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Chapter 4

Basic Requirements for Quality Management Systems


Article 27

Management responsibility

The boiler and pressure vessel manufacturer shall define and document its policy and objective for quality. The manufacturer should make necessary measures to ensure this policy is understood and implemented at all of its staff and should meet the following requirements:
1. The quality related activities, responsibility, authority and the relationship among them should be clearly defined. There should be the control and coordinate measures for the interrelation among the different activities.
2. The responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality, especially those who are authorized to conduct work independently, shall be defined and documented (including the responsibility of the personnel who is in charge of material, welding, and NDE). The manufacturer’s management with executive responsibility shall appoint a member of the manufacturer’s own management as quality assurance engineer and defining his/her duty and authority for assuring the establishment, implementation, maintenance and improvement of its quality system



Article 28

The boiler and pressure vessel manufacturer should establish a quality system documentation suitable for design and manufacturing of boiler and pressure vessel, which should include the fundamental elements of quality management.

1. Quality Manual should be established as a means for assuring that the product conforms to the specified requirements. The quality manual should include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system.

2. The manufacturer should prepare documented procedures consistent with the requirements and manufacturer’s stated quality policy, and effectively implement the quality system and its documented procedures.

3. The forms required by quality manual should be documented with standard format. The contents in the current quality record forms should meet the requirements for quality control of boiler and pressure vessel product with relevant levels.

4. The implementing quality plan should assure the quality of product. The quality control points for product in the quality plan (including checkpoint, witness point and hold point) should be reasonably arranged.



Article 29

Document and data control

The manufacturer should establish documented procedures to control all documents and data. They should include:

1. Establishment of document management procedure
(1) The manufacturer should clearly identify the documents to be controlled.
(2) The manufacturer should establish the procedures for draft, joint review, distribution, change, recovery and maintenance of documents.

2. The manufacturer should establish the provisions for assuring that only the latest version of the documents can be used in the relevant departments.

3. The manufacturer should establish the procedure for management of external documents such as, standards and customer-provided drawings.



Article 30

Design control

1. The manufacturer should clearly identify the responsibility of personnel at all level in design department.

2. The manufacturer should keep the relevant codes, regulations and standards concerned to the boiler and pressure vessel manufacture.

3. The design documents should specify that the boiler and pressure vessel produced should meet the relevant safety quality requirements ( see Chapter 5 onwards).

4. The manufacturer should establish the provisions of collecting and implementing new standards.

5. The manufacturer should establish the procedure for design control (including the links of design input, output, review, change and verification).



Article 31

Purchasing and material control

Purchasing and material control should include:
1. Purchasing

1). The procedure for effective quality control of supplier should be formulated.

2). The disposal measures for unacceptable goods provided by supplier should be formulated.

3). The pressure parts should be provided by the suppliers that have recognized by Chinese government or its authorized department. The manufacturer should effectively control of the quality of products subcontracted.

4). The control procedure for purchasing documents should be formulated.

5). The rules for check, accept and control of the purchasing materials and products i.e. plate, tube for pressure parts should be formulated.

2. Storage and distribution of material

1).The manufacturer should establish the rules for storage of the raw materials, and purchasing products including stockpile, identification, sorting etc.

2). The manufacturer should clearly prescribe the measures for storage the material in warehouse.

3). The manufacturer should establish the rules for material distribution including material release and substitution.

4). The manufacturer should establish the rules for transplantation of material identification including the transplantation during processing and the handling of surplus material.



Article 32

Technology control

1. The manufacturer should establish the procedures for the management of technological documents, including draft, release, change, review and approval of them.

2. The manufacturer should establish the technological flow diagram or product processing card or product technology card (or work instruction) suitable for the boiler and pressure vessel products.

3. The manufacturer should establish the technological flow diagram or technological document for instructing the operator (work instruction) for main pressure parts.



Article 33

Welding control

1. Management of welding consumables
The manufacturer should keep and effectively implement a management rule for welding consumables including order, receive, inspection, storage, drying, release, use and restore of them.

2. Welding management

1). The manufacturer should establish the stipulations for training, qualification and the file management of welders and welding operators.

2). The manufacturer should establish the stipulations for welding procedure qualification (PQR), welding specification (WPS) or welding process card suitable for its boiler and pressure vessel products and the requirements of the relevant technical codes. The management stipulations for verifying the PQR and the distribution, use, amend of WPS are both required.

3). The manufacturer should take necessary measures for assuring that welding of pressure parts must be performed by qualified welders. The procedures for welder qualification, the management of the record of the welder performance qualification (WPQ) and the method and implementation for identifying the welder symbol on welds should both be required.

4). The manufacturer should stipulate the procedures for the approval formalities for welding repair, the requirement of re-examination of repaired weld and the process of welding repair of flaws in base metal.

5). The manufacturer should establish the stipulation for keeping welding record of main pressure parts.



Article 34

Heat treatment control

1. The manufacturer should establish the procedures for management of technological documents for heat treatment including draft, review and approval, use, distribution, recording and maintenance of them.

2. The manufacturer should establish the rules for the management of heat treatment quality control.

3. The manufacturer should establish procedure for the management of the subcontractor, which should include, at least, the evaluation of the subcontractor and the quality control items for subcontracted products, if the heat treatment is consigned to subcontractors.



Article 35

NDE control

1. The manufacturer should formulate a procedure for quality control of NDE including determining the NDE methods, selection of standards and codes, draft and approval of NDE technological documents, control of operation, sign and issue of NDE report and the management of radiograph films.

2. The manufacturer should formulate the technological process card and record forms suitable for the manufacturing products.

3. The manufacturer should formulate the rules for the management of qualification of NDE personnel.

4. The manufacturer should establish procedure for the management of the subcontractor which should include, at least, the evaluation of the subcontractor and the quality control for subcontracted items, if the NDE is consigned to subcontractors.



Article 36

Chemical and physical examination and testing

1. The manufacturer should formulate a management procedure for chemical and physical examination testing.

2. The manufacturer should formulate a procedure for verification of the chemical and physical examination and testing results and for repeat examination and testing of them.

3. The manufacturer should establish procedure for the management of the subcontractor which should include, at least, the evaluation of the subcontractor and the quality control for subcontracted items, if the chemical and physical examination and testing are consigned to subcontractors.



Article 37

Pressure testing control

1. The manufacturer should formulate technology and related procedure for pressure testing.

2. The manufacturer should formulate a procedure on quality control for pressure testing including the supervision and verification of pressure testing, safety protection during pressure testing and the temperatures of test medium and of environment, etc.



Article 38

Control of other inspection and testing

1. The manufacturer should formulate a procedure for the management of inspection and testing including the authority and responsibility of inspector, incoming inspection, process inspection, final inspection, the file of inspection report and the management of quality testimony, etc.

2. The manufacturer should formulate and implement inspection and testing plan.

3. The manufacturer should formulate provisions for identification of inspection and testing status.



Article 39

Control of metrology and equipment

1. The manufacturer should formulate the provision of metrology management to assure the measuring meters, instruments and tools to be used are in their valid calibration period.

2. The manufacturer should formulate the provisions for effective control, calibration and maintenance of the measuring meters and testing instruments.

3. There should have provisions that the metrology environment should be suitable to the undertaking metrology testing.

4. There should have the provisions for the management of manufacturing equipment.



Article 40

Control of non-conformity product

1. The manufacturer should establish documented procedures to ensure that product that does not conform to specified requirements is prevented from inadvertent use or installation.

2. The manufacturer should establish provisions for identification, record, evaluation, segregation (where practical), disposition of non-conforming products.
1). The provisions for drafting, review and approval and file of non-conformity report should be established.
2). The relevant provisions for the links of disposal of non-conformity products (use as it is, rework and scrap)should be established.
3). The provision that the re-inspection of reworked product should be established.



Article 41

Quality improvement

1. A flow chart for feedback, collection and analysis, and disposal of product quality information (both inside and outside manufacturer) should be established.

2. A procedure on planning and implementing internal quality audit should be established in order to ensure the normal implementation of quality assurance system, analyzing and investigating the exist quality problems and putting forward the solving and preventing measures to the problems.

3. The Provisions for internal quality audit including that the audit should be carried out by personnel independent of those having direct responsibility for the activity being audited should be established.
1). It should have a provision for receiving, disposal and answer to the comments of the quality audit and the corrective or improvement measures to them.
2). It should have a provision for solving the product quality problems raised by supervisory inspection agency (or the third party inspection agency) or customers in time.



Article 42

Training

The manufacturer should established a documented procedures for the training of quality assurance engineers, welding engineers, inspectors, chemical and physical testing personnel, NDE examiner, welder and welding operators and those personnel engaged in manufacture, verification and management whose activities great affecting quality.



Article 43

The procedure for implementing China boiler and pressure vessel manufacture licensing system

1. The manufacturer should establish a documented procedure for implementing China boiler and pressure vessel manufacture licensing system. It should clearly defined the control procedure for boiler and pressure vessel products to be used in China. It should be also specified that the auditors conducting survey and assessment for manufacture licensing shall have free access, at the manufacturer facility, to all concerned drawings, calculation sheets, procedures, records, the inspection and test results and other necessary documents and data.

2. The manufacturer should specify the use and management of boiler and pressure vessel manufacture license.

3. The manufacturer should specify that it should provide with the product certificate of compliance and other delivery documents to the Chinese customer.