CSA N299.4:19 pdf download – Quality assurance program requirements for the supply of items and services for nuclear power plants, Category.
4 General requirements 4.1 General The supplier shall a) document, implement, and maintain a QA program in accordance with the requirements of this Standard; b) inform the customer as early as reasonably possible of any significant item or service performance risks, or changes to the QA program or the organizational structure that could impact the conditions under which the supplier acceptance was granted (see Annex D on risk evaluation for changes and impacts); c) upon request, submit the currently implemented QA documentation to the customer for evaluation; and d) provide customer access to the applicable premises or working areas, including those of the subsuppliers, for the purpose of surveillance. Notes: 1) Customer representatives may perform evaluations and surveillance at buildings or premises where the customer’s work is being performed. This right of access may extend to all subsuppliers in the supply chain such as agents, distributors, item manufacturers, and assembly and test facilities. 2) The right of access includes the right to review items and services, documents, records, and descriptions pertaining to the customer’s work. However, suppliers have the right to refuse access to unrelated work being done for other customers, and to refuse access to items, services, or audits where their QA program is not applicable, as long as this is not in contradiction with the information contained in their QA documentation.
4.3 Management responsibilities 4.3.1 The supplier shall a) appoint a representative authorized to resolve quality matters; and b) define the representative’s authority and responsibility for establishing, implementing, maintaining, and ensuring the effective execution of activities subject to this Standard. Note: The management representative should be the supplier’s primary contact with customers on quality matters. 4.3.2 When conditions adverse to quality are identified, the management representative is responsible to ensure that a) nonconforming items or services are identified, recorded, dispositioned, and corrected; and b) nonconforming items or services are controlled until a disposition has been obtained and implemented. 4.4 Independent verification Unless otherwise agreed to in writing by the customer, the supplier shall assign personnel to perform the verification other than those performing the work being verified. This shall not preclude such personnel from reporting directly to immediate supervisors responsible for performing the work. 4.5 Software 4.5.1 Software employed in work methods or tools Software employed in work methods or tools shall be a) documented and approved; b) placed under configuration control; and c) verified or validated, as appropriate.
4.5.2 Embedded software
Software that forms part of or is incorporated into items or services shall be subject to performance
testing and final acceptance in accordance with this Standard. When known, the customer shall be
promptly notified that an item to be supplied includes embedded software.
4.5.3 Design analysis software
Design analysis software activities shall not be applicable to a Category 4 QA program.
4.6 Safety culture
Safety culture requirements are not applicable to a Category 4 QA program.
4.7 Use of experience
Use of experience requirements are not applicable to a Category 4 QA program.
4.8 Counterfeit, fraudulent, and suspect items (CFSIs)
The supplier shall develop and implement a process for the detection and prevention of CFSIs to ensure
that genuine parts and services, duly tested and verified to meet specified requirements, are provided.
The process shall include the
a) ability to identify the origin of the primary source of the item(s), when specified by the customer;
and
b) identification of CFSIs. Items identified as CFSIs shall be reported to the customer, and then processed in accordance with Clause 7.17.
Note: For additional guidance on CFSIs, see Annex C.CSA N299.4:19 pdf download.
