CSA N299.3:19 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 F on risk evaluation for changes and impacts); and c) provide customer access to the applicable premises or working areas, including those of the subsuppliers, for the purpose of surveillance, AHJ requirement verification, and audit. Notes: 1) Customer representatives may perform evaluations, surveillance, and audits 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 manuals.
4.2 Customer’s responsibilities Customers shall a) evaluate and select suppliers based on their ability to meet specified requirements by the time the work starts, which shall include an evaluation of i) the QA manual (or for Category 4, QA program description) and associated documentation; ii) the QA program implementation (for CSA N299 Category 1, 2, 3, or equivalent), including the supplier’s procurement process; iii) the ability to provide a technically adequate and economical item or service; iv) the ability to respect delivery dates; v) other required locations, plan(s), and resources; and vi) the supply performance history; Notes: 1) Evidence of conformance to this Standard by a recognized authority should be considered to fulfill this responsibility. 2) The frequency of the supplier evaluations depends on the results of previous supplier monitoring activity, the effectiveness of QA programs, and the response received to requests for corrective action. This can be determined by evaluating QA program performance, item or service conformance, and the accuracy of records generated by the QA programs. b) specify the following items: i) the scope of and requirements for the work; ii) the QA program standards and specifications the supplier is required to meet, as well as any specific ones to be included in subcontracts; iii) the QA program standards and specifications that apply to customer-supplied items or services; iv) traceability in accordance with Clause 7.11; v) the requirements of the AHJ that apply to the items or services; vi) documentation to be delivered to the customer and retained by the supplier, as well as the applicable retention period; and vii) experience applicable to the item or service (see Clause 4.7); Note: Typically, these items are found in the tender and contract. c) carry out surveillance and audits, when required, to ensure that the supplier and, where applicable, the subsupplier(s) are conforming to this Standard;
4.3.2.2 When conditions adverse to quality are identified, the management representative is responsible for ensuring that a) nonconforming items or services are dispositioned; b) corrections of nonconforming items and services are confirmed; and c) further processing, delivery, or installation of a nonconforming item or service is controlled until a disposition has been obtained internally or when required from the customer. 4.4 Independent verification Unless otherwise agreed to in writing by the customer, the supplier shall assign personnel to perform independent verification of characteristics for acceptance. Such personnel shall meet the following requirements: a) did not perform the work to be verified; and b) did not supervise directly the work to be verified. Verification of design activities shall be performed in accordance with Clause 7.4.10. Note: Personnel that do not meet the requirements of this Clause may perform additional checks (e.g., machine set-up, intermediate measurements). 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.CSA N299.3:19 pdf download.
