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I&C Safety Guide DRAFT 20110803.doc
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2.8. The management systems for development of I&c systems should comply with the recommendations of Safety Guides gs-g-3.1, Ref. [5] and gs-g-3.5, Ref. [6].

2.9. The management systems requirements and recommendations of these documents broadly apply to development activities for all NPP systems, structures, and components. For the most part the application to I&C does not need further interpretation in this safety guide. What is unique for I&C systems is the specific development process needed (See chapter 6). The GS-R-3, Ref. [4] topics of particular interest in the development of I&C systems are listed below.

  • Management Systems;

  • Safety culture;

  • Management commitment;

  • Statutory and regulatory compliance;

  • Organizational policies;

  • Planning;

  • Responsibilities and authority;

  • Resource Management;

  • Provision of resources;

  • Awareness and training;

  • Process Implementation;

  • Control of documents, products, and records;

  • Interaction and communication between responsible parties;

  • Management of organizational change;

  • Measurement, Assessment and Improvement;

  • Process maturity; and

  • Control of non-conformances.

Generic management system processes

2.10. GS-R-3 paragraph 5.1 states:

The processes of the management system that are needed to achieve the goals, provide the means to meet all requirements and deliver the products of the organization shall be identified, and their development shall be planned, implemented, assessed and continually improved.

2.11. GS-G-3.1, Ref. [5] and GS-G-3.5, Ref. [6] describe the generic management system processes to be included in I&C development.

2.12. This section supplements the guidance of these documents for the generic life cycle activities.

Configuration management

2.13. GS-R-3 paragraphs 5.12 thru 5.22 state:

Documents shall be controlled. …It shall be ensured that document users are aware of and use appropriate and correct documents. …

Changes to documents shall be reviewed and recorded and shall be subject to the same level of approval as the documents themselves. …

Controls shall be used to ensure that products do not bypass the required verification activities. …

Products shall be identified to ensure their proper use. Where traceability is a requirement, the organization shall control and record the unique identification of the product.

2.14. In GS-R-3, Ref. [4] these topics are discussed under the heading of control of documents, control of products, and control of records. For engineering activities the control of documents and products is more commonly grouped under the heading of configuration management. The GS-R-3 requirements for control of records also apply to documents under configuration management, although some records may be controlled under a records management system that is separate from the configuration management system. GS-G-3.1, Ref. [5] and GS-G-3.5, Ref. [6] provide additional recommendations on these four topics. IAEA TECDOC-1335 [25] provides a detailed discussion of configuration management.

2.15. All I&c configuration items and their associated configuration documents should be designated, given a unique identification, and placed under configuration control.

2.16. Configuration items are usually the deliverable and separately installed items of a system, the documents that define these items, and the tools that might affect the quality of the installed items. Configuration items for I&C systems include developed items, reused items, and procured items. Configuration items typically include, for example:

  • Hardware components, and replaceable elements of such components;

  • Development documents such as: specifications, design documents, fabrication drawings and instructions, installation drawings and instructions, and software and HDL code listings;

  • Software and HDL code that is installed in plant components, including applications software, operating systems, and support software;

  • Software compilers;

  • Equipment configuration data and configuration files for computer-based systems;

  • Physical tools and software tools that are used to produce, control, configure, verify or validate I&C components, including parameter settings used when employing these tools.

2.17. Configuration control should include techniques and procedures for analyzing the impact of changes, for ensuring versions are combined correctly, and for establishing and maintaining a chronological record (e.g., what versions of tools are used at a particular point in design).

2.18. Configuration item identification should include the revision level.

2.19. The configuration item identification should be used to verify that items are installed in the correct physical and topological location and that correct software is installed in the correct hardware component.

2.20. The identity of software configuration items installed in I&C components and the values of configuration data should retrievable from the hardware item.

2.21. The ability to retrieve the identity of installed configuration items and the values of configuration data support verification that the devices are properly configured. This verification may be supported by automatic checking features or tools.

2.22. The identity of installed software and the values of configuration data might be retrieved, for example, by using software maintenance tools.

2.23. Records of relevant information should be maintained for each configuration item.

2.24. Information to be recorded might include, for example, when the configuration item was completed, what changes were incorporated in the various versions, the dependencies on other configuration items, the item’s current approval status, and the persons responsible for creating, reviewing and approving it.

2.25. Detailed control over each individual unit of configuration data, of software modules of the software build and of HDL code should be maintained after verification and throughout operation.

2.26. The use of software tools for version control is encouraged.

2.27. Life cycle process documents should be under configuration management.

2.28. The configuration management program for life cycle documents may be different from that used for I&C configuration items.

2.29. Life cycle documents that must be under control include, for example:

  • Plans for life cycle phases;

  • Procedures for life cycle activities;

  • Analysis documents;

  • Records of verification and validation activities;

  • Test specifications, procedures, plans, and results; and

  • Process review and audit documents

Consideration of risk insights

2.30. SSR 2/1 paragraph 5.76 states:

The design shall take due account of the probabilistic safety analysis of the plant for all modes of operation and all plant states, including shutdown, with reference in particular to:

(1) Establishing that a balanced design has been achieved such that no particular feature or postulated initiating event makes a disproportionately large or significantly uncertain contribution to the overall risks, and that, to the extent practicable, the levels of defense in depth are independent;

(2) Providing assurance that small deviations in plant parameters that could give rise to large variations in plant conditions (‘cliff edge effects’) will be prevented;

(3) Comparing the results of the analysis with the acceptance criteria for risk where these have been specified.

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