Annex 4 requirements of factory quality assurance of China

Compulsory Certification on Ex product

0. Introduction
This document is specially formulated to standardize and guide to establish
the quality management system for continuous compliance with CCC
certification requirements according to the requirements of Compulsory Product
Certification Management Regulation. This document is one of the basis for
enterprise to establish the quality management system and for SITIIAS to carry
out on-siteaudit.
The factory shall establish and maintain the quality management system
that meets the requirements of this document according to the type of protection,
Ex structure and characteristics of production on the target of ensuring
consistency between products and the approval documents. The site in this
document refers to the applicant, manfuacturer or factory that undertakes
corresponding duties.

1. Responsibilities and resources

1.1 Responsibilities
The site shall specify the responsiblities, authorities and relationships of
various personnel related to the certification requirements, and designate a
person to be responsible for Ex quality from the management of the
organization; regardless of the responsibilities of the member in other aspects,
the person shall have the following responsibilities and authorities:
(a) Ensure the requirements of this document are effectively established,
implemented and maintained;
(b) ensure product product compliies with standards;
(c) Correctly use CCC certificate and mark and ensure that the certificateis
continuously valid.
(d) Keep in touch with SITIIAS, track changes about certification and
communicate to relevant internal personnel or departments for implementation.
The personnel in charge of Ex quality shall be fully competent for the job,
and can also serve as the technical director of certification.

1.2 Resources
The site shall provide sufficient production equipment, inspection and
testing equipment to meet the needs of stably producing; provide appropriate
human resources to ensure that the personnel involved in the work that has an
impact on the quality of product; establish and maintain necessary environment
and facilities suitable for production, inspection and testing, storage, etc.
For externally rented resource, the site shall ensure continuous availability
and proper use of the external resources; the factory shall keep the records
related to the external resources, such as contract and agreement, use records,
etc.
when there are significant changes in the production and inspection
equipment, the site shall conduct corresponding applicability assessment,
calibration and testing to ensure that the changes do not affect the production
or are not below the level of the original equipment.records shall be retained
and submited to SITIIAS for filing.

2 Documents and records

The site shall establish and maintain documented procedures to ensure
effective control of the documents required by this document, necessary
external documents, certification documents, production technology documents
and records. The drawings, templates, process documents, work instruction
and other production related documents shall ensure consistency of the Ex
structure and the safety parameters, and guarantee the continuous
effectiveness of documents. The product design standards or specifications
shall not be lower than the certification criteria of the product.
Documented procedures of the factory shall ensure:
a) The site shall ensure the adequacy and suitability of the documents and
used the valid versions.
b) An implementation system shall be established to ensure that all
drawings related to the production of Ex products are consistent with the
certified drawings.
c) The quality management system shall ensure that the elements
specified in the certification documents (critical Ex parameters) are not modified.
d) The documented procedures shall ensure that all related products are
changed simultaneou when shared certification drawings associated with
multiple certificates are changed.
e) If the manufacturing plant also produces non-Ex equipment, there shall
be a system that clearly identifies and differentiates between the technical
documents of different products.
f) The correctness shall be guaranteed when the technical documents or
factory-related documents are delivered to related party.
g) The manufacturer shall have documented procedures and verify
annually of the validity of all CCC certificates, standards, applicable laws,
regulations and other external regulations.
The site shall make sure that the records are clear, complete and traceable
to serve as the evidence that products meet the specified requirements. The
retention period of records related to the quality and traceability of Ex products
shall not be less than the product life cycle (generally 10 years), and ensure
that the records of at least 3 inspection cycles are obtained during this audit.
The site shall identify and keep important documents and quality
information related to product certification, such as certification documents
(certification drawings and instructions), type test report, factory inspection
results, CCC certificate status (valid, suspended, revoked, cancelled, etc.),
certification change approval information, supervision and sampling test report,
product quality complaints and results of handling, etc.

3 Purchasing and quality control of critical parts

3.1 Purchasing control

The site shall establish, evaluate and keep the list of qualified
manufacturer/factory for purchased parts and purchase from the qualified
vendors. The site shall retain records of thepurchasingpurchasing and use of
critical parts, such as purchase order, list of out-put and in-put of warehouse,
account, etc.
For critical purchased parts (see the list of critical parts for CCC Ex
products), the site shall identify and clarity their technical requirements in the
purchasing documents, and these technical requirements shall ensure that the
final product meets the certification requirements.
For the suppliers that provide purchased parts related to critical certification
parameters, the site shall evaluate the suppliers’ ability to ensure compliance
with the specified requirements and then choose a qualified supplier. One or
more of the following methods may be used to evaluate the suppliers’ ability to
provide qualified products, processes and services:
--- The supplier has the quality management system of CCC Ex product
--- Adopt appropriate control methods to perform on-site assessment of
the supplier, keep documented and valid on-site assessment records. The
following factors shall be considered during assessment:
- Criticality of product, process or service
- Difficulty or uncertainty in the manufacturing process
- Supplier location and validity of subsequent communications
- Subcontracting of the product, process or service by the supplier or not
- Evaluate calibration/certification service provider for compliance with
the specified requirements;
- Regular review of the supplier, and theinterval shall not exceed one year.
- The suppliers from which purchasing is not made for more than one
year shall be re-evaluated as new suppliers, and then a qualified one shall be
chosen.
For outsourcing that may affect the type of protection and cannot be
confirmed by inspection (for example, encapsulated intrinsic safety circuit),
SITIIAS or the site shall carry out periodic factory audit or control to prove the
uniformity of product. If SITIIAS needs to audit the supplier that affects critical
certification parameters, the manufacturing plant shall make arrangement.
The purchasing documents shall clearly describe the contents with detailed
requirements in the technical documents (for example, process control, testing
or inspection).
For the parts that the compliance cannot be checked after manufacturing
(for example, encapsulated intrinsic safety circuit), specific quality control
procedures, raw materials and processes associated with the parts shall be
indicated in the purchasing information.
The site shall specify the program in the form of documents, for example,
the technical specifications described in special purchase orders shall
guarantee that the order is traceable. If the site fails to provide the above
documents in subsequent orders, the site shall have the procedures available
to ensure that the supplier has the copy of the current document.

3.2 Quality control of purchased parts

The site shall establish and maintain documented procedures, complete
verification and/or inspection requirements of the purchased parts during
purchasing (incoming), and retain relevant records.
For quality characteristics of the purchased parts, the site shall choose
appropriate control methods to ensure that the requirements specified in the
technical documents are continuously satisfied and the final product meet the
certification requirements, and retain relevant records. The appropriate control
methods include:
(a) If CCC certificate or voluntary product certification results that can be
accepted by CCC of the final product are obtained, the factory shall ensure that
the certificate is valid.
(b) If the purchased parts without relevant certificates, the site shall
regularly confirm and verify for compliance with the requirements of the
implementation rules/detailed rules of product certification.
(c) The factory shall develop the control program by its own, and its control
effect shall not be lower than the requirements of (a) or (b) above.
When purchasing critical parts from the distributor or the trader, the factory
shall take appropriate measures to ensure the consistency of the purchased
parts and continuous compliance with the technical requirements.
For products produced by the subcontractor, the site shall control them as
purchased parts to ensure that all subcontracted products continuously meet
the specified requirements.
The self-produced critical parts shall be controlled according to Article 4.

4 Production process control

4.1 The site shall identify the processes that affect the quality of certified
products (referred to as the “critical processes”), and the critical process shall
be identified and meet the specified requirements. The operators of critical
processes shall have corresponding competences; the critical processes shall
be controlled to guarantee the compliance of certified products with the
standards and product conformity; if the quality of certified products cannot be
guaranteed without regulations of document for the critical processes,
corresponding operation instructions shall be developed to make the production
process controlled.

4.2 If the production process has requirements for the environmental conditions,
the site shall ensure that the working environment meets the specified
requirements.

4.3 The site shall monitor and measure appropriate process parameters as
necessary.

4.4 The site shall establish and keep a maintenance system of the production
equipment to ensure that the capabilities of equipment continuously meet the
production requirements.

4.5 When necessary, the site shall check, monitor and measure the product and
its characteristics at appropriate stage of production as required to guarantee
the compliance of the product with the standards and product conformity.

5 Routine test and/or verification test

The site shall establish and maintain documented procedures, and perform
the routine test and/or verification test of the final product; the test procedures
shall meet the specified requirements, and the procedures shall include the item,
content, method, judgment, etc. The factory shall implement and maintain
relevant test records.
For the test entrusted to an external agency, the site shall ensure that the
capabilities of the external agency meet the test requirements, and keep
relevant capability evaluation results, such as laboratory accreditation, etc.

6 Inspection and testing equipment

6.1 Basic requirements

The site shall provide sufficient inspection and testing instruments and
equipment, and ensure that the capabilities of the instruments and equipment
used during purchasing, manufacturing, final inspection, etc. meet the
inspection and testing requirements for mass production of certified products.
The inspection and testing personnel shall correctly use the instruments
and equipment, master the inspection and testing requirements and implement
them effectively.

6.2 Calibration and verification

The inspection and testing instruments and equipment used to check
whether the certified products produced meet the specified requirements shall
be calibrated and verified according to the specified interval, and the calibration
or verification interval can be determined according to the frequency of use and
previous calibration of the instruments and equipment; in case internal
calibration, the factory shall specify the calibration method, acceptance criteria
and calibration interval, etc.; calibration or verification shall be traceable to the
national or international standards. The calibration or verification status of
instruments and equipment shall be easily identified by the using and
management personnel. The site shall maintain the calibration or verification
records of the equipment.
If the calibration or verification is entrusted to an external agency, the
factory shall ensure that the capability of the external agency meets the
calibration or verification requirements, and keep relevant capability evaluation
results.
Note: For critical monitoring and measuring devices during production process
control, the site shall manage according to the implementation rules/detailed rules of
product certification.

6.3 Function check

When necessary, the site shall perform function test of the routine
inspection equipment as required.
If it is discovered that the results of function check fail to meet the
requirements, the products that have been tested shall be traceable; these
products shall be retested when necessary. The factory shall stipulate that
measures shall be taken by the operator when he or she discovers that the
instrument or equipment fails.
The site shall keep records of the results of function check and the
measures taken when the function of the instrument or equipment fails.

7 Control of non-conforming product

7.1 For non-conforming products discovered during purchasing, manufacturing,

inspection, etc., the factory shall take measures of identification, isolation and
disposal to avoid unintended use or delivery of non-conforming products. The
reworked or repaired products shall be re-inspected.

7.2 For the information of externally non-conforming certified products including

national and provincial supervision and spot check, product recall, customer
complaints, etc., the site shall analyze the causes of nonconformity and take
appropriate corrective actions. The site shall keep records of nonconforming
information, cause analysis, disposal and corrective actions, etc. of the certified
products.

7.3 The factory shall inform SITIIAS in a timely manner when it is informed
that there are major quality problems in its certified products (such as
nonconforming products of national and provincial supervision and spot
check, etc.).

8 Internal quality audit

The factory shall establish documented internal quality audit procedures to
guarantee continuous compliance of factory quality assurance ability, product
conformity and compliance of products with standards. For the problems
discovered during review, the factory shall take appropriate corrective and
preventive measures. The factory shall keep the internal quality audit results.

9 Change and consistency control of certified products

The factory shall establish and maintain documented procedures to control
the changes that may affect product conformity and the compliance of products
with standards (such as process, production conditions, critical parts, product
structure, etc.), and the procedures shall meet the specified requirements. The
changes shall be implemented after approval by SITIIAS or the authorized
person of Ex certification, and the factory shall keep relevant records.
The site shall control product conformity from product design (design
change), process and resources, purchasing, manufacturing, inspection,
product protection and delivery and other applicable quality links to ensure that
the products continuously meet the certification criteria.

10 Product protection and delivery

The siteshall carry out product protection during purchasing,
manufacturing, inspection, etc. according to the specified requirements,
including identification, handling, packaging, storage, protection, etc. When
necessary, the site shall control the product delivery process as required.

11 CCC certificate and marks

The site shall manage and use CCC certificate and mark according to the
regulations of Compulsory Product Certification Management Regulations and
Regulations for Compulsory Product Certificatio Marks. For uniformly-printed
CCC marks of standard specification or CCC marks applied by printing, molding,
etc., the site shall keep records of use. The following products shall not be
applied with CCC marks or released:
(a) Uncertified products in the compulsory product certification catalog;
(b) The products that have not been confirmed but for which the certified
changes need to be confirmed by SITIIAS;
 (c) Products that exceed the validity of certification;
(d) Products listed in the certificate that has been suspended, revoked or
cancelled;
(e) Non-conforming product.