This standard provides guidance for the management of a reliability program. It includes the basic features of a comprehensive reliability program such as planning, organization, guidance, and control of resources to produce reliable and maintainable products. From a management perspective, it only covers what must be done, why, when, and how. As for who should do it and where, there are no specific regulations because organizations and engineering projects vary. This standard applies to hardware and/or software products where reliability is very important during the use and maintenance phases. The main purpose of the requirements is to control the impact on reliability throughout the product life cycle from planning to use. GB/T 19000.4-1995 Quality Management and Quality Assurance Standard Part 4: Guidelines for Reliability Program Management GB/T19000.4-1995 Standard Download Decompression Password: www.bzxz.net
This standard provides guidance for the management of a reliability program. It includes the basic features of a comprehensive reliability program such as planning, organization, guidance, and control of resources to produce reliable and maintainable products. From a management perspective, it only covers what must be done, why, when and how, but does not specify who should do it and where, because organizations and engineering projects vary. This standard applies to hardware and/or software products whose reliability is very important during the use and maintenance phases. The main purpose of the requirements is to control the impact on reliability throughout the product life cycle from planning to use.

GB/T19000.4—1995
This standard is equivalent to the International Electrotechnical Commission: IEC300-1 Dependability Management—Part 1: Dependability Program Management/International Organization for Standardization: IS09000-4 Quality Management and Quality Assurance Standard—Part 4: Dependability Program Management Guide. This standard is the first-level standard in the series of standards of the International Electrotechnical Commission (IEC) in the field of reliability, and is also one of the GB/T19000—ISO9000 series of standards. This standard will be used in conjunction with 1EC300-2 in specific implementation. The international standard ISO9000-41EC300-1:1993 replaced the original International Electrotechnical Commission standard IEC300. This standard was jointly proposed by the State Administration of Technical Supervision and the Ministry of Electronics Industry. This standard is jointly managed by the National Technical Committee for Quality Management and Quality Assurance Standardization and the National Technical Committee for Reliability and Maintainability of Electrical and Electronic Products.
This standard was jointly drafted by the China Institute of Standardization and Information Classification and Coding and the Fifth Institute of the Ministry of Electronics. The main sponsors of this standard are Qi Kuitong, Zhang Shanfang, He Guowei, Tu Qingci and Hu Xianghong. 339
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ISO/IEC Foreword
IEC (International Electrotechnical Commission) and ISO (International Organization for Standardization) constitute a worldwide professional system for standardization. The member bodies of ISO or IEC participate in the formulation of international standards through the technical committees they establish to deal with technical activities in their respective fields. ISO and IEC cooperate with each other in areas of common concern. International organizations (official and unofficial) that maintain contact with ISO and IEC may also participate in relevant T. cooperation.
The draft international standard is submitted to the national groups for voting. The international standard can only be formally adopted if it obtains the consent of at least 75% of the national groups participating in the voting.
International standards ISO9000-4IEC300-1:1993 were formulated in close cooperation between IEC/TC56 (credibility) and ISO/TC176/SC2 (quality system).
This International Standard contains terms and definitions specific to reliability management. It is expected that future versions of this standard and ISO 8402 (Quality management and quality assurance - Terms) will include terms and definitions that are consistent with this. IEC 300:1984 is withdrawn and replaced by this standard. This version of the standard is based on the following documents:
56(CO)189
All voting information for this standard is in the above voting report. 311)
Voting report
56(CO)200
GB/T19000.4—1995
Reliability is one of the most important performance characteristics of many products. Reliability assurance involves the performance of product reliability, maintainability and maintenance support provided by the customer (and/or supplier). Reliability assurance is a joint responsibility of both the supplier and the customer. The increasing dependence of society on services (such as transportation, power, communication and information services) has led to higher requirements and expectations from users for service quality. The reliability of the products used for these services is an important factor affecting the quality of the services. Lack of resources, concerns about safety and the environment, increasing complexity of products and a high emphasis on the life cycle costs of products also require an emphasis on the assurance of reliability and its elements. Experience has shown that maintenance costs can significantly exceed the initial purchase cost. Many products are developed to meet user needs or requirements specified in specifications. These requirements usually involve reliability, maintainability, and sometimes availability under specified maintenance guarantee conditions. The customer is usually solely responsible for use and maintenance. Some products are sold or leased with agreements or warranties that carry reliability characteristic measures, whether or not there is a maintenance guarantee provided by the supplier.
For other products, reliability specifications can be part of the design or maintenance process. An effective reliability outline is in the mutual interest of both the supplier and the customer for the relevant life cycle phases. 311
National Standard of the People's Republic of China
Quality management and quality assurance standards-Part 4: Guide to dependability programme management
Quality management and quality assurance standards-Part 4: Guide to dependability programme management1Scope
GB/T 19000.4—1995
idtISO9000-4iEc300-1:1993
Replaces GB699286
This standard provides guidance for dependability programme management. It includes the basic features of a comprehensive dependability programme, such as planning, organization, direction, and control of resources, to produce reliable and maintainable products. From a management perspective, it only involves what must be done, why it is done, when and how it is done. As for who should do it and where it is done, there is no specific provision, because organizations and projects are different. This standard applies to hardware and/or software products where reliability is important during the use and maintenance phases. The main purpose of the requirements described is to control the impact on reliability throughout the product life cycle from planning to use. Any agreement to adopt the guidance given in this standard may select certain parts to suit specific circumstances. When parts of this standard are referenced, the parties concerned should agree and record the extent of their applicability, including guidance provided by other parts of the IEC 300 series. In this way, any selected clauses will be converted into formal requirements. NOTES:
1 The guidance provided in this standard is mainly applicable to suppliers supplying a small number of qualified customers, but it is also applicable to the supply of consumer products. 2 The guidance provided in this standard applies not only to the defined life cycle phases, but also to any sub-phases. 3 When referring to gender, the masculine terms used in this standard also apply to the feminine. 4 The use of "documents" and "document records" in this standard is not limited to paper as the medium. 5 The term "customer" and the term "acquirer" used in this standard are synonymous. 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards are subject to revision, and parties using this standard should explore the possibility of using the latest version of the following standards. IEC and ISO members hold currently valid international standards. IEC50 (191): 1990 International Electrotechnical Vocabulary (IEV) - Chapter 191 Dependability and Service Quality IEC300-21) Dependability Management - Part 2: Dependability Outline Elements and Work Items (to be promulgated) GB/T6583 Quality Management and Quality Assurance Vocabulary (idtISO8402) GB/T19001 Quality Assurance Model for Quality System Design/Development, Production, Installation and Service (idt1SO9001) GB/T19002
Quality Assurance Model for Quality System Production and Installation (idtISO9002) GB/T 19003
GB/T 19004
Quality Assurance Model for Final Inspection and Testing of Quality System (idtISO9003) Guide to Quality Management and Quality System Elements (idtISO9004) 1) IEC300-2 is currently in the draft standard stage, and its correct translation will be given in the appropriate materials of this standard. Approved by the State Administration of Technical Supervision on November 14, 1995 342
Implementation on June 1, 1996
3 Definitions
GB/T19000.4--1995
This standard adopts the terms and definitions given in IEC50 (191) and GB/T6583--ISO8402 and the following terms and definitions. 3.1 Dependability
Describes availability and its influencing factors: a collection of performance such as reliability, maintainability and maintenance support. Note: Dependability is usually only used in non-definite description situations. 3.2 Dependability Program The organizational structure, responsibilities, procedures, processes and resources used to manage dependability. Note: The dependability program covers all stages of the life cycle from product planning to use and possible disposal. It consists of program elements broken down into work items.
3.3 Dependability Plan Dependability Plan A document that specifies the specific dependability practices, resources, and sequence of activities associated with a particular product, contract, or project. 3.4 Product product
Any specified deliverable item or service. 4 Management Responsibility
4.1 Policy
The supplier shall develop and maintain a document describing the policy and objectives of the product reliability characteristics and related assurance services. This document may be part of the quality policy document developed in accordance with the guidance provided in 4.1.1 of GB/T19001--ISO9001 and 4.2 and 4.3 of GB/T19004--ISO9004. 4.2 OrganizationwwW.bzxz.Net
The supplier shall establish and maintain the elements and resources that can realize the reliability assurance program in its organization. These elements may be unrelated to the product and engineering project, or they may be related to the product or engineering project. They should be easily identifiable and may be independent of the organizational responsibilities for implementing quality assurance activities, but have appropriate interface relationships. The reliability assurance function and the quality assurance function may have some common organizational departments, so they can be combined to perform the assurance function together, but they are still identifiable. 4.3 Quality System
The supplier shall establish and maintain a documented quality system in accordance with GB/T19001--ISO9001, GB/T19002--ISO9002 or GB/T19003-ISO9003 as appropriate. 4.4 Market Research and Product Planning
The supplier shall establish and follow a market research procedure to determine future customer needs for the credibility of products to be introduced into the market and convert these needs into specifications.
Early product planning activities, including feasibility studies, shall be conducted on the basis of credibility specifications based on market research. 4.5 Management Review
The supplier shall review the credibility outline developed in accordance with the guidance provided in this standard at appropriate intervals at the management level and maintain review records.
Note: This review shall be coordinated with the management review conducted in 4.1.3 of GB/T19001--ISO9001. 4.6 Dependability Program Review
The supplier shall develop and follow a review procedure to conduct a systematic, periodic, and independent review of the suitability of the processes, procedures, and tools used in the dependability program. This includes:
A review of the dependability program and its elements and work items, including the basis for their selection; A review of all documents describing the program and its elements, work items, and execution results; A consideration of the effectiveness and effects of the dependability program and any approved changes; 313
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—Evaluate the cost-effectiveness of the program by benefits (high dependability, low maintenance costs, etc.).
5 Common program elements for products or engineering projects 5.1 Implementation of the dependability program
The supplier shall be able to select work items to implement the dependability program in accordance with IEC300-2 to ensure that the specified dependability requirements are met. The structure and elements of the reliability program and the detailed description of the procedures, analysis methods, tools, and statistical principles used to define, control, and evaluate reliability characteristics shall be documented.
5.2 Methods
The supplier shall develop and use effective statistical methods and models and other relevant qualitative and quantitative methods and models suitable for the prediction, analysis, and evaluation of product reliability characteristics. An education and training program shall be promulgated and implemented for all types of personnel using these methods. 5.3 Database
The supplier shall establish and maintain a database of relevant reliability data fed back from testing and/or use of the product to assist in product design, improvement of existing products, maintenance and support planning, or to meet other needs of the reliability program. 5.4 Reliability Records
All documents, including reliability requirements and their allocation, reliability plans and reliability analysis and prediction results, reliability test procedures and results, and field data analysis records, shall be kept for a period of time that is consistent with the expected product life. A summary of relevant documents, including revision status, shall be established and maintained in accordance with GB/T19001-ISO9001, Section 4.5. 6 Product or Project Specific Outline Elements 6.1 Planning and Management
The supplier shall develop a reliability plan and make it part of the overall product plan or project plan. The reliability plan shall be reviewed during the project and product review and, if necessary, revised. The review shall also check whether the outline elements and work items, analysis and results are consistent with the planned and specified reliability requirements. The supplier shall develop and follow procedures for maintaining traceability as specified in the reliability requirements of IEC300-2. Reliability is one of the main factors in the technical status management procedure. The supplier shall develop and follow the technical status management procedure in accordance with the guidance provided in GB/T19004-ISO9004, Section 8.8. Note: The work items of this element are specified in IEC300-2, Section 6.1 (Reliability Plan, Project Decision Management, Traceability Management, Technical Status Management).
6.2 Contract review and liaison
The supplier shall establish and follow a contract review procedure in accordance with clause 4.3 of GB/T19001-ISO9001:1994 to ensure that the reliability requirements and the conditions and constraints for determining the reliability requirements have been properly specified and documented; that those availability requirements that differ from those proposed in the tender have been resolved; that the conditions for use and maintenance support have been properly specified by the customer; and that the acceptance test criteria have been determined. Records of the review shall be kept, including the decisions made during the review. The supplier shall designate a management representative to liaise with the customer. Note: The work items of this element are specified in clause 6.2 of IFC300-2 (Contract review, management representative). 6.3 Reliability requirements
The supplier shall establish specifications including qualitative and quantitative requirements for availability, reliability and maintainability, and shall take into account information provided by the customer and clearly state the assumptions for maintenance support. Before the product design begins, the supplier shall review the reliability requirements. This review shall ensure that any incomplete, ambiguous or conflicting reliability requirements are clarified or modified. If necessary, the overall reliability requirements shall be allocated to the various parts of the designed product. Note:
"Reliability requirements may need to be redefined during the product life cycle. The work items of this element are specified in IEC300-2 Section 6.3 (Reliability requirement specification, requirement description, requirement allocation). 31
6.4 Second process
GB/T 19000.4—1995
The supplier shall develop and follow guidelines and practices for product design and its maintenance support to ensure the desired reliability is achieved. Note: The work items of this element are specified in IFC300-2 Section 6.4 (Reliability Engineering, Maintainability Engineering, Maintenance Support Engineering, Testability Engineering, Human Factors Engineering).
6.5 Externally provided products
The supplier shall establish and follow procedures for specifying the reliability requirements for externally provided products. The supplier shall require and ensure that any subcontracted hardware and software in the final product can meet all requirements of the reliability outline. Note: The work items of this element are specified in IFC300-2 Section 6.5 (Subcontracted products, customer-provided products). 6.6 Analysis, prediction and design review
The supplier shall determine and implement the reliability analysis, prediction and formal design review work (outline work items) suitable for the product or engineering project.
Note: The work items of this element are specified in IEC300-2 Section 6.6 (Failure mode and effect analysis, fault tree analysis, stress and load analysis, human factors analysis, prediction, trade-off analysis, risk analysis, formal design review). 6.7 Verification, validation and testing
The supplier shall establish and follow work procedures for effective and appropriate verification and validation of reliability requirements. Note: The work items of this element are specified in IEC300-2 Section 6.7 (verification, confirmation and test planning, life test, reliability test, reliability growth test, production test, acceptance test, reliability stress screening). 6.8 Life cycle cost outline
The supplier shall establish and follow the procedures for evaluating the life cycle cost elements of the product or engineering project. Note: The work items of this element are specified in IFC300-2 Section 6.8 (Life cycle cost outline). 6.9 Use and maintenance support planning
The supplier shall provide the customer with the information required for the use of the product. The supplier shall determine and inform the customer of the requirements for product maintenance support, including recommended spare parts (scope and scale), test equipment, special tools, technical level of maintenance personnel, etc.
Note: The work items of this element are specified in IEC300-2 Section 6.9 (maintenance support planning, installation, support services, support engineering, spare parts supply). 6.10 Improvements and Modifications
To ensure compliance with reliability requirements, the supplier shall establish and follow procedures to systematically identify and implement necessary improvements to the reliability, maintainability and maintainability of the product.
The supplier shall establish and follow procedures to ensure that when there are changes or modifications to the product, or when the reliability characteristic data changes, the review is carried out: if necessary, the original analysis and prediction are revised to determine the possible impact on reliability and whether product improvements need to be initiated. Note: The work items for this element are specified in IFC300-2 Section 6.10 (Improvement Outline, Modification Control). 6.11 Feedback
The supplier shall establish and follow procedures for processing, storing and analyzing failure and malfunction data from testing and manufacturing and reliability information used by customers.
The supplier shall explain and convey to the customer the information on the field data required by the customer, and work with the customer to establish appropriate procedures for the collection, storage and analysis of field data.
Note: The work items of this element 7 are specified in 1EC300-2 Section 6.11 (data collection, data analysis). 315
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