Basic elements of the quality assurance system for special equipment manufacturing, installation, modification and maintenance

This requirement applies to the manufacturing and installation of special equipment (including raw materials, components, safety accessories and safety protection devices) Establish and implement the quality assurance system for , renovation and maintenance units.

1 Management responsibilities

1.1 Quality policy and quality objectives

The quality policy and objectives shall be approved by the legal representative (or his authorized agent) and formed Official document. Quality policies and objectives should meet the following requirements:

(1) In line with the actual situation of the unit and the scope and characteristics of the licensed projects, highlighting the safety performance requirements of special equipment;

(2) The quality policy reflects the commitment to the continuous improvement of the safety performance and quality of special equipment, and specifies the quality direction and goals pursued by the unit;

(3) The quality goals are quantified and decomposed, and implemented into each quality level Control the system and its related departments and responsible personnel, and conduct regular assessments of quality objectives.

1.2 Quality Assurance System Organization

Based on the characteristics of the licensed project and the actual situation of the unit, establish a quality assurance system organization that independently performs special equipment safety performance management responsibilities.

1.3 Responsibilities and authorities

It is stipulated that the legal representative is responsible for the safety and quality of special equipment, and appoints quality assurance engineers and responsible personnel of each quality control system. The quality assurance engineer should be a member of the management and Have knowledge related to the licensed project profession, and have the management responsibilities and authority to establish, implement, maintain and improve the quality assurance system.

Appoint quality control systems (such as design, materials, processes, welding, machining, metal structure production, electronic control system production, heat treatment, non-destructive testing inspection and testing, installation and commissioning, other major process control systems, etc. ) Responsible personnel, stipulates the responsibilities and authorities of each quality control personnel and those who need to independently exercise and ensure the safety performance of special equipment, and clarify the relationship between each quality control system, the quality assurance engineer and the responsible personnel of each quality control system, and the relationship between each quality control system. Work interface control and coordination measures between persons responsible for the control system.

1.4 Management Review

A management review of the special equipment manufacturing, installation, transformation and maintenance quality assurance system should be conducted at least once a year to ensure the adaptability, adequacy and effectiveness of the quality assurance system performance, meet the requirements of the quality policy and objectives, and maintain management review records.

2 Quality Assurance System Documents

Quality assurance system documents include quality assurance manuals, procedure documents (management systems), and operation (process) documents (such as operation instructions, process procedures, and processes). cards, operating procedures, etc., the same below), records (sheets, cards), etc.

2.1 Quality Assurance Manual

The quality assurance manual should describe the structural hierarchy and interrelationships of the quality assurance system documents, and at least include the following contents:

(1) Terms and abbreviations;

(2) Scope of application of the system;

(3) Quality policy and objectives;

(4) Quality assurance system organization and management Responsibilities;

(5) Requirements for the basic elements of the quality assurance system, quality control system, control links and control points.

2.2 Procedure documents (management system)

Program documents (management system) are consistent with the quality policy, meet the requirements of the basic elements of the quality assurance manual, and are consistent with the actual situation of the unit, Be operable.

2.3 Operation (process) documents and quality records

Operation (process) documents and quality records should comply with the characteristics of the licensed project and meet the control needs of the quality assurance system implementation process. The file format and the included items and content should be standardized.

2.4 Quality Plan

Quality plan can effectively control the safety performance of products (equipment), and can reasonably set up control links and control points (including audit points and witnesses) according to the requirements of each quality control system. point, stop point), meet the characteristics of the accepted permit project and the actual situation of the applicant unit, and include the following content:

(1) Control content and requirements;

(2) In the process Actual operation requirements;

(3) Provisions for signature and confirmation by the person responsible for the quality control system and relevant personnel.

3 Document and record control

3.1 Document control

The scope, procedures and contents of document control are as follows:

(1) Subject to Determine the categories of control documents, including quality assurance system documents, external documents (note), other documents that need to be controlled, etc.;

Note: external documents include laws, regulations, safety technical specifications, standards, and design documents, Design document appraisal report, type test report, supervision inspection report, sub-supplier product quality certification documents, qualification certification documents, etc. Among them, safety technical specifications and standards must have official versions.

(2) The preparation, countersigning, approval, marking, issuance, modification, and recycling of documents. The control of external documents should also include provisions for collection, purchase, and receipt;

(3 ) Provisions on the effective version of controlled documents used by relevant departments, personnel and locations implementing the quality assurance system;

(4) Provisions on the storage methods, storage facilities, retention periods and destruction of documents.

3.2 Control of records

The scope, procedures, and content of record control are as follows:

(1) Quality formed during the manufacturing, installation, modification, and maintenance processes of special equipment Record filling, confirmation, collection, filing, storage, etc.

(2) The custody and retention period of records, etc.;

(3) The relevant controlled record forms used by quality assurance system implementation departments, personnel and locations must be valid versions.

4 Contract Control

The scope, procedures and content of contract control are as follows:

(1) The scope and content of contract review, including the laws and regulations for execution , safety technical specifications, standards and technical conditions, etc., form review records and effectively preserve them;

(2) Contract signing, modification, countersigning procedures, etc.

5 Design control

The scope, procedures, and contents of design control are as follows:

(1) The content of design input includes the underlying regulations, safety technical specifications, Standards and technical conditions, etc., shall be formed into design input documents (such as design briefs, etc.);

(2) Design output shall be formed into design documents (including design instructions, design calculations, design drawings, etc.), and the design The documents should meet the requirements of regulations, safety technical specifications, standards and technical conditions;

(3) If design verification is required in accordance with relevant regulations, design verification regulations shall be formulated;

(4) Regulations on the modification of design documents;

(5) Regulations on the control of external design documents when the design documents are provided by external units;

(6) Regulations and safety technical specifications on design When there are provisions for licensing, design document appraisal, product type testing, etc., relevant provisions should be formulated.

6 Control of materials and parts

The scope, procedures and content of the control of materials and parts (including supporting equipment, the same below) are as follows:

(1 ) Procurement of materials and parts (including procurement plans and procurement contracts), clarify the methods and content of quality control for sub-suppliers, including evaluation, selection, and re-evaluation of sub-suppliers, and preparation of sub-supplier evaluation reports, Establish a list of qualified suppliers, etc. Sub-suppliers that have administrative licensing requirements for laws and safety technical specifications should confirm the sub-supplier's licensing qualifications;

(2) Acceptance (re-inspection) of materials and parts ) control, including that materials and parts that have not been accepted (re-inspected) or are unqualified shall not be put into use;

(3) The preparation, marking method, location and location of material identification (traceability identification) Logo transplantation, etc.;

(4) Storage and custody of materials and parts, including storage areas, partitioned stacking or batches (material batches), etc.;

(5) Materials and parts procurement and use control, including quality certification documents, grades, specifications, material furnace batch numbers, confirmation of inspection results, material procurement, cutting and blanking, molding, transplantation and confirmation of material identification before processing, remaining materials, Treatment of waste materials, etc.;

(6) Substitution of materials and parts, including basic requirements and scope of substitution, approval of substitution, inspection and testing of substitution, etc.

7 Operation (process) control

The scope, procedures, and contents of operation (process) control are as follows:

(1) Basics of operation (process) documents Requirements, including conditions and principle requirements for the formulation of general or special process documents;

(2) Operation (process) discipline inspection, including process discipline inspection time, personnel, inspection procedures, inspection items, content, etc.;

(3) Management of tooling and molds, including the design, production and inspection of tooling and molds, documentation, marking, storage, regular inspection, maintenance and scrapping of tooling and molds, etc.

8 Welding control

The scope, content, and content of welding control are as follows:

(1) Welding personnel management, including welding personnel training, qualification assessment, and maintenance Qualified items for certified welding personnel, identification of certified welding personnel, files of welding personnel and their assessment records, etc.;

(2) Welding material control, including the procurement, acceptance, inspection, storage, Drying, distribution, use and recycling, etc.;

(3) Welding procedure qualification report (PQR) and welding procedure instruction book (WPS) control, including welding procedure report, relevant inspection and testing report, process qualification procedure Welding records and storage of welding procedure qualification samples;

(4) Welding procedure qualification items cover the welding procedures required for special equipment welding;

(5) Welding process control, Including welding process, product welding records, welding equipment statistics and statistical data analysis;

(6) Weld repair (base metal defect repair welding) control, including weld repair (base metal defect repair welding) Process, number of weld repairs and weld repair approval, re-inspection and testing after weld repair (base metal defect repair welding), etc.;

(7) There are product welding test plate requirements based on safety technical specifications and standards. At the same time, the control of product welding test plates includes the number, production, welding methods, marking, heat treatment, inspection and testing items, sample processing, inspection and testing methods, welding test plates and unqualified materials for test samples, and Such preservation, etc.

9 Heat treatment control

Based on the characteristics of the licensed project and the actual situation of the unit, and in accordance with the requirements of safety technical specifications and standards, the scope, procedures and content of heat treatment control are formulated as follows:

(1) Heat treatment process requirements;

(2) Heat treatment control, including the heat treatment equipment, temperature measurement device, automatic temperature recording device, and heat treatment records (indicate the heat treatment furnace number and workpiece number/product number, heat treatment date, heat treatment operator signature, heat treatment responsible person signature, etc.) and report filling, review and confirmation, etc.;

(3) When the heat treatment is undertaken by the subcontractor, the subcontractor shall Heat treatment quality control, including evaluation, selection and re-evaluation of subcontractors, subcontractor heat treatment process control, subcontractor heat treatment reports and records (indicate heat treatment furnace number, workpiece number/product number, heat treatment date, heat treatment operator Signature, signature of person responsible for heat treatment, etc.) and review and confirmation of reports, etc.

10 Non-destructive testing control

Based on the characteristics of the licensed project and the actual situation of the unit, and in accordance with the requirements of safety technical specifications and standards, the scope, procedures and content of non-destructive testing control are formulated as follows:< /p>

(1) Management of non-destructive testing personnel, including training and assessment of non-destructive testing personnel, qualification certificates, management of certified projects, responsibilities and authorities of non-destructive testing personnel, etc.;

( 2) Basic requirements for general and special non-destructive testing processes, including non-destructive testing methods, safety technical specifications, standards, etc.;

(3) Non-destructive testing process control, including non-destructive testing methods, quantities and proportions, Detection of unqualified parts, expansion ratio, assessment standards, etc.;

(4) Non-destructive testing process records and report control, including non-destructive testing records, report filling, review, re-evaluation, issuance, and RT film Storage, storage of UT test blocks, etc.;

(5) Non-destructive testing equipment and equipment control;

(6) When the non-destructive testing work is undertaken by a subcontractor, the subcontractor shall Non-destructive testing quality control, including confirmation of subcontractor qualifications, scope and personnel qualifications, evaluation, selection, re-evaluation and report formation of subcontractors, and review of subcontractors' non-destructive testing processes, non-destructive testing records and reports Confirm etc.

11 Physical and chemical inspection control

The scope, procedures and content of physical and chemical inspection control are as follows:

(1) Training and induction of physical and chemical inspection personnel;

< p>(2) Physical and chemical inspection control, including the determination of physical and chemical inspection methods and the control of operating processes;

(3) Physical and chemical inspection records, report filling, review, conclusion confirmation, issuance, re-testing and testing Management of samples, reagents, standard samples, etc.;

(4) Sample processing and sample testing for physical and chemical inspections;

(5) When physical and chemical inspections are undertaken by subcontractors, The quality control of physical and chemical inspection of subcontractors includes the evaluation, selection, re-evaluation and formation of evaluation reports of subcontractors, review and confirmation of physical and chemical inspection processes, physical and chemical inspection records and reports of subcontractors, etc.

12 Inspection and test control

The scope, procedures and contents of inspection and test control are as follows:

(1) Basic requirements for inspection and test process documents, including Basis, content, methods, etc.;

(2) Process inspection and test control, including inspection and testing required before the previous process has been completed or the necessary inspection and test report has not been issued and confirmed. Provisions for entering the next process or release;

(3) Final inspection and test control (such as factory inspection, completion acceptance, commissioning acceptance, trial operation acceptance, etc.), including all processes before final inspection and testing The inspection and test have been completed, and the inspection and test conclusions meet the safety technical specifications and standards;

(4) Inspection and test condition control, including inspection and test site, environment, temperature, medium, and equipment (Device), tooling, test load, safety protection, test supervision and confirmation, etc.;

(5) Inspection and test status, such as qualified, unqualified, and label control to be inspected;

< p>(6) When safety technical specifications and standards include type tests or other special tests, regulations on type test or other special test control shall be prepared, including type test items and their product range, type test institutions, type test reports, type tests, etc. Test conclusions and other special test conditions, methods, processes, records, reports and test conclusions, etc.;

(7) Inspection and test records and report control, including inspection and test records, report filling, review and Confirmation, etc., inspection and test records, reports, special requirements for collection, archiving and storage of prototypes (samples, test pieces), etc.

13 Equipment and inspection and testing instrument control

The scope, procedures and content of equipment, inspection and testing device control are as follows:

(1) Equipment and inspection and testing equipment Test equipment, including procurement, acceptance, operation, maintenance, use environment, verification, calibration, maintenance, scrapping, etc.;

(2) Equipment and inspection and test equipment file management, including the establishment of equipment and inspection and test inspection Equipment ledgers and files, quality certification documents, instructions for use, usage records, maintenance records, calibration and verification plans, calibration and verification records and reports and other archival information;

(3) Equipment and inspection and test device status Control, including verification and calibration marks, periodic inspection reports of equipment required by statutory inspections, etc.

14 Control of non-conforming products (items)

Based on the actual situation of the unit, the scope, procedures and content of control of non-conforming products (items) are formulated as follows:

(1) Recording, labeling, storage, isolation, etc. of non-conforming products (items);

(2) Cause analysis, disposal and post-disposal inspection of non-conforming products (items);

(3) The formulation, review, approval, implementation and tracking verification of corrective measures for non-conforming products (items).

15 Quality improvement and services

The scope, procedures and contents of quality improvement and services are as follows:

(1) Quality information control, including internal and external quality Information, quality issues raised by quality technical supervision departments and supervision and inspection agencies, quality information collection, summary, analysis, feedback, processing, etc.;

(2) It is stipulated that a complete internal audit should be conducted at least once a year, and the audit findings Analyze the causes of problems, take corrective measures and track and verify their effectiveness;

(3) Conduct regular statistics and analysis on the first-time pass rate and repair rate of products, and propose specific preventive measures, etc.;

< p>(4) User services, including service planning, implementation, verification and reporting, as well as related personnel responsibilities, etc.

16 Personnel training, assessment and management

The scope, procedures and content of personnel training, assessment and management are as follows:

(1) Personnel training requirements , content, planning and implementation, etc.;

(2) Training and assessment files of relevant personnel required for special equipment licensing;

(3) Relevant personnel required for special equipment licensing Management, including hiring, borrowing, and transfer management.

Note: This article does not include welding personnel, non-destructive testing personnel, and physical and chemical testing personnel. The training, assessment and management of these personnel are stipulated in the corresponding articles.

17 Other process controls

Based on the characteristics of the licensed project, other process controls should be compiled separately as control elements. The scope, procedures, and content of the controls are as follows:

(1) Clarify other processes that have an important impact on the safety performance of special equipment;

Characteristics of licensed projects, determine other process control regulations that have an important impact on the safety performance of special equipment;

(2) Appoint other personnel responsible for process control and clarify their responsibilities and authorities;

(3) Other special control requirements in the implementation of process control, process records, inspection and test items, inspection and test records and Report.

Note: Other processes refer to processes that have an impact on the safety performance of special equipment and require special control during the manufacturing, installation, modification, and maintenance of special equipment.

Such as grooving of bursting discs, pressing of spherical pieces, forming of heads, forging processing, surface treatment of containers, wrapping or tape wrapping around containers, stretch forming, closing, bottom closing, and bottle mouth processing of seamless gas bottles etc., filling ingredients, autoclaving, drying, etc. for dissolved acetylene cylinders, fiber winding, drying, curing, etc. for wrapping gas cylinders, installation of medical oxygen chambers, communication systems, electrical systems, lighting systems, supply and exhaust systems, etc. , the expansion process of boiler tube plate and flue, steam drum and downcomer, boiler installation and commissioning, extrusion molding of non-metallic pipe fittings and pipes, etc., steelmaking, continuous casting, molding in the production process of steel plates for boilers and pressure vessels, etc. Casting, heating and heat treatment, pressure processing and finished product finishing, etc.; bending and forming of metal pipe fittings, valve assembly and testing process, penetration engineering in pressure pipeline installation, cathodic protection device installation, ball cleaning, anti-corrosion, concealment Engineering, etc., installation and commissioning of electronic control systems, hydraulic systems, pneumatic systems and complete machines, processing of important parts, production and inspection of safety components, production of metal structures, batch management of mass-produced products, etc.

18 Implement the special equipment licensing system

Based on the characteristics of the licensed project and the actual situation of the unit, formulate and implement the special equipment licensing system control. The scope, procedures and content of the control are as follows:

(1) Implement the special equipment licensing system;

(2) Accept the supervision of quality and technical supervision departments at all levels;

(3) Accept supervision and inspection, including regulations, When safety technical specifications require the implementation of supervisory inspections for the manufacture, installation, modification, and maintenance of special equipment, regulations for accepting supervisory inspections of special equipment shall be formulated, a designated person shall be responsible for the work contact with the supervisory and inspection personnel, and conditions for supervision and inspection work shall be provided. Procedures for handling the "Supervisory Inspection Liaison Sheet" and "Supervisory Inspection Opinion Notice" proposed by the inspection agency;

(4) Do a good job in special equipment license management, including compliance with relevant laws, regulations and safety Technical specifications, special equipment licensing requirements (such as name, location, quality assurance system), timely handling of change applications and filing requirements, management regulations for special equipment licenses and license marks, replacement of special equipment licenses Certification requirements, etc.;

(5) Provide relevant information, including relevant information on the manufacturing, installation, modification and maintenance of special equipment to quality and technical supervision departments, inspection agencies and society in accordance with regulations and safety technical specifications. .

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