CCC factory inspection requirement
Compulsory Product Certification Requirements
for Factory’s Quality Assurance Ability
Manufacturer shall meet the requirements for factory’s quality assurance ability specified in this document, in order to ensure that all certified products are identical with the sample(s) against which the type test was approved.
1. Responsibilities and Resources
Manufacturer shall define the responsibilities and inter-relations of all the personnel involved in quality activities. And manufacture should appoint a management representative for quality, who, irrespective of other responsibilities, shall be responsible to:
a) ensuring that quality system, which meets the requirements of this document, is established, implemented and maintained.
b) ensuring that the products with the compulsory certification mark are produced in conformity with the standards to which they were certified.
c) establishing documented procedures to ensure that compulsory certification marks are kept and used appropriately.
d) establishing documented procedure to ensure that the compulsory certification mark is not affixed on any non-conforming product or changed product that was not notified to certification body.
The management representative for quality shall be competent to perform the work.
Factory shall be equipped with necessary production facility and testing equipment in order to consistently manufacture the products in conformity with relevant standards. In addition, and factory shall provide relevant human resources, to ensure that personnel performing work affecting product quality is competent, and shall establish and maintain necessary environment suitable for manufacturing, testing and inspection, storage etc.
2. Documents and Records
2.1 Manufacturer shall establish and maintain documented quality plan or relevant documents for certified products, and the documents need to ensure that related processes to product quality are operated and controlled effectively. Quality plan shall define the objective of product design, realization process, test and related resource, as well as the requirements for changes (i.e. specification, processing, critical components etc.) to certified products, use and management of marks.
Standard or specification that the design is based on, as one essential part of quality plan, shall be stricter than the requirements specified in this Rules.
2.2 Manufacturer shall establish and maintain documented procedure to control the documents required in this document, to ensure that
a) all documents issued and changed shall be approved by authorized personnel prior to issue and change.
b) changes and current revision status of documents are identified to prevent unintended use of obsolete documents.
c) relevant valid versions of applicable documents are available at points of use.
2.3 Manufacturer shall establish and maintain documented procedures to define the controls for the identification, storage, protection and disposition of records. Records shall be legible, integral to provide evidence of product conformity to requirements.
Records shall be retained for an appropriate period.
3. Purchasing and receiving Inspection
3.1 Control of Supplier
Manufacturer shall establish the procedures that define the criteria for selection, evaluation and routine supervision of supplier, which provide critical components and material, to ensure the supplier has ability to provide the critical components and material in accordance with requirements.
Records of the evaluations and routine supervision shall be maintained.
3.2 Inspection/Verification for Critical Components and Material
Factory shall establish and maintain procedures of inspection or verification for purchased critical components and material, and procedure of periodic verification inspection, to ensure that critical components and material meet specified certification requirements.
Inspection for purchased critical components and material may be carried out at the factory or supplier’s premises. Where inspection is performed at supplier’s premise, Manufacturer shall specify the intended inspection requirements to supplier.
Manufacturer shall maintain records of inspection or verification of critical components, verification inspection records, evidence of conformity and relevant inspection data, etc.
4. Process Control and Inspection
4.1 Manufacturer shall identify critical production processes and arrange operators with appropriate qualification at the processes. Where product quality can not be guaranteed when no operating document, appropriate operating instructions shall be prepared to make production processes under control.
4.2 Where environment condition is required, factory shall meet the requirements.
4.3 Manufacturer shall monitor and control appropriate process parameters and product characteristics, as applicable.
4.4 Manufacturer shall establish and maintain maintenance procedure for the manufacturing equipment.
4.5 Production shall be inspected at appropriate stages of manufacture to ensure that products, components and parts are in accordance with the certification approved sample.
5. Routine Tests and Verification Tests
Factory shall establish and maintain documented routine tests and verification tests procedures to verify and demonstrate that products are in compliance with relevant requirements. The procedures shall include test items, contents, method, acceptance criteria etc. Test records shall be maintained. Routine tests and verification tests shall meet the requirements specified in relevant product certification implementation rule.
Routine tests are performed on 100% of production and are normally carried out at the final stage of production. Normally no further operations, except for labeling and packing, may be carried out after these tests.
Verification tests are tests on samples taken randomly in order to verify and demonstrate that products consistently meet standard requirements.
6. Inspection and Test Equipment
The equipment used for inspection and test must be regularly calibrated and checked for correct operation, and meet inspection and test capacity requirements.
Manufacture should stipulate the operation rules of the inspection and test equipment. Testing personnel should follow the rules and use the equipment correctly.
Inspection and test equipment used for determining the conformity of the products being manufactured shall be calibrated on a regular basis. All calibrations undertaken on such equipment must be traceable to national or international standards. For in-house calibration, the method, acceptance criteria, calibration interval etc. shall be documented. Calibration status of the equipment shall be easily identified by operator and personnel in-charge.
Calibration records shall be maintained appropriately.
6.2 Functional Check
The Functional check to the equipment used for routine tests and verification tests shall be undertaken on a daily basis. When functional check is found to be not satisfied with specified requirements, arrangements shall allow previous product to be traced, retrieved and re-tested if necessary. Operator shall be instructed on what action is to be taken if a functional test is found to be unsatisfactory.
The results of functional check and all subsequent corrective action taken must be recorded.
7. Control of Non-conforming Product
Manufacturer shall establish procedure of control of non-conforming product, which shall includes identification method, segregation, disposal, corrective action and preventive action. Repaired and reworked product shall be re-tested. Records of repairing for critical components and parts and disposal of non-conforming product shall be maintained.
8. Internal Audit
Internal audit procedures shall be established and documented to ensure that quality system is implemented effectively and certified products are complied with specific requirements. The results of internal audit shall be maintained.
Factory shall keep records of all complaints, especially to a product’s non-compliance with requirements of relevant standard, and make these complaints as one of input of internal audit.
Corrective and preventive action shall be taken to non-conformities and records shall be maintained.
9. Changes to Certified Product
Any constructional Changes from original sample for Type Testing should be controlled so as to make certified products consistently be in conformity with relevant standard.
Manufacturer shall establish procedures to monitor changes of the critical component, material, construction and factors that may affect compliance with relevant standard. The changes on certified products must be notified to the certification body for authorization, prior to their implementation.
10. Packing, Handling and Storage
Finished products shall be packaged, stored and handled in such a way as to ensure that they will continue to comply with the applicable standards.