CSA N286.7:26

N/A
Preface This is the fourth edition of CSA N286.7, Quality assurance of analytical, scientific, and design computer programs . It supersedes the previous editions published in 2016, 1999, and 1994. The major changes to this edition include • updated definitions for alignment with CSA common definitions and CNSC REGDOC-3.6; • clarified error reporting requirements; • clarified expectations in use of the graded approach; • additional identification of alternative validation methods; • reformatted acquisitions section for improved structure; and • added clause titles at all levels for the purposes of accessibility. This Standard identifies the quality assurance requirements to support the management system for high energy reactor facilities (see Clause 7.1 of CSA N286) where analytical tools are utilized in the life cycle of nuclear facilities. The CSA N-Series of Standards provide an interlinked set of requirements for the management of nuclear facilities and activities. CSA N286 provides overall direction to management to develop and implement sound management practices and controls, while the other CSA nuclear Standards provide technical requirements and guidance that support the management system. This Standard works in harmony with CSA N286 and does not duplicate the generic requirements of CSA N286; however, it might provide more specific direction for those requirements. The Canadian nuclear industry has recognized the need to establish rigorous and effective requirements for application of quality assurance process to computer programs. In 1999, CSA had issued the CSA N286.7 Standard that specifies requirements for analytical tools used to design, analyze, or support safety related systems of the nuclear power plants, replacing the draft issued in 1994. CSA N286.7-99 contained high-level requirements that need interpretation or clarification in order to be implemented. This resulted in the development of the CSA N286.7.1 guidance document having a main purpose to assist practitioners within management organizations in the preparation and implementation of software quality assurance process in compliance with CSA N286.7-99. This Standard amalgamates the CSA N286.7.1 guidance document, Guideline for the application of N286.7, within the body of the Standard. As such, the CSA N286.7.1 Standard will not be maintained. During the preparation of this Standard, stakeholders recognized two distinct areas of related activity, and this Standard has been organized to reflect this: • design, development, and maintenance of analytical software; and • acquisition, qualification, control, and use of analytical software tools within the overall management system. Users of this Standard are reminded that the site selection, design, manufacture, construction, installation, commissioning, operation, and decommissioning of nuclear facilities in Canada are subject to the Nuclear Safety and Control Act and its Regulations. The Canadian Nuclear Safety Commission might impose additional requirements to those specified in this Standard. CSA Group acknowledges that the development of this Standard was made possible, in part, by the financial support of Bruce Power, Ontario Power Generation, Canadian Nuclear Safety Commission, New Brunswick Power, Canadian Nuclear Laboratories, Candu Energy Inc. – an AtkinsRéalis Company, BWXT Canada, Cameco Corporation, Kinectrics, Orano Canada Inc., Nuclear Waste Management Organization (NWMO), AECOM, Calian, Framatome Canada Ltd., GE Vernova-Hitachi, Tetra Tech, Westinghouse Electric Canada, and AECL. This Standard was prepared by the Subcommittee on Quality Assurance of Analytical, Scientific, and Design Computer Programs under the jurisdiction of the Technical Committee on Management Systems for Nuclear Facilities and the Strategic Steering Committee on Nuclear Standards, and has been formally approved by the Technical Committee. Scope 1.1 General 1.1.1 Software This Standard addresses quality assurance requirements for software used as tools in design, safety analysis, and supporting activities. 1.1.2 Structure The quality assurance requirements for software used to perform or support the activities are described in this Standard. This Standard recognizes that the scope has two parts and has been organized to reflect this: a) design, development, and maintenance of software; and b) acquisition, qualification, control, and use of software. 1.1.3 Purpose 1.1.3.1 Types of software This Standard specifies the requirements for the quality assurance program applicable to the design, development, maintenance, modification, acquisition, and use of analytical, scientific, and design computer programs that are used in high energy reactor applications. Note: High energy reactor is as defined in CSA N286. Such computer programs are used by or for the business to perform or support a) design and analysis of equipment, systems, structures, and components that impact safety, as identified by management; b) deterministic and probabilistic safety analyses and operational reliability studies; c) reactor physics and fuel management calculations; and d) transfer of data between computer programs or pre- or post-processing calculations associated with Items a), b), and c) of Clause 1.1.3.1. 1.1.3.2 Applicable software This Standard applies to the following: a) in-house developed computer programs (i.e., software developed within the business); b) third-party computer programs (i.e., software developed by a supplier); c) legacy software; and d) programmed applications (e.g., scripts, macros, and spreadsheet-based analysis) written within software normally excluded from this Standard. 1.2 Computer programs and software excluded from this Standard This Standard does not apply to computer programs such as a) those used to control plant safety systems and operational control systems; Note: See CSA N290.14 for examples of safety and operational control systems. b) embedded software contained within items, where the software is qualified along with the item as a unit (e.g., measurement and test equipment); c) software used to collect or present design inputs (e.g., data acquisition systems and computer-aided design programs); d) business software (e.g., work management, productivity tools, commercially available databases, and spreadsheet programs); e) software used to manage information (e.g., records management software); f) commercially available compilers, interpreters, and operating systems; and g) commercially available mathematical routine libraries. 1.3 Simple software Simple software may be excluded from the requirements of this Standard with the exception of Clause 12.1on general requirements for selection of use. 1.4 Interpretation and application of results Interpretation or application of computer program results in design and analysis activities is outside the scope of this Standard. 1.5 Graded manner All of the requirements of this Standard may be applied in a graded manner commensurate with risk as described in Clause 5. 1.6 Terminology In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the Standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (nonmandatory) to define their application.