the requirements, including production, inspection, testing, storage and other aspects, such as: temperature, humidity, noise, vibration, magnetic field, illumination, cleanliness, sterility, dustproof and so on. Factories should identify environmental requirements and provide and manage resources to meet requirements;
● Whether due to external reasons (such as certification system, certification standards, etc.) or internal reasons (personnel changes, equipment replacement, environmental changes, etc.), resources change, the factory should take corresponding measures to ensure that the quality of certified products meets the mandatory Requirements for sexual certification standards.

Review points:
● Does the factory determine the capability requirements of the personnel in each position that have an impact on the quality of the certified product, and what measures are adopted to enable the personnel to meet the job capability requirements, and whether the capabilities of the personnel in each position meet the requirements;
● Through the review of relevant processes and activities, determine whether the resources provided by the enterprise are sufficient and appropriate, and whether the resources have been effectively managed and controlled;
● When the resources change, whether the factory has a smooth pipeline and timely understanding of the corresponding information, whether it can take timely measures to ensure that its resources meet the stable production of certified products;

Section 2 files and records

2.1 The factory shall establish and maintain a quality plan or similar file for the certified product, as well as a file for the effective operation and control of the relevant process to ensure product quality. The quality plan shall include the product design objectives, implementation process, testing and related resources, as well as the provisions on the change of the certified products (standards, processes, critical components parts, etc.) and the use and management of the marks after the products are certified.

The product design standard or specification shall be a content of the quality plan, and its requirements shall not be lower than the national standard requirements for the product.

Understanding points:
● Critical components, which directly affect the components and materials related to the quality of the whole machine (car) product certification. Typically, these critical components are available as stand-alone components and can be tested and certified to the relevant independent component standards;
● The factory shall establish and maintain relevant files for the certified products, and the contents of the files shall cover the provisions of Article 2.1. When the product and process are relatively simple, all items can be included in the quality plan. If this is not possible, the above rules can be written to different files. For example, the quality plan only specifies who and when to use which programs and related resources; the management of certified product changes, the management of the use of certification marks is specified in the program file; the design goals of the products are specified in the corresponding standards or specifications; , monitoring and measurement processes, resource allocation and use, etc. are specified in the operating instructions, operating procedures, etc.;
● The product design objectives specified in this document shall include at least the requirements for meeting the compulsory product certification standards;
● The implementation process refers to the production process of certified products.

Review points:
● Review the quality plan and related process management files or program files developed for the certified products according to the above requirements, and pay attention to verify the feasibility and effectiveness of the quality plan during the on-site review;
● Check the standard and specification list (or similar files) to confirm that the standards and specifications used by the manufacturer are not lower than the requirements of the mandatory certification standards.

2.2 The factory shall establish and maintain a staging program to effectively control the files and materials required by this document. These controls should ensure that:
a) before the release of the file and the changes should be approved by the licensor to ensure its suitability;
b) the change and revision status of the file is identified to prevent unintended use of the waste file;
c) Make sure that a valid version of the file is available at the point of use.

Understanding points:
The understanding of this clause is basically the same as the understanding of system certification.
● All files and materials used to control the quality of certified products should be controlled;
● The control of files and materials is mainly reflected in the fact that files and materials must be approved by the licensor before they can be used formally; approved files and materials should be used in activities related to the quality of certified products.

Review points:
● Whether a control program for files and data has been developed;
● Check the program file to see if the content covers the rules in 2.2 a) to c);
● At the time of the on-site review, be sure to verify that the requirements set out are implemented.

2.3 The factory shall establish and maintain a staging program for the identification, storage, storage and handling of the quality records. The quality records shall be clear and complete as evidence that the products meet the specified requirements.
Quality records should have an appropriate shelf life.

Understanding points:
●The quality record management should be institutionalized and standardized, and the quality records that play an important role in product traceability must be retained. In other words, the retained quality record should serve to verify that the certified product meets the specified requirements.
● Control requirements for quality records:
a) The identification of the record can be done by color, number, etc.
b) For the storage of records, an appropriate environment should be arranged to prevent damage or loss of records.
c) The custody of records should include the protection and management of records so that the records are easily accessible.
d) The processing of records should include a record of how the destruction is ultimately required.
● The requirements for filling in the records are: the writing is clear, not subject to change, according to the regulations, the content is complete.
● All quality records should have a shelf life. The retention period shall take into account factors such as the characteristics of the certified product, legal and regulatory requirements, certification requirements, and traceability deadlines.

Review points:
● Check the program file (or similar file) of the management quality record, and whether the program specifies whether the quality record is identified, stored, stored, or processed, and whether the regulations are sufficient and appropriate;
● In the on-site review, the stored quality records (usually based on recent quality records) and the quality records used in the field can be randomly selected to confirm the compliance of the regulations and implementation;
● Whether all quality records have a retention period and whether the regulations are appropriate;
● Fill in the quality record clearly and completely.

Section III Procurement and Purchase Inspection

3.1 Supplier Control
Factories should develop procedures for the selection, evaluation, and day-to-day management of suppliers of critical components and materials to ensure that suppliers have the ability to ensure that critical components and materials are produced to meet requirements.
The factory shall maintain a selection evaluation and daily management record of the supplier.

Understanding points:
● Suppliers, companies or individuals that supply components, materials or services to factories that produce certified products;
● Critical components and materials refer to components and materials that have a greater impact on product safety, environmental protection, EMC, and main performance, such as the “Critical components List” in the Certification Implementation Rules (sometimes may not be limited to these);
● The factory should establish a corresponding program to control the supplier, and its control method must be clearly defined for selection, evaluation and daily management;
● Supplier selection includes determining the supplier’s scope, setting selection criteria, clearly selecting methods and programs, and so on. If the purchased product involves compulsory certification, there should be such a requirement in the selection criteria;
● The supplier’s assessment includes the establishment of assessment criteria or criteria, the identification of conformity assessment requirements or indicators, the requirements for assessing personnel, the permissions and responsibilities for the approval of assessment results, and the methods and procedures for performing assessments. Different assessment criteria can be applied to all types of purchased products;
● The daily management of the supplier includes specifying the management method, determining the degree of control (generally or strictly), and clarifying the treatment method when the problem occurs;
● The supplier’s selection evaluation records for suppliers should include the list of qualified suppliers, the supplier’s quality assurance ability questionnaire, and so on. The daily management records that should be kept by the factory include the supply performance. When there is a problem with the supplier’s product, the factory asks it to take corrective measures and verify the information of its implementation;

The above records shall be controlled in accordance with the requirements of Article 2.3.

Review points:
● Is there a procedure for selecting, evaluating, and managing the supplier, whether the criteria for selection, evaluation, and routine management are clear and appropriate;
● Whether the supplier has been selected, assessed and routinely managed according to the requirements of the program;
● Whether the corresponding record has been saved.